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... EFFECT OF OCCUPATIONAL THERAPY IN PROMOTING MEDICATION ADHERENCE IN PRIMARY CARE: A RANDOMIZED CONTROL TRIAL Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Traci A. Garrison, MSOT, OTR/L Copyright July 23, 2019 By: Traci A. Garrison, MSOT, OTR/L All rights reserved Approved by: Elizabeth S. Moore, PhD Committee Chair Jaclyn K. Schwartz, PhD, OTR/L Committee Member Todd E. Daniel, PhD Committee Member Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program University of Indianapolis Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis Running head: OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE Effect of Occupational Therapy in Promoting Medication Adherence in Primary Care: A Randomized Control Trial Traci Garrison University of Indianapolis 1 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 2 Abstract Hypertension (HTN) and type 2 diabetes mellitus (T2DM) are common chronic diseases addressed in primary care settings (Wang et al., 2018). Poor medication adherence creates inferior outcomes in both populations (Doggrell, 2010; Stewart et al., 2014). This randomized controlled trial using a pretest-posttest control group design examined whether the addition of an occupational therapy intervention to usual care by a clinical pharmacist compared to usual care alone affected medication adherence rates among adults with uncontrolled HTN and/or T2DM. Twenty-nine participants were recruited from a primary care clinic after being referred to the clinical pharmacist to improve HTN or T2DM management. Data from the seven-item Adherence to Refills and Medication Scale (ARMS-7), stages of change measure, pill count, blood pressure and/or hemoglobin A1c were collected. Both groups were found to be similar across all demographic characteristics. The proportion of adherent participants (as measured by the ARMS-7, blood pressure, and pill count) increased in both groups but between groups changes were not statistically significant. A post hoc comparison of mixed ANOVA results for ARMS-7 measurements indicated that the occupational therapy intervention was having a unique effect as compared to the control. Effect scores for pill count (d = .55) also suggested that the occupational therapy intervention was positively affecting adherence. While analyses of blood pressure and A1c values were limited by missing data points, both groups demonstrated improvement in these areas. Occupational therapists can be utilized to positively influence medication adherence in a primary care setting. Keywords: hypertension, diabetes, adherence, occupational therapy OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 3 Acknowledgements The finalization of this paper was only possible by the generous and consistent support of many people. My greatest thanks are extended to my husband, Tim, and children, Silas, Luke, and Selah, who have continually offered patience and understanding over the last five years. They have continually adjusted their own calendars, wants, and needs so that I could complete my doctoral work. They have without complaint encouraged, supported, and lifted me so that I could finish. I also thank my parents who provided everything from practical everyday help to extraordinary and unexpected support. I truly would not and could not have pursued this degree if it had not been for the wholehearted support of my family. This degree belongs to them as much as it does to me. I also extend my great thanks to my research committee, Dr. Elizabeth Moore, Dr. Jaclyn Schwartz, and Dr. Todd Daniel. Each member offered steady guidance, refinement, and encouragement. The roller coaster of emotions and challenges that accompanies research often goes without acknowledgement. Thank you for keeping me on the right track both propelling me forward and slowing me down as needed. Your willingness to readily share your wisdom and expertise, despite the inconveniences I am sure it created, did not go without notice. I am also thankful for my colleagues at Missouri State University Dr. Sapna Chakraborty, Dr. Tara Boehne, Dr. Ashlea Cardin, Dr. Marc Willey, and Erin Snider who have walked each step of this degree with me. They have provided grace upon grace when work demands and school demands collided. I will forever be grateful for your kindnesses and words of encouragement. I am also grateful to Dr. Lisa Cillessen and other colleagues at Jordan Valley Community Health Center who embraced my research and patiently allowed me to take over any extra corner of space in order to provide occupational therapy services to their clients. I also thank the many dear friends who consistently checked on my progress and prayed for everything from recruitment to statistics. Lastly, I thank the new colleagues and friends that I gained along the way through my studies at the University of Indianapolis. I am a better clinician and researcher because of our collaboration. Thank you for ensuring that I knew I was never alone in the journey. I consider myself undeservedly blessed by each of these individuals. I simply could not have arrived at this point without each support that was lent to me. I will strive to offer the same support to each of you in your future endeavors. With deepest gratitude, Traci A. Garrison July 15, 2019 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 4 Table of Contents Abstract ........................................................................................................................................... 2 Acknowledgements ......................................................................................................................... 3 Literature Review.......................................................................................................................... 11 Medication Adherence .............................................................................................................. 15 Measurement. ........................................................................................................................ 15 Factors influencing adherence. .............................................................................................. 16 Interventions. ......................................................................................................................... 17 Significance of the study ........................................................................................................... 21 Method .......................................................................................................................................... 22 Study Design ............................................................................................................................. 22 Participant Selection.................................................................................................................. 23 Instrumentation.......................................................................................................................... 24 Adherence to Refills and Medication Scale. ......................................................................... 24 Stages of Change Measure. ................................................................................................... 24 Pill count. ............................................................................................................................... 24 Blood pressure. ...................................................................................................................... 25 Hemoglobin A1c.................................................................................................................... 25 Charlson Age-Comorbidity Index ......................................................................................... 26 Procedures ................................................................................................................................. 26 Recruitment and informed consent. ....................................................................................... 26 Group assignment (randomization). ...................................................................................... 26 Data collection. ...................................................................................................................... 27 Intervention. ........................................................................................................................... 28 Data Screening and Analysis..................................................................................................... 29 Results ........................................................................................................................................... 29 Participant Characteristics ......................................................................................................... 29 Gender Distribution ................................................................................................................... 30 Age Distribution ........................................................................................................................ 30 Ethnicity .................................................................................................................................... 30 Number of Medications ............................................................................................................. 31 In-Home Assistance .................................................................................................................. 31 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 5 Number of Documented Comorbidities .................................................................................... 32 Charlson Age-Comorbidity Index (CACI) Scores .................................................................... 32 Differences Between Groups .................................................................................................... 32 Adherence as measured by the ARMS-7 ............................................................................... 32 Adherence as measured by pill count. ................................................................................... 33 Adherence as measured by blood pressure. ........................................................................... 34 Adherence as measured by hemoglobin A1c. ....................................................................... 35 Readiness for change as measured by the stages of change measure .................................... 35 Demographic influence on adherence. .................................................................................. 36 Discussion ..................................................................................................................................... 36 Conclusion .................................................................................................................................... 44 References ..................................................................................................................................... 45 Appendices .................................................................................................................................... 67 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 6 List of Tables Table 1 Demographic Statistics for Participants ....................................................................... 59 Table 2 Demographic Statistics of Variables............................................................................ 60 Table 3 Demographic Statistics for MAP ................................................................................. 61 Table 4 Stages of Change Descriptive Statistics....................................................................... 62 Table 5 Demographic Correlation Results ................................................................................ 63 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 7 List of Figures Figure 1 ARMS-7 Line Chart ................................................................................................... 65 Figure 2 MAP difference between groups ................................................................................ 66 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 8 Effect of Occupational Therapy in Promoting Medication Adherence in Primary Care: A Randomized Control Trial The commonly stated goal of primary care is to address health needs in a holistic manner across the lifespan (World Health Organization [WHO], 2019). The primary care model includes prevention, wellness, and treatments for both acute and chronic illnesses (Client Protection and Affordable Care Act, 2010). Recent estimates state that approximately 133 million Americans live with a chronic disease, and over one-quarter of the United States population lives with multiple chronic diseases (National Health Council [NHC], 2014; U.S. Department of Health and Human Services, 2010). Individuals with chronic disease have higher rates of disability, lower levels of independence, an increased burden of care, and lower quality of life scores (Bobitt, Aguayo, Payne, Jansen, & Schwingel, 2019). It is estimated that 75-95% of all healthcare costs in the United States are due to chronic conditions (Centers for Disease Control and Prevention, 2013; NHC, 2014). Chronic disease management can create many challenges for the client and healthcare team. Recent findings show that these issues are best served by a client-centered and strong interprofessional approach (Bobitt et al., 2019; Gorina, Limonero, & lvarez, 2019). The WHO has recently focused on four main chronic diseases categories. These include cancers, chronic respiratory disease, cardiovascular disease, and diabetes (WHO, 2018a). Hypertension (HTN) earned specific focus by the WHO (2018a) within the category of cardiovascular disease, as it has been declared a global public health crisis due to its devastating contributions to heart disease, stroke, and kidney failure (WHO, 2013). Type 2 diabetes (T2DM) was also highlighted as an area of concern due to its growing numbers on the global stage, its concomitant mortality and morbidity, and associated rising healthcare costs (Danaei et al., 2011; WHO, 2018a). OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 9 In the United States alone, 75 million individuals are defined as hypertensive, and this number is expected to rise (Merai et al., 2016; Reboussin et al., 2017). While HTN is predictive of the development of disease and disability, it can be managed through lifestyle changes and medication (Will et al., 2016). Unfortunately, approximately half of all individuals who are prescribed antihypertensive medications do not take them correctly, resulting in uncontrolled HTN, subsequent poor health outcomes, and increased societal costs (Stewart et al., 2014; WHO, 2003; Will et al., 2016). While many studies have examined various approaches to address adherence, no single method has been identified as successful (Geboers et al., 2015; Nieuwlaat et al., 2014). Similar to HTN, type 2 diabetes also demonstrates increasing numbers; they have risen from 108 million in 1980 to 422 million in 2014 (WHO, 2018b). It is also known to be the primary cause of blindness, kidney failure, heart attacks, stroke, and lower limb amputation (WHO, 2018b). It is also a multifaceted disease that often requires significant lifestyle change and management of several medications to achieve optimal health outcomes (Bailey & Kodack, 2011). Unlike many chronic conditions, the client with T2DM has a variety of treatment options available. Despite the variety of options, roughly only half of clients with T2DM achieve optimal blood glucose levels, and two-thirds of clients with T2DM die from subsequently developed cardiovascular disease (Bailey & Kodack, 2011). Like HTN, poor medication adherence is one of the primary factors creating inferior outcomes in the T2DM population (Doggrell, 2010). Better adherence to prescribed medication schedules has been shown to improve glycemic control and decrease the physical and financial costs of the disease, including the reduction of hospital readmission rates (Doggrell, 2010; Jiang et al., 2016). OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 10 Occupational therapists are uniquely suited to assess and address the wide variety of factors that influence a clients willingness and ability to adhere to a prescribed medication regimen. Specifically, practitioners are equipped to assess and treat issues related to cognition, neuromuscular control, and integrating medications into clients daily routines (American Occupational Therapy Association [AOTA], 2014). Additionally, the practitioner can address deficits that result from the disease process, such as memory difficulties, or side effects from the medications, such as tremors (AOTA, 2017). Research, while limited, supports the occupational therapists role in addressing medication management and adherence (Schwartz & Smith, 2016). The Integrative Medication Self-Management Intervention (IMedS) is an occupational therapy intervention recently designed to improve client adherence to medications. The IMedS has been tested in a randomized Phase I feasibility study. This feasibility study found that medication adherence could be influenced by the IMedS (Schwartz & Smith, 2016). A qualitative analysis of the use of the IMedS also showed that the intervention facilitated new medication habits and routines (Schwartz et al., 2017). The efficacy of the IMedS needs to be studied with a larger sample size to better understand its ability to improve medication adherence. The purpose of this study was to determine whether the addition of the IMedS to usual care, as compared to usual care alone, would affect medication adherence rates among community-dwelling adults with HTN and/or T2DM. To meet this purpose, this study addressed the following objectives: 1) to determine if the addition of the delivery of the IMedS by an occupational therapist to usual care improves medication adherence rates, as measured by the Adherence to OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 11 Refills and Medication Scale (ARMS-7), pill count, and blood pressure and/or hemoglobin A1c; 2) to determine whether the administration of the IMedS in addition to usual care influences an individuals readiness for change as measured by the stages of change measure; and 3) to explore whether participant demographics (e.g., gender, age, ethnicity, assist at home, comorbidities, and number of medications) influence medication adherence rates. Findings from this study provide insights into the role of the occupational therapist addressing medication adherence in a primary care population, information for the continued refinement of the use of the stages of change measure to medication adherence, and further the data available related to the relationships between participant characteristics and adherence. Expanded understanding of these topics better enables the healthcare team to increase adherence with the goals of improving the health of clients with HTN and/or T2DM and reducing associated healthcare costs. Literature Review Primary healthcare can provide an ideal setting to develop self-care management skills in clients with chronic conditions (WHO, 2019). A multidisciplinary approach has been shown to be effective in improving self-care related to chronic disease management (Kuhmmer et al., 2016; WHO, 2002). Hypertension and T2DM are two chronic diseases often addressed in primary care in the United States (Nguyen, Makam, & Halm, 2016; Wang et al., 2018). Medication adherence is a key factor in improving disease management for HTN and T2DM (Doggrell, 2010; Jiang et al., 2016; Khayyat et al., 2019; Will et al., 2016). Medication OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 12 adherence has been defined as the extent to which clients take their medication as prescribed (Ho, Bryson, & Rumsfeld, 2009). Poor adherencesometimes described as non-complianceis explained as a person not following the prescribed dosage or schedule ordered by his or her medical provider (Robnett, Dionne, Jacques, LaChance, & Mailhot, 2007). Understanding these diseases, their impact on individuals and populations, and barriers and supports for adherence, affects the development of effective interventions. Hypertension or high blood pressure has been designated as a global public health issue by the WHO. Worldwide 1.56 billion individuals are projected to be diagnosed as hypertensive by 2025 (Jarari et al., 2015; WHO, 2013). Hypertension is of particular concern because of its contribution to the development of heart disease, stroke, kidney failure, early mortality and disability, and increased use of healthcare resources (Merai et al., 2016). The global rise in HTN is thought to be related to a growing aging population, unhealthy diets, sedentary lifestyles with associated weight gain, and persistent stress (WHO, 2013). Individuals have historically been considered to be hypertensive if their systolic blood pressure is 140 mm Hg, their diastolic is 90 mm Hg, or if they are prescribed medications to lower their blood pressure (Merai et al., 2016). The American College of Cardiology Foundation and the American Heart Association recently suggested that target systolic blood pressure should be adjusted to < 130 mmHg (Reboussin et al., 2017). In the United States alone, 16 million adults are being treated for HTN, an estimated 11.5 million are unaware of their HTN, and 7 million are aware but not treating the disease (Merai et al., 2016). While HTN is linked to many detrimental health outcomes, individuals often do not identify warning signs or experience symptoms. The lack of obvious symptoms often delays the initial diagnosis of HTN and OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 13 negatively influences an individuals understanding of the need for treatment (Merai et al., 2016; WHO, 2013). Evidence suggests that antihypertensive medications can reduce the risk of the negative health outcomes associated with HTN (James et al., 2014). Unfortunately, previous research has found that half of individuals stop taking their antihypertensive medications within one year of initial prescription (Vrijens, Vincze, Kristanto, Urquhart, & Burnier, 2008). The American Medical Association provides guidelines for prescribing antihypertensive medications from four different drug classes. These guidelines also note that more than one antihypertensive drug is often required to achieve blood pressure control (James et al., 2014). As the number of medications increases, so does the difficulty of correctly managing and affording all medications. When clients require multiple medicationsoften known as polypharmacymedication rates decrease (Tajeu et al., 2016). While polypharmacy is a challenge, the benefits of multiple medications can often outweigh the drawbacks. The answer is not always to reduce the number of medications, but to find ways to better manage the medications (Munger, 2010; Vrettos, Voukelatou, Katsoras, Theotoka, & Kalliakmanis, 2017). Though chronic diseases present significant challenges to both the individual and the healthcare system at large, many chronic diseases can be prevented or managed by improving self-care skills (Lorig et al., 1999). In addition to blood pressure medications, individuals with HTN are often instructed to make lifestyle changes related to diet and exercise. One large randomized trial found that adjusting diet and exercise, along with proper medication use, yielded the best outcomes for blood pressure control (Appel et al., 2003). A systematic qualitative review of adherence studies revealed a more complex picture that identified consistent challenges to adequately studying and understanding adherence issues related to diet, OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 14 exercise, and medication management, as well as the interaction of these self-management behaviors (Jin, Sklar, Min Sen Oh, & Chuen Li, 2008). While improving diet, exercising, and taking prescribed medications is expected to reduce blood pressure, many people with HTN find it difficult to adjust longstanding eating and activity habits. Coupling these changes with new medication routines further increases the demand on individuals to make more extensive changes to daily habits and routines (McDonald, Blackwell, & Meurer, 2006). Similar to HTN, T2DM also presents as a complex disease, the treatment of which often involves the management of a multitude of self-care behaviors. As the number of individuals with T2DM has risen, so has a myriad of treatment choices; protocols, guidelines, and algorithms related to diabetes medications have been established to meet a range of client needs under diverse circumstances (Bailey & Kodack, 2011). The chronic nature of T2DM and demands of managing self-care behaviors, including diet, activity level, blood sugar testing, and multiple medications, makes achieving optimal glycemic control a test of discipline for every client and an educational challenge for the healthcare team. The complexity of options and demanding nature of these diseases requires individuals to alter both dietary and daily habits in order to adhere to the medical providers recommended course of action for managing the disease (McDonald et al., 2006; Sontakke, Jadhav, Pimpalkhute, Jaiswal, & Bajait, 2015). Osborn, Mayberry, and Kim (2016) examined the roles of these self-care behaviors and found medication adherence to be the only statistically significant self-care behavior to improve glycemic control in clients with T2DM and low socioeconomic status. While pharmacists and medical providers are often experts in developing optimal plans for disease management, the clients understanding and adoption of appropriate self-care behaviors are critical links to successful adherence (Gorina et al., 2019; Tajeu et al., 2016). Osborn et al. (2016) concluded that a key element to achieving OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 15 successful medication management is defining a process that creates supports and removes barriers for individuals to correctly manage their medications. Medication Adherence Medication adherence is the extent to which clients take their medication as prescribed (Ho et al., 2009), while poor adherence is when a person does not follow the prescribed treatment ordered by the medical provider (Robnett et al., 2007). The topic of medication adherence has also been studied under the term compliance, but adherence has become the preferred term secondary to the passivity implied by the term compliance. Medication adherence infers a cooperative alliance between the provider and the client (Osterberg & Blaschke, 2005). Measurement. Previous studies measured adherence via a variety of direct and indirect approaches (Lam & Fresco, 2015). Direct measures include measurements of the drug in blood or urine and observation of an individual taking the medication. While direct measures theoretically increase measurement objectivity, the metabolization of the drug may affect measurement accuracy. Additionally, direct measurements are often intrusive and expensive (Osterberg & Blashke, 2005). Indirect measures include measures related to refills (medication possession ratios or proportion of days covered), pill counts, electronic medication packaging devices, self-report measures in the form of questionnaires or interviews, and comparison of blood pressure readings or hemoglobin A1c (HbA1c) measurements (Lam & Fresco, 2015; Nieuwlaat et al., 2014; Stewart et al., 2014). Indirect measures also have their limitations and strengths (Lam & Fresco, 2015). Indirect measures of refills are readily available from database reviews but offer no guarantee that medications are being taken correctly (Osterberg & Blashke, 2005). Counting the number of pills that are present at consecutive appointments offers a cost-efficient and simple OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 16 method that has been shown to have high accuracy. Counting pills may be inaccurate when clients stockpile surplus medications or when medications have been misplaced. Pill counting also does not confirm whether the pills removed from the bottle were taken as prescribed (Lam & Fresco, 2015; Osterberg & Blashke, 2005). Electronic dispensing devices have been demonstrated to be accurate, but they are expensive and often too heavy to travel with an individual (Lam & Fresco, 2015). While self-report measures are inexpensive, easily administered, have high clinical utility, and have been found to provide reasonably accurate estimates of adherence, there are always the concerns that come with the subjective analysis of ones own performance (Lam & Fresco, 2015; Nguyen, La Caze, & Cottrell, 2014; Osterberg & Blashke, 2005). Factors influencing adherence. Methods of medication adherence assessment have been widely used to identify factors that influence adherence. Due to the interactive complexity of the factors known to influence adherence, the factors have been divided into (a) client, (b) provider, and (c) health system (Hugtenburg, Timmers, Elders, Vervloet, & van Dijk, 2013; Neiman et al., 2017). Client factors have been further subdivided into intentional (e.g., active decision to not take the medication because of beliefs, side effects, cost, etc.) and unintentional factors (e.g., forgetting to take the medication, misunderstanding the instructions, etc.) (Ho et al., 2009; Neiman et al., 2017). A large survey (N = 24,000) found that approximately 30% of participants were intentionally non-adherent, leaving the majority of reasons in the unintentional category (Gadkari & McHorney, 2012). Provider factors refer to the complex dosing of medications and lack of communication between the client and provider and between prescribing providers (Neiman et al., 2017). Healthcare system factors include a lack of access to care, limited clientcentered education materials, and prohibitive financial cost (Neiman et al., 2017). OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 17 Individual client characteristics have also been studied to determine if they have an influence on adherence. Studies have linked adherence to education level, age, gender, race or ethnicity (Holmes et al., 2012), socioeconomic status (Kripalani et al., 2015), comorbidities (Rolnick, Pawloski, Hedblom, Asche, & Bruzek, 2013), number of medications (Holmes et al., 2012f), and number of unique providers (Holmes et al., 2012). Whittle et al. (2016) concluded that many of these studies were flawed in their methods and have low generalizability. These authors found in their own large randomized control trial of hypertensive therapies that while client characteristics can be significantly associated with adherence, the association does not fully explain adherence and should be thoughtfully examined when used to inform future efforts to improve adherence (Whittle et al., 2016). Though demographics are often analyzed in adherence studies, Whittle et al.s (2016) conclusion agrees with previous work by DiMatteo (2004) which looked at demographic factors across multiple studies and found they had only a small effect on adherence. Interventions. The variety of identified factors influencing adherence make creating effective interventions difficult. Demands of managing self-care behaviors, including diet, activity level, and multiple medications, make achieving optimal blood pressure and glycemic control a test of discipline for every client and an educational challenge for the medical team (Alhalaiqa, Deane, & Gray, 2013; Schroeder, Fahey, & Ebrahim, 2008). Identifying an accessible process within the medical team that will create individualized supports for and remove barriers to successful medication management has also been shown to be difficult (Alhalaiqa et al., 2013; Schroeder et al., 2008). Systematic reviews related to medication adherence reveal that efforts to improve adherence in individuals with HTN and T2DM have included interventions delivered by nurses, OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 18 pharmacists, physicians, and multidisciplinary healthcare teams (Cramer, 2004; Sapkota, Brien, Greenfield, & Aslani, 2015; Schroeder et al., 2008). A systematic review of the interventions specifically used to address adherence to antihypertensive medications concluded that simplifying dosing regimens improved adherence, but not necessarily blood pressure levels (Schroeder et al., 2008). Schroeder et al. (2008) also found the use of motivational strategies and complex, multi-faceted approaches to be promising but suggested that more research was needed (Schroeder et al., 2008). A systematic review of the interventions used thus far to address T2DM adherence concluded that none consistently improved adherence across this population (Sapkota et al., 2015). A separate systematic review focusing on medication adherence across a variety of diagnoses found the most effective medication management interventions were multifaceted with frequent client interactions (Nieuwlaat et al., 2014). These complex interventions included personalized ongoing support with in-depth education and/or counseling and frequent support from allied health professionals or caregivers (Nieuwlaat et al., 2014). In a qualitative study of individuals with HTN who underwent adherence training, the researchers found that clientcentered interventions that focused on eliminating barriers to adherence and improving beliefs and attitudes toward medication ultimately improved adherence, lowered blood pressure, and reduced the risk of associated health concerns (Alhalaiqa et al., 2013). These results indicate a scripted and globally applied approach will not be effective in addressing medication adherence. A solution appears to lie in an intervention that is client-centered and addresses the specific strengths and barriers that exist within the individual, their environment, and the medication management activities required of them. Occupational therapy practitioners are well-suited for this role as they are equipped to use everyday life activities (occupations) to improve or enable participation in roles, habits, and OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 19 routines in a variety of settings (e.g. home, community, work, etc.). Occupational therapy practitioners are specifically trained to examine the activities an individual needs or wants to do, the environmental context(s) in which the occupation occurs, and the contributing personal factors required for success (e.g., body functions, values, beliefs, psychosocial functions, cognition, etc.), while also assessing the relationship that exists between all of these elements to either support or impede success (AOTA, 2014). They also promote medication adherence as they address self-care occupations and assess and intervene in specific and global aspects of the medication management process (AOTA, 2017). Medication management for the occupational therapy practitioner refers to the daily systems and processes of taking medications as prescribed (Schwartz & Smith, 2017, p. 1). These processes include interacting with prescribing providers, navigating pharmacy systems, understanding instructions for proper medication administration, and maintaining these habits over the prescribed time (AOTA, 2017). The occupational therapist is well suited to identify and address challenges in a clients medication management processes. For instance, it falls in the occupational therapy practitioners scope of practice to address cognitive deficits, such as decreased memory or problem-solving; to adjust schedules to integrate proper timing of medications into an individuals daily habits and roles; to identify community resources to support acquisition of medications; to provide environmental adaptations to enable proper medication adherence (e.g., alarms suited for the client with cognitive, visual, or hearing deficits, external and internal cue training, devices for adapting medication bottles to address coordination, sensory, or range of motion deficits, etc.); and to support occupational engagement to improve overall health and wellness (AOTA, 2014; Cole, 2011). OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 20 The occupational therapists role in primary healthcare has been developing over recent years. In 2014, the AOTA released a statement advocating for the occupational therapists position in primary care and outlining the occupational therapy practitioners roles in primary care. Included in this statement was a discussion of specific roles related to the management of chronic conditions. Medication management is highlighted as an area of intervention in primary care with specific emphasis on how the occupational therapy practitioner supports clients in achieving lifestyle modifications by incorporating medication management and other healthcare activities into the clients roles and routines (AOTA, 2014). To allow for proper implementation and assessment of outcomes, interventions benefit from a manualized approach. The IMedS is an occupational therapy manualized intervention based on theory, current occupational therapy practice, and best evidence on the topic of medication adherence (Schwartz, 2015). It consists of a three-step process that leads the client from the reflection of past performance, to goal setting, and onto strategy identification and implementation. This intervention guides the client through identifying strategies in the following six areas: altering the medication management activity, advocacy, assistive technology, environmental modifications, and securing refills on time (Schwartz et al., 2017). A Phase I study indicated promise for the effectiveness of an occupational therapy intervention being applied to issues of medication adherence and concluded that the IMedS should be further tested to support the use of evidence-based occupational therapy interventions (Schwartz & Smith, 2016). The development of the IMedS was partially informed by the transtheoretical model (Schwartz, 2015). This model has been effectively used to improve health behaviors (Werch, Ames, Moore, Thombs, & Hart, 2009). Also known as the stages-of-change model, the OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 21 transtheoretical model defines five linear stages that a client progresses through during behavior change: precontemplation, contemplation, preparation, action, and maintenance (Prochaska, DiClemente, & Norcross, 1993). The application of the transtheoretical model or stages-ofchange model to medication adherence in a hypertensive population has previously shown that behavior change interventions should be aligned with the individuals current stage of change in order to improve effectiveness but no known research has examined how an intervention influences individual progression through the stages (Chang, McAlister, Taylor, & Chan, 2003; Willey et al., 2000). Research has recently found that a persons self-identified position along the stages of change continuum is predictive of adherence in a T2DM population (Arafat et al., 2019). Significance of the study To this point, limited research has been conducted regarding the occupational therapy practitioners role and effectiveness in the medication management process. Yuen (1993) and Sanders and Van Oss (2013) assert that occupational therapy practitioners are well-positioned to utilize their understanding of addressing performance deficits and developing daily routines to promote medication adherence. Fricke and Unsworth (2001) found that clients and practitioners alike identified maintaining the ability to manage medications as a high priority for supporting independent community living. Schwartz and Smith (2016) provided more objective information in their randomized, feasibility study of whether an occupational therapy-specific intervention could help individuals with chronic health conditions improve their medication adherence. The conclusions of this Phase I study were that occupational therapy practitioners can positively influence adherence and that further research is needed (Schwartz & Smith, 2016). The subsequent qualitative analysis of this Phase I study found that the occupational therapy OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 22 intervention group participants reported greater improvements in medication adherence and to have implemented twice as many new adaptive strategies as the standard of care group (Schwartz et al., 2017). The individual, medical team, and community at-large are affected by the challenges of improving medication adherence and the real consequences of poorly managed chronic disease, as they contribute to personal, medical, and societal costs (Schroeder et al., 2008; WHO, 2013; WHO, 2016). Though the factors influencing adherence are well-documented, no clear means to improve adherence have been identified (Nieuwlaat et al., 2014). Research has demonstrated that there are a variety of viable methods available to assess adherence and client-centered interventions that allow for individualized problem solving have the potential to positively affect adherence (Nieuwlaat et al., 2014; Nguyen et al., 2014; Schroeder et al., 2008). The occupational therapy practitioner is well positioned as an established healthcare professional in the medical team to offer skilled interventions to address improving medication management (Schwartz & Smith, 2017). A better understanding of the occupational therapists role in addressing medication management assists in defining the occupational therapists role in this area on the interdisciplinary medical team, refining interventions for adherence, and the adjustment or development of future occupational therapy interventions. Method Study Design This randomized controlled trial using a pretest-posttest control group design took place from June 9, 2018, through April 30, 2019, at Jordan Valley Community Health Center (JVCHC) in Springfield, Missouri. Prior to participant recruitment, the study was approved by the Institutional Review Board (IRB) at the University of Indianapolis and reliance agreements were OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 23 ratified between Missouri State University and University of Missouri-Kansas City (UMKC). The legal department at JVCHC provided a letter of cooperation. Participant Selection A convenience sample of adults (age 18 years and older) with HTN and/or T2DM being treated at the JVCHC by the clinical pharmacist were recruited for the study until the required number of participants was achieved. The JVCHC protocol guides medical providers to consult the clinical pharmacist if clients with a hypertension diagnosis have an elevated blood pressure on two different readings for his/her specific age and diagnosis situation and/or when a clients HbA1c is > 9% or the client is newly diagnosed with T2DM. Clinic clients were considered eligible for inclusion in the study if they were 18 years or older, had a confirmed diagnosis of HTN and/or T2DM, and they provided written informed consent. Clients were excluded if they had a medical power of attorney and/or were unable to provide their own informed consent. An a priori sample size estimation was conducted using G*Power, version 3.1 (Faul, Erdfelder, Lang, & Buchner, 2009). In the absence of known means, standard deviations, or minimal clinically important difference information for the ARMS-7, it was determined to use a moderate effect size of .30 based on an assessment of a systematic review and meta-analysis examining interventions for adherence in individuals with hypertension (Conn, Ruppar, Chase, Enriquez, & Cooper, 2015). The calculation was based on using repeated measures ANOVA, within-between interaction test with two groups and two measurements and the following parameters: two-tailed test, alpha of .05, a conservative power of .95, and a moderate effect size of .30. From the calculation, it was estimated that a minimum of 32 participants were needed to detect a possible statistically significant effect. After five months of limited recruitment, clients OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 24 who otherwise met the inclusion criteria with T2DM (with or without HTN) were subsequently added to the inclusion criteria with IRB approval. Instrumentation Adherence to Refills and Medication Scale. The ARMS-7 (Appendix A) consists of seven questions that provide a self-report of medication adherence (Kripalani et al., 2015). Permission was granted by the author for the use of the ARMS-7 (Appendix E). The ARMS-7 is a reliable and validated instrument that was developed using individuals with cardiovascular disease, including hypertension. The measure requires a response to questions about medication adherence based on a four-point scale. Scores on the ARMS-7 range from 7 to 28. The instrument was designed to be flexible and, in this study, higher values will indicate better adherence (Kripalani, Risser, Gatti, & Jacobson, 2009). The ARMS has also demonstrated a higher correlation with medication refills as compared to the extensively used 4-item scale by Morisky, predictive validity with blood pressure control, and had been shown to be appropriate across literacy levels (Kripalani et al., 2009; Kripalani et al., 2015; McNaughton, Jacobson, & Kripalani, 2014). Stages of Change Measure. Participants readiness for change was measured by a singleitem measure that has demonstrated a strong correlation r = .91 with other stages of change scales that have multiple-items (Cook & Perri, 2004). This one-item measure is simple, free to use without permission, and eliminates confusion that can occur with multi-item scales (Cook & Perri, 2004) (Appendix F). Pill count. Pill count is an objective, simple, and inexpensive measurement of how many pills remain in an individuals bottle as compared to refill timing and the number that should remain (Hawkshead & Krousel-Wood, 2007). A percentage of adherence can be calculated by OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 25 dividing the number of doses taken by the number of doses that should have been taken multiplied by 100 (Hawkshead & Krousel-Wood, 2007). In a study focusing on hypertension, Hamilton (2003) found significant correlations between pill count and adherence measured by more expensive electronic monitoring systems (r = .29 .39; p < .01). Though it requires the assumption that missing pills were ingested by the intended recipient and should be combined with other measures of adherence, pill count is widely considered a gold standard for measuring adherence (Prado, Kupek, & Mion, 2007). Blood pressure. Accurate blood pressure readings are integral to assessing and monitoring hypertension. Comparison of blood pressure readings over time has been utilized as a method of assessing adherence in a population with HTN (Lam & Fresco, 2015). Use of the manual auscultatory method is regarded as the most accurate non-invasive method of measuring blood pressure as compared to automated devices (Chen, Chen, Feng, Chen, & Zheng, 2017). Significant differences have been found between manual and automated measurement devices (p = .003) particularly regarding systolic blood pressure. The guidelines for the proper administration of a manual blood pressure measurement to be used in this study are outlined in Appendix D (Pickering et al., 2005). Hemoglobin A1c. The hemoglobin A1c (HbA1c) blood test provides a value that represents a persons average blood glucose level over a 3-month period (National Institute of Diabetes and Digestive and Kidney Diseases, 2019). Research from quality assurance assessments has shown the HbA1c to test to provide a reliable result (Penttil et al., 2016). The HbA1c test is used in conjunction with other clinical correlates to both diagnose T2DM and for prognostication for complications of the disease (Sherwani, Khan, Ekhzaimy, Masood, & OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 26 Sakharkar, 2016). The HbA1c test results have been used in previous studies to evaluate medication adherence (Bailey & Kodack, 2011; Kelly et al., 2016). Charlson Age-Comorbidity Index. To better assess the impact of comorbid conditions, once all data were collected comorbidities were weighted via the validated Charlson agecomorbidity index (CACI) (Charlson, Szatrowski, Peterson, & Gold, 1994). The formula for the CACI score considers the age of the individual and ranks comorbidities based on identified risk of contributing to mortality (Charlson et al., 1994). The CACI was originally validated for individuals who had elective surgery and had either hypertension or diabetes. While the index is useful in providing information about the degree of illness an individual has the authors encourage studies with smaller numbers to also examine comorbidities and age separately (Charlson et al., 1994). These analyses were also completed for this study. Procedures Recruitment and informed consent. As the standard of care in the clinic, clients identified as having uncontrolled HTN or T2DM are given a referral to the clinical pharmacist by the participants primary care provider. At this consultation, the pharmacist confirmed the clients uncontrolled HTN and/or T2DM diagnosis via the electronic medical record (EMR) and proceed through the JVCHC protocol for HTN or diabetes. The pharmacist then informed the client about the study and inquired of his or her interest in participating in the study. If the client indicated interest, the pharmacist began the informed consent process or introduced the primary researcher (T.G.) who then completed the informed consent process. Group assignment (randomization). Participants who completed the consent process were consecutively and randomly assigned to either the TAU group or a TAU plus occupational therapy group. Group assignment was performed using sequentially numbered, identical, opaque, OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 27 sealed white envelopes. The clinical pharmacist or primary researcher selected the first envelope in the sequence and recorded the participants group assignment in the EMR and a study binder that was locked in a secure filing cabinet at JVCHC. Participants information was also deidentified at this time and given a study participant number. If the participant was assigned to the group receiving occupational therapy, the clinical pharmacist initiated a referral to occupational therapy for the participant. The primary researcher then recorded the additional demographic information and assessment information described herein on a password-secured laptop using participant identification numbers. Data collection. Once consent was received, the primary researcher collected demographic data specific to age, gender, race/ethnicity, number of prescribed medications, the availability of a caregiver to assist with medications, and diagnosed comorbidities. The comorbidities were scored via the CACI as described above. This information was transferred to a password secured electronic spreadsheet matched only to the participants study number. Medication adherence was measured by the primary researcher or the pharmacist via administration of the self-report ARMS-7 instrument during the participant recruitment process and subsequently measured via pill count and blood pressure readings and/or HbA1c levels from the EMR. The participants current stage of behavior change was assessed via the single-item stages of change measure. The primary researcher or the clinical pharmacist recorded this information within the participants EMR. The primary researcher or the clinical pharmacist collected the outcome data from all participants a minimum of two times during either the pharmacy or occupational therapy intervention sessions. Outcome measures were sought at the initial visit and at each subsequent visit. The number of visits varied based on participant need and participation (Table 2). All assessments and reassessments occurred at JVCHC. Scores were OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 28 recorded in the participants EMR. After data collection was complete, all scores were transferred to a study data collection form utilizing a participant number and no personal identifying information to allow for data analysis. This document was password protected and secured on the primary researchers password protected laptop. Intervention. If the participant was assigned to the TAU group, he/she received an intervention from the clinical pharmacist at JVCHC. This is the standard practice in the clinic. The aforementioned protocols were utilized to ensure that all members of the TAU group received a similar intervention experience. In general, the TAU process consisted of the clinical pharmacist providing education about the pathophysiology of the diagnosis, an interview related to diet, exercise, and social history related to the diagnosis, a discussion about medication adherence, and setting self-management goals related to managing the disease. The pharmacist may also adjust medications as needed. The TAU process for clients with hypertension is described in detail in Appendices B (HTN) and C (diabetes). If the participant was assigned to the occupational therapy intervention group, the intervention was guided by the IMedS. Use of motivational interviewing with a focus on health literacy were utilized throughout the IMedS intervention as participants were guided through self-identifying personal medication management goals and self-selecting personalized strategies to improve adherence. The full manual is available for review at the referenced website (Schwartz, n.d.). The occupational therapy intervention was also informed by the administration of the medication management subtask of the Performance Assessment of Self-Care Skills (PASS) (Rogers, & Holm, 1989). OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 29 Data Screening and Analysis The raw data were transferred to a password protected Excel spreadsheet by the primary researcher and reviewed for accuracy. Data analyses were completed using IBM SPSS for Windows, Version 24 (IBM Corp., Armonk, NY). Descriptive statistics were conducted, and the results were used to describe the sample and baseline characteristics of the experimental and control groups (Table 1 and Table 2). Nominal data are presented as frequency and percentage while interval and ratio data are reported as mean and standard deviation or median and interquartile range, dependent on whether the data are normally distributed. To determine if participants in both groups were similar in demographic and baseline characteristics, comparisons were conducted using Fishers exact test for nominal data and either an independent t-test or non-parametric Mann-Whitney U test for interval and ratio data, dependent on whether or not the data were normally distributed as determined by the Shapiro-Wilk test. Results Originally, 32 participants, enrolled in the study; however, three participants did not return after the initial appointment. Data for these three participants were eliminated from analysis, leaving a total sample size of 29. Due to randomness in the assignment to groups, there were 12 participants in the control group and 17 participants in the experimental group. Participant Characteristics The final sample size of 29 participants was nearly equally divided between male (51.7%) and female (48.3%). The sample included four ethnic groups with the large majority being Caucasian (75.9%). The mean age for the total sample was 51.59 years (SD = 10.08). Further details regarding demographic characteristics are found in Tables 1 and 2. As previously OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 30 described, the experimental and control groups were found to be similar across all demographic characteristics. Gender Distribution Gender distribution varied somewhat between the groups. The control group was 66.7% (n = 8) male, but the experimental group was 41.2% male (n = 7). A Fishers exact test was performed to evaluate whether there was an association between group and gender and to test for potential gender differences between groups. There was no statistically significant association between group and gender as assessed by Fishers exact test, two-sided, p = .264. Gender was therefore assumed to be equally distributed between groups. Further demographic details can be found in Table 1. Age Distribution An independent-samples t-test was then performed to test for equivalencies in age between the control group and the experimental groups. There were no outliers in the data, as assessed by inspection of a boxplot. Age for each level of group was normally distributed, as assessed by Shapiro-Wilks test (p > .05), and the assumption of homogeneity of variances was met, as assessed by Levenes test for equality of variances (p = .105). Results revealed no significant differences in age between the experimental group (M = 52.00, SE = 2.81) and the control group (M = 51.00, SE = 2.30), t(27) = 0.26, p = .798 (Table 2). Age was assumed to be equivalent between the experimental and control groups. Ethnicity The sample contained four self-defined ethnic groups with Caucasian being the largest (75.9%). A chi-square analysis was not able to be performed to test for equivalence in the distribution of ethnicity because there were fewer than five participants per group. Frequencies OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 31 for each group are available in Table 1. A review of the tabled data revealed a similar pattern and frequency between groups indicating that ethnicity was equally distributed between groups and the sample was weighted toward Caucasian participants. These percentages are similar to those found in the census data for the surrounding area (U.S. Census Bureau, 2010). Number of Medications An independent-samples t-test was performed to determine if there were differences in the number of medications prescribed between the control group and the experimental group. There were no outliers in the data, as assessed by inspection of a boxplot. The number of medications for each group was normally distributed, as assessed by the Shapiro-Wilk test (p > .05), and there was homogeneity of variances, as assessed by the Levenes test for equality of variances (p = .052). Results revealed no significant differences in number of medications between the experimental group (M = 8.18, SE = 0.91) and the control group (M = 6.75, SE = 1.48), t(27) = 0.87, p = .393 (Table 2). The number of medications was assumed to be equivalent between groups. In-Home Assistance The presence of assistance at home was evaluated and a review of percentages revealed that 35.3% of the experimental group had assistance at home while 75.0% of the control group had available assistance to manage their medications (Table 1). A Fishers exact test was performed to see if there was an association between group and the presence of assistance for medication management. No statistically significant association was found between group and assistance at home as assessed by Fishers exact test, two-sided, p = .060. Therefore, assistance at home was considered to be equivalent between groups. OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 32 Number of Documented Comorbidities An independent-samples t-test was performed to determine if there were differences in the number of documented comorbidities between the control group and the experimental group. An inspection of a boxplot demonstrated no outliers in the data. These results were found to be normally distributed as assessed by Shapiro-Wilk test (p > .05), and there was homogeneity of variances, as assessed by Levenes test for equality of variances (p = .818). Results revealed no significant differences in number of comorbidities between the experimental group (M = 3.41, SE = 0.33) and the control group (M =2.75, SE = 0.37), t(27) = 1.31, p = .201 (Table 2). Charlson Age-Comorbidity Index (CACI) Scores Comorbidities were also weighted based on the CACI. A Mann-Whitney U test was completed to determine if there were differences in CACI scores between the experimental and control groups because these scores were not normally distributed, as assessed by ShapiroWilks test (p < .05). Median CACI scores for the control group (1.50) and experimental group (2.00) were not statistically significantly different, U = 85.00, z = -0.81, p = .471, using an exact sampling distribution for U (Dineen & Blakesley, 1973). This result, combined with the above analysis of the actual number of comorbidities, indicates no significant difference between groups based on overall comorbidities. In general, the experimental and control groups were deemed sufficiently homogenous in composition such that further analysis would proceed without the need for any adjustment to the groups. Differences Between Groups Adherence as measured by the ARMS-7. Included in the first objective of the study was to determine whether the addition of the delivery of the IMedS by an occupational therapist to usual care resulted in better medication adherence, as measured by the self-report, seven- OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 33 question ARMS-7 instrument. A difference score was created between the final and the initial ARMS-7 score. The assumption of normality was met for the difference score (Shapiro-Wilks, p > .05). An independent-samples t-test was performed. Results revealed no significant differences in the ARMS-7 change score between the experimental group (M = 1.33, SE = .70) and the control group (M = 0.86, SE = .67), t(20) = 0.42, p = .678 A mixed ANOVA was used to test whether the ARMS changed differentially by group. The three times of ARMS measurement as the within factor and control versus experimental group as the between factor. There was a significant main effect for ARMS, F(2, 23) = 6.11, p = .007, eta = .35, but there was not a significant interaction between ARMS and group belonging, F(2, 23) = 2.24, p = .129, eta = .16. Both groups improved similarly. The means plot revealed a V shape for the experimental group that bore further analysis (Figure 1) because of its dissimilarity to the pattern of change in the control group. Despite the overall interaction being non-significant, the means for the experimental group were explored separately with a post hoc repeated measures t-test. The test was significantly different for the post hoc comparison for time two and time three for the ARMS-7 measurement, t(14) = 3.41, p = .004, dc = .65. The effect size was reported using Dunlaps correction for intercorrelation of the measurements (Dunlap, Cortina, Vaslow, & Burke, 1996), instead of Cohens d (Cohen, 1988), which tends to over-report the true effect. The limited power of the test, owing to the relatively small sample size, however, was not sufficient to find this in the initial analysis. Ultimately, participants in the experimental group arrived at a self-assessed adherence rate slightly greater than the control group (Figure 1). Adherence as measured by pill count. Determining whether the addition of the delivery of the IMedS by an occupational therapist to usual care improves medication adherence as OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 34 measured by a pill count was also included in the first objective. An ANOVA analysis was not completed on the individual pill counts due to multiple missing data points and an observed negative skew. A difference score between the first and final pill counts was calculated. Because some participants were also taking more medications than prescribed, yielding percentages above 100%, the participants pill count percentage (e.g., 119%) was subtracted from 100 and then the absolute value of that calculation was subtracted from 100 again. The assumption of normality for the change score was not met (Shapiro-Wilks, p < .05). A Mann-Whitney U test was used to assess for differences between groups. The difference score was not significantly different between the experimental and control groups for pill count, U = 46.00, z = -1.28, p = .215. The mean pill count percentages for the difference score were noted to demonstrate a sizeable difference with the experimental group having a mean of 20.57 and the control group a mean of 7.89. An effect size calculation was completed using Measure of the Effect (MOTE), version 0.0.0.9100, to examine mean differences on a standardized scale (Buchanan, Scofield, & Valentine, 2017). This calculation revealed d = 0.55, indicating a medium effect size for the occupational therapy intervention on pill count in the experimental group (Cohen, 1988). Correlation analyses, including a review of scatterplots, were completed to assess the relationship between the ARMS-7 scores and the pill count scores. Due to missing pill count data, the statistical analyses were limited and no conclusions could be drawn. Adherence as measured by blood pressure. Also included in the first objective of the study was to determine whether the addition of the delivery of the IMedS by an occupational therapist to usual care improves blood pressure, as measured by the mean arterial pressure (MAP) within the experimental group. The mean values for the experimental group and the control group across time can be seen in Table 3. The assumption of normality was violated OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 35 (Shapiro-Wilks, p < .05) for the data. The data were also found to be positively skewed and with multiple outliers. A difference score was calculated between the final MAP and the initial MAP scores. The difference was assessed with a Mann-Whitney U test. The median difference score was not significantly different between the experimental (Mdn = -4.00) and control groups (Mdn = 8.33), U = 60.00, z = -1.17, p = .259. In line with previous analyses, the effect size was calculated and found to be -0.31 indicating a small effect size for the control group intervention on the difference in MAP as compared to the intervention group (Figure 2). Adherence as measured by hemoglobin A1c. The A1c values could not be compared between groups due to an inequality of relevant participants (experimental: n = 10; control: n = 1). Overall, 9 out of 10 participants in the experimental group demonstrated a desired decrease in their A1c (M = -1.09, SD = 1.85) and the one participant in the control group decreased by .80 units. Considering the previously designated standard of change of at least 0.50 standard deviation of improvement, half of the participants in the intervention group demonstrated a significant improvement in their A1c (Norman, Sloan, & Wyrwich, 2003). Readiness for change as measured by the stages of change measure. The second objective of the study was to determine whether the administration of the IMedS in addition to usual care influenced an individuals readiness for change, as measured by the stages of change (SOC) measure. The SOC score was not normally distributed, therefore a nonparametric Friedman test (alternative to a repeated measures ANOVA) was used to determine if there was a difference in stage of change scores across the three measurement times. The Friedman ANOVA statistic, X2 (2, N = 25) = 1.50, p = .472 indicated that there was not a statistical difference in OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 36 SOC scores across the three measures at an alpha .05 level. Descriptive statistics for each of the measurements are listed in Table 4. Demographic influence on adherence. The final objective was to explore whether participant demographics (e.g., gender, age, race/ethnicity, assist at home, comorbidities, and number of medications) impact medication adherence rates. Various correlation analyses were completed based on the level of measurement. Full results are found in Table 5. No relationship was found between the individual change scores for the adherence measures of the ARMS-7, pill count, or MAP and the demographic factors, other than for the number of medications and the ARMS-7 (r = .49, p = .019). This indicates a positive linear association of the number of medications and an improvement in the ARMS-7 score. Using a Type I Error correction the pvalue was adjusted to .017. Using this criterion, this relationship would not be considered significant. Analyzing the relationship between individual adherence measurements and demographics can provide some insights but should be viewed with caution as the literature indicates that adherence should be measured in multiple ways (Kreyes, 2016; Lam & Fresco, 2015; Pednekar et al., 2019). Coupling the statistics from this study that demonstrate no significant difference in demographics between the control and experimental groups with the cumulative measurements of adherence may also indicate that participant demographics are not significantly impacting medication adherence rates. Discussion The purpose of this study was to meet three objectives. The first objective was to use at least three different medication adherence measures to evaluate the influence of the addition of the IMedS to usual care on adherence as compared to usual care alone. The second objective was OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 37 to determine whether the administration of the IMedS influenced an individuals readiness for change. The third objective was to explore the influence of demographics on adherence. The first and third objectives were met, but the second objective was impeded by a lack of sensitivity of the stages of change measure. The randomization process provided groups that were evenly matched on the identified demographic areas. As suggested by the literature, multiple methods were used to assess adherence for both groups (Kreyes, 2016; Lam & Fresco, 2015; Pednekar et al., 2019). The proportion of adherent participants increased in both groups but was not significantly different between groups for the change scores calculated for the ARMS-7, MAP, and pill count. This finding corroborates previous work by Doggrell (2010) that found no clear preference for an intervention from any specific profession. While three outcome measures were used, as previously discussed, each has its own limitations which may have influenced study findings. This study agrees with previous findings that individuals tend to overestimate their level of adherence with the initial ARMS-7 score mean being 26/28 (Kelly et al., 2016; Nyugen et al, 2014). This provided a challenge for distinguishing an inclusion criterion based on the ARMS-7 because clients rarely self-identified as nonadherent. If adherence is truly high, there is no need for intervention, and if change does occur it will be so slight that it would likely go undetected (Doggrell, 2010). However, assessments and discussions completed during the intervention process would often show that participants were unaware or unwilling to acknowledge non-adherent behaviors. While blood pressure provides an objective measurement, it varies throughout the day and can be influenced by extraneous variables such as recent caffeine intake, timing of exercise, stress, a participants decision to not take the medicine when going into public due to side effects (e.g., increased urination), or the OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 38 duration of use of antihypertensive medications (Mancia et al., 1983). Pill count data was limited by the participants willingness to allow the researcher to count their pills, forgetting to bring their pills, and by combining pills from multiple bottles. Recent literature suggests that a composite adherence reference standard should be developed and validated (Kreyes, 2016). This standard would use the results from several imperfect measurements to calculate a more accurate composite score rather than using only a comparison of the individual scores. Kreyes (2016) also included suggestions to address missing data. Such a validated score would have yielded more clarity in this study. Outcomes may also be affected by time in care. Conn (2015) previously concluded that the most effective adherence measures addressed multiple components and were delivered over several days. While the IMedS process intends to address many areas, intervention time was often limited by having to share appointment time between the pharmacist and the occupational therapist, or the participant needing to attend another appointment, or both. Several participants in both groups missed appointments due to a lack of transportation or other individual stressors. Analysis of how individual outcome measures changed across groups yielded interesting findings. These results could be better evaluated with a larger sample size. The significant main effect found for the ARMS-7 and the significant difference found for the post hoc comparison for time two and time three for the ARMS-7 measurement indicated that the occupational therapy intervention was having a unique effect as compared to the control (Figure 1). These findings may suggest that participants in the experimental group receiving occupational therapy services may change in their adherence rates in a different manner as compared to the control. The combination of motivational interviewing and a collaborative analysis of habits and roles improved the participants ability to identify missed doses or habits of non-adherence. This OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 39 increased awareness appeared to create the drop in self-reported adherence as patients reported their actual adherence more accurately. In these cases, participants were also noted to verbalize a heightened understanding and commitment to making changes in their daily habits related to medication adherence. Once the participants identified the need for improving their adherence and implemented self-selected strategies, their adherence rose to just above that of the control group. Standardized mean difference effect sizes (d) were calculated for the pill count and MAP outcomes to further reflect the post-intervention difference between the treatment and control participants. These effect sizes, though limited by sample size, provide information for clinical application and may be useful in future research to strengthen power analyses. The pill count outcomes were further evaluated for differences across time and group due to the differences identified in the mean percentage change between the occupational therapy group (M = 20.6%) and the control group (M = 7.9%). The comparison of the two interventions yielded a medium difference between the two (d = 0.55), suggesting that the occupational therapy intervention was positively affecting adherence as measured by pill count. This difference supports previous IMedS research that medication adherence is responsive to occupational therapy (Schwartz & Smith, 2016). These findings also expand upon previous research that demonstrated the intervention can be effective in a lab setting, by now showing the IMedS approach can be useful in a primary care clinic. Effect size analysis of the MAP change score yielded d = -0.31, indicating the control group saw a larger change for blood pressure as compared to the intervention group. Since both groups were receiving an intervention by the clinical pharmacist for adjustment of medications and counseling, it seems the difference may be due to small variations between groups or OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 40 individual factors that influence blood pressure that were not tracked in the study (e.g., caffeine intake, stress level, etc.). Though not statistically significant, the intervention group demonstrated an older mean age, was managing more medications, had less assistance at home, and had a higher number of comorbidities. The control group also started with a higher mean MAP, which may have made it easier to detect change. While remaining cautious due to the number of missing data points for MAP, both groups saw an overall decrease in MAP, indicating that the interventions were having the desired effect in this hypertensive population. While A1c could not be compared between groups because of the inequality of participants with T2DM, it is notable that 90% of participants in the experimental group demonstrated a desired decrease in their A1c (M = -1.09, SD = 1.85), or half of the group when using the standard of change of one half of the standard deviation reduction in A1c. These participants received both the pharmacy and occupational therapy intervention. Future research should focus on whether the occupational therapy intervention was necessary to produce this change. The literature supports the approach taken by the IMedS as administered by an occupational therapist. In a systematic review of medication adherence interventions, Conn et al. (2015) reported that the intervention components showing the most promise were those addressing the link between habits and adherence behaviors, providing adherence feedback, selfmonitoring of blood pressure, the use of pill boxes, and motivational interviewing. The occupational therapists clinical process inherently views a client through their individualized daily occupations, habits, and routines, which has also been identified as a key component of effective adherence interventions (Lngst et al., 2015). The occupational therapist also used the pill count information as objective feedback to increase self-awareness of habits that were OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 41 promoting or limiting adherence. Participants also employed combinations of environmental supports like taking blood pressure at home; use of pill boxes; and establishing environmental cues such as checklists, alarms, and smartphone applications. The occupational therapists interventions also included assessing and treating cognitive and coordination limitations affecting the medication management process. Motivational interviewing throughout the intervention appeared to be key for prolonged use of new strategies, as it helped the individual identify areas for improvement and strategies that best fit their unique contexts. The single-item stages of change scale lacked the sensitivity to evaluate readiness for change in this population. In particular, the wording for the choices indicating the stages of action and maintenance was such that participants would be unable to move from one stage to the next within the duration of this study (Appendix F). The assessment of readiness for change still applies to future adherence research as previous studies suggested that self-reported adherence may be a better measure of overall health-related behaviors than of medication adherence alone (LaFleur, Nelson, Sauer, & Nebeker, 2011). Evaluating readiness for change can help the clinician view the clients behavior more holistically. This can support best practice for shaping appropriate interventions to facilitate positive behavior change related to adherence that then may also influence other lifestyle changes that are particularly necessary for healthy management of HTN and T2DM. Arafat et al. (2019) found that a two-item stages of change measure significantly predicted adherence as measured by the self-report, eight-item Morisky Medication Adherence Scale. Future research should consider the use of the two-item scale for the duration of the study and how an individuals readiness for change influences adherence as measured by an objective, non-self-report measure. OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 42 No significant influence of demographics was found once Type I error corrections were completed for the demographics of age, gender, ethnicity, assistance at home, number of medications, and number of comorbidities (Table 1 and 2). This corroborates a large randomized control trial (N = 28,967) by Whittle et al. (2016), which looked at demographic factors across multiple studies and found they had only a small effect on adherence. This finding is also substantiated by a previous meta-analysis (DiMatteo, 2004) that concluded participant demographics have little impact on medication adherence. Study Limitations While the randomization of participants created analogous groups for analysis, potentially confounding factors that influence MAP and A1c were not evaluated or controlled. Confounding variables of diet, exercise, health literacy, medication beliefs, and others may have influenced outcomes in either direction (Nfrdi, Nakamoto, & Schulz, 2017). Another factor that was not tracked but may have influenced adherence is whether the participant could consistently afford his or her medications (Sontakke et al., 2015). Missed doses for financial reasons would, at a minimum, affect the ARMS-7 report and the pill count data. A ceiling effect could potentially influence the results. It was determined to include participants that scored up to and including the highest score on the ARMS-7, but their inclusion allowed those with high self-report of adherence into the study. Although it was later determined that most were not as adherent as they reported, those with truly high adherence had very limited room to improve. These individuals demonstrated little to no change in the outcome variables. Related to this, the researchers were unable to determine from this data set whether the ARMS-7 was measuring adherence as it was intended, or whether it was more accurately measuring the participants self-awareness of his or her adherence. Further studies should be designed to OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 43 evaluate whether self-report measures are most accurately measuring actual adherence or the level of awareness of adherence. The total sample size was also a limiting factor. The recruitment efforts took nearly twice as long as anticipated and staffing resources prevented an extension of the study. The minimum number of participants were recruited, although with a subsequent attrition of three participants. Implications for Clinical Practice These results are consistent with previous research that occupational therapists offer interventions that can increase medication adherence (Schwartz & Smith, 2016; Sanders & Van Oss, 2013). This study also demonstrated that it is feasible for an occupational therapist to provide this intervention in a primary care setting. Recent qualitative research has identified behavior change techniques for improving medication adherence in primary care that fit well within the occupational therapists scope of practice (e.g., memory, attention, and decision processes; environmental contexts and resources; and social influences) (Patton et al., 2018). While there are clear benefits to an occupational therapist addressing this area in an outpatient or home health setting, the primary care setting provides particular benefits for individuals with limited access to healthcare, as it reduces demands on the client to make a follow-up appointment and travel for additional services (Gorina, Limonero, & lvarez, 2019). Recent research by Khayyat et al. (2019) also identified an association between quality of life and medication adherence specifically in client populations with HTN and diabetes in the primary care setting. While the occupational therapists role in primary care is in its early stages of evolution, it is clear that the occupational therapist is well equipped to work with the pharmacy and provider team to improve medication management and adherence. OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 44 Conclusion This study expands the research related to medication management interventions delivered by an occupational therapist, specifically a manualized approach with the IMedS. It supports the conclusion that an occupational therapist can positively influence adherence, with an emphasis on the use of motivational interviewing to coach a client through the analysis of his or her roles and routines and how medication management strategies can be better integrated into meaningful activities. 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American Journal of Occupational Therapy, 47(1), 30-33. 58 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 59 Table 1 Demographic Characteristics of Participants in the Study (N = 29) Variable Experimental Control Total N Percent N Percent N Percent 7 41.2% 8 66.7% 15 51.7% 10 58.8% 4 33.3% 14 48.3% 12 70.6% 10 83.3% 22 75.9% Hispanic 3 17.6% 1 8.3% 4 13.8% African American 1 5.9% 0 0% 1 3.4% Asian 1 5.9% 1 8.3% 2 6.9% Yes 6 35.3% 9 75.0% 15 51.7% No 11 64.7% 3 25.0% 14 48.3% Gender Male Female Race Caucasian/NonHispanic Assistance at home OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 60 Table 2 Demographic Statistics for Variables (N = 29) Variable Experimental Control M SD Range M SD Range Age (years) 52 11.57 30-72 51 7.97 33-65 Number of medications 8.2 3.75 2-15 6.8 5.11 1-15 Comorbidities 3.4 1.37 1-6 2.8 1.29 1-5 Total number of visits 7.1 1.98 3-11 2.8 .577 2-4 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE Table 3 Descriptive Statistics for MAP (N = 25) Variable Experimental (n = 15) Control (n = 10) M SD M SD MAP-Initial 98.78 9.89 105.57 9.85 MAP-Midpoint 91.87 28.24 103.73 6.85 MAP-Final 90.62 26.96 88.6 31.78 61 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 62 Table 4 Stages of Change Descriptive Statistics (N = 23) Variable Measurement Experimental Control M Mdn SD SE M Mdn SD SE SOC - Initial 4.4 4.0 .63 .16 4.13 4.0 .64 .23 SOC - Midpoint 4.3 4.0 .82 .21 4.13 4.0 .35 .13 SOC - Final 4.5 5 .64 .17 4.13 4.0 .35 .13 Note. SOC = Stages of Change OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 63 Table 5 Demographic Correlation Results Variable Age Gender ARMS Change Score Pill Count Change Score MAP Change Score (Analysis) (Analysis) (Analysis) r = .17, p = .443 rs = .08, p = .710 rs = .12, p = .555 (Pearson Correlation) (Spearman rho) (Spearman rho) r = .38, p = .078 r = .07, p = .747 r = -.06, p = .774 (Point biserial correlation) (Point biserial correlation) (Point biserial correlation) Ethnicity Assist at home X2 (3, N = 22) = .66, p = X2 (3, N = 24) = 4.98, p = X2 (3, N = 26) = 3.2, p .882 .173 = .362 (Kruskal-Wallis) (Kruskal-Wallis) (Kruskal-Wallis) r = .23, p = .302 r = -.13, p = .549 r = -.07, p = .727 (Point biserial correlation) (Point biserial correlation) (Point biserial correlation) Number of r = .38, p = .084 r = .25, p = .239 rs = .30, p = .139 (Pearson Correlation) (Pearson Correlation) (Spearman rho) Number of r = .49, p = .019 r = .28, p = .183 rs = .15, p = .480 medications (Pearson Correlation) (Pearson Correlation) (Spearman rho) comorbidities OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE CACI Score 64 rs = .16, p = .487 rs = -.22, p = .313 rs = .26, p = .198 (Spearman rho) (Spearman rho) (Spearman rho) Note. CACI = Charlson age-comorbidity index OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 65 Figure 1. ARMS-7 Line Chart. This figure represents mean ARMS-7 scores by group over time. (p = .004) OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE MAP Difference 0 Control Group Experimental Group -5 -10 -15 -20 -25 Figure 2. MAP difference between groups. This figure represents the MAP mean difference scores between groups. (p = .259) 66 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 67 Appendix A ADHERENCE TO REFILLS AND MEDICATIONS SCALE (ARMS) I will now ask you how often you actually miss taking your medicines. There are no right or wrong answers. For each question, please answer none of the time, some of the time, most of the time, or all of the time. 1. How often do you forget to take your medicine? 1234 2. How often do you decide not to take your medicine? 1234 3. How often do you forget to get prescriptions filled? 1234 4. How often do you run out of medicine? 1234 5. How often do you skip a dose of your medicine before you go to the doctor? 1234 6. How often do you miss taking your medicine when you feel better? 1234 7. How often do you miss taking your medicine when you feel sick? 1234 8. How often do you miss taking your medicine when you are careless? 1234 9. How often do you change the dose of your medicines to suit your needs (like 1 2 3 4 when you take more or less pills than youre supposed to)? 10. How often do you forget to take your medicine when you are supposed to take it more than once a day? 1234 11. How often do you put off refilling your medicines because they cost too much money? 1 2 3 4 12. How often do you plan ahead and refill your medicines before they run out? 1234 Scoring: Item 12 should be reverse coded. Then add up the points. Scoring may be completed with either higher or lower scores indicating better adherence. Scores can be treated as a continuous measure or dichotomized. The ARMS-7 consists of the 7 items highlighted above in blue. OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 68 Appendix B Clinical Pharmacist Hypertension Protocol Policy Statement: Jordan Valley Community Health Center (JVCHC) has established procedures for follow-up blood pressure monitoring appointments and titration of blood pressure medications by a pharmacist. Procedures: 1. Follow-up Blood Pressure Check When a clients blood pressure is elevated on two different readings, the primary care provider (PCP) shall have the client return to clinic within 2-4 weeks for a pharmacy visit for a blood pressure check. o If the pharmacist is unavailable at an ideal time for the client, he/ she may be scheduled for a blood pressure check with the Tampa Nurse. The pharmacist will document the prescription order for medication therapy services in the electronic medical record (EMR) per Appendix A. 2. Pharmacist will educate client on pathophysiology of hypertension and importance of medication adherence 3. Pharmacist will assess medication adherence (i.e. utilizing standard assessment of ARMS-7) 4. Pharmacist will obtain diet, exercise, and social history and set self-management goals as needed 5. Pharmacist will ensure appropriate labs have been obtained (e.g., SCr, K+) 6. Pharmacist will verify clients medication allergies and current medication list at each visit 7. Pharmacist will check clients blood pressure manually If first reading is above goal, the blood pressure will be repeated 5 minutes later before any clinical discussions are made Blood pressure goals set by the PCP will be followed If the PCP does not specify a client-specific goal, the following goals will be used: <150/90 mmHg 60 years of age and no other conditions on this table (JNC8) 80 years of age with CAD (AHA/ACC/ASH) <140/90 mmHg <60 years of age and no other conditions on this table (JNC8) <80 years of age with CAD (AHA/ACC/ASH) DM (ADA, JNC8) CKD with albuminuria <30mg/day (KDIGO) Stroke or TIA (AHA/ASA) <130/80 mmHg CKD with albuminuria 30mg/day (KDIGO) Kidney transplant (KDIGO) OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 8. 9. 10. 11. 12. 13. 14. 15. 69 If the clients blood pressure is >180/110 on two separate readings with no associated symptoms (e.g., headache, nosebleeds, chest pain, shortness of breath), the PCP or an available provider will be notified immediately for consultation. If the clients blood pressure is >180/110 with associated symptoms (e.g., headache, nosebleeds, chest pain, shortness of breath), the PCP or an available provider will be notified and the emergency medical system (i.e., call 911) will be activated. If the clients blood pressure is at goal during follow up appointment: No medication changes will be made Client shall have blood pressure rechecked within 6 months of last PCP visit Nurse or pharmacist may refill meds per medication refill protocol Pharmacist will task PCP with appointment documentation If clients blood pressure is not at goal during follow up appointment: Pharmacist will assess clients adherence o May contact clients pharmacy as needed Pharmacist will use clinical judgment to adjust medications per Appendix B, C, and D o In general, blood pressure medications may be doubled in strength when blood pressure is above goal (e.g., lisinopril 10 to 20mg, HCTZ 12.5 to 25mg, losartan 25 to 50mg, amlodipine 5 to 10mg, metoprolol succ 50 to 100mg). o If the blood pressure is >20/10 over goal, consider increasing/ initiating two medications. Client will be scheduled for another blood pressure check within 2-4 weeks Pharmacist will task PCP with appointment documentation During subsequent blood pressure checks, the pharmacist will follow the above procedures. If the clients blood pressure is not at goal after several appointments with no identifiable causes: Consider resistant HTN In-depth consult with PCP to determine appropriate add-on therapy based on clientspecific factors Pharmacist will consult with PCP if the client is on more than three (3) blood pressure lowering medications to assess for secondary causes of hypertension If a client no shows to their pharmacist appointment: If the client no shows or cancels a pharmacy appointment, the pharmacist will attempt to reach client via telephone to reschedule the appointment. In the event the pharmacist is unable to contact the client after three (3) attempts and a mailed letter, the PCP will be notified. OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 70 Appendix A. Pharmacy EMR Template: Prescription Order for Blood Pressure Medication Therapy Services I. II. The pharmacist will document the prescription order as the first chief of complaint of clients first pharmacy visit as: MTS Prescription Order a. The MTS prescription order will be renewed and documented in the EMR on an annual basis as needed per the provider. The format for the MTS Prescription Order will be as follows: Clients name: Clients address: Clients DOB: Date of prescription order: Clinical indication: hypertension Authorizing physician: Physicians address: Appendix B. Considerations in selecting blood pressure medications. Medication Ideal clients Considerations Cautioned Use Category Thiazide diuretic* HF, stroke, CAD Electrolyte Gout, renal levels impairment AngiotensinHF, post MI, DM, Electrolyte Women of child converting enzyme CKD, stroke, CAD levels bearing age, renal inhibitor* artery stenosis Angiotensin HF, post MI, DM, Electrolyte Women of child receptor blocker* CKD, CAD levels bearing age, renal artery stenosis Calcium Channel CAD Constipation Edema Blocker* DHP Non DHP Afib, CAD Syncope Bradycardia, HF, edema Beta Blocker HF, post MI, CAD, Afib Abrupt withdrawal Bradycardia, bronchospasms Aldosterone antagonist HF, post MI, CAD Renal impairment Loop Diuretic HF, edema Alpha-1 antagonist Alpha-2 agonist Add-on therapy Add-on therapy Electrolyte levels, CNS effects Electrolyte levels, fluid intake, photosensitivity Syncope CNS effects Contraindicated Hypersensitivity, anuria Hypersensitivity, pregnant women Hypersensitivity, pregnant women Hypersensitivity Gout, renal impairment Hypersensitivity, SSS, AV block, acute MI Hypersensitivity, SSS, AV block, decompensated HF Hypersensitivity, anuria, Addisons disease Hypersensitivity, anuria Angina, elderly Bradycardia, elderly Hypersensitivity Hypersensitivity OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE Vasodilator Add-on therapy TID-QID dosing 71 Renal impairment, edema Hypersensitivity, mitral valve rheumatic heart *Recommended first-line therapy per JNC8. If no compelling indica ons, consider a thiazide diuretic or CCB over ACEI or ARB in black clients. Appendix C. Evidence-based dosing of blood pressure medications. Antihypertensive Medication Target Daily Dose, mg Thiazide-type diuretic Chlorthalidone 25 Hydrochlorothiazide 25 Angiotensin-converting enzyme inhibitor Lisinopril 40 Enalapril 20 (may be in divided doses) Angiotensin receptor blocker Losartan 100 Valsartan 160-320 Irbestartan 300 Candesartan 12-32 Calcium channel blocker Amlodipine 10 Diltiazem ER 360 Beta-Blocker Metoprolol 100-200 (divided doses if tartrate) Atenolol 100 *Adapted from JNC8. Appendix D. Sample medication titration for blood pressure above goal. BP >140/90 (or >150/90 in elderly) BP >160/100, consider 2 drug combination (diuretic 12.5mg + lisinopril 10mg) Initiate diuretic 12.5mg (chlorthalidone or HCTZ) or lisinopril 10mg* BP >160/100, consider 2 medication changes (e.g., increase lisinopril + initiate diuretic, increase lisinopril + diuretic, etc) BP >140/90 Increase diuretic to 25mg or lisinopril to 20mg (may titrate to 40mg) BP >140/90 BP at goal, <140/90 or <150/90 in elderly: - Continue therapy, encourage home BP monitoring, recheck BP in 3-6 months - Routinely monitor adherence, side effects, SCr, K+ OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE BP >160/100, consider maximizing lisinopril (40mg) + diuretic (25mg) Initiate diuretic 12.5mg or lisinopril 10mg whichever client is currently not being used BP >140/90 BP >160/100, consider initiating amlodipine 5mg (may titrate to 10mg) 72 *If client develops a cough or intolerant to ACE-I consider substitute with ARB. Client adherence to medication will be assessed at all follow-up appointments. May use dil azem ER. Increase second medication (e.g. lisinopril 20 or 40mg + diuretic 25mg) BP >140/90 Initiate amlodipine 5mg (may trate to 10mg) BP >140/90, consult with PCP and assess add-on therapy OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 73 Appendix C Policy Statement: Clinical Pharmacist Diabetes Protocol Jordan Valley Community Health Center (JVCHC) has established procedures for follow-up diabetes monitoring appointments and titration of diabetic medications by a pharmacist. Procedures: 1. Diabetes Management Follow-up When patients HbA1c is >9% or the patient is newly diagnosed, the primary care provider (PCP) shall have the patient return to clinic within 4 weeks for a pharmacy visit for diabetes management. A PCP may refer other patients with diabetes at their discretion. A referral to the pharmacist for follow-up will serve as the prescription order for Medication Therapy Services (MTS). o The pharmacist will document the prescription order for medication therapy services in the electronic medical record (EMR) per Appendix A. 2. Pharmacist will educate patient on pathophysiology of diabetes and importance of medication adherence. 3. Pharmacist will obtain diet, exercise, and social history and set self-management goals as needed. Patient will be referred to the dietician as needed. 4. Pharmacist will ensure appropriate labs have been obtained (e.g., SCr, HbA1c, UACR) 5. Pharmacist will verify patients medication allergies and current medication list at each visit. 6. Pharmacist will review diabetes Standards of Care with the patient. Recommended vaccines o Annual flu vaccine o Hepatitis B vaccine series o Pneumococcal vaccine PPSV23 for all patients <65 years old PCV13 followed by PPSV23 for all patients 65 years old Regular specialty visits o Annual foot exam and daily self foot assessment o Annual dilated eye exam o Dental exam every 6 months Controlled blood pressure (<140/90) o Recommended ACE inhibitor or ARB unless patient is pregnant Regular lipid monitoring and treatment as needed o If patient is 40-75 years old, patient should be on a moderate to high intensity statin based on ASCVD risk unless patient is pregnant o If patient is <40 or >75 years old, patients ASCVD risk should be assessed to determine appropriate treatment o If patient is not indicated for a statin, fasting lipid panel every 5 years OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 74 Recommended anti-platelet therapy o Patients with a 10-year cardiovascular risk >10% shall take aspirin 81 mg daily unless contraindicated Patients 50 years old with one additional risk factor (family history of premature ASCVD, hypertension, smoking, dyslipidemia, albuminuria) 7. Pharmacist will review HbA1c and SMBG readings HbA1c and blood glucose goals set by PCP will be followed. If the PCP does not specify a patient-specific goal, the following ADA goals will be used: Nonpregnant adults HbA1C <7% Fasting/Pre-Prandial Glucose 80-130 mg/dL Pregnant adults <6.5% 90 mg/dL Gestational diabetes Adult patients with history of severe hypoglycemia, advanced microvascular or macrovascular complications, or limited life expectancy 95 mg/dL <8% 80-150 mg/dL Post-Prandial Glucose <180 mg/dL 1 hr 130-140 mg/dL 2 hr 120 mg/dL 1 hr 140 mg/dL 2 hr 120 mg/dL <200 mg/dL 8. If patients SMBG readings are at goal during follow-up appointment: No medication changes will be made. Patient shall have HbA1C rechecked in 3 months from last check, may extend to 6 months if last HbA1c was at goal. Nurse or pharmacist may refill medications per medication refill protocol. Patient will follow up with pharmacist and PCP as needed. Pharmacist will task PCP with appointment documentation. 9. If patients SMBG readings are not at goal during follow-up appointment: Pharmacist will assess patients adherence. o May contact patients pharmacy as needed Pharmacist will use clinical judgement to adjust medications per Appendix B, C, D, and E. Patients will be scheduled for another diabetes management follow-up within 2-4 weeks. Pharmacist will task PCP with appointment documentation. 10. During subsequent diabetes management appointments, the pharmacist will follow the above procedures. 11. If the patients HbA1C or blood glucose are still not at goal after several appointments with no identifiable causes: In-depth consult with PCP to determine appropriate add-on therapy based on patientspecific factors. 12. If a patient no shows to their pharmacy appointment: If the patient no shows or cancels a pharmacy appointment, the pharmacist will attempt to reach the patient via telephone to reschedule appointment. In the even the pharmacist is unable to contact the patient after three (3) attempts and a mailed letter, the PCP will be notified. OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 75 Appendix A. Pharmacy EMR Template: Prescription Order for Diabetes Medication Therapy Services I. II. III. A referral to the pharmacist for diabetes management follow-up will serve as the prescription order from the provider unless otherwise noted by the provider. The prescription will be valid for 1 year from the date of referral. The pharmacist will document the prescription order as the first chief complaint of patients first pharmacy visit as: MTS Prescription Order. a. The MTS prescription order will be renewed and documented in the EMR on an annual basis as needed per the provider. The format for the MTS Prescription Order will be as follows: Patients name: Patients address: Patients DOB: Date of prescription order: Clinical indication: diabetes Authorizing physician: Physicians address: OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 76 Appendix B. Consideration in selecting diabetic medications Medication Category Ideal Patients Considerations Biguanide* All type 2 DM without significant renal impairment Weight neutral, GI upset, lactic acidosis, B12 deficiency eGRF 30-45 mL/min, hepatic impairment Sulfonylureas (SU) Type 2 DM with elevated PPG Weight gain, hypoglycemia Renal impairment Thiazolidinediones (TZD) Type 2 DM contraindicated or intolerance to metformin Weight gain, edema h/o bladder cancer, fracture risk Hypersensitivity, HF Dipeptidyl Peptidase-4 (DPP4) Inhibitors Type 2 DM with high risk for hypoglycemia Weight neutral, pancreatitis, joint pain Renal impairment (except linagliptin) Hypersensitivity Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors Type 2 DM with uncontrolled HTN or overweight Weight loss, UTI, mycosis, dehydration Renal impairment, osteoporosis Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Type 2 DM with high risk for hypoglycemia or overweight Weight loss, GI upset, injection, pancreatitis Renal impairment (exenatide) Weight gain, Insulin Type 1 & 2 DM injection, hypoglycemia *Recommended first-line therapy per ADA. Cautioned Use Contraindicated Hypersensitivity, eGFR<30 mL/min, contrast media Hypersensitivity, severe hepatic impairment Hypersensitivity, eGFR<30 mL/min, severe hepatic impairment Hypersensitivity, medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2 Hypersensitivity OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 77 Appendix C. Evidence-based dosing of type 2 diabetes medications. Antidiabetic Medication Biguanide Metformin Metformin ER Sulfonylurea Glimepiride Glipizide Glipizide ER Glyburide Glyburide micronized Thiazolidinedione Pioglitazone Rosiglitazone DPP-4 Inhibitor Linagliptin Saxagliptin Sitagliptin Alogliptin SGLT2 Inhibitor Canagliflozin Dapagliflozin Empagliflozin GLP1 Agonist Dulaglutide Exenatide Exenatide ER Liraglutide Semaglutide Initial Daily Dose Max Daily Dose 500 mg 500 mg 1000 mg BID 2000 mg 1-2 mg 5 mg 5 mg 2.5-5 mg 1.5-3 mg 8 mg 20 mg BID 20 mg 10 mg BID 12 mg 15-30 mg 4 mg 45 mg 4 mg BID 5 mg 2.5-5 mg 100 mg 25 mg 5 mg 2.5-5 mg 100 mg 25 mg 100 mg 5 mg 10 mg 300 mg 10 mg 25 mg 0.75 mg weekly 5 mcg BID 2 mg weekly 0.6 mg 0.5 mg weekly 1.5 mg weekly 10 mcg BID 2 mg weekly 1.8 mg 1.5 mg weekly OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE Appendix D. Sample medication titration for uncontrolled diabetes. 78 OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 79 Appendix E. Sample insulin titration for uncontrolled type 2 diabetes. Initiate basal insuin 10 units or 0.1-0.2 units/kg daily Check SMBGs at least daily If hypoglycemia occurs, address cause, decrease by 4 units or 10-20% If not at goal, increase by 2-4 units or 10-15% once to twice weekly until at goal or dose >0.5 units/kg/day SMBGs at goal and A1c at goal If not at goal, consider trial of GLP-1 antagonist or treat PPG with meal time insulin Continue current regimen Recheck A1c every 3-6 months Start 4-5 units daily before the largest meal Check SMBGs at least twice daily If hypoglycemia occurs, address cause, decrease by 4 units or 10-20% Increase bolus by 1-2 units or 10% of dose once to twice weekly SMBGs and A1c at goal If not at goal, consider adding bolus to 2-3 meals per day Continue current regimen Recheck A1c every 3-6 months Continue to titrate basal or bolus insulin as needed until goals are reached OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 80 Appendix D Manual Blood Pressure Instructions 1. Place the bottom edge of the deflated blood pressure (BP) cuff 1 inch above the antecubital space with the center of the cuff bladder over the medial surface of the arm. 2. The width of the inflatable bladder of the BP cuff should be 40% of the circumference of the mid-point of the upper arm. 3. Position the arm so that it is relaxed and supported at the level of the heart. 4. In the seated position, legs should be flat on the ground and uncrossed. 5. Use the bell of the stethoscope, rather than the diaphragm (manual BP only), over the brachial artery area with no clothing or dressings touching the device. 6. Eyes should be level with the meniscus of a mercury manometer or centered in front of the gauge of an aneroid when reading pressures (manual BP only). 7. With the stethoscope in place, increase the pressure in the cuff to 30 mm Hg beyond the point where the radial artery pulse is no longer palpable (manual BP only). 8. Decrease the pressure in the BP cuff slowly (rate of 2 to 3 mm Hg/sec) (manual BP only). 9. Systolic BP is the point at which the initial tapping of the Korotkoff sounds are auscultated and diastolic BP is the point when there is a sudden muffling of the Korotkoff sounds (manual BP only). (Pickering et al., 2005) OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 81 Appendix E Email Correspondence with Permission for use of ARMS-7 ARMS-7.docARMS.DOC 58 KB 28 KB Traci, Thanks for your interest in the ARMS. You are welcome to use it in your work, with proper citation. There is no cost for use or more formal licensing process. Attached are the full instrument and a shorter version which I more often use, which correlates highly with the original and saves a little time. Best, Sunil From: Garrison, Traci A [mailto:TraciGarrison@MissouriState.edu] Sent: Wednesday, January 10, 2018 11:12 AM To: Kripalani, Sunil Subject: Use of Adherence to Refills and Medications Scale Dear Dr. Kripalani, I hope this finds you having an excellent start to your semester. I am an occupational therapist working on my Doctor of Health Science degree at the University of Indianapolis. I am hoping to complete my doctoral research on whether a client-centered occupational therapy intervention can influence medication adherence in a client population with hypertension. I have read about the ARMS and am contacting you in regards to using it in my research. I will be working directly with a clinical pharmacist. We will be specifically looking at whether an in-home OT assessment and intervention that addresses medication management can improve adherence as compared to the intervention provided by the clinical pharmacist alone. We believe the ARMS is well-suited for this study due to its brevity and ability to provide information about both medication-taking behaviors and barriers to adherence. I would love to speak to you or communicate via e-mail about the proper use of the ARMS in this research. Please contact me by any of the means listed below regarding questions, concerns, and your availability to discuss the ARMS. I greatly appreciate your time. Kindest regards, Traci Garrison, MSOT, OTR/L OCCUPATIONAL THERAPY AND MEDICATION ADHERENCE 82 Appendix F SINGLE-ITEM STAGE OF CHANGE MEASURE Directions: People sometimes find it difficult to take their medication as directed by their physician. As directed means consistently taking the amount of medication prescribed by your physician at the time(s) prescribed by your physician. Please find the statement that best describes the way you feel right now about taking your medication as directed. A. I do not take and right now I am not considering taking my medication as directed, B. I do not take but right now I am considering taking my medication as directed. C. I do not take but I am planning to start taking my medication as directed, D. Right now, I consistently take my medication as directed, however, I have been doing so for less than six months. E. Right now, I consistently take my medication as directed and I have been doing so at least six months.  ...

... Immigrants Experience of Inpatient Rehabilitation Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: John M. Dudzik, MHS, OTR/L Copyright June 28, 2021 By: John M. Dudzik, MHS, OTR/L All rights reserved Approved by: Jennifer Fogo, PhD, OTR Committee Chair ______________________________ Lori Breeden, EdD, OTR Committee Member ______________________________ Steven Wiley, PT, PhD, GCS Committee Member ______________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ 1 Immigrants Experience of Inpatient Rehabilitation John M. Dudzik University of Indianapolis 2 Abstract Background: In recent years, the United States has experienced profound changes in the diversity of its population. An increase in the number of immigrants to this country has contributed to these changing demographics. Healthcare providers are faced with the challenge of meeting the unique needs of these individuals and groups. However, there is limited research investigating the experiences of immigrant patients in an inpatient rehabilitation program. Objective: This study aims to describe the experiences and perspectives of immigrants admitted to an inpatient rehabilitation program. Design: A qualitative phenomenological study was conducted to examine the experiences of immigrant patients in an inpatient rehabilitation program. Methods: A purposive sampling process was used to recruit 10 patients who were immigrants to the United States with a native or primary language other than English. Semi-structured interviews were conducted with all individuals. Data analysis included reviewing all transcripts for intra- and inter-case content. Findings: Two themes emerged: Understanding the language and life of rehabilitation, and Trust and decision-making in the rehabilitation experience. Conclusion: The immigrant participants were able to understand and take part in the rehabilitation program. English language skills for several participants presented difficulties in the care process but did not detract from the participants experience, affect their recovery, or delay their discharge and return to home. Decision-making regarding the course of care was largely determined by healthcare providers, with participants trusting in and accepting the caregivers expertise to provide appropriate and effective care. Keywords: Immigrants, inpatient rehabilitation, healthcare, literacy, decision-making 3 Acknowledgments I would like to express my genuine appreciation and thanks to my committee chair, Doctor Jennifer Fogo. You have been a source of knowledge, counsel, and patience throughout the process of completing this project. I could not have completed this work without your mentorship and feedback. My thanks for your understanding and support in overcoming the myriad of challenges that arose in the past several years. As you know, life doesnt always follow a straight path. I would also like to thank my committee members, Doctor Steve Wiley, and Professor Lori Breeden for their ongoing contributions to this project. You provided guidance and assistance that was instrumental in bringing this project to fruition. I am very grateful for your patience and support over the sometimes drawn-out efforts needed to complete this work. You helped me learn a great deal about developing and completing this research from the content through to the analysis of the findings. I would like to thank Professor Paula Jo Belice, who was always ready to assist and encourage me in my work. You provided positive and kind support in all phases of the project. Your insights, drawn from your own experiences, not only helped me understand the steps needed to complete the analysis of my work but also to see the light at the end of the tunnel as I progressed. I want to express my sincerest gratitude to the patients who participated in this study. Thank you for your time and patience in sharing your insights as well as providing comments to improve the information gained in the interviews. I want to extend my thanks to John Dunkin and Sheri Garlick for their support throughout all my academic work. I am so very grateful for having the opportunity to not only attain my 4 masters degree but to continue and complete many critical elements of this doctoral project while I was at Alexian Rehabilitation Hospital. This project is a reflection of the outstanding rehabilitation program they lead. I would also like to thank the many colleagues in occupational therapy who have encouraged me in this work and offered their insights as this project progressed. Finally, to my wife, Diane, and my daughter, Courtenay, to whom I can never thank enough for all you did to help me complete this journeyfrom start to finish! Everything from proofreading my work to being a sounding board through good times and bad. I know I could not have achieved this without your patience, encouragement, assistance, and love. We all have dreams. But in order to make dreams come into reality, it takes an awful lot of determination, dedication, self-discipline, and effort. Jesse Owens 5 Table of Contents Acknowledgements 3 Introduction 7 Immigrants and Healthcare in the United States 7 Health Disparities in Immigrant Populations 7 Cultural Influences on Immigrant Health 8 Language, Literacy, and Immigrant Health 10 Immigrant Patients and Healthcare Providers 12 Methods 15 Interpretative phenomenological analysis (IPA) 15 Recruitment 16 Participants 16 Study Design 17 Data Collection 17 Researcher Role 19 Internal Review Board 19 Data Analysis 20 Trustworthiness 21 6 Findings 22 Theme 1: Understanding the language and life of rehabilitation 22 Theme 2: Trust and decision-making in the rehabilitation experience 27 Summary of Findings 32 Discussion 33 Understanding the language and life of rehabilitation 33 Trust and decision-making in the rehabilitation experience 40 Strengths and Limitations 45 Conclusion 47 References 50 Appendix A Interview Guide 58 Appendix B - Participant Demographics 60 Appendix C- Informed Consent Form 61 7 Immigrants Experience of Inpatient Rehabilitation Immigrants and Healthcare in the United States The changing face of the United States can be readily seen in the increase in the number of foreign-born individuals in the US from 19.7 million, or 7.9 percent of the total population in 1990, to approximately 40 million, or 13 percent in 2010 (Morse & Cui, 2013). These trends are expected to continue with immigrants contributing up to 82% of the growth in the United States population in the coming decades. As a result of this influx of immigrants, by 2050 nearly one in five Americans (19%) will be foreign-born. In addition, the nations ethnic and racial mix is expected to change. Non-Hispanic whites, who made up 67% of the population as of 2008, are expected to decrease to 47% of the population in 2050. In contrast, the Latino population is expected to rise from 14% to 29% and the Asian population will grow from 5% to 9% during the same period, with the Black population remaining at the same percentage (13%) as it is currently (Passel & Cohn, 2008). Health Disparities among Immigrant Populations Immigrants to the United States experience a wide array of changes as they adapt to life in this country, affecting virtually every aspect of their lives. At the same time, the social and economic systems of the United States face the task of responding effectively to the diverse needs of these individuals. A critical concern is immigrants access to and use of health care in this country. The disparities in health status and access to health care between native- and foreign-born individuals have been shown to exist in the United States. Prus et al. (2010) found that 33.4% of foreign-born non-White individuals in the United States, aged 4564 years, reported poor health while less than 13% of native-born White Americans of the same age reported similar conditions. Access to care is also significantly lower for the foreign-born non- 8 Whites as 24.2% of this group indicated they did not have a regular doctor and 16.5% reported that they had unmet health needs. In contrast, 12.7% of native-born Whites lacked a regular doctor and 10.4% noted unmet health needs. Moreover, these disadvantages were found to exist regardless of a persons socio-economic status, lifestyle, and access to health insurance (Prus et al., 2010). Several factors contribute to health disparities among immigrants including the length of time an individual has lived in the United States, their level of English proficiency, and their income (Lasser et al., 2006; Lee & Choi, 2009). The cultural values and practices of immigrants can also influence how they utilize health care services (Shaw et al., 2008). Culture, language, health literacy, and socio-economic factors that many immigrants encounter can limit their ability to manage health care needs effectively (Garces et al., 2008; Lee, et al., 2010). The increase in immigrant populations has led to a growing need for health care providers to have the skills and tools to address the unique cultural, language, and social needs and practices of these individuals (Dressler & Pils, 2009; Omu & Reynolds, 2012). Together, these factors present significant challenges to providing interventions to meet the health care needs of immigrants (Zou & Parry, 2012). Understanding immigrants experiences and perspectives of the health services they receive is essential for healthcare providers to devise strategies and tools that are culturally sensitive and appropriate for the populations they serve. Cultural Influences on Immigrant Health An essential concept to explore when discussing immigrants and health care is the impact of an individuals cultural background on their ability to take care of their health effectively. Several studies illustrate ways that culture can affect an immigrants beliefs about and ability to respond to health care needs. Garces et al. (2008) and Lee et al. (2010) found that cultural values 9 and practices, language and health literacy skills, and socio-economic status encountered by many immigrants can limit their ability to manage their health successfully. Morris et al. (2009) found that culture directly affected refugees concept of prevention services, independence, expectations of care and stigma around health conditions - all of which influenced their health care choices (p.535). Immigrant populations may define health and illness differently than those found in mainstream Western models. Kiesser et al. (2006), and Martin (2009) discussed how immigrant groups may have a more holistic perspective of health and illness, one which seeks to address not only injury or illness, but rather a balance of spiritual, natural, physical, emotional, and moral conditions within a person. These groups often rely more readily on traditional, complementary, and alternative medicine (TCAM) as remedies to illness in place of or before resorting to healthcare services typically found in the United States as well. Lee et al. (2010) found similar results in Asian American populations. Immigrants cultural beliefs about health and health care can also shape their decisions in seeking health care. Kiesser et al. (2006) found that Mexican immigrants utilized home remedies not only due to the accessibility and familiarity of these choices but also as a result of their beliefs that issues of health management are best addressed at home rather than in a doctors office. The authors found that immigrants viewed the conventional medical setting in the United States as a foreign and, at times, frightening, environment. The medical jargon, complexity, and impersonality of the health care system they encountered when in these settings compounded the discomfort they experienced. Participants in Kimbroughs (2007) study also reported that they would rather rely on herbal or home remedies because they were not used to going to doctors for their care. 10 Language, Literacy, and Immigrant Health An immigrants culture, as well as their English language skills, may affect their ability to effectively participate in and manage their health. Individuals receiving medical care must have adequate proficiency in reading and/or oral communication to understand the care they are receiving and to communicate their medical needs. Several researchers have demonstrated how literacy, and health literacy, in particular, can negatively impact immigrants in this respect. Dressler and Pils (2009) described barriers healthcare providers encountered when working with migrant and ethnic minorities. The clinicians in this study reported how language and crosscultural issues affected many aspects of inpatient rehabilitation care. Dressler and Pils noted that language barriers hindered the patients participation in treatment because the clinicians were unable to convey the importance of and/or objectives of therapies and of rehabilitation to them (p. 1186). Clinicians in this study also felt the rehabilitation process was hampered when tests and evaluations could not be completed due to language barriers, and that their program had limited resources to overcome these obstacles. Jirwe et al. (2010) reported that student nurses experienced difficulties in communicating with patients when they did not share a common language with them. These barriers negatively affected their ability to interact with and to form therapeutic relations with patients. The language skills of immigrants can also be a significant factor in the health behaviors of these individuals. Proficiency in verbal, written, or visual communication in English is essential for immigrants to access healthcare services. Twenty percent of the respondents in a study of Latino immigrants in southeast Michigan by Harari et al. (2008) identified language barriers as the primary obstacle to health care access. In this study, 82% of respondents stated they had difficulty communicating with their doctor during their last visit, and 8% reported 11 traveling as far as 35 miles to seek health care at a clinic with Spanish-speaking staff. These findings are similar to those noted by Morris et al. (2009) who noted that Every participant perceived language to be a major, if not the most major barrier to refugee health care access (p.533). Over half of the studys participants used healthcare services only when very ill, or not at all, as a result of language barriers. Suurmond et al. (2011) found that immigrant patients reported negative health care events as a result of insufficient information or ineffective communication and from differences in expectations about medical procedures due to language differences between them and care providers. These findings are similar to the examination of Hispanic immigrants by Garces et al. (2008) in Midwest rural communities. The authors of this study stated that: Participants with no or limited English proficiency mentioned that their limited skills speaking and understanding English seem to have a negative impact on their ability to seek and access health care services, to get information about local health care services available to them, and to understand their own health problems and treatments. (p. 641). Easton et al. (2013) found that low literacy had a significant impact on verbal communication and on understanding written information. They found that individuals with low literacy frequently concealed their lack of understanding from healthcare providers by feigning understanding of conversations or not asking questions about their care, even though they were unsure of the information they received. The Patient Protection and Affordable Care Act of 2010 defines health literacy as the degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make appropriate health decisions (Centers for Disease Control and Prevention, Health Literacy, para 1). However, Zou and Parry (2012) found that 12 immigrants often lack the basic knowledge and skills to navigate western healthcare systems (p. 484) and found that some immigrant populations have limited basic medical knowledge and understanding of health maintenance and disease prevention. Immigrant focus groups in Kimbroughs study (2007) reported one of their biggest challenges was understanding medication instructions and labels, as well as acquiring the knowledge they needed for continuing medications to manage chronic health conditions such as diabetes. These difficulties increased when healthcare providers did not appreciate the degree to which their patients did not understand their medical condition and prescribed treatments. Individuals with little or no skills in English encounter these obstacles as well. Lee et al. (2010) found that Asians with a relatively good command of the English language have difficulty in describing symptoms, understanding the physicians explanation and treatment, and reading prescriptions (p. 26). Immigrant Patients and Healthcare Providers Culture and language may also combine to affect an immigrant's abilities to establish effective working relationships with caregivers. As a result, immigrants may anticipate a different type of care or participate in treatment in ways that are not consistent with expectations found in a more Western-based model of care. Healthcare providers, who are aware of and able to address the unique needs and customs of immigrants, can have a significant effect on their care and overall health. Omu and Reynolds (2012) investigated the perceptions of healthcare providers in a rehabilitation program in Kuwait. The clinicians reported that patients cultural beliefs and practices had an impact on patients participation in treatment, including their ability to set meaningful therapy goals. The clinicians, who used a Western model of stroke care, found their approaches were often different from the beliefs and practices of their patients, who held more traditional views of their role, and of their families involvement, in rehabilitation. Omu 13 and Reynolds also reported that the level of education about stroke and rehabilitation within Kuwaiti society limited the patients and familys expectations about stroke recovery. The development of a relationship enabling healthcare providers to get to know immigrants as persons, not merely as sick or injured individuals, was found to be a critical element in influencing immigrants choices in medical care. Participants in studies by Lee et al. (2010), Markova et al. (2007), Marshall et al. (2010), and Morris et al. (2009), expressed a preference for healthcare providers who spoke their language and were of the same gender and ethnic background. The immigrant participants in these studies expressed that these factors were necessary for healthcare providers to understand their specific cultural needs and that they established a trusting relationship and a greater degree of satisfaction with the healthcare providers who shared their backgrounds. Ascertaining the patients perspective of their health care experience is an indispensable element of developing appropriate treatment interventions. Kimbrough (2007) used focus groups to investigate immigrants identified health care needs. The immigrants in the focus groups identified essential needs, such as increasing the cultural awareness of healthcare providers and making culturally and linguistically appropriate patient education and information available to immigrants to help them maintain their health and manage illness successfully. Participants stated that trained interpreters were essential to address communication barriers they encountered. Gill et al. (2014) used focus groups to describe the experiences, needs, and preferences of English-speaking inpatients of a rehabilitation program and those of their families as well. The participants reported that the timing and quality of their communication with staff, including non-verbal communication, had a significant impact on their rehabilitation experience. Patients and families also indicated they needed different types of information at different stages of their 14 rehabilitation, and that using techniques such as audio-visual presentations could help them understand and retain the information they received. Participants pointed out that although communication between staff and patients was important, communication among clinicians about coordinating and delivering care was critical to their recovery as well (Gill et al., 2014). Meeting and communicating with staff also helped establish effective relationships during the immigrants admission and fostered better care. Currently, there is little research that examined the perspectives of immigrants to the US who receive care in an Inpatient Rehabilitation Facility (IRF). There is a growing need to develop treatment approaches to meet the unique needs of the increasingly diverse population of the United States. These needs are especially acute in inpatient rehabilitation due to shorter lengths of stay, the intensity of services, and the importance of consistency in patient care (Dressler & Pils, 2009). Collaboration between health care recipients and the professionals providing health care services will be necessary to address the needs of immigrants. The first step in this process is understanding immigrants perspectives of health care. In their review of immigration statistics and reports on literacy, Zou and Parry (2010) recommended that strategies should be developed for technological and educational approaches suited to immigrants needs, especially language skills. In addition, they advocated for the formation of partnerships with healthcare professionals, and more importantly, with immigrant communities, to improve health care services for patients of these communities. Graces et al. (2008), Valenzuela et al. (2013) and Vincent et al. (2006) described how the concerns and practices of ethnic and immigrant populations could be addressed by examining their perspectives and experiences of health care service using focus groups and community needs assessments. 15 Over the past several decades, the influx of immigrants into the US has contributed to profound changes in the ethnic and cultural diversity of the US. Immigrants face many challenges of adapting to the new social customs and economic systems of the US, including health care services (Prus et al., 2010). Improving access to and use of health care is essential to address their needs. Several factors influence immigrants use of health services effectively. These include cultural beliefs and practices, English proficiency, and health literacy (Dressler & Pils, 2009; Garces et al., 2008; Lee et al., 2010). Healthcare providers must establish interventions to address the unique needs of these diverse populations. Understanding immigrants views of their experiences is necessary to create and implement these interventions (Graces et al., 2008; Valenzuela et al., 2013; Vincent et al., 2006). An interpretive phenomenological approach was used to examine the meaning that immigrant patients attribute to being in an IRF. The purpose of this study was to gain a better understanding of the experiences of immigrants in an IRF. Additionally, the study further aimed at exploring the factors that assist or hinder immigrants recovery and return home. The insights gained can be utilized to develop interventions to improve patient care and outcomes in rehabilitation settings. Methods Interpretative phenomenological analysis (IPA) was used in this study to examine the lived experiences of immigrants in an IRF. As defined by Smith, Flowers, and Larkin (2009), IPA is a qualitative research approach that aims to capture and explore the meaning that research participants assign to their experiences. Data in the study was collected through in-person interviews, which invite participants to offer a rich, detailed account of their experiences (p. 57). Data analysis with an IPA approach is an iterative and inductive process that is employed to 16 identify superordinate themes that reflect the lived experience of the participants (Smith et al., 2009). Recruitment I used a purposive sampling process to select ten patients from the inpatient rehabilitation program at the Alexian Rehabilitation Hospital (ARH). I identified potential participants by reviewing patient demographic information provided by the admissions office and from referrals by therapists whose patients were in the rehabilitation program. I met with the therapy team to identify patients who met the inclusion criteria. When immigrant patients meeting the inclusion criteria were within 4 to 10 days of their discharge, I invited them to learn about the study by scheduling an in person meeting with each potential participant to present information and answer questions about the study. Individuals recruited for the study were no more than 13 days from their anticipated discharge from the IRF and were scheduled for continued therapy services in the day rehabilitation (DR), outpatient (OP) therapy or home health (HH) programs through ARH after their discharge. Participants Participants were immigrants to the United States, at least 18 years old, with a native or primary language other than English. They were able to communicate in English or through an interpreter and had the cognitive ability to understand and respond to questions in a 30-minute interview as indicated by a Functional Independence Measure (FIM) rating of 5 or greater for the social interaction, problem-solving, and memory components of the FIM. Ten patients from the IRF agreed to take part in the study. The participants were migrants from nine different countries who had immigrated to the United States between 26 and 60 years before their hospitalization at ARH. Their ages ranged from 52 to 80 years (average age 66.2 years). Five of the participants 17 were admitted following a stroke and the remaining five had were admitted for such musculoskeletal diagnoses as hip fracture and total knee replacement (Appendix B). Study Design Data Collection Procedures I met with each individual and reviewed the informed consent document, answering all questions. Interpreter services were used if requested or needed by the participant, to translate the information on the consent form and assist in answering any questions asked by the participant. Translated versions of the consent form in five languages most commonly spoken by the patient population at ARH were also made available. Individuals who agreed to participate in the study were asked to sign the consent form (Appendix C). Before initiating the interview, I reviewed the study procedures and timeline to ensure that the participants were still interested in taking part in the study. Interpreter services were offered to all participants in the study. The interpreter service was available in person, or by phone/internet using ARHs interpreter services, depending on availability of the services and preference of the participant at the time of the interview. One participant requested an interpreter for the interview to ensure the participant understood the purpose and format of the study. The IRFs online service, using an iPad, was used to access an interpreter for this interview. I implemented data collection procedures similar to those described by Martin (2009). I obtained data through a single face-to-face interview using a semi-structured interview guide. The interview guide included close-ended questions to collect demographic information and open-ended questions, including probes, to elicit a comprehensive description of the experience of each participant (Appendix A). Open-ended questions enabled participants to describe ideas and experiences in their own words rather than respond to preconceived concepts of the 18 researcher. A second researcher reviewed the interview guide to ensure appropriateness and clarity of the interview questions before the use of the guide for a pilot study. Four individuals who met the inclusion criteria were interviewed to provide feedback about the clarity and suitability of the questions on the interview guide before the start of the study. I modified the guide based on additional insights gained through this process. Data collected from these patients was not analyzed or used in the study. I completed the interviews at the IRF dates and times convenient for the participants. The participants were interviewed at a location in the facility that was free from distractions and excessive noise. Nine of the ten interviews were conducted in English, and one was conducted through an interpreter accessed with the iPad at the request of the participant. The interview conducted with the iPad service was transcribed verbatim into English by a certified interpreter to ensure that the translation was consistent and correct. All of the interviews were audiorecorded and lasted for between 18 and 34 minutes, with an average length of 25 minutes. I took field notes during the interviews to document additional comments or observations during interviews. Informed consent forms, recordings of the interviews, and transcripts were stored electronically in password-protected files on the primary researchers computer. Field notes were stored in a locked file cabinet in the primary researchers office until transcribed. The transcribed field notes were stored electronically in password-protected files on the primary researchers computer. The participants identities were protected by substituting their names and other identifiers with alphanumeric codes. The electronic files and hard copies of information will be destroyed three years after the conclusion of the study. 19 Researchers Role As an occupational therapist, with more than 30 years of experience in a variety of adult physical rehabilitation settings, I was employed at the study site for over 17 years. Therefore, I am familiar with many aspects of patient care in an IRF. Consequently, I am familiar with medical and therapy interventions as well as educational methods and materials used at ARH for educating patients and their families. As a native born, English-speaking individual, however, I do not share an immigrants experience and perspective. I used the hermeneutic perspective of IPA to interpret the participants experiences through the participants own descriptions of those experiences (Smith, et al., 2009). In this study, I was both an insider, because of my clinical training and experience, and an outsider because of the lack of immigrant self-experience. As a result of this my background as a clinician could have contributed to preconceived ideas and expectations of patients experiences in an IRF. I used reflexivity throughout the study to be aware of my own biases and expectations about the participating patients experiences in rehabilitation. I journaled my personal reactions about participants comments and experiences recorded during the interviews, reviewing information during the data analysis process to ensure that I remained focused on the participants experiences as they were stated. Internal Review Board and Confidentiality This study was approved and completed in accordance with the procedures reviewed and approved by the Institutional Review Board of Board (IRB) at Alexian Brothers Medical Center and the University of Indianapolis. 20 Data Analysis I read and re-read the interview transcripts while listening to the recordings. I provided the participants with copies of the transcripts so they could read the interview text without my presence or potential influence. Follow-up meetings were offered to the participants to ensure accuracy of the transcripts, to clarify words or phrases that could not be identified during transcription, and to provide an opportunity for participants to offer feedback and ask questions. When face-to-face meetings were not possible, copies of transcripts were mailed to participants with requesting them to provide feedback in person, by phone, or in writing. At least two followup phone calls were made to the participants who did not return the transcripts within two weeks. I spoke face to face with four participants and by phone to an additional two participants. Four participants neither returned the transcripts nor could be reached by phone. After receiving feedback on the transcripts, I reviewed the transcripts repeatedly to develop preliminary codes describing the participants experiences. A three-column grid, as described in Saldaa, (2010, p. 17), was used to establish preliminary codes based on the participants comments. I grouped similar codes and supporting data into themes for each participant. The resulting themes were organized to allow a comparison and analysis of each participants themes and supporting comments. To examine the participants words to identify commonalities and differences in their experiences to develop final thematic ideas, I used a cross-case analysis process using a conceptually clustered matrix as described in Miles et al. (2014, p.173-178). Participants quotes that were identified for each theme during the cross-case analysis provided support for the resulting themes. A second researcher with expertise in qualitative analysis independently reviewed the codes and themes to enhance the credibility and dependability of the resulting themes. The two researchers discussed the themes and reached a 21 consensus on the final themes. An audit trail documenting the research and analysis process was maintained throughout the study to ensure the rigor of the study and reduce bias in it. Trustworthiness To establish the trustworthiness of the study, I engaged in reflexivity by keeping a journal of experiences and feelings during the study as a way of separating them from those of the participants. This step minimized the potential of personal experiences and biases to distort the meanings of the participant's experiences of the phenomenon (Cresswell, 2013; Henderson & Rheault, 2004). All participants reviewed written transcripts of their interview and offered corrections and revisions to their content as needed when participants came to ARH for their scheduled DR or OP appointments (Henderson & Rheault, 2004; Martin, 2009). If participants were not able to take part in a feedback session in person, I attempted to do so by phone, at a time of the participants choosing. Transparency for the study was increased by establishing an external audit trail for examining participants interview transcripts. Further, another researcher with a background in qualitative research provided peer review to confirm or refute my findings from this study. The iterative approach used in the study helped reduce bias by presenting opportunities to review the findings repeatedly to gain a better understanding of the participants responses and to bracket the researchers reactions more thoroughly. Dependability was addressed by describing the research process, presenting relevant aspects of this process including participants quotes and concepts that supported the themes that were identified. Participants demographic information and the inclusion criteria imparted transferability to the study. 22 Findings The purpose of this study was to examine and describe the experiences and perspectives of immigrants to the US as they completed their episode of healthcare at an IRF. Two themes emerged from my review and analysis of the participants responses during their interviews. The first theme, Understanding the Language and Life of Rehabilitation was derived from participants remarks that reflected their understanding of the daily routine on the IRF. These remarks focused on their day-to-day schedule, medical care, and therapy sessions. Participants also shared their views about the care they received and interventions they felt were most effective and useful in their recovery. The second theme, Trust and Decision-making in the Rehabilitation Experience, was developed from the participants responses about their interactions with healthcare providers and their families as they completed their rehabilitation. The participants conveyed their sense of trust and confidence in healthcare providers expertise in directing the course of their rehabilitation and facilitating their recovery. They also expressed feelings and concerns about their impending discharge, including thoughts about the support and assistance of their families when they returned home. Theme 1: Understanding the Language and Life of Rehabilitation The participants responses about their experiences during their admission reflected their level of understanding about the medical care, therapy sessions, and the day-to-day routine of the IRF. The participants varied in their ability to describe a typical daily schedule. Some respondents provided a more general overview of their day. For example, one participant (Female, 60) stated, Oh, so my routine activities here and plus ever, whatever Im doing it or only activities here? First thing I can tell like in this rehab center, since I came I get up 7 oclock, 7 to 3 23 my schedule is so tight, I cannot do here that, thats for sure. They keep me busy all the time. No matter what. And meantime, they careful for that too I get enough breaks. So, from the time when they start the schedule. How do you call that? Its in sequence. Another participant (Male, 65) made similar remarks, Oh, wake up, get part of your medications, mostly in my case, get your pain medication, and soon after it, get your food, breakfast. Have your breakfast, and then starts the rehabilitation service. Others offered more specific descriptions of the routine they experienced as one (Female, 70) explained, So, from the time when they start the schedule. How do you call that? Its in sequence like 8 oclock for OT, then PT 9 oclock or 9:30, and then the speech sometimes is in the afternoon, but also everythings in the morning and so by 12 oclock youre done. Although most participants comments were focused on their therapy schedule, several commented on physician and nursing care as well. The routine is they come, check on the person, how hes feeling, they take the temperature, blood sugar, then they do the medications, theyre supposed to have the medicine, they give you the medication, thats the nurse now and get the housekeeping come to look what I need in the room (Male, 68). Even though most participants were able to present their perspective of the daily routine in the IRF, several individuals had difficulty describing therapy and medical services they experienced during rehabilitation. For example, one participant (Female, 80) stated Uh, I dont know what theyre called. I dont remember what theyre called, like you know, all the therapy I got from them it's the ones that I needed what, but I dont remember the names. 24 Many participants indicated they preferred an active, hands-on approach to therapy, and especially therapy sessions associated with mobility or self-care and stated, Walking. Standing. Maybe, like kitchen, getting out of bed, trying out different chairs (Male, 55), ... the most I will say is that they have been teaching me how to walk, how to go to the bathroom (Female, 68), and Practice and how to walk how to walk with a walker, how to go stairs... The best was the practice. (Male, 75). The participants demonstrated their understanding of the goals of the various types of therapy they received by describing the differences in the services they received. One (Male, 65) participant remarked, Occupational therapy teaches you how to do [sic] in cases that you have to do something at home... The other is physical therapy, where it teaches you strength that you need to perform a certain task and, in a way, in a lot of ways, both are the same. Another (Female, 60) offered her perspective about the differences between PT and OT and the benefits of those activities in her recovery by stating, First impression was that I needed my legs not OT, I was thinking OT means upper body exercising, but then... when I, when they took me in the kitchen, and then they told me do this, do that. Like I to get stuff from the fridge, and put it on the dining table and then I realized its necessary too [laughs]. Its not only PT. The participants understanding of the purpose of therapy was also noted in their comments about the importance of the direct interactions they experienced with clinicians. Participants described how the instruction and feedback they received from therapists enabled them to understand the objectives and outcomes of treatment activities more readily such as: 25 Most effective think [sic] is when they show you what to do, a certain movement, and tell you why you have to do it. What does it do to your body, or to your well-being, which is what you need in the end result... When the therapists, takes their time to explain everything to you, because just Oh, you see this movement, just do it 15 times. Yeah, but Id like to know what the end result will be for me (Male, 65). Participants not only recognized the benefits and efficacy of the training they received through direct practice and repetition but they also expressed awareness that their relationship with clinicians helped them in the recovery needed for going home. One participant (Male, 68) noted The trainers I think theyre doing marvelous job, we get enough time, one hour is more than enough to work with the person. Another (Male, 52) stated I mean learning how to proceed and dealing with my injury thats the goal, and thats what everybody [referring to therapy staff] here is been doing. The participants reported similar perspectives about their relationship with the medical care staff. For example, one participant (Female, 69) said, I know the doctors and nurses were very nice for me they teach me, like, if sugar is low, I have to go drink or eat because to morning would be no good with that goes very low. Moreover, participants acknowledged their role in furthering their recovery by completing activities outside of therapy sessions, as indicated by (Female, 70) Its to follow the instructions they give me to do when I am in the gym. When I go back to my room to have simple exercises that they ask me to do. Despite the preference for a more active, movement-oriented approach to therapy, the participants acknowledged the value of other forms of instruction, such as printed materials, for carrying over training outside of treatment sessions with one participant (Male, 55) commenting: 26 Not harder no, maybe the one paper I got, yeah, thats very helpful because you go home and its like forgetting, youre getting everything of your own stuff, but if you get paper, the ones you give me, I should get some more stuff, the paper from the therapist. And it gives you more resources. Another participant (male, 68) had similar observations about materials he received from SP stating, They give me the papers and I have to answer it, and then they to check how Im doing. They dont let me know immediately, they will wait until the next day to give me the same work but a higher level and look what you didnt do yesterday, but now you do it. So, its like you improve yourself by answering. The majority of participants expressed their preferences for the treatment techniques used in their rehabilitation. One individual (Male, 65) was more assertive in expressing his likes and dislikes about the care he received stating his preference for one to one therapy, stating What I personally dont like when its mat therapy. A group of two, three, four or five people have to do everything with the same trainer. He had similar remarks about aspects of nursing care he did not agree with, commenting Oh, some of the things, they baby you. In my opinion, the nurses and their assistants plain and simple baby you. This individuals remarks are distinct from all other participants who expressed satisfaction with their care such as (Male, 68) Theyre complete helpful, especially this, the trainers, they know what to do, and they do it from the beginning slowly. Just as some participants had difficulties in describing the daily routine of rehabilitation, several individuals also commented on the challenges they encountered in understanding the instructions they received during their therapy sessions. One participant (Female, 68) stated, 27 Well, I think that it [using an interpreter service via iPad during therapy] is something good because, in other ways, we wouldnt be able to do the therapy. Another (Male, 68) stressed the need for demonstration by therapists and repetition to facilitate learning the skills in the PT that he had experienced, commenting, Sometimes I can miss communication [sic] Like okay, now were going to do step up, step down. I get confused, what you do want me to step up where or you know, so no, its like I show you, one step up, one step down, like you walk, like dont drag your feet, its like I couldnt understand exactly maybe, because she thinks I know it, but I have to more, to more explanation [sic]. A participant (Female, 69), who stated that she typically spent up to six months of the year in her home country of Poland, shared the following about her speech therapy activities, She tell me story, she have to ask me about the story, yeah, I have to remember, but I remember, but sometimes was problems with the English language because I talked to her. Theme 2: Trust and Decision-making in the Rehabilitation Experience The participants responses throughout this study illustrated their trust in the judgment, efforts, and recommendations of the healthcare providers at ARH. They articulated their beliefs that their caregivers were knowledgeable and attentive to their needs and ascribed much of the progress they made during their admission to the staffs care. The participants expressed this trust and confidence in their care providers in a number of ways. Several participants used more general terms to express their feelings such as one (Female, 68) who remarked Well, I think that I will say its good because you [therapists, doctors] are ones that know how to do those these things, and if you are here its because you know how to do all those things when describing interventions by various clinicians. Other participants were more explicit about their trust in the 28 health care provider, as indicated when one participant (Female, 80) remarked Their dedication. Theyre, you know, very dedicated to me, so you know that I can trust the way they are, I feel very, that I trust the doctor. Another (Male, 75) said I dont know with some other people, but the people [therapists] I have experienced, everybody know what to do, and everybody doing right. Some participants specifically spoke of their trust in the expertise provided by doctors and nursing staff, one (Female, 60) commenting: Ahhh, if they both [the doctor and the nurse] doing the same day but Im more satisfied the doctor see that, or the nurse, you know, doctor is doctor, nurse is nurse. I know that, but still even the nurses say Oh, you are okay but still when the doctor say, I feel more comfortable and more trusting kind of. Like a kid does something in cooking and then you say something and mom says, oh yeah its good and then father says oh but its all great both of them in a like that kind of confidence. Others had similar observations about Allied Health staff, with one participant remarking ... I think OT, PT, and SP therapists they know their own field and they, its a different form of teaching, the different fields, its just different (Female, 70) and another saying Theyre complete helpful, especially this, the trainers, they know what to do, and they do it from the beginning slowly (Male, 68). A patients ability to take part in decision-making can influence their understanding of the purpose of these activities and ultimately affect their capacity to achieve goals set during their admission. Participants expressed faith in the skills and interventions of healthcare providers at ARH. They acknowledged that clinicians of all disciplines directed their care process, with participants providing limited input to this aspect of their care. Deference to 29 clinicians judgment and recommendations was reflected when participants repeatedly used the word they, as stated by one individual (Female, 68) they [therapists] telling me, helping me, teaching me when referring to the training she received. Though occurring less frequently, the participants recounted similar experiences of trust in the care they received from physicians and nurses. As one participant (Female, 60) stated, Yeah, the doctor teach me how to stretch your legs early morning when you get up before you go to therapy, yeah. He teach me, no doubt about it. Participants not only expressed their confidence in the skills of clinicians in the rehabilitation program but they also indicated they felt that following instructions of the clinicians was essential to their recovery, as noted by one participant (Male, 52), You have to be patient, and learn, and cooperate with, with the therapists, and follow what they say, in order for my benefit to be better. Another (Male 68) stated, Just to listen what the instructor tell me, and do it exactly, because they been doing it to so many patients. Im not going to come here to not listen, because I want to get me in shape so I can go home. So anything they tell me, [emphasis added] Ill start giving more attention and dont aggravate them, or something making them upset. The minute that Im in the train [sic] with that person, I have to keep my ears openand they know they what to supposed to work with me theres no choice for me to say No, I dont want to, I have to listen, and okay, and we go through it together. [emphasis added]. Although most participants acknowledged that they provided little feedback to the clinicians on the directions they gave during therapy, one individual voiced a contrasting point of view. The participant, (Male, 65), who earlier emphatically expressed his preferences for individual rather than group treatment sessions, also conveyed his perspective about the methods 30 of instruction he expected from therapists during his sessions, saying: When the therapists, takes their time to explain everything to you, because just Oh, you see this movement, just do it 15 times. Yeah, but Id like to know what the end result will be for me. This participant also described why he felt it was important for a patient to be actively involved in the rehabilitation process stating: In therapy, I think that we have as patients, we have also to give feedback to therapists, what is helping us, what we dont need what is too difficult, maybe to change the ways, but we have to give feedback because therapists cannot read minds and they wont be able to help us. This remark is consistent with other participants who acknowledged they also had responsibilities in their recovery such as: To me everything, I mean, I keep saying everything, everything is very important because I learn, I learn every day when they come out with something, I learn, and I put it in practice. And I do it because I know its all my own benefit. Because thats going to help me out to get better (Male, 52). Another (Female, 80) stated: the way Im learning here, its really that you know, its with patience Im going to be able to do because Im, I was always the way I wanted do it, where I, everything that I want to do, and to recuperate from this injury, thats what I want. The participants perspectives of trust in the inpatient rehabilitation process that they experienced were also reflected in their responses about preparations for discharge from the IRF. The participants revealed a range of feelings and concerns about their level of recovery and independence, from confidence to uncertainty. One (Female, 60) noted the progress she made 31 during her rehabilitation and how she believed it helped her be ready for home. Im ready, Im prepared, and I feel more like, Im oh, and I can go home and I can do much better than before. Another (Female, 80) remarked Well, all the exercise, the therapy you know, made the possibility for me to go home because I really, I really am much more better [sic] than when I came in. Even though the majority of participants acknowledged the improvements they made and conveyed a sense of eagerness to go home, several participants mentioned feelings of uncertainty about their readiness for discharge. Several participants indicated that they believed they had not recovered fully during their admission as one (Female, 70) reported: I think Im maybe prepared not 100%, maybe 85%. Another (Male, 65) stated, I am scared of going home and at the same time excited I hope that I will be 100% prepared but it will never happen, because it never works out the way you want to. [emphasis added]. Participants also voiced faith in their families willingness and abilities to assist them at home following their discharge home. One participant (Male, 68) stated, Theyre excited. [Laughs]. Theyre excited. And they know its a challenge to make it safe for me in there, they know the house is big, and a lot of stairs, maybe slippery floor. They were already talking about having everything ready for that So, theyre all willing to give the extra hand. Somebody be at home with me, somebody, hour I need help with anything in there However, just as some participants conveyed a sense of apprehension about their readiness to go home, some also expressed uncertainty about their families preparedness. One participant (Female, 68) related I just hope that my family is going to be able to take care of me and they are going to do as much as they can as well, so I can be well. Another participant 32 (Male, 65) voiced similar concerns stating My wife is excited, and she is kind of nervous about me coming home but, its her job. If you can say that about the wife. Most participants also recognized their own role for continued success in recovery by acknowledging they had a personal responsibility following discharge. One participant stated, I know I have to be busy and not sitting back and thinking (Female, 69). Another (Male, 68) reported, they told me you going to go home, you did a marvelous job, but remember, if you stop of [sic] training at home or if you start eating salt food [sic] or getting your sugars up, you can come back. Another participant acknowledged: Well, they are explaining me all the things that weve been doing, thats to protect me, and to keep me safe, and then all those things Ive been learning here, I put in practice at home. Even though if myself, but I know I have my wife at home and that she will help me 100%. So, whatever they are telling me, its is just to get well and to get strong and trying to get me back to what I was (Male 52). In contrast, other participants appeared to be more willing to depend on the assistance of their families following discharge home. One participant (Female, 80) commented Happy, theyre [referring to her family] happy you know, theyre willing to help, as a matter fact today they got a little experience to be, you know, the way to act when Im home. Another participant (Male, 55) said, My mother do everything for her little boy. My father, the same thing, even things that are not 100% like walking. Summary of Findings The participants responses regarding their time in the IRF revealed differences in how they perceived and understood their experience. They expressed clear preferences for treatment that incorporated physical activities and indicated their readiness to follow the directions of the 33 healthcare professionals they encountered. Several participants described difficulties understanding information presented in English, although this did not appear to negatively impact their perspective of or participation in care. The participants understanding and perspectives of their care also reflected the trust and collaboration they developed with their healthcare providers. This demonstrated their belief that the healthcare providers interventions helped them in their recovery and prepared them for discharge from the rehabilitation program. The trust they experienced may also have been a factor in the participants limited role in the decision-making process for their care, as they described deferring to the expertise and directions of their caregivers in selecting care and treatment activities. Although several participants voiced a degree of uncertainty about their abilities and readiness to go home, the participants expressed appreciation for the training they received in preparation for discharge and of the assistance and support from their families at home. Discussion Theme 1: Understanding the Language and Life of Rehabilitation The first theme, Understanding the Language and Life of Rehabilitation can be explained by two primary concepts. The first of these concepts is based on the participants understanding of daily routine in the IRF and experiences with the care they received during their admission. The participants differed in their ability to describe a typical day in the rehabilitation program. Some were able to identify specific aspects and offer a detailed account of their routine, while others were unable to do so or could provide only a vague description of their schedule. There are no studies exploring patients understanding of the overall expectations and format of an IRF. However, as an occupational therapist with extensive experience in inpatient rehabilitation, I have encountered instances in which patients, regardless of their background, have difficulty 34 appreciating the purpose of their admission to an IRF and understanding the different roles and responsibilities of healthcare providers in the program. Several factors can affect an individuals perception of different aspects of their admission to an IRF. For example, an IRF has requirements for admission that are different from many other levels of care. These include regular participation in three hours of therapy, as well as the need to follow a structured schedule for many activities, from meals to therapy sessions. In addition, patients may be engaging with healthcare providers whose functions are unfamiliar to the patients, such as occupational and speech therapy. Although all aspects of a rehabilitation program are important in a patients recovery, therapy interventions to improve a patients functional status are a primary reason for an individuals admission to an IRF. The participants responses about therapy intervention during their admission revealed that they considered regaining mobility or upper extremity (UE) function a focus of their rehabilitation. Many of the participants viewed improved mobility, in particular, as a primary indicator of their recovery and as a skill essential for achieving their goal of returning home. This phenomenon is not unique among the experiences of the immigrant participants in this study. Native-born patients of in- and out-patient rehabilitation programs also identified physical activity, and especially those that focused on body functions, such as walking and balance, and improving motor skills, such as arm and leg control, as the most important aspects of their rehabilitation (Galvin et al., 2009; Gustafsson & McLaughlin, 2009; Jppinen et al., 2017; Luker et al., 2015). Although the participants in the current study commented more frequently on the activities for improving overall motor abilities, they also acknowledged the benefits of therapy that addressed functional skills. Several participants noted that by engaging in treatment 35 activities, such as homemaking, they gained a greater appreciation of their limitations and how these interventions would facilitate their return to home. Researchers also found that when patients worked on meaningful and functional tasks that they encountered at home, it helped them regain their previous level of activity (Gustafsson & McLaughlin, 2009; Luker et al., 2015). In contrast to responses about the benefits they perceived with functional interventions, several participants voiced dissatisfaction with rote activities such as tabletop UE exercises during therapy sessions. However, the participants stated they gained a better understanding of the rationale for these exercises when therapists took time to explain the role these activities played in their recovery. These findings are similar to those found in Luker, which reported that efforts by therapists to communicate the role of seemingly menial and repetitive exercises in the recovery process assisted in patients understanding the value of these activities (Luker et al., 2015). The participants in the current study not only articulated an understanding of various types of therapy they received, they also expressed their preferences for how training should be provided during their sessions with allied health clinicians. The participants preferred individual versus group therapy, with activities gradually upgraded to be more challenging and intensive as they progressed. The participants believed one-to-one therapy sessions provided a better opportunity to understand the purpose of activities because the interventions were more individualized. Moreover, they felt therapists were more attentive to their needs and provided demonstration, repetition, and feedback more easily during one-to-one sessions. Davenport et al. (2019) also reported that patients were most receptive to demonstration, practicing tasks while being observed by clinicians, and treatment that was progressed over time. Tholin and Forsberg (2014) found that native-born patients in a rehabilitation program were most satisfied when the 36 rehabilitation was intense, specific, varied, gradually increasing in intensity and was conducted by professional staff as well (p.825). The participants of this study not only expressed their preferences for individualized, daily therapy sessions, several participants also stated that completing activities outside of their regularly scheduled treatment, or homework, from therapists helped them carry over training from therapy. Galvin et al (2009) and Luker et al. (2015) found that patients believed they could have benefited from more intensive and frequent physiotherapy than they normally received and that being able to do so would have hastened their recovery. In addition to having activity outside of therapy sessions, participants also acknowledged the benefits of receiving printed materials from staff. The participants believed these helped them recall and complete treatment activities when staff were not present and that it would help continue their recovery after discharge home. Jappinen et al. (2017) support this finding, noting that native-born post-surgical patients found printed materials to be beneficial in carrying over training following therapy. Therefore, it may be assumed that this preference was not unique to an immigrant in an IRF. Most of the participants commented on the value of therapy activities in the gym like strengthening or walking, and functional tasks like homemaking. However, few participants remarked about their experiences completing Activities of Daily Living (ADL) even though this part of therapy interventions comprised a primary emphasis of OT in the IRF. Although there is little research about patients perspectives of OT in rehabilitation, Jappinen et al. (2017) reported that patients might not mention the importance of practicing ADL skills due to their limited interaction with OT during their admission. Jappinen contended that this was due to a decreased emphasis on addressing daily living skills for these patients during their admission. The findings in Jappinen contrast with the experiences of participants in the current study who engaged in 37 regularly scheduled ADL sessions with OT throughout their stay in the IRF and still did not mention ADL as a significant experience during their admission. It is my experience that many patients do not fully understand the purpose of OT in a rehabilitation program, especially as it relates to interventions like ADL. I have observed that patients often view ADL sessions with OT as an extension of nursing care to help them get ready in the morning, rather than skilled interventions to assist them in regaining functional independence in self-care. These misperceptions persist even though patients participate in extensive ADL sessions with OT throughout their admission. Further research could aid in identifying factors that contribute to patients limited appreciation of the role of OT in facilitating their independence in performing the ADLs in a rehabilitation setting, regardless of whether the patient is native-born or an immigrant. The participants also mentioned interactions with nursing and medical care less often than participating in therapy sessions. Overall, the participants responses showed a greater awareness of the purpose of therapy activities compared to their understanding of nursing or medical care. The limited descriptions about the involvement of nurses and doctors in their care may have resulted from participants spending consistent, scheduled time with therapy staff, increasing their familiarity with clinicians and therapys role in the rehabilitation process. The participants were typically scheduled for a daily routine of three hours of therapy, which were usually completed with the same clinician every day. In contrast, contact with medical staff and participants was often unscheduled and fleeting, which may have impacted their appreciation of the tasks these healthcare staff provide in the IRF. Tyrell et al. (2012) reported that native-born patients in inpatient rehabilitation often express a decreased appreciation of nursing even though they understand the day-to-day nursing 38 activities. Patients acknowledged that the nurses provided assistance or supervision and also encouraged the patients to complete their routine tasks independently (Tyrell et al., 2012). The participants in the current study voiced similar thoughts about the support they received from nursing staff during their recovery, demonstrating their understanding of the role of nursing in an IRF may not be different from patients who are native-born. The immigrant participants not only expressed their understanding of and preferences in their care while in the rehabilitation program but also described the therapeutic relationships with healthcare providers they experienced. Although one participant voiced dissatisfaction with participating in group therapy sessions and that he felt nursing staff babied him, the participants generally expressed satisfaction with all aspects of the therapy and medical care they received. The participants stated that therapists wanted them to get well, that the doctors were nice, and that they couldnt expect more than that from the program. Patients in IRF often believe they are actively involved in their care and valued as individuals when they can express their concerns, understand their condition and treatment options and feel they are understood by the care providers. Their interaction and connection with healthcare providers also influence how engaged they are in their care and how much responsibility in the rehabilitation process they assume (Jppinen et al., 2017; Luker et al., 2015; Peiris et al., 2012; Siouta et al., 2016; Tholin & Forsberg 2014; Tyrell et al. 2012). The participants attributed their progress in rehabilitation to the relationships they experienced with staff as well as the effectiveness of treatment approaches they experienced, recognizing how clinicians skills and feedback helped their recovery. Davenport et al. (2019) described similar findings, noting that Therapists who offered patience, praise, encouragement, belief, feedback and motivation were highly regarded by patients (p.1971). Jppinen et al. 39 (2017) and Tholin and Forsberg (2014) also reported that patients believed feedback about their progress was essential to recovery. In addition, they expected therapists to assist them with overcoming uncertainty about completing exercises and provide guidance and adequate time to learn the exercises. The second concept that emerged from immigrant participants responses illustrated the impact of communication and language skills on their experiences. I anticipated that the participants language skills would exert some degree of influence on their ability to communicate with the IRF staff in English and anticipated that several participants might need interpreters for the interviews. However, this did not happen. Only one participant in this study requested for an interpreter for the interview. However, several participants did need to have questions rephrased or re-stated to facilitate their responses. This may indicate that some participants experienced limitations in understanding and using English, especially for verbal communication. However, the lack of language skills did not prevent participants from answering questions or expressing their thoughts during the interviews when these steps were taken. Although the participants language skills did not prevent them from expressing themselves during the interviews, several participants expressed difficulty understanding directions given during therapy sessions. This may be a reflection on the participants literacy or lack of fluency in English because most instructions would have been provided verbally as they engaged in treatment activities in the therapy gym. There is no research examining the impact of limited English fluency on patients experiences. However, Easton et al. (2013) found that even for patients whose primary language was English, and who could communicate with the health 40 providers in English, low health literacy was an obstacle in their interactions with healthcare providers. Easton et al (2013) also found that patients with low literacy were sometimes deterred from asking questions or would at times feign understanding of care-related information for the fear of disclosing their lack of understanding. I have observed instances in which patients in the IRF responded similarly, indicating an understanding of a task or instructions, while their subsequent performance of the, yet their subsequent action or behavior was not necessarily accurate or complete. The participants of this study did not report concerns about understanding their care or being unable to request healthcare providers to clarify training. On the contrary, the participants said they felt able to ask for and received additional instruction and demonstration from staff whenever it was needed. The participants noted the healthcare providers made specific efforts to demonstrate or clarify instructions that enabled them to comprehend more fully the instructions they received. Theme 2: Trust and Decision-making in the Rehabilitation Experience The immigrant participants perspectives about interaction and collaboration with healthcare providers and family during their stay, and in preparation for their discharge home, were the focus of the second theme of this study, Trust and Decision-making in the Rehabilitation Experience. Based on the findings of this study, immigrants in the IRF placed a considerable amount of trust in their healthcare providers. All the participants in the current study expressed the confidence they had in the ARH healthcare providers ability to provide effective therapy and medical interventions. Although there is limited research about the role of trust in facilitating patient care, the immigrant participants trust in the efforts of healthcare providers at the IRF is supported by several studies. Patients use trust to evaluate the quality of 41 the services they receive (Berhardson et al., 2017; Nygrdh et al., 2011; Taylor et al., 2019). Patients in a study by Berg et al. (2012) reported gaining a sense of security because they could get advice and speak to professionals who understood their condition (p.212). Nygrdh et al. (2011) and Peek (2009) noted that confidence in the skills and decision-making of clinicians was essential to building a patients sense of ability and independence because they were confident they were receiving the best care possible. Some participants expressed that they had difficulty understanding therapy instructions. Nonetheless, all participants expressed a sense of carrying on a dialogue with clinicians during treatment and being respected by staff. The collaboration formed with healthcare providers during their rehabilitation also increased their involvement and motivation. Peek et al. (2009) also reported that clinicians interpersonal skills are important in creating an environment where patients feel comfortable expressing their concerns, being honest about adherence, and playing a more active role in health-care decisions (p.1138). Patients have expressed that consistency in care from staff helped them get to know the healthcare providers as individuals and to gain a better sense of their clinical skills. As a result, these patients felt there was no need to question the knowledge and decisions of staff. This provided them with a greater sense of security in how their care was handled (Jppinen et al., 2017; Nygrdh et al., 2011; Siouta et al., 2016; Taylor et al., 2019). The immigrant participants remarks about decision-making during their rehabilitation emerged clearly in the findings. The participants statements indicated they deferred to healthcare providers in the IRF when determining goals for home or when identifying treatment activities to attain those goals. These findings are in contrast with current perspectives concerning patient participation in decision-making. Client-centered care requires that clinicians 42 share decision-making to ensure that the healthcare provider, patient, and family members make a healthcare decision that is best for the patient. The optimal decision takes into account evidence-based information about available options, the clinicians knowledge and experience, and the patients values and preferences (Agency for Healthcare Research and Quality, 2014, The SHARE Approach). The recommendations of the SHARE Approach are supported by Luker et al. (2015) who reported that establishing a partnership among clinicians, patients, and their families enabled treatment goals and interventions to be tailored to an individuals unique needs and capabilities. This also contributes to patients experiencing greater engagement in treatment because they helped determine their treatment goals (Lindahl et al., 2013; Nygrdh et al., 2011; & Taylor et al., 2019). Most participants expressed a perspective that staff knew best about selecting and directing interventions. The trust participants had in healthcare providers and their skills may have facilitated a willingness on their part to forgo offering input, having confidence that the clinicians judgment and expertise would assure that appropriate interventions were carried out. This is consistent with my experiences as an occupational therapist in inpatient rehabilitation. Patients in these instances deferred to therapists in determining goals and treatment activities based on their perception of a therapists clinical knowledge and experience in providing treatment interventions. Researchers have reported that while some patients want to be actively involved in decision making, others prefer to leave decisions to the therapist because clinicians were viewed as experts, with patients deferring decision-making to care providers expertise (Berhardsson et al., 2017; Kringen et al., 2011; Tholin & Fosberg, 2014). Although the participants statements indicated a limited role in decision-making, they described the interaction and communication they experienced with clinicians as effective in 43 meeting their needs. Facilitating participation in decision-making requires that healthcare providers make relevant information available to patients to create an environment in which a patient feels able and willing to assume responsibility to take part in making choices about their care (Kringen et al., 2011). Patients often report that the timing and quality of communication from healthcare providers in a way they readily understand is essential for them to participate in the decision-making process. This communication offers a way for clinicians to confirm the level and accuracy of a patients knowledge about their condition, and if it is adequate to make informed choices (Gill et al., 2014; Ibrahim et al., 2019; Lamontagne et al., 2019; Lindberg et al., 2013; Peek et al., 2009). The participants in the current study did not report participating in decision-making in the IRF in this manner. However, their remarks demonstrate the participants belief in the staffs efforts to ensure that they understood the care and training they received. Barriers to patient involvement in decision-making can result from organizational or clinician-based approaches to interventions they provide (Elwyn et al., 2012; Levack et al., 2011; van Seben et al., 2019). Patients participation in their care can also be affected when they do not fully understand the information that is provided. Native-born patients report feeling disempowered or dissatisfied with their care more frequently due to difficulties comprehending and processing information from clinicians, especially when it is given verbally. As a result, these patients report greater confusion and uncertainty about their care and feel unprepared to make healthcare decisions (Ibrahim, et al., 2018; Nygrdh et al., 2011; Peek et al., 2009). In contrast, the immigrant participants in the current study did not report that their care was negatively affected by difficulties they encountered in communicating with the IRF staff. Several participants did note that they experienced problems in following instructions in therapy, especially when these were given verbally. However, these participants also described the steps 44 healthcare providers took to provide increased time, demonstration, and practice in therapy to overcome any problems the participants experienced in understanding their care. The participants comments revealed not only their thoughts about the training they and their families received in preparation for going home. Their remarks also illustrated the anticipation, confidence, and in some instances, uncertainty they felt as their discharge approached. Differences in the perspectives about expectations of patients recovery by healthcare providers on the one hand, and patients and their family caregivers on the other, can arise as discharge from an IRF nears. Patients and family caregivers may focus on getting better, with the expectation they will remain in the IRF until they fully recover. On the other hand, healthcare providers may establish goals aimed at hastening the patients return to a community level setting or to enable patients to meet organizational and financial constraints (Levack et al., 2011; van Seben et al., 2019). These differences present challenges to the patients and their family members who are then faced with addressing residual limitations as well as the need for more assistance or modifications at home (Lutz et al., 2011). Patients want to become independent in self-care to go home as soon as possible and anticipate they will not be discharged until they regain the skills needed to be self-sufficient (van Seben et al., 2019). Several participants in the current study had similar perspectives. These participants stated that they had hoped to recover functionally more than they had before being discharged. They also expressed the view that remaining in the rehabilitation program for additional time could help regain their prior level of function. Others voiced concerns that their residual limitations in dayto-day activities would place a greater burden of care on their family. Addressing these concerns requires presenting opportunities for patients and their families/caregivers to practice tasks with the therapist prior to discharge. Participants in the 45 current study commented that their training in the IRF was beneficial and prepared them to manage themselves safely at home. Jppinen et al. (2017) also reported that native-born patients felt they gained confidence in mobility they needed to be independent as a result of the PT they received. These patients believed that therapy enabled them to move and complete tasks, such as negotiating stairs at home, more safely and with less effort. Lamontagne et al. (2019) reported patients were satisfied with the training and information they received, and that it helped them get ready for the next phase in their rehabilitation. Several participants recognized they would need at least some level of assistance from their family initially due to residual limitations in their functional abilities. Some participants expressed uncertainty about their familys overall readiness. However, all of the participants appreciated their familys willingness and dedication to helping them when they returned home. They stated that the training they and their families received in preparation for their discharge was useful because it enabled them and their families to have a better sense of each others capabilities and responsibilities in the home. Research into education processes that facilitate patients discharge is limited. Even though many patients regain independence in some aspects of their lives, there are instances in which patients continue to need assistance in some form when they are discharged from an IRF. Tholin and Fosberg (2014) also found that patients felt that family and others were essential for social support and assistance with day-to-day tasks after they went home. Strengths and Limitations This study has several strengths including the qualitative research approach used in it examines the participants experiences and points of view. Interpretative phenomenological analysis (IPA) is an approach that examines how people try to make sense of significant life 46 experiences. IPA endeavors to do this by exploring the meaning of those events as defined and described by the individuals experiencing them. (Smith et al., 2009). The use of IPA was effective in bringing forward the immigrant participants experiences in the IRF and the meaning each one of them placed on those experiences. IPA also enabled me to incorporate my knowledge as an OT about interventions and care commonly used in a rehabilitation program to facilitate interpreting the participants responses. This clinical expertise enabled me to establish insights into the immigrant participants' experiences of the rehabilitation process for at the IRF and how these might compare with native-born patients. Trustworthiness and credibility of the findings was assured by utilizing reflexivity, verbatim quotes to establish detailed participant descriptions of their experiences, member checking, and peer review of interviews and analysis during the study. The diversity of the participants is also a strength of the study, as it made it possible to explore a wider range of views and experiences, offering a richer perspective of those experiences for the study. At the same time, interviewing individuals from a single program contributed to establishing an understanding of differences and similarities in the participants experiences. The description of the participants and the analysis techniques used in the study also helped to establish findings that are transferable to similar studies. There were also limitations to this study. The diversity of the participant group, while offering the strengths noted above, limited how well the studys findings might be applied to specific or larger populations, as does the fact that the participants were selected from a single rehabilitation program. The number of years the participants resided in the U. S. (39.7 years on average) may have diminished the impact of being an immigrant, as the participants would have had more time to assimilate American social and cultural practices compared to more recent immigrants. The length of time that the participants have spent in the US may have also enabled 47 them to gain a higher level of proficiency in English. As a result, their language skills may lessen the studys applicability to immigrant populations whose proficiency in English, especially related to healthcare, is more limited. Finally, while the researchers background as a clinician may have facilitated understanding of the rehabilitation process and patient experiences, the participants knowledge of the researchers clinical role in the program may have affected their responses in the interview process. Conclusion The perspectives of immigrant patients in an IRF were examined in this study to gain a better understanding of their rehabilitation experiences. Two primary themes emerged in this study: understanding the language and life of rehabilitation, and trust and decision-making in the rehabilitation experience. Most of the participants understood the routine of the IRF as well as the training and care they received. This enabled them to participate effectively in their care, which contributed to their satisfaction with the rehabilitation experience. Several participants described difficulties they encountered in understanding some aspects of their care, and especially when receiving verbal instructions during therapy sessions. These situations illustrated the impact that language skills can produce during rehabilitation. However, the participants also conveyed their perspectives that the communication and collaboration with clinicians helped them to overcome these obstacles as and when they arose. This suggests that even though language and communication presented challenges in some instances, it did not detract from the participants experience on the IRF, limit their recovery or delay their discharge home. The participants did not state whether they were encouraged to take part in determining goals and activities for their care in the IRF. The participants did express trust in the expertise 48 and judgment of the staff to provide effective interventions in the IRF. As a result, the participants may have been more willing to defer to healthcare providers in decision-making and directing care during their admission. This sense of trust also extended to their feelings about the training they completed in preparation for their discharge from the IRF. The findings of this study indicate that being an immigrant did not have a significant impact on the participants understanding of and ability to take part in the rehabilitation program. However, challenges in communication and the limited role in decision-making that the participants experienced point to potential areas for improvement in patient care. It is critical to recognize the impact of a patients fluency or mastery of the English language when considering their participation in the decision-making process. For example, if therapists have a good understanding of their patients capabilities, they can provide the appropriate level of assistance or instruction. Incorporating language and literacy assessments, such as the Basic English Skills Test (BEST), Rapid Estimate of Adult Literacy in Medicine (REALM) or the Test of Functional Health Literacy in Adults (TOFHLA) into the evaluation process could help identify individuals with limited fluency or literacy in English. These measures can then aid in the development of techniques and strategies to mitigate the impact of limited language skills in patient care. Increasing patient participation in decision-making is an important element of patientcentered care. A greater understanding of patients experiences can facilitate implementing measures to insure patients are able to take a more active role in decision-making regarding the care they receive. Clinicians can incorporate measures to understand factors that influence the decision-making process, such as recognizing the impact of patients culture and language. Clinicians can also take steps to increase patients understanding of the objectives of an admission to an IRF as well as the importance of a patients participation in determining goals 49 and activities during their stay. The model proposed by Elwyn et al. (2012) or assessments such as the Canadian Occupational Performance Measure (COPM) may offer ways to put shared decision-making into practice on a more systematic basis by healthcare providers and patients, and ultimately, ensure a more consistent and higher level of care to these patients in all settings. Future studies could establish a better understanding of the impact of language and communication by modifying the inclusion criteria to focus on individuals who have lived in the US for a shorter period, for example, five years or less, or those for whom English is not their primary or preferred language. This may produce markedly different responses than were found in the current study, as individuals who are more recent immigrants have less time to become assimilated, to establish a functional level of proficiency in English, and have less exposure to and familiarity with the US healthcare system, all of which could impact their experience of receiving rehabilitation services. A study that includes matched groups of native-born and immigrant patients could provide another means of determining the impact if any that language or cultural backgrounds might have on the experiences of individuals in an IRF. 50 References Agency for Healthcare Research and Quality. (2014). April 2014 | AHRQ Pub. No. 14-0034-1EF. Retrieved August 15, 2020, from https://www.ahrq.gov/health-literacy/professionaltraining/shared-decision/tools/factsheet.html. Berg, S. K., Pedersen, B. D., Svendsen, J. H., Zwisler, A-D., Kristensen, L., & Pedersen, P. U. (2012). COPE-ICD: Patient experience in an ICD specific rehabilitation programme. European Journal of Cardiovascular Nursing, 11(2), 207215. https://doi.org/10.1016/j.ejcnurse.2011.03.005 Berhardsson, S., Larson, M. E. H., Johansson, K. & berg, B. (2017). In physio we trust. A qualitative study of patients preferences for physiotherapy. 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A qualitative study of patientcentered goal-setting in geriatric rehabilitation: Patient and professional perspectives. Clinical Rehabilitation, 33(1), 128140. https://doi.org/10.1177/0269215518791663 58 Appendix A Interview Guide Name/ID of interviewee: Interviewee age: Interviewee gender: Location of interview: Date of interview: May I ask about your education? Do you work? Do you live with family? When did you come to the United States? 1. How would you describe a typical day in the rehab program to a friend? 2. What kind of teaching are you receiving from the doctors and nurses? 3. What therapy are you receiving? (Discuss each therapy named by the patient). Tell me about your experience in ________therapy. 4. What types of teaching/instruction are you getting from them (hands on, written, verbal)? 5. What things make it easier, or make it harder, for you to understand the care you receive? Can you tell me more about them? 6. Is there anything you feel could be changed for your care? Can you tell me more about it? 7. Tell me more about going home. What are your expectations when you get home? How well prepared do you feel you are to leave the hospital? 59 Describe things the doctors/nurses/therapists are doing to help you get ready for home. 60 Appendix B Participant Demographics ______________________________________________________________________________ Interview/ Gender Years in US Age at arrival in the US Preferred Language Nationality Age 1 (F) 2 (M) 3 (F) 4 (F) 5 (F) Mexican Palestinian Filipino Polish Italian 26 46 45 36 60 42 22 25 33 21 6 (M) Columbian 68 68 70 69 80 55 30 25 Spanish English English English English English 7 (M) Hungarian 52 30 22 English 8 (M) Ukrainian 65 37 28 English 9 (F) Indian 60 33 28 10 (M) Polish 75 54 21 66.2 Avg. 39.7 Avg. Diagnosis Length of Stay 15 days 8 days 16 days 24 days 16 days English Stroke Stroke Stroke Stroke Hip fracture Pelvic fracture Multiple Trauma R foot Transmetatarsal amputation R TKA English Stroke 20 days 23 days 8 days 33 days 16 days 26.7 Avg. ______________________________________________________________________________ *Note Median age is 33 61 Appendix C ALEXIAN BROTHERS HEALTH NETWORK Alexian Rehabilitation Hospital Consent Form and HIPAA Authorization to Participate in Research Title: Immigrant Patient Care Experiences during Rehabilitation Principal investigator(s): John M. Dudzik, MHS, OTR/L Funding Source: None Introduction: You are being asked to take part in a research study. This document has important information about the reason for the study, what you will do if you choose to be in this study, and the way we would like to use information about you and your stay on the rehabilitation unit. What is the study about? The purpose of this study is gather information about the healthcare experience of patients in the rehabilitation program at Alexian Rehabilitation Hospital. The aim will be achieved by completing interviews from recent patients of the program. Why are you asking me? You are being asked to participate because you because are currently a patient in the rehabilitation program and are about to be discharged home. What will you have to do if you agree to be in the study? If you consent to participate, you will be interviewed in person by the researcher, John M. Dudzik, before you are discharged from the rehabilitation program. The interview may take up to thirty (30) minutes and John M. Dudzik will ask you questions about your experiences as a patient. 62 After the interview, a typed word-for-word transcript of the interview will be provided to you in a printed form, and you will be asked to check the transcript for accuracy, or to clarify or expand on discussed topics as appropriate. An additional meeting with the researcher, John M. Dudzik, will be scheduled and you will be asked to provide your feedback on the interview transcript. The review may take up to thirty minutes. If you are unable to participate in a face-to-face meeting to review the transcript, a copy of the transcript will be mailed to you. You are asked to provide feedback by phone or in writing. The total time requirement for participation in the research study will be approximately two to three hours. Is there any audio or video recording? This research project will include an audio recording of the interview. The recording will be transcribed by a paid transcriptionist. A transcript of the interview will be provided to an additional researcher who is an expert consultant in qualitative research. This additional researcher will review the transcripts to assist with data analysis of the interviews No personal information will be asked for on the recording in order to guard your privacy. The recording will be downloaded from the recorder(s) to a dedicated computer and stored in a password-protected file identifiable only by number. The recording will be stored on the computer until the end of the study and deleted after that time. The primary researcher and the transcriptionist are the only individuals who will have access to the recording of the interview. Because your voice will be potentially identifiable by anyone who hears the recording, confidentiality for things you say on the recording cannot be guaranteed, although the researcher will limit access to the audio files using the safeguards described in this paragraph. 63 What are the dangers to me? The risk of loss of confidentiality is minimal. All information obtained in this study is strictly confidential unless disclosure is required by law. The IRB and regulatory agencies may review research records. Prior to commencing the interview, you will be assigned an identification number for use throughout the study. This number, instead of your name, will be used to label all information related to your interview. Electronic files will be labeled by number and will be password protected. The informed consent document will be stored in a locked file cabinet in the researchers worksite. The risk of time loss is minimal. Participation in the study should require approximately two to three hours. For your convenience, the interview will be scheduled at a time of your choosing. Additional communication will be conducted via electronic mail or telephone. The risk of discomfort in answering questions is minimal. The interview location will be in an office to insure privacy and increase comfort with the environment during the interview process. You may take a break or stop at any time. You have the right to refuse to answer any question posed and to terminate the interview at any time. Are there any benefits for taking part in this research study? You are not likely to have any direct benefits from participating in this study. Will I get paid for being in the study? Will it cost me anything? There are no costs to you, or payments made for participating in this study. Who may I contact if I have questions or concerns about this study? If you have any questions about the research study, your research rights, or have a research-related injury please contact John M. Dudzik, MHS, OTR/L at 847-437-5500, X7286 or X7273. 64 If you have any questions about your privacy rights, you may contact Shivi Stanley, Manager, AMITA Health Institutional Review Board at 847-506-4479 or the Corporate Responsibility Officer for ABHN at (847)-385-7510. How will you keep my information private? The transcription will not include personal information that could be linked to you. The electronic files of the recorded interviews will be password protected and destroyed at the conclusion of the study. Informed consent forms and other hard copy materials will be destroyed with a shredder at the completion of the study. All information is strictly confidential unless disclosure is required by law. The research records may be reviewed by John M. Dudzik. What are my rights as a research subject? If you choose to participate in this study, you have the right to be treated with respect, including respect for your decision whether or not you wish to continue with being in the study. Choosing not to be in this study or to stop being in this study will result in no penalty or loss of benefits to which you are entitled. Choosing not to be in this study will not affect your rights to any present or future medical treatment. What if I do not want to participate or I want to leave the study? Participation in this study is voluntary. You have the right to leave this study at any time or to refuse to participate without penalty. If you choose to withdraw, any information collected about you before the date you leave the study will be kept in the research records until the conclusion of the study, but you may request in writing that the data not be utilized in the study. Other Considerations: If significant new information related to the study becomes available which may impact your willingness to continue to participate, this information will be provided to you by the 65 investigator. Voluntary Consent by Participant: By signing below, you indicate that: this study has been explained to you you have read this document, or it has been read to you your questions about this research study have been answered you have been told that you may ask the researchers any study-related questions in the future or contact them in the event of a research-related injury you are entitled to a copy of this form after you have read and signed it you voluntarily agree to participate in the study entitled: Participant's Signature: ___________________________ Date: ________________ Participants Name: ______________________________ Date: ________________ Name of person obtaining consent: ___________________ Signature of Person Obtaining Consent: _______________________Date: ________  ...

... Use of a Tummy Time Intervention and Parent Education in Infant Born Preterm: A Randomized Controlled Trial Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Dawn Drumm, PT Copyright April 21, 2021 By: Dawn Drumm, PT All rights reserved Approved by: Kathy Martin, PT, DHSc Committee Chair ______________________________ Suzann K. Campbell, PT, PhD Committee Member ______________________________ Jenifer Cartland, PhD Committee Member ______________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ TUMMY TIME INTERVENTION AND PARENT EDUCATION . Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: A Randomized Controlled Trial Dawn Drumm University of Indianapolis 1 TUMMY TIME INTERVENTION AND PARENT EDUCATION 2 Abstract Background: Prematurity is a global health problem with over 50% of infants born < 30 weeks gestation diagnosed with mild to severe motor disabilities. For infants born preterm, opportunities for tummy time may be limited and parental adherence may influence motor outcomes. Design: Randomized controlled trial investigating the effects of a tummy time intervention and parent education, as compared to standard care, on motor outcomes and adherence. Methods: 24 infants born < 37 weeks gestation were randomized to an intervention or control group. Motor outcome was compared between groups using the Test of Infant Motor Performance (TIMP). Adherence to the recommended tummy time dosage was measured via parental recording on the PT pal application. Results: A 2 x 2 mixed design ANOVA analyzed the extent of change between each groups TIMP z-score preintervention and postintervention. There was no statistically significant association between the group assignment and time on motor outcome. There was a significant difference in TIMP scores at different time points with both groups declining from pre- to postintervention. Decline was greater in the control group and may be clinically significant. Infants achieving at least 400 total tummy time minutes scored within the average range on the postintervention TIMP. No difference in adherence was observed between groups; adherence was not impacted by education session or application. Discussion/Conclusions: The tummy time intervention and parent education had no effect on motor outcome or adherence. Small sample size likely impacted our results. Further research on optimal dosing and parent-led interventions are recommended. TUMMY TIME INTERVENTION AND PARENT EDUCATION 3 Acknowledgements As I near the end of this doctoral program, I feel extremely fortunate to have had this opportunity to grow professionally and personally in so many ways over the past seven years. While it has not been easy, Ive learned and grown from every struggle. There are many who have provided support and guidance and I am eternally grateful to them all. First, I would like to thank my committee members, Dr. Kathryn Martin, Dr. Suzann K. Campbell and Dr. Jenifer Cartland. I cannot express enough my appreciation in having your guidance, mentorship, encouragement and support. I was beyond lucky to have your expertise during this project and I hope you all know how much I do and will continue to look up to all of you. I would also like to extend my gratitude to Dr. Elizabeth Moore and Dr. Laura Santurri who both continued to provide ongoing mentorship and were always more than willing to lend their guidance. I feel fortunate to have learned so much from both of you. My sincere gratitude also goes out to Laura Zawacki, who spent hours of her time to help with my study. Lastly, Id like to thank all my participants and parents who so willingly trusted me with their infants. I feel honored to be in the NICU and look forward to continuing my work and being able to be a part of their journey. I could not have completed this program without the support and love from my family. Many thanks need to be extended to my husband JD who made many sacrifices so I could spend hours studying and data collecting. He is my rock and Im excited to see what the next journey will lead us to. My children, Teagan, Declan and Liam, Im so happy to be your mom. I hope seeing me persevere helps you know that you can do anything you choose. As I like to preach, if it were easy, everyone would do it. I love you with all my heart and soul. With gratitude, Dawn Drumm, PT TUMMY TIME INTERVENTION AND PARENT EDUCATION 4 Table of Contents Title Page ........................................................................................................................................ 1 Abstract ........................................................................................................................................... 2 Acknowledgements ......................................................................................................................... 3 Chapter 1: Introduction ................................................................................................................... 6 Problem Statement ...................................................................................................................... 7 Purpose Statement ....................................................................................................................... 8 Research Hypotheses................................................................................................................... 8 Statement of Significance............................................................................................................ 8 Definition of Terms ..................................................................................................................... 9 Chapter 2: Literature Review ........................................................................................................ 11 Developmental Theories ........................................................................................................... 13 Prone Positioning and Typical Motor Development ................................................................. 16 Barriers Impacting Prone Positioning in the Typical Developing Infant .................................. 17 Barriers Impacting Prone Positioning in the NICU .................................................................. 19 Parent Education and Barriers Related to Adherence ............................................................... 20 Motor Development in Infants born Preterm ............................................................................ 21 Plasticity and Motor Development............................................................................................ 23 Chapter 3: Method ........................................................................................................................ 26 Study Design ............................................................................................................................. 26 Participants ................................................................................................................................ 26 Instrumentation.......................................................................................................................... 28 Procedures ................................................................................................................................. 31 Data Collection.......................................................................................................................... 32 Data Management and Statistical Analysis ............................................................................... 37 Chapter 4: Results ......................................................................................................................... 38 Demographic Comparisons between Intervention and Control Groups ................................... 39 Motor Assessment Comparison Pre-Intervention and Post-Intervention .................................. 39 Hypothesis 1: Comparison TIMP Scores Between Intervention and Control Groups .............. 40 Hypothesis 2: Adherence to Tummy Time ............................................................................... 41 Relationship between Ethnicity and Post-TIMP Z-Scores ........................................................ 42 Regression Analysis .................................................................................................................. 42 TUMMY TIME INTERVENTION AND PARENT EDUCATION 5 Physical Therapy ....................................................................................................................... 43 Correlation between Tummy Time Minutes and TIMP scores ................................................. 43 Chapter 5: Discussion ................................................................................................................... 44 Limitations ................................................................................................................................ 54 Recommendations for Further Research ................................................................................... 56 Conclusion................................................................................................................................. 57 References ..................................................................................................................................... 58 Appendix ....................................................................................................................................... 70 Table 1 ....................................................................................................................................... 70 Table 2 ....................................................................................................................................... 71 Table 3 ....................................................................................................................................... 73 Table 4 ....................................................................................................................................... 74 Table 5 ....................................................................................................................................... 75 Table 6 ....................................................................................................................................... 76 Table 7 ....................................................................................................................................... 77 Table 8 ....................................................................................................................................... 78 Table 9 ....................................................................................................................................... 79 Table 10 ..................................................................................................................................... 80 Table 11 ..................................................................................................................................... 81 Table 12 ..................................................................................................................................... 82 Table 13 ..................................................................................................................................... 83 Table 14 ..................................................................................................................................... 84 Figure 1 ..................................................................................................................................... 85 Figure 2 ..................................................................................................................................... 86 Figure 3 ..................................................................................................................................... 87 Figure 4 ..................................................................................................................................... 88 Figure 5 ..................................................................................................................................... 89 Appendix A ................................................................................................................................... 90 TUMMY TIME INTERVENTION AND PARENT EDUCATION 6 Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: A Randomized Controlled Trial Motor skill acquisition within the first year of life is crucial for optimal development (Raniero et al, 2010). Opportunities for positioning in prone allow infants to utilize anti-gravity extension and learn how to lift their heads upright, turn their head in both directions, move and extend their legs and push up with their arms (Hewitt et al., 2017). These movement patterns allow for further motor skill development such as rolling, sitting, crawling, and transitional movements into sitting and standing (Hewitt et al., 2017). Research has indicated that the lack of prone experiences, often referred to as tummy time, affects infants motor development negatively and decreases an infants ability to practice motor skills that require antigravity extension (Wentz, 2017; Zachry & Kitzmann, 2011). Additionally, there is ongoing evidence that neuroplasticity is enhanced through early opportunities for active movement and allows for potential positive improvements in neurodevelopment among infants born preterm (berg et al, 2020). In 1992, the American Academy of Pediatrics instituted the public education program in the United States known as the Back to Sleep campaign (American Academy of Pediatrics, 2011). This recommendation was made to reduce the incidence of Sudden Infant Death Syndrome (American Academy of Pediatrics, 2017; Zachary & Kitzmann, 2011). Although the incidence of Sudden Infant Death Syndrome has dramatically reduced, supine sleep positioning has influenced awake positioning with parents and caregivers potentially limiting or avoiding tummy time as an accepted play position (Kuo et al., 2008; Mildred et al., 1995; Monson et al., 2003; Oriel et al., 2006; Wentz, 2017; Zachry & Kitzmann, 2011). As increased delays were noted after the Back to Sleep campaign, recommendations were proposed by the American TUMMY TIME INTERVENTION AND PARENT EDUCATION 7 Academy of Pediatrics to increase wakeful tummy time positioning; however, parents and caregivers may still be limiting or avoiding positioning their typically developing infants in prone (American Academy of Pediatrics 2017; Oriel et al., 2006; Zachry & Kitzmann, 2011). Infants born preterm may lack experiences in prone due to the need to follow Back to Sleep recommendations, but also due to their medical complexity. A lack of exposure to wakeful prone may impact the developing brain and place these infants at risk for neuromotor impairments (American Academy of Pediatrics, 2011; Vanderveen et al., 2009). Early neurorehabilitation may improve motor recovery as specific and targeted motor interventions and strategies provided during the NICU hospitalization may allow for improved organization and optimize motor development (Matre, 2015; Rogers & Hintz, 2016); Ustad et al., 2016). Providing opportunities for movement, specifically tummy time, may decrease the risk for neuromotor impairment as well as support neuroplasticity and motor skill acquisition for the infant born preterm (Rogers & Hintz; Ustad et al., 2016; Vanderveen et al., 2009). Problem Statement Previous studies have indicated that healthy term infants who experienced time in the prone position achieved motor milestones earlier than those infants who did not (Kuo et al., 2008; Lobo & Galloway, 2012). Bentzley et al. (2015) reported that infants born premature who demonstrated poor ability to lift their head in prone had associated poorer motor outcome scores on the Test of Infant Motor Performance at 12 weeks and later at 12 months on the Bayley Scales of Infant and Toddler Development (Bayley III). The relationship between motor outcome and the use of a tummy time protocol among premature infants in a neonatal intensive care unit remains unknown. TUMMY TIME INTERVENTION AND PARENT EDUCATION 8 Purpose Statement The purpose of this randomized controlled clinical trial was to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week intervention period of this eight-week trial. For this study, motor outcomes were measured using the Test of Infant Motor Performance (TIMP). Additionally, the study measured adherence rates between both groups to the recommended dosage of tummy time. Research Hypotheses To address the study purpose, the following null hypotheses were tested over a total of eight weeks: 1. There will not be a statistically significant difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education and only. 2. There will not be a statistically significant difference in adherence (median minutes per week) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only. Statement of Significance The significance of this study is that the results can be utilized by other neonatal and pediatric therapists who work with infants born preterm and utilize many interventions in their clinical decision making. Additionally, parents, nurses and neonatologists will also benefit by recognizing the significance of incorporating this play position as an important aspect of the TUMMY TIME INTERVENTION AND PARENT EDUCATION 9 infants day as well as encouraging parents to feel comfortable and carry over this activity while visiting with their infant during their hospitalization and once home. Lastly, this tummy time intervention may help positively influence and improve parent adherence to utilizing and accepting wakeful prone positioning as an accepted play position for their infant born preterm. Definition of Terms Adherence rate: number of minutes/week completed /number of recommended minutes) (Median-Mirapeix et al., 2017). Dynamic Systems Theory: Theory related to motor development where the infant receives feedback from different systems including the infant (internal subsystems), the environment and from the task. The influence of the environment and demands of the task may impact motor behavior and outcome (Dudek-Shriber & Zelazny, 2007; Oberg et al., 2012). Intraventricular hemorrhage (IVH): Characterized as bleeding into the ventricular system due to the rupture of microvessels within the germinal matrix tissue. Range in severity from grade I to IV (Wu et al., 2020). Neonatal intensive care unit (NICU): Intensive care unit that specializes in the care of infants born preterm or newborns in need of specialized medically complex care. Neuronal group selection theory (NGST) According to this theory, the brain, specifically the cortical and subcortical systems, are collaboratively organized into a set of variable networks of which organization is determined by behavior and development (Hadders-Algra, 2000a; Hadders-Algra, 2000b) Neuroplasticity: Process that allows for reorganization of neural connections after injury or where the developing brain can dynamically adapt in response to environmental cues (Demaster et al. 2018; Fiel et al., 2014). TUMMY TIME INTERVENTION AND PARENT EDUCATION 10 Perception-action theory: Movement (action) provides perceptual information back to the infant which in turn impacts movement and interaction with the environment (Dusing et al., 2014). Preterm infant: An infant born at < 37 weeks gestation PT Pal: A cloud-based application that allows clinicians to send patients digital prescriptions of activities and tasks directly to the patients mobile device. Alerts can be sent to patients to improve adherence and clinicians can also collect data on adherence (PT Pal, 2018). S Standard of care: This reflects the control group who received parent education and uses the PT Pal application to record tummy time minutes. Test of Infant Motor Performance (TIMP): A motor scale that assesses both the motor and postural control of infants born preterm between 34 weeks post conceptual age through four months corrected age as well as for infants born at term and up to four months of chronological age. Normative values are available starting at 34 weeks gestation. (Campbell, 2012; Rose & Westcott, 2005) Tummy time: Positioning an infant on their stomach while they are awake and supervised (Hewitt et al., 2017) TUMMY TIME INTERVENTION AND PARENT EDUCATION 11 Literature Review Prematurity remains a global health problem, with infants born preterm at risk for developing many long- term sequelae such as cognitive, behavioral, and motor impairments. (Rogers & Hintz, 2016; Spittle et al., 2016). According to the Centers for Disease Control and Prevention (2019), recent population-based studies from around the world report prevalence estimates of cerebral palsy (CP) ranging from 1 to nearly 4 per 1,000 live births and in 2019, preterm birth affected 1 of every 10 infants born in the United States. Many infants born very preterm (< 32 weeks gestation) survive, however the rate of neurodevelopmental impairments has not declined (Anderson et al., 2020; Travers et al., 2020). Infants born preterm are vulnerable to several complications including brain injury, respiratory and feeding difficulties as well as visual and hearing impairments. (Rogers & Hintz, 2016). Approximately 15% of children born at < 30 weeks gestation are diagnosed with cerebral palsy and 50% are diagnosed with mild to severe motor disability (Spittle et al., 2016). Cerebral palsy is the most common physical disability in childhood. There have been significant improvements in early detection of CP and in higher income countries like Australia, both incidence and degree of motor impairment have declined. (Novak et al., 2019). Even without a diagnosis of CP, subtle challenges that impact quality of life and general family functioning may still be a cause for significant disability (Anderson et al., 2020). Rogers & Hintz (2016) discuss intact survival, describing infants who survive without significant medical or neurodevelopmental sequelae such as visual or hearing impairments, motor delays or cognitive deficits. While survival has dramatically improved, long term sequelae and intact survival rates continues with little change, remaining a significant concern for both parents and clinicians (Vanderveen et al., 2009; Rogers & Hintz, 2016). TUMMY TIME INTERVENTION AND PARENT EDUCATION 12 Despite technological and medical advances, infants born preterm and medically complex remain at high risk for multiple morbidities that impact their motor, cognitive and behavioral trajectory (Glass et al., 2015; Rogers & Hintz, 2016; Subedi et al., 2017). Environment plays a critical role as seen in animal models where animals in enriched environments have larger brains and improved cognitive and behavioral outcomes (Anderson et al., 2020). Brain development is vulnerable to external factors, such as stress from the NICU or home environment and other socioeconomic factors that can impact neurodevelopmental outcomes (Anderson et al., 2020; Travers et al., 2020; Vanderveen et al., 2009). Additionally, extended hospitalizations within the NICU, which can cause significant stress for parents and along with the infants multiple medical complexities, may impact neurodevelopmental outcomes and be a more impactful predictor of outcome than degree of prematurity or birth weight (Subedi et al., 2017). Neuroplasticity describes the process of the central nervous system to adapt to the environment through structural and functional changes, allowing for improved organization of neural connections and establishment of crucial motor pathways in infants born preterm with and without brain injuries (Demaster et al., 2019; Fiel et al., 2014; Ismail et al, 2016; Ustad et al., 2016). In preterm infants, typical development is altered due to interruptions (preterm birth and its complications) or disruptions (injury such as from hypoxia, illness). Early neurorehabilitation may offer opportunities for the infant born preterm to minimize or recover from potential risks of impairment, which may then influence and allow the infant to have the opportunity for more typical motor experiences (Fiel et al., 2014; Matre, 2015; Ustad et al., 2016). Therapeutic interventions ideally will target the connections between the biological makeup of the infant and the external environment and thus may positively influence motor development (Vanderveen et al., 2009). From the biological standpoint, experience may alter brain structures (improve TUMMY TIME INTERVENTION AND PARENT EDUCATION 13 synaptic function) and practice may influence maturing corticospinal tract development (Fiel et al., 2014; berg et al., 2012). Demaster et al. (2018) discuss the emerging evidence that while infants born preterm are impacted by negative environmental stimuli, they may also benefit from positive conditions (e.g., highly sensitive caregiving) to improve developmental outcomes. Ultimately, early intervention likely influences neuroplasticity and could provide opportunity for optimal outcome; however, the availability of evidenced-based interventions to support this is limited in the literature (Matre, 2015). Developmental Theories The dynamic systems theory of motor development provides one framework for understanding infant development (Monson et al., 2003). Dynamic systems theory (DST) postulates that many systems impact an infants motor development, including the neuromuscular and central nervous systems. Changes that occur in an infants motor behavior results from an interaction among the infant, their environment, and the given task (Monson et al., 2003). A relevant example is the environmental change that occurred after the Back to Sleep campaign in 1994, where sleep recommendations changed to recommend that all infants needed to sleep on their backs versus side or prone sleeping (Kuo et al., 2008; Zachry & Kitzmann, 2011). Studies completed since this campaign have reported an association between supine sleeping and gross motor developmental delays among healthy term infants (Kuo et al., 2008; Lee, 2015). Based on this theory, varying the positions of an infant during wakeful time should impact their motor development (Pin et al., 2007). Changing an infants position during wakeful time is crucial towards optimal development for all infants, even those born preterm (Pin et al., 2007). Prone or tummy time is of utmost importance in the development of antigravity movements and head control and should be one of the positions all infants experience TUMMY TIME INTERVENTION AND PARENT EDUCATION 14 during wakeful time (Bly, 1994; Mendres-Smith et al., 2020; Pin et al., 2007). The perceptionaction theory proposes that a movement (action) provides perceptual information back to the infant which impacts movement and interaction with the environment (Dusing et al., 2014). According to this theory, the perception-action cycle facilitates movement within the infant and promotes cognitive development. Postural control, which involves controlling the bodys position to orient the body to a specific environmental activity, is an important factor in motor behavior (Dusing et al., 2014). By providing more opportunities in prone, infants may be encouraged to move more, thus improving and enhancing postural control capabilities. The neuronal group selection theory (NGST) is a concept developed by Dr. GM Edelman. According to this theory, the brain, specifically the cortical and subcortical systems, are collaboratively organized into a set of variable networks of which organization is determined by behavior and development. Neuronal groups are comprised of numerous selected units of inter-connected neurons that serve as a functional unit with respect to a specific motor repertoire (Hadders-Algra, 2000b). Development, per NGST, is determined through a selection process based on afferent information that is generated by experience (Hadders-Algra, 2000a; HaddersAlgra, 2000b). Immediately after selection occurs, variation in the short- term decreases but then increases again over time as the infant is exposed to a multitude of experiences. This occurrence leads to a stronger connection between and within the developing neuronal groups. (HaddersAlgra, 2000a) Two phases of variation are discussed in NGST; primary and secondary variability. During primary variability, motor behavior is highly variable; as reflected in general movements (Hadders-Algra, 2000a). These specific movements occur during fetal life and infancy; variability is the hallmark of this movement repertoire. This phase reflects exploration which TUMMY TIME INTERVENTION AND PARENT EDUCATION 15 allows neural systems to be developed through experience of self-generated activity. During secondary variability, new neuronal groups are established which are a result of further synapse formation and synapse elimination (Hadders-Algra, 2000a, p. 570). This phase is strengthened through experience and can take years before an effective and efficient motor pattern is produced for specific conditions. This occurs from mid-infancy, progresses between ages 2-3 years and matures in adolescence (Haddres-Algra, 2000a). By providing opportunities in prone, infants born preterm may be able to strengthen this selection process as experience and experimental selection allows for the most effective motor patterns to be generated. Experience in prone is important for all infants, healthy and term and those born premature, to allow for exploration and the development of motor repertoires needed to support typical motor development. Additionally, from the NGST hypotheses, early intervention after brain injury should focus on increasing the primary variation through practice. and experience (Hadders-Algra, 2000b). This could be accomplished by varying an infants position/posture, such as positioning in tummy time. Additionally, interventions that focus on facilitating selection should be included; specifically, those that allow for increased practice and trial and error (Hadders-Algra, 2000b). Through frequent tummy time positioning as designed in this study, infants who experience this position may increase their opportunity for movement experiences potentially improving their primary variation and selection capabilities. (HaddersAlgra, 2000b) TUMMY TIME INTERVENTION AND PARENT EDUCATION 16 Prone Positioning and Typical Motor Development For the typically developing infant, dramatic changes in head control occur during the first few months of the postnatal period (Bly, 1994; Lee & Galloway, 2012). Prone extension is considered a critical developmental milestone and a precursor for a typically developing infant to attain quadruped, sitting, and eventual standing (Horowitz & Sharby, 1988; Salls et al., 2002). Prone extension involves movement and muscle engagement of the head, upper extremities, trunk, and lower extremities in extension (Horowitz & Sharby, 1988). Providing opportunities for infants to experience prone is potentially crucial for development. According to Kuo et al., (2008), previous research has demonstrated that healthy term infants who were allowed time in prone over the first 6 months of life compared to those who spent no or little time in prone, demonstrated improved motor outcomes. Spending time in prone allows the infant to work in an anti-gravity position, strengthening head, neck, shoulder, and trunk muscles used in prone extension. Lobo and Galloway (2012) conducted a study with typically developing two-monthold infants who received enhanced handling opportunities. During the three-week intervention, caregivers were asked to perform handling for 15 minutes daily. Enhanced handling included activities in supported sitting, standing, and positioning that encouraged prone as well as head and trunk control; movement was considered enhanced because it was not considered typical in daily life in Western cultures. The results concluded that infants in the experimental group who received enhanced handling showed advanced skill development, particularly advancement of skills in prone (Lobo & Galloway, 2012). In a related study, Lee and Galloway (2012) looked at providing early movement and postural control experiences in young (one to four-months) healthy term infants; the intervention included 20 minutes of daily movement, including prone positioning. Through bi-weekly testing with the TIMP, Lee & Galloway found that the TUMMY TIME INTERVENTION AND PARENT EDUCATION 17 intervention group had higher scores related to the head control and prone items. Babik et al., (2017) discussed the point of exploration versus strength. In their example, they noted that when one-month old infants were given time to practice controlling their heads up against gravity, the infants head control improved approximately two weeks before that of a control group (no practice). The authors suggested the rationale for this result was additional time and opportunity to explore this movement versus a lack of strength as the limiter of baseline head control. This appears to indicate that a degree of exploration and practice and not just strengthening interventions are needed to promote both typical and preterm development both in and out of the NICU environment. Experiencing the prone position may help infants improve their abilities to facilitate development of neuronal connections and maturation of the brain (Kuo et al., 2008; Lobo & Galloway, 2012; Ustad et al., 2016). As stated earlier, motor skill acquisition, according to the dynamic systems theory and NGST, improves with variety and experience in multiple positions (Lobo & Galloway, 2012). Additionally, specific muscle strengthening occurs during tummy time allowing infants the opportunity to gain anti-gravity muscle strength that is necessary for attaining expected future milestones (Zachry & Kitzmann, 2011). The influences of exploration and strengthening may both contribute to infant development, particularly for infants born preterm. Developmental theories such as the DST and NGST appear to support this hypothesis. Barriers Impacting Prone Positioning in the Typical Developing Infant There are significant benefits to placing infants in the prone position during wakefulness with a primary reason being to support the infants motor development. There are also barriers that have been noted in the literature for typically developing infants. It is critical to understand how supine sleeping has impacted prone positioning for development. As discussed, the Back to TUMMY TIME INTERVENTION AND PARENT EDUCATION 18 Sleep campaign recommended supine sleeping, and the prevalence of Sudden Infant Death Syndrome (SIDS) subsequently decreased significantly with rates declining by more than 50% (Hauck et al., 2015). Unfortunately, while safe sleeping is a necessity for all infants, the impact on motor development, particularly on the relationship of placing infants in prone for tummy time has been adverse. Since this campaigns introduction, there has been a shift in motor development trajectories (Monson et al., 2003; Kuo et al., 2008). Additionally, there is evidence that typically developing infants are not being placed in prone while awake and are not meeting sufficient time requirements to support typical development. Unwarranted fear of play in prone and poor tolerance for this position are two main reasons why caregivers may avoid this position (Lee, 2015; Monson et al., 2003; Wentz, 2017). Parents may report a fear of increased risk of Sudden Infant Death Syndrome (SIDS) if they place their infants in prone for tummy time (Zachry & Kitzmann, 2011). Infants may become fussy, resist being positioned in prone, and cry, which then causes distress in the parent. While many parents understand the importance of tummy time, they may not like to see their infant distressed. Parents may lack information on how to offer their infant alternative options on tummy time equivalent positions, such as in a carry or other holding positions. Therapists can assist in teaching parents ways to use their voice, visuals, positioning techniques and toys to encourage tummy time practice (Kadey & Roane, 2012; Mendres-Smith et al., 2020). Additionally, parents are not meeting time requirements for prone play, as 81 minutes a day has been indicated as necessary to achieve optimal gross motor development (Dudek-Shriber & Zelazny, 2007). Factors such as parent attitudes and behaviors, the infants age tummy time was initiated, as well as the infants tolerance are all potential influences that impact tummy time and prone capabilities (Hewitt et al., 2017). Other influences on adherence to tummy time include age of infant, gender of the TUMMY TIME INTERVENTION AND PARENT EDUCATION 19 infant, sleep position, type of positioning and handling from the caregiver as well as gestational age and tolerance of the infant (Dudek-Shriber, & Zelazny, 2007; Hewitt et al., 2017; Monson et al., 2003; Kuo et al., 2008). Further investigation is warranted in this area. Barriers Impacting Prone Positioning in the NICU For the preterm infant in the NICU, movement and motor opportunities are altered, reduced, or completely lacking due to positioning restrictions, medical illness, difficulties with respiration, and other significant complex issues. Infants born preterm may have intestinal surgeries with post-surgical positioning restrictions. Dusing et al., (2012) reported challenges within the NICU, including medical instability and medical complexities, with the infant needing minimal handling to insure appropriate developmental care and reduction of stress. Parental compliance to perform recommended developmentally appropriate activities may be limited and considered a barrier as well. Medina-Mirapeix et al. (2017) reported on predictors of parental adherence to home program activities for children with disabilities. Barriers the parents reported included lack of time, forgetfulness, fatigue, difficulty finding time in daily routine, stress, and lack of clarity about who had the responsibility to perform the home program. Hospitalizations may be lengthy and parental visitation may be limited because families live hours away or they need to return to work. Wakeful prone positioning may be difficult to attain as parents may have limited time to visit, or they are fearful of performing this activity with their medically fragile infant (Dusing et al., 2012). These factors all may influence parental awareness as well as adherence to ensure parents provide adequate developmental opportunities in prone. Additionally, nurses often care for multiple patients and may not be able to spend additional time in non-nursing care activities. Physical and occupational therapy may be provided, however TUMMY TIME INTERVENTION AND PARENT EDUCATION 20 timing when infants are awake and ready for wakeful tummy time may be challenging to target appropriately. Parent Education and Barriers Related to Adherence It is common practice for physical therapists to prescribe home exercise programs; and for infants and children, parents are often involved to help oversee or implement the program recommendations. For parents of children born preterm, learning how to implement and continue positioning and developmental activities and exercises within the neonatal intensive care unit (NICU) and once home, supports the infants motor, social and emotional development (Dusing et al., 2012; Ronan et al., 2015). This is a common and critical aspect of therapy goals and plan of care for infants receiving therapy in the NICU. Additional benefits to adherence to a home program include improved motor performance, enhancement of parents self-efficacy to adherence and improving maternal bonding to the infant born preterm (Ronan et al., 2015). Lekskulchai and Cole (2001) compared a parent-led intervention to a control group and a comparative group among infants immediately post NICU discharge. They reported that motor performance as assessed on the TIMP improved among the parent-led group compared to a control group. Ustad et al. (2016) found similar results in motor performance scores (TIMP or the TIMP screening items) which also included parent-led intervention compared to a control within the NICU setting. There are potential barriers to adherence to a home program, specifically for caregivers with medically complex children. Medina-Mirapeix et al. (2017) examined adherence rates among caregivers with children with varying developmental disabilities. The authors found several factors associated with adherence including knowledge of the home program, selfefficacy, and confidence in carry over, social supports, health condition of the child, and TUMMY TIME INTERVENTION AND PARENT EDUCATION 21 involvement of the health care professional in instruction and follow up of the home program. The authors also reported on key determinants to adherence, including presenting information on the usefulness of the exercises as well as ongoing progress updates. These factors significantly improved the odds of caregiver compliance to the home program. Motor Development in Infants born Preterm The preterm period is a sensitive time frame for optimizing motor development; providing interventions during this period, particularly wakeful prone, may be ideal to enhance the motor potential for preterm infants (Matre, 2015; Ustad et al., 2016). Ustad et al. (2016) reported that there could be more significant benefits from interventions that began while the infant remained hospitalized in the NICU. This may be due to changes in brain development, specifically, the development of corticospinal fiber connections with spinal motor neurons (Ustad et al., p.6). Preterm infants who experience interventions early may demonstrate alterations in the anatomy of their developing brain, which may in turn enhance not only their motor development, but also improve their overall health, educational, and social outcomes (Vanderveen et al., 2009). Pediatric physical therapists and occupational therapists with expertise in the NICU are well-versed in providing these interventions (Dusing et al., 2012). Although interventions have been developed for use while the infant born preterm is hospitalized in the NICU, the availability of evidence-based rehabilitation treatment for the preterm infant remains limited (Matre, 2015). As discussed earlier, movement experiences in the infant born preterm are often limited. Babik et al., (2017) discussed how non-object-oriented exploratory behaviors are critical for development. Non-object-oriented exploratory behaviors are defined as behaviors infants engage in when not directly interacting with portable objects (Babik et al., 2017, p. 916). Examples of these movements include hand to mouth, head and hand movement TUMMY TIME INTERVENTION AND PARENT EDUCATION 22 toward midline, open hand postures, and of relevance to this study, exploration of head movement against gravity. This exploration is crucial for both preterm and term infants as it assists in helping infants learn how to control their bodies during complex activities such as those involved in tummy time. In their 24-month longitudinal study, Babik et al. (2017) concluded that infants born between 22 and 30-weeks gestation and observed through video analysis, demonstrated fewer bouts of exploration of these non-objects oriented exploratory behaviors and specifically noted significant differences in their ability in holding their heads up in prone compared to term infants. Additionally, infants born preterm are at higher risk for motor impairment that can continue as a life-long disability (Matre, 2015; berg et al., 2012). Ustad et al. (2016) hypothesized that providing appropriately targeted training strategies affect brain and corticospinal development and are thereby likely to influence the brains capacity to compensate for deficits after lesions (p. 2). While not conclusive, specific movement experiences and intervention strategies may positively impact the brain of premature infants (Ustad et al., 2016). The Norwegian Physiotherapy Study in Preterm Infants (NOPPI) study utilized a protocol that included parent-led interventions in supine, side lying, sitting and prone (Ustad et al., 2016). These activities involved movements that addressed strengthening of selective muscles involved in postural control. Additionally, parents were taught to adjust their handling based on responses observed in their infant, thus insuring more active participation, and improving parent-infant interactions. The NOPPI study included a specific protocol of activities that families were first instructed in and then asked to carry out on their own for 10 minutes twice a day for three weeks. The protocol included a variety of movement in many positions, including prone, and the parentled component may have also allowed parents to understand their infants behavior better, which TUMMY TIME INTERVENTION AND PARENT EDUCATION 23 has been shown to positively influence developmental outcome (Ustad et al., 2016). Additionally, Ustad et al. (2016) utilized the TIMP to effectively measure motor outcome within the NICU setting and the results demonstrated a significant difference within the intervention group versus the control group. Plasticity and Motor Development There is large potential for an infants brain to adapt to injury or complex medical sequelae, much more so than seen in the adult brain. This has been a cornerstone of focus in infants born preterm, and especially in those with brain injury or medical complexity. (Ismail et al., 2016). By allowing the infant to experience opportunities for movement and engaging in interventions that target specific goals for the infant and family, synaptic connections and corticospinal development can take place and allow for the infant to build a foundation for optimal motor development (Ustad et al., 2016). Ismail et al. (2017) discuss neuroplasticity and defines it as the inherently dynamic biological capacity of the central nervous system (CNS) to undergo maturation, change structurally and functionally in response to experience and to adapt following injury (p. 23). Experience is an important factor in neuroplasticity for infants with or without brain injury. Ismail et al. (2017) discuss five different patterns of plasticity: developmental, adaptive, reactive, excessive/destabilizing and CNS vulnerability. These patterns can overlap and are not exclusive. For this study, adaptive plasticity will be discussed in further detail as this pattern most likely provides the best insights into how providing a structured tummy time protocol may positively assist brain development and plasticity in development. Injury to the corticospinal tracts (CST) is believed to be a factor involved in the motor impairments that are observed in infants and children with cerebral palsy. In typical TUMMY TIME INTERVENTION AND PARENT EDUCATION 24 development, the motor cortex transmits bilateral projections to spinal motor neurons; with a synaptic competition between the two projections on alpha motor neuron (Ismail et al., 2016, p. 32). After this, a retraction of the ipsilateral projection and strengthening of contralateral projection occurs. From this information, the timing of an injury may impact the developmental outcome. Using a cat model, Friel et al. (2014) demonstrated that promoting activity in the damaged system of the CST or decreasing the activity of the undamaged system, immediately post injury, led to partial repair of the CST and reestablishment of some motor function. Specifically, they found that constraint of the unaffected limb plus intensive training, that was done immediately after the injury, showed the most promising return of motor cortex based on motor mapping (Friel et al., 2014). So how does one apply this research of plasticity and reorganization to therapy? By providing interventions such as prone positioning early in the developmental window (NICU), one could extrapolate that experiences during this sensitive window of time may enhance motor development or recovery if there has been injury. Lobo and Galloway (2012) discussed a different mechanism related to plasticity in their study which included comparing an advanced handling (including prone) intervention versus a standard of care control group among two-month-old infants. The infants within the experimental group may have primed their neuromuscular systems which allowed for gains in strength (Lobo & Galloway, 2012, p. 9). Additionally, from experiencing the prone position, infants may have improved their abilities to facilitate development of neuronal connections and maturation of the brain (Kuo et al., 2008; Lobo & Galloway, 2012; Ustad et al., 2016). Motor skill acquisition, according to the dynamic systems theory, improves with variety and experience in multiple positions (Lobo & Galloway, 2012). From the perception-action theory, providing greater amounts of experience in prone may positively influence perceptional information to the TUMMY TIME INTERVENTION AND PARENT EDUCATION 25 infant and improve their postural control. Using a prone protocol may strengthen the selection process from the NGST perspective. Additionally, specific muscle strengthening occurs during tummy time allowing infants to gain anti-gravity muscle strength that is necessary for attaining expected future milestones (Zachry & Kitzmann, 2011). The influences of exploration and strengthening may both contribute to infant development, particularly for infants born preterm. In summary, infants born preterm are a vulnerable population at risk for motor impairments. Motor development is not linear and as stated in the dynamic systems theory, development is viewed as a combination of both genetic influences and experiences involving the infant, their environment and a given task (berg et al., 2012). Additionally, plasticity, or the ability of the infant to adapt neural networks based on experience, can be crucial in optimizing motor development, even when injury has occurred (Ismail et al., 2016; Lee & Galloway, 2012; berg et al., 2012). Experience can impact an infants evolving brain; therefore, motor skills may be impacted by early intervention and experiences which provided the rationale for the importance of wakeful prone movement opportunities (Lobo & Galloway, 2012; Matre, 2015, berg et al., 2012). There are several gaps identified within the literature related to this study. One includes the need to determine how a tummy time intervention plus parent education compared to standard care of parent education only impacts motor development in infants born preterm. Additionally, more research is needed to identify how parent education approaches can impact parent adherence to a home program while in the NICU. The primary goals of this 8-week randomized controlled clinical trial were to investigate the motor outcomes and parent adherence of a tummy time and parent education protocol within the NICU setting and compare this to standard care among infants born preterm. Results from this randomized controlled trial will TUMMY TIME INTERVENTION AND PARENT EDUCATION 26 ideally provide therapists and other clinicians working in NICU settings evidence-based information on how tummy time impacts motor performance in infants born preterm as well as how parent education with the use of a mobile application influenced parent adherence to the recommended home program frequency. Method Study Design A randomized controlled trial design was used to investigate whether a tummy time protocol intervention compared to a standard of care group improved motor outcome as well as parent adherence rates to provided activity recommendations among infants born preterm. The intervention period was 4 weeks, and the total study length was 8 weeks. Parental adherence and infant motor performance were the outcomes measured after completion of the intervention and study period. The study was conducted at Ann & Robert H. Lurie Childrens Hospital from February 2019 to March 2020. Prior to participant recruitment, the study was approved by the Institutional Review Boards at Lurie Childrens and the University of Indianapolis via a reliance agreement. All interventions were completed within Lurie Childrens neonatal intensive care unit. Participants A convenience sample was recruited from patients admitted to the NICU at Lurie Childrens. Lurie Childrens is a Level IV, 64 bed unit that treats over 2000 infants a year and receives more referrals than any other Level IV NICU facilities in Illinois (Ann &Robert H. Lurie Childrens Hospital of Chicago, n.d.). To be eligible to participate in the study, participants met the following inclusion criteria born premature (< 37 weeks gestation), received medical care within Lurie Childrens NICU, be between 35 and 36-weeks gestation at time of initiation TUMMY TIME INTERVENTION AND PARENT EDUCATION 27 into the intervention and a maximum of 45 weeks postmenstrual age and received medical clearance from the NICU attending neonatologist to participate in the study. A primary parent was selected for each infant eligible that participated in the study. The role of the primary parent was related to use of the PT Pal application. Inclusion criteria for parent(s) was the need for access to a workable mobile device and spoke either English or Spanish as their primary language. For Spanish speaking parents, a hospital video interpreting system was available for interpretation. All written handouts for tummy time education were provided in the participants primary language. Exclusion criteria for the primary parent was not having a working mobile device and speaking a language other than English or Spanish. Infants were excluded if they were unable to be placed in the prone position, physiologically unstable for handling, orally intubated or had a tracheostomy. Sample Size A minimum of 36 infants and the primary parent fitting the inclusion and exclusion criteria was the goal of enrollment for this study. The total sample size came to 27, with 3 who were eligible but declined to participate (refer to Figure 1). The final sample of 24 was allocated to 11 participants in the intervention and 13 participants in the control. Sample size was determined using G*Power, version 3.1 (Faul et al., 2009). The calculation was based on comparing mean differences between two independent groups and the following parameters, two-tailed test, alpha of .05, power of 0.80 and a small effect size of .30 from the calculation, a total sample size of 24 participants is recommended. (12 in each of two groups, the intervention group, and the standard of care group) (Thaleimer & Cook, 2002; Ustad et al., 2016). Considering the possibility of missed sessions and attrition rates, the total sample size was expanded by 50% increasing each group size to 18 participants, for a total of 36 pairs of TUMMY TIME INTERVENTION AND PARENT EDUCATION 28 participants. However, the study concluded with 27 participants as the sample reached its initial sample size recommended after a year of data collection. Instrumentation Neurobiologic Risk Score The NBRS is designed to identify risk for developmental delay and outcome due to neonatal medical risks. It is an objective measure that assesses risk of developmental delay based on neonatal medical events (refer to Table A3). Brazy et al. (1993) identified categories of risk as: low risk (NBRS 4), intermediate risk (NBRS 5-7) and high risk (NBRS 8). Participants in this study were categorized in either low or intermediate/high risk. Scoring includes receiving mechanical ventilation, having a pH < 7, seizures, intraventricular hemorrhage, periventricular leukomalacia, infection, and hypoglycemia. Zero points are given if absent; if present, the item is graded 1, 2, or 4 based on severity (Brazy et al., 1993). Based on research by Brazy et al. (1993) among infants born preterm at < 1500 g., there is a strong correlation with the NBRS scores taken at time of discharge from the NICU and scores from the Bayley Mental Developmental Index (MDI) and Psychomotor Developmental Index (PDI) from the first edition of the Bayley Scales of Infant Development and neurologic examination score (NS) taken at 6, 15, and 24 months (Brazy et al, 1993). Correlation values were r = -.53 for the MDI, r = -.55 for the PDI and r = .60 for the NS. The Test of Infant Motor Performance The TIMP is a 42-item functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose & Westcott, 2005). The TIMP assesses the posture and selective control of movement of the infant. It was developed to identify infants with delayed TUMMY TIME INTERVENTION AND PARENT EDUCATION 29 motor development and to measure change that may occur after an intervention. The TIMP has established age standards of performance for infants between the ages of 34 weeks postmenstrual age (PMA) and 17 weeks corrected age (Campbell et al., 2006). There are 42 items on current Version 5, requires an average of 36 minutes to administer and raw scores are converted to age norms over two-week increments (Campbell, 2012). Z-scores, percentile ranks, and ageequivalent scoring can be calculated as well (Campbell et al., 1995; Campbell et al., 2006). A score within +/- 1 standard deviation (SD) of the mean for the age group indicates an average score, low average is a range between -0.5 and -1 SD below the mean for the age group, below average is the range of scores between -1 SD and -2 SD below the mean for the age group and scores more than -2 SD below the mean for the age group fall in the far below category. The TIMP demonstrates strong test-retest reliability across the age ranges of the TIMP, r = .89 (Noble & Boyd, 2012; Rose & Wescott, 2005; Spittle et al., 2008). Additionally, the TIMP demonstrated excellent intra-rater reliability with an ICC = .98- .99 and excellent interrater reliability with an ICC = .95 (Noble & Boyd, 2012; Spittle et al., 2008). The TIMP also has strong discriminant and predictive validity (Campbell, 2012) Campbell and Hedeker (2001) examined the validity of the TIMP for discriminating among infants with varying medical risk. Using a random-effects growth curve analysis, the authors identified differences among each group over time, noting that infants in the low-tomedium risk groups performed better on the TIMP versus those infants with known brain insult. This demonstrates that the TIMP discriminates among infants with varying risk for developmental delays (Campbell & Hedeker, 2001). The predictive validity of the TIMP was established against the Bruininks-Oseretsky Test of Motor Proficiency. Using a cut off z-score of -1.6, the TIMP had an accuracy rate of 89% in TUMMY TIME INTERVENTION AND PARENT EDUCATION 30 identifying infant outcome and a sensitivity of 50%, specificity of 100%, positive predictive value of 1.00, and negative predictive value of .87 (Flegel & Kolobe, 2002). The TIMP has strong psychometrics with respect to its validity, construct, content, and criterion validity receiving excellent grades with an adequate grade only related to responsiveness which has not been studied (Noble & Boyd, 2012). Concurrent validity with the TIMP and the Alberta Infant Motor Scale (AIMS) has shown a correlation between raw scores on the TIMP, and the AIMS was .64 (p < .0001) and that between TIMP raw scores and the AIMS percentile ranks was .60 (p < .0001) (Campbell, 2012). From a clinical standpoint, 39% of infants who test poorly on the TIMP at 3 months are likely to have motor development below the 5th percentile on the AIMS at 12 months and nearly all infants who score poorly on the 12-month AIMS were identified as having a poor TIMP scores at 3 months (92%) (Campbell, 2012). PT Pal Pro Application Patient Pal Pro (2018) is an application designed for clinicians to send their patients instructions on exercises directly to their phone. The application allows the clinician to set orders which provide the patient a reminder on how long to complete the exercise (set by a timer), what exercises need to be done as well as how to complete the activity. While there are no validity or reliability studies on this specific application, there has been literature on the use of mobile applications and adherence to specific interventions with respect to physical activity, medication use, smoking cessation, weight management and mental health interventions. Rathbone and Prescott (2017) completed a systematic review from January 2008 to January 2017 with the primary outcome measures consisting of adherence, feasibility, and usability. For medication adherence, three applications addressed showed large effect sizes and one study on physical activity showed moderate to large effect size on step count after 3-month use. Further TUMMY TIME INTERVENTION AND PARENT EDUCATION 31 research is warranted however there appears to be promising use in the efficacy of using mobile apps in a variety of health interventions (Rathbone & Prescott, 2017). Procedures Reliability Procedures The TIMP was performed by an expert TIMP tester clinician (Laura Zawacki, MPT, PCS) with scoring reliability of fewer than 5% mis-fitting ratings based on Rasch analysis. Ms. Zawacki has participated in several studies utilizing the TIMP including the normative study on 990 infants for which she supervised tester training. Recruitment Procedure A convenience sample was recruited within the Level IV NICU at Ann & Robert H. Lurie Childrens Hospital of Chicago. Recruitment of participants took place in the NICU through the placement of advertisement flyers and census review of potential participants during attendance at interdisciplinary rounds. Additionally, the primary investigator had access to medical charts and a weekly census that was screened for potential participants. Informed Consent The primary investigator confirmed each infants eligibility and the parents willingness to participate. Written informed consent (available in both English and Spanish) was completed by the primary researcher from the primary parent at the time of enrollment into the randomized controlled trial study. Oral and written information was provided to parents of the infants born preterm who fulfilled the inclusion criteria. All consents (parent permission and adult consent) were signed by the primary parent after which the initial TIMP was scheduled and the NBRS scoring was completed by the primary researcher. TUMMY TIME INTERVENTION AND PARENT EDUCATION 32 Group Assignment Participants were randomly assigned to one of two groups (Group 1 = tummy time protocol group, Group 2 = standard care group). A physical therapist who was not involved in the study was responsible for randomizing the envelope contents. Individual randomization assignments were concealed according to the following procedure. The group assignment (Group 1 or Group 2) was recorded on a 3.5 x 5-inch index card. The card was folded in half such that the group name was on the inside of the fold. The folded index card was then placed inside the envelope, and the envelope was sealed. Envelopes were placed in a single box and as participants were identified, the envelope at the top was taken out of the box which indicated to which group the participant was assigned and what number was assigned to the participant. Once the participant number was assigned, the information regarding the participant was logged under the assigned number with no participant identity attached to the data. Data Collection Initial pre-TIMP assessments were collected within the neonatal intensive care unit at Lurie Childrens by the blinded assessor (Ms. Zawacki, MPT, PCS). For all infants who discharged prior to the four-week point of the study, post-TIMP assessments were collected by Ms. Zawacki at the participants home. The primary researcher (D. D.) was present at every pre and post TIMP assessment. All data from the tummy time intervention was recorded directly via a secure non-subject identified google doc worksheet in the primary investigators encrypted Chromebook computer. All other outcomes and data were transferred to a password secured electronic spreadsheet matched to only the participants study number within the primary researchers password protected laptop. The PT Pal application was utilized remotely with data TUMMY TIME INTERVENTION AND PARENT EDUCATION 33 (tummy time minutes) entered directly from the parent on their mobile device and retrieved by the primary researcher. Descriptive Variables Infant characteristics were collected via review of the medical record. Infant characteristics collected included neurobiologic risk score (NBRS), gestational age at birth, gender, infant race/ethnicity, birth weight, and postmenstrual age at time of initiation of the study. Additionally, if the infant was receiving physical and/or occupational therapy, the frequency of services as well as minutes of therapy was collected. This was noted as number of therapy minutes and visits received during the entire eight-week study period. The NBRS was collected and scored upon initiation into the study to assess each participants medical risk. The total score range is from 0-28 and is based on 7-items that reflect the impact of medical events related to potential motor development (Brazy et al., 1993). Scores were collected by the primary researcher (D.D.) via review of the medical record of each participant in this study and reflected medical complexity at the time of initiation into the study (Lefebvre et al., 1998). Outcome Variables For this study, the TIMP measured motor performance pre- and post-intervention among both the intervention and control groups. The TIMP raw score was transformed into a standardized z-score by comparison to age norms that were established in 2-week increments based on a population-based study of 990 U.S. infants (Campbell et al., 2006). TIMP raw and standardized z- scores were collected at baseline and at the end of the four-week intervention period from both the intervention and standard of care groups. Adherence was measured via the PT Pal application. The primary researcher asked parents in both groups to adhere to the recommended tummy time frequency of two times a day, four times/week for 10 minutes each TUMMY TIME INTERVENTION AND PARENT EDUCATION 34 session over the 8-week study resulting in a total of 640 minutes of tummy time. Adherence, based on work from Medina-Mirapeix et al. (2017), is defined as a compliance ratio of number of minutes completed divided by number of minutes recommended with 66% set as adherent. This was the benchmark utilized to determine each participants adherence. Total tummy time minutes were collected with median minutes of tummy time per week used as the outcome measured for both groups. Compliance ratios were also calculated to determine each participants adherence to the dosage recommended. The application allowed the primary researcher to send parent(s) a daily digital prescription of the recommended tummy time activity, visual aids and reminders (memos) to complete the recommended frequency. As the parent completed each 10 minutes session, they clicked a circle on the app loaded to their mobile device which recorded their timed session. This in turn allowed for remote monitoring of adherence with the ability for the primary researcher to generate a report from the PT Pal application. Interventions If the participant was assigned to the experimental group, they received the intervention, education session and recommendations on tummy time all from the primary investigator. If the participant was assigned to the control group, they received standard of care which consisted of receiving the education session from the primary investigator. Both groups were asked to record their tummy time minutes on the PT Pal application. Table A1 illustrates each step for each group. Intervention Group 1: Tummy time protocol (see Table A1) The intervention was completed by the primary researcher (DD) with a dosage protocol of tummy time set at 2x/day for 10 minutes each, 4 days/week. The following describes the processes for completion of the intervention. TUMMY TIME INTERVENTION AND PARENT EDUCATION 35 Infant participated if described behavioral state of drowsy, alert, or crying state was achieved just prior to intervention. During the intervention, the infant would need to maintain an alert state as described by Brazelton (Brazelton T.B., 1995). (refer to Table A2) The infant remained clothed, but swaddling was removed. Two variations of tummy time position were performed: flat prone on crib surface or flat prone on a mat surface. Fifteen degrees of inclination for the head of bed angle was allowed if required for the infant to maintain physiological stability or for medical necessity. Flat on mat surface was performed unless lines/tubing prohibited the ability to position the infant on the mat surface. A mirror and small, uniform toy (multi-sensory) were provided for visual and auditory stimulation to the infant. Verbal conversation from the PI or parent to the infant was allowed during the intervention. Timing of intervention was done via a stopwatch; timing began immediately after the infant was positioned prone. Infant remained on all monitors (heart rate and pulse oximeter for SpO2 level) during the intervention. Infant was monitored by the primary investigator during the entire 10 minutes. Physiological stability was monitored throughout the intervention. The intervention was paused if one or more of the following occur: 10% increase in heart rate, oxygen levels (SpO2) decreased below 93% and an increase in respiratory rate by 10%. If physiological instability occurred, the intervention and timing was paused. The infant was repositioned and if the bedside nurse reported TUMMY TIME INTERVENTION AND PARENT EDUCATION 36 to the investigator that the intervention could resume, timing and the intervention continued. If the participant could not complete the remainder of the tummy time protocol, the intervention was halted or could be resumed later/date or marked as incomplete if infant could not complete the intervention safely (maintaining physiological stability). All interventions were logged by the primary researcher with a notation that 10 minutes was achieved continuously or with a pause/break needed but completed. A category of incomplete was marked if the participant was unable to achieve the full ten-minute protocol. The infants behavioral state prior, during, and at the end was recorded. If the parent(s) was present, this was noted within the primary researchers data collection spreadsheet. Parents were encouraged to observe if present during the intervention and was documented. Adherence during the 8-week study period was measured remotely through the PT Pal application. Criteria for Group 1 Missed Intervention Sessions Infant received sedation for procedure and were not able to achieve wakeful state for at least 10 minutes. Prior to planned session intervention, the infant experienced consecutive and continuous apnea, bradycardia or tachycardia or other events (e.g., seizures, intraventricular hemorrhage (IVH, or increased intracranial pressure that deviated vitals more than 10% from the infants baseline (quiet rest) heart rate, respiratory rate, and oxygen saturation. TUMMY TIME INTERVENTION AND PARENT EDUCATION 37 Infant received a gastrostomy tube. Infants were able to resume the study two weeks post placement of the gastrostomy tube. Infant received a surgical procedure (other than gastrostomy tube) that would limit prone positioning for more than 1 day. If infant could not participate in a session for other reasons, this was tracked on the primary researchers secured, encrypted computer. Intervention Group 2: Standard Care Parent education and parent-led tummy time as noted in Table A1. Data Management and Statistical Analysis Descriptive statistics were conducted on demographic data for the entire sample. To determine if there were differences in demographics between the intervention group and control group, data were compared. Nominal data are presented as frequencies and percentages while interval and ratio data are reported as means and standard deviations or medians and interquartile ranges, depending on whether the data were normally distributed. Nominal data were compared using a Fishers exact test. Interval and ratio data were compared using independent t tests if the data was normally distributed, or Mann-Whitney U tests if the data were not normally distributed. To determine if there was significant difference in TIMP z -scores between the two groups over time, a 2 x 2 mixed design repeated measures ANOVA was conducted. The independent variables are time (within subject factors) and group (between subject factors). The dependent variable is the TIMP scores (pre/post). To determine if there was a significant difference in adherence rates as measured by median total minutes per week of tummy time, a Mann-Whitney U test was performed. TUMMY TIME INTERVENTION AND PARENT EDUCATION 38 Normality of data was be determined using the Shapiro-Wilk test. Data were analyzed using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corporation, Armonk, NY). All comparisons were two-tailed with a significance level less than .05 considered to be statistically significant. Correlations were conducted using Spearman rho tests for non-normally distributed data. Correlation coefficients were interpreted as follows: correlations of 0-.25 were considered very low to no correlation, .25-.50 low correlation, .50-.70 were considered moderate to good correlation and above .75 were considered good to excellent (Portney &Watkins, 2015). Results There were 30 invited participants; however, informed consent was not obtained for three infants, leaving a sample size of 27. Of the 27 infants, 13 (48%) were randomized into the intervention group and 14 (52%) into the control group. Three participants did not complete the study, two in the intervention group and one in the control group. In the intervention group, one participant withdrew after the baseline assessment due to unexpected discharge and the other participant was lost to follow-up, unable to be reached at home for the postintervention assessment. The participant in the control group was removed from the study due to incorrect randomization (twin was assigned to same group as sibling). The final sample sized used for analysis was 24. Figure 1 presents participant enrollment and randomization process. Participation Criteria Per the study proposal, the criterion to remain in the study were that infants had to participate in a minimum of 75% of the tummy time sessions or an attendance rate of at least 24 out of 32. Upon completion of the study, only 27% (3 of the 11 participants) in the intervention group achieved an attendance rate of at least 24 tummy time sessions. Attendance rate was TUMMY TIME INTERVENTION AND PARENT EDUCATION 39 impacted by surgical procedures, inability to attain wakeful state, procedures requiring limited to no activity and competition of other therapies. If the original criterion were used to remain the study, it would have resulted in extreme loss of data; therefore, the requirement was eliminated, and all data were included in the analysis. Participant Characteristics The mean and standard deviations for gestational age at birth was 32.0 weeks (3.17) for the intervention group 30.9 weeks (3.64) for the control group. The mean post-menstrual age at pre-assessment was 42.4 weeks for the intervention group and 39.0 weeks for the control group. The mean post-menstrual age was 45.9 weeks for the intervention group and 44.3 weeks for the control group. Among the intervention group, 90.9% and 46.2% of the control participants were non-Caucasian and 9.1% of the intervention group and 53.8% of the control were Caucasian. Among the intervention group, 36.4% were males and 63.6% were females. Among the control group, 30.8% were males and 69.2% were females. The mean and standard deviation for birth weight was 1.4 kg (0.65) for the intervention group and 1.6 kg (0.67) for the control group. Demographic Comparisons between Intervention and Control Groups Table 1 and 2 present participant demographic comparisons and characteristics. There were no significant differences in birth weight, gender, gestational age at birth, post-menstrual age pre-intervention, postconceptional age post intervention, or medical complexity (as scored through the NBRS). There was a significant association (p = .033) between ethnicity and the intervention and control group, with a greater proportion of Caucasians in the control group. Motor Assessment Comparison Pre-Intervention and Post-Intervention Table 3 and 4 present motor assessment comparison scores at pre- and post-intervention. An independent t test was conducted to compare TIMP z-scores between the two groups at the TUMMY TIME INTERVENTION AND PARENT EDUCATION 40 initiation and after the intervention period (week 4 of 8) of the study. An independent t test, t (22) = -1.88, p = .074 indicated that the groups did not differ statistically at an alpha of .05 preintervention. An independent t test, t (22)= -.72, p = .48 indicated that the groups did not differ statistically at an alpha of .05 post-intervention. The null hypothesis is accepted, and it is inferred participant TIMP z-scores did not differ between the intervention and control group at baseline or post-intervention. Hypothesis 1: Comparison TIMP Scores Between Intervention and Control Groups The 2x2 mixed design ANOVA results are presented in Table 5 and in the line graph in Figure 2. Pre-intervention-TIMP z-scores were -0.21 (0.86) for the intervention group and 0.45 (0.86) for the control group. Post-intervention TIMP z scores were -0.38 (1.14) for the intervention group and -0.11(.69) for the control group. There was not a statistically significant interaction between the intervention and control group for TIMP z -scores measured preintervention and post-intervention, F (1, 22) = 1.29, p = .27 therefore, the null hypothesis is accepted. There was a statistically significant main effect for change in TIMP scores from preintervention to post-intervention, F (1, 22) = 4.46, p = .046 indicating that TIMP z scores of both groups declined from pre-intervention to post-intervention with the mean difference (pre to post) 0.170 for the intervention group and 0.564 for the control group. Decline was noted to be greater in the control group. These results may also be clinically relevant as there was a large effect size, p2 = .17 (Cohen, 1988) and may also reflect regression to the mean. There was not a statistically significant main effect between groups, F (1, 22) = 2.11, p = 0.16, indicating there was not a significant difference in TIMP z-scores between the groups. TUMMY TIME INTERVENTION AND PARENT EDUCATION 41 Hypothesis 2: Adherence to Tummy Time Table 6 and Figure 3 present adherence data and Table 7 reflect each participants compliance ratio. Data were analyzed to see if there were differences in median minutes among each group in adherence to performing the recommended dosage of tummy time. Total tummy time minutes were collected over the total study length and a benchmark adherence rate (66%) and compliance ratio were calculated. Using these standards, 15.4% of the control participants and 18.2% of the intervention participants met these standards over the entire study period. The data were not normally distributed; therefore, a non-parametric test was used to compare total tummy time minutes between the groups. The Mann-Whitney U test, Z = - 0.20, p = .84 indicated that the groups did not differ statistically at an alpha .05 level. The null hypothesis is accepted, and it is inferred that adherence to the recommended tummy time dosage was not impacted by the primary researchers (DD) education session/study recommendations or application use. Relationship between Ethnicity and Pre-TIMP Z-Scores Table 8 illustrates the differences between pre-TIMP z-score and ethnicity groups (Caucasian and non-Caucasian groups). To determine if there was a difference in preintervention TIMP z-scores between the Caucasian and non-Caucasian groups, an independenttest was performed. Demographics post randomization included 9.1% (n = 1) of the intervention group were Caucasian, 90.9% (n = 10) in the intervention group were non-Caucasian. Among the control group, 53.8% (n = 7) were Caucasian and 46.2% (n = 6) were non-Caucasian. The mean TIMP pre-intervention z-score was 0.67 and a standard deviation of 0.91 among the Caucasian group (n = 8) and -0.11 and a standard deviation of 0.81 for the non-Caucasian participants (n = 16), both within the average range for age. An independent t-test with a t (22) = 2.13, p = .044 indicated that the groups did statistically differ at an alpha level of .05. The 95% confidence TUMMY TIME INTERVENTION AND PARENT EDUCATION 42 interval of the mean between the groups ranged from 0.02 to 1.54. The null hypothesis is rejected inferring that there is a statistically significant difference in pre-intervention TIMP z-scores between non-Caucasian and Caucasian participants. Relationship between Ethnicity and Post-TIMP Z-Scores Table 9 and Figure 4 reflects the median post-intervention TIMP z-scores by ethnicity. To determine if there was a difference in post-intervention TIMP z-scores between the Caucasian and non-Caucasian groups, a Mann-Whitney U test was performed as normal distribution was not achieved. The median TIMP post-intervention z-score was 0.01 among the Caucasian group (n = 8) and -0.02 for the non-Caucasian participants (n = 16). The Mann-Whitney U test, Z = 0.49, p = .62 indicated that the groups did not differ statistically at the alpha .05 level. The null hypothesis is accepted and thus inferred that ethnicity did not impact the post-TIMP motor outcome score and thus there is no statistically significant difference in post-intervention TIMP z-scores between non-Caucasians and Caucasian participants. Regression Analysis Table 10 reflects the regression results without filtering cases and Table 11 reflects with cases filtered. A multiple regression analysis was run to explain post-TIMP z-scores from ethnicity, medical complexity (NBRS scores), group assignment, and the tummy time minutes. There was a linear relationship as assessed by partial regression plots and a plot of studentized residuals against the predicted values. There was independence of residuals, as assessed by a Durbin-Watson statistic of 1.8. There was homoscedasticity, as assessed by visual inspection of a plot of studentized residuals versus unstandardized predicted values. There was no evidence of multicollinearity, as assessed by tolerance values greater than 0.1. There was one value from the studentized deleted residuals (participant #27) greater than three standard deviations and no TUMMY TIME INTERVENTION AND PARENT EDUCATION 43 values for Cooks distance above one. There was one outlier (participant #27) and five leverage values greater than 0.2 identified (participant #s 7,10, 17, 14 and 26). The assumption of normality was met as assessed on the P-P plot line. Running the regression with all data points, the multiple regression model did not demonstrate statistical significance as predicted on the post- TIMP z-score, F (4, 19) = 1.04, p = .42, adj R2 = .007. Running the regression with elimination of the outlier and leverage values greater than 0.2 demonstrated that the multiple regression model did not demonstrate statistical significance as predicted on the post- TIMP zscore, F (4, 13) = 1.00, p = .45, adj R2 = -0.0001. Physical Therapy Table 12 presents mean, and weekly average physical therapy minutes received per group and Table 13 presents the mean physical therapy visits. For this study, the average number of physical therapy minutes/week and physical therapy visits/week received outside of the study intervention protocol during the 8-week study period were collected. Analysis of physical therapy minutes over 8-weeks resulted in a mean and standard deviation for the intervention group at 436.8 minutes (283.1) and 267.7 minutes (196.2) for the control. An independent t test, t (22) =) = 1.72, p = .099 indicated that the groups did not differ statistically at an alpha of .05. Analysis of physical therapy visits resulted in a mean and standard deviation for the intervention group at 16.1 (10.7) and 9.1 (7.5) for the control. An independent t test, t (22) =1.88, p=.073 indicated that the groups did not differ statistically at an alpha of .05. Correlation between Tummy Time Minutes and TIMP scores Correlation results are presented in Table 14 and the scatterplot in Figure 5. A Spearmans rank-order correlation was run to assess the relationship between post-intervention TIMP z-scores and total tummy time minutes in infants born preterm. Although the trend was TUMMY TIME INTERVENTION AND PARENT EDUCATION 44 positive, there was no statistically significant correlation between total tummy time minutes and post -TIMP z-scores, Rs (22) = .377, p = =.070, representing a weak relationship. Infants achieving at least 400 total tummy time minutes scored within the average range on the postintervention TIMP. Discussion We identified two objectives for this study: 1. Will infants born preterm receiving a wakeful tummy time intervention over a 4-week intervention period demonstrate improved motor outcomes compared to the control group? and 2. Is adherence to therapy home program recommendations improved with the use of a mobile application and parent education? Although we were unable to support our main hypotheses that infants receiving more wakeful tummy time would demonstrate improved motor outcomes on the TIMP and adherence to the prescribed dose would be influenced with the use of the PT Pal application, we did expand our understanding of the impact of dosing, feasibility, and adherence with a mobile application. Other factors including ethnicity and medical complexity were addressed for their role in our motor outcome results. The importance of tummy time has been well- researched in full term infants. DudekShriber and Zelazny (2007) identified that tummy time (> 80 minutes/day by 4 months of age) is necessary to achieve typical developmental motor skill acquisition for healthy term infants. Our dosage of wakeful tummy time was chosen based on the study completed by berg et al. (2019) who utilized a parent administered home program that included 10 minutes of specific therapeutic activities twice a day. The SPEEDI pilot study utilized a similar dosing as well (Dusing et al., 2018). This method also allowed for a second opportunity within the same day in case the first trial was not feasible. TUMMY TIME INTERVENTION AND PARENT EDUCATION 45 Neonatal therapists utilize a variety of interventions, and thus it is important that we identify those that are the most impactful. There are several studies that have identified what has been shown to be effective. berg et al. (2020) reported the most effective interventions are those involving both the parent and the infant with a focus on an optimal level of dosing. In their parent-administered intervention initiated in the NICU, a statistically significant positive relationship from the end intervention time and the TIMP z-score at 3 months CA. was identified (berg et al, 2020). Oberg et al (2020) also discuss, as quoted in the systematic review by Hughes et al. (2016) that motor interventions focusing on the infants active movements in a variety of positions were the most beneficial for enhancing motor skills from birth to 24 months CA (p. 866). In the randomized controlled trial termed SPEEDI (Supporting Play and Early Development Intervention) study by Dusing et al. (2018)), which was an intense, variable and parent-focused intervention, demonstrated a moderate to large effect size in TIMP change scores as well as the Bayley Scales of Infant and Toddler Development. were identified. Therapists utilize a variety of interventions. Ross et al. (2017) identified therapy pattern usage of 56 different therapeutic interventions in level IV neonatal units. While having a variety of treatments provides individualized options for these infants, it also makes it challenging to know what interventions are the most effective. In the review by Hughes et al. (2016), it was reported that studies utilizing a targeted motor-focused intervention such as prone play or reaching showed improved motor outcomes (61.5%) compared to those with a more nonspecific focus (40.9%) such as enhancing the parent-infant relationship. For this study, we wanted to analyze a specific treatment to determine its effectiveness among infants born preterm. TUMMY TIME INTERVENTION AND PARENT EDUCATION 46 Intervention Dosage There is ongoing evidence that shows early intervention at sufficient dosing is more impactful than long-term low intensity (Dusing et al., 2015). While there were challenges of medical complexity and confounding factors of additional therapies and lack of adherence, our study does seem to support that that our set dosage was adequate. Our correlation analysis showed that those infants who achieved at least 400 total tummy time minutes over the 8-week period scored within the average range on the post-intervention TIMP. Thus, dosage may impact motor skill outcome in the short term. As we experienced in this study, we did not achieve our prescribed dosage, and this occurred as well in the study by berg et al. (2020). While berg et al.(2020) did not identify motor outcome differences between groups 3-months after the intervention ended, they did note that increased dosage of intervention in the NICU was associated with better motor outcome scores at 3 months CA (berg et al. 2020). Specifically, the adjusted odds of having a z-score of < 0 was 6 times higher for those whose parents had spent < 222 minutes on the intervention (berg et al. 2020, p. 866). The capacity of the brain to adapt, remodel and recover is likely dependent on the amount of time an infant experience opportunity for movement. While our sample size is small, our analysis supports the fact that dosage matters, and adequate high dosing does impact motor outcome. Adherence Adherence is the extent to which a persons behavior corresponds with agreed recommendations from a healthcare provider (Rezaie & Kendi, 2020, p. 64). Adherence to home program carry over is challenging to identify and measure as there is limited research on adherence within the pediatric population and specifically in the NICU. Baaran et al. (2014) report that estimates of non-adherence to home program recommendations is as high as 50%. In TUMMY TIME INTERVENTION AND PARENT EDUCATION 47 the qualitative study by Rezaie & Kendi, (2020), several barriers to adherence were identified including child and family related factors (e.g., severity of diagnosis), therapist related factors (e.g., communication skills and competence), environmental factors (access, cultural view) and therapy related factors (type of intervention and length of treatment). Regardless of which factor is causal, it is evident that parents do less than what is recommended. Rone-Adams et al. (2004) also report that as many as 50% of parents do not adhere to the prescribed therapeutic home program recommendations. Engaging parents to be active participants may influence their infants motor trajectory and possibly decrease motor delays when compared to those who are not as compliant and thus serves as an important factor to address (Javier et al., 2012). MedinaMirapeix et al. (2017) discuss several barriers of adherence for children with developmental disabilities, these being related to the individual, social supports and resources and illness/health condition of the child. They reported that adherence increased three-fold when outside social supports were in place for the primary caregiver (Medina-Mirapeix et al., 2017). Our social supports were highest during the NICU stay (visual aids of poster and nursing and the primary researcher serving as supports) and correlated with improved adherence with the PT Pal application which declined over the length of the study period. Medina-Mirapeix et al. (2017), reported that when there is professional interaction and communication with parents, this serves as a key determinant of home exercise program overall adherence (p. 552). Every week, the primary investigator sent the parent a memo providing a supportive message on their current performance and to continue tummy time as instructed. This might have been enhanced by faceto-face interaction or observing the parent with the infant and providing anticipatory guidance. This factor was supported in the study by Medina-Mirapeix et al. (2017) as when skills were checked frequently by the professional, parents increased adherence to frequency more than TUMMY TIME INTERVENTION AND PARENT EDUCATION 48 two times. During the last two weeks of the study, when most infants were home, only eight out of the twenty-four participants continued to record their tummy time minutes on the application. Once the infant is home, taking care of siblings, working and possible childcare needs outside of the home all potentially contributed to the decline of performance and accurate recording of tummy time on the application which is supported by Medina-Mirapeix et al (2017) who state that adherence, is impacted by the age of the parent(s), having other siblings, working situations, social support and level of illness in the infant. Stress is another factor and has been one of the most cited characteristics of families caring for a disabled child (Rone-Adams et al., 2004). A follow up parent-perspective survey on the use of the application would have been ideal to investigate this result finding. The use of more direct communication with the parents, even with a phone or telehealth form of communication might have positively influenced our adherence. Regardless of the many potential influences on adherence, only 15.4% control and 18.2% of the intervention participants were considered adherent. This is consistent in the literature that adherence among parents of children with disabilities is typically less than the recommendations provided by the therapist (Medina-Mirapeix et al., 2017) Medical Complexity The influence of medical risk was likely a barrier to the studys success in achieving our protocol dosage and possibly impacted parental participation and compliance in tummy time. The opportunity for movement and practice can be challenging to achieve in the NICU due to each infants individual medical complexity. Lekskulchai and Cole (2001) supported this concept stating, poor quality postural stability and mobility in the preterm population might be related to differences in experiences such as longer hospital stays, neurological impairment associated with medical complications or immobility due to the constraints of medical technology (p. 169). The TUMMY TIME INTERVENTION AND PARENT EDUCATION 49 feasibility study by Dusing et al. (2015) also found challenges with respect to medical complexity in their study using the SPEEDI protocol (Supporting Play Exploration and Early Development). The authors acknowledged the difficulty of performing interventions in the NICU with respect to the timing of the therapist-led interventions and stated, It is not surprising given the medical fragility of infants in the NICU (Dusing et al., 2015, p. 273). With less practice and potentially less movement experiences available, it is possible this served as a disadvantage for our intervention group given this group was higher in medical complexity (intervention group at 36.4% intermediate/high risk versus 15.4% in the control). Perhaps utilizing more parental involvement as well as nursing supports could have assisted more optimal timing of our interventions. This is supported by research from Dusing et al. (2015) as noted These challenges demonstrate a potential need to increase the role of parents and nurses in identifying infant readiness for interaction and providing developmental play activities in the NICU at times when the infant is alert (p. 273). The influence of medical complexity may have impacted parental involvement and how much tummy time the parents performed. It is evident that parent-infant interaction and parentdelivered activities may improve motor capabilities in infants born preterm (Dusing et al., 2012; berg et al., 2020). While an important factor, there are unique challenges faced in the NICU. Parents may perceive that their infant is too sleepy or too fragile for play (Hughes et al., 2016). Infants born preterm can have unclear behavioral cues, autonomic instability, motor-based stress signs as well as unstable behavioral states that can make it difficult for parents to engage, play and interact with their infants (Dusing et al., 2020). Parents have reported feelings of not feeling they are a part of their infants care since most of the care is completed by the NICU medical staff (Dusing et al., 2012). Additionally, parents may return to work to accrue time off when the TUMMY TIME INTERVENTION AND PARENT EDUCATION 50 infant is able to come home (Dusing et al., 2012). While these are significant challenges, there are potential solutions such as the modified parent education approach (Dusing et al., 2012) who concluded multiple visits are necessary for parents to learn the therapists recommendations. This approach focused on introducing principles of development early in the NICU stay, providing many opportunities to review and practice while accommodating to the parents visiting schedule, having materials that correlated with the parents learning styles and lastly involving nursing staff to join in the developmental care aspects being promoted by therapies (Dusing et al., 2012). Additionally, adding some or all these components to this study may have assisted in improving our parent involvement and while we did not collect data on parental involvement, in retrospect, identifying the amount would have been ideal. Narrowing our sample to specific diagnoses could have limited our variability allowing for the ability to better evaluate the study interventions impact on developmental outcomes. In the study by Lekskulchai & Cole (2001), their sample was narrowed by excluding infants with genetic disorders and other high-risk conditions (IVH > grade 3, hydrocephalus) and additionally included a comparative group of infants who scored an average TIMP score at baseline. Previous intervention studies from Morgan et al. (2016) and Dusing et al. (2015) have shown significant motor and cognitive outcome gains when focusing on a high-risk preterm population (those at high risk for cerebral palsy). Using a more specific sample for this intervention may have allowed us to better determine the relationship of targeted tummy time and its ability to support neurodevelopmental outcomes. The role of pain or stress may have contributed to challenges in the infants attaining appropriate states for intervention. Seven (five in intervention and two in the control group) participants underwent surgical procedures requiring sedation and intubation including the TUMMY TIME INTERVENTION AND PARENT EDUCATION 51 following procedures: gastrostomy tube (2 participants), ventriculoperitoneal shunt (2 participants), subglottic stenosis repair (1 participant) and bowel repair (2 participants). Cumulative pain from procedures could be a contributory medical risk factor that led to challenges achieving the dosage goals for the intervention and/or participation in tummy time with parents. While this was not measured, it is noted since it may have been a contributing factor. The relationship between early painful experiences and neurodevelopment is not fully understood and further research is warranted (Bogginni et al., 2018). Infants born preterm or very preterm may need time to recuperate from their medical complex issues before experiencing gains in their motor development. Demaster et al. (2019) discussed how biological adversity impacts very preterm infants experiences through disruptions in their neurological and motor development resulting from infection, toxins, malnutrition, anesthesia, as well as lack of caregiver interactions. These infants may be predisposed for more significant motor delays and therefore may need more time and graded interventions to benefit and demonstrate motor skill improvements once they have recovered from their complex medical needs. Perhaps, in the short-term, medically complex preterm infants may not make significant gains with respect to their motor development but may still benefit from early environmental enrichment in combination with parent engagement with therapist guidance and coaching (Morgan et al. 2016; berg et al., 2020). Ethnicity Despite randomization, representation of ethnic groups was significantly different with the intervention group having a higher percentage of non-Caucasians compared to the control. The impact of ethnicity and motor outcome is complex and likely impacted by many confounding factors. Travers et al. (2020) conducted an observational cohort study which TUMMY TIME INTERVENTION AND PARENT EDUCATION 52 included 25 U.S. medical centers and looked at racial/ethnic disparities and the impact on motor outcome as well as sepsis and mortality. Among the 20,092 infants who ranged in gestational age from 22-27 weeks, moderate-severe neurodevelopment impairment increased over the study period (2006 to 2014) among all racial/ethnic groups. Impairments rose among black infants by 70%, Hispanic infants by 123% and by 130% for white infants. The rationale behind the increase among all groups is likely multi-factorial however it was noted that the use of antenatal corticosteroids and lower rates of late-onset sepsis were likely contributory to this effect; thus, indicating advanced medical care. While possibly not influencing the results of this study, it is an important fact that if motor impairments are increasing differentially over time among all these ethnic groups, the influence of other factors, such as social adversity and parenting stress may impact motor outcome and should be addressed in the neonatal therapists plan of care. Physical Therapy Therapists tend to choose and shift between many types of interventions based on age of the infant, ability to tolerate handling, medical complexity, and behavioral state regulation needs. The most common therapy frequencies at Lurie Childrens NICU range from 2-3 times week, typically spending anywhere from 15-45 minutes with each patient with a total amount of minutes roughly between 30-135 minutes per week. The intervention group received a slightly higher average number of minutes (54.6 minutes/week) while the control received slightly less (33.5 minutes/week). One would hypothesize that the increased physical therapy minutes within the intervention group might have related to medical complexity as therapists typically choose higher frequencies when therapy needs are determined to be higher; however, this may not always be the case. For example, an infant with clubfoot or other orthopedic involvement may warrant daily therapy for ROM. This is a challenging relationship to isolate since therapy is TUMMY TIME INTERVENTION AND PARENT EDUCATION 53 standard of care in our NICU. Ross et al. (2017) supported this stating that in their study 100% of infants in the cohort received therapy, making this relationship difficult to untangle in a unit where therapy services are standard of care (p. 112). Additionally, the authors found that while increased therapy did not demonstrate better neurobehavioral behaviors, they did identify that more frequent therapy could be attributed to more complex medical conditions (Ross et al., 2017, p.108). While our results did not demonstrate differences in the number of minutes or visits and most participants received therapies (only one did not), both groups still demonstrated a decline in motor outcome scores relative to their age standards. This relationship remains unclear. To better understand this relationship and to control so many variables, isolating and limiting the variability in our sample and utilizing a larger sample might have improved our ability to assess physical therapy influences on our intervention group. Neuroplasticity The impact of neuroplasticity and its influence on specific developmental interventions need further investigation. Kleim & Jones (2008) discuss principles of intensity, timing, and age of training. With intensity, sufficient dosing is necessary and lower-intensity stimulation may weaken synaptic responses while higher ones may induce more (Kleim & Jones, 2008). Timing can influence motor function with consideration of there being a specific time window where neural organization is most impactful (Kleim & Jones, 2008). Timing of our assessments also might have influenced our results. Completing our post-TIMP at a later point in time, such as 3 months corrected age and/or even later and studying the longer- term effects would have been useful to further identify the outcome of our interventions and if there were lasting effects. It is also challenging to identify the just right amount of activity for infants in the NICU and this typically is highly individualized (Morgan et al., 2016). Plasticity is a double-edged sword, on TUMMY TIME INTERVENTION AND PARENT EDUCATION 54 one side, high plasticity of rapidly developing neutral tissue makes preterm brain more vulnerable to injury and on the other side, plasticity may be a mechanism through which positive experiences can normalize neurological development for preterm children (Demaster, et al., 2019, p. 166). Methods of this studys intervention carefully balanced principles of early protection while promoting active, infant-generated movement. Developmental care standards were followed by allowing a natural timing for the intervention (only performed when infant quiet/alert and wakeful) and engaging the parents with active participation through education and ongoing involvement. The education session focused on providing basic information on a variety of ways to promote tummy time, but also emphasized that parents should be responsive to their infants cues to minimize stress and regulate their motor, autonomic and state systems (Demaster et al., 2019). While the studys methods sufficiently balanced protecting the infant from further stress while encouraging the opportunity for movement, enough dosage and parent-led participation were not sufficient. Interventions initiated in the NICU needs to incorporate therapies with a focus on developmental care principles, parental handling, as well as programs to empower parents to be agents of change capable of improving their childs long-term psychological health outcomes through nurturing of their childs emotional and cognitive development (Demaster et al., 2019, p. 171). Limitations Our study has several limitations and likely the most significant was the need for a larger sample size due to the additional influences from medical complexity, ethnicity, medical risk, and physical therapy. We set the dosing for the intervention group at 80 minutes per week(640 minutes over 8-weeks) or 20 minutes over 4 days. Of the 11 participants in the intervention group, only 3 participants or 27% of the group achieved the optimal dosing of the intervention TUMMY TIME INTERVENTION AND PARENT EDUCATION 55 provided by the primary researcher. As anticipated, infants in a Level IV neonatal unit are typically medically complex and there were challenges of balancing surgeries, therapies, feedings, and other procedures that made wakeful tummy time difficult to schedule. Medical complexity was assessed through the neurobiologic risk score at the time of initiation into the study. A higher percentage of intermediate/high risk infants were randomized to the intervention group compared to the control. While this was not shown to be statistically significant, we experienced more infants (three in the intervention versus only one in the control) needing surgeries/procedures during their NICU stay. These surgeries limited the data collection process since these infants had to pause wakeful tummy time until cleared by the surgical and neonatal teams thus skewing the data collection process and the results. Physical therapy services might have impacted the ability to fully analyze our intervention. During the study period, participants received, on average, over 30 minutes of physical therapy per week. While not transparent, receiving therapy services may have limited our ability to delineate out the interventions impact on each infants motor outcome. While parents from both groups were asked to participate in performing tummy time, the provision of tummy time was decreased in both groups over the 8-week study. While research indicates that parent handling offers benefits to both motor and cognitive outcomes (Demaster, 2019; Morgan et al., 2016), there are many factors that influence adherence and this was challenging to address due to the multitude of variables in this study (Rone-Adams et al., (2004); Rezaie & Kendie, 2020). Increasing greater parent-led participation and handling as part of the intervention is optimal but challenging to achieve. To support this, Demaster et al. (2019) reports that many therapies focus on the infants physical needs, and potentially, the addition of stronger caregiver programs that focus on parental involvement and engagement may play a larger role in TUMMY TIME INTERVENTION AND PARENT EDUCATION 56 improvement during the neonatal period and beyond. Incorporating a parent-handling and therapist coaching focus, or a combination of the two, might have yielded different results for this study. Lastly, participants did not adhere to the therapy recommendations on dosage, and though many factors influence this, the bottom line one should anticipate that parents will likely do less than what we ask them to do. Recommendations for Further Research Further studies in the NICU are recommended to provide the highest level of evidenced based practice to this fragile and vulnerable population. Given the challenges with dosing, as well as the evidence that supports parent handling, it would be ideal to further pursue interventions that focus on parent handling, a combination of parent and therapist handling or parent-handling with therapist coaching. Increasing our sample size would have ideally assisted in managing the variability we saw with medical risk, ethnicity, dosing, and additional physical therapy influences. An additional component to add would have been to include cognitive outcomes. Studies show that cognitive outcome is improved with developmental interventions (Anderson et al., 2020) and it would have been ideal to include this information if we extended our follow up time frames past 12 months. Caring for an infant born preterm can cause stress and anxiety and adding parental satisfaction as well as parental distress assessments would have been beneficial to measure since there is ongoing evidence that identifying this may support parent-led interventions. To monitor and support adherence, an application may be ideal but other methods might be easier for parents to utilize. A pre-study feasibility and assessment would be recommended to optimize what parents prefer. With numbers falling short of what was requested, it would have been ideal to have considered a pilot study on the use of the application and obtain parental input on the design and how best to encourage use. Lastly, increasing the TUMMY TIME INTERVENTION AND PARENT EDUCATION 57 time frame for follow up to include 3-month corrected age assessments and even further, would be optimal to address if there were any longer lasting effects of our intervention. Conclusion While the targeted intervention and parent education did not result in outcomes that we anticipated, we were able to isolate important factors that may have impacted our motor outcome and adherence and can now provide further insight into what needs to be addressed for further research. Allowing parents to begin to practice and receive education on the importance of movement, specifically tummy time, may have encouraged more parent engaged handling and movement than if they had not participated in the study. 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American Journal of Occupational Therapy, 65(1), 101105. doi.org/10.5014/ajot.2011.09100 TUMMY TIME INTERVENTION AND PARENT EDUCATION 70 Appendix Table 1 Participant Demographic Characteristics Characteristic Intervention Group Control Group (n = 11) (n = 13) M(SD) M(SD) p Gestational age at birth (weeks) 32.0 (3.17) 30.9(3.64) .42 Post-menstrual age PRE (weeks) 42.4 (7.96) 39.0 (2.49) .25 Post-menstrual age POST (weeks) 45.9 (3.97) 44.3 (2.77) .26 Birth weight (kg) 1.4 (0.65) 1.6 (0.67) .43 N (%) N (%) p Gender 36.4 (4) 63.6 (7) 30.8(4) 69.2(9) males females males females .56 NBRS Intermediate/high risk 36.4 (4) 15.4 (2) Low risk 63.6 (7) 84.6 (11) 9.1 (1) 53.8 (7) 90.9 (10) 46.2 (6) .36 Ethnicity Caucasian Non-Caucasian .033 Note. PRE = preintervention; POST=postintervention; NBRS = Neurobiologic Risk Score TUMMY TIME INTERVENTION AND PARENT EDUCATION Table 2 Participant Clinical Characteristics Participant Group Diagnosis #1 Control Prematurity, RDS #2 Control Prematurity, RDS #3 Control Prematurity, NEC #4 Intervention Genetic syndrome (Trisomy 21) #5 Control Prematurity, choanal atresia #6 Control Prematurity, imperforate anus #7 Intervention Extreme prematurity, NEC, BPD #8 Intervention Prematurity #9 Control Prematurity #10 Control Extreme prematurity, NEC, BPD #12 Control Prematurity, jejunal atresia #14 Intervention Congenital syndrome, spina bifida #15 Intervention Extreme prematurity, RDS #16 Control prematurity #17 Intervention Extreme prematurity, RDS #18 Control Prematurity #19 Control Extreme prematurity, Grade IV IVH, BPD #20 Intervention Prematurity, posthemorrhagic hydrocephalus, VP shunt #21 Control Prematurity #22 Intervention Extreme prematurity, RDS, Grade IV IVH, VP shunt, #23 Control Genetic Syndrome (Trisomy 21) #24 Intervention Prematurity, subglottic stenosis, microcephaly #26 Intervention Prematurity and genetic syndrome #27 Intervention Prematurity, BPD and genetic syndrome 71 TUMMY TIME INTERVENTION AND PARENT EDUCATION Note. Extreme prematurity: < 28 weeks gestational age at birth. Prematurity: > 28 weeks gestational age at birth. BPD= bronchopulmonary dysplasia. RDS= respiratory distress syndrome. NEC= necrotizing enterocolitis. IVH= intraventricular hemorrhage. VP shunt= ventriculoperitoneal shunt 72 TUMMY TIME INTERVENTION AND PARENT EDUCATION 73 Table 3 Pre-Intervention TIMP Z-scores Group N M (SD) Intervention 11 -0.21 (0.86) Control 13 0.45 (0.86) t p -1.88 .074 TUMMY TIME INTERVENTION AND PARENT EDUCATION 74 Table 4 Post-Intervention TIMP Z-scores Group N M (SD) Intervention 11 -0.38 (1.14) Control 13 -0.11 (0.69) t p -.72 .48 TUMMY TIME INTERVENTION AND PARENT EDUCATION 75 Table 5 2 x2 Mixed Design ANOVA Main effect Mean Square (MS) F p Group 2.6 2.11 0.16 Group*Time 0.46 1.29 0.27 Time 1.6 4.46 0.046 TUMMY TIME INTERVENTION AND PARENT EDUCATION Table 6 Median Tummy Time Minutes and Mann-Whitney U Test Results Group Mdn Intervention 124.0 Control 191.0 Z p-value - 0.20 0.84 76 TUMMY TIME INTERVENTION AND PARENT EDUCATION 77 Table 7 Adherence and Compliance Ratio Data per Participant Participant Group Compliance Ratio Adherence achieved (Y/N) #1 Control 56% N #2 Control 70% Y #3 Control 21% N #4 Intervention 17% N #5 Control 30% N #6 Control 38% N #7 Intervention 6% N #8 Intervention 19% N #9 Control 26% N #10 Control 13% N #12 Control 85% Y #14 Intervention 0% N #15 Intervention 65% N #16 Control 6% N #17 Intervention 148% Y #18 Control 35% N #19 Control 0% N #20 Intervention 38% N #21 Control 38% N #22 Intervention 19% N #23 Control 50% N #24 Intervention 0% N #26 Intervention 97% Y #27 Intervention 36% N Note: Compliance ratio=minutes completed/minutes recommended; Adherence benchmark=Equal to or higher than 66% TUMMY TIME INTERVENTION AND PARENT EDUCATION 78 Table 8 Pre-Intervention TIMP Z-scores and Ethnicity Group N M (SD) Caucasian 8 0.67 (0.91) NonCaucasian 16 -0.11 (0.81) t p value 2.13 .044 TUMMY TIME INTERVENTION AND PARENT EDUCATION 79 Table 9 Post-Intervention TIMP Z-scores and Ethnicity Group N Mdn Caucasian 8 0.01 Non-Caucasian 16 -0.02 p-value Z-value 0.62 -0.49 TUMMY TIME INTERVENTION AND PARENT EDUCATION 80 Table 10 Multiple Regression Unfiltered Cases Post-TIMP Z-Score B 95% CI for LL SE B R R2 UL Model 0.424 Constant -1.134 - 2.50 0.28 0.68 NBRS 0.114 -0.723 0.95 0.40 0.06 Group 0.417 -0.45 1.28 0.414 0.233 TotalTTminutes 0.002 0.000 0.003 0.001 0.378 Ethnicity 0.265 -0.67 1.2 0.448 0.135 0.007 Note. B = unstandardized regression coefficient; CI = confidence interval; LL = lower limit; UL=upper limit; SE B = standard error of the coefficient; = standardized coefficient; R = coefficient of determination; R2= adjusted R2 TUMMY TIME INTERVENTION AND PARENT EDUCATION 81 Table 11 Multiple Regression Filtered Cases Post-TIMP ZScore B 95% CI for B LL SE B -0.93 -0.19 0.67 0 0.79 -2.37 -1.21 -0.23 -0.003 -0.18 R2 0.45 -0.001 UL Model Constant NBRS Group TotalTTminutes Ethnicity R 0.51 0.83 1.56 0.002 1.75 0.67 0.47 0.41 0.001 0.45 -0.11 0.46 -0.051 0.511 Note. B=unstandardized regression coefficient; CI=confidence interval; LL= lower limit; UL=upper limit; SE B=standard error of the coefficient; = standardized coefficient; R = coefficient of determination; R2= adjusted R2 TUMMY TIME INTERVENTION AND PARENT EDUCATION 82 Table 12 Total Mean and Weekly Physical Therapy Minutes per Group Group PT minutes SD PT minutes/week p-value (M) M) Intervention 436.8 283.1 54.6 Control 267.7 196.2 33.5 0.099 TUMMY TIME INTERVENTION AND PARENT EDUCATION 83 Table 13 Mean Physical Therapy Visits per Group Group PT visits/week (M) SD p-value Intervention 16.1 10.7 .073 Control 9.1 7.5 TUMMY TIME INTERVENTION AND PARENT EDUCATION 84 Table 14 Spearman Rank Order Correlation Variable Post-TIMP Z-score Coefficient correlation p-value 0.377 0.070 TUMMY TIME INTERVENTION AND PARENT EDUCATION Figure 1 Flow of Participants through the study 85 TUMMY TIME INTERVENTION AND PARENT EDUCATION Figure 2 ANOVA results Time (1=Pre-TIMP 2= Post-TIMP) 86 TUMMY TIME INTERVENTION AND PARENT EDUCATION Figure 3 Median Total Tummy Minutes per Group over 8-week Study Period n=11 (.00) n=13 (1.0) 87 TUMMY TIME INTERVENTION AND PARENT EDUCATION Figure 4 Median Post-TIMP z- Scores by Ethnicity .00=Caucasian (n=8) 1.00 = Non-Caucasian (n=16) 88 TUMMY TIME INTERVENTION AND PARENT EDUCATION Figure 5 Post-Intervention z-Scores and Total Tummy Time Minutes 89 TUMMY TIME INTERVENTION AND PARENT EDUCATION 90 Appendix A Table A1 Protocol Design Between Groups Step Standardized education session Intervention Group Standard of Care Group At initiation of the study, participants received education session for 60minute session. Included education on tummy time, video (Pathways, 2012) and hands on practice with infant or doll if infant not in wakeful state. Tummy Time Intervention Primary investigator performed Parent-led tummy time intervention tummy time intervention at dosage at dosage of 4x/week, 2x/day x 4 of 4x/week, 2 x/day x 4 weeks. weeks or higher if desired. Parents educated to continue tummy time on own at the same dosage or higher if desired. Adherence with PT Pal Application TIMP assessment Monitored for adherence during Monitored for adherence during entire 8 -week study. Parent(s) were entire 8-week study. Parent(s) encouraged to continue tummy time provided tummy time and recorded per provided recommendations. adherence to PT Pal application. Parent(s) recorded adherence to PT Parent(s) recorded adherence to PT Pal application. Compiled Pal application. Compiled adherence data from PT Pal adherence data from PT Pal application. application. Performed at baseline and at end of Performed at baseline and at end of four-week intervention period. four-week intervention period. TUMMY TIME INTERVENTION AND PARENT EDUCATION Appendix A Table A2 Brazelton Neonatal Behavioral Assessment Scale State State 1 Definition Deep sleep with eyes closed and no eye movement State 2 Light sleep with eyes closed and rapid eye movement State 3 Drowsy or semi-dozing and eyes may be open or heavylidded State 4 Alert with eyes open and minimal motor activity State 5 Alert with eyes open with considerable motor activity State 6 Crying with high motor activity (Brazelton T.B., 1995). 91 TUMMY TIME INTERVENTION AND PARENT EDUCATION Table A3 Neurobiologic Risk Scale 92  ...

... POSTPARTUM DEPRESSION AND A CHILDS FIRST YEAR OF LIFE Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Aimee Dietsch, MA Copyright December 8, 2021 By: Aimee Dietsch, MA All rights reserved Approved by: Laura Santurri, PhD, MPH, CPH Committee Chair ______________________________ Heidi Ewen, PhD, FGSA, FAGHE Committee Member ______________________________ Lisa Borrero, PhD, FAGHE Committee Member ______________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ POSTPARTUM DEPRESSION 1 Postpartum Depression and a Childs First Year of Life Aimee M. Dietsch Department of Interprofessional Health & Aging Studies, University of Indianapolis Author Note I have no known conflict of interest to disclose. Correspondence concerning this article should be addressed to Aimee Dietsch, University of Indianapolis, 1400 E. Hanna Ave. Indianapolis, IN 46227. Email: dietscha@uindy.edu POSTPARTUM DEPRESSION 2 Abstract Background: Postpartum depression (PPD) is a significant complication that many new mothers face during pregnancy and in the weeks and months following a child's birth. Quantitative data suggest that a mothers PPD negatively impacts routine well-visits and pediatric care for the new child. However, little is known about what challenges or facilitates their healthcare decisionmaking. Objective: This qualitative study used interpretative phenomenological analysis (IPA) to explore and understand mothers perceptions about healthcare decision-making while having experienced PPD. This study also investigated a mothers perceptions and experiences of making routine vaccination decisions during the childs first year of life while having PPD. Method: Using IPA, the researcher used purposive sampling to recruit eight individuals from local clinics and community organizations that met the studys inclusion criteria. Participants were interviewed about their PPD experiences and healthcare decision-making influences through a semi-structured interview. Transcribed interviews and initial interpretations were shared with participants to clarify information and aid in the analysis process. The researcher followed a heuristic process for analyzing interview data to cultivate a deeper understanding of the study topic. Results: Four super-ordinates themes were discovered. Those themes pertained to mothers relationship with their clinician, stress, depression, and anxiety contributors during PPD, impacts of PPD on mothering and baby, support structures for mother and baby. Discussion: The experience of universality connected all themes and identified the need for cohesive approaches from clinical providers of pre- and postnatal care. Group model approaches to postnatal care appear to mitigate or reduce the impact of PPD. Keywords: postpartum depression, maternal depression, healthcare decision-making, vaccinations, interpretative phenomenological analysis, group care, heurism POSTPARTUM DEPRESSION 3 Acknowledgments Nearing the end of my doctoral program, I reflect on what led me to pursue this amazing personal and professional growth opportunity. I have many family members, friends, colleagues, and professors to thank for their endless support and encouragement over the last three years because I would not have been able to complete this program without it. First, I must thank my three children, Spicer, Declan, and Mirin. You three are why I do anything, and I hope to have shown you that we never give up on our dreams, no matter what. You have no idea how much you kept motivating me to pursue this goal, and I could not have done this without your love and inspiration. I would also like to thank my husband Ryan, my Mom and Dad, sister Alycia, brother Rian, Dr. James Tisdale, and many friends for the encouragement and support to begin and ultimately complete my doctoral program. I would also like to thank my committee members, Dr. Laura Santurri, Dr. Lisa Borrero, and Dr. Heidi Ewen. Thanks to your solid advice, expertise, and knowledge, I have developed and written a manuscript that I would never have thought possible. I remember early project discussions with Dr. Ewen during my orientation week and went home that weekend feeling overwhelmed yet enthused to begin this journey. I would also like to thank Dr. Julie Gahimer as she was such an encouraging force, and I am grateful for her support and wisdom as part of my process. I am forever grateful to everyone who has shared their wisdom and support, especially during a challenging time globally. We did this together! With sincerest gratitude to all, Aimee Dietsch POSTPARTUM DEPRESSION 4 Table of Contents Title Page ........................................................................................................................................ 1 Abstract ........................................................................................................................................... 2 Acknowledgments........................................................................................................................... 3 Chapter 1: Introduction ................................................................................................................... 6 Problem Statement .............................................................................................................. 8 Purpose Statement ............................................................................................................... 8 Research Questions ............................................................................................................. 8 Significance of the Study .................................................................................................... 9 Chapter 2: Literature Review .......................................................................................................... 9 Prevalence of PPD ............................................................................................................ 11 Maternal Depression and Healthcare-Seeking Behaviors................................................. 11 Clinician Responsibility.................................................................................................... 12 Assessment Tools.............................................................................................................. 13 Decision-Making............................................................................................................... 14 Chapter 3: Method ........................................................................................................................ 17 Study Design ..................................................................................................................... 17 Participants ........................................................................................................................ 18 Procedures ......................................................................................................................... 19 Recruitment ........................................................................................................... 19 Data Collection Process ........................................................................................ 23 Data Management & Analysis .............................................................................. 25 Study Rigor ........................................................................................................... 31 POSTPARTUM DEPRESSION 5 Chapter 4: Results ......................................................................................................................... 33 Super-ordinate Theme A: Relationship with Clinician..................................................... 34 Super-ordinate Theme B: Stress, Depression, and Anxiety Contributors During PPD .... 38 Super-ordinate Theme C: Impacts of PPD on Mothering and Baby: The Dyad .............. 42 Super-ordinate Theme D: Support Structures for the Mother and Baby Dyad................. 45 Chapter 5: Discussion ................................................................................................................... 49 Race, Ethnicity, and Educational Factors ......................................................................... 49 Relationship Influence ...................................................................................................... 50 Life Event Contributors .................................................................................................... 51 Universality ....................................................................................................................... 51 Limitations ........................................................................................................................ 58 Implications and Future Research ..................................................................................... 59 Conclusion ........................................................................................................................ 62 References ..................................................................................................................................... 64 Table 1 Participant Characteristics ............................................................................................... 73 Table 2 Themes and Subordinate Theme Frequencies ................................................................. 74 Appendices .................................................................................................................................... 75 Appendix A University of Indianapolis IRB Approved Study Guide ................................ 75 Appendix B Screening Questions to Confirm Eligibility ................................................... 79 Appendix C Interview Guide .............................................................................................. 80 POSTPARTUM DEPRESSION 6 Postpartum Depression and a Childs First Year of Life Becoming a new mother is a significant life event; the changes a woman experiences during and after pregnancy are not free of challenges (Slomian et al., 2019). Some of the challenges involve choices new mothers face regarding their newborns care, which may feel overwhelming (e.g., breastfeeding or bottle feeding), especially when those decisions have involved some controversy (e.g., vaccinations or circumcision) (Johansson et al., 2020). When considering how stressful pregnancy and childbirth can be, the Holmes-Rahe Stress Inventory or the Social Readjustment Rating Scale (SRRS) weighs these events at 79 combined life change units (LCUs), which would place these life events (pregnancy at 40 LCUs and childbirth at 39 LCUs) as second to the stress of experiencing the death of a spouse (Noone, 2017). According to Noone (2017), the SRRS ranks life events based on the degree of change or disruption typically experienced by individuals, totaled over a year, to determine stress levels and the probability of developing stress-related illnesses (a total score of <150 is desirable for lower levels of stress over one year). The SRSS was created with the stressor as the focus and how those events or circumstances challenge an individuals ability to adapt (Figueroa-Fankhanel, 2014). Postpartum depression (PPD), another challenge and complication affecting some new mothers, has 10 to 15% prevalence rates depending on diagnostic criteria (Johansson et al., 2020; Liberto, 2012; van der Zee-van den Berg et al., 2017). These rates vary due to some researchers including overall maternal depression rates in their studies. While conflicting prevalence rates have been documented in different quantitative studies, the American Psychiatric Associations (2013) Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) classifies postpartum depression as a bipolar disorder or depression with peripartum onset. In it, it is indicated that between 3% and 6% of women will POSTPARTUM DEPRESSION 7 experience the onset of a major depressive episode during pregnancy or in the weeks or months following delivery (American Psychiatric Association, 2013, p. 89). According to the American College of Obstetricians and Gynecologists (ACOG, 2018), PPD is reported as one of the most common medical complications during pregnancy and the postpartum period, affecting one in seven women (p. e208). Slomian et al. (2019) stated that the postpartum period, four to six weeks post-delivery, is the riskiest time for a new mother after the baby is born. While the postpartum period is a time during which some women develop PPD, the condition often goes undetected due to a new mothers uncertainty about her feelings, limited opportunities to discuss those new or troubling emotions, or reluctance to communicate those emotions. These factors can be compounded with clinicians who either fail to recognize the symptoms since the onset of symptoms mirror the baby blues, or clinicians neglect to discuss them altogether (Evans et al., 2015; Liberto, 2012; van der Zee-van den Berg et al., 2017). This issue led to ACOGs universal PPD screening recommendations, which suggested that obstetrician-gynecologist (OB-GYN) clinical staff are responsible for perinatal screening, follow-up, and treatment (Evans et al., 2015). Earlier research by Minkovitz et al. (2005) examined maternal depression and revealed that mothers exhibiting symptoms of depression have irregular patterns of healthcare-seeking for their children, resulting in unfavorable childhood health outcomes and an increase in the risk of vaccine-preventable disease (Bianco et al., 2018). For example, mothers with maternal depression are 74% to 81% less likely to engage or participate in their childs 2- and 4-month well-baby visits (Minkovitz et al., 2005). In a qualitative study that explored the lived experiences of mothers with PPD and their partners, Johansson et al. (2020) reported mothers feeling overwhelmed with the responsibility of caring for a new child and believing that the POSTPARTUM DEPRESSION 8 burden of care was solely on them due to their significant others lack of interest or involvement. What is less understood and missing from the literature are the perceptions that new mothers with PPD have about how the disorder may influence their ability to make healthcare decisions for their new child. Problem Statement There do not appear to be many available studies that specifically address or provide any analysis of the perceptions and experiences of mothers with PPD. Most of the available research provides a quantitative analysis of PPD, including the benefits of early detection and treatment, how PPD affects maternal parenting, and other associated risks (Johansson et al., 2020). Additionally, there do not appear to be many studies that discuss how having PPD affects mothers healthcare decisions, including those decisions to engage in routine well-baby visits and vaccinations. Due to the lack of qualitative studies in the literature about this topic, additional research is needed to understand how new mothers experience and perceive having PPD as well as how PPD relates to health-related decision-making for their new child. Purpose Statement This interpretative phenomenological analysis (IPA) study aims to explore the perceptions of new mothers who have been diagnosed with PPD and their ability to make healthcare decisions for their new child. Of specific focus are the perceptions related to their ability to make routine vaccination decisions during the childs first year of life. Research Questions Specifically, this study addresses the following research questions: How do new mothers with PPD perceive the experience of making healthcare decisions for their child during its first year of life? POSTPARTUM DEPRESSION 9 o What do new mothers with PPD perceive as challenges and facilitators in making routine vaccination decisions for their child within its first year of life? Significance of the Study This study can provide clinicians with insight as to how PPD influences maternal healthcare choices and offers these mothers an opportunity to express their experiences in a new format or platform to be heard. The study may highlight communication opportunities with postpartum patients so that healthcare decision-making resources, assessments, and referrals can be tailored or designed with their particular patient needs in mind. The study may also help improve healthcare outcomes for both the new baby and the new mother by identifying barriers previously unknown. Literature Review When considering PPD, it is essential first to understand what it is and how it is distinct from other mood changes during the postpartum period. With pregnancy comes hormonal fluctuations and physical changes as the unborn child makes its demands on the expectant mother. After the child arrives, many new mothers experience feelings of sadness and temporary emotional discomfort known as the maternity blues (or familiarly known as the baby blues) (Evans et al., 2015; Massachusetts General Hospital [MGH] Center for Womens Mental Health, 2019). These maternity blues typically last only two weeks after delivery and do not interfere with the new mothers ability to care for herself or the new child (Evans et al., 2015; Massachusetts General Hospital [MGH] Center for Womens Mental Health, 2019). Approximately 50-80% of women experience these baby blues as part of the normal hormonal fluctuations and rebalancing after childbirth. The initial onset of PPD often is mistaken for the POSTPARTUM DEPRESSION 10 baby blues, and thus, diagnosis opportunities are missed (Evans et al., 2015). As a mood disorder, PPD usually occurs after delivery within the first year but tends to emerge within the first two or three months and can last more than a year after childbirth if untreated (Dagher et al., 2014; MGH, 2019). Freedman (2018) suggested that mothers could present with PPD even as late as six to 12 months after delivery and that screening should continue throughout the childs first year of life. According to MGH (2019), mothers with PPD tend to experience a combination of symptoms. The most prevalent symptoms are a depressed or sad mood, loss of interest in usual activities, feelings of guilt or worthlessness, fatigue, and suicidal thoughts (MGH, 2019). PPD is problematic for both the new mother and the new baby, as many complications can arise with long-lasting effects (Evans et al., 2015). Indeed, longitudinal studies on PPD and infant care reveal long-term adverse effects (Field, 2010; Liberto, 2012). Negative impacts, including poor child development and socialization, decreased bonding and breastfeeding, and weaker parenting practices that entail a childs health and safety and have shown to have lasting effects into early adulthood (Balbierz et al., 2015; Field, 2010). Other categories of mood disturbances and psychiatric challenges that new mothers face during the postpartum period are Postpartum Psychosis and Postpartum Obsessive-Compulsive Disorder (OCD). According to MGH (2019), postpartum psychosis is the most severe mood disturbance for new mothers. Postpartum psychosis includes an array of psychotic behaviors that mirror bipolar mania, irregular and erratic mood shifts, delusions, and auditory hallucinations that put both baby and mother at risk for infanticide and suicide (MGH, 2019). Postpartum OCD is a debilitating anxiety disorder triggered during the postpartum period and frequently presents with depression (Challacombe et al., 2017). POSTPARTUM DEPRESSION 11 Prevalence of PPD The literature reported differing prevalence rates for PPD. While typically diagnosed within the first three months after delivery, PPD rates are reported in various ways. Reports focused on global or local rates, and some incorporated certain mental health disorders, such as minor depression, while others did not. The American Psychiatric Associations (2013) Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) suggested that the national prevalence of PPD is between 3 to 6%; however, that number increases to approximately 19% when minor depression is included (van der Zee-van den Berg et al., 2015). The DSM-5 also stated that 50% of postpartum onset occurs before the actual childbirth (APA, 2013). Madlala and Kassier (2018) reported global rates between 12% and 20%, while Balbierz et al. (2015) suggested the prevalence rates between 8 and 10%. Several other studies have settled on a prevalence rate between 10% to 15% based on reportable DSM-5 diagnosis criteria and study outcomes (Johansson et al., 2020; Liberto, 2012; van der Zee-van den Berg et al., 2017). Much of the varying prevalence rates can be attributed to PPD being undetected by clinicians and the reality that many mothers who experience PPD-related symptoms do not seek professional help (Evans et al., 2015; Olin et al., 2015). Maternal Depression and Healthcare-Seeking Behaviors An early study by Minkovitz et al. (2005) examined maternal depressive symptoms during the postpartum phase to determine if those symptoms were linked to the number of childs well-care visits during their first 30 months. This study did not differentiate between the various types of maternal depression, including PPD. This cohort study would reveal new information about mothers with maternal depression and their inconsistent healthcare-seeking behaviors, inspiring this research study's development. Minkovitz et al. (2005) further evaluated POSTPARTUM DEPRESSION 12 what provider type should conduct PPD screenings and where a mother should be screened for PPD. When mothers had maternal depression and not PPD, specifically, children between the ages of two to four months had more missed well-visit appointments (Minkovitz et al., 2005). The most significant age for missed well-visit appointments occurred during the sixth and 24 months (Minkovitz et al., 2005). Frequently, the vaccines for preventing diphtheria, tetanus toxoids, and pertussis (DTP) were missed at two and four months, although not statistically significant (Minkovitz et al., 2005). Being up to date for vaccinations at 24 months and ageappropriate vaccines, particularly the vaccine for preventing measles, mumps, and rubella (MMR), were missed at a statistically significant rate (Minkovitz et al., 2005). This may be the only study or available study known by the researcher that specifically addressed maternal depression and healthcare-seeking behaviors for their children. This study does not address new mothers perceptions of having PPD and how having PPD contributed to the results in the Minkovitz et al. (2005) study. Clinician Responsibility Minkovitz et al. (2005) advocated for increased provider training to better recognize maternal depression, given that treatment referrals are typically triggered during provider visits. As a result of these necessary and timely referrals, children might receive better and more timely care (Minkovitz et al., 2005). From 2012 through 2020, several research studies began investigating who best should screen for PPD since much of the earlier focus placed the responsibility on OB-GYN's. While OB-GYNs are ideal providers to assess and diagnose PPD due to frequent maternity appointments and postpartum follow-up, other providers commonly engaged in assessment and diagnosis are family practitioners and pediatricians. Of the three aforementioned primary POSTPARTUM DEPRESSION 13 provider types engaging in PPD assessments and diagnosis, several studies suggested that pediatric offices may have better opportunities to screen, diagnose, and manage PPD while new mothers attended their childs well-visit appointment (Evans et al., 2015; Olin et al., 2016; van der Zee-van den Berg et al., 2017). Liberto (2012) discussed that a new mother would likely encounter at least eight pediatric appointments for her childs well-visits during its first 24 months of life, while the OB-GYN relationship typically ends after the six-week post-delivery appointment. Therefore, it makes sense that a pediatrician would be better suited to assess the signs and symptoms of PPD over time due to their more frequent involvement with the mother and child. In a follow-up to their 2015 recommendation, ACOG (2018) suggested that OB-GYNs and other obstetric providers (e.g., nurse mid-wives) perform at least one full mental health assessment of their patients using a valid assessment tool during the postpartum visit and be ready to make referrals for therapeutic interventions or medical treatment as needed. This update to the recommendations added clarification to include other obstetric providers (although provider types were only identified as obstetric providers) and care coordination. ACOG (2018) recommended coordination of care between the OB-GYN and the newborns pediatric provider since women tend to be reluctant to report mood concerns. ACOG (2018) reported that healthcare providers do not always recognize PPD symptoms. Care collaboration and screening with validated assessment tools and follow-up improve these mothers' long-term outcomes (ACOG, 2018). Assessment Tools The most frequently used assessment tools for diagnosing PPD identified by ACOG (2018) are the Edinburgh Postnatal Depression Scale, the Postpartum Depression Screening POSTPARTUM DEPRESSION 14 Scale, the Patient Health Questionnaire 9, the Beck Depression Inventory, the Beck Depression Inventory-II, the Center for Epidemiologic Studies Depression Scale, and the Zung Self-Rating Depression Scale. Even so, Evans et al. (2015) found that more than half of OB-GYNS, family practitioners, and pediatricians identified their most common assessment method for PPD as no more than their clinical judgment. The provider type with the most confidence in recognizing PPD using their clinical judgment was OB-GYNs (Evans et al., 2015). Pediatricians reported having the least confidence and the least likely ability to recognize PPD, although pediatricians identified as relying on their clinical judgment the most (Evans et al., 2015). While pediatricians have been suggested as ideal partners in care coordination for mothers identified with PPD, they may also be the logical better option for screening new mothers for PPD. Once the postpartum visit with their OB-GYN has passed, and no diagnosis at that five or six-week appointment was discovered, the opportunity for continued PPD screening no longer seems to exist. Decision-Making Fadda et al. (2015) reported that vaccination decisions are among the first decisions a parent faces after their child's birth. They suggested that choosing or refusing to vaccinate stems from beliefs or attitudes about risks from the vaccination side effects, how effective the vaccine is against disease prevention, and other safety concerns (Fadda et al., 2015). While their study focused on the measles-mumps-rubella (MMR) vaccination, the researchers provided insights on the lack of health literacy and the deliberate choice to allow health care professionals or the opinions of anti-vaccination campaigners, some of which was emotionally driven, to drive their decision-making (Fadda et al., 2015). In a study to assess the maternal perceptions of childhood vaccinations and reasons for or against vaccinating, both Veerasingham et al. (2017) and McNeil et al. (2019) found many POSTPARTUM DEPRESSION 15 mothers participate or refuse to vaccinate their children. Some of those decision-making factors involve where the mother received their information. Source information for vaccination decision-making included influences from friends or family members as part of social norms or beliefs, health professionals opinions, and guidance provided through internet resources, including social media (McNeil et al., 2019). Some mothers reported feeling pressured to vaccinate or not, while others reported feeling supported in vaccinating or not depending on the strength of those influences, as mentioned earlier (McNeil et al., 2019). Veerasingham et al. (2017) reported findings that 56% of women in their study (N = 6158, n = 2467) did not receive any immunization information prior to childbirth (to include family and friends, social media, and professional health sources like midwives, antenatal classes, and obstetricians). Results also concluded that antenatal classes did not encourage mothers or impact immunizations' timeliness (Veerasingham et al., 2017). Kaufman et al. (2018) found, in their evaluation of several randomized control trials, evidence that face-to-face interventions (i.e., prenatal/antennal classes, one-on-one or group sessions, and home visits) may slightly improve a parents decision to vaccinate while only potentially changing their attitude or understanding about why to vaccinate. Kaufman et al. (2018) also reported that several of their studies involved low- to middle-income countries, so their discoveries and insights about parental vaccination decision-making and prenatal education's influences may prove applicable and relevant to a smaller qualitative study such as this. Research involving a mothers experience with PPD and their decision-making in healthcare is scarce. There have been several studies evaluated for examining how mothers or new mothers made decisions about their childs healthcare or general care to gain an understanding of the available research and understand better where research could be explored POSTPARTUM DEPRESSION 16 or expanded. Olin et al. (2016) reported that adherence to vaccination schedules for a child could become compromised when a mother struggles with depression. Their research focused more on appropriate PPD treatment and treatment programs (Olin et al., 2016). Insights into a new mothers mental health status weeks and months after delivery could help understand how issues like PPD affect decision-making, yet research was lacking in this area. For example, one qualitative study compared inner-city mothers child care decision-making to suburban mothers child care decision-making and found no difference in that the primary concern was ultimately the childs well-being (Anderson et al., 2002). While there were similar attempts to adhere to immunization schedules, mental health issues like PPD were not evaluated (Anderson et al., 2002). This information is relevant in showing that studies about mothers concerns or care for their new child exist; however, healthcare decision-making is not always included, and mental health, like PPD, is not evaluated. Studies have found that depression impairs decision-making in the general population, and therefore it would make sense that mothers with PPD would also face this challenge (Hindmarch et al., 2013; Leykin et al., 2010). Another qualitative study found that anxious new parents often sought health information via the internet (Rathbone & Prescott, 2019). Researchers did not pursue a mental health discussion to include PPD or PPD experiences, which could have added to further exploration on the topic and added to a deeper understanding of when the anxiety originated and what the experience was like in making healthcare decisions, including if PPD was a factor (Rathbone & Prescott, 2019). Although research has analyzed PPD and parental stress relative to parenting behaviors (Gross & Marcussen, 2017; Johansson et al., 2020), few to none have examined the effects of PPD on healthcare decision-making for the new child. POSTPARTUM DEPRESSION 17 Furthermore, most of the available studies investigated for this topic discussed the importance of an early PPD diagnosis and the potential for adverse outcomes if PPD is left untreated (Evans et al., 2015; Hoffman et al., 2017; Hutchens & Kearney, 2020; Liberto, 2012; Slomian et al., 2019). However, there are very few qualitative studies. The lack of research in this subject area provides an opportunity for qualitative exploration that may ultimately increase awareness and understanding of womens PPD experience as new mothers share. This research hopes to provide a course of direction for developing tailored treatments and resources to meet their individual needs and give a voice to new mothers with PPD so that their experience is understood beyond clinical paradigms. Method Study Design Interpretative phenomenological analysis (IPA) is a qualitative approach that seeks to examine how people make sense of their major life experiences (Smith et al., 2009, p.1). Using IPA to explore the perceptions of mothers who have been diagnosed with PPD and using a double hermeneutic approach, this study aimed to reveal other pieces of these mothers stories. This study design complemented the existing quantitative research by providing a new understanding of the influences and challenges a mother with PPD may face when making healthcare decisions for their child. IPA is a phenomenological and idiographic approach with the intent to understand what each experience was like and how each mother made sense of it (Smith et al., 2009). An additional focus was the mothers perceptions of making routine vaccination decisions during the childs first year of life. The University of Indianapolis Institutional Review Board approved beginning study activities, and data was collected through interviews. POSTPARTUM DEPRESSION 18 Participants To align with IPA techniques, homogeneity was achieved through purposive sampling, which allowed the researcher to recruit participants with a specific lived experience (i.e., PPD; Smith et al., 2009). A homogeneous purposive sample for this research study provided the study groups perspective and experience with the study topic instead of representing a population (Smith et al., 2009). Although considered akin to convenience sampling, a snowball sampling approach was included from the original purposeful sample to expand the recruitment pool (Koerber & McMichael, 2008). A snowball sampling approach garnered additional participants by coordinating with those already recruited who identified additional participants who fit the inclusion criteria (Koerber & McMichael, 2008). Inclusion criteria consisted of new mothers who had their first live birth within one year or less from the start of data collection. Participants must also have self-reported that they currently had or have had PPD. Exclusion criteria included new mothers with self-reported substance abuse issues before being diagnosed with PPD and mothers who did not speak or read English fluently. Due to the sensitive nature of inquiring about substance abuse, the researcher asked one polar question about the mothers substance use history. If the mother responded that she had a history of substance abuse, the researcher gently communicated the studys requirements and thanked her for her interest in participating. The researcher did not inquire further into the substance use history or pose any further questions. The researcher only moved forward with participants who met the inclusion criteria. The researcher interviewed eight participants for this study. A small sample of participants allowed for a more in-depth and thorough interview and analysis of each case and furthered the opportunity to evaluate their experiences (Smith & Osborn, 2003). Smith and POSTPARTUM DEPRESSION 19 Osborn (2003) often recommend a sample size of five or six participants for new IPA researchers, yet there is no standard or appropriate sample size. Rather, there are factors or characteristics that make a sample size suitable for IPA research (Smith and Osborn, 2003). The right sample size involves considering the depth of information obtained during analysis and any study limitations the researcher may be facing (Smith & Osborn, 2003). Many IPA studies have been conducted with samples as few as one and some with more than fifteen (Smith & Osborn, 2003). IPA intends to garner as much information and detail or engagement with the studied topic to provide a detailed interpretative account without dilution and with the smallest sample size necessary to do so (Smith & Osborn, 2003, p. 56). Similarly, Giacomini and Cook (2000) indicated that a study sample should provide a window-like view on the topic (Koerber & McMichael, 2008). Providing a window-like view or an opportunity to understand individual experiences without overgeneralizing to a larger population ensured that enough individuals were interviewed to fully portray a clear picture of the explored topic and participant experience. Procedures Recruitment The researcher enlisted recruitment assistance from program directors within local clinics, clinical administrative staff at health departments, and physicians from area OB-GYN offices and pediatric centers in Easton, Maryland. The researcher contacted each provider office or community organization by telephone to schedule a phone or virtual meeting with the available clinical or marketing leadership at each office or organization. During this outreach, the researcher introduced herself, provided information about the study, and discussed the study's intent along with recruitment goals (refer to Appendix A). The researcher requested permission POSTPARTUM DEPRESSION 20 to recruit patients or individuals from the broader community who frequent those locations by posting flyers within the facility. Flyers were developed for physician offices and community organizations and placed in waiting room locations or wallboards for visibility. Flyers included information on the study topic and intent, study incentives, inclusion and exclusion requirements, participant confidentiality, and contact information for those interested in participating. The flyer also explained that each participant would receive a $20.00 Target gift card after completing the research interview. Contact information consisted of the researchers name and the established email address created specifically for this study (myppdstory@gmail.com). As outlined on the recruitment flyer, individuals confirmed their interest by emailing the researcher, including their name and contact information. The interested participants received an automated email response to verify receipt. The automatic response provided additional details about when they would be contacted via email (within two business days) and thanked them for their willingness to participate. The automatic response again informed any interested participants of the study topic, its purpose, and the purpose of the forthcoming informed consent process. Additionally, the autoreply included a study information sheet to ensure the participant had ample time to read and review study information before their scheduled interview time. The study information sheet included details about the studys purpose, participants rights and responsibilities, methods to protect their confidentiality, the benefits and risks of participation, as well as informed consent and how it would be obtained. The researcher screened for inclusion and exclusion criteria during the scheduled interview before obtaining consent and conducting the interview (refer to Appendix B). POSTPARTUM DEPRESSION 21 Since the initial recruitment method yielded little interest, the researcher engaged in a social media campaign. There are many web-based social media forums specific to mothers and mothers with postpartum depression appropriate for recruitment activities. The researcher recruited participants through several Facebook postpartum support groups, including Birthed It Up, Mom Stuff, First Time Mom Support Group, Postpartum Mamas, Talbot County Moms, and the Postpartum Anxiety Group. The researcher had to request membership to post the research study recruitment information on the aforementioned forum sites. Once membership was granted, recruitment activities were initiated, site administrators approved posts to the group forums. Other local community social-media-based forums were utilized for recruitment, such as Easton Happenings and LinkedIn. The recruitment flyer created for physicians offices and community organizations was converted to a format suitable for internet distribution and included all pertinent study information. To not appear intrusive to the various support groups and their process, an opening post accompanied the recruitment flyer identifying the researcher as a mother and a doctoral student interested in volunteers willing to share their individual PPD stories. Often, women responded directly to the post indicating their interest. The researcher gently directed each woman through a post-response to initiate contact with the researcher through the designated email account. The same email response was used throughout the recruitment process and provided information about the informed consent process once interested individuals submitted their inquiry to the studys general email account. Regardless of the recruitment source, all interested individuals initiated contact with the researcher through the same direct email process. Informed Consent The researcher responded to interested participants by email within two business days to POSTPARTUM DEPRESSION 22 engage in the informed consent process. During the email exchange, the researcher inquired if the interested individual had any questions about the studys information sheet or informed consent process and proceeded with coordinating scheduled interview meeting times. The researcher reminded interested participants about the study's key components and purpose, their rights and responsibilities, methods to protect their confidentiality, and the benefits and risks of participation. During this process, additional information provided included how the participant could contact the researcher, the IRB, and associated university professors should any questions about the study or research process arise. Information shared also included where the research data would be reported and how participant information would be used. Before starting each interview, participants answered several questions about their basic demographic information (i.e., name, race, educational background) and questions to assess inclusion and exclusion criteria. Participants were also provided the opportunity to ask questions about the study and research process from the information they received via email. With IPA as the study design, participants were also informed of the potential use of verbatim quotations in the final manuscript. Participants were also advised that verbal consent may be requested throughout the interview process and during the discussion of any unanticipated sensitive topics (Smith et al., 2009). The researcher did not require any participants' signatures as written informed consent was waived in lieu of verbal consent. The researcher documented the verbal consent by making a written note, as this portion of the interaction with the participant was not audio recorded. The interview began once verbal consent to participate and to be audio recorded was received, at which time the researcher documented the conversation's time and date. The researcher also informed participants that all of the information obtained during the interview would be kept confidential and destroyed three years post-study completion. POSTPARTUM DEPRESSION 23 Data Collection Process Data collection consisted of one semi-structured interview with each participant, conducted via Zoom video conferencing software. After the first participant interview, and following each interview after that, the researcher engaged in a memoing process to document any thoughts or ideas about the information being shared and to identify any potential biases as they arose (Birks et al., 2008). The researcher maintained a separate notebook for documenting the free association of thoughts and ideas after each interaction and throughout the data collection process. Satterlund (2012) suggested that the memoing process helped finalize research results by identifying informational patterns that could be included in the final report analyses. At the start of each interview, the researcher verbally established consent via the informed consent procedures. Additionally, the participant was reminded about the studys purpose, invited to ask any questions, and reminded that the study was confidential. Participants were also reminded that they would receive a $20.00 Target gift card after the interview, even if they did not answer all interview questions. During the interview process, the researcher used a semi-structured interview guide (refer to Appendix C) designed for this study, including nine main open-ended questions and probing sub-questions that allowed the participant to further elaborate and expand on their responses. Additionally, the interview questions were developed to deduce specific to the point of redundancy (Creswell & Poth, 2018; Trotter, 2012). This process involved asking similar interview questions to participants throughout the interview to understand their individual stories and experiences while obtaining enough repetitious information to create generalized themes. POSTPARTUM DEPRESSION 24 The researcher initiated each interview with the first interview guide question to engage the participant broadly in discussing what it is like being a mom. Depending on how the participant responded, sub-questions or probing questions were then used to facilitate further investigation. Frequently, participants were open to sharing their thoughts and feelings about motherhood and freely discussed their experiences. Occasionally, when asked about their perceptions of PPD prior to being diagnosed (Question #2), mothers would address the subquestions without having to be directly asked. This frequently happened throughout the interview process and with the majority of the other interview questions. Sub-questions were asked of a participant when they were not already addressed via their response to the opening interview question. The interview process maintained a conversational tone, and the researcher navigated to different questions depending on the flow of participant responses. All of the interview questions were addressed, however, not always in the order presented in the interview guide. Following the natural flow of the interview allowed for more comfortability and connection between the researcher and the participant and elicited a more natural interaction as described by Smith et al. (2009). The researcher was also mindful of silences between interview responses and waited before moving on to the next question. This pause between questions often provided additional data as the participant may have felt inclined to continue elaborating on the question topic. Smith et al. (2009) indicated that the nature of individuals is to take those silences as cues to continue speaking during the interview process. In keeping with this process, the researcher asked clarifying questions that were not part of the interview guide during the interviewing on a few occasions. Specifically, a participant might reveal new information during one response that would prompt the researcher to revisit a POSTPARTUM DEPRESSION 25 previous question to align better with the conveyed information. This scenario did not frequently occur enough to require a change to the interview guide but instead allowed the research an opportunity to reframe a question to assist the participant in understanding the question asked. Participants engaged in the interview process and rhythm, relaxing to the questioning. Due to the topic's sensitive nature, the researcher occasionally self-disclosed aspects of mothering when participants seemed unsure or less confident about their responses. Smith et al. (2009) suggested that disclosure should be handled carefully and with rapport development as the forefront intention. As recommended, the researcher engaged in selective disclosure, usually at the end of the interview (Smith et al., 2009). Before the interview ended, the researcher asked participants if they had any additional information they wanted to share aside from the researchers questioning. During this time, all participants expressed gratitude for the research undertaken and appreciated helping other mothers with PPD. The interview ended once the final question was asked, and participants were satisfied with sharing final details or additional information. Most interviews lasted 90 minutes, with only a few (two) lasting 60 minutes or slightly less. At the interviews conclusion, the researcher informed participants that they would receive an email with the interview's verbatim transcription and any emerging themes identified by the researcher. The participants were encouraged to verify the transcripts accuracy and review the themes to ensure they reflected the participants perspective as they had intended (Henderson & Rheault, 2004). Data Management & Analysis Consistent with IPA, the researcher followed a step-by-step heuristic process for analyzing interview data. According to Cherry (2020), heuristics are important in understanding how individuals make sense of their world and how those interpretations facilitate decision- POSTPARTUM DEPRESSION 26 making. Heuristic inquiry within the IPA process is an authentic attempt to deepen the understanding of the researched experience. Kenny (2012) suggested that the heuristic process and study question choose the researcher. Heurism seeks to understand and explain the human experience, provide a more in-depth exploration of the study topic, and transform the researcher beyond a yet realized purpose (Kenny, 2012). Audio recordings were obtained on two separate digital recorders for each interview. Zoom, the video conferencing application used for the interviews, has meeting recording options that were not used during this research study due to safety concerns with the storage and security of participants personal information. The researcher used Temi, a speech-to-text transcription application, to identify and transcribe all spoken words by both the participant and the researcher. During the transcription review, the researcher engaged in a semantic transcription process by hand that included spoken words and sounds made by the participant and the researcher (Smith et al., 2009). For example, the interview transcript included brackets and italicized sounds to identify sighs or laughter not always captured by the Temi application. All participant information was de-identified by the researcher and assigned an alpha-numerical identification code to support the confidentiality of participant data for the duration of the study. The researcher used Google Drive for interview data management and shared access information with the doctoral project committee and key study personnel throughout the studys progress. Once the transcription had been completed for each interview, the associated recordings were removed from the two digital audio recorders and transferred to the researchers universitysecured Google drive. In keeping with the immersive process for data analysis described by Smith et al. (2009), the researcher read and then re-read the first interview transcript while documenting any POSTPARTUM DEPRESSION 27 recollections from the interview to aid in bracketing as the first analytic step (Smith et al., 2009). In an IPA study, the bracketing process represents the beginning of active engagement for the researcher while focusing on participant responses. Reading and rereading the interview transcript further connected the researcher with the participants story to solidify their individuality. As discussed later in the fifth step (which involves following steps one through four for each interview), adhering to this process for each participant interview allowed the researcher to compartmentalize each interview experience without allowing any previous interview responses or beliefs about the study topic to interfere (Smith et al., 2009). Several days or weeks between interviews also assisted the researcher by providing quality time to become engrossed in the interview transcriptions. The next step involved examining the transcript beyond repeated readings and launched the annotation and theme identification process. This examination deepened the researchers appreciation for the responses provided and allowed the researcher to experience the participant's world, as they expressed it, beyond the interview itself. By having read and re-read the interview transcripts in the first step, the researcher was better prepared to determine theme identification that may have been missed without the initial immersion process. In this second step, the researcher discerned participants main experiences or perceptions and the meaning or attachment to those main experiences or perceptions (i.e., relationships, patient-experience) in order to interpret their world and establish meaning to their recount of events. Annotating the interview transcript with exploratory notations was vital in breaking out specific descriptive, linguistic, or conceptual comments as another facet of step two. In a threephase annotating process, the researcher first noted anything of interest to further expand the familiarity with each transcript by conducting a line-by-line analysis of each interview POSTPARTUM DEPRESSION 28 transcription (Smith et al., 2009). Using a color-coding method, as recommended by Smith et al. (2009), comments identified as descriptive were highlighted in blue, linguistic comments in green, and conceptual comments in pink. This helped the researcher visually identify interview areas of interest, interpret the interview information in smaller segments, and generate codes and themes later on. The researcher used the comment function in the transcript margins to generate ideas about what the participant was conveying. Those margined comments became the theme codebook framework and helped solidify the researchers thoughts and ideas about participant experiences. In annotating for descriptive commenting, the researcher generally identified those critical points that appeared important to the participant (Smith et al., 2009). Most of the transcribed interview data were categorized as descriptive due to the nature of Zoom conferencing and the inability to conduct interviews face-to-face. In analyzing linguistic comments, the researcher identified any metaphorical language or other response behaviors by the participants (e.g., laughter, hesitancy, tone) to explore meaning from the interview (Smith et al., 2009). For example, participants occasionally laughed during the interview, resulting from nervousness or a genuinely positive experience. Another participant became audibly tearful with a shaky voice. These details add meaning to the participants' spoken words, and the researcher identified those comment types whenever possible. In reviewing comments from a conceptual perspective, the researcher further analyzed the transcript data and used interpretation to draw from professional knowledge and experience (Smith et al., 2009). This aspect of annotation was more challenging and required the researcher to deduce aspects of the interview transcript that appeared most important or impactful for the participant. Conceptual comments drove the superordinate theme development and helped establish common experiences, feelings, or perceptions POSTPARTUM DEPRESSION 29 across participant interviews. Once the annotations were complete, the researcher enlisted a second coder to independently analyze all transcripts to increase interpretation credibility (Creswell & Poth, 2018). A Licensed Clinical Professional Counselor (LCPC) from Maryland served as a second coder. Following the independent analysis, the second coder and the researcher met to compare annotations and solidify themes for coding purposes. Once all of the exploratory notations were reviewed and agreed upon, the researcher designed a codebook that kept track of repeated words or phrases, which further aided the third and fourth analysis process. All exploratory notations (descriptive, linguistic, or conceptual) were coded and entered into the codebook. In some cases, notations were sub-coded. In the third step, the researcher analyzed the exploratory comments and codes (descriptive, linguistic, and conceptual) to identify emerging themes (Smith et al., 2009). Since the purpose of IPA is a collaborative process between the participant conveying their experience and the researcher making sense of how the participants make sense of their experience, the themes derived from the transcript analyses should involve the psychological essence of what the researcher discovers and the experience of the participant (Smith et al., 2009). To do this, the researcher often had to interpret what participants were communicating and connect with how it would feel to have that similar experience. For example, the code "scheduled imprisonment " was derived when a participant described what it was like to have a new baby and the toll it took on her to remain home due to frequent feedings and naps. While this code did not apply to all participants, the researcher attempted to identify with the participant and describe that aspect of parenting and how pained she was. The researcher intentionally engaged in a deep connection with all of the interview transcripts and identified with each participants experience as much as POSTPARTUM DEPRESSION 30 possible, even without having had PPD. This psychological essence represents the hermeneutic circle, which is critical to IPA; the participants whole experience is understood by analyzing individual parts of the interview and their overall experience (Smith et al., 2009). The researcher strove to understand the participants experience by evaluating personal details from participant interviews and connecting them to broader themes without losing the impact or influence of those unique details related to the participants experience (i.e., verbal and non-verbal cues to their experience). The researcher then organized and mapped themes related to one another during the fourth analytic step (Smith et al., 2009). To ensure that participants had a say in how the researcher made sense of their experiences, each participant received an electronic copy of their transcribed interview, including the researchers interpretation of any emerging themes. Included in that email, the researcher requested that each participant review their transcript, including emergent themes. The researcher asked that any feedback or clarification be provided via tracked changes and comments within the document and returned to the researcher within two weeks from the date of receipt. The researcher advised participants that their input or clarification would be accepted in an email format versus tracked changes in Word if that process better suited their access and skill level. Smith et al. (2009) do not explicitly suggest sharing or not sharing the transcript as part of the analysis process; however, they recommend engaging the participant in clarifying words or phrase meaning when particular words or phrases stand out or have meaning to the researcher. Participants were also informed that a follow-up phone call discussion or Zoom conference could be scheduled if needed. No study participants requested changes to their interview transcripts or emerging themes; therefore, there were no follow-up calls or meetings. POSTPARTUM DEPRESSION 31 In keeping with the fifth step in the IPA analytic process, the researcher repeated steps one through four for each interview. The researcher began analyzing each subsequent interview transcript using the IPA process steps while bracketing those previous ideas and themes to mitigate any interferences or influences (Smith et al., 2009). While analyzing each interview was rigorous and time-consuming, this process allowed the researcher to pause and invest in each participants experience. In the sixth and final step, the researcher evaluated themes across all interviews and identified patterns by converting the codebook into a functional pivot table. The pivot table function in Excel aided in the data aggregation or grouping of individual codes so that themes could be easily derived. This pivot table served as a guidepost for the researcher and provided easier quote identification and extraction during data analysis. Study Rigor Gubas four aspects of qualitative researchs trustworthiness are favored concepts researchers use to demonstrate study rigor (Shenton, 2004). Each concept has a quantitative research equivalent, and those related concepts are identified parenthetically. Gubas criteria include credibility (internal validity), transferability (external validity), dependability (reliability), and confirmability (objectivity) (Henderson & Rheault, 2004). A member checking process ensured perceptions gathered accurately reflected the participants reality to establish credibility. The member checking process provided participants with an additional opportunity to add details or clarify any portion of the transcribed interview and themes provided. Additionally, providing participants with the opportunity to review any emerging themes helped the researcher verify their interpreted experiences authentically. Shenton (2004) suggested involving the participants in any emerging themes discovered during the interview exchanges as another contextual layer to the member checking process. While POSTPARTUM DEPRESSION 32 many qualitative research methods include reflexive bracketing, that process seems problematic with the IPA design as the researchers preconceptions may only be discovered during the interview process with participants or after the analysis has been conducted (Ahern 1999; Chan et al., 2013; Smith et al., 2009). To establish rigor under the IPA design, the researcher must evaluate each interview individually without allowing any initial or subsequent interview analysis to cloud perception and should bracket any thoughts about any of those analyses as much as possible (Smith et al., 2009). Transferability is a challenging concept in that it requires a demonstration that researchers can apply results to a similar population (Shenton, 2004). Since this study was conducted with a smaller sample, the literature review is critical for establishing the research need. A full description of the phenomenon under research, coupled with the participants detailed background demographics, provides the framework for transferability inferences (Henderson & Rheault, 2004; Shenton, 2004). The desire was to establish that decision-making challenges in mothers with PPD are likely a shared experience of many mothers with PPD regardless of those earlier explored demographic factors. In establishing dependability, the goal was transparency by documenting research steps (e.g., an audit trail). To prevent overgeneralizing, transcribed interview data were coded and then re-coded in Excel for a thorough auditable analysis (Henderson & Rheault, 2004). With the use of a second coder, a peer review process was established whereby results were shared, compared, and audited (Henderson & Rheault, 2004). This studys confirmability was addressed by reducing bias while providing an opportunity for replicability (Shenton, 2004). Triangulation and reflexivity, done via memoing, helped safeguard congruence in the data collection process and reduce bias by admitting or POSTPARTUM DEPRESSION 33 identifying any researchers predisposition with the process or overall outcome. Specifically, triangulation in this study involved the second coders assistance as a resource for identifying code or theme overlaps and validating emerging themes from the transcribed interviews prior to member checking. In memoing, Birks et al. (2008) suggested this process could help clarify thoughts and assumptions throughout the research study while also providing more opportunities to extract meaning from the data, map any decisions made during the research, and identify how the researcher established conclusions. Memoing from the start of this study (and regularly throughout) assisted the research process by documenting any biases, impressions, and feelings that may never have been revealed to the researcher otherwise (Birks et al., 2008). Identifying any biases or the influences those biases may have had on the analysis (or study process) established additional rigor and credibility in the area of objectivity for this research. Results The eight participants (mothers with PPD) in this study and their characteristics are described in Table 1. Identification codes were used to protect the privacy of all participants. Participants ranged in age from 24 to 42 years. All participants had professional careers with varying levels of education. One participant had some college experience; one with an associate degree, three with bachelors degrees; two with masters degrees; and one with a doctoral degree. Six of the participants worked in the healthcare field, and the other two worked in education. Participants identified themselves as White/Caucasian (n= 5), Hispanic (n=2), and Black (n=1). All mothers had a live birth within 12 months of their scheduled interview, and no one identified as having had a substance use disorder before having PPD. Data analysis resulted in 34 codes used to categorize participant interview data. Of those 34 codes, four dominant themes, or Super-ordinate themes, emerged across participant POSTPARTUM DEPRESSION 34 interviews. Those themes, their respective subordinate themes, and their reported frequency are represented in Table 2. Two codes (n=2) were removed during the analysis of interview results due to their infrequent use or participant-specific application (<2 coded interview references). Additionally, participant responses correlated with Advice for Clinicians and Advice for Moms were excluded from interview analysis for major theme development. All participants were asked specific questions about advice or recommendations they would offer, and their suggestions are incorporated in the Discussion chapter. Super-ordinate Theme A: Relationship with Clinician The most notable theme across all participant interviews pertained to ones perceived relationship with their clinician. The most frequently coded categories comprising this theme were Clinician Trust and Clinicians as Unsupportive. While each participant varied in their particular healthcare perceptions and experiences, these top two codes were derived from all participant interviews. Subordinate Theme A1: Clinician Trust Clinician Trust was the most frequently coded category, with participants conveying their dependence on trusted clinical professions time and again when relying on them for healthcare support or healthcare decision-making. All eight participant interviews indicated in some way the importance of rapport and trust, which they seemed to correlate with their ability to selfdisclose, to open up, and ask more questions about symptoms, treatment, and their childs healthcare needs. Participants also reported the importance of professionalism and competency, which helped provide a sense of safety, particularly during the COVID-19 public health emergency, and while experiencing PPD. POSTPARTUM DEPRESSION 35 Participant 2QJ perceived herself as more capable of making healthcare decisions for herself and her baby after having worked with her familys pediatrician for several years: I think Im also just trusting my gut a little bit more, and because I have, I really have incredible providers; both my pediatrician and my nurse-midwives are just fabulous. Like I trusted them, you know, and Ive now had three years to work with, with, with all those folks. So, you know, I think Im probably able to make decisions faster because I, I trust them, and I trust me. Participant 6KB expressed satisfaction with her childs pediatrician and was comforted by their understanding of her PPD diagnosis and stated: I really like babys pediatrician. And so that helped a lot. And she also knew that I had postpartum depression, so it was helpful that she understood that. And then also that she, I think she was very confident in what she was telling me to do for baby. So that helped a lot too. While many participants identified with rapport and professionalism as a means to develop trust in their providers, Participant 7PF indicated that she became more confident in healthcare decision-making with her provider helping to support those decisions alongside her, describing and defining medical information in a way that she could understand: Um, this one is very comforting and explains things and, um, and gives a little bit more of that research and that reason behind why she does it and, um, explains things in a way that isnt like necessarily dumbing it down. But, um, not as much of the medical terms so that we can, we can understand as non-medical professionals. POSTPARTUM DEPRESSION 36 Subordinate Theme A2: Clinicians as Unsupportive As the second most frequently identified code, participants identified their experiences with their OBGYNS or other clinicians as unsupportive when they believed their PPD experiences were being unappreciated and when the clinician suggested a prescribed medication as the initial course of treatment. Participant 8ZC recalled her experience: So, and all the emotions that I was going through, I was just like, okay, I guess if this is whats, you know, going to make me feel better instead of him just, and then he also didnt like, recommend any therapy, nothing like that. So it was just kinda like deal with it on your own. And heres, heres some medication, you know? Participant 1WN shared a similar experience. And I think part of the problem with lack of providers being able to spend time with moms postpartum is that the easy fix is saying, let's, let's put you on some meds rather than necessarily like doing therapy or like figuring out what the problem is and offering some solutions (Participant 1WN). Some participants communicated a sense of forced responsibility and were left to figure things out on their own. Other participants self-referred for behavioral health treatment or believed that there were not a lot of behavioral health resources or information provided to moms when compared to the different types of maternity resources (i.e., lactation consultants, nutritionists): I knew like baby blues like I knew there was a really good chance that I would feel yucky immediately after birth, but I did not know that it could last for months or yearsUm, and yeah, a little bit upset because my OB hadnt talked to me about it. (Participant 6KB) POSTPARTUM DEPRESSION 37 Once the baby was born, there was often a sense of abandonment once the clinical relationship ended. Participant 7PF expressed her perceptions of how the clinical relationship changed after the birth of her child and how that affected her healthcare decision-making: I felt like it was so focused on baby afterward, which is important. I mean, theyre, theyre fresh to the world. They, you do have to be extremely concerned about everything going on and making sure that theyre healthy and eating and whatnot, but, um, I felt like, okay, Ive been seeing my doctor every week for the past, um, for the past how many months, and now I guess I wont see you for six weeks and what do I do? Especially as a first-time mom, I just felt like I was kind of thrown to the wolves of like, okay, figure it out. Similarly, Participant 5RY questioned who should follow up or check on mom after the OBGYN relationship ends. She stated, We kind of, short-changed new moms, and I know were all busy whatnot, but like just the one visit after, um, you have a baby, is crazy (Participant 5RY). She goes on to probe, who else is supposed to figure out things, like maybe your pediatrician when you see them a ton like for her to pick up on, hey, you know, moms not doing welllike nobody is like checking up on you (Participant 5RY). Occasionally, participants would communicate that they changed providers or sought their own course of treatment. It was also noted that doctors appeared too busy to provide the level of attention mothers with PPD thought they required to feel supported during this time. Additionally, participants frequently commented on how they would have benefited from additional follow-up from clinicians, especially when PPD was suspected or diagnosed. POSTPARTUM DEPRESSION 38 Super-ordinate Theme B: Stress, Depression, and Anxiety Contributors During PPD The second most prominent theme across all participant interviews pertained to factors contributing to stress, depression, and anxiety during PPD. This theme comprised of codes such as Expectations, Isolation, and Life Events as the most frequently coded categories. Generally, this theme identified factors that facilitated challenges while having PPD and include situations such as a mothers poor symptom identification and acknowledgment due to incomprehension of her diagnoses, the death or terminal illness of a loved one, barriers to treatment and care, pandemic challenges, exhaustion, and competing priorities. Subordinate Theme B1: Expectations As a frequently coded category for this theme, mothers conveyed their expectations of the clinical relationship and expectations derived from societal, cultural, or religious dogmas: Im not in a relationship, and thats kind of what is expected. Um, as, uh, as a first step thats, Ill put that out there as kind of, uh, uh, not to say discrimination, but, um, I guess this, the single mother thing is, was, was hard at least for my religious parents. (Participant 5RY) Participant 1WN revealed her belief that there is a societal expectation that motherhood is picture-perfect at all times. She stated: I dont think social media and Pinterest and you know, the news and all of that help because you see these moms that are, you know, perfect in their bikinis or moms that are great at throwing birthday parties theres a lot of social pressures like having your baby look beautiful and cute and ready for a picture at all times. In expressing her perceptions about the experience of motherhood, Participant 6KBs expectations related to how she believed she should feel. She stated: POSTPARTUM DEPRESSION 39 Um, like when I woke up and would think to myself, okay, here I stay all day, and I should be very happy about that, but I dont feel happy about that. Um, and I should feel joy when playing with my child, but I dont always feel joy (Participant 6KB). Other participants communicated expectations about how their families would interact with one another and their assistance with taking care of the new child, including healthcare decisions and routine appointments. Participant 4DS responded, I was really trying and taking the baby to the doctor. I did my best. I kind of like took him to all of his vaccinations, and nobody helped me... Similarly, Participant 8ZC anticipated more assistance and support, noting: I honestly really think, I guess a big part in like with my situation was just that I didnt have, I didnt feel like I had the support from my family and stuff as much as my family and friends as much as I thought I would. Participants 1WN and 5RY both made a similar reference to the it takes a village to raise a child cultural idiom, which signified a cultural and societal expectation. Participant 1WN noted, And whoever made the idea that mom and dad should be able to take care of kids without a village, I completely disagree. Participant 5RY stated, And I see, well, it takes a village, and Im like, where is this village? Subordinate Theme B2: Isolation Isolation was found to be a frequently coded theme and equally reported when compared to the Expectations category. It should be pointed out that this study was conducted during a time when all participants delivered their children during the COVID-19 public health emergency. While many participants reported feelings of isolation based on pandemic protocols and limited social interactions, others expressed loneliness that could not be explicitly correlated to the stayat-home suggestions or distancing measures. Sometimes the feelings of loneliness or being POSTPARTUM DEPRESSION 40 isolated mirrored the Expectations category but were carefully considered as its own category based on how the participants conveyed their experience (i.e., tone of voice and inflection) and their word choice. All of the participants were from different states across the nation and may have experienced the pandemic differently based on their states mandates; however, this category stands out as an area of concern for behavioral health implications: Its that been hard too, because I actually have more friends having babies this time around, but not all of them are local, but the problem is like, we cant go visit each other and you know, not everyone wants to go into your house or play outside, or travel and that has made it harder to. So, even the resources you do have you just, or friends and support you do have, its harder to see and get along and meet and all that. (Participant 1WN) They [clinicians] didnt follow-up with that [PPD screening] ...it was up to me to find help. And I felt obviously with being a little unmotivated, you know, it was, it was hard to pull myself out of that, and I felt that it was, I was alone in that sense. (Participant 3GB) Um, and that, you know, a couple of my spiritual friends are like, oh yeah, the universe is saying this, this and I was like, I dont know guys, like I was just freaked because I had to do it alone, you know, without getting some help, really, physically with nobody able to come and help or anything like that. (Participant 5RY) Um, and we dont live close to family, so thats tricky. I feel probably like of all the negative feelings; I feel like isolated the most, sometimes lonely, um, the most, because we dont live super close. My parents are five hours away, and theyre the closest family that we have. Um, so its just kind of our immediate family that we spend time with, and POSTPARTUM DEPRESSION 41 we moved two years ago, so were still making friends in this area. Um, and COVID hasnt helped with that. (Participant 6KB) Um, my class threw me a baby shower. And so, because there they were the only people that I saw on a regular basis in person. And so, um, so that was, that was a sweet thing, but like all my friends and my family, I didnt have one with them when is it safe for people to come and meet him? And what are the rules going to be? Are we going to have people wear masks? Are we going to have them, um, hold him at all? And, um, and that those little decisions around COVID have been, have been an added, added, tricky-ness that isnt always, um, there with first-time moms. (Participant 7PF) Subordinate Theme B3: Life Events While Life Events were not a dominating theme pertaining to specific healthcare decisions, participants frequently identified significant life events that may have exacerbated their PPD symptoms and influenced their healthcare decision-making during the childs first year. Many participants communicated challenging circumstances such as a death in the family, premature birth with a NICU stay, and other medical conditions or illnesses. Furthermore, all of the participants delivered their babies contemporaneously with the coronavirus pandemic. A few of the significant life events experienced by participants after the birth of their child are as follows: Participant 3GB: um, she was diagnosed with, um, like, um, foot deformity called microdactylyUm, well, her contralateral side. So, um, so some people think, um, well, meaning people, orthos are saying amputation of the foot, and then some others are thinking, plastics, you know, its, its a lot to figure it out, but anyway, I feel like thats, all that, I feel contributed to my postpartum depression. POSTPARTUM DEPRESSION 42 Participant 4DS: I dont have anybody. My grandma once came to help me with the baby, with the kid. But unfortunately, I tried to bring her back, but they didnt give her the visa, and she passed away in February. Participant 5RY: I had to make the decision [to not terminate the pregnancy] while there was a pandemic, and I just couldnt see beyond it. So, um, that was something I think that affected me too. Uh, so that, that was pretty toughAnd then he was, he was premature, so was in the NICU for two weeks And it was a hundred, but it was a hundred percent stress [poor maternal weight gain]. Ill tell you that. But I never told him [OBGYN] like, what was going on. I mean, he knew I was, I think he figured out I was single, you know, cause all my appointments I was by myself, but I guess everybody was by themselves during COVID. Participant 8ZC: And it was more so, like, I kind of feel like they were more, how do I explain it? They were more concerned about like my past trauma versus the current pregnancy. And then like, cause I didnt even get diagnosed until after I had already had my son. So that was, hes, he was my sixth pregnancySo when he came early, the doctors were concerned about, you know, my doctor at least was concerned about the emotional state that I was in just because he did come early and he was in the NICU So then when I started going to therapy for the postpartum, thats when everything kind of took effect, and I started, thats when we jumped back all the way through the loss of my daughter, and they said Ive probably been in that state since her. Super-ordinate Theme C: Impacts of PPD on Mothering and Baby: The Dyad While this theme comprised various ways participants perceived the effects of postpartum depression and their experience with motherhood, the top two coded categories were POSTPARTUM DEPRESSION 43 Evolved Awareness and Self-Care. The Evolved Awareness category revealed participants awareness about who they were as a woman and a mother and their ability to absolve themselves of guilt or self-blame for their temporary mental health condition. Participant statements were categorized as Self-Care when they mentioned neglecting their care (i.e., medical, behavioral health, social, hygienic) for the sake of their childs care and well-being or when they engaged in self-care activities. Subordinate Theme C1: Evolved Awareness As participants delved into their personal experiences with PPD and their healthcare decision-making, those decisions evolved as their personal awareness about who they were as women and mothers also developed. One participant shared that her previous mental health experiences helped to shape her view of her own mental health needs and stated: And, and if, I think if I hadnt had, um, previous mental health, um, and, um, working with clinicians, um, with that type of thing I, I probably wouldnt have opened up about my experience and I wouldnt have been willing to say, hey, somethings wrong. I need help (Participant 7PF). Participants were able to express awareness of their own understanding as a mother with PPD, how PPD may impact their children or other relationships, and how their healthcareseeking has changed over time. One participant realized that her PPD was affecting her relationship with her oldest daughter, and while against taking medication, including analgesics, she decided to begin prescribed treatment. She stated: Im very against medicine, like in all forms, actually, even when I have like menstrual cramps, I like do not take ibuprofen unless I feel like Im going to vomit it, basically. So I was so, so, so against taking any anti-anxiety anti-depression medicine, but like I said, POSTPARTUM DEPRESSION 44 um, I knew that I needed to do what was best for my older daughter. And I, I felt that my mood was affecting her mood (Participant 6KB). Participant 4DS realized that before having PPD, she did not participate in healthcareseeking as it pertained to mental health services. Having PPD changed how she thought about healthcare and stated, Oh, like now Im more focused on discovering things that could make me happy. Healthcare decisions that could make me happy. Healthcare decisions help me or my family memberbefore, I wasnt like this (Participant 4DS). Subordinate Theme C2: Self-Care Self-Care was centered around participants expressing neglect for their own personal care to meet their babys needs or when they engaged in self-care practices to mitigate the impact of PPD. Participants in this study often found it easier to make healthcare decisions for their child and attend well-baby visits more so than they would choose to do for themselves. For example, Participant 2QJ indicated that routine vaccination decisions were more manageable, particularly with her second child; however, deciding to take prescribed medication for her PPD was more challenging. She stated: So theyre not, you know, theyre, theyre pretty close in age, these guys [children], um, so things like, are we going to, you know, get him his routine vaccinations? Yes, we are. We did it with our first, you know, so that actually hasnt been hard, um, has been easier the second time around. The decision to take, um, I am on an antidepressant, the decision to take that was hard. (Participant 2QJ) Participant 3GB indicated that as a healthcare worker, it might be her nature to put others needs ahead of her own, which became more challenging with her PPD diagnosis. In an emotional recount of her self-perceptions and experiences, she stated, I just felt that I needed to POSTPARTUM DEPRESSION 45 suppress my needs to ensure that she was taking [sic] care of. Um, and thats what gets me emotional (Participant 3GB). Participant 3GB continued, Ive always been that type of person. I felt like I, you know, as a therapist, as a wife and mom, I just feel like I always tend to leave myself at the end... Participant 7PF communicated about her healthcare decision-making as it related to selfcare and protecting her family during the pandemic. She stated: I was given the opportunity to become vaccinated [COVID-19]. Um, and at the time, vaccines were not as available. And so we were concerned that it was going to be my only opportunity. And so we had about an hour to make that decision of like, okay, vaccine or no vaccine. And luckily, our, um, my OB had prepped us for that possibility and had given us some research there (Participant 7PF). In an effort to care for her own medical needs, Participant 5RY demonstrated independent healthcare-seeking self-care when she secured a pelvic floor specialist after discussing her concerns with a friend. She stated, I never went to a, one of my healthcare providers and, and told them about this stuff, I found out on my own, through my friends referral (Participant 5RY). Super-ordinate Theme D: Support Structures for the Mother and Baby Dyad The final Super-ordinate theme, Support Structures for the Mother and Baby Dyad, is comprised of categories that assisted participants in their healthcare decision-making or that new moms would have found helpful in making informed decisions about their care and their childs care. Categories in this theme either helped new mothers feel supported or not supported enough due to the ongoing pandemic and occasional family conflict. Additionally, the categories comprising this theme were derived from universality, having or desiring connections with their POSTPARTUM DEPRESSION 46 families, sometimes other mothers and mothering groups, or were validations throughout their experience. The top two coded categories in this major theme were Family Supports and Validation, although Mom Groups was closely-ranked as the third most frequently coded category. Subordinate Theme D1: Family Supports Participants identified trusted supports aside from their clinical relationships for assistance in their healthcare decision-making. Participants conveyed their trust in family members who had experienced motherhood, frequently their mothers and aunts, as well as those family members who were in the healthcare field or had previous healthcare experience. While the COVID-19 public health emergency created challenges with face-to-visits with family for the majority of the participants, most expressed a trusted connection and desired their support. The desire for supportive families was conveyed for those even without them. Participant 6KB reported healthcare support with nursing her baby as her spouses aunt is a lactation consultant. She utilized this resource beyond lactation needs as well as other members of her family for support. She stated: So then my husbands aunt is also a lactation consultant, so I, um, text her a lot, um, with questions. So handyAnd then, um, my sister had a baby in June, so we are constantly just talking about baby things, and my mom had five children. And so Im constantly asking her, um, questions about baby (Participant 6KB). Participant 7PF utilized her spouses research-minded skills for understanding routine vaccinations, which aided in making those health-care decisions for their new child. She reported: POSTPARTUM DEPRESSION 47 My husbands an engineer and is very research-based. And so he really likes articles and whatnot, and, um, and likes to know the details and, and like how the vaccination is created. And hes really interested in that. And so Ive really relied on him for that research piece of it (Participant 7PF). Subordinate Theme D2: Validation Participants frequently identified when reassurance or validation would have been beneficial. Having PPD can be a challenging complication of motherhood, and some moms felt that words of encouragement and confirmation that they were making sound healthcare decisions for themselves or their new child would have been supportive. When asked what moms with PPD would need to feel supported, Participant 2QJ communicated, I think, um, some reassurance that its okay to ask questions and some reassurance that its okay to be indecisive because that, of course, can be a thing that happens when youre depressed. She elaborated more by stating: Um, clinicians need to know that, Hey, if the person in front of you, whos trying to make a decision about a vaccine or some other treatment option also has PPD going to take her a little bit longer to make that decision. She might feel not confident making a decision like shes going to get in her own way sometimes because thats what depression does (Participant 2QJ). Participant 8ZC suggested that new moms need to be validated and supported, especially when communicating unpopular feelings or thoughts about motherhood. She communicated feelings of wanting to be heard instead of being misunderstood for having PPD. She stated, So I guess just having that, that non-judgment support and having people there who just want to, you know, who want to be around you and arent judging POSTPARTUM DEPRESSION 48 you every five seconds. She went on to indicate the value of validation in that it helps to facilitate better health, and [moms would] be more willing to go through the treatment and do what [they] need to, to get better (Participant 8ZC). Participant 6KB suggested that if providers would talk more about PPD with their patients, there may be less guilt and stigma. Um, they [providers] can talk about it early and prepare their patients for these feelings. Um, and let them know that it's a very normal condition and that they don't have to feel guiltyI had no idea that it was so prevalent, um, in our society. So just like normalizing it, I guess (Participant 6KB). Subordinate Theme D3: Mom Groups This category is one of interest as many mothers communicated some desire to participate in groups that facilitated connections with other mothers. The COVID-19 public health emergency dampened the face-to-face connection for most of the groups discussed during participant interviews, although one participant was able to connect with other moms through Zoom conferencing. When participants were unable to participate in mom groups, there was often an unsolicited expressed interest or desire to connect with other moms. For example, Participant 2QJ had planned prior to the pandemic to join a group. She communicated: I had all these plans for my maternity leave. There were some like local moms groups. I was going to join, there was a mom and me exercise class I was going to do, I was, so I was honestly kind of excited about maternity leave, and obviously, none of that was happening. Participant 5RY explored mom groups for healthcare education and resources and stated: POSTPARTUM DEPRESSION 49 I joined a mommy and me exercise group and, you know, a couple of the girls were, you know, just, um, talking about how things changed. Now we can call them mom pods, they get women together, and you know, the same geographic area out here [we] talk about experiences and have it be moderated by, um, you know, like a counselor. So it, it is helpful, but it was getting expensive. Participant 1WN communicated that the mom groups were significant for receiving information before delivery and facilitated by a healthcare provider. She stated, then you sit there, and you get all the information and education in a group with a couple other women which supported a sense of connection and universality (Participant 1WN). Discussion Postpartum depression is a serious health condition affecting new moms in the first year after the child's birth (ACOG, 2018; Hadfield & Wittkowski, 2017; Johansson et al., 2020; Liberto, 2012; van der Zee-van den Berg et al., 2017). Therefore, the purpose of this IPA study was to explore the perceptions of new mothers who have been diagnosed with PPD and their ability to make healthcare decisions for their new child. Additionally, specific focus was on a new mother's ability to make routine vaccination decisions during the childs first year of life. While super-ordinate themes created the foundation of the researcher's interpretation, the process of the hermeneutics also involved delving into the lived experiences of each participant to tell her story as part of a whole PPD healthcare decision-making experience. Race, Ethnicity, and Educational Factors Liu et al. (2018) examined race/ethnicity differences in over 3,000 women in New York City and found no significant differences in PPD likelihood; however, maternal employment in the postpartum period did increase the likelihood of PPD. While participants in this research POSTPARTUM DEPRESSION 50 study were diverse in age and race/ethnicity, all women were college-educated, and all but two were currently employed. Liu et al. (2018) also noted that education and income levels, when associated with PPD, varied amongst their sample, with lower education and socioeconomic groups being a PPD contributor. Six of the participants in this study worked in the healthcare field, and their experiences in navigating resources may have been more advanced than mothers in other professions. Participants 1WN, 4DS, and 5RY expressed concerns about how new moms outside of the healthcare realm and without healthcare experience successfully accessed those PPD resources when they had challenges. Relationship Influence Although not a specific aspect of inquiry in this research, all but one mother identified as in a committed relationship. This demographic detail may allude to PPD protective factors. In their PPD study about partner relationship quality and PPD predictors, Faisal-Curry et al. (2021) found that women who have good relationships with their partners tend to experience a lesser PPD impact (with the inverse being true as well). Akbari et al. (2021) also reported similar findings indicating that mothers with positive support systems, including relationships with significant others, can lower maternal distress and facilitate increased satisfaction. Women in this research study identified Family Supports as a positive support structure. While several participants communicated relationship stressors, there was no indication that those aspects contributed to their PPD, exacerbated their symptoms, or influenced their PPD experience specifically. Furthermore, participants in this study, with or without familial supports, were engaged in their new childs healthcare. POSTPARTUM DEPRESSION 51 Life Event Contributors Another mentioned consideration is the impact of the COVID-19 pandemic on new mothers and their PPD experience. Guvenc et al. (2020) found that women in their study had a higher rate of depression due to the COVID-19 lifestyle or living conditions changes which negatively affected new moms. While risks for developing PPD are generally known to include stressful life events and a prior history of anxiety and depression, Kornfield et al. (2021) indicated that the COVID-19 pandemic represented an acute environmental stressor that may heighten perinatal depression. Kornfield et al. (2021) further noted that the pandemic created an additional strain as social interactions were limited, loss of loved ones occurred, and the fear of safely delivering a child with limited in-person medical care was added. Most of the participants in this research study experienced a significant life event during the pandemic, including premature births, NICU stays, and loss of loved ones. All of the women in this study delivered their children during this isolating time. Much of what these participants expressed as isolation during their postpartum period did not always convey a correlation to the pandemic. However, they may not have been aware that the pandemic was a co-occurring contributor to their depression. For example, Participant 5RY struggled with PPD symptom recognition and differentiating between situational challenges. She stated, It's hard for me to kind of tease out in my mind if it was if it's kind of depression or just, like I said, like it being really hard during COVID, or being hard by myself (Participant 5RY). Universality In a systematic review of the available research on PPD and women's psychological and psychosocial intervention seeking, Hadfield and Wittkowski (2017) found four main themes in the literature pertaining to women's experience in seeking mental health support for their PPD, POSTPARTUM DEPRESSION 52 which included the help-seeking process, barriers to seeking and accepting help, valued aspects of support, and outcomes. Canty et al. (2019) researched mothers perspectives on follow-up for PPD screening in primary care. They also identified four similar themes: personal health/attitude, family/friends, community, and healthcare system factors (Canty et al., 2019). Identical to those findings, the four principal or super-ordinate themes in this research study were (in order by frequency) "Relationship with Clinician," "Stress, Depression, and Anxiety Contributors During PPD," "Impacts of PPD on Mothering and Baby: The Dyad," and "Support Structures for the Mother and Baby Dyad." Although themes in this study were categorized differently, the superand subordinate themes discovered in this research study appeared to be consistent with those similar research themes, including those conducted in other countries (Hadfield & Wittkowski, 2017). Both Hadfield and Wittkowski (2017) and Canty et al. (2017) reported findings suggesting universality in the experiences of women with PPD and their behavioral healthcare seeking. This research study also discovered similar tones of universality amongst participants about healthcare-seeking experiences and making those decisions for their new baby. Relationship with Clinician and Universality Most of the mothers trusted their clinician(s) or clinical team(s). Study participants repeatedly acknowledged that they trusted their providers knowledge and expertise when needing assistance with making decisions for specific treatment options (i.e., the baby was receiving care in the NICU, various routine vaccine decisions and choices, and guidance for maternal resources such as breastfeeding and nutrition). Participants in this study did not seem challenged to rely on their chosen healthcare professionals for their new baby's care. However, participants in this study did reveal that they found their healthcare professionals or clinicians unsupportive when needing support and resources for their PPD. Canty et al. (2019) reported that POSTPARTUM DEPRESSION 53 mothers in their study also felt the same. Most participants screened for PPD by their OBGYN often had to seek their own care or self-refer to behavioral health agencies and were left to figure things out independently. Only one participant (Participant 4DS) indicated that her babys pediatrician screened her for PPD even though her OBGYN had already screened her. Participants indicated that when their healthcare provider offered treatment, they were often only provided a medication option and no additional behavioral health resources for management. These experiences were consistent with the literature reported by the Canty et al. (2019) and Hadfield and Wittkowski (2017) studies. Another study found that women felt their PPD symptoms were ignored or dismissed (OHara & McCabe, 2013, as cited in Hadfield and Wittkowski, 2017). While many of the studies evaluated in the Hadfield and Wittkowski research were older than ten years, much of their data synthesis is still relevant and consistent with the findings in this research study. PPD Contributors and Universality Another universal experience expressed by participants was that of PPD contributors. As discussed earlier in this chapter, many women experienced feelings of isolation; however, feelings of guilt and shame for having PPD were also frequently identified. Canty et al. (2019) found that mothers often reported similar feelings of discomfort and maternal anxiety. Expressing feelings of shame, Participant 7PF stated, I think it was so hard because I was, so I was so in love with my son, and I absolutely loved becoming a mother that I felt guilty that I was having, um, those moments. As an educator, Participant 6KD expressed confusion and incomprehension with her PPD experience and felt guilty since she always wanted children and loved teaching. POSTPARTUM DEPRESSION 54 Similarly, Participant 8ZC expressed her incomprehension and belief that having healthcare experience would somehow prevent her from having PPD. She stated, I was working in the healthcare field myself, and so I'm like, I can't, you know, I, there's no way I have, you know, something wrong emotionally. Like I'm good (Participant 8ZC). While there was no available literature about the impact of a mothers profession on navigating healthcare while also working in the healthcare realm, this topic could warrant further exploration. It is interesting to note that most women in this study worked in healthcare and were healthcare-knowledgeable. Yet, these same women experienced similar PPD contributors and barriers to care. Another interesting aspect of this particular theme was the perceptions related to this cant happen to me aligned with the earlier qualitative research studies and still relevant (Bilszta et al., 2010, as cited in Hadfield and Wittkowski, 2017). This mindset of PPD cant happen to me signified the internal struggle with being the perfect mom and unrealistic expectations (Cooke et al., 2012). Participant 1WN communicated her thoughts about the perceived perfect mother, which Stana and Miller (2019) remind are impossible standards, potentially driving women to psychological distress. It would seem that this belief system may be heavier or more involved for those women working in healthcare who struggle with their symptom recognition. It may also seem defeating to have a clinician ignore a woman attempting to communicate these thoughts and not have the healthcare literacy to effectively express her thoughts and emotions. Impacts of PPD on Mothering and Baby and Universality Participants perceptions of having PPD and how that impacted their mothering experience were similar across interviews. While subthemes about evolved awareness and selfcare were more dominant in this research study, participants also commented about POSTPARTUM DEPRESSION 55 stigmatization. Findings from this study were similar to results reported by Bilszta et al., 2010 (as cited in Hadfield & Wittkowski, 2017) when mothers reported their reluctance to take medication for fear of embarrassment. The way women in this study discussed their experience with stigma also corresponded to their thoughts about self-care. As they reflected on their experience, women in this research study wished PPD was more normalized and openly discussed. Participant 6KB suggested that if providers would talk more about PPD with their patients, there may be less guilt and stigma and potentially more self-care. Canty et al. (2019) similarly identified self-care as an impact of PPD on mothering, noting that lack of self-care was an issue that many mothers in their study faced. Canty et al. (2019) also acknowledged that mothers identifying with the stigma of PPD might hesitate to discuss their feelings or emotions, a form of self-care, with their providers. Support Structures for the Mother and Baby Dyad and Universality Mothering groups, social connection, and validation were subordinate themes coded under the Support Structures for the Mother and Baby Dyad theme. Additionally, this theme comprised categories that aided new mothers in their healthcare decision-making and support new mothers would have benefited from in making informed decisions about their care and their new babys care. As identified previously, Family Supports was a key factor for new moms, although themes pertaining to validation and receiving support through mothering groups were also identified. It seems that women would prefer a woman-centered community model approach to managing motherhood and PPD (Edge, 2011, as cited in Hadfield & Wittkowski, 2017). Participant 1WN communicated the support she felt when she was with other mothers when she said, [we] all had babies right around the same time I did, so we would walk, or we did like a mommy and me class at the library. Like it just, it was a lot of support. Participant 8ZC POSTPARTUM DEPRESSION 56 suggested similar thoughts when she spoke about needing validation and support. Participant 5RY offered that the value of mothering group connections is that it keeps her accountable and others interested in her well-being. Canty et al. (2019) identified family members not being available to support as a significant barrier to healthcare seeking. While the participants in this study frequently identified family support as crucial support in their PPD experience, most families were unable to be supportive in a traditional sense (i.e., frequent in-person visits) due to the COVID-19 pandemic. It seemed as though most of the women in this study had supportive families, or supportive relationships, even if they could not access them. While Canty et al. (2019) had a larger qualitative study sample (n=17), the mothers in this research study did not generally experience family support as a barrier to their healthcare-seeking behavior. Additionally, mothers in this study and the Canty et al. (2019) study were often able to navigate their PPD symptoms and healthcare-seeking when supported by friends and family. Universality and Successful Group Models While many of the women in this study provided windows into their experiences, all four super-ordinate themes were present in these women's stories and how they connected their PPD experiences in making healthcare decisions. As the study revealed, connections to providers and their roles as new mothers centered around universality as they made the best healthcare choices for their new babies. When it came to clinical support and treatment, connection with an educated provider was essential for optimal treatment and postnatal support and a protective factor in health outcomes (Ando et al., 2021). Further expanding on the universality experience, participant 1WN used the term centering pregnancy (CP) on describing a midwifery practice for connecting mothers. Research POSTPARTUM DEPRESSION 57 by Xaverius and Grady (2014) suggested that CP was an innovative and effective group model approach in delivering prenatal care. According to Xaverius and Grady (2014), some of the essential elements of CP include (but are not limited to): Patient self-assessment and ongoing evaluation Provider in group space Education and support Formal and informal socialization Group cohesion Patient and provider consistency Optimal group size Family support options Additionally, mothers who engaged in CP models of care had higher well-child visits during the childs first year of life when compared to mothers involved in traditional care (Gullet et al., 2019; Irigoyen et al., 2020). One study posited that women were less likely to suffer from PPD when engaged in CP groups (Trotman et al., 2015), although other studies found no difference in Edinburgh Postnatal Depression Scale scores (Boothe et al., 2021; Kennedy et al., 2011). Interview participants shared advice for providers, to which participant 4DS suggested that if clinicians support moms during pregnancy, they should support them post-delivery similarly. Participant 8ZC reminded that clinicians need to know too, that some people don't have support systems. Like, they [clinicians] are their only support system. This statement suggested universality and that resources outside of friends and family are invaluable to new moms. Participant 2QJ elaborated and shared, There's a whole bunch of stuff you don't know. POSTPARTUM DEPRESSION 58 And then you also worry that you're doing it wrong. Um, so having access to other parents, but I think especially other moms, is really important. One program, the 4th Trimester Project, elevates new moms' voices by providing attention to the areas of concern identified by the women in this research study. The 4th Trimester Project out of North Carolina and funded by the Patient-Centered Outcomes Research Institute (PCORI), sought to address the many issues new moms face during the postpartum period and brought together mothers, healthcare providers, and other stakeholders to identify areas to improve (Tully et al., 2017). During the projects development and research, the four major topics that emerged were the imbalance in postpartum care, misalignment of clinical practice guidelines with womens experiences and needs, validation of women as experts of themselves (and as mothers) and their children, and the need for more comprehensive care (Tully et al., 2017). Limitations The risk of researcher bias influencing the outcomes of the analysis of the results is a limitation worth noting. The researcher coordinated and conducted all participant interviews and completed the initial coding of all participant interview data. The researcher employed a licensed behavioral health therapist as a second coder to aid in the coding and theme generation. As part of the bracketing process, the researcher engaged in a memoing process to alleviate any damaging effects of judgment and preconception about the participants or their interview responses. Memoing after each interview provided the researcher an opportunity to document any feelings, thoughts, or perceptions before scheduling the following interview. The memoing process also allowed the researcher to record ideas and meanings about the participants experiences and aspects of the challenging interview process. POSTPARTUM DEPRESSION 59 Additionally, the memoing process also served as a self-protective measure due to the topic's sensitive nature as the researcher is also a mother. The researcher did not know any of the participants and was not linked to any of the participants professionally or otherwise. Finally, the research sample was recruited during a global pandemic when social distancing and limited social interactions were encouraged. The current and ongoing public health emergency posed a limitation to the research study since face-to-face interviews were not possible. Implications and Future Research Study questions in future iterations of this research should elaborate on healthcare decision-making drivers. All of the participants in this study indicated that their babies were up to date on all routine vaccinations and well-baby visits indicated that these decisions were not a challenge for new mothers with PPD. However, this study did reveal that these participants struggled with their providers understanding or supporting their behavioral health or self-care needs. Due to providers lack of knowledge or support, these participants believed their mental health treatment-seeking was more challenging. These new mothers often secured their own psychological or medical care. Farr et al. (2014) suggested that onsite behavioral health services have proven effective with engaging mothers in treatment, although this may not be a realistic option for all providers. Clinicians engaging in follow-up care may be an additional protective factor if new moms are not left to figure things out independently. If moms with PPD trust their doctors with their babies, it seems reasonable to suggest they would also be more inclined to adhere to PPD treatment when empowered and collaborating with an educated provider. Additionally, the follow-up needs of mothers may not necessarily be the same for all mothers experiencing PPD. However, the difficulties of follow-up do not seem to outweigh the benefits considering the mother and baby dyad and long-term health outcomes. POSTPARTUM DEPRESSION 60 The findings of this research study suggest that systemic changes are needed at both the clinical policy level and within health plan organizations. Participants in this research study expressed needing and desiring more therapeutic options and collaboration in their PPD treatment, including a follow-up when a PPD assessment is conducted, even when not diagnosed. Although they were never formally diagnosed, several participants in this study self-reported having PPD, even when screening indicated a PPD diagnosis was likely. Several studies have confirmed and reminded that PPD is often under-detected therefore under-treated (Evans et al., 2015; Olin et al., 2015; Legere et al., 2017). Legere et al. (2017) further suggested that the lack of detection and treatment may be due to a lack of professional education and development among healthcare providers. Evans et al. (2015) found that more than half of OB-GYNS, family practitioners, and pediatricians indicated that they most frequently use clinical judgment for their most common PPD assessment method, highlighting the need for better assessment and detection. Pediatric providers in a Georgia research study stated barriers to PPD assessment included time constraints, limited training resources, or that diagnosis and treatment of the mother was beyond their scope of expertise (Barrow et al., 2020). The findings of this research study and the available literature suggest a strong need for education and professional development for healthcare providers in PPD (Legere et al., 2017). Legere et al. (2017) further elaborated on this need by suggesting that health plans and providers should conduct a needs assessment on their priority populations, those servicing maternity and/or mental health enrollees. Designating healthcare providers who pursue(d) formalized education in postpartum care, specifically PPD, should be deemed "champions" to encourage other providers to follow suit (Legere et al., 2017). POSTPARTUM DEPRESSION 61 In summary, implications based on the interview responses from this study can be used by clinicians to form better patient relationships and improve mother and child outcomes through screening and treatment. These implications include, but are not limited to: Implement a Centering Pregnancy model or roll-out of the 4th Trimester Project nationally for integrative holistic care within medical practices and clinical homes. Designate a POP (PCP, OBGYN, PEDS) collaborative for coordination of care. Partnerships and coordinated care between OBGYN offices, primary care physicians, and pediatric facilities promote a long-lasting relationship with mother and baby. Upon making any referrals, assess the new mom for any barriers to care and address those through the POP collaborative. Practices and health plans should consider using nurse practitioners, physician assistants, or interns to conduct PPD screenings and assist in referral. OBGYNs should establish relationships with behavioral health clinics for referral and treatment to prevent new mothers from having to self-refer and figure out their treatment options. Bridge behavioral health and medical care during hospital stay/post-delivery for a more integrative care approach. Since many delivering hospitals send clinical staff in to educate the new mother on kangaroo care, safe sleep, and breastfeeding, the hospital should also consider arranging a behavioral health staff visit before discharge so that the new mother has a referral on hand. Health plan and provider workflow reforms to ensure new moms receive more frequent follow-up calls, especially when there is a suspected PPD diagnosis or when mom is missing postpartum or pediatrician appointments. POSTPARTUM DEPRESSION 62 Health plans should facilitate PCP-assignment if the pregnant enrollee does not have one designated to mitigate the reported feelings of OBGYN-abandonment when the clinical relationship ends (e.g., after delivery). Hand-off appointments, as part of the coordination of care, should be established with the PCP for establishing patient care and reinforcing clinician trust. Refine patient education and health literacy materials regarding PPD beyond pamphlets. Moms in this study frequently described their experiences as forced responsibility having to figure out their PPD treatment options and coordinating their care. Instead of clinicians offering up resources or alternative treatment options, these participants reported that they had to research and locate behavioral health services independently. Mothers in this research study also communicated a desire to have a collaborative approach to their care after delivery. However, more focus tends to be on the new baby, which challenges them to prioritize their care. Areas for future research consideration are the effectiveness of postnatal education in reducing PPD, programming like group health models and the 4th Trimester project, and education that focuses on the postnatal period for moms beyond the 6-week postpartum check-up. Future research may also consider the mental health impact of public health emergencies and pandemics on new mothers so that care delivery is tailored to mitigate the additional effects of isolation. Conclusion PPD is a challenging mental health problem that many new mothers face during their child's first year of life. 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(2012). Qualitative research sample design and sample size: Resolving and unresolved issues and inferential imperatives. Preventative Medicine, 55, 398-400. https://doi.org/10.1016/j/ypmed.2012.07.003 POSTPARTUM DEPRESSION 72 Tully, K. P., Stuebe, A. M., & Verbiest, S. B. (2017). The fourth trimester: A critical transition period with unmet maternal health needs. American Journal of Obstetrics and Gynecology, 217(1), 3741. https://doi.org/10.1016/j.ajog.2017.03.032 U.S. Centers for Medicare & Medicaid Services. (n.d.). Well-baby and well-child visits. CMS HealthCare.gov Glossary. https://www.healthcare.gov/glossary/well-baby-and-wellchild-visits/ van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., IJzerman, M. J., HaasnootSmallegange, R. M. E., & Reijneveld, S. A. (2017). Screening for postpartum depression in well-baby care settings: A systematic review. Maternal and Child Health Journal, 21(1), 920. Veerasingham, P., Grant, C. C., Chelimo, C., Philipson, K., Gilchrist, C. A., Berry, S., Morton, S. (2017). Vaccine education during pregnancy and timeliness of infant immunization. Pediatrics, 140(3). https://doi.org/10.1542/peds.2016-3727 Xaverius, P. K., & Grady, M. A. (2014). Centering pregnancy in Missouri: A system level analysis. The Scientific World Journal, 110. https://doi.org/10.1155/2014/285386 POSTPARTUM DEPRESSION 73 Participant Characteristics Table 1 Participant Characteristics Identification Code 1WN 2QJ 3GB 4DS 5RY 6KB 7PF 8ZC Age 33 40 35 41 42 29 24 28 Highest Education Level Masters Doctorate Associate Bachelors Masters Bachelors Bachelors Some College Race White White Hispanic Black White White White Hispanic POSTPARTUM DEPRESSION 74 Interview Themes and Subordinate Theme Frequencies Table 2 Interview Themes and Subordinate Theme Frequencies Super-ordinate Themes Relationship with Clinician Stress, Depression, and Anxiety Contributors During PPD Impacts of PPD on Mothering and Baby: The Dyad Supports Structures for the Mother and Baby Dyad Subordinate Themes Clinician Mistrust Clinician Trust Clinicians as Unsupportive Follow-up Needed Barriers to Care Competing Priorities Effort or Excuse Exhaustion Expectations Guilt/Shame Incomprehension Isolation Life Events Social/Familial/Cultural Influences Stress Acceptance Evolved Awareness Informed Loves Motherhood Reflection Scheduled Imprisonment Self-Care Stigma Family Supports Mom Groups Social Connection Universality Validation Frequency Totals 19 83 59 15 7 19 5 6 32 16 17 32 31 14 6 14 40 29 14 17 2 36 11 39 24 12 14 28 POSTPARTUM DEPRESSION 75 Appendix A University of Indianapolis Institutional Review Board Approved Study Guide Minimal Risk UIndy Study # 01389 Study Version: 1 Study Version Date: 3/11/2021 Informed Consent Form (ICF) Version: 1 ICF Version Date: 3/11/21 KEY INFORMATION FOR POTENTIAL RESEARCH PARTICIPANTS The University of Indianapolis is requesting your participation in this research study to understand better how PPD influences maternal healthcare choices. Your consent to participate in this study is entirely voluntary and will be conducted through phone, teleconferencing applications, or faceto-face, depending on your preference. Interviews are expected to take no more than 120 minutes (2 hours) of your time for the project. Interviews will be conducted with open-ended questions in a non-judgmental manner, and you have the right to answer based on your level of comfort without penalty. You will be presented a $20.00 Target Gift Card as a gift for your participation. CONSENT TO PARTICIPATE IN RESEARCH STUDY Postpartum Depression and a Childs First Year of Life Study Principal Investigator (PI): Dr. Laura Santurri UIndy Email: Santurril@uindy.edu UIndy Telephone: 317-788-2409 / 800-232-8634 x 2409. Dr. Laura Santurri, Ph.D., MPH, CPH, Dr. Heidi Ewen, Ph.D., FGSA, FAGHE, Dr. Lisa Borrero, Ph.D., and Aimee Dietsch, MA, from the Department of Interprofessional Health & Aging Studies at the University of Indianapolis (UIndy) are conducting a research study. You are invited to take part in a research project which seeks to explore and understand mothers perceptions about healthcare decision-making while having experienced postpartum depression (PPD). Why is this study being done? This qualitative study aims to explore the perceptions of new mothers who have been diagnosed with PPD and their ability to make healthcare decisions for their new child. Perceptions related to their ability to make routine vaccination decisions during the childs first year of life are also being explored. This research will involve an interview where you will be asked questions by the Research Assistant (Dietsch) related to your perceptions and experiences. What will happen if I take part in this research study? If you volunteer to participate in this study, the researcher will ask you to do the following: POSTPARTUM DEPRESSION 76 Commit approximately 45 90 minutes for the interview. Additional time of approximately 30 minutes will be required to confirm and clarify comments and interpretations following data analysis. The interview will be audio-recorded and transcribed verbatim (word for word) to assist the Research Assistant (Dietsch) in accurately analyzing the interview at a later date and to capture a more complete picture of what was said/discussed. The interview will not be video recorded. Only the Principal Investigator and Research Assistants will have access to the transcriptions and audio recordings. You will be provided with a copy of your personal interview, including codes, categories, and themes used to analyze the data. Additionally, if you would like a copy of the final results of the study, inform the Research Assistant (Dietsch), and it will be provided to you. How long will I be in the research study? Allow for up to 45 90 minutes for the interview. Additional time of approximately 30 minutes for a follow-up discussion may be required to confirm and clarify comments and interpretations following data analysis. Are there any potential risks or discomforts that I can expect from this study? Embarrassment, emotional or psychological distress. Interviews will be conducted in a non-judgmental manner with open-ended questions. You will have the right to take a break, to skip a question, to change the line of questioning, or to terminate the interviewall without penalty. Are there any potential benefits if I participate? There are no direct benefits to participants. The results of the research may provide clinicians with insight as to how PPD influences maternal healthcare choices while also offering these mothers an opportunity to express their experiences. This research may highlight communication opportunities with postpartum patients so that healthcare decision-making resources, assessments, and referrals can be tailored or designed with particular patient needs in mind. This research may also help improve healthcare outcomes for both new babies and new mothers by identifying barriers previously unknown. Will I be paid for participating? You will receive a $20.00 gift card as a thank you for participating. Will information about me and my participation be kept confidential? The results of this study may be published in a scholarly book or journal, presented at professional conferences, or used for teaching purposes. However, only aggregate data will be used. Personal identifiers will not be used in any publication, presentation, or teaching materials. POSTPARTUM DEPRESSION 77 Verbal informed consent will be obtained in lieu of a written signed informed consent. Once verbal consent is obtained, the interview will proceed. Interviews will be conducted in a private online virtual setting via Zoom or Google Meet or face-to-face. Private information will not be linked to your name and will only be requested in the minimum levels required to answer the research question. Raw interview transcripts and coded interviews, including demographic information and answers to interview questions and audio recordings, will be accessible only to Aimee Dietsch, Dr. Laura Santurri, Dr. Heidi Ewen, Dr. Lisa Borrero and Ryan Dietsch, LCPC. All data will be stored electronically using an encrypted transcription and a data analysis software application. The data will only be retrievable with the projects unique username and password. At the end of the study, electronic files will be deleted from the software application services. Data will be stored for three years and will be destroyed once the three-year post study has passed. Will the data from my study be used in the future for other studies? Your data will not be used or distributed for future research studies, even if there is no way for your data to be linked with any information that could identify you. What are my rights if I take part in this study? You can choose whether or not you want to be in this study, and you may withdraw your consent and discontinue participation at any time. Whatever decision you make, there will be no penalty to you and no loss of benefits to which you were otherwise entitled. You may refuse to answer any question/s that you do not want to answer and still remain in the study. Who can I contact if I have questions about this study? If you have any questions, comments, or concerns about the research, you can talk to one of the researchers. Please contact: Principal Investigator: Dr. Laura Santurri santurril@uindy.edu 800-232-8634 ext. 2409 Research Assistants: Aimee Dietsch, MA dietscha@uindy.edu 443-862-0351 Dr. Heidi Ewen ewenh@uindy.edu 800-232-8634 ext. 4425 Dr. Lisa Borrero borerrol@uindy.edu 800-232-8634 ext. 5944 Ryan Dietsch, LCPC rjd868@yahoo.com 443-537-3614 The Director of the Human Research Protections Program (HRPP): POSTPARTUM DEPRESSION 78 If you have questions about your rights as a research participant, or you have concerns or suggestions, and you want to talk to someone other than the researchers, you may contact the Director of the Human Research Protections Program by either emailing hrpp@uindy.edu or calling 800-232-8634 ext. 5774. POSTPARTUM DEPRESSION 79 Appendix B Screening Questions to Confirm Eligibility Inclusion and Exclusion Criteria: Do you speak and read English fluently? Yes_ No _ Do you have a history of substance abuse? Yes_ No _ Have you had a live birth within the last 12 months? Yes_ No_ Do you think you have postpartum depression (PPD), or have you been diagnosed with PPD? Yes_ No _ Demographic Questions Participant name: _______________________________________________________________ What is your race? ______________________________________________________________ What is your age? _______________________________________________________________ What is your educational background? ______________________________________________ POSTPARTUM DEPRESSION 80 Appendix C Interview Guide Thank you for volunteering to be interviewed as part of the study I am completing as a Doctor of Health Science student at the University of Indianapolis. This study involves exploring how mothers with postpartum depression perceive the experience of making healthcare decisions for their children during their first year of life. In this interview, I will ask you questions about your perceptions of having a postpartum depression (PPD) diagnosis and how having PPD influenced your new child's healthcare decisions. I will also be asking questions about how you perceived your ability to make routine vaccination decisions for your child during this time. The information you provide may help clinicians develop more tailored approaches for communicating specific healthcare information to new moms that will ultimately improve healthcare outcomes for children. The interview will last approximately 45-90 minutes. I will provide you with a copy of your interview transcript once completed and transcribed so that you have an opportunity to review and determine if more clarification or information is needed. Upon reviewing the transcript, I would like to schedule a follow-up call through Zoom or Google Meet to review any areas that you would like to discuss further or for your feedback based on my interpretation of your responses. The interview is confidential, and once the analysis has been completed, the results will be stored in a secure location for three years. All data and information collected for the study will be destroyed once the three-year post study has passed. You may ask any clarifying questions regarding the purpose of this interview and how the data will be used at any time. You may skip any question that makes you feel uncomfortable and can withdraw from participation at any time without consequence. If you have any questions after the interview, POSTPARTUM DEPRESSION 81 please feel free to reach out to me, as my contact information is also listed on the study information sheet. To ensure that I record your responses correctly, I will audio record the interview. Before I begin, Id like to re-confirm your consent to participate in the study. (once consent has been confirmed) Wonderful, thank you. (start the audio recorder) I have begun audio recording. Interview Questions 1. Tell me what it is like being a mom. a. What was life like prior to you becoming pregnant/a new parent? b. What kinds of support do moms need? c. What kinds of healthcare education and support do moms need? 2. What were your perceptions of PPD prior to being diagnosed? a. Have you ever suffered from depression? b. Have you ever been previously diagnosed with postpartum depression (PPD)? If yes, with what child were you diagnosed with PPD? c. Tell me your thoughts or feelings about having a postpartum depression diagnosis. d. Tell me about your experiences with navigating all of the new healthcare decisions (i.e., postpartum visits, well-baby visits, any routine vaccinations) prior to having a PPD diagnosis and with having PPD. e. Were any decisions more challenging than others? Any that were easier? Why is that? 3. What was it like for you to make healthcare decisions during this time in your life? POSTPARTUM DEPRESSION 82 a. How confident were you with your decision-making during this time? b. Was it easier or difficult to make healthcare decisions for yourself? Why? c. Was it easier or difficult to make healthcare decisions for your new child? Why? d. Can you elaborate on those feelings or experiences? 4. How did you go about making routine vaccination decisions during your childs first year of life? a. What decision-making resources were available to you during this time? b. Did you utilize those resources? c. Why or why not? 5. How have your perceptions of making healthcare decisions changed over time? a. Can you give examples of the changes? 6. What do you think moms who are newly diagnosed with PPD or undiagnosed would need to feel supported during this time? a. What do clinicians need to know? b. Is there anything clinicians can do better? 7. Is there anything you would do differently? The same? 8. Is there any advice that you would offer to mothers? 9. Is there anything additional that you could share with me that would help me understand your experience?  ...

... Floor to Stand Performance among Persons Following Stroke Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Angela F. Davis, PT, MHS Copyright December 2, 2020 By: Angela F. Davis, PT, MHS All rights reserved Approved by: Stephanie A. Miller, PT, PhD Committee Chair ______________________________ Dennis W. Klima, PT, PhD Committee Member ______________________________ Amanda Leonard, PT, DScPT Committee Member ______________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ 1 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Floor to Stand Performance among Persons Following Stroke Angela F. Davis1, Stephanie A. Miller2, Dennis W. Klima3, and Amanda Leonard4 1 Department of Interprofessional Health and Aging Studies, University of Indianapolis 2 Department of Interprofessional Health and Aging Studies, University of Indianapolis 3 Department of Physical Therapy, University of Maryland Eastern Shore 4 University of Maryland Rehabilitation & Orthopaedics Institute Author Note Stephanie A. Miller https://orcid.org/0000-0002-7810-186X We have no known conflict of interest to disclose. Correspondence concerning this document should be addressed to Angela F. Davis, University of Maryland Rehabilitation & Orthopaedics Institute, 2200 Kernan Drive, Baltimore, MD 21207, Email: angiept23@gmail.com 2 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Abstract Studies have examined floor to stand performance in varied adult populations both quantitatively and qualitatively. Despite an elevated risk of falls and inability to independently return to stand after a fall, few have examined the ability to perform floor to stand in patients recovering from stroke. The purposes of this study were to (1) identify relationships between floor to stand performance using the Timed Supine to Stand test (TSS) and physical performance measures of gait, balance and balance confidence, along with individual characteristics in persons in the subacute phase after stroke and (2) to analyze movement strategies used in the completion of the TSS. Fifty-eight adults [59.2 (13.9); 34 (58.6%) male] in the subacute phase after ischemic or hemorrhagic stroke who could stand from the floor with no more than supervision completed the TSS and physical performance assessments. The median time to complete the TSS in our sample was 13.0 (15.5) seconds. Fifty-five (94.8%) participants used an asymmetric roll strategy combined with intermediate positions to complete the TSS. TSS time was significantly correlated with physical performance tests including Timed Up and Go (TUG) test (r = .70, p < .01), gait velocity (r = -.67, p < .01), Dynamic Gait Index (r = -.52, p < .01), Activities-specific Balance Confidence scale (r = -.43, p < .01), and individual characteristics including days since stroke (r = .30, p < .05). Thirty-two percent of the variance in TSS time (p < .001) was attributed to TUG time and use of the quadruped position in the transition to stand. Findings serve to improve functional mobility assessment post stroke and to formulate effective treatment interventions to improve floor to stand performance after stroke. Keywords: timed supine to stand, physical performance, movement pattern 3 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Table of Contents List of Tables.. 5 Introduction.... 6 Research Questions.7 Literature Review.. 8 Stroke and Falls. 8 Floor Rise in Adult Populations.11 Floor Rise in Populations with Neurological Diagnoses17 Justification for the Study...... 19 Impact on the Field of Physical Therapy21 Methods..... 22 Study Design.. 22 Participants. 22 Data Collection...... 23 Instruments. 24 Procedures.. 27 Data Management and Analysis.32 Results 34 Discussion and Conclusion 37 Study Limitations44 Future Study46 Conclusion..47 4 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE References....49 Table 1..59 Table 2..60 Table 3..61 Table 4..62 Table 5..63 Appendix 1: Data Collection Form..66 Appendix 2: Dynamic Gait Index.. .67 Appendix 3: Activities-specific Balance Confidence Scale....72 Appendix 4: Fugl-Meyer Assessment of Motor Recovery after Stroke..74 Appendix 5: Informed Consent Document.76 Appendix 6: IRB Documents. .78 5 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE List of Tables Table 1: Participant Sociodemographic and Physical Performance Characteristics Table 2: Physical Performance Measures Table 3: Bivariate Correlations with Timed Supine to Stand Performance Table 4: Predictive Determinants of the Timed Supine to Stand Test Table 5: Movement Pattern Analysis during the Timed Supine to Stand Test 6 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Floor to Stand Performance among Persons Following Stroke Stroke, also known as cerebral vascular accident (CVA), is the leading cause of longterm disability, with 800,000 persons experiencing stroke each year in the United States (Benjamin et al., 2018). Falling is one of the most common complications after stroke, and occurs in all phases of recovery. It has been reported that 14-65% of those diagnosed with stroke fall at least once during their hospitalization, and 37-73% fall during the first six months after being discharged home (Batchelor, et al., , 2012). The first two months after discharge home from rehabilitation have been identified as a critical time for falls, with over 50% of falls occurring during this period (Mackintosh, et al., 2005). In addition, 30% of patients with both minor cognitive impairment and moderate-to-high levels of mobility reported at least one fall in the 12 weeks post-discharge from rehabilitation (Van der Kooi et al., 2017). Tilson et al. (2012) reported that while the primary goal of rehabilitation after stroke is to improve mobility in the presence of motor, balance, and visual-spatial deficits, fall risk can be an adverse consequence. Many stroke survivors who experience a fall are unable to stand from the floor unassisted (Mackintosh et al., 2005; Tilson et al., 2012). Inability to stand from the floor after a fall is defined as a critical fall (Bloch, 2012); moreover, critical falls are associated with higher rates of mortality (Brito et al., 2012). The ability to rise from the floor is a significant contributor to physical independence throughout the lifespan (Vansant, 1988). Studies on strategies used to stand from the floor, time required to stand, and their correlation with other physical performance measures have been studied in healthy adult populations (Alexander, et al., 1997; Bergland & Laake, 2005; Bohannon & Lusardi, 2004; Klima et al., 2016; Moffett, et al., 2020; Ulbrich, et al., 2000; Vansant, 1998;). Results from these studies demonstrated variations in strategies used, increased time required for task completion, and an inability to complete the task 7 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE in the presence of advanced age and physical impairments. Similar challenges with the task of standing from the floor have been reported in patients with neurological conditions including use of less advanced movement strategies and increased time for completion (Belt et al., 2001; Boswell, et al., 1993; Ng et al., 2015; Unrau, et al., 1994). Despite the elevated risk for falls post-stroke, concomitant reported difficulty in standing from the floor, and potential for critical falls, little research has examined the ability to stand from the floor in this population. Ng et al. (2015) demonstrated reliability and validity of the floor transfer test for use with patients with chronic stroke, and demonstrated a correlation between this test and other physical performance measures. Movement strategies used to complete standing from the floor after stroke have not been identified or compared to healthy adult populations. Therefore, the purpose of this study is to explore the relationship of the ability to stand from the floor with other physical performance measures and to identify floor rise strategies in the early subacute phase of stroke prior to discharge from acute rehabilitation. The research questions are twofold. 1. Is the ability to stand from the floor as measured by the timed supine to stand test related to functional performance (gait performance and balance confidence), as well as individual characteristics (age, gender, body mass index) in persons in the subacute phase of stroke? 2. What are the strategies used to complete the timed supine to stand test by individuals in the early subacute phase of stroke recovery? Establishing correlations with other standard of care physical performance measures will serve to concurrently validate the timed supine to stand test in persons with stroke and better allow physical therapists to identify patients with deficits in the ability to stand from the floor. 8 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Identifying strategies used and the time required for task completion will assist physical therapists to better prepare patients to independently stand from the floor should a fall occur. Literature Review Stroke, or cerebrovascular accident (CVA) is the leading cause of long-term disability in the United States (U.S.), with 800,000 people experiencing stroke each year (Benjamin et al., 2018). While the number of deaths because of stroke has declined since 2005, there are nearly 92.1 million adults living in the U.S. with cardiovascular disease or after-effects of stroke (Benjamin et al., 2018). The associated health care and lost productivity exceeds $329.7 billion annually in the U.S. (Benjamin et al., 2018). Stroke and Falls The primary goal of post-stroke rehabilitation is to improve mobility given motor, balance and visual-spatial deficits. Tilson et al. (2012) warned that working toward this goal may increase the risk for falls. Falls are one of the most common complications after stroke. The fall rate is higher after stroke than in the general population of community dwelling adults at 20-57% versus 15%, respectively (Batchelor, et al., 2012). Falls are reported at all levels of recovery after stroke. Great variability and wide ranges of fall rates exist among studies reporting falls incidence post-stroke (Van der Kooi et al., 2017). For example, during hospitalization, 14-65% of people with stroke fall at least once (Batchelor et al., 2012). In the first six months after discharge from rehabilitation, 37-73% reported falls (Batchelor et al., 2012; Lim, et al., 2012). In patients at least one year after stroke, the fall rate has been reported to be 36% compared to 24% in age and gender-matched controls (Mackintosh, et al., 2005). Even 10 years following stroke, the fall rate has been reported as twice that of age and gender-matched controls, with the rate of recurrent falls also higher (Jorgensen, et al., 2002). The variability in reported incidence of falls 9 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE post-stroke is thought to be related to unclear definition of a fall episode, decreased accuracy of retrospective fall reporting, variability of patient groups studied, variation in the time period in which falls were studied and variation in applied treatment protocols (Van der Kooi et al., 2017). Among all the time periods studied regarding falls post-stroke, the most critical period appears to be in the transition from the inpatient setting to the community. Van der Kooi et al. (2017) reported a 28% fall rate in patients after stroke in the 12 weeks after discharge from inpatient rehabilitation. Lim et al. (2012) reported a single fall rate of 19% and a repeated fall rate of 29% in patients after stroke within an average of 20 months after discharge from the inpatient setting. One or more falls during this time have correlated negatively with improvements in self-reported functional status as measured by the Stroke Impact Scale-16 in participants with minor cognitive deficits and moderate to high mobility scores (Van der Kooi et al., 2017) and fear of falling prevalence in participants who were ambulatory (Lim et al., 2012). Patients after stroke are at increased risk for falls when walking or performing activities of daily living (ADL) due to the presence of stroke-related deficits including hemiparesis or hemiplegia, abnormal movement patterns, altered muscle tone, sensory changes, visual impairment, cognitive effects, emotional impact, impaired balance, and fatigue (Kelley et al., 2010). The consequences of falls impact both stroke survivors and their caregivers; moreover, many negative effects have been reported in the literature. The immediate effect could be serious injury (Kelley et al., 2010). Additionally, the stroke survivor may limit activity and participation and increase dependence on caregivers for assist in mobility and ADL tasks (Schmid & Rittman, 2009). This may increase the economic burden of informal caregiving (Joo, et al., 2017). Finally, falls can lead to increased fear of falling for both the stroke survivor and the caregiver (Kelley et 10 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE al., 2010; Schmid & Rittman, 2009), which may result in further self or caregiver-imposed limitations on activity and participation. Another concern is the issue of the critical fall. A critical fall is defined as a fall with the inability to retain upright posture, whatever the reason (Bloch, 2012). A critical fall results in increased periods of time spent on the floor, which is associated with increased mortality. Bloch (2012) reported that a critical fall nearly doubles the risk of death due to complications including the development of pressure ulcers, dehydration, hypothermia, rhabdomyolysis or renal failure. Brito et al. (2014) demonstrated support of this point with association between increased difficulty rising from the floor and higher rates of all-cause mortality among healthy older adults. This concept of the critical fall applies to patients after stroke, as many experience difficulties in rising from the floor or inability to rise from the floor unassisted after a fall. Less than half of individuals with stroke surveyed reported the ability to get up from the floor after a non-injurious fall (Tinetti, et al., 1993). This finding has been supported by more recent studies in which researchers reported on the incidence of assistance needed in getting up from the floor in patients with stroke. Mackintosh et al. (2005) reported 38% of their participants post stroke participating in a rehabilitation program and returning to live in the community needed assistance to get up after a fall in the six months after discharge from rehabilitation. In their summary article, Batchelor et al. (2012) reported 20-30% of people with stroke are unable to get up from the floor unaided after a fall. Furthermore, of the participants with stroke who participated in the Locomotor Experience Applied Post-stroke (LEAPS) trial and experienced a fall or multiple falls in the two to twelve months after stroke, 74% experienced a fall from which they could not rise independently (Tilson et al., 2012). 11 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Floor Rise in Adult Populations The ability of individuals to rise from the floor has been studied across the lifespan with healthy individuals and those with physical impairment. Previous studies have examined movement strategies and timed performance for rising from the floor, as well as psychometrics and correlation of floor rise tests with other physical performance measures. There are three methods cited in the literature for analysis of movement strategies used to rise from the floor in select adult populations. Each method has added information to the pool of literature regarding movement strategies used to complete floor rise and variations in patterns used based on the parameters, correlates or diagnoses studied. The most widely adapted method of analysis of floor rise movement strategies is that of VanSant (1988). In a seminal study, VanSant (1988) described the component method of movement analysis for supine to stand in healthy young adults. The movement patterns where divided into three sections including the upper extremity, axial and the lower extremity to allow analysis at each component. Analysis of 32 participants resulted in identification of five categories of upper extremity action, four categories of lower extremity action and four categories of axial movement (VanSant, 1988). Higher frequencies of movements observed were considered more advanced movement patterns. The most advanced movement strategies identified were symmetrical push (46%) in the upper extremity, an asymmetrical squat (40.9%) in the lower extremity and symmetrical movement of the head and trunk (46.2%) for the axial component (VanSant, 1988). Twenty-one different combinations of component action across the 320 trials completed by the 32 young adult participants were identified (VanSant, 1988). This seminal work introduced the idea of variations in movement patterns both within and between participants used for rising from supine on the floor to standing (VanSant, 1988). 12 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE The method of movement analysis described by VanSant (1988) has been used in multiple studies to both examine movement patterns used in select adult populations and to identify further variations and contributors to this task (Alexander et al., 1997; Green & Williams, 1992; King & VanSant, 1995; Ulbrich et al., 2000). First, a moderate (once or twice per week) to high (daily) level of physical activity in 72 young adults age 30-39 years was noted to lead to more advanced, symmetrical movement pattern selection for standing from the floor compared to those with no or rare physical activity (Green & Williams, 1992). Furthermore, the presence of a solid ankle-foot orthosis (SAFO) in 39 young, healthy adults age 20-28 years changed the choice of movement pattern used to stand from the floor from a symmetrical pattern when no SAFO was used, to less advanced asymmetrical patterns in the upper extremity, axial and lower extremity components when either a unilateral or bilateral SAFO was present (King & VanSant, 1995). Finally, the presence of older age and physical impairment were noted to impact the selection of movement strategy to stand from the floor, the time needed and the use of intermediate positions. (Alexander et al. 1997; Ulbrich et al., 2000). Specifically, Alexander et al. (1997) reported that healthy older adults required 2.4-5.5 seconds to rise from the floor compared to healthy young adults that required 1.4-2.6 seconds, and older adult women with physical impairment who could complete the tasks required 6.4-13.2 seconds for task completion. Additionally, older adults with physical impairment more commonly required a modified starting position such as side-lying and external support such as a table to rise from the floor and reported increased difficulty in task completion due to reports of pain, weakness, and/or balance impairments (Alexander et al., 1997). Fifteen percent of older adults with a mean age of 81 years, with physical impairment were unable to complete the rising from the floor task with any type of modification or support in this study population (Alexander et al., 1997). 13 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Ulbrich et al. (2000) further examined this older adult population with physical impairment regarding movement strategies selected and time. They reported a hierarchy of performance within these parameters with healthy young adults completing the floor rise task in the least amount of time using the most advanced symmetric strategies and least amount of intermediate positions or supports (Ulrich et al., 2000). Older adults with physical impairment required the most time, selected the least advanced and most asymmetric movement strategies and used the highest number of intermediate positions (Ulrich et al., 2000). Healthy older adults fell in the middle of these groups for time and use of intermediate positions or supports (Ulbrich et al., 2000). The sitting-rising test (SRT) is another method for movement analysis of the floor rise task (Brito et al., 2012). Using this method, the investigators scored participant ability to rise from the floor from zero to five, with one point subtracted for each support used for both the standing to sitting and sitting to stand task, half of a point subtracted for evaluators perception of instability, with a total score of 0 to 10 reported. This method varied from VanSants method since it did not have the participants move fully from supine to stand and did not use component analysis of the upper body, trunk and lower body (Brito et al., 2012). This method focused on intermediate positions described by Ulbrich et al. (2000). Using this method, Brito et al. (2012) demonstrated the impact flexibility can have on the task of rising from the floor with lower SRT scores reported for participants with lower levels of flexibility. Brito et al. (2014) later used this strategy to associate the ability of adults to rise from the floor with all-cause mortality. The authors reported that lower SRT scores were associated with higher mortality and that each unit increase in SRT score was associated with a 21% improvement in survival over an average of six years (Brito el al., 2014). 14 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE The final method found in the literature for description of floor rise was utilized by Schwickert et al. (2016) to compare movement strategies used by younger adults to that of older healthy adults. The investigators completed video analysis of recorded performance of the floor rise task for each participant to identify shared movement strategies and intermediate positions (Schwickert et al., 2016). They identified seven components of the task including lying, initiation, positioning, supporting, elevation, stabilization, standing, and walking (Schwickert et al., 2016). The investigators subsequently observed the components used and sequence of components comparing younger subjects to older subjects in the task of supine lying to standing or walking (Schwickert et al., 2016). The younger adult group moved through the seven components of the task without use of stabilization, taking only six steps to complete the task (Schwickert et al., 2016). The older adult group utilized the same seven components but used multiple additional steps of supporting and positioning (intermediate positions) between the phases of initiation and elevation, and between their first and second attempts at elevation, resulting in a total of 20 steps to complete the task (Schwickert et al., 2016). Additional differences between the groups identified lower extremity power and flexibility as possible contributors to floor rise ability and pattern used in addition to age, similar to findings previously reported by Alexander et al. (1997) and Brito et al. (2012). In addition to further analysis of movement strategies used by adults, quantitative floor rise ability has been studied with regard to psychometrics of such assessment, including correlation with other measures of physical performance in healthy adults aged 50-90 years (Bohannon & Lusardi, 2004) and with older adults over age 60 years (Klima et al., 2016). Bohannon and Lusardi (2004) utilized VanSants method of movement analysis to identify strategies used to stand from the floor and identified relationships between time to rise from the 15 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE floor and age (r = .39, p < .005), lower body strength using five times sit to stand time (r = .64, p < .001) and balance using single leg stance time (r = -.36 and r = -.42, p < .005). Klima et al. (2016) also found similar movement patterns to those identified by VanSant using the component method of movement analysis but reported higher use of asymmetric movement patterns in the older adult population. Klima et al. (2016) also correlated the Timed Supine to Stand test (TSS) that measures time needed to rise from supine on the floor to stand, with age (r = .57, p < .001) gait speed (r = -.61, p < .001), grip strength (r = -.30, p < .05), the Timed Up and Go test (TUG) (r = .71, p < .001) and the Activities-Specific Balance Confidence (ABC) scale (r = -.51, p < .05) . The authors identified the TUG as the most significant predictor of variance (48%) in TSS time (Klima et al., 2016). One significant difference between these studies was the speed with which participants were encouraged to rise from the floor. Bohannon and Lusardi (2004) instructed participants to rise as quickly as possible (p. 235), while Klima et al. (2016) instructed participants to stand up at their own speed comfortably following the go command (p. 208). Additional methods of floor rise assessment have been studied to determine psychometrics, including correlation to other physical performance measures, without movement analysis (Bergland & Laake, 2005; Ardali et al., 2019; Ardali et al., 2020; Moffett et al., 2020). Study populations have included healthy women over age 75 years (Bergland & Laake, 2005), community dwelling older adults aged 65-96 years (Ardali et al., 2019; Ardali et al., 2020) and community dwelling women over age 55 (Moffett et al., 2020). Bergland and Laake (2005) used the floor transfer (FT) test in which participants were asked to transfer from standing to supine on the floor and back to standing without support and in their own time. The authors reported the ability to rise from the floor using this method to be correlated with ability to climb steps higher 16 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE than 20 cm (r = .79, p < .001), TUG (r = .72, p < .001) and walking outdoors (r = .67, p < .001) (Bergland & Laake, 2005). Ardali et al. (2019) used the FT test as well, but with a video shown to participants before performance that demonstrated safe performance of the task. Additionally, if participants were unable to complete this task without support, they were tested again under modified conditions that allowed the use of a standard armchair without armrests after watching a second video that demonstrated this task (Ardali et al., 2019). Results of the FT test were correlated with the Self-reported FT Ability Questionnaire (r = .926, 95% CI .869 - .980), Physical Functioning Subscale (r = .879, 95% CI .79 - .932), Phenotype of Physical Frailty Scale (r = .860, 95% CI .758 - .921) and the Short Physical Performance Battery (r = .876, 95% CI .785 - .930), indicating support of the floor transfer test in screening for physical disability, frailty and functional mobility among community dwelling older adults (Ardali et al., 2019). Furthermore, Ardali et al. (2020) went on to demonstrate parallel reliability between the Selfreported FT ability and FT test of .92, 95% CI (.88 - .97). In the most recent study of floor rise assessment, Moffett et al. (2020), utilized yet another method of assessment termed the Timed Up from Floor Test (TUFF). The TUFF test required participants to rise from supine on the floor to a steady standing position using any method they chose as quickly as they were safely able (Moffett et al., 2020). While a chair was placed nearby for support if needed, participants were excluded if they utilized the chair for assistance (Moffett et al., 2020). Results of the TUFF test were correlated with the Short Form-36 Physical Functioning Scale (r = -.69, P < .001), usual gait speed (r = -.48, P < .001), fast gait speed (r = -.74, P < .001) and the 30-second sit to stand test (r = -.46, P < .001) (Moffett et al., 2020). 17 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Floor Rise in Populations with Neurological Diagnoses Additional studies (Belt et al., 2001; Boswell, et al., 1993; Unrau, et al., 1994) investigated whether the component movement analysis described by VanSant can be applied to individuals with neurological diagnoses known to have difficulty in rising from the floor, and whether patterns used are similar to healthy participants. Boswell et al. (1993) applied these research questions to children age 4 to 7 years with spastic cerebral palsy by comparing the movement patterns of their participants to those described by VanSant (1988) with a healthy pediatric population of the same age. The authors concluded that VanSants categories of movement established for healthy children could be used to classify movement patterns of children with cerebral palsy, albeit with some modification (Boswell et al., 1993). Children with cerebral palsy were reported to use more variability of movement, more repetition within steps, more segmented movement and more asymmetric movement patterns (Boswell et al., 1993). Unrau et al. (1994) applied VanSants movement descriptions for supine to stand over ten trials with fifteen adults with Down syndrome (DS), age 22-65 years. Across the 150 trials observed, 64% of the upper extremity movements, 14.6% of the axial movements and 33.8% of the lower extremity movements observed had not previously been described by VanSant (Unrau et al., 1994). Of the movement patterns observed in each component that had been previously described by VanSant, adults with DS demonstrated less developmentally advanced, asymmetric movements with more interruptions in the task and separation of the task into stages of flexing and moving to sitting, repositioning transitional movement, side-sitting to kneeling with upper extremity support and rising to standing (Unrau et al., 1994). Belt et al. (2001) used VanSants model of movement analysis as well with a small sample of nine participants with Prader-Willi syndrome (PWS) age 7 to 36 years and compared 18 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE them to nine participants who served as age and gender matched controls. These authors were able to apply this movement analysis strategy to this patient population with minor modifications. Participants with PWS required an average of 5.4 seconds to stand from the floor compared to 2.86 seconds in age and gender matched controls (Belt et al., 2001). Additionally, those with PWS used less developmentally advanced patterns in upper extremity, lower extremity and axial components (Belt et al., 2001). Notable differences included use of more intermediate positions with four-point arm and leg contact with the floor during rising, use of arms against the legs to assist with coming to stand, increased trunk rotation and less within subject variability (Belt et al., 2001). Limited data exist regarding floor rise in patients with stroke. Bohannon and colleagues (1995) performed a retrospective chart review of 52 patients age 36-88 years, with a median time from stroke to initial assessment of 10 days and a median length of stay in an acute rehabilitation unit of 17 days. Data were collected over a 15-month period using admission and discharge Functional Independence Measure (FIM) scores for chair to mat transfers that were also applied to floor to stand transfers (Bohannon, et al., 1995). No movement analysis was included in the study. Participants showed improvement in floor to stand transfers during their acute rehabilitation stay, with improved median FIM scores from one (dependent) to four (minimal assistance) (Bohannon et al., 1995). Floor to stand ability was correlated with chair to mat transfer ability and length of stay, but not with gender or age. The authors concluded that improvements could be made in floor to stand ability with patients whom had suffered a stroke but pointed out that improvements in this skill lagged behind improvements noted in chair to mat transfers, which improved to a median FIM score of six (modified independence) (Bohannon et al., 1995). Unfortunately, one limitation of the study included incomplete documentation that 19 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE limited the ability to identify factors that predict floor to stand ability or provide reasoning for the continued need for assistance in floor to stand transfers at discharge (Bohannon et al., 1995). More recently, Ng et al. (2015) applied the Timed Floor Transfer Test (FTT) to assess floor rise ability in 47 people with chronic stroke, without movement analysis. During the Timed Floor Transfer Test, participants moved from standing to sitting on the floor and back to standing with a chair nearby for support if needed, and at their preferred speed (Ng et al., 2015). The mean completion time for the FTT in patients with chronic stroke was 20.9 seconds. The FTT demonstrated excellent intra-rater reliability with ICC of 0.855 0.895, 95% CI (0.777 0.940), excellent inter-rater reliability with ICC of 1.000, 95% CI (1.000 1.000) and excellent testretest reliability with ICC of 0.954, 95% CI (0.878 0.979) (Ng et al., 2015). The minimal detectable change (MDC) of FTT completion times was 7.7 seconds (Ng et al., 2015). The FTT correlated significantly with the Fugl-Meyer Assessment for the lower extremities (r = -0.419, p < 0.001), 5-times sit to stand test (r = 0.650, p < 0.0001), Berg Balance Scale (r = -0.69, p < 0.0001) and TUG (r = 0.705, p < 0.0001), but not with the Activities-Specific Balance Confidence Scale (r = -0.31, p 0.061) (Ng et al., 2015). Furthermore, an FTT completion time of 8.75 seconds differentiated the elderly adult participants from participants with stroke (Ng et al., 2015). Similar to findings of Klima et al. (2016), the TUG was the most significant correlate with quantitative floor rise ability. Justification for the Study Studies examining falls in patients after stroke have demonstrated a significantly increased risk for falls and an increased likelihood of inability to rise from the floor in this population. Patients after stroke have many of the factors known to correlate to increased difficulty in rising from the floor established in the literature including more advanced age 20 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE (Alexander et al., 1997; Schwickert et al., 2016); increased physical impairment (Alexander et al., 1997; Ulbrich et al., 2000); lower physical activity level (Green & Williams, 1992); presence of an AFO (King &VanSant, 1995); decreased flexibility (Brito et al., 2012; Schwickert et al., 2016); decreased lower extremity strength and balance (Bohannon & Lusardi, 2004); and slower gait speed, increased time needed for the TUG test and lower balance confidence (Klima et al., 2016). However, these correlations and predictors of variance in performance have not been established specifically in persons following stroke, except for a small sample of adults with chronic stroke as studied by Ng et al. (2015). It is not clear whether these relationships exist with persons with stroke at varied levels of recovery due to limited investigations in the literature to date. This knowledge in patients with stroke could assist therapists in predicting which patients may have difficulty with the floor rise task placing them a higher risk for a critical fall, and thus better direct interventions, education and training for these individuals during rehabilitation. Additionally, significant research has been performed analyzing the adults ability to rise from the floor regarding completion time and movement patterns utilized. This research has been applied to children and adults with neurological diagnoses such as cerebral palsy (Boswell et al., 1993), Down syndrome (Unrau et al., 1994) and Prader-Willi syndrome (Belt et al., 2001), but has not been completed in patients after stroke. Such research was called for by Bohannon et al. (1995) after their retrospective chart review revealed improvements in floor rise ability during acute rehabilitation. They noted an absence of specific information available to clinicians to assist in guided instruction of the floor rise task and called for future research to include descriptions of this task in patients with stroke who can successfully rise from the floor (Bohannon et al., 1995). Hofmeyer et al. (2002) demonstrated benefits of a short-term, strategybased intervention to improve floor rise ability in older adults at risk for falls, indicating specific 21 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE training could be beneficial. Perhaps this intervention could improve floor rise ability in patients after stroke once common movement patterns are more fully understood to afford focused instruction. Additionally, more than 80% of therapists surveyed did not report that they teach older patients with instability and tendency to fall how to get up from the floor (Simpson & Salkin, 1993). Perhaps increased knowledge of specific movement patterns used would increase the number of therapists willing to instruct patients post stroke in techniques to get up from the floor to better prepare their patients. Impact on the Field of Physical Therapy Understanding how the ability to rise from the floor is associated with other physical performance measures used as standard of care in patients after stroke supports the concurrent validity of the timed supine to stand test. Use of the timed supine to stand test in practice with patients after stroke may allow a more complete picture of the functional capacity of this patient population, allow more consistent goal setting in this area and increase use of interventions directed at improving this task. Examining strong correlations between floor rise and other physical performance measures affords an understanding of those variables linked to floor rise ability. This may assist physical therapists in prioritizing treatment interventions associated with floor to stand performance such as lower body strength, balance training, gait training or functional task practice. Identification of strategies used to rise from the floor in patients after stroke may assist physical therapists by providing more specific information in possible ways to train the floor rise task using guided, strategy-based functional training. Perhaps this would increase the confidence of physical therapists in getting their patients with stroke onto the floor for this specific training. 22 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE An increase in this training may reduce the risk of an inability to rise from the floor after a fall and thereby reduce the associated risk of prolonged time spent on the floor including increased mortality. Method Study Design This study was a non-experimental correlational study using a cross-sectional design that examined the timed supine to stand test performance among persons in the early subacute phase of stroke. The study took place on the inpatient stroke rehabilitation unit of an acute rehabilitation facility within a larger university-based medical system in Baltimore, Maryland. Data were collected from July of 2019 until June of 2020. Prior to data collection, this study was approved by the Institutional Review Board of the University of Maryland Eastern Shore, with a reciprocal agreement with the University of Indianapolis, and approval from the research medical executive committee of the University of Maryland Rehabilitation and Orthopaedic Institute. Participants A convenience sample of adult patients admitted to the inpatient stroke rehabilitation unit of an acute rehabilitation facility after ischemic or hemorrhagic stroke were recruited for the study. Inclusion criteria consisted of: 1) diagnosis of ischemic or hemorrhagic cerebrovascular accident (stroke); 2) age 18 or older and 3) able to stand from the floor unassisted or with supervision. This study excluded individuals who 1) had experienced cerebellar stroke, 2) had language or cognitive deficits that precluded understanding of the study and provision of consent as recommended by the treatment team, 3) had any health conditions that prevented participation in the physical performance measures in this study including standing from the floor, and 4) 23 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE persons with previous diagnosis of a chronic progressive or non-progressive neurologic condition such as Multiple Sclerosis, Parkinsons disease, Amyotrophic Lateral Sclerosis, spinal cord injury or previous stroke. Sample size An a priori power analysis was performed to determine the requisite sample size for the multiple regression analysis using the PASS 15.0.3 statistical program (Gastonis & Sampson, 1989). A minimum sample size of 52 participants was required to achieve 80% power to detect an effect size (f2) of 0.20 for two independent variables using an F test with significance level of .05. To account for the possibility that non-parametric test would need to be used, the sample size was increased by 10%, to a goal of 57. The final sample after data collection was 58. Data Collection Data were collected by the primary researcher (A. D.) using a data collection form. Once completed, data were then entered into an Excel spreadsheet. All information collected for the study was congruent with physical therapy standard care provided by the inpatient rehabilitation staff regardless of this research initiative. The following data were obtained from the electronic medical record: age, body mass index, and details regarding the categorical type, lesion location and onset of stroke for each participant. The following outcome measures were collected by the primary researcher one to three days prior to discharge to home from the inpatient stroke unit: 10-meter walk test (10 MWT), Timed Up and Go (TUG) test, Activities-specific Balance Confidence (ABC) scale, Dynamic Gait Index (DGI), timed supine to stand test (TSS) and specific subsections of the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA). Subsections of the FMA for the upper extremity included reflexes (I), flexor synergy (II), extensor synergy (III), movement combining synergies (IV), movement out of synergy (V), 24 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE normal reflex activity (VI), the wrist (VII), mass flexion and extension of the hand (VIII) and coordination/speed (IX). Subsections of the FMA for the lower extremity included reflex activity (I), flexor synergy (II), extensor synergy (III), movement combining synergies (IV), movement out of synergy (V), normal reflexes (VI) and coordination/speed (VII). Operationalization of variables For this study functional performance was operationalized by using scores from activitybased measures including the 10 MWT, TUG, DGI and TSS. Motor impairment of the upper and lower extremities at the body structure and functions level were operationalized using the FMA. Balance confidence was operationalized by using the ABC scale. Gait tests (10 MWT and TUG) and the TSS test were performed at participants self-selected speed. Strategy to stand from the floor was defined as the movement pattern used by participants to complete the TSS. Instruments Timed supine to stand test The TSS is a publicly available tool to assess a persons ability to transition from a supine position to stand position and measures the time required to rise to stand. The TSS demonstrates excellent test-retest reliability (intraclass correlation coefficient [ICC] = .94) when used with older adults for time to complete supine to stand, (Klima et al., 2016). The TSS used with other physical performance measures in older adults has been reported as a method to depict the functional profile by Klima et al. (2016). Significant correlations were found with age (r = .57, p < .001), gait velocity (r = -.61, p < .05), balance confidence using the ABC scale (r = -.51, p < .05), and the TUG test (r = .71, p < .001). 25 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 10-meter walk test The 10 MWT is a publicly available tool to assess physical function using self-selected and maximal walking speeds calculated in meters per second. Gait speed is supported as a valid, reliable and sensitive measure for the assessment of functional status in a wide range of populations, including stroke (Middleton et al., 2015), and has been termed a critical vital sign (Fritz & Lusardi, 2009). Fulk and Echtermach (2008) reported appropriate test-retest reliability in patients participating in rehabilitation after stroke, ICC = .86 for all subjects combined; ICC = .97 for those who required physical assistance to walk; ICC = .80 for those able to walk without physical assistance. Correlations were identified between gait speed and ADL, r = -.76 (Maeda et al., 2000); the Dynamic Gait Index, r = -.68 in the first week of therapy and r = -.87 two months after therapy, p < .001 (Lin et al., 2010); and the TUG test, ICC = -.84 at preferred gait speed and ICC = -.91 at fast gait speed (Lin et al., 2010). Timed Up and Go test The TUG test is a publicly available tool that was used to assess participants functional gait mobility. While the TUG was originally designed to detect fall risk in the frail elderly (Podsiadlo & Richardson, 1991), it has been extensively used and validated in patients with stroke. Test-retest reliability has been reported as excellent in patients with chronic stroke with ICC = .95 .97 (Flansbjer et al., 2005; Hiengkaew et al., 2012; Ng & Hui-Chan, 2005). The TUG also has demonstrated an association with gait speed in patients with stroke, r = -.90, p < .010 (Ng & Hui-Chan, 2005). Additionally, the TUG had the greatest correlation with ability to rise from the floor in community dwelling older adults, r = .71, p < .001 (Klima et al., 2016). 26 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Activities-specific Balance Confidence scale The ABC scale is a publicly available, 16-item self-report measure of balance confidence while performing various activities in the home or community (Powell & Meyers, 1995). Each item is rated on a 0 to 100% rating scale, where 100% indicates higher balance confidence. The ABC scale has demonstrated excellent test-retest reliability, ICC = 0.85, 95% CI [.68, .93], for the total test (Botner et al., 2005) and excellent internal consistency, Cronbachs alpha = .94 (Salbach et al., 2006) among individuals with stroke. Correlations with the ABC tool have also been established among persons with stroke with respect to maximal gait speed, rs = .43, 95% CI [.18, .63]; preferred gait speed. rs = .42, 95% CI [.16, .62]; TUG test, rs = -.34, 95% CI [-.07, .56] (Salbach et al., 2006) and the Dynamic Gait Index. r = .68 (Jonsdottir & Cattaneo, 2007). Dynamic Gait Index The DGI is a publicly available gait tool that includes eight items designed to assess the participants ability to modify their gait with added task demands including varying gait speeds, multidirectional head turns, turning, stepping over and negotiating around obstacles and stair climbing. Each item is scored on an ordinal scale of zero (poor) to three (excellent), for a possible total of 24 points. While the DGI was originally designed to predict falls in the older adult population (Shumway-Cook et al., 1997), metric support has been extrapolated for individuals with stroke. Lin et al. (2010) reported excellent test-retest reliability (ICC = .94) among persons with acute and chronic stroke. Similar findings were reported by Jonsdottir and Catteneo (2007) with excellent test-retest reliability of the DGI among persons with chronic stroke (ICC = .97). Lin et al. (2010) reported excellent construct validity of the DGI with the 10 MWT at various points during stroke recovery (r = -.68 during first week of physical therapy; r = 27 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE -.87 two months after physical therapy; r = -.83 five months after physical therapy). Additionally, the DGI has a robust correlation (r = .68) with the ABC scale (Lin et al., 2010). Fugl-Meyer Assessment of Motor Recovery after Stroke The FMA is a widely used, publicly available quantitative measure of motor impairment following stroke (Gladstone et al., 2002). Items included are scored on an ordinal scale of zero (cannot perform) to two (performs fully) for total possible maximum of 226 points (Fugl-Meyer et al., 1975). Instrument domains include motor function of the upper and lower extremity, sensory function, balance, joint range of motion and joint pain (Fugl-Meyer et al., 1975). Only the domain of motor function of the upper and lower extremities were included in this study. Psychometric support has been established for the FMA in varied populations including a general rehabilitation sample, acute stroke and chronic stroke. Platz et al. (2005) reported excellent test-retest reliability in a general rehabilitation sample including 37 individuals with stroke (ICC = .97 for motor scores, ICC = .81 for sensation scores, and ICC = .95 for passive joint motion). Excellent internal consistency across administrations of the FMA at 14, 30, 90and 180-days post-stroke has been reported, Cronbachs alpha = .94 .98 (Lin et al., 2004). Correlation of the FMA with gait speed is moderate, r = .61, at comfortable and maximal gait speeds (Nadeau at al., 1999) and moderate with Functional Independence Measure (FIM), r = .63 (Shelton et al., 2000). Procedures Screening Prior to the initiation of the study, physical therapists and physicians on the inpatient units where the patients with stroke could be admitted (including the stroke, brain injury and 28 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE complex medical units) participated in an educational session where the purpose, research questions, inclusion criteria, exclusion criteria, and procedures were disseminated. Potential participants were identified and screened using the established inclusion and exclusion criteria by their primary physical therapist on the treating inpatient unit or attending physician working with the patient as part of their interdisciplinary treatment team. Individuals who initially met the established criteria and were willing to learn more about the study were referred to the primary researcher via phone call or email to provide the name of the potential participant. Recruitment For those who met established criteria, the primary researcher met with the potential participant on the inpatient unit, at bedside, or in a private area of the physical therapy gym, and introduced and described the study and answered questions. After this meeting, if the participant was interested in study participation, the formal informed consent process was then completed or scheduled over the following two days. Informed consent All participants who met the established criteria met with the primary researcher to provide informed consent. This meeting occurred at the participants bedside or a private area on the unit prior to the onset of formal testing. Information reviewed during the informed consent process included the purpose of the study, research questions, possible risks and benefits, study procedure including all testing and data collection from the electronic medical record, participant rights including freedom to discontinue participation, methods for privacy and confidentiality and contact information of appropriate individuals to address questions or concerns as needed. 29 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Participants were provided the opportunity to ask questions during this meeting and afforded the opportunity to further consider their participation as needed prior to signing informed consent. Data collection The primary researcher established preliminary reliability on physical performance measures including the TUG, 10 MWT, TSS, DGI and FMA to ensure testing accuracy. Testing to establish reliability was completed with five persons after stroke on the outpatient unit. Each test was scored by the primary researcher when performed and was simultaneously video recorded. After two to three days the primary researcher re-scored each test using the recorded performance until the desired reliability was achieved. Preliminary intratester reliability was established with all outcome measures, and ICC statistics for each test were > .98. Upon completion of the informed consent process, a review of the electronic medical record was completed by the primary researcher to obtain information including age, most recent body mass index, and details regarding type, lesion location and date of stroke for each participant. Physical performance measure data was collected by the primary researcher using a data collection form (Appendix 1). Testing The primary researcher conducted the following physical performance testing one to three days prior to discharge home from the inpatient rehabilitation unit. Testing was completed in the physical therapy gym of the inpatient rehabilitation unit; moreover, the below testing order was utilized for each participant to ensure consistency among participants regarding any possible testing-related fatigue. All testing was completed in a single session. Timed supine to stand test. A standardized protocol for this test has not been established. For this study, participants performed the TSS on a carpet square measuring 82.75 30 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE inches in length, 58.75 inches in width and 0.3 inches in thickness. Participants were instructed to stand up at their self-selected, comfortable speed, following the go command. Timing began at the command of go and stopped when the participant had achieved a stable standing position without compensatory movement or postural sway (Klima et al., 2016). A standard chair with arms that was 18 in height from seat to floor was available laterally to assist if needed. Participants could wear an AFO if needed. Compensatory steps prior to stable stance were counted and recorded. This task was video recorded using a Go Pro HERO6 camera set upon a tripod and positioned off the corner of the carpet square, opposite the chair provided. 10-meter walk test. Strategies reported by Steffen and Seney (2008) and Watson (2002) were utilized to improve consistency of testing for this population of participants with a neurologic condition. Participants negotiated a 10-meter walking path with 2-meters allotted at the start of the path for acceleration, 2-meters allotted at the end of the path for deceleration, and the 6-meters marked in the center of the path as the only distance timed. Distance increments were marked on the floor with tape lines. Each participant completed two trials at their selfselected speed. The scores for the two trials were averaged. Instructions to the participants for the self-selected trials were to walk at your own comfortable walking pace and stop at the far mark. Any needed assistive device or bracing needed for ambulation were used during this test and documented. Timed Up and Go test. The procedure established by Podsiadlo and Richardson (1991) were utilized for the TUG. Participants started with their back resting on the backrest in a standard chair (seat height 46 cm) with arms resting on the armrests (height 67 cm). Any assistive device used for walking was placed within arms reach. Additional devices used for walking were used if necessary. Participants began at the command of go by standing up, 31 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE ambulating along a three-meter path to a taped line on the floor, turning around at the line, walking back to the chair and sitting down. Participants were instructed to use a comfortable and safe walking speed. Timing was completed using a stopwatch, beginning at the command of go and ceasing when the participants buttocks touched the seat of the chair. Dynamic Gait Index. The original version, eight-item test as established by ShumwayCook and Woollacott (1995) was utilized for completion of the DGI (Appendix 2). All eight items were administered as described on the original, publicly available scoring sheet, including specific instructions to participants for each item. The test was completed along a designated 6.1meter (20 foot) walkway, used a shoebox for the stepping over task, two identical cones for the obstacle negotiation task and a set of four practice steps for the stair climbing task. Activities-Specific Balance Confidence scale. The ABC (Appendix 3) was completed via personal interview with each participant. An enlarged version of the visual analogue scale was utilized throughout the interview. Instructions established by Powell and Meyers (1995) were provided verbally to each participant at the start of the interview and repeated as needed throughout the interview process. Per established instructions, participants were asked to indicate their level of confidence in doing each of the 16 activities included on this scale without losing their balance or becoming unsteady. Each of the 16 items were read aloud to each participant. The confidence level was indicated by selection of a percentage using the provided visual analogue scale from 0-100%. If the participant had not yet done an included activity, they were asked to imagine how confident they would be if they had to complete the task. Scoring was completed per the procedure established by Powell and Meyers (1995). Fugl-Meyer Assessment of Motor Recovery after Stroke. The original version of the FMA (Appendix 4) as established by Fugl-Meyer et al. (1975) was administered with all 32 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE participants. Both the upper (FMA-UE) and lower (FMA-LE) assessments were completed using the standardized procedure established by Sullivan et al. (2011) for clinical practice and clinical trials. Data Management and Analysis Each participant was assigned a unique study identification number (1-58) at the time of informed consent completion. This study identification number was matched to the participants name using a log sheet until all data were collected and entered into a Microsoft Excel spreadsheet. Once all data were entered into the spreadsheet, the log sheet was destroyed. Data management included reviewing data sheets for accuracy and completeness, and periodic data range checks. Descriptive statistics were performed on the entire sample. Nominal data were reported as frequencies and percentages, ordinal data and non-normally distributed interval and ratio data as medians and interquartile range (IQR), and normally distributed interval and ratio data as means and standard deviations. To answer the first research question regarding the relationship between functional performance (gait performance and balance confidence) and the ability to stand from the floor as measured with the timed supine to stand test in participants in the early subacute phase of CVA, a Pearson correlation or nonparametric Spearman rho correlation, depending on whether the data are normally distributed, were used to examine physical performance variable relationships. To address individual characteristics associated with supine to stand ability as measured with the supine to stand test, demographic characteristics were compared using a Fishers exact test or Pearson chi-square test for nominal data, Mann-Whitney U test for ordinal or non-normally distributed interval and ratio data, and independent t test for normally distributed interval and ratio data. Significant correlates and demographic variables were entered into a multiple 33 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE regression model to identify predictive determinants of the dependent variable, timed supine to stand performance. Model summaries were analyzed for coefficient of determination contributions and collinearity diagnostics. To address our second research question regarding strategies used to complete the timed supine to stand test in participants in the early subacute phase of stroke, qualitative descriptions of motor patterns strategized to stand were developed by review of video recorded performance of the TSS. Overall motor patterns were categorized into patterns A, B or C, then subclassified into upper extremity, axial and lower extremity components as described by VanSant (1988). Per VanSants (1988) description, pattern A includes symmetrical push of the upper extremities, symmetrical axial movement and symmetrical squat with the lower extremities; pattern B varies from this in the lower extremity component only with use of asymmetrical squat; and pattern C varies more greatly and includes asymmetric push and reach of the upper extremity, partial rotation of the axial component and half kneel with the lower extremities. These three components were analyzed through the three phases of supine to stand identified in an older adult population by Bohannon and Lusardi (2004) including initiation, transitional weight transfer and rising to upright. Within the initiation phase, information was recorded regarding whether the participant led with the upper extremity, lower extremity or head and trunk, and to which direction the initial movement occurred. During the transitional weight transfer, use of patterns described by Bohannon and Lusardi (2004) were recorded including asymmetrical side sit to half knee pivot, quadruped push up or sit up and roll over. During the rise to upright phase, additional information was recorded and included: initiating lower extremity beginning the task, use of a chair for support, affected or unaffected upper extremity use, transitional chair sitting prior to stand, and the number of compensatory steps taken to 34 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE achieve stable stance. Furthermore, use of intermediate positions described by Ulbrich et al. (2000) were recorded. These included sit, crouch, sidelying, tuck, half-tuck, kneel, half-kneel, quadruped and bearwalk patterns (Ulbrich et al., 2000). Additional descriptive details recorded included use of an AFO, the side of hemiparesis and the initial chair position. Data were categorized by the above classification schemes and descriptive frequency percentages were calculated. Preliminary intrarater reliability was established for pattern classification and methods used in previous studies of supine to stand performance (Belt et al., 2001; Bohannon & Lusardi, 2004; King &VanSant, 1995; Klima et al., 2016). Five randomly selected TSS trials were analyzed and classified by the primary researcher. After an interval of two days, these trials were reclassified by the same researcher. The Kappa statistic was calculated for nominal motor patterns employed to stand, with consistency agreement exceeding .98 for all sub-classification schemes. Data were analyzed using IBM SPSS Statistics for Windows, Version 25.0 (IBM Corp., Armonk, NY). Normality of data were determined using the Shapiro-Wilk test, all comparisons were two-tailed, and a significance level of less than .05 was considered statistically significant. Results Characteristics of the Sample Fifty-eight participants [mean age 59.22 (13.89) years] were included in the study. Over half (58.6%) the sample was male (Table 1). Major reasons for exclusion included previous history of stroke and physical assistance during the floor rise task. Demographic features included a mean body mass index (BMI) of 30.2 (6.83) kg/m2. The mean number of days since participants stroke, when tested, was 19.4 (9.2) days. Vascular events included ischemic 35 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE (86.2%), hemorrhagic (6.9%) or combination (6.9%) strokes. Fugl-Meyer motor scores were 49.5 (9.3) for the upper extremity subsection and 31.0 (6.0) for the lower extremity subsection. Physical Performance Measures The median time needed to complete the TSS was 13.0 seconds (15.5) for the entire sample; a Shapiro-Wilks analysis identified a non-normal distribution of the measure. Means and standard deviations are reported for normally distributed variables, including physical performance measures, and are noted in Table 2. The nonparametric Kruskal-Wallis analysis noted no significant difference in TSS (p=.32) among participants with left [15.3s (9.7)], right [27.7s (29.8)], and bilateral lesions [13.3s (8.7)]; however, magnitude differences were large between cohorts. Forty-one participants (70.7%) required the use of a chair to complete the TSS measure. Seventeen participants (29.3%) used an assistive device in ambulation. A Chi-Square test of independence determined a significant interaction; participants who used an ambulatory assistive device were more likely to use the chair to rise during the TSS Test (x2(1) = 10.0, p = .001). Twenty-six participants utilized a quadruped maneuver; participants who employed this strategy were significantly older (64.7 vs. 54.8 years; p = .02) and demonstrated higher FuglMeyer upper extremity scores (p=.006). Bivariate Correlations and Multivariate Analysis Spearmans rho correlations (Munro, 2000) noted that TSS performance had a low positive association with number of days since stroke (r = .30; p < .05) and low negative correlation with the ABC (r = -.43, p < .01); in addition, a moderate negative relationship with both gait velocity (r = -.67, p < .01) and the DGI (r = -.52, p < .01) was demonstrated. There was a strong positive association between TSS and TUG (r = .70, p < .01) performance. Age and 36 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE BMI were not significant correlates (r = .22 and .25, p > .05, respectively). Bivariate demographic and performance correlations are noted in Table 3 A multiple linear regression analysis (Table 4) demonstrated that the TUG and use of the quadruped position predicted 32% of the variance in TSS completion time (F (2,55) = 14.7; p < .001). Positive variable beta weights are noted in Table 4. Exploratory gait and balance confidence independent variables (including gait velocity, the DGI and ABC) were entered into the regression with no significant contributions to the model. In addition, Pearson product moment correlations between gait variables were high (r = .80 to - .85; p < .001) and yielded collinear constructs. Movement Component Analysis Frequency analysis of movement patterns utilized are noted in Table 5. Fifty-five (94.8%) participants utilized Pattern C for the transition from supine on the floor to steady stand, as described by VanSant in the movement component analysis (1988). Two (3.4%) participants utilized Pattern B, and one (1.7%) demonstrated Pattern A. In the extended component analysis, twenty (34.4%) participants utilized an upper extremity pattern (VanSant, 1988); furthermore, 16 participants (27.6%) employed the upper extremity push and reach to asymmetrical push pattern. Axial patterns were identified in 44 (75.8%) participants, with 30 (51.7%) demonstrating the frequent full rotation abdomen up transition. Only ten (17.2%) participants demonstrated a lower extremity pattern; seven (12.1%) participants used the half kneel technique (Table 5). Movement strategy pair combinations as described by Bohannon and Lusardi (2004) in healthy older adults were identified (Table 5). Eight (13.8%) utilized an asymmetrical side sit to half knee pivot, technique, while nine (15.5%) employed a quadruped push-up maneuver. Three subjects (5.2%) demonstrated the sit up and roll over combination. 37 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Intermediate Positions, Hemiplegic Extremity Use, and Compensatory Steps Finally, movement patterns were analyzed according to those intermediate positions described by Ulbrich and colleagues (2000) in older adults (Table 5). Most commonly, participants utilized a half kneel position (43, 74.1%). Of these, 22 (51.2%) utilized the hemiparetic lower extremity as the lead leg to transition to stand. This was followed by the following patterns: tuck (40, 68.9%), kneel (29, 50.0%), quadruped (26, 44.8%), sit (20, 34.5%), bearwalk (14, 24.1%), sidelying (11, 18.9%), half tuck (10, 17.2%) and crouch (7, 12.1%) transitions. Additional analyses examined use of the involved extremities to rise to stand. Of those participants using the tuck position, 14 (35.0%) used the hemiparetic lower extremity to stand. In the half tuck position, five (50.0%) used their hemiparetic lower extremity as the lead limb for the maneuver. Forty-one (70.7%) participants strategized with upper extremity use to rise to stand. Within this group, 27 (65.9%) used their involved or hemiparetic upper extremity to assist in rising from supine to stand. Forty-one (81.0%) participants took compensatory steps at terminal stance; moreover, the mean number of compensatory steps was 2.4 (1.9). Although weak, there was a significant association between TSS time and number of compensatory steps taken (r=.29; p=.03). Discussion The purpose of this study was to examine floor to stand ability both quantitatively and qualitatively among persons in the early subacute phase of stroke recovery, prior to discharge home from acute rehabilitation. Specifically, the aim was to examine the relationship of floor to stand time using the TSS with other physical performance measures and demographic 38 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE characteristics of our participants, and to identify movement patterns commonly used to complete the floor to stand task. Timed Supine to Stand While multiple methods of quantitative floor to stand assessment have been reported in the literature, the TSS as described by Klima et al. (2016) was selected for this study. The procedure for the TSS most closely simulated recovery after a fall by timing only supine to stand at ones comfortable pace and with upper extremity support available. Similar testing procedures of preferred speed and with upper extremity support were used by Alexander et al (1997) and Ulbrich et al (2000) in studies with older adults that included a subset of participants with physical impairment. In the only other study examining floor to stand completion in persons with stroke, Ng et al (2015) used a timed floor transfer test (FTT) that included timing the standing to sitting on the floor maneuver and subsequent return to standing. Although participants completed this test at preferred speed and with chair assist as necessary, this procedure is dissimilar to what may be needed to return to stand after a fall. Our test-retest reliability for the TSS was excellent (ICC > .98), and commensurate with coefficients previously cited (ICC = .94). Consistent with Klima et al. (2016), the TSS measure demonstrated concurrent validity with other physical performance and balance confidence outcomes commonly used among patients after stroke including the TUG, gait velocity, DGI and ABC. Our results demonstrate that the TSS is feasible for patients after first ischemic or hemorrhagic stroke, in the early subacute phase of recovery, who were able to complete floor to stand with no more than supervision. All participants were able to complete the TSS and required a median time of 13.0 (15.5) seconds to complete the task. This time is longer than means reported by Alexander et al. (1997) and Ulbrich et al. (2000) for healthy older adults (5.5 39 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE seconds), Bohannon and Lusardi (2004) for healthy adults age 50-90 (4.1 seconds), Klima et al. (2016) for community dwelling older adults (8.0 seconds), and Moffett et al. (2020) for community dwelling women over age 55 (5.8 seconds). However, our median time was shorter than the mean time needed for older female participants with physical impairment (17.1 seconds) reported by Alexander et al. (1997) and Ulbrich et al. (2000). The longer time required by participants in the Ulbrich analysis (2000) may be explained by age, as the mean age was 81 years, compared to 59.2 years in this study. Other discrepant times reported for floor to stand may be explained by differences in samples tested (gender, age and inclusion/exclusion criteria), procedures used (availability of external support, start position and number of trials) and instructions provided (preferred versus maximal speed). Bivariate Correlations and Multivariate Analysis Our finding of a significant relationship between floor to stand time and the TUG (r = .70) has been reported by others examining similar relationships in varied adult populations including Bergland and Laake (2005) (r = .72), Ng et al. (2015) (r = .71) and Klima et al. (2016) (r = .71). Furthermore, Klima et al. (2016) reported that TUG performance predicted 48% of the variance in TSS time in healthy community dwelling older adults. In our study, multiple linear regression analysis demonstrated that TUG performance predicted 28% of the variance in TSS performance, and the use of the quadruped position increased the coefficient of determination to 32%. Similar findings have been noted between floor to stand completion and other tasks requiring antigravity muscle activation for rising to stand such as standing from a chair (Bohannon & Lusardi, 2004; Moffett et al., 2020) and climbing steps (Bergland & Laake, 2005). Select physical impairments present in our participants post stroke including lower extremity weakness, decreased coordination and decreased balance plausibly contributed to the relationship 40 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE between TUG and floor to stand (Ng et al., 2020) and the use of quadruped could be due to compensation by maintaining both upper and lower body contact with the floor (Ulbrich et al., 2000). While age was not significantly correlated with TSS time as in previous studies (Alexander et al., 1997; Ulbrich et al., 2000; Bohannon & Lusardi, 2004; Klima et al, 2016), those who used the quadruped position were significantly older (p < .001). Ulbrich et al. (2000) noted that older adults with physical impairment were more likely to use such intermediate positions. Furthermore, those who employed the use of quadruped in the sequence used to return to stand had higher scores on FMA-UE (p = .006). This indicates that in older adults after stroke, when upper extremity function is present on the involved side, it is often utilized to maintain stability for the transition to stand. The relationship between TSS and gait velocity continues to validate gait velocity as a measure of physical function post stroke, and as a critical vital sign as indicated by Fritz and Lusardi (2009). Our moderate relationship (r = -.67) is similar to that reported by Klima et al. (2016) (r = -.61) for community dwelling older adults, and slightly higher than the low-level correlation reported by Moffett et al. (2020) (r = -.48) for community dwelling women over age 55. Those who completed floor to stand more slowly demonstrated both decreased gait velocity and increased time to complete the TUG. The strength of the relationship between the ABC and TSS (r = -.43) was less significant than that reported by Klima et al. (2016) (r = -.51) for community dwelling older adults. This is not unexpected as our participants had not yet discharged to the community from inpatient rehabilitation after first stroke. In many cases our participants were asked to imagine how they would feel about balance confidence in community situations that they had not yet encountered while completing the ABC. This could explain the lower mean ABC score reported in our study 41 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE (69.2), compared to that reported by Ng et al. (2015) (77.5) who studied a sample of patients after chronic stroke living in the community. Nevertheless, our results indicate that those who took longer to complete floor to stand have lower confidence in their ability to complete household and community mobility tasks. We are aware of no other study which has compared TSS performance with DGI performance. The DGI was selected as a measure of balance for our study due to the allowance of an assistive device if needed. This proved necessary for 17 (29.3%) of our study participants. The moderate relationship (r = -.52) between TSS and DGI indicates that those who required more time to complete floor to stand demonstrated poorer dynamic gait ability. Further, participants who used an assistive device for gait performance were more likely to use the chair to complete floor to stand. Although BMI has been described as a contributor to floor rise ability in prior studies (Ulbrich et al., 2000; Ardali et al., 2020), our results did not show this relationship. This is similar to the group of community dwelling older adults studied by Klima, et al. (2016). While the active community dwelling older adult sample studied by Klima et al (2016) had a relatively low overall BMI, 32.8% of our sample was overweight, and 44.8% were obese (Centers for Disease Control and Prevention, 2020). This is similar to the sample of participants studied by Ardali et al. (2020) in which 76.5% of those dependent in floor to stand were described as overweight. Ulbrich et al. (2000) also reported that BMI was significantly higher in the subset of older adults with physical impairment who required more time and use of intermediate positions to move from supine to stand. While the amount of elevated BMI was similar to these studies, the difference in TSS time based on this factor did not reach significance (r = .25). This may be 42 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE explained by insufficient power to detect significance of BMI as a contributor to TSS performance in this study. In our study, greater number of days post stroke was associated with increased TSS time. Greater number of days between stroke and testing could indicate more severe stroke with associated longer acute hospital stay prior to inpatient rehabilitation. Greater severity of stroke may have also contributed to a greater number of days between stroke and testing needed to achieve the supervision level required for inclusion in this study. Furthermore, if participants were newly able to perform floor to stand task with only supervision, they may have been more cautious in their performance without assistance thus increasing the time needed for TSS completion Movement Component Analysis To our knowledge, this is the first detailed analysis of movement strategies used by participants recovering from stroke to complete the floor to standing task. In the only other study of floor to stand ability in patients after stroke completed by Ng et al. (2015), movement analysis was not included. While we were able to classify all 58 of our participants overall movement pattern as either A, B or C according to VanSants method of component movement analysis (1988), fewer upper extremity, axial and lower extremity component patterns noted could be classified according to her descriptions. Of those upper extremity, lower extremity and axial components that fit into VanSants classifications (1988), most included asymmetrical patterns indicating less developmentally advanced movements. These findings are similar to previous studies of participants with neurologic diagnoses including studies of patients with CP (Boswell et al., 1993), Downs Syndrome (Unrau et al., 1994) and Prader-Willi Syndrome (Belt et al., 2001). In each of these studies, authors concluded that VanSants method of component movement 43 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE analysis could be utilized to describe movement, but less developmentally advanced movement strategies required expansion to capture all movement strategies observed. Thus, we expanded our classification system to include pair combinations described by Bohannon and Lusardi (2004) and intermediate positions described by Ulbrich et al. (2000) to comprehensively capture and calculate frequencies of all movement strategies identified on movement analysis, and allow further investigation of involvement of the hemiparetic upper and lower extremity. In our sample, most overall movement patterns could be classified as movement pattern C defined by VanSant which included a form of asymmetrical push and reach with the upper extremity, partial rotation of the axial component and an asymmetrical pattern with lower extremities. This is commensurate with Klima et al. (2016) who identified pattern C as the most common pattern used by older community dwelling adults. Twenty (34.5%) of our participants used a pair combination described by Bohannon and Lusardi (2004) with the most used being quadruped push up. Calculating the frequency of each intermediate position as a group proved more challenging, as many participants used more than one in series in their effort to achieve stand. The sequence of intermediate positions to move from supine to stand had some common themes, but largely varied between participants. Common themes included moving from supine through sidelying, sitting or tuck; progressing next through quadruped, kneeling, half-kneeling, or a combination of these; then transition to stand, often utilizing the chair for external support. This variability in performance is supported by the seminal work of VanSant (1988) who first proposed the concept that movement patterns for floor to stand can vary both within and between individuals. These finding are further reinforced by Ulbrich et al. (2000) who found the use of intermediate positions to be associated with older age and the presence of physical impairment, both of which were present in our sample of participants. 44 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Several of the most common intermediate positions used included the half kneel, tuck and quadruped positions. These, along with the nearby chair, were used frequently to assist with the transition to stand. Of those who used the half-kneel and tuck positions, 51% and 35% used their hemiparetic lower extremity as the lead leg for transition to stand, respectively. Twenty-six used the quadruped position, which allowed bilateral upper and lower extremity use, for which the hemiparetic extremity(s) were utilized. Those who utilized the quadruped position demonstrated significantly higher FMA-UE scores (p = .006) indicating a greater amount of upper extremity motor recovery. Additionally, 66% of those who used the chair for transition to stand did so with the support of their affected upper extremity, either in isolation or in combination with the less involved arm. The large percentage of participants using their involved upper and lower extremities might be explained by relatively high upper and lower extremity motor Fugl-Meyer scores in our study population. Our mean FMA-UE score was 49 of 56 and the mean FMA-LE score was 31 of 34, indicating higher level of motor recovery post stroke in our sample. Finally, while the differences in TSS times between participants with right, left and bilateral involvement were not statistically significant, the large magnitude of differences between these cohorts warrants further discussion. Those after right brain lesions, with left sided involvement required more time to complete the TSS. These differences in times may be explained by variability in the type and severity of deficits post stroke linked to lesion laterality (Mutha et al., 2012). Further investigation with a large sample regarding lesion laterality as a possible contributor to floor to stand performance is warranted. Study Limitations The study was a correlational study with a cross-sectional design. While relationships were demonstrated between floor to stand using the TSS and other physical performance measures and 45 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE individual characteristics, causal interpretations cannot be made. While our study was powered sufficiently to analyze two independent variables during multiple regression, more variables may have reached significance or contributed further to variance in TSS completion time with a larger sample size that allowed inclusion of additional variables into the model. The cross-sectional design and convenience sampling limit generalizability of results beyond patients in the early subacute phase of stroke recovery with similar functional levels. Our inclusion criteria biased our sample to patients who had achieved a high enough level of recovery during inpatient admission at the acute rehabilitation level of care to complete the floor to stand maneuver with no more than supervision. Furthermore, this requirement also likely contributed to the high levels of motor recovery noted in our sample as indicated by means reported on FMA-UE (49/56) and FMA-LE (31/34), further limiting generalizability to patients after stroke with lower levels of motor recovery in their involved upper and lower extremities. Our exclusion criteria excluded those with cerebellar stroke and prior stroke, which were the main reasons for exclusion during the screening phase of our study, after referral by the treatment team. Many of these excluded patients with history of cerebellar or prior stroke could complete the floor to stand task with no more than supervision. Each participant completed only one trial of the TSS to avoid fatigue. While this allowed us to analyze movement pattern variation between subjects to identify patterns, it did not allow within subject analysis of variable movement patterns used for floor to stand completion, which had been described previously by VanSant (1988). Finally, an education session was held prior to starting data collection to facilitate referrals to our study from the treatment team. Therapists making referrals were instructed not to vary their practice in any way with patients referred to this study. Because it was a treatment activity 46 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE implemented as part of their usual care, some participants had practiced floor to stand with instruction in technique prior to participation in the testing session for this study. This instruction and practice may have changed their self-selected movement patterns as suggested by Hofmeyer et al. (2002) who demonstrated benefits of a short-term, strategy-based intervention to improve floor rise ability in older adults at risk for falls. Future Study Further studies assessing floor to stand in patients after stroke are warranted. Future studies could involve larger sample sizes to allow further exploration of various contributors to floor to stand performance. Participants with prior stroke and with cerebellar lesions should be included, as should participants in all stages of recovery post stroke to allow further generalization of results. Inclusion of lower level patients or avoiding criteria for level of function would allow study of those patients at higher risk of needing assistance after a fall. Stratification based on Fugl-Meyer motor scores and/or Functional Independence Measure (FIM) scores may allow comparison of between group differences. Timing and movement analysis of floor to stand could include more than one trial per participant post stroke to allow analysis of within subject movement variability. Further studies to establish psychometric properties of the TSS such as means per stage of recovery, cut scores predictive of falls and/or levels of independence with TSS, minimal detectable change and minimal clinically important differences would also be useful for incorporation of this tool into the toolboxes of physical therapists assessing functional mobility of patients post stroke. Interventional studies to assess response of training of patients after stroke in floor to stand performance using the TSS to assess change in time needed and movement analysis to capture data regarding changes in movement strategies over time could support incorporation of this task into rehabilitation programs. 47 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Conclusion The median time to complete floor to stand in patients in the early subacute phase post stroke is 13.0 (15.5) seconds. This is related to a cluster of physical performance measures used in the assessment of mobility of patients after stroke including TUG, gait velocity, DGI and ABC. Timed Up and Go performance is the single most predictive physical performance measure of floor to stand performance. The use of an assistive device for gait tasks indicates the need for chair use in the transition from floor to stand. Patients in this stage of recovery most commonly use an asymmetric roll strategy to complete floor to stand and most use several intermediate positions that allow the ability to keep more contact with a supporting surface throughout the maneuver. The most common intermediate positions used include half-kneel, tuck, kneeling and quadruped. Many patients self-select the use of the hemiparetic upper and/or lower extremity during floor to stand and should be encouraged to do so. Incorporation of the involved upper and lower extremities and training of intermediate positions in part to whole task practice may assist in earlier achievement of the ability to complete the floor to stand task. This may mitigate fear of falling and lower the risk of mortality due to critical fall in the transition to home post discharge. Over time, as motor recovery, strength, balance, and balance confidence develop, training in more developmentally advanced patterns of floor to stand may be possible. As noted previously, Simpson and Salkin (1993) reported that more than 80% of therapists surveyed did not report that they teach older patients with instability and tendency to fall how to get up from the floor. One reason for this was proposed by Bohannon et al. (1995) who noted an absence of specific information available to clinicians to assist in guided instruction of the floor rise task for patients after stroke. 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Pediatric Physical Therapy, 28, 71-76.doi:10.1097/PEP.0000000000000205 59 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Table 1 Participant Sociodemographic and Physical Performance Characteristics Participant Demographic and Performance Profile Total Sample (N = 58) Age (years) 59.2 (13.9) a Gender (%) Male 34 (58.6) BMI (kg/m2) 30.2 (6.8) a Stroke Type (%) Infarct Hemorrhage Combination 50 (86.2) 4 (6.9) 4 (6.9) Side of Stroke (%) Right Left Bilateral 24 (41.4) 27 (46.6) 7 (12.1) Days Since Stroke (#) 19.4 (9.9) FMAUpper Extremity (Max 56) 49.5 (9.3) b FMA-Lower Extremity (Max 34) 31.0 (6.0) b Ambulation with assistive device (%) No Yes Rolling walker Quad cane Straight cane 41 (70.7) 17 (29.3) 8 (13.8) 5 (8.6) 4 (6.9) Use of ankle-foot orthosis (%) Yes 5 (8.6) Use of chair to rise during TSS (%) Yes 41 (70.7) Use of Quadruped Position to Rise (%) Yes 26 (44.8) Note. Data reported as frequency (%) unless otherwise indicated. a Reported as mean (SD). b Reported and median (interquartile range). 60 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Table 2 Physical Performance Measures Performance Profile Total Sample (N = 58) TSS (seconds) Left lesion CVA Right lesion CVA Bilateral lesion CVA 13.0 (15.5) a 15.3 (9.3) 27.7 (29.8) 13.3 (9.7) Gait velocity (m/s) 0.80 (0.34) TUG (seconds) 19.0 (10.4) DGI total score (out of 24) 17 (5.0) ABC Score (%) 69.2 (18.4) Note. Values are reported as mean (SD) unless otherwise indicated. a Reported as median (interquartile range). 61 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Table 3 Bivariate Correlations with Timed Supine to Stand Performance Variable TSS Age .22 BMI .25 Days Since Stroke .30* TUG .70** Gait Velocity -.67** DGI -.52** ABC -.43** Compensatory Steps .28* Note. N = 58 for all correlation. Spearmans rank correlation coefficients * p < .05, ** p < .01 62 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Table 4 Predictive Determinants of the Timed Supine to Stand Test Independent Variable B SE B t p Timed Up and Go 1.2 .23 .59 5.3 .001 Quadruped 9.9 4.7 .24 2.1 .040 Note. N = 58 for regression. Adjusted R2 = .324. P < .001. 63 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Table 5 Movement Pattern Analysis during the Timed Supine to Stand Test Pattern Variable Total Sample (N = 58) Initiation Lead with upper extremity Lead with lower extremity Lead with head and trunk 22 (37.9) 16 (27.6) 20 (34.5) Initial movement direction Right With right side involvement Left With left side involvement Forward 25 (43.1) 9 (15.5) 28 (48.3) 10 (17.2) 5 (8.6) Pattern and Squat Symmetry Pattern A 1 (1.7) Pattern B 2 (3.4) Pattern C 55 (94.8) UE pattern identified Push and reach to asymmetrical push Push and reach Symmetrical push to push and reach 20 (34.4) 16 (27.6) 2 (3.4) 2 (3.4) Axial pattern identified Full rotation abdomen up Partial rotation Symmetrical interrupted by rotation Symmetrical 44 (75.8) 30 (51.7) 6 (10.3) 5 (8.6) 3 (5.2) LE pattern identified Half kneel Asymmetrical squat Symmetrical squat 10 (17.2) 7 (12.1) 2 (3.4) 1 (1.7) 64 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Pair Combinations Asymmetrical side sit to knee pivot 8 (13.8) Quadruped push up 9 (15.5) Sit up and roll over 3 (5.2) Intermediate Positions Sit 20 (34.5) Crouch 7 (12.1) Sidelying Right With ride side involvement Left With left side involvement 11 (18.9) 5 (8.6) 2 (3.4) 6 (10.3) 3 (5.2) Tuck Right With ride side involvement Left With left side involvement 40 (68.9) 15 (25.9) 6 (10.3) 25 (43.1) 8 (13.8) Half tuck Right With right side involvement Left With left side involvement 10 (17.2) 5 (8.6) 3 (5.2) 5 (5.8) 2 (3.4) Kneel 29 (50.0) Half kneel Right With right side involvement Left With left side involvement 43 (74.1) 18 (31.0) 10 (17.2) 25 (43.1) 12 (20.7) Quadruped 26 (44.8) Bearwalk 14 (24.1) 65 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Transition to Stand Lead leg Right Left Equal 27 (46.6) 30 (51.7) 1 (1.7) Chair used to rise 41 (70.7) Upper extremity used to rise Right With right side involvement Left With left side involvement Bilateral With right side involvement With left side involvement Bilateral involvement 10 (17.2) 2 (3.4) 7 (12.1) 1 (1.7) 24 (41.3) 13 (22.4) 10 (17.2) 1 (1.7) Participants who took compensatory steps Mean number of compensatory steps 47 (81.0) 2.4 (1.9)a Note. Values reported as frequency (percentage) unless otherwise indicated. a reported as the mean and standard deviation. 66 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Appendix 1 Data Collection Form 67 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Appendix 2 Dynamic Gait Index (original 8-item test) Description: Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. Equipment needed: Box (Shoebox), Cones (2), Stairs, 20 walkway, 15 wide Completion: Time: 15 minutes Scoring: A four-point ordinal scale, ranging from 0-3. 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 24 Interpretation: < 19/24 = predictive of falls risk in community dwelling elderly 1. Gait level surface _____ Instructions: Walk at your normal speed from here to the next mark (20) Grading: Mark the lowest category that applies. (3) Normal: Walks 20, no assistive devices, good sped, no evidence for imbalance, normal gait pattern (2) Mild Impairment: Walks 20, uses assistive devices, slower speed, mild gait deviations. (1) Moderate Impairment: Walks 20, slow speed, abnormal gait pattern, evidence for imbalance. (0) Severe Impairment: Cannot walk 20 without assistance, severe gait deviations or imbalance. 2. Change in gait speed _____ 68 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Instructions: Begin walking at your normal pace (for 5), when I tell you go, walk as fast as you can (for 5). When I tell you slow, walk as slowly as you can (for 5). Grading: Mark the lowest category that applies. (3) Normal: Able to smoothly change walking speed without loss of balance or gait deviation. Shows a significant difference in walking speeds between normal, fast and slow speeds. (2) Mild Impairment: Is able to change speed but demonstrates mild gait deviations, or not gait deviations but unable to achieve a significant change in velocity, or uses an assistive device. (1) Moderate Impairment: Makes only minor adjustments to walking speed, or accomplishes a change in speed with significant gait deviations, or changes speed but has significant gait deviations, or changes speed but loses balance but is able to recover and continue walking. (0) Severe Impairment: Cannot change speeds, or loses balance and has to reach for wall or be caught. 3. Gait with horizontal head turns _____ Instructions: Begin walking at your normal pace. When I tell you to look right, keep walking straight, but turn your head to the right. Keep looking to the right until I tell you, look left, then keep walking straight and turn your head to the left. Keep your head to the left until I tell you look straight, then keep walking straight, but return your head to the center. Grading: Mark the lowest category that applies. (3) Normal: Performs head turns smoothly with no change in gait. 69 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE (2) Mild Impairment: Performs head turns smoothly with slight change in gait velocity, i.e., minor disruption to smooth gait path or uses walking aid. (1) Moderate Impairment: Performs head turns with moderate change in gait velocity, slows down, staggers but recovers, can continue to walk. (0) Severe Impairment: Performs task with severe disruption of gait, i.e., staggers outside 15 path, loses balance, stops, reaches for wall. 4. Gait with vertical head turns _____ Instructions: Begin walking at your normal pace. When I tell you to look up, keep walking straight, but tip your head up. Keep looking up until I tell you, look down, then keep walking straight and tip your head down. Keep your head down until I tell you look straight, then keep walking straight, but return your head to the center. Grading: Mark the lowest category that applies. (3) Normal: Performs head turns smoothly with no change in gait. (2) Mild Impairment: Performs head turns smoothly with slight change in gait velocity, i.e., minor disruption to smooth gait path or uses walking aid. (1) Moderate Impairment: Performs head turns with moderate change in gait velocity, slows down, staggers but recovers, can continue to walk. (0) Severe Impairment: Performs task with severe disruption of gait, i.e., staggers outside 15 path, loses balance, stops, reaches for wall. 5. Gait and pivot turn _____ Instructions: Begin walking at your normal pace. When I tell you, turn and stop, turn as quickly as you can to face the opposite direction and stop. Grading: Mark the lowest category that applies. 70 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE (3) Normal: Pivot turns safely within 3 seconds and stops quickly with no loss of balance. (2) Mild Impairment: Pivot turns safely in > 3 seconds and stops with no loss of balance. (1) Moderate Impairment: Turns slowly, requires verbal cueing, requires several small steps to catch balance following turn and stop. (0) Severe Impairment: Cannot turn safely, requires assistance to turn and stop. 6. Step over obstacle ____ Instructions: Begin walking at your normal speed. When you come to the shoebox, step over it, not around it, and keep walking. Grading: Mark the lowest category that applies. (3) Normal: Is able to step over the box without changing gait speed, no evidence of imbalance. (2) Mild Impairment: Is able to step over box, but must slow down and adjust steps to clear box safely. (1) Moderate Impairment: Is able to step over box but must stop, then step over. May require verbal cueing. (0) Severe Impairment: Cannot perform without assistance. 7. Step around obstacles _____ Instructions: Begin walking at normal speed. When you come to the first cone (about 6 away), walk around the right side of it. When you come to the second cone (6 past first cone), walk around it to the left. Grading: Mark the lowest category that applies. (3) Normal: Is able to walk around cones safely without changing gait speed; no evidence of imbalance. 71 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE (2) Mild Impairment: Is able to step around both cones, but must slow down and adjust steps to clear cones. (1) Moderate Impairment: Is able to clear cones but must significantly slow, speed to accomplish task, or requires verbal cueing. (0) Severe Impairment: Unable to clear cones, walks into one or both cones, or requires physical assistance. 8. Steps _____ Instructions: Walk up these stairs as you would at home, i.e., using the railing if necessary. At the top, turn around and walk down. Grading: Mark the lowest category that applies. (3) Normal: Alternating feet, no rail. (2) Mild Impairment: Alternating feet, must use rail. (1) Moderate Impairment: Two feet to a stair, must use rail. (0) Severe Impairment: Cannot do safely. TOTAL SCORE: ___ / 24 72 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Appendix 3 The Activities-specific Balance Confidence (ABC) Scale For each of the following activities, please indicate your level of self-confidence by choosing a corresponding number from the following rating scale: 0% 10 20 30 40 no confidence 50 60 70 80 90 100% completely confident How confident are you that you will not lose your balance or become unsteady when you walk around the house? ____% walk up or down stairs? ____% bend over and pick up a slipper from the front of a closet floor ____% reach for a small can off a shelf at eye level? ____% stand on your tiptoes and reach for something above your head? ____% stand on a chair and reach for something? ____% sweep the floor? ____% walk outside the house to a car parked in the driveway? ____% get into or out of a car? ____% walk across a parking lot to the mall? ____% walk up or down a ramp? ____% walk in a crowded mall where people rapidly walk past you? ____% are bumped into by people as you walk through the mall?____% step onto or off an escalator while you are holding onto a railing? ____% step onto or off an escalator while holding onto parcels such that you cannot hold onto the railing? ____% 73 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE walk outside on icy sidewalks? ____% 74 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Appendix 4 Fugl-Meyer Assessment of Motor Recovery after Stroke 75 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 76 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Appendix 5 Informed Consent Document Identification of Project: Floor to Stand Performance among Persons Following Stroke Statement of Age of Participant: I state that I am 18 years of age or older, in good health, and wish to participate in a program of research being conducted by Dr. Dennis Klima, Dr. Amanda Leonard, Dr. Stephanie Combs-Miller and Angela Davis at University of Maryland Rehabilitation and Orthopedic Institute in conjunction with University of Maryland Eastern Shore and University of Indianapolis. Purpose: The purpose of this research is to study getting up from the floor among persons who have had a stroke in conjunction with walking speed, walking performance, balance, balance confidence, movement, age, body weight and type, location and date of stroke. Procedures: The procedures will involve data collected from my electronic medical record including age, body weight and type, location and date of my stroke. The procedures will also include six parts, in which the following will be tested in one session: 1. 2. 3. 4. 5. 6. Timed floor to stand (video recorded) Walking speed (10-meter walk test) Walking performance (Timed Up & Go test) Balance (Dynamic Gait Index) Balance confidence (Activities-Specific Balance Confidence scale) Movement of my affected arm and leg (Fugl-Meyer Assessment) Confidentiality: All information collected in this study is confidential, and my name will not be identified at any time. Benefits: I understand that this study is not designed to help me personally, but that the investigators hope to learn more about physical performance and rising from the floor. 77 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Freedom to Withdraw from and Ask Questions: I understand that I am free to ask questions and to withdraw from participation at any time without penalty. Where Medical Care is Available: In the event of physical injury resulting from participation in this study, I understand that immediate medical treatment is available at University of Maryland Rehabilitation and Orthopedic Institute. However, I understand that the University of Maryland Rehabilitation and Orthopedic Institute, University of Maryland Eastern Shore and University of Indianapolis does not provide any medical or hospitalization insurance coverage for participants in the research study, nor will these institutions provide any compensation for any injury sustained as a result of participation in this research study except as required by law. Conclusion: You are making a decision whether or not you will participate in this study. If you sign the consent form, you are agreeing to participate based on your reading and understanding of this form. If you have any questions regarding this study, please ask one of the investigators, or call Dr. Dennis Klima at 410-651-6354. If you have questions regarding your rights as a research participant, please contact the Chair of the University of Maryland Eastern Shore Institutional Review Board, Dr. Clayton Faubion, by calling 410-651-6379. Names: Principle Investigator: Dr. Dennis Klima, PT, MS, Ph.D, GCS, NCS Co-Investigators: Dr. Stephanie Combs-Miller, PT, Ph.D, NCS Dr. Amanda Leonard, PT, DScPT, NCS Student Investigator: Angela Davis, PT, MHS, NCS Address: University of Maryland Eastern Shore University of Maryland Rehabilitation Department of Physical Therapy and Orthopedic Institute Hazel Hall, 2nd Floor 2200 Kernan Drive Princess Anne, MD, 21853 Baltimore, MD 21207 Phone: 410-651-6301 Phone: 410-448-2500 Signature of Participant: ________________________________ Date: __________ Signature of Witness: ___________________________________ Date: __________ 78 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE Appendix 6 IRB Approval Documents 79 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 80 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 81 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 82 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 83 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 84 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE 85 FLOOR TO STAND PERFORMANCE FOLLOWING STROKE  ...

... Current Trends in Blood Flow Restriction Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Molly Cuffe, ATC Copyright June 29, 2021 By: Molly Cuffe, ATC All rights reserved Approved by: Emily Slaven, PT, PhD Committee Chair ______________________________ Joel Novak, PT, DPT, CSCS Committee Member ______________________________ Adnan Saithna, MD Committee Member ______________________________ H. Scott Strohmeyer, PhD Committee Member ______________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ CURRENT TRENDS IN BLOOD FLOW RESTRICTION Current Trends in Blood Flow Restriction Molly Cuffe University of Indianapolis 1 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 2 Abstract Background/Significance: Blood flow restriction (BFR) involves the application of a device to alter blood flow to an extremity. Several types of devices can facilitate blood flow restriction, and safe application can limit adverse effects. Purpose: The purpose of the study was to explore how individuals in the United States of America applied BFR/KAATSU devices and administered BFR/KAATSU training. In addition, the study sought to examine safety related to BFR/KAATSU training. Methods: The study was completed using survey research. Subjects were recruited through Facebook, email, and word of mouth. The survey was developed, piloted, and finally deployed March 22, 2021-April 21, 2021. Results: In total, 148 consented to the research; 108 completed the survey, and of those 108, 70 indicated current use of BFR/KAATSU equipment. Professions represented included athletic training, personal training, physical therapy, and strength and conditioning. The most common devices used were inflatable devices (n=43, 61.4%). Education completed prior to device administration was formal (n= 39, 55.7%) and/or self-directed (n=37, 52.9%). Barriers were faced by 29 (41.4%) when trying to enact training. Techniques and parameters varied during application. Screening processes were used (n=50, 71.4%) prior to training. The devices were used to determine restrictive pressure (n=31, 44.3%), and a supine position was used most when determining initial restrictive pressure (n=33, 47.1%). For subsequent restrictive pressure measurements, respondents repeated the same method used initially (n=38, 54.3%). Workload was often defined as the length of time under tension/load (n=22, 31.4%) and exercise was directly supervised (n=52, 74.3%). Adverse effects including bruising, lightheadedness, and cramping were seen (n=15, 21.4%). The devices have been applied on those with pathology (n=16, 22.9%). Conclusions: Those using blood flow restriction/KAATSU training came from a variety of professions and used a variety of devices CURRENT TRENDS IN BLOOD FLOW RESTRICTION for BFR/KAATSU training. Individuals applied devices using a variety of parameters on populations for which efficacy has and has not been well defined. Keywords: blood flow restriction, KAATSU training 3 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 4 Acknowledgements First and foremost, thank you Dr. Slaven, Thank you for working with me the past two years as I navigated all the challenges of the doctoral project overlaid with the pandemic none of us could have envisioned. I have been grateful and honored to have you as a mentor throughout this process. Your steadfast patience, encouragement, and support was unwavering and I will always and forever be grateful for the opportunity to work with you. My committee- Dr. Novak, Dr. Saithna, and Dr. Strohmeyer- without your ideas and expertise this final project would not have been possible. I am incredibly appreciative of the time and assistance you dedicated to make this project possible. Thank you. To the faculty- Dr. Santurri, Dr. Borrero, Dr. Gahimer, Dr. Miller, Dr. Moore, Dr. Roark, and Dr. Rauch. I had no idea what to expect embarking on this adventure and I am grateful for the many opportunities and lessons. The program has fostered new ideas, forged new friendships, and facilitated growth both clinically and professionally. Thank you to those who worked tirelessly behind the scenes, most especially Teri Short and Dr. Wakeford. Your support for students does not go unnoticed. And thank you to my coworkers and the administrators at the University of Central Missouri. You have advocated and fought for my position in more ways than I will ever know and I am incredibly grateful for all of you throughout this process. Finally, to my family- my husband, grandmother, parents, siblings, nephews, and nieces. Education has always been viewed in the highest regard; forever encouraged and always advocated. Thank you for your patience and support throughout this entire endeavor. Most graciously, Molly Cuffe June 2021 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 5 Title Page.... 1 Abstract.. 2 Acknowledgements.... 4 Chapter 1: Introduction ....... 8 Background....8 Purpose.10 Significance of Study...10 Chapter 2: Literature Review... 11 Current Body of Knowledge11 Knee Wraps....11 KAATSU Training Device.12 Elastic Tourniquets.12 Inflatable Devices.. 13 Device Comparison13 Restriction Pressure..... 13 Cuff Properties... 16 Safety... 17 Blood Flow Restriction and Exercise.. 19 Aerobic Exercise19 Resistance Training21 Rehabilitation23 Gaps in Knowledge. 24 Clinician Relevance... 26 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 6 Chapter 3: Method.... 26 Participants.. 26 Sample Size... 27 Data Collection... 27 Operationalization of Variables. 27 Instrumentation.... 27 Procedures....28 Data Management.... 31 Data Analysis... 31 Chapter 4: Results... 31 Study Validity.. 31 Study Response Rates. 32 Previous BFR/KAATSU Training Use. 32 Current BFR/KAATSU Training Use. 33 Education... 33 Implementation.. 33 Barriers.33 Screening. 34 Application.. 34 Patient Demographics and Safety 36 Patient Demographics. 36 Safety. 37 Chapter 5 Discussion. 38 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 7 Discussion38 Study Limitations.45 Real World Implications... 46 Future Directions. 47 Conclusion 47 References. 49 Tables Table 1... 62 Table 2... 63 Table 3... 65 Table 4... 66 Table 5... 67 Table 6... 68 Appendices Appendix A... 69 Appendix B... 74 Appendix C... 75 Appendix D... 76 Appendix E... 81 Appendix F... 95 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 8 Current Use of Blood Flow Restriction Blood flow training was developed in the 1960s by Yoshiaki Sato for his own personal fitness training and rehabilitation (Sato, 2005). Sato termed his methodology KAATSU Training; KA is Japanese for additional and ATSU is Japanese for pressure. KAATSU training devices work by modifying blood flow (KAATSU Training, n.d.a). Since the release of his methodology in the 1980s (Sato, 2005), blood flow training continues to be popularized for its training and therapeutic intervention capabilities (Nakajima et al., 2006; Patterson et al., 2019; Sato, 2005). Blood flow restriction (BFR) training involves the application of a device to an extremity to alter blood flow and may include brief and partial limitations in blood flow during exercise. Specifically, the pressure applied by the device is intended to limit arterial blood flow to a limb while fully restricting venous outflow in working muscles during exercise (Scott et al., 2015; Patterson et al., 2019). Devices used to alter blood flow (either modify blood flow or restrict blood flow) vary in style. Patterson and Brandner (2018) identified multiple devices including the KAATSU devices as well as inflatable devices, knee wraps, or the use of elastic tourniquets which can all be used to facilitate BFR training. The devices are applied proximally along a limb with minimal pressure to facilitate restriction (McEwen et al., 2019). Restriction pressures can be determined through a variety of means including the use of doppler ultrasound (Masri et al., 2016), the device itself (McEwan et al., 2019), or subjective rating scales (Wilson et al., 2013). The effects of BFR are believed to facilitate muscle enlargement or hypertrophy through the combination of mechanical tension, or force, and metabolic stress occurring secondary to exercise. The use of low load exercise with BFR creates low force and high stress on muscles producing physiological changes such as cellular swelling, hormone production, and altered fast CURRENT TRENDS IN BLOOD FLOW RESTRICTION 9 twitch muscle recruitment. These changes then produce muscle growth (Pearson & Hussain, 2015). Blood flow restriction/KAATSU training can be used in conjunction with a variety of exercise techniques on individuals who are healthy or those who have comorbidities. Methods of exercise used with BFR/KAATSU training devices include aerobic exercise and resistance exercise. Aerobic exercise frequently used with BFR/KAATSU training include walking and cycling (Patterson & Brandner, 2018). Implementation of BFR with aerobic exercise in populations across the lifespan yielded improvements in muscle strength and hypertrophy in as little as three to six weeks following implementation (Patterson et al., 2019). When applied with resistance training, BFR in conjunction with low load exercise was also effective at improving muscle strength and hypertrophy in populations across the lifespan, both healthy and unhealthy (Patterson et al., 2019). In a healthy athletic population, the use of BFR with low load resistance exercise was effective when alternated with free flow (no BFR) exercise, specifically high load resistance training for strength gains (Wilk et al, 2018). As an adjunct to therapeutic intervention, BFR with low load resistance training has been used on patients with musculoskeletal weakness to gain muscle strength when high load exercise was contraindicated (Hughes et al., 2017). Furthermore, the use of BFR training post operatively has demonstrated success in those with anterior cruciate ligament (ACL) tears where improvements in leg strength and quadriceps cross sectional area have been seen following the implementation of BFR with low load resistance training (Ohta et al., 2003). Currently, little is known regarding how individuals are using different types of BFR/KAATSU training devices in the United States of America. The authors of three observational studies looked at experiences with BFR/KAATSU training (Patterson & Brandner, CURRENT TRENDS IN BLOOD FLOW RESTRICTION 10 2018; Nakajima et al., 2006; Yasuda et al., 2017). Researchers assessed how practitioners worldwide administer BFR (Patterson & Brandner, 2018) and conducted epidemiological studies addressing safety concerns specific to KAATSU training (Nakajima et al., 2006; Yasuda et al., 2017). Purpose The purpose of this study was to explore how individuals across different professions administered and used various forms of BFR/KAATSU training devices in the United States of America. In addition, the study sought to explore safety related to BFR/KAATSU training with various devices. The follow objectives were addressed to meet the purpose: Objective 1: Determine how BFR/KAATSU devices were being used across disciplines. Objective 2: Determine potential safety concerns among users of different forms of BFR/KAATUS devices. Objective 1 and 2 were quantified using a single setting using a computer-based survey. Significance of Study This study adds to the existing body of literature through its exploration of how BFR/KAATSU was being administered. Understanding how different forms of BFR/KAATSU training devices were being used can expose gaps in the literature needing further exploration. In addition, information concerning adverse effects could facilitate additional precautions when using different devices for BFR/KAATSU training. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 11 Literature Review Blood flow restriction training involves the modification of blood flow (KAATSU Training, n.d.b) which may include the brief and partial occlusion of arterial blood flow into a limb while fully restricting venous outflow in working muscles during exercise (Patterson et al., 2019). Currently, there are several styles of BFR/KAATSU training devices. The devices have been used across multiple age groups in conjunction with aerobic exercises, resistance training, and rehabilitative exercises. Current Body of Knowledge Blood flow restriction involves the application of a device to an extremity to alter blood flow. Training with the devices can facilitate blood flow modification as seen with the use of KAATSU equipment (KAATSU Training, n.d.a). Other devices facilitate blood flow restriction through the brief and partial restriction of arterial blood flow into the limb with the full restriction of venous outflow in working muscles during exercise (Patterson et al., 2019). A variety of devices have been used to alter or restrict blood flow. Patterson and Brandner (2018), in part, assessed clinician use of the following forms of devices which have been used to alter or restrict blood flow: knee wraps, KAATSU training device, elastic tourniquets, handheld inflatable devices, and automatic inflatable devices. Knee Wraps Knee wraps have been described in the literature by authors as elastic in nature (Head et al., 2015; Wilson et al., 2013) and as wraps used for power lifting purposes (Luebbers et al., 2014; Luebbers et al., 2019). Loenneke and Pujol (2009) described the use of knee wraps as a form of practical occlusion (practical BFR) and suggested when using a knee wrap to facilitate the restriction of blood flow, the wrap should be placed around the proximal targeted muscle CURRENT TRENDS IN BLOOD FLOW RESTRICTION 12 group. Researchers have used wraps approximately 7.6 cm wide (Head et al., 2015; Luebbers et al., 2014; Luebbers et al., 2019; Wilson et al., 2013) but lacked consistency in the length of the wrap ranging from no wrap length identified (Wilson et al., 2013) to 188 cm in wrap length (Head et al., 2015). Practical BFR has been applied to both the upper extremity (Luebbers et al., 2014) and lower extremity (Head et al, 2015; Luebbers et al., 2014; Luebbers et al., 2019; Wilson et al., 2013). All of the styles of knee wraps currently being used to facilitate BFR are unknown at this time. If, however, the wraps being used are considered straps or tubing and marketed specifically to limit blood circulation when applied to a body part, the devices are considered non pneumatic tourniquet devices by the United States Food and Drug Administration (FDA). The devices are considered a Class 1 device which do not need pre-market approval when used for their intended purpose (FDA, 2020a). KAATSU Training Device The KAATSU training device was the original blood flow training device. KAATSU Training received a patent in the 1990s in the United States of America (Sato, 2005), and current KAATSU training devices are marketed as either an air band or an elastic band with pneumatic control (KAATSU Training, n.d.b). The devices are described to facilitate blood flow modification rather than blood flow restriction. The devices have been shown to reduce venous blood flow without occluding arterial blood flow (KAATSU Training, n.d.a; Nakajima et al., 2006), facilitate pooling of venous blood, and decrease cardiac preload (Nakajima et al., 2006). Elastic Tourniquets Tourniquets are air powered devices that apply pressure to a limb thereby reducing or occluding circulation to a body part. The devices consist of an inflatable cuff, a unit which CURRENT TRENDS IN BLOOD FLOW RESTRICTION 13 regulates pressure, and tubing which connects the cuff to the regulating unit (FDA, 2020a). Pneumatic tourniquets are described as Class 1 devices by the FDA (2020a) and used for surgery. Because tourniquets used for BFR are not used for surgery, the devices do not meet premarket exemption guidelines and need FDA premarket approval prior to being sold (FDA, 2020a). Tourniquets, when used to facilitate BFR, are recommended for use in conjunction with rehabilitation exercises (McEwan et al., 2019; Patterson et al., 2019). Inflatable Devices Inflatable devices are cuffs applied to the limb that can be inflated through an automatic device or handheld pump. Within the literature, terms such as a pressure cuff (Byrk et al., 2016) may be seen as opposed to inflatable devices or inflatable pumps. If the cuff being used to facilitate restriction is a blood pressure cuff, the device is regulated as a Class 2 device by the FDA (2020b). Device Comparison Hughes, Rosenblatt, Gissane et al. (2018) compared different types of BFR devices: a device which allowed for automatic rapid inflation (inflatable device), an automatic personalized tourniquet (elastic tourniquet), and a manual handheld device with sphygmometer (inflatable device). Among the results included pressure variations during exercise in the automatic rapid inflation device and the manual handheld device with a sphygmometer (Hughes, Rosenblatt, Gissane et al., 2018). Pressure variations which can be seen in non-tourniquet devices have been noted as a concern particularly during rehabilitation exercise by McEwan et al. (2019). Restriction Pressure As noted, several factors have influenced the experience an individual has when using BFR/KAATSU training devices. Essential to the experience; however, is the ability for the CURRENT TRENDS IN BLOOD FLOW RESTRICTION 14 device to alter blood flow and/or occlude venous blood flow resulting from the restriction of arterial blood flow distal to the site of the limb occlusion. The application of a cuff to a site along a limb with a minimal amount of pressure is needed to facilitate the process (McEwen et al., 2019). Factors affecting the process of arterial blood restriction include the cuffs construction and dimensions, restriction pressure, the site of restriction, individual attributes, and individual physiology (McEwen et al., 2019; Patterson et al., 2019). Limb circumference (Jessee et al., 2016; Loenneke et al., 2012; Sieljacks et al., 2018) and diastolic blood pressure (Loenneke et al., 2012; Sieljacks et al., 2018) have also been noted to influence pressure. There has been wide acceptance in using an individualized approach when determining limb restriction pressure. Individualizing restriction pressure has facilitated consistency and safety. Restriction pressures too high can decrease nerve conduction velocity, promote thrombus development, and minimize outcome effectiveness (McEwen et al., 2019; Wilk et al., 2018). In addition, higher restriction pressures have led to a greater load placed on the cardiovascular system (McEwen et al., 2019), and increased ones discomfort (Patterson et al., 2019). The application of BFR/KAATSU training is optimally performed at low to moderate restriction pressures. The use of limb occlusion pressure is a method used to determine restriction pressures. One recommendation is to use 40-80% ones limb occlusion pressure when completing exercise (Patterson et al., 2019). Staying at the lower end of the recommended limb occlusion pressures presented by Patterson et al. (2019) will produce lower levels of pain and perceived exertion. Soligon et al. (2018) studied a group of males completing equal total training volume exercise at various BFR limb arterial occlusion pressures or with high intensity exercise and no BFR. Soligon found lower ratings of perceived exertion and pain among the BFR group using lower occlusion pressures, specifically 40% or 50% limb occlusion pressure (Soligon et al., CURRENT TRENDS IN BLOOD FLOW RESTRICTION 15 2018). Researchers have demonstrated pressure affects blood flow in a nonlinear fashion within the brachial artery (Mouser et al., 2017), and superficial femoral artery perhaps providing reason for more comfortable yet equivalent experience when setting limb occlusion pressure within the range of 40% to 80%, either at rest or at exercise (Crossley et al., 2020). Lower levels of occlusion pressures over a period of time have also demonstrated improved perceptual response by subjects. Mattocks et al. (2019) found that following an eight-week intervention, ratings of perceived exertion and discomfort were reduced in the upper body when using 40% and 80% occlusion pressures, while ratings of perceived exertion and discomfort in the lower body were reduced when using 40% occlusion pressures. Low load resistance training with BFR also yielded a lower rate of perceived exertion when compared to high load resistance training albeit higher levels of pain. Both forms of exercise yield reductions in both rates of perceived exertion and pain values over an eight-week knee extension training protocol (Teixeira et al., 2020). Different types of equipment may be used to objectively determine occlusion pressure. Equipment may include an automatic unit or a doppler ultrasound. While doppler ultrasound has shown reproducibility in finding total occlusion pressure of the brachial artery (Bezerra de Morais et al., 2017) and its use has been advocated for when finding limb occlusion pressure (Masri et al., 2016), McEwen et al. (2019) indicated potential limitations due to their manual operation. Other methods, including the use of pulse oximetry, are being explored for their role in determining arterial occlusion pressure (Lima-Soares et al., 2020; Zeng et al., 2019). When using practical BFR, (use of wraps), objective methods to measure restrictive pressure do not exist. Wilson et al., (2013) subjectively quantified values based on perceived pressure using a 10-point scale with the following criterion: 0 out of 10 was the control, 7 out of CURRENT TRENDS IN BLOOD FLOW RESTRICTION 16 10 was considered moderate pressure, and 10 out of 10 was considered tight pressure. Wilson found a moderate perceived pressure described as a 7 out of 10 on a 0 to 10-point scale repeatedly correlated with venous occlusion but not arterial occlusion (Wilson et al., 2013). Multiple authors have noted a subjects perceived pressure rating of 7 out of 10 when using knee wraps for BFR training research (Formiga et al., 2020; Head et al., 2015; Paton et al., 2017). Cuff Properties When considering the cuff, cuff material has less variability than cuff width on restriction pressure. Both nylon cuffs and elastic cuffs are considered acceptable for use when applying BFR (Patterson et al., 2019). Of greater concern has been limb circumference as well as cuff width when determining restriction pressure for BFR use. Limb circumference was shown to have limited impact when using wider cuffs in cadavers (Crenshaw et al., 1988). The authors of a more recent BFR specific study showed diastolic blood pressure, thigh circumference, and ankle blood pressure influenced the pressure of wider cuffs (13.5 cm) while in smaller width cuffs (5 cm) diastolic blood pressure and thigh circumference influenced cuff pressure in BFR/KAATSU training devices (Loenneke et al., 2012). Thigh circumference has since been demonstrated as a predictor of arterial occlusion pressure in the lower extremity when using BFR (Loenneke et al., 2015). Adding further variability to restriction pressure determination has been the width of the cuff used. When assessing cuff width and pressure on cadaver-based subjects, Crenshaw et al. (1988) found higher pressure values were needed to eliminate a pulse when using cuffs with narrow widths (4.5 cm). When using cuffs with wider widths (18 cm) lower pressure values were needed to eliminate a pulse (Crenshaw et al., 1988). When using BFR, cuff width has also been noted to influence pressure (Jessee et al., 2016; Loenneke et al., 2012; Scott et al., 2015; CURRENT TRENDS IN BLOOD FLOW RESTRICTION 17 Sieljacks et al., 2018). Like Crenshaw et al. (1988), wider width cuffs (13-14 cm) were found to take a lower pressure value to achieve arterial occlusion pressure while more narrow cuffs (5-6 cm) achieve arterial occlusion pressure at a higher pressure (Loenneke et al., 2012; Sieljacks et al., 2018). When facilitating practical BFR, researchers have used wraps that were approximately 7.6 cm wide (Head et al., 2015; Luebbers et al., 2014; Luebbers et al., 2019; Wilson et al., 2013). Using cuffs widths both narrow and large pose a risk. Smaller width cuffs need a higher pressure to obtain occlusion risking potential nerve damage (Crenshaw et al., 1988), health risks, and limited exercises benefits (Loenneke et al., 2014; Scott et al., 2015), while wider cuffs can restrict movement, facilitate pain, and increase perceived exertion rates (Scott et al., 2015). To accommodate for the variety in limb size and cuff sizes, one consideration is to use a BFR pressure that is based on limb occlusion pressure while avoiding cuffs which impede movement patterns (Patterson et al., 2019). Safety Several researchers have highlighted the importance of correct application and safety in training (Hughes et al., 2017; Loenneke et al., 2011; Patterson et al., 2019; Sato, 2005). Loenneke et al. (2011) found when compared to free flow high load resistance exercise, BFR/KAATSU training produced no change in nerve conduction velocity, muscle damage, and oxidative stress while high load exercise increased all three areas. In addition, these authors reported stroke volume, blood pressure, heart rate, fibrinolytic potential, coagulation activity, and post occlusion blood flow all responded the same as free flow high load resistance exercise in short term studies (Loenneke et al., 2011). While research is needed to identify potential causes of susceptibility to adverse physiologic responses, when BFR is applied and performed CURRENT TRENDS IN BLOOD FLOW RESTRICTION 18 appropriately muscle damage should not occur unless one is otherwise prone to muscle damage (Patterson et al., 2019). While several concerns surrounding the physiological response to BFR training have been dispelled, adverse effects have been identified. Safety concerns noted by Nakajima et al. (2006) related to the KAATSU training devices included subcutaneous hemorrhage and numbness, while other more serious health concerns including venous thrombus, pulmonary embolism, rhabdomyolysis, and cerebral infarction were noted to have occurred. Yasuda et al. (2017) found symptoms including dizziness, subcutaneous hemorrhage, drowsiness, itchiness, nausea, and numbness among clients who are healthy or may have comorbidities using KAATSU training devices. However, some of the complications are suspected to have occurred secondary to other health concerns or improper use of the device by the device administrator (Yasuda et al., 2017). Errors with BFR application can include incorrect cuff pressure and the width of the cuff used (Patterson et al., 2019). One condition that has been reported in the literature secondary to BFR/KAATSU training use was rhabdomyolysis. Cases of rhabdomyolysis have been acknowledged (Hughes et al., 2017; Nakajima et al., 2006), including one in an untrained individual with obesity and one in a trained athlete (Hughes et al., 2017). Tabata et al. (2016) likewise described the patients: one patient presented with rhabdomyolysis and bacterial pharyngitis simultaneously following a workout with BFR. While the contents of the workout with BFR were unknown, the authors indicated multiple factors likely contributed to the onset of rhabdomyolysis. The second case of rhabdomyolysis involved a hockey player completing knee extension exercises using a set sustained occlusion pressure of 100 mm Hg (Tabata et al., 2016). No cases of rhabdomyolysis, cerebral hemorrhage, cerebral infarction, or thrombosis were reported by Yasuda et al. (2017) CURRENT TRENDS IN BLOOD FLOW RESTRICTION 19 during use with KAATSU devices. The risk of rhabdomyolysis is thought to be no greater than other forms of exercise (Patterson et al., 2019). Another area lacking knowledge as it relates to BFR training involves how males and females have experienced BFR. Couts et al. (2018) found research related to BFR training focussed on the male gender with information specific to the female gender lacking. While the menstrual cycle is noted as a potential cause for low representation (Counts et al., 2018), it is unknown if safety concerns vary by gender. Additional safety research pertaining to BFR is needed (Loenneke et al., 2011; Patterson et al., 2019) and ongoing (Patterson et al., 2019). Blood Flow Restriction and Exercise The physiological effects of BFR are related to mechanical tension and metabolic stress. Combined they facilitate mechanisms stimulating muscle hypertrophy (Pearson & Hussain, 2015; Wilk et al., 2018). These mechanisms include cell swelling, fast twitch muscle fiber recruitment, and hormone production (Pearson & Hussain, 2015). Aerobic Exercise Blood flow restriction has been used in conjunction with aerobic exercise (Patterson et al., 2019). Aerobically, walking and cycling were common forms of exercises used with BFR, while swimming and running were also performed (Patterson & Brandner, 2018). Despite a lack of standardization for the use of BFR with aerobic exercise, it is believed to take approximately three to six weeks to see changes in strength and muscle hypertrophy (Patterson et al., 2019). One recommendation for walking or cycling with BFR has been established by Patterson et al. (2019) and includes exercising two to three times per week at less than 50% heart rate reserve, VO2 Max, for 5 to 20 minutes at 40-80% arterial occlusion pressure. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 20 Forminga et al. (2020) demonstrated that the use of low to moderate aerobic exercise (running or biking) developed a greater aerobic capacity than low to moderate free flow aerobic exercise. High intensity aerobic exercise with BFR did not improve aerobic capacity more than aerobic capacity in free flow aerobic exercise (Formiga et al., 2020). Chen et al. (2019) assessed the use of BFR in conjunction with running warm up exercises and found no improvement in knee extensor strength or 60-meter sprint performance following a single bout of warm up either with or without BFR followed by either strength testing or a 60-meter sprint. The authors found knee flexor strength was greater when completing warm up running exercises with BFR as was concentric hamstring-quadriceps ratio. In addition, muscle activation of the vastus lateralis and biceps femoris were greater following BFR running exercise warmup; however, no difference was found between warm up groups and tibialis anterior and medial gastrocnemius. Interactions were found between time and warm up in rate of perceived exertion, heart rate, as well as blood lactate (Chen et al., 2019). One barrier to the research by Chen et al. (2019) could have been the length of the study as Patterson et al. (2019) noted three to six weeks is needed to demonstrate muscle strength gains. When practical BFR has been used with aerobic exercise bilaterally, Paton et al. (2017) found positive effects in a group of healthy subjects. When compared to a free flow group completing 30 second repetitions of running, Paton et al. (2017) found those with practical BFR had increased heart rate, increased peak running velocity, increased incremental test time, and improved time to exhaustion when compared to the free flow group. Both groups saw an improvement in maximal oxygen uptake. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 21 Resistance Training The use of BFR with resistance training has been researched more than its uses with aerobic exercise. The use of low load resistance exercise with BFR to gain muscle strength and hypertrophy has one of the following suggestions for use: two-four times per week using 75 repetitions (30-15-15-15) or repetitions to failure (Patterson et al., 2019). Each repetition should last 1-2 seconds for the complete movement and 30-60 seconds rest should be allotted between sets for a total of 5-10 minutes restriction at a time. Reperfusion may occur between sets or between single or multiple exercises. When BFR is in use, arterial occlusion pressure should be set at 40-80% (Patterson et al., 2019). Despite the recommendation, there is data to support not completing exercises with BFR to failure. For instance, when a single bout of low load eccentric exercise was performed with BFR to failure, muscle damage occurred similarly to eccentric exercise with no BFR, and additional bouts of low load eccentric exercise with BFR yielded lower levels of muscle damage (Sieljacks et al., 2016). Additionally, Sieljacks et al. (2019) had 14 male subjects complete 20 to 22 exercise bouts with BFR, one leg to failure and the opposing leg not to failure. Similar changes were seen in muscle size and function between legs. When the exercise was not taken to failure, subjects experienced a lower rate of perceived exertion, a lower discomfort level, and less delayed onset muscle soreness (Sieljacks et al., 2019). Blood flow restriction with low intensity resistance training has also demonstrated the ability to increase blood pressure, heart rate, and rate-pressure product more than low intensity training alone in reviews of subjects of varied genders (Neto et al., 2017). Blood flow changes were found similar to free flow exercise among unspecified populations (Loenneke et al., 2011). CURRENT TRENDS IN BLOOD FLOW RESTRICTION 22 Another difference between free flow training and BFR training are the mechanisms which produce strength. Neural changes and mass create strength in free flow exercise particularly high load resistance training, while BFR training allows one to develop muscle strength through muscle hypertrophy (Wilk et al., 2018) secondary to physiological changes occurring with BFR use including cellular swelling, hormone production, and altered fast twitch muscle recruitment (Pearson & Hussain, 2015). As such, strength gains will vary depending on training methods implemented. When compared to BFR with low load resistance training, free flow high load resistance training produced greater strength gains (Cook et al., 2017; Lixandro et al., 2018). This is contraindicated by Grnfeldt et al. (2020) who found both forms of exercise produced similar muscle strength gains across 16 studies assessing a lone variable in adults across the lifespan. Within an older adult population, strength gains were found to be similar when completing either free flow high load resistance training or low load BFR training (Cook et al., 2017). Compared to low load resistance training alone, strength gains and muscle mass were consistently greater in the group completing BFR with low load resistance training (Slysz et al., 2016). Due to the variability in strength gains, when high load resistance training has been contraindicated, the use of BFR has been recommended to aid in the maintenance and development of strength (Hughes et al., 2017). If BFR training is used among a healthy athletic population, a combination of free flow high load resistance training and BFR with low load resistance training is recommended to accommodate for the difference in strength development (Wilk et al., 2018). The use of practical BFR as a means to develop strength has been mixed. A randomized control of 12 individuals using either elastic wrap with a perceived 7 out of 10 tightness, or a 0 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 23 out of 10 perceived tightness completed single leg body squats until failure twice weekly for six weeks. The authors reported no difference in quadriceps strength, hypertrophy, or function (Head et al., 2015). Luebbers et al. (2014) did see improvements in one repetition maximum squat performance following seven weeks of practical BFR training among collegiate athletes. No improvements, however, were seen in muscle size or the extent of gain in a one repetition max bench press in those completing high intensity workouts, high intensity workouts with low load modification and no practical BFR, or those completing a modified lifting program with practical BFR (Luebbers et al., 2014). A group of high school students completing either a high load training program, a low load training program, or a low load training program with practical BFR saw improvements in a one repetition max on the parallel back squat following the completion of the low load program with practical BFR (Luebbers et al., 2019). Rehabilitation. Blood flow restriction with and without low load resistance training has been used to help reduce pain, treat atrophy, increase strength, and muscle size in a variety of health conditions. Conditions which BFR has demonstrated effectiveness include post-operative ACL repairs (Barber-Westin, & Noyes, 2019; Hughes et al., 2017; Hughes, Paton, et al., 2018; Hughes, Rosenblatt, Paton, et al., 2018; Ohta et al., 2003); osteoarthritis (Barber-Westin, & Noyes, 2019; Bryk et al., 2016; Ferraz et al., 2018); trauma (Hylden et al., 2015); polymyositis and dermatomyositis (Matter et al., 2014); sarcopenia (Hughes et al., 2017), and other forms of lower extremity pain (Ledlow et al., 2018). In addition, an older population with coronary artery disease saw improved strength and decreased systolic blood pressure following BFR training with low load resistance exercise (Kambi et al., 2019). Researchers have also found fewer cases of adverse knee pain in patients completing BFR training with post-operative ACL repairs (Hughes, Paton, et al., 2018). Similar reductions in adverse knee pain were seen in patients with CURRENT TRENDS IN BLOOD FLOW RESTRICTION 24 osteoarthritis completing BFR training when compared to patients with osteoarthritis completing moderate intensity resistance training (Harper et al., 2019). One area with mixed results from rehabilitation exercise with BFR includes tendinopathies and the structural change BFR training may facilitate in the tendon. For example, it is believed that the patellar tendon is capable of hypertrophy (Kongsgaard et al., 2007), but research involving an equine population (Abe et al., 2006) and human population (Kubo et al., 2006) found minimal tendon changes following BFR training. Centner et al. (2019) focused on the Achilles tendon demonstrating tendon changes may be capable. These authors assessed the effect of a 14-week intervention on Achilles tendon properties, maximum torque velocity, cross sectional area of the gastrocnemius medialis muscle and Achilles tendon, and tendon stiffness in a sample of untrained males using a control, free flow high load resistance training, or low load resistance training with blood flow restriction. Centner et al. (2019) found improvements in Achilles tendon cross sectional area, Achilles tendon stiffness, gastrocnemius medialis muscle cross sectional area, and maximum torque velocity in both training groups. Pain ratings were not assessed by the authors of the articles pertaining to BFR and tendinopathy (Abe et al., 2006; Centner et al., 2019; Kubo et al., 2006). As with all applicable uses of BFR, many avenues of research are still needed. Gaps in Knowledge From the review, several gaps exist in the literature. Gaps include how individuals of various health professions are using various platforms of BFR in practice, and specific adverse effects when using various styles of BFR/KAATSU training devices. In addition, a review of the literature only yielded three observational studies related to BFR/KAATSU training use. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 25 The authors of the observational studies focused on clinician use of BFR (Patterson and Brandner, 2018) and the use of KAATSU training specifically (Nakajima et al., 2006; Yasuda et al., 2017). Patterson and Brandner (2018) assessed the use of BFR training globally by physicians, strength and conditioning specialists, rehabilitation specialists, sport specific scientists, personal trainers and researchers. Patterson and Brandner asked questions related to BFR training devices, BFR training use, safety and methods related to passive BFR training, aerobic BFR training, and BFR resistance exercise training. The authors demonstrated those using BFR training do so in a variety of methods with safe results (Patterson and Brandner, 2018) lending to a position statement by Patterson et al. (2019). In the remaining studies, authors focused on the use and safety related to the KAATSU training (Nakajima et al., 2006; Yasuda et al., 2017). Nakajima et al. (2006) explored how KAATSU training was used and the adverse effects seen. Nakajima demonstrated that KAATSU training was being used for a variety of pathologies with minimal adverse effects. Yasuda et al. (2017) completed a study similar to Nakajima et al. (2006) exploring KAATSU training, how the training methods were being implemented, adverse effects, and what may have changed since the Nakajima article. KAATSU training has been performed on a variety of pathologies, across a variety of demographics with minimal adverse effects (Yasuda et al., 2017). Prior researchers demonstrated safety in BFR training with inconsistencies in the use of BFR devices (Patterson et al., 2019). Furthermore, KAATSU training methods have demonstrated effectiveness in implementation by trained professionals across demographics for a variety of uses (Nakajima et al., 2006; Yasuda et al., 2017). At this time, it is unknown how individuals of various health related professions specifically in the United States of America are using different styles of BFR/KAATSU training devices. Nor is it known what adverse effects, if CURRENT TRENDS IN BLOOD FLOW RESTRICTION 26 any, have been seen with individual BFR/KAATSU training device use. There is a need to better understand how BFR/KAATSU training is being applied and used in clinical application within the United States of America. Clinician Relevance Currently, there are several styles of BFR/KAATSU training devices available on the market. Having an understanding of how styles are being used as compared to the literature can provide those working in health-related fields additional knowledge to make informed decisions regarding the use and applicability of BFR/KAATSU training to ones respected profession. Method This was an observational study in which the researcher explored how individuals across different professions in the United States of America used various forms of BFR/KAATSU training devices via survey research. In addition, safety related to BFR/KAATSU training was investigated. The study took place March 22, 2021-April 21, 2021. Prior to starting participant recruitment, the study was approved by the University of Indianapolis' Institutional Review Board. Participants Those using BFR/KAATSU training devices were included in the study. To be included in the study, participants met the following criteria: (a) English speaking, (b) older than 18 years old, and (c) use BFR/KAATSU training for aerobic exercise, strength training exercise, or rehabilitation purposes in the United States. Subjects were excluded if (a) BFR/KAATSU training was not being used with patients/clients/athletes. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 27 Sample Size Sample size was determined using a standardized formula presented by Smith (n.d.): ((z-score)^2 x standard deviation x (1-standard deviation))/(margin of error)^2. The following data will be used: confidence interval of 95%, Z-Score of 1.96, a margin of error of 5% and a standard deviation of .5. A sample size of 384 participants were needed. Data Collection Once data collection was completed in Qualtrics (Version XM), the primary investigator exported data for analysis from Qualtrics into Microsoft Excel (Version 2101) then the statistical software management system, IBM SPSS Statistics for Windows (Version 27). Operationalization of Variables For this study, blood flow training included any device allowing for modification of blood flow and used in conjunction with aerobic activity, strength training activity, or activities related to rehabilitative exercise. Instrumentation The researcher developed the survey. More information regarding the survey itself can be found in the Procedures section. A test pilot of the survey was administered in November 2020. A content expert recruited subjects and served as a liaison between the researcher and the subjects taking the pilot survey to ensure anonymity. The survey was restrictively administered to the group of 10 subjects on two separate occasions, one week apart. All 10 participants completed the survey the first time while eight participants completed the survey the second time. Data was analyzed using IBM SPSS Statistics for Windows (Version 24). Participants were all Caucasian with 60% of subjects identifying as male and 40% identifying as females. All were from the Midwest with a mean age between 31 and 40 years. Participants represented the CURRENT TRENDS IN BLOOD FLOW RESTRICTION 28 professions of athletic training, physical therapy, and strength and conditioning with an average time in their respective fields of less than 10 years. The survey took participants approximately 13 minutes to complete. The purpose of the test pilot was to assess the content presented in the survey. Individual constructs were both normally and not normally distributed assessing Shapiro Wilkes with p<.05. Subsequent Pearson correlation and Spearman Rho correlation showed significance between measures with an alpha value of p<.05. Constructs with correlations display moderate correlation to high correlation. Cronbachs alpha on 24 applicable items was =.484. Considering the statistical results in conjunction with subject feedback, the following questions were modified and presented in Appendix A: four questions were modified secondary to the pilot (questions D, E, H, and N), three questions were deleted as the repeated the informed consent (questions A, B, and C), and eight questions were edited to provide more inclusive language (questions F, G, I, J, K, L, M, and O). Further analysis comparing test pilot subjects to the subject pool was completed following the study. Procedures Recruitment was completed through convenience and snowball sampling. Several groups were contacted using a similar email template (Appendix B) to help facilitate recruitment. The following groups agreed to be a part of sampling on Facebook: Kansas City Athletic Trainers Society; Women in Athletic Training Group; and the following National Strength and Conditioning Association (NSCA) Special Interest Groups: College Coaches, Personal Trainers, Sport Science and Performance Technology, and Sports Medicine/Rehabilitation. Groups for which the recruitment statement and survey were posted had the following numbers at the time of posting: CURRENT TRENDS IN BLOOD FLOW RESTRICTION 29 Kansas City Athletic Trainers Society: 445 members Women in Athletic Training Group: 9,065 members National Strength and Conditioning Association (NSCA) Special Interest Groups College Coaches: 3,596 members Personal Trainers: 2,371 members Sport Science and Performance Technology: 1,752 members Sports Medicine/Rehabilitation: 2,961 members The following groups agreed to be surveyed through email Collegiate Strength and Conditioning Association: membership sent to: 2,601 individuals. In total, there were potentially 20,190 subjects recruited through Facebook and 2,601 subjects through email. This did not include the effects of snowball recruitment. The recruitment message was posted by the researcher and was uniform across all Facebook group pages (Appendix C). A similar uniform message was emailed out by the Collegiate Strength and Conditioning Association on the researchers behalf (Appendix C). The survey was initially available for 14 days beginning and ending at midnight. Following seven days, the same uniform message was re-sent or reposted in all platforms that agreed to take part in sampling (Appendix C). Due to low response rate during the initial two week survey window, the survey was reopened for an additional two weeks and the same uniform message was redistributed through each platform. Following the second period of two weeks the survey was closed and data analysis began. The survey began with potential participants reviewing an electronic informed consent form and asking if subjects accepted the informed consent form (Appendix D). Following CURRENT TRENDS IN BLOOD FLOW RESTRICTION 30 completion of the informed consent form, the subjects progressed through the survey. All subjects completed the same survey, which was developed, housed, and deployed through Qualtrics. It was anticipated that the survey would take subjects approximately 13 minutes to complete. Participants were asked up to but no more than 37 questions divided into the following sections: Informed Consent, Product Use, Current Use, Safety, Demographics of patients, clients, and athletes, and Demographics of the respondent. The Informed Consent portion of the survey housed the informed consent documentation and participants were asked to consent to the research. The questions within Product Use focussed on the types of BFR/KAATSU training devices both previously and currently being used by the subject. The Current Use section asked questions pertaining to the methods used to apply BFR/KAATSU training. The Safety section assessed safety and adverse effects when using BFR/KAATSU training devices. The final two sets of questions asked about demographics of the patients/clients/athletes for which BFR/KAATSU training was applied and the demographics of the individual completing the survey (Appendix E). A subject could terminate participation in the survey at any given time by closing out of the survey. At the conclusion of the survey, regardless of how much of the survey was completed, all were taken to a separate page also housed through Qualtrics. Participants were offered the opportunity to enroll for a chance to win one of five $10 gift cards. If participants entered the drawing, they were required to provide an email address (Appendix F). Gift cards were sent within one week of the final survey conclusion. Winners were selected using a random selection formula in Microsoft Excel: Formula =INDEX(ColumnCellNumber:ColumnCellNumber, RANDBETWEEN (FirstCellNumber,LastCellNumber)). An example of the formula would be Formula =INDEX(A2:A20, RANDBETWEEN(1, 20)) (Computergaga, 2015). If emails with the gift CURRENT TRENDS IN BLOOD FLOW RESTRICTION 31 cards were returned, new emails were selected using the aforementioned formula and gift cards were sent to new recipients. Data Management Following data collection, data was managed accordingly. Acknowledgment and acceptance of the informed consent were asked first within the survey and subsequently housed within Qualtrics. All additional survey data was likewise housed through Qualtrics. At the conclusion of the survey, data was exported to Microsoft Excel then uploaded for analysis into the statistical software management system, IBM SPSS Statistics for Windows. Data Analysis Descriptive statistics were used to describe the group. Nominal data was presented as frequencies and percentages while normally distributed interval and ratio data was reported as means and standard deviations and non-normally distributed interval and ratio data as medians and interquartile ranges. Data was analyzed using IBM SPSS Statistics for Windows (Version 27). Results Study Validity The study involved the development of a 37-question survey. To demonstrate face validity, a random sample of 10 responses were compared with the sample of 10 responses from the survey test pilot (test pilot information can be found within the Method section). Data collected from individual questions was either normally distributed (Shapiro-Wilkes p<.05) or non-normally distributed (Shapiro Wilkes p>.05). No correlations were found between the two groups. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 32 Study Response Rates The study sought to explore how individuals across a variety of professions within the United States of America were using BFR/KAATSU training devices and to explore safety related to BFR/KAATSU training. Both convenience sampling and snowball sampling were used and the survey was deployed March 22, 2021 through April 21, 2021. During this time 149 responses were collected; 148 individuals consented to participate in the survey research. Of those consenting to the survey research, there were 40 (27%) individuals who did not complete the survey, 38 (25.7%) who were not currently using BFR/KAATSU training, and 70 (47.3%) who at the time of the survey were using BFR/KAATSU training. Through convenience sampling, the survey was made available to 22,791 individuals via Facebook and email for a response rate less than 1%. This excluded those who were made aware of the survey research through other individuals (i.e., snowball sampling) creating a lower response rate than the one reflected. Previous BFR/KAATSU Training Use Information regarding those previously using BFR/KAATSU training devices (n=108) and those currently using BFR/KAATSU training devices (n=70) can be found in Table 1. Individuals who were not actively administering BFR/KAATSU training (n=38, 35.2%) were henceforth excluded. Reasons identified for no longer using BFR/KAATSU training include: I previously utilized for injury rehabilitation, is no longer necessary, not allowed per company because I have not taken company's training, I am at a different school where we do not have blood flow restriction devices, and I do not have the resources in my athletic training room to use this form of rehab. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 33 Current BFR/KAATSU Training Use The remaining respondents (n=70) identified as males (n=41, 58.6%) and females (n=29, 41.4%). Additional information on demographics and professional careers can be found in Table 2. In regards to length of time to complete the survey, one outlier was removed as response time was 193,194 seconds (3,219.9 minutes). For the remaining responses (n=69), the survey took respondents an average of 657.65 seconds (10.96 minutes) to complete; a minimum of 226 seconds (3.76 minutes) and a maximum of 2,937 seconds (48.95 minutes). Education Respondents suggested obtaining both formal education (n=39, 55.7%) and self education (n=37, 52.9%) for their respective BFR/KAATSU devices. Of those who received formal training, 29 (74.4%) felt their training promoted a singular device, and 24 (61.5%) indicated their education was tailored toward a specific device. The majority (n=58, 82.9%) felt that some sort of education should take place prior to BFR/KAATSU training implementation, while five felt education prior to implementation was not needed and an additional seven had no opinion on the matter. Implementation Barriers. Barriers were faced by 29 (41.4%) when trying to implement BFR/KAATSU training into practice. Barriers noted by those facing barriers included the cost of equipment (n=20, 69%), lack of training (n=10, 34.5%), doubts of effectiveness (n=9, 31%), and a lack of clinical efficacy (n=4, 13.8%). Other barriers noted were: concerns of medical complications (e.g. DVTs), concerns of medical staff, confidence in applying technique and having patient/client understand that BFR training is hard, lack of physician/surgeon buy-in, patient consent, patient fear, patient unwilling to try, and lack of supervisor approval. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 34 Screening. Screening processes facilitated by respondents were comprised of medical screening forms including risk assessments and/or in person physical examinations (n=27, 38.6%), both waiver/release forms and medical screening forms including risk assessments and/or in person physical examinations (n=22, 31.4%), waivers/release forms (n=1, 1.4%), and other screening processes (n=2, 2.9%): assure pt [sic] has no contraindication to BFR per a list and acquire consent from patient after describing treatment, and screening is done based off of recommendations of Owens Recovery Science. Additionally, 57 (81.4%) respondents gave consideration to the psychosocial aspects related to BFR/KAATSU training. Eighteen (25.7%) did not conduct screening. Reasons suggested for a lack of screening were: all participants are screened by medical department prior to contact with us, they are cleared by ATs for physical activity our requisites are met, initial health screening showed not signs of potential adverse interactions, we already know based on the medical history/chart if they are able to use this or not, communication with AT to determine if they are a good candidate for modality of BFR, we ask if they have history of blood clots, verbal consent, elite athletes, it is safe to use on the athletic population and patients I use it on, only self use, I have only used on myself, use only on myself, and we just dont have one outside of the one they sign for therapy. Application. Survey responses suggested the following methods to determine restrictive pressure: the use of comfort (i.e., 7/10 perceived tightness) (n=13, 18.6%), limb circumference (n=4, 5.7%), standard blood pressure (n=5, 7.1%), doppler ultrasound (n=11, 15.7%), or the device was set to determine restrictive pressure (n=31, 44.3%). The remaining six responses (8.6%) provided other methods to determine restrictive pressures: systolic pressure x 1.5, comfort and blood pressure, skin color, there should be a faint pulse, color should return to skin CURRENT TRENDS IN BLOOD FLOW RESTRICTION 35 when pressed, capillary refill with progressive tightness based on both refill and feedback, device, will often lower pressure for first session, and not able to use any equipment. The majority (n=67, 95.7%) believed personalizing restrictive pressure would reduce adverse effects, and multiple positions were used to determine restrictive pressure. Restrictive pressure determination was completed with the patient/client/athlete in a supine position (n=33, 47.1%), seated position (n=11, 15.7%), standing position (n=9, 12.9%), and in an exercise dependent position (n=17, 24.3%). For subsequent exercises, restrictive pressure was determined by the same measures as the initial assessment (n=38, 54.3%), a different method from the initial method based on exercise position (n=11, 15.7%), or no additional measurement of restriction pressure was made for subsequent exercises (n=21, 30%). Workload was determined using: heart rate (n=5, 7.1%), percentage of 1 RM (n=18, 25.7%), length of time under tension/load (n=22, 31.4%), work to failure (n=14, 20%), and other methods (n=11, 15.7%). Other methods suggested were using Delfi protocol, adding resistance if not worked to failure by end of protocol at next session, both %1 RM and length of time under tension, load and reps, low weight, high rep, 15-20 minutes, 30/15/15/15, prescribed reps/sets from educational training, reps in deserve [sic], muscle fatigue scale, perceived exertion, RPE, by feel, muscle groups worked, and unknown. Blood flow restriction and KAATSU devices were applied for various lengths of time. Devices provided restriction for the duration of the workout (n=24, 34.3%), devices were loosened or released between exercises (n=29, 41.4%), devices were loosened or released between sets of an exercise (n=10, 14.3%), or through other methods (n=5, 7.1%); two individuals did not respond to the question. Other methods described by respondents were: as tolerated for prescribed exercise, client dependent- either intermittent or continuous, client CURRENT TRENDS IN BLOOD FLOW RESTRICTION 36 dependent, provide restriction for duration up to 8 minutes max, and unknown. The majority of respondents provided direct supervision to the patient/client/athlete while BFR/KAATSU training was being administered (n=52, 74.3%). Additional respondents provided some supervision to the patient/client/athlete while BFR/KAATSU training was being administered (n=14, 20%), while others provided no supervision to the patient/client/athlete while BFR/KAATSU training was being administered (n=4, 5.7%). Patients/clients/athletes received BFR/KAATSU training on the upper extremity (n=4, 5.7%), lower extremity (n=18, 25.7%), or both the upper extremity and lower extremities (n=48, 68.6%). Activities for which BFR/KAATSU training were administered included strength training exercises (n=47, 67.1%), aerobic exercise (n=15, 21.4%), rehabilitation exercises (n=57, 81.4%), and other activities (n=5, 7.1%). Activities described were: active recovery, effects of BFR on sprint time, healing, I know PTs use it for rapid rehab after surgery, and recovery. Specific forms of exercises performed with BFR/KAATSU can be seen in Table 3. Blood flow restriction and KAATSU training were administered: 1-2 sessions per week (n=51, 72.9%), 3-4 sessions per week (n=18, 25.7%), and 5-6 sessions per week (n=1, 1.4%) but not 7 or more sessions per week (n=0, 0%). Patient Demographics and Safety Patient Demographics Blood flow restriction/KAATSU training was performed on those who were identified as male (n=64, 91.4%), female (n=48, 68.57%), gender non conforming (n=2, 2.9%), transgender (n=3, 4.3%), and unknown (n=1, 1.4%). Patients were of various ethnicities and were identified as white (n=61, 87.1%), black, African American (n=42, 60%), Asian (n=16, 22.9%), Pacific Islander, Hawaiian (n=10, 14.3%), Hispanic/Latino/a (n=27, 38.6%), Native American or CURRENT TRENDS IN BLOOD FLOW RESTRICTION 37 Alaskan Native (n=11, 15.7%), and those of an unknown ethnicity (n=1, 1.4%) or those who were multi-racial (n=1, 1.4%). Patients/clients/athletes were under 20 years old (n=45, 64.3%), 21-30 years old (n=58, 82.9%), 31-40 years old (n=31, 44.3%), 41-50 years old (n=20, 28.6%), 51-60 years old (n=12, 17.1%), and over the age of 60 years old (n=6, 8.6%). Safety Blood flow restriction and KAATSU training was administered on patients/clients/athletes with pathology by 16 (22.9%) respondents. Pathologies noted by respondents for which they have applied BFR/KAATSU training were hypertension, diabetes, obesity, EDS [sic], osteopenia, and unspecified cardiac conditions. Adverse effects from the administration of BFR/KAATSU training were seen by 15 (21.4%) respondents. Adverse effects seen can be seen in Table 4. Those who discontinued the use of BFR/KAATSU training did so for a variety of reasons presented in Table 5. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 38 Discussion To date three survey based research studies have been completed on the administration of BFR (Patterson and Brandner, 2018) and KAATSU training (Nakajima et al., 2006; Yasuda et al., 2017). The present study sought to add to the current body of knowledge through two objectives: the first objective was to better understand how individuals of various professions in the United States of America were using BFR/KAATSU training devices and the second objective was to investigate subsequent safety related concerns. Information was sought from those who have previously used BFR/KAATSU training devices and those using BFR/KAATSU training devices at the time of the study. A variety of devices have been used in the facilitation of BFR/KAATSU training. The most common type of device applied was the inflatable device (43.5%, n=47) followed by elastic tourniquet based devices (19.4%, n=21). Respondents reported equal use of KAATSU devices and knee wraps. Results of the current study were similar to a previous study by Patterson and Brandner (2018) where the use of inflatable devices, KAATSU devices, and knee wraps were comparable. One area that differed between the present study and Patterson and Bradner (2018) was the use of elastic tourniquet based devices. While the present study found 19.4% of respondents (n=108) have used an elastic tourniquet based device, Patterson and Brandner (2018) found only 3.6% of respondents (n=115) have used an elastic tourniquet based device. It can be hypothesized that the respondents of the present study incorrectly identified the types of devices previously used as they did with the currently used devices which are reflected in Tables 1 and 6, and discussed later within the discussion section. Terminology used to describe the devices was based on Patterson and Brandner (2018) and may not reflect how respondents describe their devices, particularly tourniquet based devices. Other terminology, including CURRENT TRENDS IN BLOOD FLOW RESTRICTION 39 pneumatic tourniquet, has been used when describing tourniquet based devices (McEwen et al., 2019; Patterson et al., 2019). It is unknown if there was confusion surrounding the terms used to describe the devices. The present study also found 35.18% (n=38) of individuals no longer administering BFR/KAATSU training. Minimal additional data was provided justifying discontinuation. Reasons that were cited included facility resources and facility policy on training prior to use of BFR/KAATSU training. No additional literature pertaining to complete cessation of BFR/KAATSU training secondary to facility or training concerns could be found. However, others have noted side effects or adverse reactions (Nakajima et al., 2006; Patterson and Brandner, 2018; Yasuda et al., 2017) which could lead to temporary or permanent discontinuation of training. Side effects seen among those who were currently using devices can be found later in the discussion section. At the time of the study, BFR/KAATSU training was being administered by those identifying as male/female genders across the country. Most predominantly, those administering BFR/KAATSU training were from a younger population (18-40 years old and practicing less than 20 years) and represented a variety of professions including athletic training, occupational therapy, physical therapy, personal training, and strength and conditioning. In previous survey based research, authors have likewise noted administration by those of male and female genders (Nakajima et al., 2006; Patterson and Brandner, 2018; Yasuda et al., 2017), and administration by a younger demographic across a variety of professions (Patterson and Brandner, 2018). Those administering BFR/KAATSU training at the time of the survey research employed a variety of devices. However, the most frequently applied device was the inflatable device likewise noted as the most prevalent previously used device in the current study. This finding CURRENT TRENDS IN BLOOD FLOW RESTRICTION 40 again mirrored Patterson and Brandner (2018) as handheld inflatable devices and automatic inflatable devices were reported as the most commonly used devices. While the majority of those currently using BFR/KAATSU training suggested application of an inflatable device (61.4%, n=43 of 70), there was a discrepancy within the current study in how respondents identified devices used as compared to the type of the device the unit actually represented. Table 1 reflects the device respondents believed he/she were using while Table 6 reflects what type of device the unit actually represented. While terminology used was based on the classification used by Patterson and Brandner (2018), it is unknown if the terminology confused the respondents. For instance, the present study used the term elastic tourniquet (Patterson & Brandner, 2018) while other authors have used pneumatic tourniquet in their writing to describe tourniquet based devices (McEwen et al., 2019; Patterson et al., 2019), perhaps leading respondents to classify devices differently. Additionally, literature could not be found related to some devices used in the present study, including devices intended for flotation, cryo/thermotherapy, and bracing. More information on the types of devices used can be found in Table 6. It is believed this is the first study to assess barriers implementing BFR/KAATSU training. In the present study, several experienced barriers when implementing BFR/KAATSU training. The most frequently cited barrier was the cost of the apparatuses. While not assessed by the study, it can be noted that the most frequently cited devices (Table 1 and Table 6) have device specific training which can add to the potential cost for the user. In addition to the cost, some faced barriers on the effectiveness of BFR/KAATSU training, as well as concerns by overseeing medical practitioners or supervisors and the patients/clients/athletes for which BFR/KAATSU training was being administered. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 41 The majority of respondents (82.9%, n=58) believe training prior to BFR/KAATSU implementation should take place. While no additional information could be found regarding perceptions of BFR/KAATSU training implementation, respondents of this survey indicated training was necessitated by the BFR/KAATSU device company or the facilities where one is employed. Education received by respondents was both formal and self facilitated but not all training promoted a singular device or was tailored toward a specific device. It is unknown how education was disseminated among the respondents of this survey. Nearly three-quarters of respondents indicated conducting some sort of screening process and just over 80% gave consideration to the psychosocial aspects of BFR/KAATSU training. The most predominantly facilitated process was a medical screening or a medical screening and a waiver with the patient/client/athlete prior to use. Yasuda et al. (2017) also found most respondents performed interviews or assessments prior to application of KAATSU training either the first time or every time the device was applied. The present study also revealed 25.7% of respondents had no screening process. Upon further examination there were indications a screening process took place at some point. Comments on the open ended question included reference to screenings by other departments and use of initial health screenings. The same open ended question suggested some screened on a limited basis or not at all. Those that assessed patients/clients/athletes on a limited basis suggested inquiring about blood clot history, while others asked for verbal consent. Also noted in the comments was the perception that no screening was needed when applying BFR/KAATSU training on those who were perceived as healthy. Patterson and Brander (2018) saw similar comments in which respondents felt there were no contraindications in populations of individuals who may be healthy, young, or athletic. In reviews of healthy populations, low intensity exercise with blood CURRENT TRENDS IN BLOOD FLOW RESTRICTION 42 flow restriction has shown effects on hemodynamics within a normal spectrum (Neto et al., 2017) and improved strength gains and muscle mass greater than low intensity exercise alone (Slysz et al., 2016). Furthermore, stroke volume, blood pressure, heart rate, fibrinolytic potential, coagulation activity, and post occlusion blood flow responded the same as free flow high load resistance exercise in short term studies (Loenneke et al., 2011). Additionally, Patterson et al. (2019) suggested when applied and performed appropriately BFR should not produce muscle damage unless other susceptibility to adverse physiologic effects exist. For all populations, correct application and safety in training are important (Hughes et al., 2017; Loenneke et al., 2011; Patterson et al., 2019; Sato, 2005). Regardless, for those wanting to implement a screening tool, Kacin et al. (2015) created a screening questionnaire which can aid a health professional in determining if the treatment is appropriate. The present study found 95.7% of those administering BFR/KAATSU training believed personalized restrictive pressure was needed to prevent adverse effects. There was variability in the procedures performed to determine restrictive pressure. Techniques used to determine restrictive pressure included the use of doppler ultrasounds, the device themselves, subjective rating scales and the use of capillary refill. When administering BFR/KAATSU training, methods to obtain the pressure vary. For instance, the application of doppler ultrasound has shown reproducibility (Bezerra de Morais et al., 2017) and both the doppler ultrasound (Masri et al., 2016) and devices set to determine limb occlusion pressure (McEwan et al., 2019) have been advocated. For those unable to afford/operate doppler ultrasound, pulse oximeters have shown potential in determining occlusion pressure within the upper extremity (Lima-Soares et al., 2020; Zeng et al., 2019). Subjective rating scales can also be conducted with devices for which pressure cannot be determined through conventional means (Wilson et al., 2013). Additional CURRENT TRENDS IN BLOOD FLOW RESTRICTION 43 procedures performed by respondents of the present study related to the use of skin color, pulse, and capillary refill. Within the current study, 24.3% (n=17) determined restrictive pressure in an exercise dependent position with 15.7% (n=11) determining restrictive pressures for subsequent exercises using methods based on the exercise position. Sieljacks et al. (2018) and Hughes, Jeffries et al. (2018) demonstrated body position does influence arterial occlusion pressure in lower extremity exercise. In this investigation, responses related to the administration of BFR/KAATSU training both matched and conflicted with previous authors. Frequency of use is one area that was similar. In this study training methods were most applied 1-2 times per week (72.9%, n=51) or 3-4 sessions per week (25.7%, n=18). Authors have suggested BFR/KAATSU training was most administered one to three sessions per week (Nakajima et al., 2006), or one to two sessions and three to four sessions per week (Patterson & Brandner, 2018). Patterson et al. (2019) suggested administering BFR two to three times per week. Types of exercise employed also presented similarly between the current study and research from previous authors. Patterson and Brandner (2018) found cycling and walking were the most frequent aerobic exercises used with BFR which was reflected in the current study. Workload was one area which differed. Patterson and Brandner (2018) found most respondents determined workload using percentage of a one repetition maximum (1RM) with the following repetitions: 30 -15-15-15, or the use of repetitions to failure while the current study found length of time under tension/load was more frequently used than a percentage of 1RM or work for failure. Like Patterson and Brandner (2018), the results of this investigation indicate great variability in administration. The second objective of the study was to explore safety related to the use of BFR/KAATSU training. The survey explored three areas related to safety. Safety topics CURRENT TRENDS IN BLOOD FLOW RESTRICTION 44 addressed were the use of BFR/KAATSU training on individuals with pathology, adverse effects seen following device use, and reasons for discontinuing BFR/KAATSU training. In the present study, 22.8% (n=16) of respondents applied BFR/KAATSU training to those with pathology. Respondents indicated BFR/KAATSU training was most applied to individuals with obesity (37.5%, n=6), hypertension (37.5%, n=6), diabetes (25%, n=4), and osteoporosis (12.5%, n=1). Literature related to the use of BFR/KAATSU training with the four identified pathologies was limited. Nakajima et al. (2006) and Yasuda et al., (2017) have found practitioners using KAATSU training among those with obesity, hypertension, and diabetes. Bond et al., (2017) has assessed the effects of BFR on individuals who are both sedentary and obese finding increases in 1 RM and post occlusion blood flow. Nascimento et al. (2019) suggested greater understanding of blood flow restrictions effect on coagulation would be beneficial for those at an increased risk of thrombi development including individuals with obesity, hypertension, and diabetes. Blood flow restriction has; however, shown positive hemodynamic effects (Loenneke et al., 2011; Nascimento et al., 2019; Neto et al., 2017; Yan et al., 2018) including among those with hypertension (Barili et al., 2018). Specific to those who have diabetes, Kacin et al., (2015) indicated the potential risk of neurological injury caused by ischemia and nerve compression particularly among those with reduced peripheral nerve function. Few studies have explored the effects of administering BFR/KAATSU training on those with osteopenia. Silva et al. (2015) found a small sample of women with osteoporosis were able to improve maximal dynamic strength on knee extension exercise and Yasuda et al. (2017) found practitioners using KAATSU training among individuals with osteoporosis. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 45 For those uncertain how BFR/KAATSU training responds within a population or those with pathologies for which the efficacy of BFR/KAATSU training has not been ascertained, including the pathologies noted by respondents of the present study, some additional recommendations have been made. Nascimento et al. (2019) proposed an alternative exercise regime for resistance training using 50% of the 1 RM. In addition, Kacin et al. (2015) developed a screening tool which may help in the assessment process. Finally, Patterson et al. (2018) suggested the use of clinical prediction rules to assess for additional risk particularly for venous thromboembolism. Adverse effects were seen by those applying devices marketed for BFR/KAATSU training as well as those applying devices not marketed for BFR/KAATSU training. Details about adverse reactions can be seen in Table 4. With the exception of one adverse effect where prior food consumption was called into question, it is unknown if other personal factors influenced the adverse reaction. The adverse effects described in this investigation matched common reactions presented by other authors (Nakajima et al., 2016; Yasuda et al., 2017). Individuals discontinued the use of BFR/KAATSU training due to changes to training, facility concerns, monetary issues, as well as safety. Reasons for discontinuation of BFR/KAATSU training (Table 5) directly related to side effects (e.g. lightheadedness and pain) were similar to side effects reported previously (Nakajima et al., 2006; Patterson and Brandner, 2018; Yasuda et al., 2017). Nascimento et al. (2019) recommended further research to quantify side effects to develop clearer parameters for use particularly among patients/clients/athletes who may have pathology or who may be older. Furthermore, quantifying a side effect versus an adverse reaction may limit ambiguity seen in the present study. Study Limitations CURRENT TRENDS IN BLOOD FLOW RESTRICTION 46 There were limitations in the current study. While a test pilot was completed, Cronbachs alpha was low (=.484) and correlations were variable. Revisions to the survey were completed but additional test pilots were not performed to ensure internal consistency. Validity was assessed through correlations between the test pilot group and a random sample of ten following the conclusion of the survey. No correlations were found between the groups. The two groups reflected varying professions which could have influenced the results. Additionally, the survey was long at 37 questions taking an average of nearly 11 minutes to complete. Future investigations should explore survey constructs including verbiage for greater clarity. The survey response rate was low at less than 1% creating the potential for bias, and a lack of generalization. The low sample size and parsing data into those that have previously used and were currently using BFR/KAATSU training devices also contributed to the low sample size. Furthermore, of the 148 consenting to participate in the research 27% did not complete the survey. The percentage of those not completing the survey raises concerns with the survey itself and length of time needed to complete the survey. The majority of the survey were selection based questions. The questions potentially prevented respondents from elaborating or required a best fit answer which may not reflect what was actually being done. Participants were; however, given the opportunity to provide written responses on several constructs. The written work likewise posed limitations. Some of the written work presented incomplete thoughts and typographical errors limiting the ability to interpret what was written. Real World Implications The data represented a very small subset of the population who may be applying BFR/KAATSU training devices. Notable takeaways from the present study include the CURRENT TRENDS IN BLOOD FLOW RESTRICTION 47 variability in the devices used, training received, screening applied, and the overall administration of BFR. Devices being used for BFR that have not been scientifically explored, should be avoided until their safety and efficacy can be demonstrated. Training is encouraged prior to use and is a shared viewpoint with many who participated in the survey research. While screening processes vary, tools do exist for those needing a process. The versatility presented in the current study makes the generalization of consideration based documents (Patterson et al., 2018) difficult but these documents may provide a general framework for use. Finally, additional considerations should be given to those with pathology and those who experience side effects and/or adverse reactions to BFR/KAATSU training as these areas lack complete understanding. Future Directions From the current study, several gaps have been highlighted for which research should continue. Data from the present study failed to demonstrate reasons why individuals may no longer be using BFR/KAATSU training and warrants additional attention. Additionally, barriers described within the study deserve further exploration. The types of devices used, device associated training and education, and the application of devices administered also lacks detail. Finally, research is still lacking on safety and efficacy related to BFR/KAATSU training particularly among those with pathology. Conclusion The current study sought to explore how individuals of various professions were using BFR/KAATSU training within the United States of America as well as to seek a better understanding of the safety related to BFR/KAATSU training. Through survey research it was discovered that BFR/KAATSU training was applied by a variety of professions in a variety of settings. Devices varied in style and brand including those marketed and not marketed for CURRENT TRENDS IN BLOOD FLOW RESTRICTION 48 BFR/KAATSU specific use. Those administering BFR/KAATSU training have done so on a variety of individuals with and without health complications. Adverse reactions and side effects have been seen and likewise noted by other authors (Nakajima et al., 2016; Yasuda et al., 2017). Overall, the study demonstrated diversity in the devices used, training received, screening applied, and the overall administration of BFR. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 49 References Abe, T., Kearns, C. F., Manso Filho, H. C., Sato, Y., & McKeever, K. H. (2006). Muscle, tendon, and somatotropin responses to the restriction of muscle blood flow induced by KAATSU-walk training. Equine Veterinary Journal, 7(S36), 345-348. https://doi.org/10.1111/j.2042-3306.2006.tb05566.x Baker, B. S., Stannard, M. S., Duren, D. L., Cook, J. L., & Stannard, J. P. (2020). Does blood flow restriction therapy in patients older than age 50 result in muscle hypertrophy, increased strength, or greater physical function? A systematic review. 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International Journal of Sports Physiology and Performance, 14(10), 1408-1414. https://doi.org/10.1123/ijspp.2019-0043 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 62 Table 1 Previously and Currently Used Devices as Indicated by Respondents Type of device Previously used Currently used Currently used devices identified Elastic tourniquet device n=21 n=9 3M (n=1) BFR Bands (n=1) Generic brand (n=1) HMKL (n=1) Koala Bands (n=1) Konmed/OBM (n=1) Defi PTS-PBFR (n=1) Inflatable device n=47 n=43 Air Bands (n=4) Mad-Up (n=2) Occlusion Cuffs (n=1) Edge Rehab Cuffs (n=2) Smart Cuffs (n=10) B Strong (n=7) Defi PTS-PBFR (n=16) Fitcuffs (n=2) H+ Cuffs (n=2) BFR Signature Series (n=1) BFR Occlude (n=1) Throwraft original TD 2401 (Note: this is a personal floatation device) (n=1) VALD (n=2) Unknown name (n=2) KAATSU training device n=11 n=9 Air Cuffs (n=1) Dumbbell pressure exercise (n=1) Inflatable Cuffs (n=1) KAASTU Cycle Pro (n=1) Nano (n=2) Knee wraps n=11 n=2 LP Sports Protector (n=1) Other n=8 n=7 Ace bandages (n=1) Delfi PTS-PBFR (n=3) KELVI (n=1) Rock Cuff (n=1) BFR Bands (n=1) KELVI BFR (n=1) RockCuff (n=1) DELFI-PTS-PBFR (n=5) CURRENT TRENDS IN BLOOD FLOW RESTRICTION Table 2 Demographics Demographics of respondents Gender Male (n=41) Female (n=29) Age (in years) 18-30 (n=36) 31-40 (n=27) 41-50 (n=5) 51-60 (n=1) 61 and older (n=1) Ethnicity White (n=57) Black, African American (n=3) Asian (n=1) White/Black, African American (n=1) American Indian or Alaskan Native (n=4) Asian/Native Hawaiian or Pacific Islander (n=1) Hispanic or Latino/a (n=1) White/Hispanic or Latino/a (n=1) All race (n=1) Location Northeast (n=11) Southeast (n=17) Midwest (n=27) West (n=7) Southwest (n=7) Unanswered (n=1) 63 CURRENT TRENDS IN BLOOD FLOW RESTRICTION Profession 64 Athletic Training (n=33) Personal Training (n=6) Physical Therapy (n=19) Physical Therapy Aide (n=3) Strength and Conditioning (n=20) Other Athletic Training Student (n=1) Lecturer of Exercise Science (n=1) Occupational Therapy (n=1) Semi-retired Consultant (n=1) Years in Profession 1-10 years (n=50) 11-20 years (n=18) 21-30 years (n=1) 31 or more years (n=1) CURRENT TRENDS IN BLOOD FLOW RESTRICTION Table 3 Exercise Employed with BFR/KAATSU Training Types of exercises used with BFR/KAATSU training Number of respondents using this form of exercise (n=) Single Joint Exercise 51 Single Joint Machine Based Exercise 37 Single Joint Free Weight Exercise 47 Multi Joint Exercise 57 Multi Joint Machine Based Exercise 32 Multi Joint Free Weight Exercise 49 Cycling 29 Walking 15 Jogging 10 Swimming 4 Rowing 1 Other 1 Recumbent stepper Sport Specific 65 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 66 Table 4 Adverse Reactions Described by Respondents Described demographics Adverse Outcome Elderly Age: 70s Other noted factors Device used Screening procedure Bruising, petechiae Not enough info to determine device used; several devices indicated for current use Waiver/Release and medical screening Bodybuilding athlete Age: 40s Bruising, petechiae Not enough info to determine device used; several devices indicated for current use Waiver/Release and medical screening Male Age: 18-25 Giddy Not enough info to determine device used; several devices indicated for current use Medical screening Caucasian female Age: 18-21 Lightheaded, increased body temperature KELVI Medical Screening Athlete Age: college Dizzy, lightheaded Ace Bandage No Screening Caucasian female Age: mid 60s Elevated heart rate, sweating, shortness of breath Smart Cuffs Waiver/Release and medical screening Male Age: 40s Increased pain with cuff occlusion Delfi PTS-PBFR Consent, ask contraindications Unknown Lightheadedness, muscle cramping Delfi PTS-PBFR Waiver/Release and medical screening Hispanic Female Age: 21 Nausea, vomiting Delfi PTS-PBFR Waiver/Release and medical screening Athletes High school, college Varied gender and race Moderate cramping, lightheadedness, or did not tolerate sensation Delfi PTS-PBFR ORS specified Did not eat prior CURRENT TRENDS IN BLOOD FLOW RESTRICTION 67 Table 5 Reasons Respondents Discontinued BFR/KAATSU Training Non safety related Safety related Other Heavy load strength training is able to be performed consistently Client was found to have developed a blood clot issue Dangerous actions for people with poor health Discomfort, Fatigue Some tired, occasionally need a short rest Over time, a blood clot can develop that can lead to a fatal pulmonary embolism It is used with our Physical Therapists and Sports Medicine Staffs in our settings. We have not incorporated in team/individual training, only utilize for personal use. Discomfort, had a patient who had fear of blood pressure cuffs but never told therapist, increased paraesthesia in the limb Excessive pain, discomfort, or noticeable swelling Pain due to too much restriction I want to do it another way Exercise pursor [sic] reflex symptoms Money N/A Extreme discomfort and loss of touch sensation Progression to higher intensities due to rehab progress Failure or too uncomfortable for patient Time restrictions Time under pressure was reached Wasnt anything special Feeling much discomfort while exercising. Only use for 10-15 min. If athlete complains of severe and unusual discomfort. If the person cannot handle the pressure or repeatedly cannot hit target range When the patient reaches 15-20 minutes time of BFR cuff placed on leg or arm Improper operation caused by bump Work reasons Patient discomfort, significant DOMS Patient discomfort Perceived exertion gets too high or significant fatigue or muscle failure Prescreen, but if I find later that the person has a history of clotting I will discontinue Unable to tolerate the cuff, fatigue, inability to complete repetition range without severe compensatory patterns of movement Vomiting, lightheadedness CURRENT TRENDS IN BLOOD FLOW RESTRICTION Table 6 Actual Device Type Type of device Device name Tourniquet device Delfi PTS-PBFR Inflatable device AirBands BFR Bands-Signature Series B Strong Fit Cuffs H+ Cuffs MAD- UP Occlusion Cuff Smart Cuffs The EDGE Restriction Systems VALD KAATSU Training device KAATSU Cycle 2.0 KAATSU Nano Wraps BFR Bands Koala Bands Rock Cuff Other 3M ACE bandage Conmed/OBM HMKL KELVI (Cryo/Thermotherapy Device) LP Sports Protector Throwraft Original TD2401 (Personal Flotation Device) 68 CURRENT TRENDS IN BLOOD FLOW RESTRICTION Appendix A Changes Made to Survey Following Survey Test Pilot Previous Question A. Are you 18 years or older? Revised Question Deleted Yes No B. Are you currently or have (in the past) used blood flow restriction/KAATSU Training in patient, client care? Deleted I am currently using blood flow restriction/KAATSU Training in patient, client care. I have previously used blood flow restriction/KAATSU Training in patient, client care. Please indicate why blood flow restriction/KAATSU training is no longer being used by you for patient, client care. I am not currently using blood flow restriction/KAATSU training. C. Have you either previously or are you Deleted currently using blood flow restriction/KAATSU training for strength training, aerobic exercise, or rehabilitative purposes? Yes No 69 CURRENT TRENDS IN BLOOD FLOW RESTRICTION D. What device are you currently using to apply restriction? What device are you currently using to apply restriction? Elastic tourniquet. Please identify brand/style of device. Inflatable device. Please identify brand/style of device. KAATSU training device. Please identify brand/style of device. Knee wraps. Please identify brand/style of device. Other-please identify. I am not currently using blood flow restriction/KAATSU training. Elastic tourniquet. Please identify brand/style of device. Inflatable device. Please identify brand/style of device. KAATSU training device. Please identify brand/style of device. Knee wraps. Please identify brand/style of device. Other-please identify. I do not know what type of device I am using to apply restriction. Please identify brand/style of device. I am not currently using blood flow restriction/KAATSU training. Please indicate why blood flow restriction/KAATSU training is no longer being used by you for patient, client, or athlete care. E. Which body parts are you applying strength training exercises with blood flow restriction/KAATSU training? Which body parts are you applying exercise with blood flow restriction/KAATSU training? F. On average, how often will you have a patient/client completing exercises with blood flow restriction/KAATSU training? On average, how often will you have a patient/client/athlete complete exercises with blood flow restriction/KAATSU training? 70 CURRENT TRENDS IN BLOOD FLOW RESTRICTION G. What position is the patient/client when initially taking personalize restrictive pressure? What position is the patient/client/athlete when initially taking personalize restrictive pressure? H. If you determine personalized restrictive pressure, do you always take restrictive pressure in supine for any subsequent exercise (ie. Straight leg raise, seated leg extensions, squats) Do you use the ${position restr pr/ChoiceGroup/SelectedChoices} position to determine restrictive pressure for subsequent exercises which vary in position (ie. supine straight leg raise, seated leg extensions, squats)? Yes No Not applicable Yes, I repeat the same method to determine restrictive pressure on subsequent exercises regardless of exercise position No, I use different methods to determine restrictive pressure on subsequent exercises which vary in exercise position I do not retake personalized restrictive pressure on subsequent exercises I. Generally, how long is the device providing restriction to a patient/client completing strength training exercises? Generally, how long is the device providing restriction to a patient/client/athlete completing exercise? J. What systematic screening process is used to determine eligibility of blood flow restriction/KAATSU training in patients/clients? What systematic screening process is used to determine eligibility of blood flow restriction/KAATSU training in patients/clients/athletes? 71 CURRENT TRENDS IN BLOOD FLOW RESTRICTION K. Do you consider the psychosocial aspects surrounding the application of blood flow restriction/KAATSU training (eg. attitude/beliefs about exercise, the degree of exercise-induced discomfort, patient/client adherence) when determining its use with a patient/client? Do you consider the psychosocial aspects surrounding the application of blood flow restriction/KAATSU training (eg. attitude/beliefs about exercise, the degree of exercise-induced discomfort, patient/client/athlete adherence) when determining its use with a patient/client/athlete? L. How much supervision is provided when a patient/client is completing exercise with blood flow restriction/KAATSU training? How much supervision is provided when a patient/client/athlete is completing exercise with blood flow restriction/KAATSU training? Patient/client performing exercises with blood flow restriction/KAATSU training has no supervision for the duration of blood flow restriction/KAATSU training use Patient/client performing exercises with blood flow restriction/KAATSU training has some supervision for the duration of blood flow restriction/KAATSU training use Patient/client performing exercises with blood flow restriction/KAATSU training is directly supervised for the duration of blood flow restriction/KAATSU training use M. Identify the genders of the patients/clients completing exercise with blood flow restriction/KAATSU training? (please select all that apply) Patient/client/athlete performing exercises with blood flow restriction/KAATSU training has no supervision for the duration of blood flow restriction/KAATSU training use Patient/client/athlete performing exercises with blood flow restriction/KAATSU training has some supervision for the duration of blood flow restriction/KAATSU training use Patient/client/athlete performing exercises with blood flow restriction/KAATSU training is directly supervised for the duration of blood flow restriction/KAATSU training use Identify the genders of the patients/clients/athletes completing exercise with blood flow restriction/KAATSU training? (please select all that apply) 72 CURRENT TRENDS IN BLOOD FLOW RESTRICTION N. What were the ethnicities (races) of the patients/clients completing exercise with blood flow restriction/KAATSU training? (Select all that apply) White Black or African American American Indian or Alaskan Native Hispanic or Latino/a Asian Native Hawaiian or Pacific Islander Multiple Races Other-Please identify O. What were the age groups of the patients/clients completing exercise with blood flow restriction/KAATSU training? What were the ethnicities (races) of the patients/clients/athletes completing exercise with blood flow restriction/KAATSU training? (Select all that apply) White Black or African American American Indian or Alaskan Native Hispanic or Latino/a Asian Native Hawaiian or Pacific Islander Other-Please identify What were the age groups of the patients/clients/athletes completing exercise with blood flow restriction/KAATSU training? 73 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 74 Appendix B Letter to Prospective Subject Groups Hello, I am currently working on my doctoral degree through the University of Indianapolis pursuing a Doctor of Health Sciences degree. For my doctoral project I am hoping to explore how health professionals are using various blood flow restriction devices through the use of survey research. Once the project has been approved through the institutional review process, can I post the survey within your respective social media platform? Thank you. Sincerely, Molly Cuffe MA, ATC, LAT CURRENT TRENDS IN BLOOD FLOW RESTRICTION 75 Appendix C Hello! For Facebook Groups: I have received permission to post by (Insert name). For Email Group: Permission from the Collegiate Strength and Conditioning Coaches Association has been granted for this email My name is Molly Cuffe. I am an athletic trainer and currently a doctoral student at the University of Indianapolis pursuing a Doctor of Health Sciences degree. For my doctoral research project-Current Trends in Blood Flow Restriction- I am hoping to explore how health professionals are using various blood flow restriction devices using survey research. If you currently or have previously used any form of blood flow restriction device, you are invited to participate in the survey research using the link below. Participation in the research will take approximately 13 minutes. The link will be active from midnight on March 22, 2021 to midnight April 21, 2021. After participating in the survey research, you will have the opportunity to enter a drawing for one of five $10 gift cards. This research has been approved as exempt status by the University of Indianapolis Institutional Review Board (IRB). Date of approval: 03/12/2021 Study number: 01390. Thank you! https://uindy.co1.qualtrics.com/jfe/form/SV_9oYpHk0qHKWbtGd CURRENT TRENDS IN BLOOD FLOW RESTRICTION 76 Appendix D Informed Consent CONSENT TO PARTICIPATE IN RESEARCH STUDY Current Trends in Blood Flow Restriction Study Principal Investigator (PI): Emily Slaven Co-Investigator: Molly Cuffe UIndy Email: slavene@uindy.edu UIndy Telephone: 317-788-3305 or 800-232-8634 X3305 This research is being done by Molly Cuffe, an athletic trainer and a student in the Interprofessional Health and Aging Studies: Doctor of Health Sciences Program at the University of Indianapolis. The study is to fulfil the requirements of a doctoral project through the University of Indianapolis. The Doctoral Committee Chair is Emily Slaven, PT, PhD Associate Professor at the University of Indianapolis. Why is this study being done? The purpose of this study is to explore how individuals across different professions are administering and using various forms of blood flow restriction (BFR)/KAATSU training devices in the United States of America. In addition, this study seeks to explore the safety concerns seen by individuals of different professions administering BFR/KAATSU training devices with various devices. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 77 Inclusions: To be included in the study, participants must meet the following criteria: (a) English speaking, (b) older than 18 years old, and (c) use BFR/KAATSU training devices for aerobic exercise, resistance exercise, or rehabilitation purposes in the United States. Exclusions: The following exclusion criterion exists: (a) BFR/KAATSU training is not being used with patients/clients/athletes. What will happen if I take part in this research study? If you volunteer to participate in this study, the researcher will ask you to do the following: Participation in the research study is voluntary and involves the completion of the survey. The survey will ask you questions about the BFR/KAATSU training devices you have used and are using, the methods used, safety related concerns and demographic related questions. The survey can be completed on any device which the internet can be accessed. How long will I be in the research study? The survey will take approximately 13 minutes to complete. Are there any potential risks or discomforts that I can expect from this study? Risks associated with participation in the survey can include mental stress from recalling past experiences with BFR/KAATSU training devices. Compensation for adverse effects will not be provided by the researcher. Are there any potential benefits if I participate? CURRENT TRENDS IN BLOOD FLOW RESTRICTION 78 Completing the study may increase ones knowledge of the research process. What other choices do I have if I do not wish to participate? Your participation is voluntary. If you decide not to participate, to withdraw yourself at any point during completion of the survey, or withdraw your data following the completion of the survey, you may do so without penalty. To withdraw from the study, please close out of the survey. Will I be paid for participating? At the conclusion of the survey you will have the opportunity to enter your email address into a drawing for the chance to win one of five $10 gift cards. Will information about me and my participation be kept confidential? The results of this study may be published in a scholarly book or journal, presented at professional conferences or used for teaching purposes. However, only aggregate data will be used. Personal identifiers will not be used in any publication, presentation or teaching materials. All information collected in this survey will be anonymous. I will not record your name in this survey. De-identified data from this survey will be transferred to a statistical analysis platform. Furthermore, this survey is web based. Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties. Will the data from my study be used in the future for other studies? CURRENT TRENDS IN BLOOD FLOW RESTRICTION 79 It is possible that de-identified data from this study could be used for future research or shared with other researchers for use in studies, without additional informed consent. De-identified means that any codes and personal information that could identify you will be removed before the data is shared. What are my rights if I take part in this study? You can choose whether or not you want to be in this study, and you may withdraw your consent and discontinue participation at any time. Whatever decision you make, there will be no penalty to you, and no loss of benefits to which you were otherwise entitled. You may refuse to answer any question/s that you do not want to answer and still remain in the study. Who can I contact if I have questions about this study? The Research Team: If you have any questions, comments, or concerns about the research, you can talk to one of the researchers. Please contact: Emily Slaven, PT, PhD Associate Professor at the University of Indianapolis at 317-788-3305 or 800-232-8634 X3305 or via email at slavene@uindy.edu. The Director of the Human Research Protections Program (HRPP): If you have questions about your rights as a research participant, or you have concerns or suggestions and you want to talk to someone other than the researchers, you may contact CURRENT TRENDS IN BLOOD FLOW RESTRICTION 80 the Director of the Human Research Protections Program, by either emailing hrpp@uindy.edu or calling 1 (317) 781-5774 or 1 (800) 232-8634 ext. 5774. How do I indicate my informed consent to participate in this study? If you consent to participate in this study, then you affirm that you satisfy the inclusion criteria, and your consent is voluntary. To indicate your voluntary consent and proceed with the questionnaire, select one of the following options: I voluntarily consent to participate in this study. I do NOT consent to participate in this study. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 81 Appendix E Survey Current Use of Blood Flow Restriction Start of Block: Proposed Consent Form CONSENT TO PARTICIPATE IN RESEARCH STUDY Current Trends in Blood Flow Restriction Study Principal Investigator (PI): Emily Slaven Co-Investigator: Molly Cuffe UIndy Email: slavene@uindy.edu UIndy Telephone: 317-788-3305 or 800-232-8634 X3305 This research is being done by Molly Cuffe, an athletic trainer and a student in the Interprofessional Health and Aging Studies: Doctor of Health Sciences Program at the University of Indianapolis. The study is to fulfil the requirements of a doctoral project through the University of Indianapolis. The Doctoral Committee Chair is Emily Slaven, PT, PhD Associate Professor at the University of Indianapolis. Why is this study being done? The purpose of this study is to explore how individuals across different professions are administering and using various forms of blood flow restriction (BFR)/KAATSU training devices in the United States of America. In addition, this study seeks to explore the safety concerns seen by individuals of different professions administering BFR/KAATSU training devices with various devices. Inclusions: To be included in the study, participants must meet the following criteria: (a) English speaking, (b) older than 18 years old, and (c) use BFR/KAATSU training devices for aerobic exercise, resistance exercise, or rehabilitation purposes in the United States. Exclusions: CURRENT TRENDS IN BLOOD FLOW RESTRICTION 82 The following exclusion criterion exists: (a) BFR/KAATSU training is not being used with patients/clients/athletes. What will happen if I take part in this research study? If you volunteer to participate in this study, the researcher will ask you to do the following: Participation in the research study is voluntary and involves the completion of the survey. The survey will ask you questions about the BFR/KAATSU training devices you have used and are using, the methods used, safety related concerns and demographic related questions. The survey can be completed on any device which the internet can be accessed. How long will I be in the research study? The survey will take approximately 13 minutes to complete. Are there any potential risks or discomforts that I can expect from this study? Risks associated with participation in the survey can include mental stress from recalling past experiences with BFR/KAATSU training devices. Compensation for adverse effects will not be provided by the researcher. Are there any potential benefits if I participate? Completing the study may increase ones knowledge of the research process. What other choices do I have if I do not wish to participate? Your participation is voluntary. If you decide not to participate, to withdraw yourself at any point during completion of the survey, or withdraw your data following the completion of the survey, you may do so without penalty. To withdraw from the study, please close out of the survey. Will I be paid for participating? At the conclusion of the survey you will have the opportunity to enter your email address into a drawing for the chance to win one of five $10 gift cards. Will information about me and my participation be kept confidential? The results of this study may be published in a scholarly book or journal, presented at professional conferences or used for teaching purposes. However, only aggregate data will be used. Personal identifiers will not be used in any publication, presentation or teaching materials. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 83 All information collected in this survey will be anonymous. I will not record your name in this survey. De-identified data from this survey will be transferred to a statistical analysis platform. Furthermore, this survey is web based. Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties. Will the data from my study be used in the future for other studies? It is possible that de-identified data from this study could be used for future research or shared with other researchers for use in studies, without additional informed consent. De-identified means that any codes and personal information that could identify you will be removed before the data is shared. What are my rights if I take part in this study? You can choose whether or not you want to be in this study, and you may withdraw your consent and discontinue participation at any time. Whatever decision you make, there will be no penalty to you, and no loss of benefits to which you were otherwise entitled. You may refuse to answer any question/s that you do not want to answer and still remain in the study. Who can I contact if I have questions about this study? The Research Team: If you have any questions, comments or concerns about the research, you can talk to one of the researchers. Please contact: Emily Slaven, PT, PhD Associate Professor at the University of Indianapolis at 317-788-3305 or 800-232-8634 X3305 or via email at slavene@uindy.edu. The Director of the Human Research Protections Program (HRPP): If you have questions about your rights as a research participant, or you have concerns or suggestions and you want to talk to someone other than the researchers, you may contact the Director of the Human Research Protections Program, by either emailing hrpp@uindy.edu or calling 1 (317) 781-5774 or 1 (800) 232-8634 ext. 5774. How do I indicate my informed consent to participate in this study? If you consent to participate in this study, then you affirm that you satisfy the inclusion criteria and your consent is voluntary. To indicate your voluntary consent and proceed with the questionnaire, select one of the following options: I voluntarily consent to participate in this study. CURRENT TRENDS IN BLOOD FLOW RESTRICTION 84 I do NOT consent to participate in this study. Skip To: End of Block If Informed Consent: Please review the following prior to starting the survey. Identification of R... = I voluntary consent to participate in this study. Skip To: End of Survey If Informed Consent: Please review the following prior to starting the survey. Identification of R... = I do NOT consent to participate in this study End of Block: Proposed Consent Form Start of Block: Product Use Product Use: The following set of questions relate to the blood flow restriction/KAATSU training products which you have or are currently using. Which of the following types of devices have you used previously to apply restriction? (please select all that apply.) Elastic tourniquet (1) Inflatable device (2) KAATSU training device (3) Knee wraps (4) Other-Please specify (5) ________________________________________________ What device are you currently using to apply restriction? o Elastic tourniquet. Please identify brand/style of device. (1) ________________________________________________ o Inflatable device. Please identify brand/style of device. (2) ________________________________________________ o KAATSU training device. Please identify style of device. (3) ________________________________________________ o Knee wraps. Please identify brand/style of wrap. (4) ________________________________________________ o Other- Please specify (5) ________________________________________________ o I do know what type of device I am using to apply restriction. Please identify brand/style of device. (7) ________________________________________________ CURRENT TRENDS IN BLOOD FLOW RESTRICTION 85 o I am not currently using blood flow restriction/KAATSU training. Please indicate why blood flow restriction/KAATSU training is no longer being used by you for patient, client, or athlete care. (6) ________________________________________________ Skip To: End of Survey If What device are you currently using to apply restriction? = I am not currently using blood flow restriction/KAATSU training. Please indicate why blood flow restriction/KAATSU training is no longer being used by you for patient, client, or athlete care. Years device used Please answer all remaining questions as they apply to the device you are currently using. How many years have you used this device? o 0-1 years (1) o 2-5 years (2) o 6-10 years (3) o 11-15 years (4) o 16-20 years (5) o 20+ years (6) For what reasons are you using this device? (please select all that apply) Strength training (1) Rehabilitation (2) Aerobic training (3) Other-Please specify (4) ________________________________________________ What training did you complete prior to utilizing this blood flow restriction/KAATSU training device? (please select all that apply). Self educated (1) Formal course work (2) Display This Question: If What training did you complete prior to utilizing this blood flow restriction/KAATSU training dev... = Formal course work CURRENT TRENDS IN BLOOD FLOW RESTRICTION 86 In the formal course work you received, was the education paired with promoting a specific device? o Yes (1) o No (2) Display This Question: If In the formal course work you received, was the education paired with promoting a specific device... = Yes Do you feel that the education you received was tailored towards the use of that device? o Yes (1) o No (2) Do you believe there should be formal education on blood flow restriction/KAATSU training before being allowed to use it with patients/clients/athletes? o Yes (4) o No (5) o No opinion (6) Did you face any barriers implementing blood flow restriction/KAATSU training into practice? o Yes (1) o No (2) Display This Question: If Did you face any barriers implementing blood flow restriction/KAATSU training into practice? = Yes What barriers did you face when integrating blood flow restriction/KAATSU training into practice? (please select all that apply) Lack of training (1) Equipment cost (2) Doubts of effectiveness (3) Lack of clinical efficacy (4) CURRENT TRENDS IN BLOOD FLOW RESTRICTION 87 Other-Please explain (5) ________________________________________________ End of Block: Product Use Start of Block: Current Use Current Uses: The following set of questions relate to your current use of blood flow restriction/KAATSU training. Which body parts are you applying exercise with blood flow restriction/KAATSU training? o Upper Extremity (1) o Lower Extremity (2) o Both Upper and Lower Extremity (3) Which types of exercises are being performed with blood flow restriction/KAATSU training? (please select all that apply) Single joint exercise (1) Single joint machine based exercise (2) Single joint free weight based exercise (3) Multi joint exercise (4) Multi joint machine based exercise (5) Multi joint free weight based exercise (6) Cycling (7) Jogging (8) Swimming (9) Rowing (10) Walking (11) Other types of exercise-Please specify (12) ________________________________________________ On average, how often will you have a patient/client/athlete complete exercises with blood flow restriction/KAATSU training? o 1-2 sessions per week (1) o 3-4 sessions per week (2) CURRENT TRENDS IN BLOOD FLOW RESTRICTION 88 o 5-6 sessions per week (3) o 7+ sessions per week (4) What method are you using to determine the restrictive pressure of your blood flow restriction/KAATSU training device? o Comfort (ie 7/10 perceived tightness) (1) o Limb circumference (2) o Standard blood pressure (3) o Doppler ultrasound (4) o The device is set to determine restrictive pressure (5) o Other-Please specify (6) ________________________________________________ What position is the patient/client/athlete when initially taking personalize restrictive pressure? o Supine (1) o Seated (2) o Standing (3) o Exercise dependent (4) Do you use the ${position restr pr/ChoiceGroup/SelectedChoices} position to determine restrictive pressure for subsequent exercises which vary in position (ie. supine straight leg raise, seated leg extensions, squats)? o Yes, I repeat the same method to determine restrictive pressure on subsequent exercises regardless of exercise position (1) o No, I use different methods to determine restrictive pressure on subsequent exercises which vary in exercise position (3) o I do not retake personalized restrictive pressure on subsequent exercises (2) Do you feel that personalizing the pressure to the individual reduces the risk of adverse events during blood flow restriction/KAATSU training exercise? o Yes (4) o No (5) When applying blood flow restriction/KAATSU training what are you using to consider work load? CURRENT TRENDS IN BLOOD FLOW RESTRICTION 89 o Heart rate (1) o Percentage of 1 RM (2) o Length of time under tension/load (3) o Work to failure (4) o Other-Please describe (5) ________________________________________________ Generally, how long is the device providing restriction to a patient/client/athlete completing exercise? o The device provides restriction for the duration of the workout (1) o The device is loosened or released between exercises (continuous application) (2) o The device is loosened or released between sets of an exercise (intermittent application) (3) o Other-Please describe (4) ________________________________________________ End of Block: Current Use Start of Block: Safety The following set of questions relate to safety during blood flow restriction/KAATSU training with your current device. What systematic screening process is used to determine eligibility of blood flow restriction/KAATSU training in patients/clients/athletes? o Waiver/Release forms (4) o Medical screening forms including risk assessments and or in person physical examinations (5) o Both waiver/release forms and medical screening forms including risk assessments and or in person physical examinations (8) o Other-Please describe systemic screening process being used. (6) ________________________________________________ o No screening process is used to determine eligibility. Please explain the reason for no screening process. (7) ________________________________________________ Do you consider the psychosocial aspects surrounding the application of blood flow restriction/KAATSU training (eg. attitude/beliefs about exercise, the degree of exercise-induced CURRENT TRENDS IN BLOOD FLOW RESTRICTION 90 discomfort, patient/client/athlete adherence) when determining its use with a patient/client/athlete? o Yes (4) o No (5) How much supervision is provided when a patient/client/athlete is completing exercise with blood flow restriction/KAATSU training? o Patient/client/athlete performing exercises with blood flow restriction/KAATSU training has no supervision for the duration of blood flow restriction/KAATSU training use (1) o Patient/client/athlete performing exercises with blood flow restriction/KAATSU training has some supervision for the duration of blood flow restriction/KAATSU training use (2) o Patient/client/athlete performing exercises with blood flow restriction/KAATSU training is directly supervised for the duration of blood flow restriction/KAATSU training use (3) Have you performed blood flow restriction/KAATSU training in individuals with medical comorbidities (ie diabetes, hypertension, obesity etc)? o Yes-Please indicated comorbidities seen. (1) ________________________________________________ o No (2) Have you seen any adverse effects in patients/clients/athletes either during a session or following a session using your current device? o Yes (1) o No (2) Display This Question: If Have you seen any adverse effects in patients/clients/athletes either during a session or followi... = Yes What adverse effects have you seen in patients/clients/athletes completing exercise with restricted blood flow, either during a session or following a session using your current device? (If possible please include gender, race, approximate age range, and adverse effect). ________________________________________________________________ CURRENT TRENDS IN BLOOD FLOW RESTRICTION 91 ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ For what reasons have you discontinued use of exercise with blood flow restriction/KAATSU training while exercise is being performed? ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ End of Block: Safety Start of Block: Demographics of patients, clients, and athletes Patient/Client/Athlete Demographics: The following questions relate to the demographics of the patients/clients/athletes for which blood flow restriction/KAATSU training has been applied. Identify the genders of the patients/clients/athletes completing exercise with blood flow restriction/KAATSU training? (please select all that apply) Male (1) Female (2) Gender Nonconforming (3) Transgender (4) Unknown (5) Other-Please identify (6) ________________________________________________ CURRENT TRENDS IN BLOOD FLOW RESTRICTION 92 What were the ethnicities (races) of the patients/clients/athletes completing exercise with blood flow restriction/KAATSU training? (Select all that apply) White (1) Black or African American (2) American Indian or Alaskan Native (3) Hispanic or Latino/a (4) Asian (5) Native Hawaiian or Pacific Islander (6) Other-Please identify (8) ________________________________________________ What were the age groups of the patients/clients/athletes completing exercise with blood flow restriction/KAATSU training? <21 years old(1) 21-30 years old (2) 31-40 years old (3) 41-50 years old (4) 51-60 years old (5) 61+ years old (6) End of Block: Demographics of patients, clients and athletes Start of Block: Demographics Your Demographics: The following questions relate to your demographics. Please select the gender you identify. o Male (1) o Female (2) o Gender Nonconforming (3) o Transgender (4) o Other-Please identify (5) ________________________________________________ Please select your age group. CURRENT TRENDS IN BLOOD FLOW RESTRICTION o 18-30 years old (1) o 31-40 years old (2) o 41-50 years old (3) o 51-60 years old (4) o 61+ years old (5) Please identify your ethnicity (race). Select all that apply White (1) Black or African American (2) American Indian or Alaska Native (3) Asian (4) Native Hawaiian or Pacific Islander (5) Hispanic or Latino/a (6) Other-Please identify (7) ________________________________________________ Which region of the United States do you currently reside? o Northeast (1) o Southeast (2) o Midwest (3) o West (4) o Northwest (5) o Southwest (6) What is your current profession? (Select all that apply) Athletic Trainer (41) Chiropractor (42) Physical Therapist (43) Physical Therapist Assistant (48) Personal Trainer (44) Strength and Conditioning Specialist (45) Other-Please identify (47) ________________________________________________ 93 CURRENT TRENDS IN BLOOD FLOW RESTRICTION 94 How many years have you been in your current profession? o 0-10 years (1) o 11-20 years (2) o 21-30 years (3) o 31+ years (4) End of Block: Demographics Survey Termination: Redirect to a full URL, ex. "https://www.qualtrics.com" : https://uindy.co1.qualtrics.com/jfe/form/SV_1ZYlv7HDWDEt4pv Survey Drawing Start of Block: Default Question Block Q1 Thank you for completing the survey titled Current Trends in Blood Flow Restriction. If you would like to be entered to win one of five $10 gift cards, please provide your email address in the box below. Winners will be notified within one week of the conclusion of the survey. If you do not wish to be entered for a chance to win a gift card, please close out of the survey at this time. Thank you again! ________________________________________________________________ End of Block: Default Question Block CURRENT TRENDS IN BLOOD FLOW RESTRICTION 95 Appendix F Gift Card Entry Thank you for completing the survey titled Current Trends in Blood Flow Restriction. If you would like to be entered to win one of five $10 gift cards, please provide your email address in the box below. Winners will be notified within one week of the conclusion of the survey. If you do not wish to be entered for a chance to win a gift card, please close out of the survey at this time. Thank you again!  ...

... A RETROSPECTIVE STUDY OF THE EFFECTS OF ADDING ASTYM TREATMENT TO STANDARD OCCUPATIONAL THERAPY INTERVENTIONS WHEN TREATING INDIVIDUALS WITH LATERAL ELBOW TENDINOPATHY Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Anne Crosser, MSOTR/L Copyright December 17th, 2018 By: Anne Crosser, MSOTR/L All rights reserved Approved by: Lucinda Dale, EdD, OTR, CHT, FAOTA Committee Chair __________________________________________ Elizabeth S. Moore, PhD Committee Member __________________________________________ Emily J. Slaven, PT, PhD, MS Committee Member __________________________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program University of Indianapolis __________________________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis __________________________________________ Running head: OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY A Retrospective Study of the Effects of Adding Astym Treatment to Standard Occupational Therapy Interventions When Treating Individuals with Lateral Elbow Tendinopathy Anne M. Crosser University of Indianapolis OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY ii Table of Contents Table of Contents ....................................................................................................................... ii List of Tables.............................................................................................................................. v Abstract ..................................................................................................................................... vi Acknowledgment...................................................................................................................... vii Introduction ................................................................................................................................ 1 Purpose ........................................................................................................................... 2 Literature Review ....................................................................................................................... 3 Terminology ................................................................................................................... 3 Epidemiology.................................................................................................................. 5 Clinical presentation ....................................................................................................... 7 Pathophysiology.............................................................................................................. 8 Mechanism of degeneration ................................................................................. 8 Histopathology .................................................................................................... 9 Anatomy and morphological changes ................................................................ 10 Neurogenic inflammation and neovascularization .............................................. 11 Tendinopathy staging/grading............................................................................ 11 Treatment...................................................................................................................... 12 Treatment options and practice pattern variations .............................................. 12 Multimodality treatment reviews ....................................................................... 14 Manual therapy interventions............................................................................. 16 Exercise ............................................................................................................. 18 OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY iii Astym................................................................................................................ 19 Functional Outcomes .................................................................................................... 23 Patient reported outcomes (PRO)....................................................................... 23 Focus on Therapeutic Outcomes ........................................................................ 24 Methods ................................................................................................................................... 27 Study Design................................................................................................................. 27 Participants ................................................................................................................... 27 Data .............................................................................................................................. 28 Instruments ................................................................................................................... 30 Focus on Therapeutic Outcomes ........................................................................ 30 Numeric pain rating scale .................................................................................. 34 Jamar dynamometer........................................................................................... 35 Procedures .................................................................................................................... 36 Data Collection.................................................................................................. 36 Data Analysis .................................................................................................... 37 Results ..................................................................................................................................... 38 Patient characteristics .................................................................................................... 39 Outcomes ...................................................................................................................... 39 Discussion ................................................................................................................................ 40 Limitations .................................................................................................................... 47 Conclusion .................................................................................................................... 52 Recommendation .......................................................................................................... 53 Dissemination ............................................................................................................... 53 OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY iv References ................................................................................................................................ 54 OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY v List of Tables and Figures Table 1 Comparison of Outcomes from both Intake and Discharge between Treatment Groups............................................................................................................... 80 Table 2 Comparison of Outcome Change Scores Between Treatment Groups ................ 81 Table 3 Participant Characteristics by Sample and Group with Group Comparisons ....... 82 Table 4 Descriptives for Condition Severity by Sample and Group with Group Comparison ....................................................................................................... 83 Table 5 Descriptives for Symptom Acuity by Sample and Group with Group Comparison ....................................................................................................... 84 Table 6 Descriptives of Number of Occupational Therapy Visits and Focus on Therapeutic Outcomes Duration by Sample and Group with Group Comparison ....................................................................................................... 85 Table 7 Descriptives for Type of Work by Sample and Group and with Group Comparison ....................................................................................................... 86 Table 8 Descriptives of Work Status by Sample and Group with Group Comparison ..... 87 Table 9 Descriptives of Treatments by Sample and Group with Group Comparisons ...... 88 Table 10 Comparison of Outcomes between Intake and Discharge for the Astym and Standard Therapeutic Group .............................................................................. 90 Table 11 Comparison of Outcomes between Intake and Discharge for the Standard Therapeutic Group............................................................................................. 91 Figure 1 CONSORT Flow Diagram................................................................................. 92 OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY Abstract Different therapeutic interventions are used to manage patients with lateral elbow tendinopathy (LET). Astym treatment is an emerging rehabilitation approach used to promote healing and regeneration of soft tissue conditions; however, there is limited research on its effectiveness for individuals with LET. The purpose of this research study was to determine if the addition of Astym treatment to standard occupational therapy (OT) interventions improved Focus on Therapeutic Outcomes (FOTO) functional status (FS) measures, numeric pain rating scale (NPRS) scores, standard grip strength and provocative grip strength for individuals with LET more than standard OT interventions. A retrospective study using data from 222 individuals with LET was conducted. Patients were placed in two groups for comparison: Astym treatment and standard OT interventions (AG) and standard OT interventions (SG). All outcome scores significantly improved for both groups. Except for higher pain score at the intake evaluation for the AG group, there were no significant differences on all outcomes between groups. Results of this study indicate that standard OT interventions and standard OT interventions with the addition of Astym produce significant improvements in FOTO FS measures, NPRS scores, standard grip strength and provocative grip strength for patients with LET. Further research is needed to determine if the addition of Astym produces superior results when added to standard OT interventions. Keywords: lateral elbow tendinopathy, Astym treatment, occupational therapy vi OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY Acknowledgment There have been many personal and professional challenges that I have faced during my doctoral project. The goal of completing the doctoral project has given me the opportunity to reflect on my life, and it has given me the insight to move forward and initiate dramatic life changes outside of my comfort zone. This process pushed me to my limits, and taught me both educational and life lessons. There are numerous people I would like to thank for helping to make the completion of this project a reality. I would like to express my deepest appreciation to my committee chair, Dr. Lucinda Dale. Her dedication, leadership, assistance, knowledge, patience, enthusiasm, and humor have made the successful completion of this project possible. She helped me conquer obstacles that I did not think I could conquer, and she helped me to persevere through this process. I could not have imagined a better committee chair and mentor for this project, there are not enough words to express my gratitude. I would also like to extend a special thanks to my committee members, Dr. Elizabeth Moore, and Dr. Emily Slaven. Their expertise, guidance, encouragement, understanding and patience have been invaluable. Thanks to all of the University of Indianapolis faculty who made the completion of this process possible. Thanks to Presbyterian Healthcare Systems, and the patients who provided me with the resources to make this project possible. Thanks to my parents for their dedication to education. I will be eternally grateful to them for teaching me the value of education and for giving me the opportunities to pursue my career and educational goals. Special thanks to my husband for his willingness to support me through this process, and for his readiness to assist me in countless ways. Also, thanks to my vii OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY family and friends who supported me and encouraged me to push through this process until the ultimate goal of completing of the doctoral project was achieved. viii OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 1 A Retrospective Study of the Effects of Adding Astym Treatment to Standard Occupational Therapy Interventions When Treating Individuals with Lateral Elbow Tendinopathy Lateral elbow tendinopathy (LET) is the most common cause of lateral elbow pain (Scher, Wolf, & Owens, 2009) causing functional impairment, disability, and lost productivity (Bhabra et al., 2016). It is categorized as a significant clinical problem (Abat et al., 2017), and decision making concerning allocation and prioritization of interventions for the entire spectrum of patients with LET is inconsistent (Coombes, Bisset, & Vicenzino, 2015). Researchers have investigated underlying mechanisms and interventions for the condition; however, LET remains a complex and challenging condition for health care professionals and researchers to manage (Bisset & Vicenzino, 2015). Despite the high prevalence of LET, there is not a universally accepted effective and consistent algorithm for management of the condition (Vaquero-Picado, Barco, & Antuna, 2016). Patients generally undergo some combination of conservative interventions for the condition, with mixed patient outcomes from the various interventions (Gregory, Wysocki, & Cohen, 2016). Occupational therapists offer multiple standard interventions for the treatment of LET; however, consistent with other healthcare professionals, they have not established a standard treatment protocol. Without an established treatment protocol, variations in administration, duration, frequency and types of interventions provided by medical providers, including occupational therapists, have been identified in clinics and in the literature. In addition, it is impossible to verify adherence to the various treatment protocols that have been recommended (Raman, MacDermid, & Grewal, 2012). Therapeutic exercise, education, orthoses, and modalities such as ultrasound (US), lowlevel laser therapy (LLLT), iontophoresis, and manual therapies are among the standard OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 2 interventions available to therapists that have been researched (The University of British Columbia, 2016). Another intervention that warrants further research is Astym treatment, an emerging regenerative rehabilitation intervention. Developers and researchers of Astym treatment report that it is a therapy that stimulates the regeneration of healthy soft tissues and resolves tendinopathies, scar tissue problems, and other soft tissue dysfunctions (What is Astym Treatment?, 2012). Few researchers have studied the benefits of Astym treatment for individuals with LET, and researchers have yet to publish information on whether adding Astym treatment to standard occupational therapy (OT) interventions would benefit individuals with LET. The purpose of this retrospective study was to determine if patients diagnosed with LET who received Astym treatment and standard OT interventions (AG) had significantly different outcomes compared to patients who only received standard OT interventions (SG). Specifically, this study addressed the following objectives. 1. To determine if there was a significant difference in Focus on Therapeutic Outcomes (FOTO) functional status (FS) measure scores (which is established from the body part specific patient inquiry (PI) self-assessment survey) between AG and SG at the OT intake evaluation and the OT discharge evaluation. 2. To determine if there was a significant difference in reported pain levels on the numeric pain rating scale (NPRS), standard grip strength, and provocative grip strength between AG and SG at the OT intake evaluation and the OT discharge evaluation. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 3 Literature Review Tendinopathy is a general term used to describe clinical conditions such as pain and pathology in chronic overuse tendon disorders, and it can develop in any tendon (Bhabra et al., 2016; Maffulli, Lango, & Denaro, 2010; Ode, 2016). As a result of overuse, major tendons such as the wrist extensor tendons are vulnerable to soft tissue lesions at the musculotendinous origin (Maffulli et al., 2010). Researchers have published papers that describe conflicting information on terminology, anatomical constituents, histopathology, pain mechanism, neurochemistry, etiology, and treatment for tendinopathy (Coombes, Bisset, & Vicenzino, 2009; Fredberg & Stengaard-Pedersen, 2008). Results of these publications have left gaps in the literature and have led to more confusion and conflict on how to treat tendinopathies such as LET. With more than 40 published conservative treatment methods for elbow pain and loss of function due to LET (Goguin & Rush, 2003; Shmushkevich & Kalichman, 2013), there is a lack of consensus on optimum management of this challenging condition (Brumell et al., 2016). Abat et al. (2017) further reported that the lack of consensus relative to diagnostic tools and treatment modalities exemplifies a management dilemma for healthcare professionals. The current review of the literature includes terminology, epidemiology, clinical presentation, pathophysiology, and treatment for LET. Descriptions of Astym and FOTO, the main outcome tool used for this study, are also included in this review of the literature. Terminology Ahmed et al. (2013) make reference in their publication that Runge, in 1873, first described LET in the medical literature as writers cramp. Morris (1882) later renamed writers cramp to lawn tennis elbow. Coues (1914) was the first to use the term epicondylitis to describe an inflammatory process of the pathological changes of the tendon. Subsequent OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 4 researchers have suggested that this condition may not be an inflammatory process but rather a degenerative process. Since itis represents inflammation, there is ongoing debate on whether epicondylitis is an appropriate term to use for this diagnosis (Ali & Lehman, 2009; Nirschl & Pettrone, 1979; Rayan, 2002). Although lateral epicondylitis, lateral epicondylalgia, LET, and tennis elbow are all terms used interchangeably to describe this condition, they each represent distinct stages of the same elbow disorder. Tennis elbow is probably the most commonly accepted label used in clinical practice (Zeisig, Ohberg, & Alfredson, 2006), and it is probably the most commonly used label by patients, clinicians, and the general public (Fedorczyk, 2011). Although this term is not an inappropriate description of the status of the tendon, it is misleading because few people sustain this condition from playing tennis (Fedorczyk, 2011). There continues to be debate among researchers and clinicians regarding tendon conditions and the appropriate terminology to use when describing chronic tendon disorders (Fedorczyk, 2011; Stasinopoulos & Johnson, 2006). Tendinosis is a term used to describe histological findings identified in an overuse injury to the tendon and the patient may be asymptomatic (Fedorczyk, 2011). Tendinopathy is a term used to describe the spectrum of changes that occur in a damaged or diseased tendon (Ode, 2016; Scott, Backman, & Speed, 2015). The current proposed terminology that may be more appropriate to describe the condition being investigated for this study is tendinopathy (Rayan, 2002; Stasinopoulos & Johnson, 2006) because it incorporates all healing stages of the tendon tissue (Fedorczyk, 2011; Fredberg & Stengaard-Pedersen, 2008; Maffulli, Dhan, & Puddu, 1998; Maffulli et al., 2010; Stasinopoulos & Johnson, 2006). Furthermore, tendinopathy is a term used by experts to signify the clinical OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 5 syndrome characterized by pain, pathological characteristics, and impaired performance (Maffulli, et al., 1998); therefore, the term LET will be used for the remainder of this paper. Epidemiology Lateral elbow tendinopathy is more common than medial elbow tendinopathy, with researchers reporting a frequency of it occurring 7 to 10 times more often (Hoogvliet, Randsdorp, Dingemanse, Koes, & Huisstede, 2013; Walz, Newman, Konin, & Ross, 2010). There is an annual incidence of four to seven LET cases per 1000 patients in general medical practice (Smidt et al., 2006), prevalence is from 1% to 3% of the general adult population (Goguin & Rush, 2003), 9% to 35% of tennis players (Pluim, Staal, Windler, & Jayanthi, 2006), and up to 14.5% in the working population (Fan et al., 2009). In addition, it is the most common type of upper extremity (UE) tendinopathy in workers (Hopkins et al., 2016). In the general population, the estimated prevalence of LET is 1.3% in men and 1.1% in women (Walker-Bone, Palmer, Reading, Coggon, & Cooper, 2004). Lateral elbow tendinopathy is predominantly linked to females in the working population (Fan et al., 2009; Shiri, ViikariJuntura, Varonen, & Heliovaara, 2006). Although the association between gender and LET remains unclear (Fan et al., 2014), Waugh, Jaglal, Davis, Tomlinson, and Verrier (2004) suggested that the disorder can be more severe and more chronic in females. The prevalence of LET peaks at middle age, with the greatest incidence occurs between 45 and 54 years of age (Shiri et al., 2006), and the median age of 41 years (Nirschl & Ashman, 2003). Lateral elbow tendinopathy occurs more frequently among Caucasians (Fan et al., 2009; Nirschl, 1992). Personal, psychological and physiological factors associated with LET include the following: smoking, obesity, social support, repetitive movement, forceful activities, and job satisfaction (Descatha, Dale, Jaegers, Herquelot, & Evanoff, 2013; Fan et al., 2009; MacDermid, OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 6 Wojkowski, Kargus, Marley, & Stevenson, 2010; Shiri et al., 2006; Walker-Bone, Palmer, Reading, Coggon, & Cooper, 2012). High job strain and a history of LET or other UE musculoskeletal disorders, such as rotator cuff injuries or carpal tunnel syndrome, were also strong correlates to cases of LET (Fan et al., 2009; Fan et al., 2014; Herquelot et al., 2013; Shiri & Viikari-Juntura, 2011). Although a single incidence of lifting a heavy object or performing an awkward grasping movement can develop into an elbow tendinopathy, high activity levels involving repetitive UE motion are more often the cause of this condition (Leadbetter, 2016; Fedorczyk, 2011). Researchers report that the most recent research suggest that LET is a degenerative process due to repetitive microtrauma (Sims, Miller, Elfar, & Hammert, 2014). Clients with LET typically report that the condition is of insidious onset (McMurtrie & Watts, 2012); however, there are also reports where clients recall a history of overuse without trauma (Walrod & Young, 2018). Although the source of LET is often unknown, there is evidence that some cases are due to muscle imbalance, or overuse and/or repetitive strain that overloads the wrist and digit extensors (Goguin & Rush, 2003; Shiri & Viikari-juntura, 2011; Waseem, Nuhmani, Ram, & Sachin, 2012). The intensity, frequency, and hours spent completing a repetitive motion may also contribute to the development of pathological tissue (Cook & Purdam, 2009; Fan et al., 2009). Awkward postures, localized mechanical stress, hand-arm vibration, and highly dynamic movements are occupational factors that have been associated with increased risk of work-related LET (Fan et al., 2009, Fan et al., 2014; Shiri et al., 2006). Office work, assembly work, wood product manufacturing (Fan et al., 2014), construction work, and housekeeping (Descatha et al., 2013) are occupations that have been correlated with LET. Combined repetitive elbow flexion/extension, wrist bending/twisting and forearm rotating, twisting or screwing motions, duration of forearm supination, and the combination of OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 7 forearm supination and forceful lifting are linked to increased incidence of LET (Descatha et al., 2013; Fan et al., 2014; Herquelot et al., 2013; Walker-Bone et al., 2012). Furthermore, Fan et al. (2014) found that forearm pronation and time spent with forceful exertion including pinching, pushing, pulling, or power gripping and/or lifting were significant predictors of the development of LET of the dominant side. Clinical presentation The primary symptom of LET is localized pain and tenderness over or near the lateral humeral epicondyle, which often extends into the dorsal forearm (Mora-Relucio et al., 2016; Shmushkevich & Kalichman, 2013). Patients may report their symptoms as acute or chronic. Patients who have symptom duration greater than 12 weeks, such as the individuals in the Sevier and Stegink-Jansen (2015) study, are considered to have a chronic condition (Scott et al., 2015). Brummel, Baker, Hopkins, and Baker (2014) reported that patients with LET generally experience insidious onset and gradual progression of pain and weakness. Patients accounts of pain differ from an intermittent ache to a constant severe sharp pain (Brummel et al., 2016). Patients descriptions of pain may vary with activities. A patient may report that using hand tools causes mild pain, or a patient may report that picking up a coffee cup causes severe pain (Walrod & Young, 2018). Pain from LET may be incapacitating, and it has been reported to negatively affect the patients quality of life (Kawa & Kowza-Dzwonkowska, 2015). The pain at the lateral epicondyle of the humerus is often aggravated with resisted extension of the wrist (Arif, Sharif, & Khalid, 2017), gripping, forearm rotation, digital extension and wrist radial deviation (Cooper, 2014; Fan et al., 2014). Lateral elbow tendinopathy mainly affects the dominant UE (Kheradmandi, Ebrahimian, Ghaffarinejad, Ehyaii, & Farazdaghi, 2015) and may result in functional deficits that interfere with activities of daily living (ADL), OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 8 occupational tasks (Fan et al., 2009), and leisure activities (Kawa & Kowza-Dzwonkowska, 2015). An average episode of LET lasts 6 to 24 months (Jariwala, Dorman, Bruce, & Rickhuss, 2012), with the vast majority of patients (70-80%) recovering by one year (Boyer & Hastings, 1999). Pathophysiology Unraveling the complex etiology of LET and identifying contributing mechanisms of the condition remain an ongoing challenge. The etiology associated with degenerative tendon changes of LET is unknown, with many opposing opinions as to the origin of the condition (Abate et al., 2009; Bagayoko & Brockmeier, 2012; Bostan, Balta, Asci, Aytekin, & Eser, 2016; Sevier & Stegink-Jansen, 2015). Researchers have reported alterations in tendinous tissue around the elbow, but it is not known if the pathological tissue changes are the result of LET or if the condition caused the tissue to change (Chen, Wang, Xu, & Zheng, 2010; Kraushaar & Nirschl, 1999). Complexities associated with the etiology of LET have led to confusion and differing opinions about optimal treatment for the condition (Coombes et al., 2015). Mechanism of degeneration. Faro and Wolf (2007) reported that tendons that transmit loads under elastic and eccentric conditions, such as the extensor carpi radialis brevis (ECRB), are prone to injury. Researchers have implicated hypoxia, ischemic damage, oxidative stress, hyperthermia, and matrix metalloproteinase imbalance as mechanisms leading to tendon deterioration (Sharma & Maffulli, 2006). An invasion of dense, immature, hypertrophic, tendon fibroblasts (tenocytes), haphazard proliferation of tenocytes, and intracellular abnormalities in tenocytes have been found in the abnormal tendinosis tissue (Fredberg & Stengaard-Pedersen, 2008; Kraushaar & Nirschl, 1999; Nirschl & Ashman, 2003; Nirschl, 1992). These degenerative OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 9 components appear to cause a disturbance of the internal structure of the tendon, and cause degeneration of the cells and matrix (Coombes et al., 2009.) An increased rate of matrix remodeling may lead to a mechanically less stable tendon (Arya, 2010; Cook & Purdam, 2009), and collagen cross-linking, non-collagenous matrix, and vascular elements may also weaken the tendon (Fredberg & Stengaard-Pedersen, 2007). Rees et al. (2009) reported that when the internal stress in the tendon fibers is greater than the ultimate tensile strength of the tendon tendinous micro-tears occur. These researchers further identified that when stretching exceeds the tendon tolerance, a micro-tear occurs and the adaptation of the tendon to multiple micro-tears leads to tendinosis. Inflammatory mediators (Maffullli et al., 2010), corticosteroids, and fluoroquinolones have also been linked to tendon weakening (Fu, Rolf, Cheuk, Lui, & Chan, 2010; Le Huec et al., 1995; Rees et al., 2009). Histopathology. Seminal articles by Goldie (1964) and Coonrad and Hooper (1973) provided evidence that acute inflammatory cells were lacking and degenerative pathologic tissue existed in LET. These researchers discovered that a degenerative process was occurring in the tissue due to an abandoned or immature healing response after an injury or repetitive microtrauma from overuse. Rees, Maffulli, and Cook (2009) further explained that inflammation appears to be involved in the initiation of tendinosis, and irregular inflammatory cells may be present in the tissue, but it does not seem to spread or progress the condition. Nirschl and Pettrone (1979) published a pivotal study on LET that coined the term angiofibroblastic hyperplasia to describe degenerative tissue in chronic tendinopathy. Increased cell numbers and ground substance, vascular ingrowth, capillary budding, disorganized and immature collagen, and angiogenesis (neovascularization) were identified in the pathological tissue examined in their study (Nirschl & Pettrone, 1979). Maffulli et al. (2010) identified OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 10 loosely woven, altered structure, and a succeeding increase in non-collagenous matrix in abnormal tendinosis tissue. An invasion of immature fibroblasts (Bagayoko & Brockmeier, 2012), an increase in proteoglycan content, and a disruption of normal orderly tendon fibers from granulation tissue have also been identified (Longo, Ronga, & Maffulli, 2009). Additional findings from histopathological studies include thickened blood vessels, hyaline degeneration, fibrosis, focal areas of adipose tissue and calcific deposits in the origin of the ECRB (Cohen, Romeo, Hennigan, & Gordan, 2008; Goguin & Rush, 2003; Leadbetter, 1992; Nirschl, 1992; Regan, Wold, Coonrad, & Morrey, 1992). Increased glucosaminoglycans, extra cellular matrix deterioration, reduced type I collagen synthesis, elevated apoptotic and autophagic cell death rates of tenocytes were elements that have also been found in chronic LET (Chen et al., 2010; Kazanjian, 2010; Zeisig et al., 2006). Anatomy and morphological changes. Nirschl and Pettrone (1979) identified the ECRB as the most frequently affected tendon of the common extensor tendon in LET, followed by the extensor digitorum communis (EDC). Researchers who studied cadaveric specimens of the origin of the ECRB described the pathological tissue as grayish, edematous, and friable (Khan, Cook, Bonar, Harcourt, & Matsastrom, 1999; Nirschl & Ashman, 2003; Tosti, Jennings, & Seward, 2013). Similarly, Khan, Cook, Taunton, and Bonar (2000) and Fredberg and Stengaard-Pedersen (2008) described this abnormal tendon tissue as dull in appearance, brownish, and soft when compared to normal whitish, glistening and firm healthy tendon tissue. Researchers who biopsied pathologic ECRB tissue also identified moth-eaten fibers, mitochondrial redistribution, fibrous necrosis, signs of muscle fiber regeneration over the entire muscle, and higher percentages of the fast twitch oxidative muscle fiber type (Coombes et al., 2009; Goguin & Rush, 2003). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 11 Neurogenic inflammation and neovascularization. Maffulli et al. (2010) clarified that neovascularization is an element of tendinosis and reported that the pain fibers accompanying the neovessels contain neurochemicals involved in neurogenic inflammation. Further contributing to the symptoms of pain with LET, neovessel ingrowth, microvasculature, and neurochemicals have been identified in the tendinous origin of the ECRB (Coombes et al, 2009; Fedorczyk, 2012; Fredberg & Stengaard-Pedersen, 2008; Nirschl, 1992; Regan et al., 1992). Moreover, vasculo/neural ingrowth and multiple blood vessels in the extensor origin in chronic painful ECRB tendinosis have been identified through color Doppler (Zeisig et al., 2006). Anatomical location and its effect on vascularity contribute to the degeneration of the ECRB and pain symptoms. Anatomically the ECRB is located underneath the extensor carpi radialis longus and attached directly on the lateral epicondyle (Stoeckart, Vleeming, & Snijders, 1989). With this arrangement, Stoeckart et al. (1989) found that every time the elbow moves, the ECRB absorbs abrasive forces, which may contribute to the micro-tears found in the abnormal tissue. The vascularity and healing of the ECRB are compromised due to two avascular zones on the volar side of the ECRB (Zeisig et al., 2006). Additionally, due to regional anoxia, chemical irritation from neurochemicals in the neural tissue of ECRB tendon may contribute to pain symptoms (Alfredson & Lorentzon, 2002; Alfredson, Ljung, Thorsen, & Lorentzon, 2000; Ljung, Alfredson, & Forsgren, 2004; Schneeberger & Masquelet, 2002). Tendinopathy staging or grading. Due to the evolving research on tendinopathies and LET, there has been a paradigm shift in underlying concepts for treating the condition. Researchers have recommended staging or grading tendinopathies to assist clinicians with clinical decision-making (Cook, Rio, Purdam, & Docking, 2016; Kraushaar & Nirschl, 1999). Because interventions may not be effective if they are not specific to the degenerative stage of OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 12 the tendon (Cook et al., 2016) proposed algorithms based on chronicity of the disorder have been developed (Bhabra et al., 2016; Coombes et al., 2015). Clinical researchers continue to study interventions without knowledge of the stage of tendon pathology; therefore, optimal interventions for each stage remains unknown (McCreesh & Lewis, 2013). Symptom resolution may take longer if interventions do not facilitate appropriate healing of the degenerative stage of the tendon (Bhabra et al., 2016). The diverse presentation of symptoms and the diverse responses to healing continue to make it difficult for researchers and clinicians to find the best treatment protocol for LET. Whether or not a staging model is used to guide interventions, there is heterogeneity in clinical presentation and pathology of individuals with LET (Cook & Purdam, 2009; Coombes et al., 2015), which continues to make it difficult to determine an optimal treatment protocol. Treatment In the literature there are a host of interventions available for the treatment of LET, and a variety of practice patterns are used in clinics. Multimodal, (a term used to describe a combination of interventions), manual treatments, exercise, and Astym treatment are just a few treatment options that healthcare providers include for individuals with LET. Treatment options and practice pattern variations. There have been more than 200 scientific papers describing LET since 1996, with various conclusions about suitable therapy (Brismee, 2014). Multiple treatment options for this condition have been implemented with varying levels of efficacy and cost effectiveness (Bostan et al., 2016; Olaussen, Holmedal, Lindbaek, Brage, & Solvang, 2013). Physical interventions for LET have been widely investigated, and conservative management has been recommended as an initial approach to treatment of the condition (Bisset & Vicenzino, 2015). However, there is not a single treatment OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 13 that has been identified as the most effective intervention for long term relief of LET (Bagayoko & Brockmeier, 2012; Bisset, Paungmali, Vicenzino, & Beller, 2005; Elmajee & Pillai, 2016; Sevier & Stegink-Jansen, 2015) and different treatment protocols are used to rehabilitate patients with LET (Fedorczyk, 2012; MacDermid et al., 2010; Waseem et al., 2012). The therapeutic interventions have different theoretical mechanisms of action for achieving the goals of reducing pain and increasing function (Stasinopoulos & Stasinopoulos, 2017). Conservative treatment for LET is often effective (Walz et al., 2010), but there does not appear to be a clear understanding of the natural course of the condition. Without clinicians and researchers having a clearer understanding of the cause and the progression of the condition, it is difficult to determine if treatments for LET are actually effective or if the disorder just improves spontaneously. Given that LET is a common condition associated with significant individual and societal costs (Chourasia, Buhr, Rabago, Kijowski, & Sesto 2013), it is imperative to establish optimal prevention and treatment approaches from evidence-based management of LET (MacDermid et al., 2010). Currently there are no clinical practice guidelines for the treatment of LET. Additionally, a standardized classification model for this condition has not been incorporated into clinical practice (Wixom & LaStayo, 2012). There are many and highly varying standard therapeutic intervention options available for LET yet limited scientific support for the incorporation of these interventions in clinical practice exists. In addition, few high-level quality studies supporting interventions for LET have been published, and the outcomes of these studies vary widely (Hoogvliet et al., 2013; Raman et al., 2012). As a result, treatments for LET are continuously being investigated to establish support for the efficacy of the interventions. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 14 Therapists frequently provide conservative treatment to individuals with LET, with MacDermid et al. (2010) identifying 49 interventions used in hand therapy practice. Additionally, there are more than 16 practice patterns implemented in various combinations for acute and chronic conditions (Wixom & LaStayo, 2012). Strength of evidence to support the management of mild-to-severe LET through these practice patterns is limited (Wixom & LaStayo, 2012). Interventions differ widely in the theoretical mechanism of action (Viswas, Ramachandran, & Anantkumar, 2012). Moreover, interventions for the condition are as divergent as resting the wrist and elbow joints to inducing high musculotendinous forces across the lateral aspect of the elbow joint (Wixom & LaStayo, 2012). To complicate matters, training of clinicians is inconsistent, and the interventions selected are often based on the type of discipline training the clinician has received (MacDermid et al., 2010). Multimodality treatment reviews. Anthony et al. (2013) created an evidence informed aid to assist clinicians with decision-making regarding the management of patients with LET. In their report, they provided a summary of published evidence on non-surgical interventions commonly used to manage LET. Studies of various levels were included in their review on manual therapies, exercise, acupuncture, modalities (LLLT, US, and iontophoresis), orthoses, and taping. The researchers described variations in exercise prescription, and variations in the dosages of treatments. The result of the Anthony et al. (2013) appraisal of the literature was that there were different levels of evidence and different levels of support for the various interventions. Sims et al. (2014) published a systematic review of non-surgical interventions for LET. Randomized controlled trials on injections, iontophoresis, bracing, exercise, friction massage, extracorporeal shock wave therapy (ESWT), and laser therapy were examined. No substantial OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 15 evidence supported the use of one intervention over another. Several other researchers published reviews on available interventions for LET (Bhabra et al., 2016; Bisset & Vicenzino, 2015; Boiragi & Kaur, 2015; McMurtrie & Watts, 2012); Vaquero-Picado et al., 2016). Rest, orthoses, counterforce bracing, strengthening, stretching, US, corticosteroid injections, dry needling, acupuncture, and ESWT were among interventions that were appraised in their reports. These researchers all reported that not one intervention was identified as superior (Bhabra et al., 2016; Bisset & Vicenzino, 2015; Boiragi & Kaur, 2015; McMurtrie & Watts, 2012; Vaquero-Picado et al., 2016). Sutton et al. (2016) completed a systematic review of musculoskeletal disorders, including LET and reported that beneficial multimodal care for the management of LET included variations in the following: combinations of interventions, number of visits (range from 3 to 12) and duration of episode of care (range from 4 to 6 weeks). They also reported that superior outcomes for the management of LET were associated with multimodal programs that included education, exercise (strengthening, stretching, occupational exercises) manual therapy (manipulation) and soft tissue therapy (deep friction massage). It was found that clinicians often combined interventions in a program of multimodal care for their patients; however, there was minimal research available on the best combination of interventions. The authors recommended that to ascertain the best combination of interventions, future research of multimodal programs should begin with evidence-based interventions for the management of specific musculoskeletal conditions, such as LET. It was also stated that to determine the best combination of modalities, higher quality studies need to be completed, and researchers should compare one group with a full program of multimodal care to one group with a full program of multimodal care minus one of the interventions (Sutton, 2016). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 16 In 2016, the British Columbia Physical Therapy Task Force updated their published summary of evidence regarding standard physical therapy interventions for treatment of LET (The University of British Columbia, 2016). This task force reviewed published studies on manual interventions, exercise, acupuncture, LLLT, US, ESWT, iontophoresis, orthoses and taping. The task force found no clinical evidence to support elbow joint mobilizations, spinal mobilizations, ESWT, or taping for treatment of individuals with acute LET. Weak support was identified for soft tissue techniques, exercise, acupuncture, laser, US, iontophoresis, and orthoses for treatment of individuals with acute LET. There was strong support for elbow joint mobilizations, spinal mobilization techniques, exercise, LLLT, and taping for treatment of individuals with chronic LET. Weak evidence was identified for use of soft tissue techniques, acupuncture, US, and orthoses for treatment of individuals with chronic LET (The University of British Columbia, 2016). Manual therapy interventions. There are a host of manual interventions used to treat LET. Kumar and Jetly (2016) reported that manual interventions facilitate healing and pain reduction by increasing blood flow to an area for the removal of chemical irritants and for the transport of endogenous opiates. Collagen reorganization, stimulation of fiber orientation, fascial tissue lengthening, and restoring alignment and mobility of joints were reported as additional benefits of manual therapy (Kumar & Jetly, 2016). Elbow joint mobilizations, spinal mobilization techniques, and soft tissue techniques are manual interventions that have been reviewed (The University of British Columbia, 2016; Trivedi et al., 2014). Researchers have also examined the effectiveness of deep transverse friction massage, mobilization with movement, myofascial release (MFR), active release techniques (ART), and instrument assisted soft tissue mobilization (Balasubramaniam & OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 17 Kandhasamy, 2016; Blanchette & Normand, 2011; Chung-Yuan et al., 2016; Dasm, 2012; Hoogvliet et al., 2013; Joseph, Taft, Moskwa, & Denegar, 2012; Prabhakar & Kage, 2013; Prabhakar, Kage, & Anap, 2013). Collectively, the conclusions of publications on manual therapy indicate that techniques are effective, but future studies need (a) larger sample sizes, (b) longer term follow ups, and (c) more rigor (Kim, Choi, & Moon, 2012; Vicenzino, Cleland, & Bisset, 2007). Herd and Meserve (2008) published a systematic review on mobilization with movement (MWM), cervical spine mobilization, Cyriax physiotherapy, and other manipulative techniques used for treatment of LET. These researchers reported that the manipulative techniques and the comparison treatments varied. The quality of the studies also varied, but the authors found that all of the manipulative therapies had favorable outcomes when used to treat patients with LET. It was also determined that MWM was the most frequently studied, with supporting evidence for short and long term benefits. Herd and Meserve (2008) concluded that future studies with larger sample sizes, valid outcome measures, and long-term follow up were needed. Khuman et al. (2013) examined MFR compared to conventional therapy (US, exercise, and stretching) for the treatment of LET, and they found that MFR had superior outcomes. Ajimsha, Chithra, and Thulasyammal (2012) compared two groups of individuals with LET, and they found greater improvement in outcomes in a MFR group versus a sham US control group. Another group of researchers examined MFR, active release techniques (ART) and conventional therapy (US, stretching and strengthening), and found that MFR and ART were more effective than conventional therapy for the treatment of LET (Trivedi et al., 2014). The collective recommendations from these researchers were that higher quality studies with larger sample OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 18 sizes and longer observations were needed to increase the understanding of the optimal methods to manage LET (Ajunsha et al., 2012; Khuman et al., 2013; Trivedi et al., 2014). Exercise. Researchers have supported exercise as a conservative treatment for LET. Stasinopoulos (2016) reported that an exercise program is the most common treatment for the management of LET. Stasinopoulos and Stasinopoulos (2017) determined that eccentricconcentric training combined with isometric contraction was more effective than was only eccentric training or eccentric-concentric training for LET. Tyler, Thomas, Nicholas, Malachy, and McHugh (2010), supported the efficacy of adding eccentric strengthening to standard treatment for LET. Raman et al. (2012) found that individuals with LET had improvement in pain levels, grip strength, and function when resistive exercise was used. In a systematic review of the effectiveness of eccentric exercise (EE), Cullinane, Boocock, and Trevelyan (2013) reported that EE improved outcomes when used as a part of a multimodal therapy program for treatment of LET. Soderber, Grooten,and Ang (2012) found positive effects of EE on pain free grip and wrist extensor strength. It was found that a group that completed EE as part of their rehabilitation had significantly higher pain-free hand grip and wrist extension strength at their final follow up evaluation (Soderber et el., 2012). Despite researchers supporting the use of exercise for LET, not one type of exercise or exercise dosage has been identified as superior (Bisset & Vicenzino, 2015; Raman et al., 2012). Furthermore, Stasinopoulos (2016) reported that exercise alone has low rehabilitative success when treating LET but when combined with other interventions the effectiveness has been heightened. Regardless of the type or dosage prescribed, every therapeutic intervention in musculoskeletal LET rehabilitation introduces a mechanical force or load that is believed to begin the healing cascade (Hammer, 2008; Thompson, Scott, Loghmani, Ward, & Warden OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 19 2016). Mechanotransduction is the result of these mechanical forces on the musculoskeletal system (Khan & Scott, 2009; Lorenz, 2010). Khan and Scott (2009) and Lorenz (2010) described mechanotransduction as a process by which the body converts mechanical loading into cellular responses. It is believed that through mechanotherapy (the application of mechanical forces used by therapists) cellular activities that influence the tissue-level process of growth, modeling, remodeling, and repair will occur (Thompson et al., 2016). Thompson et al. (2016) stated that the ultimate goal of musculoskeletal regenerative rehabilitation is the restoration of function through musculoskeletal tissue regeneration and repair. Astym. To facilitate healing, Astym treatment includes the use of specific instruments for manual treatment of the soft tissue in conjunction with exercise. Astym treatment is a type of noninvasive soft tissue regenerative therapy that stimulates the healing of acute and chronic musculoskeletal pathological conditions such as LET (Astym, 2012; Sevier & Stegink-Jansen, 2015). Researchers at Performance Dynamics in Muncie, Indiana report that on a cellular level Astym treatment causes (a) dysfunctional capillary exudation, (b) local fibroblast activation and recruitment, (c) phagocytosis, and (d) release of growth factors (How Astym Treatment Works, 2012). Researchers have determined that patients with post-operative scar tissue (Davies & Brockopp, 2010), chronic or refractory tendinopathies, or repetitive over-use injuries should be considered for this treatment (What is Astym Treatment, 2012). Astym treatment began gaining recognition and popularity in the early 2000s, with more recent evidence-based research supporting its effectiveness (Sevier & Stegink-Jansen, 2015; Performance Dynamics, 2009). For more than 20 years, Astym treatment protocols have been developed and refined by a multi-disciplinary research team consisting of scientists, therapists, and physicians at Performance Dynamics, Inc. (Better Research, Better Results, 2012). These OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 20 researchers continue to refine Astym treatment protocols based on statistics from outcome data that are constantly being updated (Better Research, Better Results, 2012; Sevier & SteginkJansen, 2015). The Astym treatment is categorized as a regenerative medicine that professionals use to stimulate the regeneration and remodeling of healthy muscles, tendons, and ligaments (Kivlan, Carcia, Clemente, Phelps, & Martin, 2015). The application of hand-held instruments with a custom designed edge, functional activities, and exercise stimulate the body to resorb fibrotic scar tissue and to regenerate healthy tissue (Davies & Brockopp, 2010). Clinicians use Astym treatment to decrease pain, reduce impairments, lessen movement restrictions, and improve patient function (What is Astym?, 2012; Kivlan et al., 2015). Clinicians also use Astym treatments to desensitize and remodel scar tissue and to facilitate increases in strength and range of motion (Davies & Brockopp, 2010). Application of the Astym hand- held instruments is primarily in a parallel fashion along the involved kinematic chain. By treating in a longitudinal manner, the instruments glide over the normal tissue and engage only the abnormal or dysfunctional tissue (Davies, Brockopp, & Moe, 2016). A lubricant is utilized to reduce the friction from the instruments, while stroking motions are applied to the skin (McCormack, 2012a; McCormack, 2012b). The stroke direction, treatment edge, angle, speed, pressure, and application of shear forces imparted by Astym instruments are systematic (Davies & Brockopp, 2010; Sevier & Stegink-Jansen, 2015; Sevier et al., 2009). The instrument edges are held at a 60 to 80 angle in relation to the skin surface, allowing the Astym custom designed instrument edge to catch on dysfunctional soft tissues and the irregular fibrosis. The instruments are designed to assess the presence of dysfunctional OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 21 tissue by amplifying the tactile sensation of the underlying improperly organized tissues (Davies et al., 2016). Studies that support the use of Astym treatment to improve function have been published. Tyler and Slaven (2013) found that systematically induced stretching and strengthening combined with the Astym instrumentation led to gains in self-perceived function, walking speed, and a reduction in pain when treating osteoarthritis of the knee. The effect of Astym treatment on bilateral high hamstring tendinopathy and the mid-portion Achilles tendinopathy was examined by McCormack in 2012. When Astym instrumentation was combined with stretching and eccentric strengthening, individuals had decreased pain and increased function (McCormack, 2012a; McCormack, 2012b). Management of chronic ankle pain using joint mobilization and Astym treatment also revealed beneficial outcomes (Slaven & Mathers, 2011). Furthermore, Davies and Brockopp (2010) completed a retrospective study and found that Astym treatment coupled with manual lymph drainage, gentle massage, stretching, and strengthening had positive results when treating individuals who had scar tissue following surgical treatment for breast cancer. For patients with LET, Sevier and Stegink-Jansen (2015) completed a two group, prospective, randomized controlled trial study. Participants were randomized into either a group that completed EE and stretching or a group that completed EE and stretching plus the application of the Astym instruments. Using the Patient and Physician Global Rating of Change Scale to determine the resolution of symptoms, Sevier and Stegink-Jansen (2015) identified that 78.3% of the elbows in the Astym treatment group met resolution criteria at four or eight weeks of the initial treatment. In contrast, only 40.9% of the elbows in the EE group met the resolution criteria at four or eight weeks of the initial treatment. Of the individuals who did not respond to OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 22 EE and chose to receive four weeks of Astym treatment, 95.7% of these participants met the resolution criteria. Overall, of the individuals who received Astym treatment 83.6% met resolution criteria. Further outcome results from the Sevier and Stegink-Jansen (2015) study were that the Astym treatment groups functional gain scores on the Disability of the Arm, Shoulder and Hand (DASH) outcome questionnaire had a greater reduction in disability (p = .047) at four weeks. In addition, compared to the EE group, the Astym treatment group had greater gains in grip strength (p = .008). However, statistically significant differences were not found between the two groups when assessing pain with activity (p = .08) and function (p = .55). An additional analysis was completed after the eight to twelve-week treatment period of the participants who received Astym treatment after not responding to EE. The researchers found decreased disability on the DASH by 13.43% (p < .005), decreased pain with activity by 26.1 mm on a visual analogue scale (VAS) (p = .002), increased grip of 6.3 pounds, and increased function by 17.0 mm on a VAS (p = .004). The researchers showed that DASH scores, pain with activity, and function at six and twelve-month assessments continued to improve compared to the baseline measurements (Sevier & Stegink-Jansen, 2015). Slaven (2014) also established that Astym instrumentation may be effective for treating individuals with LET when combined with a program of stretching and strengthening. The researcher utilized a single case study A-B-C-B-C format. The A phase was the baseline, B was the stretching and strengthening phase, and C was the Astym instrumentation combined with the stretching and strengthening regime of the B phase. In the first phase B the patient experienced high levels of pain that resulted in inability to generate any grip force. With the introduction of Astym treatment into the therapy protocol, the individual with LET had an increase in pain-free OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 23 grip strength and a decrease in pain levels, which continued through both C phases and the second B phase (Slaven, 2014). Functional Outcomes In addition to common therapy interventions used to treat LET, there are standard outcome measures that are utilized to assess the condition and monitor the effectiveness of standard therapeutic care. These assessments may include grip strength, range of motion, pain pressure threshold, patient reports of pain, and provocative tests (Fedorczyk, 2011). These elements of the clinical evaluation, such as range of motion, have poor reliability and decreased responsiveness when compared to self-report measures (Von der Heyde & Droege, 2015). Patient reported outcomes (PRO). Supplemental to the traditional standard outcome measures, PRO measures are now being included in the assessment process (Anthony et al., 2013; Werneke, 2016b). Given that traditional assessment tools used in therapeutic practices may not be optimal for measuring patients function, there is strong support to include the use of PRO measures (Werneke, 2016b). Moreover, PRO measures are used to determine condition severity, prognosis, and response to therapeutic intervention. They are also used as a benchmark to assist with making clinical decisions (MacDermid & Silbernagel, 2015). With the paradigm shift in clinical practice to use PRO measures, and adding to the published support for the use of PRO measures in clinical practice, MacDermid and Silbernagel (2015) reported that these outcome measures are necessary for assessing physical impairments, activity performance, and patientreported symptoms and function. Werneke (2016a) suggested that frequent and objective feedback from PRO measures is essential for therapists to confirm the effectiveness of their therapy services. Patient reported outcome measures can be used to improve the quality of care, and improve value of healthcare OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 24 services. Furthermore, they can be used to monitor improvements in the patients quality of life and function. Patient reported outcome measures are considered to be the gold standard for measuring patient outcomes and are endorsed by the World Health Organization, Centers for Medicare and Medicaid Services, National Quality Forum, the Institute of Medicine and other policymakers, payers, professional associations, and clinical practice guidelines (Werneke, 2016b). The PRO measurement tools are evolving in health care (Hart, Wang, Cook, & Mioduski, 2010b). They define degrees of success in treatment, and PRO measures are increasingly being utilized in the assessment process. MacDermid and Silbernagel (2015) reported that tendinopathy-specific PRO measures were shown to be superior to more generic tools for some conditions, such as LET. Moreover, PRO measures that are used by clinicians to identify pain and functional limitations should be fundamental to outcome evaluation in patients with tendinopathy (MacDermid & Silbernagel, 2015). As with the traditional measurements, the PRO measures can be used at the intake evaluation, throughout the episode of care, and at the completion of care. The generated outcomes from the PRO measures have been found to complement traditional clinical tools. They also serve as a link between a patients task performance in the clinic and actual function in real-world situations (Wang, Hart, Cook, & Mioduski, 2010). Furthermore, many PRO measures have been found to be reliable, valid, and sensitive to change (Cook, Roddey, OMalley, & Gartsman, 2005; Haley et al., 2006). Focus on Therapeutic Outcomes. Publications that included the PI report of the elbow were not found in the literature; however, publications on the PI of the UE were discovered. Hart et al. (2010b) found that the shoulder PI reduced patient and clinician burden for outcomes data OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 25 collection while producing precise and responsive measures of patients levels of activity dimension. Sindhu et al. (2012) examined the influence of fear avoidance beliefs on functional status outcomes for people with musculoskeletal conditions of the shoulder. Fear avoidance is defined as the avoidance of movement or physical activity based on the belief that the movement or activity will hurt and make the condition worse (FOTO Functional Status Measure Risk Adjustment Procedures, 2013). If a person has a fear of pain or has anxiety around pain this may have a negative impact on his or her physical and functional behaviors. The findings of the Sindhu et al. (2012) study were that elevated fear avoidance beliefs on the PI report correlated with poorer recovery in individuals with UE muscle, tendon, or soft tissue disorders, or in individuals with UE osteopathy, chondropathy, or acquired musculoskeletal deformity. The results of this study led Sindhu et al. (2012) to suggest that individuals with shoulder conditions may benefit from treatment that specifically addresses fear avoidance beliefs. Wang et al. (2010) evaluated the meaningful interpretation of PI report of individuals with shoulder impairments. The researchers concluded that clinical interpretations of the PI report generated outcome measures that may be useful to clinicians in clinical practice, and may advance clinical science of rehabilitation of the UE (Wang et al., 2010). FOTO functional status measures outcome data have been utilized to establish the effectiveness of treatment with individuals with adhesive capsulitis (Jewell, Riddle, & Thacker, 2009). In this retrospective study, participants FOTO questionnaires at intake and at discharge from therapy were analyzed to determine a meaningful improvement of disability. The FOTO system was also used to generate statistically created intervention categories to aid in determining that joint mobility and exercise produced superior outcomes compared to US, massage, iontophoresis, and phonophoresis (Jewell et al., 2009). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 26 Similarly, Hart, Tepper, and Lieberman (2001) completed a retrospective study to analyze health status changes in individuals with wrist or hand impairments. Through the use of FOTO data outcomes, these researchers identified that patients had improvements in perceived physical health status during their treatment episodes that were congruent with the difference between intake and discharge on their FS measure. Their findings also supported the responsiveness of the FOTO instrument for the collection of health status measure in patients with wrist and hand impairments and confirmed the ability to differentiate changes through time in this population (Hart et al., 2001). There have been an increasing number of studies demonstrating the effectiveness of conservative treatments for LET, yet there is a large heterogeneity among trials, and no one intervention can be generalized to an entire population (Agostinucci, McLinden, & Cherry, 2012; Coff, Massy-Westropp, & Caragianis, 2009; Joseph et al., 2012; Kohia, 2008; Radpasand & Owens, 2009; Tyler, et al., 2010). The results from studies on physical interventions are varied, inconclusive, and conflicting (Bisset & Vicenzino, 2015). Additionally, there remain gaps in the literature, and study limitations impede the use of optimal evidence-based practice, and hamper the development of comprehensive clinical practice guidelines (MacDermid et al., 2010). Furthermore, MacDermid et al. (2010) reported that no treatment protocol that has been identified as being superior for managing LET, improving function, and reducing pain. Although studies have shown promising results for Astym, only a few of the published reports have evaluated the effectiveness of treatment with UE conditions, and no studies have linked Astym treatment with FOTO functional status measures for patients with LET. This study was designed to compare standard therapeutic interventions to standard therapeutic interventions coupled with Astym treatment for individuals with LET who received OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 27 OT. The aim of the study was to determine if the addition of Astym treatment to standard OT interventions yields superior FOTO FS measures when treating individuals with LET. An additional purpose of this study was to determine if the addition of Astym treatment to standard OT interventions yields superior outcomes on the NPRS, and on standard grip strength and provocative grip strength measures. In addition, the results of this study may provide support for effective evidence-based treatment interventions for professionals who treat individuals with LET. Method Study Design A non-experimental retrospective cohort study was completed using data extracted from medical records of patients diagnosed with LET who received OT at three outpatient clinics in New Mexico. Data from patient charts were categorized into one of two groups: AG or SG. This study was determined to be exempt by the Human Research Protections Program at the University of Indianapolis and the Presbyterian Healthcare Services (PHS) Institutional Review Board in Albuquerque, New Mexico. Participants A convenience sample of outpatients who received OT for LET through one of three outpatient clinics between January 1, 2014 and June 30, 2016 was used for this study. Two of the outpatient clinics were located in Albuquerque, NM, and the third clinic was located in Rio Rancho, NM. Inclusion criteria for participants were the following: aged 18 years or older, referred for treatment of LET, OT episode of care (intake evaluation, any number of follow-up treatments, and a discharge evaluation with objective measurements and outcomes), and completed FOTO for the episode of care. Exclusion criteria included FOTO episode of care (a) OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 28 for body part other than the elbow, (b) impairment other than muscle/tendon or soft tissue, and (c) not categorized as orthopedic. An a priori sample size estimation was calculated based on comparing differences between two independent means using the G*Power software program (Faul, Erdfelder, Lang, & Buchner, 2007). For an effect size of 0.50, an alpha of .05, and a power of 80%, it was estimated that a sample size of at least 128 participants was needed. To determine if a medium value for the effect size applied to this study was valid, calculations were completed using the means and standard deviations of two groups (Nagrale, Herd, Ganvir, & Ramteke, 2009) and a similar effect size was obtained. Data Data were operationalized as follows: FOTO diagnosis of an elbow condition. Confirmed diagnosis of LET: Based on the physicians referral, and the OT evaluation and treatment for LET. Age in years. Gender: male or female, based on the patient self-report. FS measure score at intake (based on the patient responses to the body part specific PI self-assessment survey that was completed on the first day of OT). FS measure score at discharge (based on the patient responses to the body part specific PI self-assessment survey that was completed on the last day of OT). Chronicity: Designated as acute or chronic. Acute category was assigned if the LET symptoms were present for less than three months at the initial exam, while chronic was assigned if the LET symptoms were present for greater then three months at the initial exam. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 29 Hand dominance: Based on patient report of using his or her right or left hand or both hands (ambidextrous), to complete the majority of daily activities. Involved UE: Based on the side (right or left) reported to have elbow pain. Mechanism of onset: Categorized as either trauma or overuse. Trauma was present if the patient reported the injury occurred from a one-time incident. Overuse was present if the patient reported the injury occurred from overuse. Severity of the condition: The severity of the condition was automatically calculated from the PI reports, and categorized as slight, moderate, severe, and very severe. Symptom acuity: The symptom acuity was based on the number of calendar days between date of onset of symptoms and date of initial intake: 8-14 days, 15-21 days, 2290 days, 91 days to 6 months, and over 6 months (FOTO Functional Status Measure Risk Adjustment Procedures, 2013). Number of visits: The number of OT sessions that a patient participated in. Episode of care: The number of days in therapy, starting from the day of the OT intake and ending on the day of OT discharge evaluation. Type of work: Six categories were used: clerical, manual labor, professional, homemaker/caretaker, semiprofessional, and not applicable (N/A). Clerical category was used for patients who spent at least 80% of their day using a computer. Manual labor category was assigned for construction workers, painters, house cleaners, cooks, and maintenance workers. The professional category was used for the jobs that included engineers, therapists, and nurses. Homemaker/caretaker was used for those who performed nonpaid work in the home. Semiprofessional was used for hair dressers, and OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 30 law enforcement. N/A category included any patient who did not meet criteria for other categories. Work status: Categories as follows: Full-time work (32 hours a week or more), part-time work (fewer than 32 hours a week), unemployed, disability, retired, student, or volunteer The type of OT interventions each patient received. The worst, and best/least numeric pain level reported at OT intake and discharge. For increased reliability and validity of the NPRS in the PHS outpatient clinics, the common practice was to administer this instrument in a quiet and private environment. Standard grip and provocative grip, mean of three trials for both at OT intake and discharge, using two Jamar dynamometers. Standard grip strength procedures were completed with the patient seated, shoulder adducted, elbow flexed to 90 degrees and the forearm and wrist in neutral (Klein, 2014; Naughton, 2012). Provocative grip strength measurements were taken with the shoulder in 90 degrees of flexion, elbow in 0 degrees of extension, and the forearm in neutral (De Smet & Fabry, 1997; Dorf, Chhabra, Golish, McGinty, & Pannunzio, 2007). Each dynamometer was routinely checked for calibration every six months, which improved the precision and reliability of the devices. All occupational therapists employed by PHS completed rigorous training to ensure consistency of assessment and treatment techniques. Instruments Focus on Therapeutic Outcomes. Focus on Therapeutic Outcomes was formed in 1992 by six rehabilitation corporations to create a standardized outcomes measurement and reporting system for outpatient rehabilitation (Hart et al., 2010a). Focus on Therapeutic Outcomes is a proprietary international medical rehabilitation database management system and company OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 31 (Hart, Deutscher, Wernekes, Holder, & Wang, 2010a; Swinkels et al., 2008) that partners with clinics to collect and provide outcome measures and data management services (Sindhu et al., 2112; What is FOTO?, 2016). The FOTO measurement system uses web-based software to analyze information on clinic performance, patient care, and patient satisfaction (Outcomes Management System + Predictive Healthcare Analytics, 2018). It is a system that reports on characteristics of patients, health care providers, and organizations (Swinkels et al., 2007). The FOTO outcomes database includes standardized assessments of function, along with instruments that collect information on demographic characteristics. The FOTO database is the largest outpatient rehabilitation outcomes databank available to researchers in the United States (Gozalo, Resnik, & Silver, 2016), with the purpose of providing reliable, valid and responsive outcome measures (Swinkels et al., 2008). The FOTO measurement system uses computerized adaptive testing (CAT) for the PRO. Computerized adaptive testing programs are efficient and feasible to use in outpatient clinics (Jette & Haley, 2005). Outcome scores from CAT programs provide comparable scores and are sensitivity to change, when compared to lengthier outcome evaluations that take longer to administer. The CAT selects items to match individual responses; therefore, the precision of the CAT is believed to be superior to fixed form outcome assessments (Jette & Haley, 2005). With a CAT measure, after the patient answers the first question, each successive item on the assessment is determined by the patients response to the previous item. Outcome measures that rely on CAT use a computer algorithm to estimate a patients level of the outcome being measured, update the estimate every time the patient answers another item, and selects the next item to be asked based on its match with the computers updated estimate of the individuals trait level (Cook et al., 2005). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 32 Patient inquiry self-report survey is a PRO used by FOTO to create a FOTO patient report on the functional level of the body part or impairment that needs treatment. Patients complete the FOTO body part specific PI self-assessment survey prior to participating in the therapy evaluation. Once the initial PI survey is completed, a risk adjustment algorithm predicts outcomes based on patient responses to the PRO (Risk Adjustment & Predictive Analytics, 2018). Examples of the 13 risk adjustment factors in the algorithm include: care type, impairment/body type, gender, age, acuity, surgical history, comorbidities, and medication (Risk Adjustment & Predictive Analytics, 2018). Although the PI is not specific to tendinopathy, the survey is specific to body parts. The PI survey, the Elbow Wrist Hand (EWH), can be further analyzed by researchers to dichotomize and understand information on specific conditions, such as LET. The EWH was used in this study and was composed of three subsections: function (12 questions), medical history (10 questions), and pain (10 questions). A FOTO patient report is created from the patient responses on the PI survey. The FOTO report created from the initial PI includes the following: patient name, patient identification number, date of birth, evaluation date, body part, impairment, history, care type, severity, age, acuity, gender, comorbidities, payer, and fear avoidance. The report also includes a FS measure score and a predicted FS measure score. The FS measure score is used to monitor functional improvement of patients. The predicted score is a FS measure score established from episodes of care from previous patients with similar conditions, which provides a baseline for therapist to compare expected outcomes to their patient. At discharge from therapy a FOTO discharge report is created from the patient completing the PI survey again. This report includes the same information as the intake, duration of episode of care in days, the number of therapy OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 33 visits, the patients new FS measure, and points of change on the FS measure. Once the clinician closes a patients FOTO episode of care a number is assigned for (a) patients perception of improvement and (b) clinicians perception of improvement (The Power and Value of the FOTO Outcomes Measurement System, 2013). The reported FS measures are established from the patients perception of functional limitation before and after the completion of treatment. The FS measure is a score from zero to one hundred that represents a patients functional ability (one hundred represents no functional impairment). The FOTO system uses functional staging to help clinicians and researchers interpret the FS measure score. Stage 1: exceedingly limited (0-24), Stage 2: poor (25-43), Stage 3: fair (44-59), Stage 4: good (60-80), Stage 5: excellent (81-100) (Functional Staging, 2018). These FS measures are used by clinicians to monitor the functional changes of patients throughout the course of each patients therapeutic episode of care (The Power and Value of the FOTO Outcomes Measurement System, 2013). The performance measures can also be utilized for the following: (a) monitor patient satisfaction, (b) identify quality of care (c) identify quality improvement approaches, (d) improve accountability, (e) create clinician and clinic risk-adjusted performance measures, and (f) enhance patients functional improvement across therapy providers by reducing practice variations (Gozalo et al., 2016). Specific to the elbow, the FOTO FS measure score is based on the EWH. There are no published studies on UE conditions, including LET, which have used the EWH as an outcome measuring tool. However, as a result of an internal analysis by the FOTO research team, it was concluded the EWH was efficient and produced precise, sensitive and responsive FS measure for patients receiving therapy for elbow, wrist, or hand impairments (Mark Werneke, personal communication July 10th, 2018). Based on 2010 FOTO data (N = 17), the EWH had strong test- OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 34 retest reliability, with an ICC of .95. The EWH was also found to have good responsiveness. Data from April 2008 to April 2010 (N = 4863) from 538 clinics in 26 states, showed that 70% of the patients attained FS measure scores equal to or greater than the minimal detectable change (MDC) at 95% confidence interval, and 70% of patients attained FS measure change scores equal to or greater than the minimal clinically important change (MCID) (Deanna Hayes, personal communication July 11, 2018). Based on an internal analysis of 4863 patients by the FOTO research advisory board for the 2014 National Quality Forum endorsement, the MCID for the EWH is 4 (Mark Werneke, personal communication July 10, 2018). However, the MCID varies based on the patients intake score; FS = 0-46 (MCID = 9.0), FS > 46-50 (MCID = 3), FS >50-54 (MCID = 2), and FS >54100 (MCID is 4) (Mark Werneke, personal communication July 10th, 2018). The MDC for the EWH also varies based on the patient FS score at intake: The FOTO research advisory board established the following MDC: FOTO score: 0-10 (MDC = 23.9), 11-20. (MDC = 9.4), 21-30 (MDC = 6.0) 31-40 (MDC = 4.4), 41-50 (MDC = 4.0), 51-60 (MDC = 4.2), 61-70 (MDC = 4.9), 71-80 (MDC = 6.3), 81-90 (MDC = 9.2), 91-100 (MDC = 21.2) (Deanna Hayes, personal communication July 11th, 2018). Numeric pain rating scale. The NPRS is the most commonly used tool to assess pain. It is a subjective 11-item unidimensional quantifier utilized in adults (Hawker, Mian, Kendzerka, & French 2011). It is a tool frequently used in clinical and research settings, with evidence supporting the reliability and validity of this measurement tool across many populations (Ferreira-Valente, Pais-Ribeiro, & Jensen, 2011). It has sufficient psychometric strength, with a test-retest stability correlation coefficient of .72 (Jensen, Turner, Romano, & Fischer, 1999). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 35 Ferreira-Valente et al. (2011) published a study comparing the relative validity of four pain scales for detecting differences in painful stimulus intensity and differences between men and women in response to experimentally induced pain. It was found that the NPRS was the most responsive measure of pain intensity with a higher Cohens effect size (d = .47) (FerreiraValente et al., 2011). Furthermore, Hawker et al. (2011) found that the construct validity of the NPRS was highly correlated to the VAS in patients with chronic pain conditions that have lasted longer than six months, with a reported correlation range from .86 to .95. The reliability and validity of the NPRS has not been established on individuals diagnosed with LET; however, its responsiveness and test-retest reliability has been reported for other UE conditions. In patients with shoulder conditions that resulted in shoulder pain, a MCID of 2.17 for the NPRS was reported suggesting good responsiveness (Michener, Snyder, & Leggin, 2011; Mintken, Glynn, & Cleland, 2009). In a study of patients with shoulder pain, the NPRS had a MCID of 1.1 and a test-retest ICC of .74 suggesting good responsiveness and stability (Mintken et al., 2009). For populations with UE pain, Stratford and Spadoni (2001) reported the MDC of the NPRS at three points. The MCID was established as one point of change for individuals with chronic musculoskeletal pain (Salaffi, Stancati, Silverstri, Ciapetti, & Grassi, 2004). Jamar dynamometer. The Jamar dynamometer is an assessment device used to measure grip strength in kilograms or pounds. It is considered to be an accurate, reliable, and valid dynamometer for measuring grip strength (Amaral, Mancini, & Marques, 2012), and researchers have used the device to establish grip strength norms in adults in the United States (Klein, 2014). The Jamar dynamometer has been reported to be reliable regardless of the medical condition or aspect of reliability being studied (Mafi, Mafi, Hindocha, Griffin, & Khan, 2012). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 36 When the Jamar dynamometer was used to assess grip strength of healthy individuals, researchers identified good to excellent test-retest reliability, r = .88 to .93 (Mathiowetz, 2002) and excellent inter-rater reliability, r = .99 (Lindstrom-Hazel, Kratt, & Bix, 2009; Mathiowetz, 2002). In community-dwelling older adults, test-retest reliability was also high, with an ICC of .90 on the left hand and .91 on the right hand (Bohannon & Schaubert, 2005). Using the Jamar hand held dynamometer, Smidt et al., (2002) researched intra-observer reproducibility of painfree grip strength and maximum grip strength with patients diagnosed with LET. It was determined that there was excellent intra-observer reliability, with both grip types (ICC .90). Kim, Park, and Shin (2014) reported that grip strength reflects functional status of the UE and found that in patients who sustained distal radius fractures, the Jamar dynamometer standard grip strength MCID and MDC was 6.5 kg. Similarly, Lang, Edwards, Birkenmeier, and Dromerick (2008) established an MCID of 5 kg for the affected dominant side and 6.2 kg for the affected non-dominant UE in patients early after stroke. Procedures Data collection: Retrospective data were obtained from the FOTO database and from PHSs Epic electronic medical record (EMR). The primary researcher, an occupational therapist from one of PHSs outpatient clinics, determined the eligibility of all charts for inclusion in the study. A list of potentially eligible patients with an elbow condition was received from a query of the FOTO database. To determine patients with LET, the primary researcher first established that the physicians referring diagnosis was for one of the following: elbow pain, tennis elbow, lateral epicondylitis, lateral elbow epicondylalgia, or lateral elbow tendinopathy. Second, the terms used by referring physicians were used to identify the treatment OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 37 diagnosis: ICD-9: 726.32 (lateral epicondylitis), ICD-10: M77.10 (lateral epicondylitis, unspecified elbow), ICD-10: M25.521 (pain in right elbow), or ICD-10: M25.522 (pain in left elbow). To confirm LET, the primary researcher reviewed each patients OT intake evaluation and verified evaluation and treatment for LET. The primary researcher also confirmed that the EMR included documentation for a complete OT episode of care (initial OT assessment, progress treatment notes for each OT session, final discharge assessment). The primary researcher cross-referenced each patients FOTO identification with the patients PI report to confirm that each patients FOTO episode of care included an intake FS measure score and a discharge FS measure score. Data for ineligible patients were deleted. Eligible patients were assigned numbers, then all data were entered into an Excel spreadsheet. To minimize data transfer error and for ease of data collection, the columns on the data matrix Excel spreadsheet corresponded to the same sequence as the FOTO data of each individuals PI report on the episode of care. Once all data were entered, the original FOTO query was deleted. Data Analysis Data were analyzed using IBM SPSS Statistics for Windows, Version 24.0 (IBM Corp., Armonk, NY). Normality of the data was determined using a Shapiro-Wilk, all tests were twotails, and a significance level of less than .05 was considered statistical significance. Descriptive statistics were conducted on the entire sample and both treatment groups. Nominal data are presented as frequencies and percentages, and interval and ratio data are presented as medians and interquartile ranges if the data were not normally distributed, and means and standard OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 38 deviations if the data were normally distributed. To determine if participants in both groups were similar in demographic characteristics, comparisons were conducted using the Pearson chisquare test for nominal data and either an independent t test or non-parametric Mann-Whitney U test for interval and ratio data, dependent on whether or not the data were normally distributed. Outcome data (FOTO score, pain, standard grip strength, and provocative grip strength) from intake and discharge were compared between the treatment groups using the nonparametric Mann-Whitney U test due to the data not being normally distributed. To determine if there was greater change in one treatment group compared to the other, change scores were created by subtracting the intake score from the discharge score. This method of analysis was used due to the data not being normally distributed. The change scores were compared for significant differences between treatment groups using a Mann-Whitney U test for non-normally distributed change scores and an independent t test for normally distributed change scores. A positive change score indicates a higher score/ value at discharge, and a negative change score indicates a lower score/value at discharge. If a participants FOTO FS measure, standard grip strength or provocative grip strength got better over time the change score was positive. If a participants pain level got better over time the change score would be negative. In addition, change from intake to discharge for the entire sample, the AG, and the SG were compared using the non-parametric Wilcoxon signed-ranks test. Results Initially, data from 805 FOTO forms from patients with orthopedic elbow impairment intakes (completed on the first day of OT) collected between January 1, 2014 and June 30, 2016 were obtained. Of the 805 intakes, there were 312 complete episodes of elbow impairment. Of the complete elbow impairment episodes, 90 of the orthopedic elbow impairments were other OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 39 conditions such as cubital tunnel syndrome, fractures, or arthritis. The remaining EMR were retained for analysis as the final sample size. See Figure 1 for the CONSORT flow chart. Patient characteristics The mean age for the total sample was 55.06 (SD = 14.07). The total sample was predominantly female, right hand dominant, right UE was more often involved, with chronic LET, and overuse as the primary mechanism of onset. The AG and SG were similar in gender, hand dominance, chronicity, involved UE, and mechanism of onset. Overuse was more frequently reported and most patients were right-hand dominant with right UE more often involved (see Table 3). The AG was younger than the SG, mean age was 53.26 (SD = 13.51) years and 56.65 (SD =14.43) years respectively, however, the difference was not statistically significant (p = .073). Frequency of condition severity showed twice the number of patients categorized as very severe for the SG compared to the AG (see Table 4); symptom acuity was more frequently greater than 22 days for both groups (see Table 5). Both groups had similar number of OT visits and FOTO episode of care (duration in days); the AG showed more clerical and manual types of work compared to the SG, and both groups more frequently had full-time workers (see Tables 6, 7, and 8). Occupational therapists used multiple types of treatments for patients in both groups with 5 of the 19 differing significantly between groups (see Table 9). Outcomes With the exception of pain at intake, there was not a statistically significant difference in any of the outcomes between the treatment groups (Table 1). When change scores were compared between the groups there were no significant differences (see Table 2). There was significant improvement (p < .001) in all outcomes for the AG (Table 10) and the SG (Table 11). Both groups surpassed the established Elbow Wrist and Hand MDC by 4.3 times for the AG and OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 40 3.8 times for the SG (Deanna Hayes, personal communication July 11th, 2018; Mark Werneke, personal communication July 10, 2018). Both groups surpassed the established Elbow Wrist and Hand MCID by 4.5 times for the AG and by 8 times for the SG (Deanna Hayes, personal communication July 11th, 2018; Mark Werneke, personal communication July 10, 2018). Both groups exceeded the MCID for the NPRS, with point change of -6 and -5 for AG and SG respectively (Farrar, Young, La Moreaux, Werth, & Poole, 2001; Salaffi et al., 2004; Stratford & Spadoni, 2001). Although both groups had improved standard grip and provocative grip, there are no established MDC or MCID for comparison for individuals with LET. Discussion Except for AG having higher NPRS scores at intake, no statistically significant difference was found between AG and SG at intake or discharge for the FS measure, NPRS, standard grip strength or provocative grip strength. Although participants differed in that SG had more severity of condition, based on the FOTO system functional staging, both groups were Stage 3 (Fair) at initial intake and both groups improved to Stage 4 (Good) at discharge. In a study where Astym treatment was compared to EE for LET, Sevier and SteginkJansen (2015) suggested that Astym is an effective treatment to improve elbow function. The current study found that AG did not have functional gains that were statistically significant compared to SG. The contradictory results of the two studies may be due to the different assessment tools used to measure outcomes. Using the self-rated DASH, Sevier and Stegink-Jansen (2015) found that the Astym group and the delayed Astym group had greater gains in function compared to the EE group The DASH incorporates functional statements that focus on use of the shoulder, elbow, wrist, and hand. It has a section that specifically addresses a patients pain level over the last week. It OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 41 also has a couple of more global functional statements such as managing transportation needs and sexual activities. Compared to the DASH, the FOTO FS measure used in this study was calculated using risk adjustment factors such as age, acuity, severity, and co-morbidities. In addition to functional questions that are specific to a body part, the PI self-assessment survey included questions about medication use for the condition and previous treatment or surgeries for the condition. Because of differences in question types between the two outcome tools, it is plausible that the results reported by Sevier and Stegink-Jansen (2015) might have been different from this study due to the diverse measurement features of each tool. In addition, because the DASH does not consider risk adjustment factors when calculating the outcome scores, the scores may improve at greater intervals. In the current study, the AG had higher pain levels at the initiation of therapy, with their NPRS scores decreasing the same amount as the SG. An established protocol that indicates the best treatment choice for LET based on a patients pain level does not exist. Therapists in this study may have chosen to implement Astym treatment based on patients high level of pain; however, due to the retrospective design of this study it is impossible to confirm this. Regardless of the treatment received, both groups in this study surpassed the MDC and MCID that were established for the NPRS for chronic neuropathic and non-neuropathic pain (Farrar et al., 2001), shoulder pain (Michener et al., 2011), and chronic musculoskeletal pain (Saliffi, Stancati, Silvestri, Ciapetti, & Grassi, 2004) confirming clinical improvement in pain levels. The clinical decrease in pain is consistent with the study on the role of Astym treatment in the management of LET (Slaven, 2014) and the Sevier and Stegnik-Jansen study (2015); however, unlike those studies, the current study did not find a statistically significant improvement in pain levels with the addition of Astym treatment. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 42 Dale, Mikuski, and Miller (2016) used the NPRS to assess pain levels of individuals with LET who received either standard intervention or a Pilates-based intervention. Similar to the current study, Dale et al. (2016) confirmed that both intervention groups had clinical improvements in pain that exceeded the MDC and MCID that was outlined in Stratford and Spadoni (2001) and Salaffi et al. (2004). Arif et al. (2017) published a randomized clinical trial that compared two manual therapy techniques for individuals with LET: one group received an ulnar medial-lateral glide and the other group received a radius anterior glide of the elbow. The authors identified similar change in pain scores (NPRS) as the current study. Both groups had decreased pain levels on the NPRS (Arif et al., 2017), with the ulnar medial lateral glide group surpassing the MDC and MCID established by Stratford and Spadoni (2001) and Salaffi et al. (2003). In a randomized, double-blinded, cross-over study that compared Kinesio taping (KT) to sham taping (ST), Cho, Hsu, Lin, and Lin (2018) found that individuals had improved pain levels on the NPRS during resisted wrist extension and pain-free grip strength. These researchers showed that the group that received KT had an average reduction of 2.1 on the NPRS indicating a clinical reduction in pain based on the established MDC and MCID (Cho et al., 2018). Consistent with the results of the published Slaven (2014), and Sevier and Stegnik-Jansen (2015) studies, there were significant improvements in the pain level of the participants. However, unlike the Slaven (2014) and the Sevier and Stegnik-Jansen (2015) study, the current study did not find the addition of Astym made a significant difference in outcomes between groups. The results of the current study may be due to the different pain outcome tools used in the studies. The researcher in the current study used a verbal NPRS, compared to the VAS used by Slaven (2014) and Sevier and Stegnik-Jansen (2015). This may have affected participant responses, for example, individuals may have had difficulty understanding the numeric rating OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 43 scale or had auditory limitations that altered their pain level response. The differences in study conclusions may also be due to the inclusion and exclusion criteria. To be included in the Sevier and Stegnik-Jansen (2015) study, participants had to have chronic pain (pain for greater than 12 weeks duration). The current study did not have that same criterion, with 57% of the participants having chronic pain. This may indicate that Astym treatments are potentially more effective with individuals who present with chronic pain. The Sevier and Stegnik-Jansen study (2015) exclusion criteria included the following: history of systemic connective tissue diseases or polyarthralgia, history of cervical radiculopathy, degenerative disease of the cervical spine, limited range of motion of the involved elbow, abrasion or direct trauma to the involved lateral elbow, abnormal antero-posterior and/or lateral X-rays of the involved elbow. Participants in the current study were not excluded based on any existing comorbidities. It is plausible that including individuals with more medical comorbidities might have negatively influenced the outcomes. For example, a participants pain reduction might have been less or the pain reduction might have taken longer to reduce or to resolve with the presence of existing comorbidities such as cervical radiculopathy. An individuals sensation of pain could have been altered or the pain cycle could have been perpetuated longer with a condition such cervical radiculopathy. In addition, if a participant had decreased elbow range of motion this might have interfered with the regeneration healing process, due to decreased circulation to already compromised tendon(s). Injections and the prescription of pain medication also excluded individuals from being included in the Sevier and Stegnik-Jansen (2015) study. It may be plausible that if the same exclusion criteria used by Sevier and Stegnik-Jansen (2015) were used for this study that the overall outcomes of the latter may have reached statistical significance. For example, individuals OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 44 who had received injections or who had been prescribed pain medication may have higher pain levels. Despite receiving one of these interventions, participants may continue to have high pain levels or they may have not responded well to these treatments. In addition, interventions provided years ago versus days ago may no longer be effective, and a participant may continue to have high pain levels. If individuals who had continued high pain levels following injections or following the use of prescribed pain medication had been excluded from the current study, the amount of change in the NPRS might have been different between groups. In the current study, standard and provocative grip strength improved, consistent with the other outcome measures. Both AG and SG had statistically significant improvements in outcomes, but when comparing the two groups there was no statistical difference. Regarding clinical changes, the standard grip strength and provocative grip strength of both groups showed improvement, suggesting the possibility for improved function. Supporting this suggestion, AG had clinical improvements in both standard and provocative grip strength that met the MDC and MCID outlined in Kim et al. (2014), and Lang et al. (2008), however, LET was not examined in these studies. The improvement in grip strength found in this study was similar to studies completed by Sevier and Stegink-Jansen (2015) and Slaven (2014), with standard and provocative grips strength of AG and SG showing statistically significant improvements. However, unlike the Sevier and Stegink-Jansen (2015) study there was not a statically significant difference between the groups. Although Fouda and Dewir (2017) did not conduct a study that assessed the efficacy of using Astym therapy to treat those with LET, they found that taping techniques for LET resulted in significant improvements in grip strength and significant decreases in pain intensity in individuals with the mean age of 35.12 years. Similarly, Shakeri, Soleimanifar, Arab, and OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 45 Behbahani (2018) in a study on the effectiveness of KT for LET, found that participants with the mean age of 34.61 years had significant improvements in function and significant decreases in pain levels. Comparably, although Stasinopoulos and Stasinopoulos (2017) did not study the effectiveness of Astym therapy, they identified that specific exercise prescriptions for LET resulted in significant improvements in function and significant reduction in pain intensity in individuals with a mean age of 43 years. The results of these studies indicate that regardless of the type of intervention provided for LET, patients have improvements in their outcomes. Gender may or may not influence the effectiveness of treatment for LET. The authors of a study on taping techniques for LET with an equivalent number of male and female participants found that all participants, regardless of gender, had statistically measurable improvements in grip strength and pain levels (Fouda & Dewir, 2017). Similarly, outcomes for grip strength and pain were similar for males and females in the current study. However, it may be possible that gender could influence the effectiveness of Astym treatment with women being more sensitive to the Astym instrumentation and having a lower pain threshold to the treatment. A literature review on sex-related influences on pain supports the hypothesis that, in general, females have greater pain sensitivity and are more sensitive to pressure pain. Ferreira-Valente et al. (2011) found that following painful stimuli women reported higher pain intensity ratings on three pain scales. In addition, due to the pain and hormone levels or neural connections, physiologically pain levels and responses to treatment for pain may vary between females and males (Fillingim, King, Ribeiro-Dasilva, Rahim-Williams, & Riley, 2008). A study on hormones and pain further support that women and men have different pain sensitivity. Results indicated that women and men may respond differently to pain and to treatments for pain (Schertzinger, Wesson-Sides, Parkitny, &Younger, 2018). OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 46 The current study included 118 full time employed individuals and 18 of the participants were left hand dominant; 95 of the participants experienced left elbow pain, and 29 had elbow pain due to a one-time incident. The Sevier and Stegink- Jansen (2015) study and the Shakeri et al. (2018) did not report participants hand dominance. Fouda and Dewir, (2017) and Stasinopoulos and Stasinopoulos (2017), reported that 85% to 100% of study participants in their studies experienced LET in their dominant arm; however, neither publication indicated if there was a link between hand dominance and outcomes. Although researchers often report hand dominance and the percentage of individuals who have LET in their dominant elbow, correlations between outcomes and UE dominance have not been reported. It may be beneficial for future researchers to study hand dominance and outcomes and LET treatments. In the current study, both groups received multimodal treatment in OT, consistent with recommendations of Sutton et al. (2016) and the British Columbia Physical Therapy Task Force (The University of British Columbia, 2016). Results of this study confirm that occupational therapists provided multimodal treatments for patients with LET similar to that of physical therapists (Bisset & Vicenzino, 2015; Marcolino et al., 2016; Sutton et al., 2016; The University of British Columbia, 2016). The AG group more often received treatment involving paraffin, moist heat, muscle energy technique, and joint mobilization compared to the SG group. The difference in use of heat could be explained by more than half of the AG group having chronic symptoms and higher pain at the OT intake, both of which responded favorably to the use of heat. Joint mobilization, used more often with the AG group in the current study, was shown to have strong support for treatment of individuals with chronic LET (Marcolino et al., 2016; The University of British Columbia, 2016). Because of the retrospective design of the study, it is not known how occupational therapists determined tendinopathy stage or if stage influenced OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 47 decisions for treatment. For the purposes of comparison in the current study, the PI assigned acute and chronic categories as 0-3 months or more than 3 months (Sevier & Stegink-Jansen, 2015), respectively, but there was no difference between the groups. In future studies, researchers should study stage and treatments to clarify which treatments are most effective for stage of tendinopathy. Although the AG had longer duration of treatment compared to the SG this was not statistically different. It may have been that occupational therapists provided longer duration of treatment for the AG because of higher pain at initial intake, with pain reduction requiring more time. Nonetheless, number of OT visits and duration of treatment found in the current study is in line with that of Sutton et al. (2016). Thirty months of EMR and FOTO data were collected for this study. During this time frame, the number of weeks patients received treatment, the number of treatment sessions each patient received, the number of times outcome measurements were collected, and the time in between each outcome measurements performed by the individual clinician varied. In contrast, the Sevier and Stegnik-Jansen study (2015) was a 12-month study with reassessments of the outcomes at designated times. Perhaps the comparison between group outcomes of this study would have been more consistent with the other study, if the current study had more control over: (a) the types of treatments, (b) number of treatments and the number of measurements, and (c) established measurement times. Limitations There are several limitations inherent in a retrospective study (Carter & Lubinsky, 2016), and therefore are present in this study. Numerous internal validity threats limit the interpretation of results. Examples of these threats include the following: lack of a control group or lack of controlled manipulation, the occurrence of history and/or maturation, the occurrence of OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 48 instrumentation change, and having a sample size too small to find statistical significance. Additional threats include missing data or unknown data, the investigator having no control over exposure or outcome assessments, and the investigator only being able to indicate association, not causation due to the study design. Significant differences in characteristics and treatment between groups could have masked the treatment effects. There were more people in the AG that had clerical or manual work compared to more people in the SG that were not working or had semiprofessional work. The differences in type of work could have influenced the effectiveness of a treatment. For example, a treatment might not have been as effective for a participant in the AG due to clerical and manual work often being a causative factor of LET (Fan et al., 2014; Descatha et al., 2013); however, there is no way to know if this altered the outcomes of treatment. For work status there were more people in the SG that were retired, unemployed, students or volunteers. It is possible that a participant in the SG could have had better outcomes due to having more time to rest from aggravating factors and having more time to focus on the recommended home exercise program; however, there is no way to determine if this altered the treatment outcomes. For this study there was not a designated control group; therefore, it was not possible to determine a cause and effect relationship with the addition of Astym treatment to standard therapeutic interventions. There was no random assignment of the participants, resulting in no control over the similarities or differences of the groups. It was also impossible to determine why a participant received Astym treatment in addition to standard therapy. Hence, it is difficult to determine if bias toward placement into one of the treatment groups occurred. History, maturation, and variations in interventions are added threats that may have significantly influenced the results of this study. In addition, construct validity could have been OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 49 impacted by experimenter or participant expectancies, interaction among different interventions, and interaction between testing and treatment. During a participants OT services, he or she may have received treatments from other disciplines. Treatments from a massage therapist, acupuncturist, chiropractor, or physician, may have contributed to a participants change scores in his or her outcomes. In addition, each participant received OT interventions that varied in the amount and the length of time. For example, the number of OT treatments, the number of Astym treatments, participants length of episode of care varied, and the time an individual participated in OT all varied. Moreover, the different types of interventions occurred in numerous sequences, and discrepancies were present in the treatments provided by the different occupational therapists. For example, different therapists may have applied varying amounts of pressure with the Astym instrumentation, or in the event that a therapist used a taping technique, the amount of tension applied by each therapist may have been different. Another example of maturation is that performance with the testing procedures may have improved because of increased comfort and experience with the testing process. In contrast, participants may not have been interested or understood the value of subsequent assessments. To help minimize some of these threats the investigator used a systematic approach to assign each EMR to a group. The researcher implemented this method to create equal representation of the entire sample, to create an equal sample size of each group, and to decrease bias. Because of the nature of this retrospective study, patients and therapists being unaware of their participation in a study reduced the likelihood of expectancy threat. To account for missing data, case deletion and variable deletion occurred. The researcher discarded charts if a FOTO episode of care did not have all of the necessary data collected. In addition, deletion of missing variable from analysis transpired if an EMR was missing the OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 50 specific demographics or outcome measurement of interest. Although all participants attended an initial OT evaluation and attended an OT discharge evaluation, not all therapists collected data on standard grip strength and provocative grip strength, which may have altered the results of the outcome. Additional threats to internal validity may include the significant differences in condition severity, number of OT sessions, duration of episode of cares, and type of work between the AG and the SG. In addition, Moist hot pack, paraffin, MET, soft tissue mobilization, and joint mobilization, were interventions that were significantly different between the AG and the SG and could alter internal validity. There was also no control over how therapists completed outcome measurements. For example, there was no control over the sequence of the administration of measurements, the number of times the outcome measurements were completed, or the interval of time between the measurements. In addition, therapists attitudes on testing procedures may have varied and their opinions on the outcome tools used may have been different. If a therapist did not see the value in using outcome tools this may have had a negative impact on a participants performance during the assessments. When discussing the outcome tools and the results of the participants outcome scores, the therapists lack of enthusiasm may have influenced a participants perception of the importance of the outcome tools used and it may have influenced a participants performance on the assessments. In addition, although therapists at PHS are encouraged to discuss the results of the participants outcome scores with the participants, the therapists may not have discussed the results. This may have caused the participants to question the importance of the assessments, and it may have caused sub-optimal performance by the participant on the assessments. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 51 Staff training may have helped to minimize some of the internal validity threats. First, therapists in this study had completed the same required PHS competency training. The therapists also competently demonstrated therapeutic interventions and assessments prior to implementing them in the clinic. Therapists only implement Astym treatments if they have completed the comprehensive training and certification program provided by Performance Dynamic. Therapists demonstrated standard procedures when using the clinics outcome tools. The therapists also had specialized instructions on the FOTO system, and they had training on the use of the PI as an outcome tool. Furthermore, training on standard clinic procedures had occurred with all employees who assisted patients with the FOTO body part specific PI selfassessment survey. Documentation errors and collection of data by multiple individuals may also threaten the validity of a study. In the current study, therapists used the same EPIC template for the intake evaluation, daily notes, and discharge. Therapists training on the EPIC documentation system was also standardized, and PHS implemented regular reviews of documentation for quality management. If a therapists documentation skills did not meet the standard requirements of PHS, the therapist was required to correct errors in all documentation and additional documentation training occurred. To minimize data collection errors, one investigator collected and coded all of the data in the current study. The investigator also cross-referenced and verified all of the data that were collected and coded into the spreadsheet. Although all of the EMRs were collected on outpatients who were receiving OT from PHS clinics in the same metropolitan area of the same region of the country, the generalizability of this retrospective study was enhanced by including a convenient sampling of participants with diverse demographics. Exclusion from the study did not occur if a participant had any existing OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 52 comorbidities. Participants also received standard interventions, such as orthotic devices, physical agent modalities, manual interventions and taping, that the traditional outpatient OT clinics offer. Furthermore, the episodes of care for individuals who received OT services were regulated by Medicare guidelines and customary insurance guidelines that are followed throughout North America. To avoid exceeding the Medicare cap, close monitoring of patients progress (or lack of progress) and close monitoring of the number of visits occurred. Despite the limitations of this study, the findings of this research begin to bridge the gap of knowledge on standard OT interventions provided to individuals with LET. The researcher of this study provided support for use of standard OT interventions and Astym in addition to standard OT interventions in an outpatient setting, with the benefits of decreased pain and improved function in individuals with LET. Because of the design of this study it is impossible to determine cause and effect relationships. Further research with more control over confounding variables is warranted to explore the efficacy and effectiveness of Astym treatment in patients with LET. Conclusion Lateral elbow tendinopathy is often difficult to treat and may be refractory to treatment. There are often prolonged symptoms, re-occurrences of the pain, and loss of function and strength observed (Sevier & Stegink-Jansen, 2015). In outpatient clinics, patients present with multiple characteristics that may impact the effectiveness of any intervention. The researcher from this retrospective study suggests that standard OT interventions can decrease pain, improve functional abilities and increase grip strength in individuals with LET; however, the addition of Astym treatment to the standard OT interventions may not result in statistically significant improvements in these outcomes than standard care alone. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 53 Recommendations There are a number of published case studies that support the use of Astym to treat musculoskeletal conditions (Bhave, Corcoran, Cherian, & Mont, 2016; McCormick, 2012; Tyler & Slaven, 2013). A larger study, long-term follow-up, and a prospective study may help determine if the addition of Astym treatment to standard therapeutic interventions for LET reduces pain and increases function. Randomized clinical trials that control more variables should be completed to examine the effectiveness of Astym treatment for the management of patients with LET as compared to standard care. Furthermore, researchers are encouraged to use FS measure scores in their studies to assess the effectiveness of Astym treatment. Dissemination The results of this study will be presented in a public forum as a requirement for the student researchers completion of the Doctorate of Health Science degree. If information learned from this study is published, participants will not be identified by name because all of the information will be reported statistically. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 54 References Abat, F., Alfredson, H., Cucchiarini, M., Madry, H., Marmotti, A., Mouton, C., Girolam, L. (2017). Current trends in tendinopathy: Consensus of the ESSKA basic science committee. Part 1: Biology, biomechanics, anatomy, and an exercise-based approach. 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Advance for Physical Therapy & Rehabilitation Medicine, 27(2), 6-7. Werneke, M. (2016b). How do physical therapist demonstrate value? Part 2: Why traditional markers of patient improvement may not be sufficient. Advance for Physical Therapy & Rehabilitation Medicine, 27(3), 6-7. What is Astym Treatment? (2012a). Retrieved from https://astym.com/Medical/About What is Astym Treatment? (2012b). Retrieved from https://astym.com/patients/about What is FOTO? (2016). Retrieved from https://www.fotoinc.com/what-is-foto Wixom, S. M., & LaStayo, P. (2012). A potential classification model for individuals with tennis elbow. Journal of Hand Therapy, 25, 418-421. doi:10.1016/j.jht.2012.06.007 Zeisig, E., Ohberg, L., & Alfredson, H. (2006). Extensor origin vascularity related to pain in patients with tennis elbow. Knee Surgery Sports Traumatology Arthroscopy, 14(7), 659663. https://doi.org/10.1007/s00167-006-0060-7 OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 80 Table 1. Comparison of Outcomes from both Intake and Discharge between Treatment Groups AG SG Mdn (IQR) Mdn (IQR) p FOTO FS measure at intake 56.00 (19.00) 51.00 (21.00) .086 FOTO FS measure at discharge 69.00 (14.00) 69.00 (18.00) .447 8.00 (2) 7.00 (4.00) .009 1.00 (2.00) 0 (2.00) .133 Standard grip at intake 47.84 (55.83) 41.00 (35.50) .214 Standard grip at discharge 66.66 (51.67) 48.00 (24.65) .280 Provocative grip at intake 33.50 (49.50) 32.00 (39.00) .194 Provocative grip at discharge 54.34 (52.50) 45.00 (32.00) .276 NPRS at intake NPRS at discharge Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group; FOTO FS = Focus on Therapeutic Outcomes functional status; NPRS = numeric pain rating scale. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 81 Table 2 Comparison of Outcome Change Scores between Treatment Groups AG SG P FOTO 18.00 (9.50) 16.00 (21.00) .674 NPRS -6.00 (3.75) -5.00 (3.00) .086 Standard grip 10.20 (19.82) 10.67 (12.00) .794 Provocative grip 14.33 (22.00) 13.00 (17.34) .874 Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group; FOTO FS = Focus on Therapeutic Outcomes functional status; NPRS = numeric pain rating scale. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 82 Table 3 Participant Characteristics by Sample and Group with Group Comparisons Total (N = 222) LET Diagnosis AG (N = 104) SG (N = 118) N (%) N (%) 104 (47) 118 (53) Gender p .708 Female 138 (62%) 66 (63.5) 72 (61.0) Male 84 (38%) 38 (36.5) 46 (39.0) Hand Dominance .948 Right 198 (89.2%) 106 (89.8) 92 (88.5) Left 18 (8.1%) 9 (7.6) 9 (8.7) Ambidextrous 6 (2.7%) 3 (2.5) 3 (2.9) Chronicity .780 Chronic 126 (57.8) 58 (55.8) 68 (57.6) Acute 96 (43.2) 46 (44.2) 50 (42.4) Involved UE .500 Right 127 (57%) 67 (30.2) 60 (27.02) Left 95 (43%) 51 (22.97) 44 (19.81) Mechanism of onset .551 Traumatic 29 (13.1) 18 (8.11) 11 (4.95) Overuse 193 (86.9) 100 (45.50) 93 (41.44) Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group; LET = lateral elbow tendinopathy; UE = upper extremity. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 83 Table 4 Descriptives for Condition Severity by Sample and Group with Group Comparison Slight Moderate Severe Very severe N (%) N (%) N (%) N (%) AG 38 (36.5) 33 (31.7) 22 (21.2) 11 (10.6) SG 46 (39.0) 24 (20.3) 20 (16.9) 28 (23.7) Total 84 (37.8) 57 (25.7) 42 (18.9) 39 (17.6) Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 84 Table 5 Descriptives for Symptom Acuity by Sample and Group with Group Comparison 8-14 days 15-21 days 22-90 days 91 days-6 > 6 months months N (%) N (%) N (%) N (%) N (%) AG 5 (4.8) 0 (0) 41 (39.4) 23 (22.1) 35 (33.7) SG 3 (2.5) 8 (6.8) 39 (33.1) 31 (26.3) 37 (31.4) Total 8 (3.6) 8 (3.6) 80 (36.0) 54 (24.3) 72 (32.4) Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 85 Table 6 Descriptives of Number of Occupational Therapy Visits and Focus on Therapeutic Outcomes Duration by Sample and Group with Group Comparison Total AG SG Mdn (IQR) Mdn (IQR) Mdn (IQR) p Number of visits 7 (5) 7.00 (4) 7.50 (5) .818 Number of days 44.50 (22) 50.00 (28) 41.00 (21) .086 Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 86 Table 7 Descriptives for Type of Work by Sample and Group and with Group Comparison Clerical Manual Professional HC N/A SP N (%) N (%) N (%) N (%) N (%) N (%) AG 27 (26.0) 22 (21.2) 2 (1.9) 3 (2.9) 39 (37.5) 11 (10.6) SG 19 (16.1) 12 (10.2) 3 (2.5) 2 (1.7) 59 (50.0) 23 (19.5) Total 46 (20.7) 34 (15.3) 5 (2.3) 5 (2.3) 98 (44.1) 34 (15.3) Note. HC = Homemaker/Caretaker; SP = Semiprofessional; AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 87 Table 8 Descriptives of Work Status by Sample and Group with Group Comparison Full-time Part-time Retired Unemployed Disability Student Volunteer N (%) N (%) N (%) N (%) N (%) N (%) N (%) AG 58 (55.8) 9 (8.7) 24 (23.1) 7 (6.7) 3 (2.9) 3 (2.9) 0 (0) SG 60 (50.8) 7 (5.9) 32 (27.1) 9 (7.6) 3 (2.5) 5 (4.2) 2 (1.7) Total 118 (53.2) 16 (7.2) 56 (25.2) 16 (7.2) 6 (2.7) 8 (3.6) 2 (0.9) Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 88 Table 9 Descriptives of Treatments by Sample and Group with Group Comparisons Total (N = 222) AG (N = 104) SG (N = 118) N (%) N (%) N (%) p Paraffin 111 (50.0) 70 (67.3) 41 (34.7) .001 Moist heat pack 147 (66.2) 83 (79.8) 64 (54.2) .001 22 (9.9) 9 (8.7) 13 (11.0) .655 142 (64.0) 72 (69.2) 70 (59.3) .161 3 (1.4) 3 (2.9) 0 (0) .101 Ice 54 (24.3) 19 (18.3) 35 (29.7) .060 Positional release 17 (7.7) 11 (10.6) 6 (5.1) .137 108 (48.6) 47 (45.2) 61 (51.7) .349 Myofascial release 57 (25.7) 29 (27.9) 28 (23.7) .539 Soft tissue 157 (70.7) 61 (58.7) 96 (81.4) .001 29 (13.1) 21 (20.2) 8 (6.8) .005 Trigger point release 86 (38.7) 47 (45.2) 39 (33.1) .073 Joint mobilization 57 (25.7) 35 (33.7) 22 (18.6) .014 Dry needling 17 (7.7) 9 (8.7) 8 (6.8) .623 Manual edema 7 (3.2) 2 (1.9) 5 (4.2) .452 Fluidotherapy Ultrasound Infrared Deep transverse friction massage manipulation Muscle energy technique mobilization OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 89 Electrical stimulation 51 (23.0) 23 (22.1) 28 (23.7) .873 Iontophoresis with 77 (34.7) 42 (40.4) 35 (29.7) .120 Taping 154 (69.4) 75 (72.1) 79 (66.9) .466 Orthosis 75 (33.8) 32 (30.8) 43 (36.4) .396 dexamethasone Note. AG = Astym and standard therapeutic intervention group; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 90 Table 10 Comparison of Outcomes between Intake and Discharge for the Astym and Standard Therapeutic Group Intake Discharge N Mdn (IQR) Mdn (IQR) p FOTO FS Measure 104 56.00 (19.00) 69.00 (14.00) .001 NPRS 104 8.00 (2.00) 1.00 (2.00) .001 Standard Grip 69 47.84 (55.83) 66.66 (51.67) .001 Provocative Grip 43 33.50 (49.50) 54.34 (52.50) .001 Note. FOTO FS = Focus on Therapeutic Outcomes functional status; NPRS = numeric pain rating scale; AG = Astym and standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 91 Table 11 Comparison of Outcomes between Intake and Discharge for the Standard Therapeutic Group Intake Discharge N Mdn (IQR) Mdn (IQR) p FOTO FS Measure 118 51.00 (21.00) 69.00 (18.00) .001 NPRS 118 7.00 (4.00) 0 (2.00) .001 Standard Grip 73 41.00 (35.50) 48.00 (24.65) .001 Provocative Grip 31 32.00 (39.00) 45.00 (32.00) .001 Note. FOTO FS = Focus on Therapeutic Outcomes functional status; NPRS = numeric pain rating sale; SG = standard therapeutic intervention group. OCCUPATIONAL THERAPY AND LATERAL ELBOW TENDINOPATHY 92 Figure 1 CONSORT Flow Diagram Enrollment Assessed for eligibility (N = 805) Excluded (n = 583) Not meeting inclusion criteria (n = 583) Selected (N = 222) Allocation Allocated to Astym with standard therapy Allocated to no Astym with standard therapy n = 104 n = 118 Analysis Analysed (n=104) Excluded from analysis (n=0) Analysed (n=118) Excluded from analysis (n=0)  ...

... Predictors that Influence Discharge Destination from Hospitalization Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Jennifer J. Cline, PT, MS Copyright December 8, 2021 By: Jennifer J. Cline, PT, MS All rights reserved Approved by: Elizabeth Moore, Ph. D Committee Chair __________________________________________ Diane Jette, PT, DSc, FAPTA Committee Member __________________________________________ Leslie Gardner, Ph. D Committee Member __________________________________________ Accepted by: Laura Santurri, PhD, MPH, CPH __________________________________________ Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis __________________________________________ DISCHARGE PREDICTORS 1 Predictors that Influence Discharge Destination from Hospitalization Jennifer J. Cline Department of Interprofessional Health and Aging Studies, University of Indianapolis DISCHARGE PREDICTORS 2 Abstract Due to the implementation of legislation from the Centers of Medicare and Medicaid, acute care hospitals can no longer afford delayed patient discharges due to non-medical reasons. Even so, discharge planning in a hospital setting remains fragmented and inefficient, resulting in an extended length of stay by 2-4 days (Stefanacci, 2019). The purpose of this study was to identify variables that can predict post-acute discharge destinations and create a prediction model to improve care efficiency. A retrospective cohort consisting of 8,324 patients was examined from a level one trauma center in the southeast. Home with no services (HNS), home with services (HCS), skilled nursing facility (SNF), and inpatient rehabilitation (IRF) were the identified discharge settings. Final results demonstrated that age, insurance coverage, and physical limitations described by the "6-clicks" scores were significant p < .05 predictors of discharge status. Relative to HNS, HCS, SNF, and IRF had decreased odds of having higher 6-clicks scores increased odds of being older, and increased odds of having Medicare, Medicaid, Private, and Medicare Advantage payor source relative to self-pay. Receiver operator curves were run to determine sensitivity and 1-specificity for the "6-clicks" scores. The area under the curve was significant at .84, and a raw cutoff score of 17.5 differentiated home from SNF and IRF discharge. Keywords: Discharge planning, activity limitations, "6-clicks scores", insurance coverage, physical therapy DISCHARGE PREDICTORS 3 Acknowledgements This project has been a significant learning experience for me. I built upon my learning regarding statistical analysis and I have been challenged to write succinctly. Reflecting on the project, I have more questions now than when I started regarding the research and evidence around post-acute care and placement for patients. As I reflect on the past three and half years, I am so grateful for the professional growth this program has offered me. I want to acknowledge those who supported me along the way. I have to thank the faculty at the University of Indianapolis. They are incredible mentors, leaders, and role models. I respect you all immensely and am so grateful for you. I want to thank my committee. Dr. Moore and Jette have been incredibly supportive and patient with me. Dr. Jette suggested I stay on the highway, and it is sage advice. Your expertise, instruction, and feedback have been remarkable. Thank you for your efforts with me and this project. I also extend a warm thank you to Deanna Dye, PT, Ph.D., and Kendra Worthy, MHA. Deanna has been so supportive throughout this process. I appreciate her 35 years of friendship. Kendra has been excellent with Excel and helped me ensure the data set was ready for analysis. Lastly, I thank my children, Katelyn and Tommy. If I showed them half the support during their education, they have shown me during this process, all is right with the world. This paper is dedicated to my patients. DISCHARGE PREDICTORS 4 Table of Contents Abstract ............................................................................................................................................2 Acknowledgements ..........................................................................................................................3 Predictors that Influence Discharge Destination from Hospitalization ...........................................9 Literature Review...........................................................................................................................11 Discharge Setting .......................................................................................................... 12 Discharge Planning ....................................................................................................... 13 Delayed Discharge .................................................................................................... 14 Hospital Readmissions .............................................................................................. 15 Payor and Pre-Approval ........................................................................................... 16 Factors Associated with Discharge Destination ............................................................ 17 Payors and Cost of Post-Acute Care ......................................................................... 17 Social Determinants of Health .................................................................................. 18 Activity Limitations .................................................................................................... 19 Age, Race, and Gender .............................................................................................. 20 Published Discharge Tools ............................................................................................ 21 Method ...........................................................................................................................................24 Study Design ................................................................................................................. 24 Participants .................................................................................................................... 24 Data ............................................................................................................................... 25 Potential Predictor Variables .................................................................................... 25 DISCHARGE PREDICTORS 5 Outcome Variable ...................................................................................................... 25 Instruments .................................................................................................................... 25 6- Clicks AM- PAC Short form.............................................................................. 25 Procedures ..................................................................................................................... 27 Data Collection.......................................................................................................... 27 Data Management ..................................................................................................... 27 Data Analysis ............................................................................................................. 28 Results ............................................................................................................................................29 Participants .................................................................................................................... 29 Participant Demographics ............................................................................................. 29 Bivariate Results ........................................................................................................... 30 Multinomial Regression Results ................................................................................... 30 Home with Services Versus Home with No Services ................................................. 31 Skilled Nursing Facility Versus Home with No Services ........................................... 31 Inpatient Rehabilitation Facility Versus Home with No Services ............................. 32 Sensitivity and Specificity .......................................................................................... 32 Discussion ......................................................................................................................................33 Home with Services Versus Home with No Services ................................................... 33 Skilled Nursing Facility Versus Home with No Services ............................................. 35 Inpatient Rehabilitation Facility Versus Home with No Services ................................ 37 DISCHARGE PREDICTORS 6 Clinical Implications ..................................................................................................... 39 Usefulness of "6-Clicks" Scores ................................................................................ 39 Effect of Payor Source ............................................................................................... 40 Impact of Age ............................................................................................................. 43 Variables Not Statistically Significant .......................................................................... 43 Variables That May Have Influenced Results............................................................... 46 Study Limitations .......................................................................................................... 52 Conclusions ...................................................................................................................52 References ......................................................................................................................................54 DISCHARGE PREDICTORS 7 List of Tables Table 1 Descriptive Statistics and Comparisons by Discharge Status..72 Table 2 Multinomial Regression Model Predicting Discharge Destination..74 Table 3 Model Sensitivity and Specificity for Discharge Destination..75 DISCHARGE PREDICTORS 8 List of Figures and Appendices Figure 1: Receiver Operator Curves Home versus Institution Discharge for 6-clicks .............. 76 Figure 2: Receiver Operator Curve (ROC) Skilled Nursing Facility versus Inpatient Rehabilitation Discharge for 6-clicks ......................................................................... 77 Figure 3: Receiver Operator Curve (ROC) Home No Services versus Home with Services Discharge for 6-clicks .............................................................................................. 778 Appendix A: Flow Diagram.......................................................................................................... 79 Appendix B: "6-Clicks" AM-PAC Inpatient Short Form ............................................................. 80 DISCHARGE PREDICTORS 9 Predictors that Influence Discharge Destination from Hospitalization As hospital length of stay (LOS) continues to decrease, from 11.5 days in 1975 to the current 4.6 days, discharge planning from a hospital is often too rushed or too delayed leaving patients ill-equipped to transition to the community (Centers for Disease Control and Prevention, 2016; Oseran, 2019). Discharge planning is defined as the transition out of hospital care and can leave patients vulnerable and at risk for a decline in functional and mental status. In turn, the care transition can be costly for hospital systems if mistakes are made in discharge placement and patients are readmitted. The purpose of this project was to determine the individual and environmental factors associated with discharge settings. Hospital discharge planning is complicated and requires input from the multi-professional team, including the physician, nursing, social work, case management, the therapy team, and, ideally, the patient. The size of the team alone leads to discharge planning challenges in terms of communication and care coordination. Patient preference is one factor; however, multiple factors can influence discharge planning. For instance, a patient may want to go home but cannot do so due to physical limitations and lack of community support. The literature cites activity limitations (Jette et al., 2014), cognitive status, age, gender (Bai et al., 2019), insurance source (Zimmerman et al., 2019), socioeconomic factors (Bai et al., 2019; Rojas-Garcia, 2018), and community support (Oseran, 2019) as some of the factors considered in assessing post-acute needs. Given these challenges, it is not surprising that waiting on a final discharge plan can cause an additional 2-4 days hospital LOS (Stefanacci, 2019). Longer LOS results in a higher risk of mortality, infections, depression, and decreased mobility and daily living activities (Rojas-Garcia et al., 2018). Therefore, efficient discharge planning and prevention of readmissions have been identified as a global problem that must be addressed for patients' welfare and the business of DISCHARGE PREDICTORS 10 healthcare. Researchers from Switzerland (Zimmerman et al., 2019), the Netherlands (Niemeyer et al.,2010), and Canada (Bai et al.,2019) have published studies suggesting prediction models or process improvement plans regarding discharge planning; however, there has not been widespread testing, and the models were developed under healthcare systems are different from the United States (U.S.). One study published in the U.S. created a model that accurately predicted skilled nursing facility (SNF) discharge on day one of hospitalization using data from the inter-professional team (Oseran et al., 2019). One member of the inter-professional team heavily involved in the discharge planning is the physical therapist. Physical therapists play an integral role in recommending post-acute placement for patients. Smith et al. (2010) found that patients were less likely to be readmitted to the hospital if physical therapist discharge recommendations were followed. However, that study did not report a clinical decision-making model for discharge recommendations. A qualitative study looked at physical therapists' experience and the social process of integrating patients' wants and needs, physical performance, ability to participate, and the context of their life (Jette et al., 2003). A data-driven model may help physical therapists and the interprofessional team make better-informed decisions instead of relying on the current subjective case-by-case discharge planning. The purpose of this retrospective cohort study was to determine if factors could be identified that related to discharge status, which would assist the inter-professional team in making evidence-based discharge planning decisions. The following research question was answered: What are the predictors of discharge destination for patients leaving an acute care level one trauma center? To answer this question, the following objective was addressed: DISCHARGE PREDICTORS 11 To determine if a prediction model, using selected variables, could accurately predict discharge destination. Discharge destinations included: home with no services (HNS), home with services (HCS), SNF, and inpatient rehabilitation (IRF). Possible predictor variables included activity limitations (6-clicks), payor source, socioeconomic status (based on zip code), race and ethnicity, marital status, age, and gender. Study results could help physical therapists improve patient/caregiver care coordination and communication and align patient expectations with realistic assumptions. Moreover, the hospital can improve flow and capacity by preventing prolonged and unnecessary discharge delays, and patients can avoid medical complications. Financial savings for the patient and the hospital system may also result by ensuring patients are placed in the appropriate level of care. Patient outcomes can be maximized when the patient receives the correct care in the proper setting. These results align with the triple aim of the Institute for Healthcare Improvement (IHI): to improve patient satisfaction, improve outcomes, and reduce health care spending (IHI, 2020). Literature Review Ensuring the proper post-acute care (PAC) support is vital for the health of patients and health care systems. Despite care after hospitalization, 20% of patients are re-hospitalized within 30 days of hospital discharge (Mechanic et al., 2014). Patients remain vulnerable while transitioning from a hospital stay into another level of care; thus, proper post-acute placement is essential to maximizing patients' health, function, and cost of care. Under specific diagnoses, if patients are readmitted to a hospital within 30 days, the financial burden falls on health care systems. Readmissions have resulted in additional spending of $41.3 billion per year (LaPointe, 2018). The Affordable Care Act passed in 2010 has incentivized hospitals to consider proper discharge settings and decrease the LOS (Agency for Healthcare Research and Quality, 2020). DISCHARGE PREDICTORS 12 Thus, early and accurate discharge planning to identify and secure appropriate post-acute services is financially significant for health care institutions and may decrease readmissions (Smith et al., 2010). PAC costs are expensive. Medicare alone paid almost $60 billion in the PAC realm in 2016. Ouslander and Sehgal (2019) reported average PAC costs, including acute rehabilitation at $15,000 per day, SNF at $400 per day, and home care at $3000 per 60-day episode of care. Because discharge setting cost varies greatly, the discharge setting recommendation requires thoughtful consideration from the hospital team, patient, and family members to balance cost with support. Discharge settings include HNS, HCS, SNF, and IRF. Home with or without HCS is the least expensive level of care. Care in the home includes nursing, therapy, social work, and nursing assistant support. Discharge Setting A SNF is a residential facility where patients stay a few days to several months or, in some instances, become a long-term resident. The average LOS at a SNF is two weeks before a patient returns home. If the patient is there to receive rehabilitation, the goals are to return to their previous living situation. Insurance companies will pay for the stay in the SNF if therapy improves the patient's health and function as deemed by a physician. Therapy is less intense than that provided in an inpatient rehabilitation facility as patients receive a certain baseline of therapy minutes each week, based on the diagnosis. IRF is the most expensive post-acute discharge setting. Patients receive at least three hours of physical therapy, occupational therapy, and speech therapy each day and must require services of at least two of the disciplines mentioned above. Additionally, patients are required to have complex medical conditions necessitating daily physician oversight. Johnson et al. (2020) determined that patients with DISCHARGE PREDICTORS 13 moderately low to moderately high physical function levels experienced a short LOS at an IRF. After an IRF stay, patients were most likely to be discharged to the community, which is the goal of IRF. Before recommending discharge to an IRF, the multi-professional team must be confident that a patient can discharge home after an IRF stay. Werner et al. (2019) compared outcomes between patients who received home care and those discharged to a SNF. Results found a 5.6% higher hospital readmission rate from home than from SNF at 30 days (Werner et al., 2019). There was no difference between mortality or function at 30 days, yet the Medicare payment was much lower to home care than to other sites. This is an example of ensuring the health care team must be confident that the patient will do well at home. Furthermore, a joint study sponsored by the American Physical Therapy Association (APTA) and the American Occupational Therapy Association studied 1.4 million Medicare beneficiaries (APTA, 2021). Overall, 14% of patients were discharged to an IRF, 48% to a SNF, and 38% to HCS. The researchers determined specific differences between PAC settings, and if settings are blended due to incentive and regulatory changes, patients will be left with a higher risk for disability and readmissions (APTA, 2021). Discharge Planning The purpose of discharge planning is to transition patients from one level of care to the next. Timely discharges ensure hospitals are efficient from a financial perspective, increase the likelihood that patients are successful when leaving the hospital, and decrease chances that patients will be readmitted. Timely discharges are more likely to happen if discharge planning involves a multi-professional team with case managers leading the process; however, there is no standardized framework for determining the best discharge setting. DISCHARGE PREDICTORS 14 The discharge planning process is complicated as the patient's function, ability to participate, wants and needs, context of their life, and presence of support at home are weighed. Financial status, as reflected by the payor source, is also an essential factor to consider. Standardization of determining discharge setting placement is complicated because patients' wants and needs must be considered (Jette et al., 2003). Patient preferences may include a postacute rehabilitation facility location and the cost of staying at the facility (Ayele et al., 2019; Ouslander & Sehgal, 2019). Studies have been published that identify possible tools that can be used to assist with the discharge planning process. These studies report checklists to consider on behalf of the patient and caregiver (Grimmer et al., 2006), qualitative frameworks (Jette et al., 2003), and graded discharge support tools (Bai et al., 2019; Bowles et al., 2014). However, the multifactorial nature and lack of standardization on determining discharge location add complexity and uncertainty to the clinicians decision-making process. Ayele et al. (2019) conducted a qualitative survey interviewing 104 clinicians regarding challenges in selecting discharge settings and cost constraints associated with the choice. Results showed that clinicians suffered moral distress and safety concerns for the patients due to the limited discharge options (Ayele et al.,2019). Delayed Discharge A delayed discharge is when a patient remains in the hospital for non-medical reasons. For patients, delayed discharges result in an increased risk of mortality, increased hospitalacquired infections, and deconditioning (Falvey et al., 2015; Rojas-Garcia et al., 2018). Cost and medical complications may be reduced with a more systematic approach. Bai et al. (2019) suggested a clinical prediction tool to identify patients at high risk for delayed discharge at a Canadian hospital. The instrument included a mnemonic SAD PODS (sex, age, dementia, DISCHARGE PREDICTORS 15 physiotherapy, occupational therapy, diabetes, and speech therapy) (Bai et al., 2019). A point was given to each category, and the research team suggested that early identification of delayed discharge risk can reprioritize care (Bai et al., 2019). The tool can be used to improve care for high-risk patients. Findings showed advanced age, female sex, dementia or diabetes diagnosis, and need for physical, occupational, or speech-language pathology were the most significant risk factors in delayed discharge, as evidenced by the statistical relationship in the final logistic regression model (Bai et al., 2019). A limitation of this study was that the reliability and validity of the tool were not reported. Hospital Readmissions Hospital readmission within 30 days of discharge is another costly outcome that a systematic approach to discharge planning might reduce. Bowles et al. (2014) identified highrisk patients by measuring age, walking ability, LOS, the number of comorbid conditions, depression, and self-rated health assessment. The project aimed to decrease readmissions by early identification of high-risk patients (Bowles et al. 2014). Case managers or nurses asked patients questions regarding mobility, disease complexity, mental, emotional, financial status, and caregiver availability. Points were assigned, and once a cutoff score was reached, one was deemed high risk for readmission. After implementing the discharge decision support system tool, there was a relative reduction in readmissions by 26% (Bowles et al., 2014). Fisher et al. (2016) examined 30-day readmission factors after older patients were discharged from an IRF. Physical functioning and mobility assessed at IRF discharge were a better predictor of readmission than mobility assessed pre-admission (Fisher et al., 2016). Because physical therapists have a specialized skill set in assessing mobility and function, they are relied upon in the hospital setting to make discharge recommendations. In a DISCHARGE PREDICTORS 16 study performed 10 years ago, practice management coordinators used a partially standardized discharge decision-making process that included physical therapists' suggestions (Smith et al., 2010). The process allowed physical therapists to assess whether patients were at high risk for poor discharge outcomes, including hospital readmission within 30 days. The authors found that if physical therapists' proposals were not followed for a PAC setting, patients were 2.5 times more likely to be readmitted to the hospital (Smith et al., 2010). Since that study was published 10 years ago, insurance companies are more likely to pre-approve or deny care received in the PAC arena (Luke, 2016) rather than leave the decision of discharge setting to clinicians. The preapproval can override other variables and recommendations from the clinicians. Therefore, physical therapists may not have as much of an influence on discharge placement. Payor and Pre-Approval Third-party payors pre-approve post-acute placement. Pre-approval means the insurance company agreed the care is necessary, and it will be covered. Payors are categorized as public (Medicare and Medicaid overseen at a national and state level, respectively) and private. Medicare is health insurance for Americans over 65 years old and pays for PAC. Traditional Medicare covers PAC and outpatient services if recommended by a physician. Medicare Advantage (MA) plans bundle Medicare Part A (hospital) and Part B (outpatient medical care) to reduce out-of-pocket costs and are considered a private plan alternative to traditional Medicare. MA enrollees now constitute 42% of all Medicare beneficiaries (Freed et al., 2021). MA plans utilize Health Maintenance organizations (HMO) and Preferred Provider Organizations (PPO) to limit physician choice and require pre-approval for benefits such as PAC services and settings. Medicaid provides care in the home on a limited basis. Outpatient therapy services (offered when a patient is at home) remain an optional benefit, and Medicaid will cover the DISCHARGE PREDICTORS 17 payment for one initial visit for outpatient therapy. However, any subsequent visits require prior authorization and are limited in number in North Carolina at the time of this study. Frequently, three additional visits are approved, but certain postoperative and neurological conditions are authorized for more visits (Carvalho et al., 2017). There is a significant disparity in comparing the level of outpatient physical therapy a Medicaid recipient receives versus a patient with private insurance (Carvalho et al., 2017). Private insurance companies pre-approve PAC. The scope of coverage varies widely according to the insurance company or state laws providing coverage. Factors Associated with Discharge Destination Payors and Cost of Post-Acute Care Health insurance companies pre-approve PAC, yet surprisingly few studies demonstrate the connection between having insurance and PAC access. In general, in the absence of a payor source, health care outcomes may be substandard. For instance, the lack of healthcare insurance has been shown to significantly impact mortality in patients who survived a critical care stay (Baldwin et al., 2017). Sedney et al. (2020) found that patients with spinal cord injuries, who were receiving Medicaid, had longer LOS, were more likely to be discharged home or to a SNF, and did not receive crucial inpatient rehabilitation to maximize their function. Sorenson et al. (2020) found that patients diagnosed with a traumatic brain injury experienced a 3-day median delayed discharge, and 52% of the time, it was due to insurance authorization. When the Affordable Care Act was enacted and Medicaid expansion provided help, there was a statistically significant improvement from 3% to 6% in PAC access, including outpatient, home health, and facility-based services (Schneider et al., 2016). Access to care improved function, quality of life, and an enhanced one-year mortality rate (Schneider et al., 2016). DISCHARGE PREDICTORS 18 Zimmerman et al. (2019) found that having a supplemental health insurance plan and sizeable social support networks influenced discharge destination and the perceived quality of rehabilitation, while medical diagnosis did not. The authors commented that financially limited patients were burdened with additional costs since they did not have supplemental insurance (Zimmerman et al., 2019). Andrews et al. (2015) examined acute hospital readmissions in patients with stroke and the intensity of rehabilitation services. The authors included payor sources as a covariate. Patients who received Medicaid experienced higher levels of rehabilitation and had lower readmission rates than those with lower levels of rehabilitation, including those with private insurance (Andrews et a., 2015). Social Determinants of Health Patients who struggle socially and financially and suffer from illness are at greater risk than those who have social support and are financially secure for untoward events during hospitalization and after discharge (Nassens et al., 2012). Social determinants of health (SDoH) include socioeconomic status (SES), employment, social support systems, and neighborhood communities. It is challenging to differentiate which social determinants of health impact a health outcome, including discharge destination after acute hospitalization. Moore et al. (2015) recommended that SES be included in discharge planning because patients admitted with a traumatic event incurred a 2.6 day longer LOS than those without traumatic injuries due to socioeconomic challenges. SES is a SDoH that contributes to overall health and includes conditions in which people live. Studies show that people of lower SES are at higher risk for readmission after hospitalization (Calvillo-King et al., 2015; Moore et al., 2015). One study published in 2017 showed that patients suffering from a stroke and lower SES were less likely to receive inpatient DISCHARGE PREDICTORS 19 rehabilitation (Yeh et al., 2017). Zip code can be used as an indirect indicator of SES based on household incomes (Berkowitz et al., 2015). Those who live in a particular zip code associated with lower economic levels are more likely to have SDoH that negatively affect their health (Agarwal et al., 2017; Goodwin et al., 2016). Kosar et al. (2020) found rural-urban disparities, defined by zip codes, in the 30-day mortality rate and access to rehabilitation, with rural areas suffering more. Continued evidence supports that people who live in medically underserved zip codes have less than optimal outcomes after a critical care illness (Baldwin et al., 2017), pulmonary embolism (Agarwal et al., 2015), traumatic brain injury (McQuistion et al., 2016), and septic shock (Goodwin et al., 2015). Included in SDoH, caregiver support is essential to a successful transition from hospital to home. Jerath et al. (2020) noted that people of lower SES might struggle with needing caregiver support at home after hospital discharge. It has been noted that many patients reported they were dependent on an informal caregiver's assistance to be successful at home after hospital discharge (Hestevik et al., 2019). This caregiver support included cooking, cleaning, dressing, shopping, medication management, and transportation (Hestevik et al., 2019). Activity Limitations Physical function and mobility assessment are predictive of discharge destination and readmission risk. Fischer et al. (2016), Porter et al. (2016), and Burke and Jha (2016) suggested that physical function is an important outcome to measure when determining value in the PAC setting. Most recently, Covert et al. (2020) studied 1,543 patients who suffered a stroke and found the "6-clicks" could predict a discharge of home versus SNF or IRF (c-statistic = .88, IQR = 0.860.89). Additional factors such as the National Institute of Health Stroke Score (NIHSS DISCHARGE PREDICTORS 20 score), age, sex, and race accurately predicted discharge between SNF and IRF (Covert et al., 2020). Age, Race, and Gender Age is an essential consideration in a discharge prediction model as older adults spend 83% of their hospitalized time in bed (Falvey et al., 2015). Aging is also associated with decreased strength, endurance resulting in decreased mobility and increased risks for comorbidities (Falvey et al., 2015). Hospital-acquired deconditioning results in an iatrogenic disability with more significant hospital admissions and lowers discharge rates to the community (Falvey et al., 2015). Balentine et al. (2015) studied PAC care after abdominal surgery. They found that advanced age is a risk factor in being discharged to an SNF even when the patient is functionally independent (Balentine et al.,2015). In terms of race and ethnicity, study results show that patients who sustained traumatic brain injuries had different outcomes based on race/ethnicity and insurance status (Schneider et al., 2016). Millham and Jain (2009) studied racial disparities in trauma care and found no mortality difference in race for gunshot wounds (GSW). However, people who were Black or Hispanic had shorter LOS and a greater likelihood of transfer to PAC settings compared to White patients (Millham & Jain, 2009). Baldwin et al. (2017) found that race did not impact outcomes after surviving a critical care stay. In terms of rehabilitation after stroke, Skolarus et al. (2017) found no racial disparities in the amount of rehabilitation patients received as measured in therapy minutes. Chase et al. (2020) found racial differences among Black or Hispanic people as they were more likely to return to the emergency room and be readmitted to the hospital after using HCS. DISCHARGE PREDICTORS 21 Lastly, gender is predictive of requiring increased PAC services. In one published discharge tool, men receive a point higher than women do to predict they will have a greater chance of returning home after hospitalization (Glauser et al., 2020). Bai et al. (2019) found that women had a greater chance of experiencing a delayed discharge as they were more likely than men to be admitted from retirement homes and tended to be widowed. Additional evidence is supported by Oseran et al. (2019), finding that being single increased the risk of being discharged to a SNF. Lastly, APTA Therapy Outcomes in Post-acute Care Settings: Study Summary (2021) showed women required a greater incidence of PAC services than men looking at-home care, SNF, and IRF (APTA.org, 2021). Insurance status, physical function, SDoH, age, gender, ethnicity, and zip code all seem to contribute to PAC access, health outcomes, and financial strain on the health care system. The health care team may benefit from a study that considers these factors. Their recommendations can be enhanced, and care can continue to be prioritized with evidence-based support. Published Discharge Tools The literature reports a few predictive discharge tools. The activity measure for postacute care (AM-PAC) inpatient mobility short form (IMSF), also referred to as 6-clicks has been used as a quick overall functional numerical score describing mobility. It is based on the World Health organization's International Classification of Function, Disability, and Health (ICF) model describing mobility as an aspect of activity limitations. Raw scores range from 6-24. A score of 6 indicates the patient cannot perform many tasks, 7-12 -shows significant mobility limitations, 13-18 indicates moderate mobility limitations, and 24 demonstrates no mobility limitations (Freburger et al., 2020). It can be converted to a measure of disability through a Gcode modifier, a Medicare system of reporting function limitations (Slavin, 2014). The disability DISCHARGE PREDICTORS 22 percentage depicts the level at which one is disabled. Jette et al. (2014) published an extensive study (almost 100,000 patients) in which a cutoff of 42.9 scale score or a 19 raw score was identified to best-predict discharge to home as compared to an. institutional setting. Warren et al. (2021) studied 17,546 admissions over 2 to 3 years and determined the cutoff for discharges home versus intuitional rehabilitation was a raw score of 16. The area under the curve was .80 95% CI [0.80, 0.81]. Jette et al. (2015) demonstrated the 6-clicks measure for mobility to have strong interrater reliability, intraclass correlation coefficient (ICC) = .85, 95% CI [.78, .90]. The reliability remained high between varying types of conditions within the following areas: medical-surgical, neurological, orthopedic, cardiovascular, and general (Jette et al., 2015). Jette et al. (2014) examined validity using receiving operating characteristic curves (ROC) to show that 6-clicks scores could be used in predicting the need for an additional therapy visit. Correlation between the AM-PAC and functional independence measure (FIM) scores were (r = .69) to further substantiate the tool (Jette et al., 2014). The Risk Assessment Prediction Tool (RAPT) consists of six questions given pre-surgery (Glauser et al., 2020). The tool measures the likelihood of discharge destination to HNS, home with benefits, or institutional inpatient rehabilitation to include SNF/IRF. Information collected from the questions includes age, gender, walking ability, walking aid (yes/no), community assistance received, and not living alone post-discharge. The cutoff scores were divided into post-discharge locations, including inpatient facility rehabilitation, HCS, and home with no benefits (Glauser et al., 2020). The tool is accurate in predicting post-acute discharge destination in patients receiving joint replacements (Tan et al., 2014), cervical neurosurgery (Berger et al., 2019), and, more recently, patients who receive a posterior lumbar fusion (Glauser et al., 2020). DISCHARGE PREDICTORS 23 Glauser et al. (2020) investigated 432 patients and found the RAPT to predict discharge destination after posterior lumbar fusion surgery accurately. Another study performed in the U.S. developed a model to assess day one of hospitalization if a patient was at risk for discharge to a SNF (Oseran et al., 2019). The research team examined charts of 11,380 patients and developed a final index to include 11 variables that would predict SNF discharge. Variables in the model included: age, marital status, payor source, living alone, type of residence, distance from the hospital. Points were given if a patent was over 85 years old, single, had public insurance, and lived less than 25 miles from the hospital. Requiring assistance with mobility and bathing were also significant factors. Three additional factors were included in the final model: admission day of the week, diagnosis, admission type (transfer, self-referral). The researchers suggested that if SNF admission is a high-risk consequence on the first day of hospitalization, interventions may be able to aim at sending the patient home instead (Oseran et al., 2019). Mohanty et al. (2015) studied over 900,000 surgical patients and determined that the risk of discharge to a non-home PAC setting was 8.8%, with age and dependent functional status as significant predictors. Discharge models have been developed by physicians (particularly surgeons) and case management. There has yet to be a model published driven by physical therapists who seem to be front-line advisors for post-acute recommendations. Identifying clinical predictors and the impact on hospital discharge will guide the physical therapist's decision-making, prioritization, and care efficiency. DISCHARGE PREDICTORS 24 Method Study Design The present study was non-experimental and used a retrospective cohort design. The study's purpose was to understand identified factors associated with the discharge setting after a hospitalization. Before data extraction, the Institutional Review Boards at Atrium Health and the University of Indianapolis approved the study. The Health and Insurance Portability and Accountability Act was followed to ensure patient information was administratively, physically, and technically secure. Participants Participants were adult patients admitted to Carolinas Medical Center (CMC) in North Carolina between January 1, 2019, and December 31, 2019. Carolinas Medical Center is the flagship hospital for Atrium Health Care, which comprises 45 hospitals throughout North Carolina, South Carolina, and Georgia. The 874-bed level one trauma center has a multi-state catchment area and had 61,887 discharges in 2019 (American Hospital Directory, 2020). CMC is a public, not-for-profit, safety- net, academic teaching hospital. At this particular location, joint replacements are not performed. Inclusion criteria for this project consisted of adults greater than 18 years of age who received at least one physical therapy visit in the acute care setting during 2019. Patients were excluded from the study if they passed away or their medical record was missing post-acute discharge destination, 6-clicks score, or payor source. Lastly, patients with insurance other than Medicare, Medicaid, MA, Commercial, or self-pay were excluded. DISCHARGE PREDICTORS 25 Data Potential Predictor Variables Data collected included the following demographics: gender (male/female), age (years), race (non-Latino Black, non-Latino white, Asian, and Latino), and marital status (married, single, separated, widower/widowed were collected. In addition, 6-clicks basic mobility scores, payor source, and zip code were also collected. The 6-clicks scores collected at the first physical therapy visit measured basic mobility using a raw score of 6-24. The payor source was defined as five categories, including public insurance: Medicare, Medicaid, any private health care insurance, MA, and self-pay. MA plans include a bundled approach to health care supported by various private health insurance companies. Private insurance consists of various private companies, including Blue Cross Blue Shield, Aetna, and Humana, to name a few. Zip code was used as an indirect measure of socioeconomic status based on household income. Median household income was applied to all zip codes collected for the study using the American Community Results data through the University of Michigan (Michigan Population Studies, 2020). Outcome Variable Post-acute discharge placement was the outcome of interest. The variable was categorized into four levels: HNS, HCS, IRF, and SNF. Instruments 6- Clicks AM- PAC Short form Basic mobility was measured using 6-clicks, one of three short forms of the AM-PAC assessments. The basic mobility 6-clicks measure is performed on every physical therapy visit at CMC. New physical therapy employees are trained in case studies published by Mediware DISCHARGE PREDICTORS 26 (Slavin, 2014) to ensure they know how to score the 6-clicks assessment. Yearly reviews occur in the physical therapy department, and senior physical therapists ensure the form is scored accurately during live patient examinations. AM-PAC comprises a large data bank that includes items measuring a set of 269 functional activities (Slavin, 2014). Researchers and clinicians developed three short forms for use in the acute care setting: basic mobility, cognitive, and activities of daily living. The short basic mobility form includes six questions that ask about the need for assistance in rolling (side to side in bed without a rail) supine to sitting, (going from lying down to a sitting position) sit to stand, transfer (moving from bed to chair), walking in the room, and stair climbing. The physical therapist observes the patient performing these activities or can exercise judgment to estimate the patient's performance. A 4-point ordinal scale rating of how much assistance is given (1 = unable, 2 = much help, 3 = a little assist, and 4 = no assistance). Responses to each question are added together to achieve the total raw score. Raw scores range from 6-24. A score of 6 indicates the patient cannot perform any mobility tasks, 7-12 -shows major mobility limitations, 13-18 indicates moderate mobility limitations, and 24 demonstrates no mobility limitations (Freburger et al., 2020). Jette et al. (2015) determined the 6-clicks measure for basic mobility to have strong interrater reliability (intraclass coefficient [ICC] = .85). The reliability remained high across varying types of patient diagnoses (Jette et al., 2015). In another study, Jette et al. (2014) established the assessment's validity by demonstrating a ceiling effect of less than 20% at first and last visits. Jette and colleagues (2014) also established construct validity in 84,446 patients. Areas under the receiver operating characteristic curves (ROC) were .86 establishing a raw cutoff score of 17-18, meaning patients who scored less than 17-18 were more likely to be recommended for discharge to an institutional setting and greater than 17-18, patients were more DISCHARGE PREDICTORS 27 likely recommended to go home (Jette, 2014). Warren et al. (2021) also performed ROC curves, and the area under the curve was .80 establishing a cutoff score of 16, recommending home if > 16 and institutional placement < 16. Known group validity was supported by demonstrated differences in basic mobility scores by age, living situation, and the number of physical therapy visits. Correlation between the AM-PAC 6-clicks scores at discharge from acute care and functional independence measure (FIM) scores at admission to PAC was also high, supporting the validity of the AM-PAC 6-clicks (Jette et al., 2014). Procedures Data Collection Patient information is initially entered into the EHR by employees working for patient registration when a patient is admitted to CMC either directly or through the emergency department. Patient registration performs an initial intake regarding the patients' age, race, gender, marital status, and insurance coverage by interviewing the patient. Discharge status is initially entered in the medical record by nursing on the day of discharge and it is confirmed within three days after discharge by patient coders. Data were extracted from the electronic health record (EHR). An employee in the Quality Department ran a query to identify patients who met the study inclusion criteria with the patient's identification number being used to link data between billing and the medical record. Data extracted by the Quality Department employees was deidentified and sent to the primary researcher (J. J. C.) in a password protected Excel file. Data Management Electronic data were stored by the primary researcher in a password protected file in Atriums secure server. Prior to statistical analysis, data were cleaned and screened for outliers. DISCHARGE PREDICTORS 28 Data Analysis Predictors of interest included "6-click scores", payor source, median income based on zip code, gender (male/female), age, race, and marital status. Age, "6-click scores", and income were considered continuous data points. Categorical variables were marital status, race, and payor source. The outcome variable of interest was discharge destination, categorized as HNS, HCS, SNF, and IRF. After further inspection of the data, it was found that there were too many empty cells in the regression output due to too many choices of marital status and race; therefore, marital status was reduced to two categories, married or single, and race was reduced to two categories, Caucasian or non-Caucasian, to reduce empty variable categories. Payor source included categories: Medicare, MA, Medicaid, private, and self-pay. Descriptive statistics were run for each variable. To identify potential predictor variables of discharge status, bivariate analyses were conducted. Bivariate analysis included chi-square tests of independence for all categorical predictor variables. Continuous variables, age, and 6clicks scores were compared using one-way ANOVA tests. If comparison tests resulted in a p < .10, the variable was identified as a potential predictor variable was included in the regression model. Due to the large sample size, effect sizes were calculated and interpreted. Cramer's V values for categorical variables and eta-squared values were interpreted and reported. Multinomial logistic regression analysis was conducted using a forward stepwise method with an alpha level of .05 to keep variables in the model. For categorical variables, reference categories were assigned: single for marital status, self-pay for payor source, and HNS for discharge destination. -2 log-linear values were ranked to order the variables then added one at a time. Variables that reduced the -2LL values the most were added first, then the second-highest value. When variables did not have a p < .05, they were removed from the model. Odds ratios DISCHARGE PREDICTORS 29 with 95% confidence intervals were determined for each predictor variable. Sensitivity and specificity of the model were calculated based on the observed versus predicted discharge destination. To explore the best 6-clicks cutoff score for determining discharge home (with or without services) versus institutional discharge setting (IRF or SNF); discharge HCS versus. HNS; and discharge to IRF versus SNF, 3 separate ROC curves were run. Cut off scores for 6clicks for best predicting discharge setting were determined from each ROC curve. Results Participants The number of adult patients admitted to CMC from 1/1/19 through 12/31/19 who received one physical therapy visit, and a 6-clicks score was 11,247. Patients were excluded who were younger than 18 and greater than 103 years of age (n = 3), discharged to facilities other than IRF or SNF (n = 2,592), or who had a payor source other than Medicare, MA, Medicaid, Private, and self-pay (n = 235). Lastly, 96 patients were removed due to missing zip codes in the EHR. The final cohort included 8,324 participants. See Appendix A for a diagram of specific exclusion parameters. Participant Demographics Approximately 52% of the sample were male. Medicare was the most common payor source (36.4%), followed by MA (23.4%), private (20%), Medicaid (10.9%), and self-pay (9.4%). Mean (SD) age for the sample was 62.40 (17.0) years, mean income was $50,399 ($17,930), and mean 6-clicks score was 16.52 (5.1). Of the 8,324 participants, 5,444 (65%) were discharged home consisting of 3,720 (45%) to HNS and 1,724 (21%) to HCS. The remaining 2,880 (35%) were discharged to an institution which included 1,674 (20%) to a SNF and 1,206 (15%) to an IRF. The mean 6-clicks score was 19.1 (4.3) for those discharged HNS, DISCHARGE PREDICTORS 30 17.5 (4.1) for those discharged HCS, 12.7 (4.4) for those discharged to a SNF, and 12.5 (4.0) for those discharged to IRF. See Table 1. Bivariate Results Chi-square analyses examining bivariate relationships between discharge setting and gender, marital status, race, and insurance were all significant (p < .001). One-way ANOVA tests examining differences in age, 6-clicks scores, and income across discharge destinations were both statistically significant (p <.001). Descriptive statistics and comparisons by discharge destination are reported in Table 1. An additional chi-square analysis was performed to determine a relationship between race and payor source (p < .001). Most patients with Medicare, private insurance, and MA were Caucasian (71.5%, 66.4%, 57.1%, respectively). Patients with Medicaid and self-pay were more likely to be non-Caucasian (60.5% and 53.5%, respectively). The effect size of payor source on discharge destination was moderate (Cramers V = 0.21) (Sullivan & Feinn, 2012). The effect size of six clicks on discharge destination was found to be large (eta-squared = 0.32), while the effect size of age was found to be moderate (eta-squared = 0.12) (Watson, 2021). Multinomial Regression Results Based on univariate and bivariate results, the following potential predictors of discharge destination were entered into the multinomial logistic regression model: gender, marital status, race, payor, age, income, 6-clicks. The final multinomial regression model was statistically significant, X2(21) = 4,669.64, p < .001. The model explained 47% (R2 = .47) of the variance in discharge destination, and the goodness of fit Pearson value (p = .922) and Deviance (p = 1.000) demonstrated that the data fit the model well. Of the predictor variables entered into the model, DISCHARGE PREDICTORS 31 four were statistically significant: 6-clicks scores, X2(3) = 3034.62, p < .001; payor source, X2(12) = 324.50, p < .001; age, X2(3) = 309.20, p < .001; marital status X2(3) = 173.50, p < .001. Home with Services Versus Home with No Services The odds of being discharged with HCS were more significant than the odds of being discharged HNS for those with Medicare compared to those who were self-pay OR = 5.85, 95% CI [ 4.28, 8.00], had Medicaid relative to self-pay OR = 2.30, 95% CI [1.64, 3.21], had private insurance versus self-pay, OR = 3.13, 95% CI [2.31, 4.25], or MA relative to self-pay, OR = 4.36, 95% CI [3.17, 5.99]. The odds of discharging to HCS relative to HNS were lower for each 1-point increase in 6-clicks scores, OR = 0.89, 95% CI [0.88, 0.92]. The odds of being discharged HCS compared to the odds of being discharged HNS increased for every year a patient age, OR = 1.02, 95% CI = [1.02, 1.03]. Skilled Nursing Facility Versus Home with No Services The odds of being discharged to a SNF were greater than the odds of being discharged HNS for those with Medicare compared to those who were self-pay, OR = 7.37, 95% CI [5.01, 10.85]. Medicaid relative to self-pay, OR = 2.43, 95% CI [1.61- 3.66], private insurance compared to self-pay, OR = 1.94, 95% CI [1.28, 2.91], and MA versus self-pay, OR = 4.6, 95% CI [3.11, 6.84]. The odds of being discharged to a SNF compared to the odds of going HNS were greater for those who were married versus single OR = .40, 95% CI [0.34, 0.46]. For each 1point increase in 6-clicks score, the odds of being discharged to a SNF compared to the odds of going HNS decreased OR = .70, 95% CI [0.69, 0.71]. Finally, for every year increase in age, the odds of being discharged to a SNF versus HNS increased OR = 1.06, 95% CI [1.05, 1.06]. Since the odds of being discharged to a SNF were low for patients with private insurance, additional DISCHARGE PREDICTORS 32 statistical analysis was performed to determine the mean age of those with private insurance, and the result was 51 years old. Inpatient Rehabilitation Facility Versus Home with No Services The odds of being discharged to an IRF were greater than the odds of being discharged home without services for those with Medicare compared to those who were self-pay OR = 4.44, 95% CI [5.01, 10.85], Medicaid versus those who were self-pay OR = 2.19 95% CI [1.54, 3.12], private insurance versus those who were self-pay OR = 3.50, 95% CI [2.52, 4.86], and MA versus those who were self-pay OR = 2.18 95% CI [1.51, 3.15]. For every increase in a unit of age, the odds of being discharged to IRF versus HNS increased OR = 1.03, 95% CI [1.02, 1.03]. Each unit increase in "6-clicks scores, the odds of being discharged to IRF versus HNS decreased OR = 0.71, 95% CI [0.69, 0.72]. See Table 2. Additional statistical analysis was performed while analyzing the results in the discussion. Mean "6-clicks" scores were determined in patients with Medicare and MA in patients discharging to IRF. Mean "6-clicks" scores for patients with Medicare were 13.00 and MA 13.10. Sensitivity and Specificity Calculations for model sensitivity and specificity are displayed in Table 3. The area under the ROC curve examining the usefulness of the 6-clicks for categorizing discharge home (with or without services) versus institution (IRF or SNF) was .84, with a cutoff score of 17.50. The area under the ROC curve examining the usefulness of 6-clicks scores for categorizing discharge HNS versus HCS was .63. The area under the ROC curve examining the usefulness of 6-clicks scores for categorizing discharge to SNF versus IRF was .51. See Figures 1 - 3. DISCHARGE PREDICTORS 33 Discussion This study consistently identified three significant variables in predicting discharge destination: age, 6-clicks scores, and payor source, providing a framework for a clinical prediction model. To parallel the reported results, the discussion will first address the factors associated with hospital discharge to HCS, IRF, and SNF compared to discharge to HNS and the effects of those factors on the discharge destination. Clinical implications will address key summary points, and insignificant variables will then be discussed. Finally, variables not included in the model that may have influenced results and considerations for future studies will be addressed. Home with Services Versus Home with No Services Patients who were older were more likely to be discharged to HCS, and those with any type of insurance compared to self-pay were more likely to be discharged to HCS. Compared to those with other payors, patients with Medicaid had the lowest likelihood of receiving HCS compared to no services. In North Carolina, HCS has to be pre-approved by Medicaid, and each visit is evaluated and granted after the initial physical therapy evaluation (NC.gov., 2019). Medicaid spending is determined by individual states and may have limited funds. The lower likelihood of being discharged to HCS for those with Medicaid versus other payors may reflect that limited funding. It is unlikely that patients without home services will experience the same degree of improvement in health and function as those receiving services; however, this study did not collect any data beyond hospital discharge. The Department of Health and Human Services report indicated that the number of home visits that included physical, occupational, and speech therapy was 8.1 per episode of care when the episode was predicated by a hospital stay (Wysocki DISCHARGE PREDICTORS 34 & Cheh, 2019). Visits that include therapy likely improve patients' function. Falvey et al. (2021), in a review of 5,822 Medicare beneficiaries who received a total joint replacement, found that those who did not improve their activities of daily living status during a home care episode had a 2-fold increase in hospital readmissions (Falvey et al., 2021). Loomer et al. (2020) noted that those with MA were 11.7% less likely to receive HCS than those with Medicare. The study included a comparison of patients from the same hospital and zip code and adjusted for demographics. The current study did not compare MA and Medicare, but the odds of being discharged home with services were higher for those with Medicare compared to self-pay (OR = 5.85) than the odds of being discharged home with services for those having MA (OR = 4.36). It appears as if those with Medicare receive more HCS than those with MA based on Loomer et al. (2020) and the results of this study. Additionally, the 6-clicks scores suggested that higher functioning patients were discharged home with (M = 17.50 SD = 4.10) and without services (M = 19.10 SD = 4.30) possibly reflecting a level of care that home care agencies and other family members could provide. Even though the differences in 6-clicks scores were minor between patients receiving home care with and without services, there were lower odds of patients receiving HCS with higher "6-clicks" scores. Mees et al. (2016), in a systematic review of literature predicting discharge destination for patients with stroke, also found higher functioning patients were discharged home. One variable contributing to the home discharge was local staffing (PT and OT) in the community to provide HCS. This study did not consider staffing as a variable, but the availability of health care professionals in the community may be a factor to consider in future studies. DISCHARGE PREDICTORS 35 Skilled Nursing Facility Versus Home with No Services Patients discharged to a SNF were the oldest in the sample, had lower 6-clicks scores, and were less likely to be married. As 6-clicks scores increased by one point, chances of being discharged to a SNF decreased 30%. The odds of being discharged to a SNF increased 6% with each year of age. Patients with Medicare were more likely to go to a SNF relative to going HNS, and those with private insurance were least likely to be discharged to a SNF compared to going HNS. The mean age of those in this study with private insurance was 51 years old, suggesting they may still be in the workforce and possibly healthier, thus not needing a SNF; however, the model controlled for age. Balentine et al. (2016) showed that post-operative patients who were older than 85 years were 27 times more likely to be discharged to a SNF compared to the younger group (<65 years old) even when there were no post-operative complications or limitations in physical ability (Balentine et al., 2016). Their findings suggest there may be an age bias in discharging patients to a SNF. The literature is inconsistent as to whether or not SNF discharges are better than home discharges as defined by hospital readmissions (Storsberg et al., 2016; Werner et al., 2019. Werner et al. (2019) examined 17 million Medicare records and found that a home discharge resulted in 5.6% more readmissions at 30 days than among those patients admitted to a SNF. However, with no difference in mortality or functional outcomes, the Medicare payment for home care was less than SNFs even when accounting for the readmissions (Werner et al., 2019). To further complicate the issue, Storsberg et al. (2016) found that hospital discharges to SNF or IRF were independent risk factors (1.51 times more likely) for readmission than a home discharge among older adults with trauma. The balance between cost of care and quality patient DISCHARGE PREDICTORS 36 outcomes continues to be an issue, and the evidence is as yet unclear as to how that might influence discharge decisions. Compared to HNS, the SNF discharge setting was the only one in which marital status was significant. In this study, being married decreased the odds of being discharged to a SNF compared to being discharged home without services. In fact, 70% of those discharged to a SNF were single. Although marital status was only a significant factor for SNF discharge and no other discharge locations in this study, many other studies have found marital status a significant factor in determining various discharge settings (Bai et al., 2019; Glauser et al., 2020; Sultana et al., 2019; Zimmerman et al., 2019). There is the possibility that single patients admitted to SNF had ADL or cognitive challenges that precluded a home discharge and required a SNF stay; however, these variables were not addressed in this study. The APTA (2021) reported rates of discharges to SNFs across the U.S. among 1.5 million Medicare beneficiaries in 2015 and 2016. The study showed that 48% of patients were discharged to SNF, whereas in the current study, 29% of patients with Medicare were admitted to SNF (APTA, 2021). Although there are 15,500 SNFs in the U.S., they may not be distributed evenly across regions. Thus, the percentage of discharges to SNF may be different when looking at specific health care systems and the services offered in their geographical region (Buntin et al., 2005; Tian, 2016). There may be higher rates of discharges to SNFs if IRFs are not available, if there are no HCS available in the community, or if the pressure to decrease LOS in the hospital results in an expedited discharge to SNF (Burke et al.,2016). Alternatively, there may be a greater incidence of discharge home instead of SNF with the availability of strong HCS. Li et al. (2018) found significant geographical variations in the use of post-acute services, particularly for SNF among those with MA and Medicare, but more variation in the use of SNF and IRF for DISCHARGE PREDICTORS 37 those with MA. The authors concluded local factors influenced PAC and not health insurance enrollment. This idea needs to be further investigated in the literature. Inpatient Rehabilitation Facility Versus Home with No Services Patients discharged to an IRF were likely to be older and have health insurance compared to those discharged home without services. While those with any type of insurance were more likely to be discharged to IRF than those who were self-pay, the odds were greatest for those with Medicare and private insurance (OR = 4.43, 95% CI [3.13,6.30] and OR = 3.50, 95% CI [2.52, 4.86], respectively). One point higher 6-clicks score resulted in a 29% lower chance of being discharged to an IRF relative to being discharge HNS. The raw mean 6-clicks scores were similar for IRF and SNF. Thus, the level of mobility may not distinguish IRF from SNF discharge setting. Although marital status was a factor with discharge to a SNF, it was not the case with discharge to an IRF. Criteria for IRF admission at this healthcare facility include funding and assistance available at home. Although marital status would seem to be a proxy for a greater likelihood of having help at home, the IRF stay may give families time to enlist assistance at home when the patient has no spouse. In this study, 15% of patients were discharged to an IRF. Three other recent studies, Warren et al. (2021), Sultana et al. (2019), and Freburger et al. (2020), showed a smaller percentage of patients, 7.2%, 8.2%, and 6.5%, respectively, going to IRF. Warren et al. (2021) had patients with various diagnoses in their study, including patients with total joint replacements. The fact is that most patients with total joint replacements are discharged home. The current study did not include patients with that diagnosis, which may contribute to a greater percentage of patients discharged to IRF compared to previous studies. Sultana et al. (2019) predicted discharge destination for patients with heart valve replacement and cardiac bypass DISCHARGE PREDICTORS 38 surgery, a narrow scope of diagnoses. Freburger et al. (2020) studied patients with pneumonia, a diagnosis that does not often necessitate a discharge to IRF. IRF beds are usually reserved for patients with more severe injuries such as stroke, spinal cord injury, or brain injury that can be life-altering in terms of the level of disability, cognitive impairment, and paralysis. The current study may also have had a higher percentage of patients discharged to IRF than other studies because there are four IRF hospitals in the healthcare system and the metropolitan area. A higher percentage of patients may be discharged to IRF due to proximity and the financial gains of selfreferring in the system. The health care system represented in this study also has the only oncology program in an IRF setting in the U.S., possibly accounting for additional discharges to an IRF. Lastly, although the diagnosis was not considered within this study's model, the healthcare system for this study is in the stroke belt, which is a region of the U.S. in which strokes occur at a much higher rate than other areas of the country. This may account for some of the differences when compared to the Warren et al. (2021) and Freburger et al. (2020) studies which took place in the southwest and mid-Atlantic (Hansen, 2019). This could also explain a higher percentage of patients being discharged to IRF. The fact remains that IRFs are significantly more expensive than the other discharge settings and in this study. Only 6% of those discharged to an IRF were self-pay. Future research needs to solidify IRF outcomes to justify the cost and identify ways to access IRF for patients who are not insured. Suppose an IRF discharge can decrease an acute hospital LOS, and patients' function improves significantly in the expected 14-day IRF LOS. In that case, the cost of IRF may be made up in days saved in a hospital stay, mainly if the acute hospital and IRF hospital are financially tied as they are in this study. It is incumbent on health science researchers and hospital systems to measure functional outcomes and ensure the improvement in patients' DISCHARGE PREDICTORS 39 function is in line with the cost of care. Since Falvey et al. (2021) demonstrated that patients were more likely to be readmitted if there was no demonstrated improvement in ADL function, this idea requires further investigation in different patient populations to evaluate the effectiveness of PAC settings. Clinical Implications Usefulness of "6-Clicks" Scores The 6-clicks basic mobility score was first validated in the literature in 2014 (Jette et al., 2014) and shown to be a predictor of discharge setting. Additional ROC analysis in the current study showed that 6-clicks was not predictive of discharge to SNF versus IRF or discharge to HCS versus HNS. However, this study confirmed the independent ability of 6clicks to predict home discharge versus institutional discharge with the raw cutoff score of 17.5. Previously published research identified cutoff scores of 17-18 and 16, established by Jette et al. (2014) and Warren et al. (2021), respectively. The current cutoff score is essentially the same as the hallmark study by Jette et al. (2014). This score is generally reliable and valid as a marker of basic mobility in large-scale studies despite the diagnosis and is useful clinically in hospital settings, especially in differentiating home versus institutional rehabilitation discharge settings as Jette et al. (2014) and this current study confirms. Based on the current evidence, therapists may consider making a general discharge recommendation of home versus institutional rehabilitation until more precise variables can be utilized and established in the literature. The interprofessional team does not have an evidencedbased model to differentiate between the patients for discharge to each of the four discharge destinations studied. Additional predictor variables need to be identified and validated to differentiate discharge to HCS versus HNS, discharge to SNF versus IRF, and discharge to HCS DISCHARGE PREDICTORS 40 versus SNF. Covert et al. (2020) demonstrated that the "6-clicks" score could predict home versus institutional rehabilitation in patients with stroke, yet to differentiate IRF versus SNF, the National Institute of Health Stroke scale, age, sex, and race along with the "6-clicks" score made a more robust prediction. Effect of Payor Source A model including payor source is a strength of this study as very few previous studies used payor source as a predicator for discharge. Zimmerman et al. (2019) conducted a small study (n = 660) in Switzerland and found that those without supplemental insurance received less intense rehabilitation. Burke et al. (2016) showed payor was significant in 3 million discharges to PAC facilities compared with home discharge. Patients with Medicare, private insurance, and Medicaid had fewer home discharges and more discharges to institutional settings. Burke et al. (2016) used 1996 data as a baseline and compared it to years 2009-2010 in looking at PAC use (home care, IRF, SNF). They attributed the increase in discharge to PAC setting to Medicare reforms incentivizing hospitals to have a shorter LOS (Burke et al., 2016). However, the data were from 2010 and published in 2016; thus, the information is dated. The current approach at this medical center is to encourage a home discharge as it is less expensive and healthcare systems are becoming accountable care organizations (Luke, 2017). Results of the current study also indicate that payor source has a significant impact on discharge destination. It is unknown if the appropriate post-acute placement was made to support patients gaining maximal function or whether decisions were based on cost or pressure to decrease LOS. Payor source has been shown to drive access to care (Garfield et al., 2019). This current study found that 77% of patients who were self-pay were discharged to HNS. Patients who are self-pay are uninsured and appear to lack access to post-acute care when compared to patients with insurance who were discharged to DISCHARGE PREDICTORS 41 HNS at a lower rate (private insurance 57%, Medicaid 56%, MA 36%, and Medicare 29%). Low-quality coverage that fails to pay for services overall means less access and options for patients (Garfield et al., 2019). In this study, patients were recruited from a safety-net hospital where care is given despite the ability to pay or citizenship based on the Emergency Medical Treatment and Labor Act of 1986 (Sacks et al.,2011). However, patients' access to services without regard for payment is not available for PAC settings in the same catchment area. An executive summary published by the Kaiser Foundation stated that safety-net hospitals remain at capacity and cannot provide specialty services such as rehabilitation (Garfield et al.,2019). Thus, patients may not receive the care needed to maximize function (Garfield et al., 2019). Patients in this study with Medicaid, although having higher odds than those who were self-pay of being discharged to HCS compared to discharged to HNS, had relatively lower odds than those with other types of insurance. Garfield et al. (2019) discussed how states in which Medicaid was not expanding were particularly challenged by assisting those of lower-income levels in post-acute services (Garfield et al., 2019). Future research should compare private and safety-net hospitals and the PAC services given, such as home care and IRF, particularly for the uninsured. Lastly, the odds of being discharged to an IRF compared to being discharged to HNS were higher for patients with Medicaid and MA than those who were self-pay. However, the odds ratios were similar OR = 2.19, 95% CI [1.54, 3.12] and OR = 2.18, 95% CI [1.5.1, 3.15], respectively for Medicaid and MA. In addition, the odds were less than half that for those with Medicare OR = 4.43, 95% CI [3.13, 6.3]. Medicaid is insurance for patients with low-income levels and requires internal administrative approval for IRF admission. MA is for patients greater than 65 years old and is a form of Medicare administered by private insurers. It remains unclear DISCHARGE PREDICTORS 42 why having either payor sources yield similar odds of being discharged to an IRF. Data from this study showed that the mean 6-clicks score for patients with MA and Medicare was 13.0 and 13.1, respectively. Thus, showing there is no difference in physical ability. One can conclude that since physical limitations were the same based on 6-clicks scores, there must be other reasons why the odds of going to IRF for patients with Medicare are double that of patients with MA compared with going HNS. Providers of MA have to pre-approve or deny IRF services (American Hospital Association, 2007). Pre-approval means the patient cannot be transferred to a post-acute setting unless the insurance company approves it while the patient is hospitalized. This may lead to more discharges to home with pressure to decrease the LOS and costs to acute care hospitals. Medicare, however, approves IRF and all post-acute services without a preapproval process, thus facilitating the transfer of care. The findings support Cao et al. (2020); MA is possibly more stringent than Medicare in paying for IRF. These results are also supported by a study by Huckfeldt et al. (2017) in which they examined over 2 million Medicare and MA insured patients with joint replacement, heart failure, and stroke. The researchers found a higher percentage of patients with Medicare discharged to IRF compared to those with MA (Huckfeldt et al., 2017). The percentage of patients with a stroke diagnosis and admission to IRF was 17.4% for those with MA and 24.8% for those with Medicare. The LOS at an IRF was lower for patients with all diagnoses with MA, and readmission rates were lower even when there seemed to be no evidence that patients with Medicare were systematically sicker than those with MA (Huckfeldt et al., 2017). Those with MA seem to be saving the insurer money in terms of postacute services, according to Huckfeldt et al. (2017); however, their study did not examine acute care LOS and possible delays in waiting on MA approval, both of which are additional costs. Payor source remains complicated and nuanced in covering post-acute services. Criteria for DISCHARGE PREDICTORS 43 patients with MA to receive post-acute services appear to be determined on a case-by-case basis. Published criteria for what constitutes an IRF versus SNF stay for those with MA may aid the acute hospital interprofessional team to make a better recommendation in a timely manner. This study demonstrates how payor sources may impact discharge destination after hospitalization across a range of diagnoses. Impact of Age Age is a significant variable noted in many studies and systematic reviews related to discharge placement prediction (Bai et al., 2019; Bowles et al., 2014; Glauser et al., 2020; Mees et al., 2016; Oseran et al., 2019; Zimmerman et al., 2019). In this study, older patients had higher odds of being discharged to any setting with services compared to home without services. Advancing age was also confirmed as a predictive factor in a previous study in which agepredicted SNF placement even when the patient was functionally independent, suggesting a predisposition for SNF placement for older patients (Balentine et al., 2016). Age has also been shown to be a factor in patients needing more intensive post-acute services (Heinemann, 2007). Glauser et al. (2020) found that age was an independent predictor of discharge destinations, with each increased year of age resulting in a 9.2% decreased chance of going home. One concern is that discharge decisions may reflect an age bias. Further research regarding the interaction between age, function, and discharge setting will be necessary to investigate whether PAC decisions are based on need rather than age alone. Variables Not Statistically Significant Variables that were found to be not significant in this study were gender, race, and income. Gender has been significant in previous studies and published discharge tools (Bai et al., 2019; Glauser et al., 2020; Sultana et al., 2019; Zimmerman et al., 2019). Both Bai et al. (2019) DISCHARGE PREDICTORS 44 and Glauser et al. (2020) created prediction tools for delayed discharge and post-acute services, respectively. Being female was considered a risk for delayed discharge and increased post-acute support as women were more likely to be widowed and residing in retirement communities (Bai et al., 2019). However, in a systematic review of literature predicting discharge placement in patients with stroke, gender was found not to be significant (Mees et al., 2016). Burke et al. (2016) examined 3 million discharges to PAC facilities and found gender had no impact on the type of PAC facility (SNF or IRF). It is also unknown if there is gender bias in post-acute placement. Race is a factor in post-acute discharge placement in patients with traumatic brain injuries (Mcquistion et al., 2016), but not for patients with stroke (Skolarus et al., 2017), gunshot wounds (Millham et al., 2009), or critical illness (Baldwin et al., 2017). Given those divergent findings, race may not have been significant in this study because it included all admitted patients regardless of their diagnosis. Although race as a variable in discharge destination was not significant, the racial make-up of payor sources was different. This study showed that 86% of patients who were Caucasian had some form of insurance compared to 70% of those who were non-Caucasian. Seven percent of Caucasians had Medicaid, while 17% of non-Caucasians had Medicaid. This supports findings from Buchmueller et al. (2020) in looking at racial disparities and health insurance coverage. While disparities have lessened with the Affordable Care Act, there is still a gap of 10% between Caucasians with Medicaid and non-Caucasian with Medicaid indicating inequities persist among the patients in this study. These findings are similar to Baldwin et al. (2017), who reported racial differences in payor sources. Interestingly, Millham et al. (2009) found no racial differences in mortality in patients with gunshot wounds. The authors attributed this result to the fact that trauma care involves DISCHARGE PREDICTORS 45 many physicians. The team working together works against racial subtleties that exist when a singular physician is caring for a patient (Millham et al., 2009). Continued investigation around the relationship between payor source, race, and post-acute services will be essential to discover the root causes of inequities. Income was also not statistically significant in this project. This finding may be because interactions between payor and income were not examined in this project or because the payor source was controlled for in the regression model. Berkowitz et al. (2015) supported using zip codes as a proxy for socioeconomic status, and median income based on zip codes was examined as a variable in this study. This proxy variable, however, may misclassify too many individuals. Gentrification in urban areas can prohibit an accurate reflection of individual income in a zip code. (Bhavsar et al., 2020). Charlotte, N.C., where this study was conducted, is one of the fastest-growing cities in the country and has experienced gentrification (Munn, 2019). Evaluating income and its relationship to health care services is essential; however, most EHRs do not have patients' individual income information. Moore et al. (2015) stratified trauma patients into quintiles based on an ecological approach determining material/social deprivation and assessing the relationship with acute LOS. Material deprivation was defined by education, employment, and income (average). Social deprivation was defined as single-parent households, widowed, living alone, or divorced. Odds ratios showed that those with the most social/material deprivation had a longer LOS than those who did not have social/material deprivation. Socioeconomic status is complicated, and using individual income will be the most precise method moving forward. Even then, measuring the number of household dependents who rely on the income-earner and financial support cannot be ignored. Moore et al. (2014) also surmised that those with no post-acute support or resources for PAC suffer longer length of DISCHARGE PREDICTORS 46 hospital stays. Although Moore et al. (2014) did not look at discharge destination as a dependent variable, their study demonstrated a complex, ecological approach to measuring socioeconomic status in which income is only one factor. That being said, the payor source may be a proxy for SES status. Zhu (2018) suggested using payor source (Medicaid) or dual eligibility (Medicare/Medicaid) as a proxy for SES. Future studies need to include specific payor sources, and in addition to the payor sources identified in this study, dual Medicare/Medicaid needs to be included. Variables That May Have Influenced Results This study did not include some variables used in other studies, and this difference may have influenced results. Diagnosis was not considered in this study; however, other studies have looked at individual diagnoses such as stroke, joint replacements, and spinal surgeries and their impact on discharge destination (Glauser et al., 2020; Mees et al., 2016; Tan et al., 2014). Other large-scale studies have controlled for diagnosis as they looked at home versus institutional discharge (Covert et al., 2020; Jette et al., 2014; Warren et al., 2021). Other predictive models did not consider diagnosis (Bai et al., 2019; Bowels et al., 2014). That may be because diagnosis is not as relevant as physical function. Ultimately, if patients are functioning at a high level, they may be discharged home despite having a stroke or a severe illness. LOS is another potential variable in considering discharge destination; however, physical function at discharge may be a more accurate predictor of discharge destination. Studies have been published on the relationship between payor source and LOS (Sedney et al., 2020; Sorenson et al., 2020). Sedney et al. (2020) studied patients with spinal cord injuries, and those with Medicaid as a payor source had a longer LOS of 20.9 days compared to patients who did not have Medicaid. Sorenson et al. (2020) noted a longer LOS in patients with traumatic brain injury DISCHARGE PREDICTORS 47 who were self-pay or had Medicaid versus Medicare or private insurance. These findings could result from the inaccessibility of PAC for those with Medicaid or the uninsured, delaying discharge. Overall, in the U.S., from 1996-2010, increasing numbers of patients were discharged to PAC facilities, possibly due to the shorter length of hospital stay prompted by Medicare reforms (Burke et al., 2016). Illness severity was not considered in this study, yet it may impact discharge destination. The recent Therapy Outcomes in Post-acute Care (TOPS) study (APTA.org, 2021) by APTA and the American Occupational Therapy Association indicated that 40% of those discharged to an IRF spent at least one day in the intensive care unit. Intensive care unit stays put patients at risk for weakness and may be a variable that impacts physical function and, therefore, discharge destination. In another study, Bowles et al. (2014) developed a discharge tool to prevent readmissions, and illness severity was a part of the tool. Using the tool, there was a relative risk reduction of readmission. In addition to illness severity, co-morbidities as a reflection of medical complexity would be interesting to consider, especially co-morbidities in the self-pay group, as they tend to have complicated conditions that may impact physical function (Sacks et al., 2011). Sultana et al. (2019) examined discharge destination in 14,000 patients in the U.S. with cardiac bypass surgery or valve replacement and included co-morbidities such as atrial fibrillation, hyperlipidemia, hypertension, diabetes. They found that patients with acute kidney failure were 2 times more likely to be discharged to a post-acute facility compared to home (Sultana et al., 2019). All other co-morbidities examined were insignificant in discharge to post-acute facilities (Sultana et al., 2019). Thus, the relationship between co-morbidities and post-acute services needs further examination in various populations. DISCHARGE PREDICTORS 48 Other measures of physical or mental function may be necessary in discharge decisionmaking, for example, measures of cognitive ability (Allen & Blue, 1998), ADL (Jette et al., 2014; Falvey et al., 2021), and gait speed (Fritz & Lusardi, 2009). A systematic review of discharge destination in patients who suffered a stroke (Mees et al., 2016) indicated cognition was second to physical function in importance in predicting home, SNF, or IRF placement. Previous studies that included many diagnoses have also mentioned cognition as a variable that may predict discharge setting (Bai et al., 2019; Jette et al., 2014). Gait speed also may be a variable to differentiate discharge destination (Fritz & Lusardi, 2009). Fritz and Lusardi (2009), in a white paper supporting the importance of gait speed as a measure of function, recommended follow-up (HCS) for patients walking less than 1.0 m/s to decrease fall risk. Based on their review of literature, they suggested that those who walk at a gait speed of 1.0 m/s or greater were less likely to have an adverse event and could go home without services (Fritz & Lusardi, 2009). Their review included studies of patients who were elderly and or suffered a stroke (Bowden et al., 2008; Montero-Odasso et al., 2005). Albany et al. (2015) measured gait speed in patients with coronary artery bypass surgery and found those discharged to SNF or IRF walked at .25m/s, and those discharged home walked at a speed of .42m/s. This confirms Fritz and Lusardi's (2009) recommendations showing patients who ambulate at a speed of .2 m/s may be more likely to be placed in a SNF. Salbach et al. (2001) measured gait speed in patients with acute stroke and found patients discharged to IRF walked slower than those discharged home (speed of .28m/s and .42m/s, respectively). Lastly, Peel et al. (2014) used gait speed to predict discharge to a transitional care program. The initial mean gait speed was .34m/s, and at discharge, it was 0.54m/s, resulting in 86.9% of patients successfully DISCHARGE PREDICTORS 49 living in the community. While gait speed may be a significant variable in a discharge model, it may not differentiate beyond home versus institutional rehabilitation. ADL can be measured using the 6-clicks daily activity score, which evaluates a patient's ability to feed, dress (upper and lower body), toilet, bathe, and groom one's self (Jette et al., 2014). Warren et al. (2021) and Jette et al. (2014) published research suggesting the daily activity 6-clicks score could be used to predict home versus institutional discharge. While Gill et al. (2004) did not study discharge destinations, they compared hospitalized patients to nonhospitalized patients. They found that hospitalized patients were 61 times more likely to have an impairment with ADL (Gill et al., 2004). This finding supports the idea that hospitalized patients may need post-acute services after a hospitalization to address impairments in ADL. As mentioned earlier, Falvey et al. (2021) determined a 2-fold risk in readmission if patients with joint replacements did not improve their ADL status. Variables in future studies need to be clinically relevant and easy to obtain from the EHR. Cognition, ADL, gait speed, co-morbidities, LOS, and intensive care unit stays are variables to consider. The medical records routinely document recommendations from speech therapists measuring cognitive status, occupational therapists measuring ADL status, and physical therapists measuring gait speed and basic mobility scores. They may provide accurate discharge recommendations while accounting for payor source and age. Previous studies have relatively long lists of predictive variables (Bai et al., 2019; Bowles et al., 2014; Oseran et al., 2019; Zimmerman et al., 2019). Bowles et al. (2014) and Oseran et al. (2019) modeled tools in which points were assigned to the significant variables and subsequently tested and validated. They determined cut off scores in their models: Bowles et al. (2014) to determine high risk versus low-risk for referral to PAC, and Oseran et al. (2019) to determine DISCHARGE PREDICTORS 50 referral to SNF or not on day one of hospitalization. Oseran et al. (2019) reported 11 variables (age, marital status, insurance, admission day of the week, pre-hospital living situation, admitted diagnosis, distance from the hospital, living alone or not, institutional living situation, difficulty with ADL, difficulty with gait a few blocks) that predicted SNF placement on day one of hospitalization. Only two variables were functional (mobility and bathing). The final model included variables present in 60% of bootstrap sample models, including the 11 variables listed above (Oseran et al., 2019). The prediction model was validated using ROC (.82), and cut off scores indicated a "rule-in" for SNF recommendation with a positive predictive value of 38% (Oseran et al., 2019). Additional cut off scores resulted in a "rule-out" for SNF recommendation and a negative predictive value of 97% (Oseran et al., 2019). The study scope was narrow, only looking at discharges to SNF. Bowles et al. (2014) created a predictive model of six variables: age, walking ability, depression, LOS, number of comorbid conditions, and self-rated health assessment scores. The model created was implemented in a usual care phase and an experimental phase. The usual care phase collected data points on the discharge decision support system, but the results were not shared with the staff. In the experimental phase, the results were shared with the staff, and they used the six variables to determine if a patient was high risk for PAC or low risk for PAC. High risk for PAC was defined as needing HCS, SNF, or IRF. Low-risk PAC was defined as being able to go home with no services. When Bowles et al. used the variables to determine discharge to SNF, IRF, or HCS, those patients had lower readmission rates, similar to those of low-risk patients. Bowles and colleagues attributed the results to the tool empowering case managers to address PAC needs early on in the hospital stay and work with the families and patients to DISCHARGE PREDICTORS 51 achieve a positive outcome. However, the variables relied on patient-reported surveys (depression and health status), which may be harder to capture in routine (Bowles et al., 2014). The literature remains inconclusive in identifying overall predictive factors in discharge recommendations. Published discharge tools and predictive models have limitations. Despite the pressure on hospital systems to decrease LOS and patients requiring the proper support to prevent readmissions, a robust clinical prediction model for discharge does not exist. The model developed in this study may have been too simplistic, as evidenced by correctly predicting only 57% of discharges; however, age, 6-clicks mobility scores, and specific payor source are standard and easy identifiers to pull from the EHR. This study, therefore, provides a solid and straightforward framework for further models to be built upon, and the scope was broad in terms of diagnosis. This study contributes to the published literature in multiple ways. Firstly, it shows that data easily pulled from the EHR can be helpful to predict discharge destination with 57% accuracy in a highly varied patient population. This fares better than the positive prediction rate of 38% in the Oseran et al. (2019) study and is not quite as strong as the 62.6% predictive accuracy in the Sultana et al. (2019) model. However, Sultana et al. (2019) only considered two diagnoses. Secondly, this study illuminates the odds of being discharged to HCS, SNF, or IRF compared to HNS based on payor source. This issue has not been satisfactorily explored in the literature and needs further examination. Thirdly, this study confirmed the predictive value and cutoff scores of the 6-clicks basic mobility score in a large population across various diagnoses that did not include joint replacements. DISCHARGE PREDICTORS 52 Study Limitations Study limitations include a sample of patients from a single medical center where joint replacements are not performed. The variables pulled from the EHR were limited, and the model correctly predicted discharge placement in only 57% of the cases. Data from retrospective chart reviews may be inferior to prospective studies. Since the data have already been recorded, there are limitations in the available data, or it may be available in substandard forms. There could have been misclassification of data points in regards to race and marital status. There also may be selection bias in choosing a sample that included patients who received physical therapy. The selection bias may result in patients with only physical limitations, and patients with singular cognitive or ADL impairments may have been excluded. A model predicting discharge destination for these types of impairments may differ from that reported here. The statistical approach used in this study, a forward stepwise regression, may produce suppressor effects, distorting the effects of predictors on the outcome variable. Interactions, mediator, and moderator effects were not examined in this analysis. Further statistical analysis to include interactions may help better understand the results. To strengthen the clinical prediction model, additional variables must be tested while maintaining parsimony in a clinical setting. Conclusions Discharge planning and post-acute placement remain fragmented and complicated, and there is not a current model that encompasses the whole of a patient's circumstances. The model created in this study suggested that age, basic mobility, and payor source are essential variables in predicting post-acute discharge placement. The model including these variables accounted for 46.5% of the variability in discharge placement and accurately predicted 57% of discharge placements. However, the model may be overly simplistic and missing a few key variables. DISCHARGE PREDICTORS 53 Older age was associated with discharge to PAC settings, as were lower levels of basic mobility as measured by 6-clicks. Although 6-clicks scores alone can predict home (with or without services) versus institutional rehabilitation (SNF or IRF), they are not specific and sensitive enough to differentiate discharge to HCS versus HNS or discharge to SNF versus IRF. Furthermore, physical function measures (cognition, ADL, gait speed) may be needed to accurately identify specific post-acute needs and provide critical information for standardizing discharge decision-making. Having insurance was associated with receiving PAC versus being discharged home without services. Critical acute hospital care is given to patients regardless of their ability to pay, yet insurance coverage appears to factor in the type of PAC received. Further investigation on payor sources and resources for the uninsured is essential in caring for the community from a legislative and qualitative lens. Although this study did not find race a factor in discharge placement, data showed racial disparities in payor sources. Future studies need to focus on clinically essential variables that can be easily accessed to improve the accuracy of post-acute placement decision-making and, in particular, differentiate home with and without services and SNF versus IRF. Large-scale studies need to capture the totality of diagnosis and medical conditions instead of focused research on one condition. 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The Journal of Surgical Research, 207, 2732. https://doi.org/10.1016/j.jss.2016.07.015 Slavin, M. (2014, February 27). AM-PACTM Short Forms: Measuring rehabilitation functional outcomes across settings. https://www.mediware.com/wpcontent/uploads/MediwarewebinarAMPACShortForms.pdf DISCHARGE PREDICTORS 70 Sullivan, G. M., & Feinn, R. (2012). Using effect size-or why the p value is not enough. Journal of Graduate Medical Education, 4(3), 279282. https://doi.org/10.4300/JGME-D-1200156.1 Sultana, I., Erraguntla, M., Kum, H.-C., Delen, D., & Lawley, M. (2019). Post-acute care referral in United States of America: A multiregional study of factors associated with referral destination in a cohort of patients with coronary artery bypass graft or valve replacement. BMC Medical Informatics and Decision Making, 19(1), Article 223. https://doi.org/10.1186/s12911-019-0955-0 Tan, C., Loo, G., Pua, Y. H., Chong, H. C., Yeo, W., Ong, P. H., Lo, N. N., & Allison, G. (2014). Predicting discharge outcomes after total knee replacement using the Risk Assessment and Predictor Tool. Physiotherapy, 100(2), 176181. https://doi.org/10.1016/j.physio.2013.02.003 Tian, W. (2016). An all-payer view of hospital discharge to postacute care, 2013. HCUP statistical brief #205. Agency for Healthcare Research and Quality. Retrieved from http://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-PostacuteCare.pdf Voskuijl, T., Hageman, M., & Ring, D. (2014). Higher Charlson Comorbidity Index scores are associated with readmission after orthopaedic surgery. Clinical Orthopaedic and Related Research, 72(5), 16381644. https://doi.org/10.1007/s11999-013-3394-8 Watson, P. (2021, April 12) Rules of thumb on magnitudes of effect sizes. University of Cambridge Cognition and Brain Sciences Unit. https://imaging.mrccbu.cam.ac.uk/statswiki/FAQ/effectSize DISCHARGE PREDICTORS 71 Warren, M., Knecht, J., Verheijde, J., & Tompkins, J. (2021). Association of AM-PAC 6clicks basic mobility and daily activity scores with discharge destination. Physical Therapy, 101(4), 1-9. https://doi.org/10.1093/ptj/pzab043 Werner, R.M., Coe, N. B., Qi, M., Konetzka, R. T. (2019) Patient outcomes after hospital discharge to home with home health care vs to a skilled nursing facility. JAMA Internal Medicine, 79(5):617623. https://doi.org/10.1001/jamainternmed.2018.7998 Wysocki, A., & Cheh, V. (2019). Patterns of care and home health utilization for communityadmitted Medicare patients. Office of the Assistant Secretary for Planning and Evaluation. https://aspe.HCS.gov/sites/default/files/migrated_legacy_files/188026/ComAdmit.pdf Yeh, H.-J., Huang, N., Chou, Y.-J., Cheng, S.-P., Lee, W.-K., Lai, C.-C., & Cheng, C.-C. (2017). Older age, low socioeconomic status, and multiple co-morbidities lower the probability of receiving inpatient rehabilitation half a year after stroke. Archives of Physical Medicine and Rehabilitation, 98(4), 707715. https://doi.org/10.1016/j.apmr.2016.08.468 Zimmermann, B. M., Kon, I., Rost, M., Leu, A., Wangmo, T., & Elger, B. S. (2019). Factors associated with post-acute discharge location after hospital stay: A cross-sectional study from a Swiss hospital. BMC Health Services Research, 19(1), 1-7. https://doi.org/10.1186/s12913-019-4101-6 Zhu, Y. (2018). Outcomes following hospital discharge: The roles of postacute care pathway and patient socioeconomic status. [Unpublished doctoral dissertation]. University of North Carolina at Chapel Hill. https://doi.org/10.17615/58ja-m DISCHARGE PREDICTORS 72 Table 1 Descriptive Statistics and Comparisons by Discharge Status (N = 8,321) All (N = 8,324) HCS (n = 1,724) HNS (n = 3,720) SNF (n = 1,674) IRF (n = 1,206) N (%) N (%) N (%) N (%) N (%) Gender p < .001 Male 4,305 (51.7) 862 (50.0) 2,062 (55.4) 735 (43.9) 646 (53.6) Female 4,019 (48.3) 862 (50.0) 1,658 (44.6) 939 (56.1) 560 (46.4) Marital Status a < .001 Married 3,537 (42.5) 841 (48.8) 1,623 (43.6) 500 (29.9) 573 (47.5) Single 4,784 (57.5) 883 (51.2) 2,096 (56.4) 1172 (70.1) 633 (52.5) Race < .001 Caucasian 5,102 (61.3) 1,119 (64.9) 2,155 (57.9) 1,046 (62.5) 800 (65.3) Non-Caucasian 3,222 (38.7) 605 (35.1) 1565 (42.1) 628 (37.5) 424 (35.2) DISCHARGE PREDICTORS 73 Payor < .001 Medicare 3,033 (36.4) 766 (44.4) 897 (24.1) 890 (53.2) 480 (39.8) Medicaid 910 (10.9) 122 (7.3) 513 (13.8) 122 (7.2) 150 (12.4) Medicare Advantage 1948 (23.4) 479 (27.8) 732 (19.7) 523 (31.2) 214 (17.7) Private 1682 (20.0) 295 (17.1) 975 (26.2) 92 (5.5) 289 (24.0) 782 (9.4) 60 (3.5) 602 (16.2) 47 (2.8) 73 (6.1) M (SD) M (SD) M (SD) M (SD) M (SD) p 62.4 (17.0) 66.5 (14.1) 57.1 (17.6) 72.1 (13.1) 63.0 (16.8) < .001 Self-Pay Age (years) Income(dollars) a 6-clicks $50,399 (17,930) $49,341 (18,340) $49,132 (15,221) $54,191 (22,310.) 16.52 (5.1) 17.50 (4.1) 19.10 (4.3) 12.70 (4.4) $50,141 (17,517) 12.50 (4.0) Note. HCS = HCS; HNS = home with no services; SNF = skilled nursing facility; IRF = inpatient rehabilitation facility a Median and interquartile range reported < .001 < .001 DISCHARGE PREDICTORS 74 Table 2 Multinomial Logistic Regression Model Predicting Discharge Destination (N = 8,324 ) Home Care Services Skilled Nursing Facility Inpatient Rehab Facility Predictor OR [95% CI] OR [95% CI] OR [95% CI] 6-clicks 0.89 [0.88, 0.91] 0.70 [0.69, 0.71] 0.71 [0.69, 0.72] Age 1.02 [1.02, 1.03] 1.06 [1.05, 1.06] 1.03 [1.02, 1.03] 0.96 [0.85, 1.10] 0.40[0.34, 0.47] 0.91 [0.78, 1.07] [Reference] [Reference] [Reference] Medicare 5.85 [4.28, 8.00] 7.37 [5.01, 10.85] 4.43 [3.13, 6.3] Medicaid 2.30 [1.64, 3.21] 2.43 [1.61, 3.66] 2.19 [1.54, 3.12] Private 3.13 [2.31, 4.25] 1.94 [1.28, 2.93] 3.50 [2.52, 4.86] MA 4.36 [3.16, 5.99] 4.61[3.11, 6.84] 2.18 [1.51, 3.15] [Reference] [Reference] [Reference] Marital Status Married Single Payor Source Self-Pay Note. MA = Medicare Advantage DISCHARGE PREDICTORS 75 Table 3 Model Sensitivity and Specificity for Discharge Destination Sensitivity Specificity HNS .87 .59 HCS .10 .96 SNF .64 .84 IRF .23 .95 Note. HNS = Home with no services; HCS = Home with services; SNF = Skilled nursing facility; IRF = Inpatient rehabilitation DISCHARGE PREDICTORS Figure 1 Receiver Operator Curves Home versus Institution Discharge for 6-clicks (Area Under the Curve 0.84) 76 DISCHARGE PREDICTORS Figure 2 Receiver Operator Curve (ROC) Skilled Nursing Facility versus Inpatient Rehabilitation Discharge for 6-clicks (Area Under the Curve .51) 77 DISCHARGE PREDICTORS Figure 3 Receiver Operator Curve (ROC) Home No Services versus Home with Services Discharge for 6-clicks (Area under the curve .63) 78 DISCHARGE PREDICTORS 79 Appendix A Flow Diagram Adults admitted 1/1/19-12/31/19 Selection with one 6-clicks score (n = 11,247) Excluded (n = 2,592) Expired (n = 695) LTC Hospital (n = 466) Hospice-Home (n = 399) Hospice-Medical Facility (n = 307) Other Acute General Hospital (n = 143) Unknown (n = 129) Possible Participants N = 8,655 Psychiatric Hospital/Unit (n = 108) Against Medical Advice (n = 94) Other Health Institution (n = 75) Intermediate Care Facility (n = 59) Police Custody/Jail (n = 55) Excluded (n = 235) Left Without Discharge Instructions (n = 38) VETERANS ADMINSTRATION (n = 92) Chemical Dep Center/Detox (n = 9) WORKERS COMP (n = 69) VA Federal Hospital (n = 8) TRICARE (n = 27) CARDINAL INNOVATIONS LME (n = 25) Rehab Fac/Unit Planned Readmission (n = 5) PHYSICIAN REACH OUT PLAN (n = 10) Discharged to Medical Home (n = 1) VICTIMS ASSISTANCE (n = 5) Life share Organ Donation Complete (n = 1) AARP UNITED HEALTHCARE (n = 3) CORPORATE BENEFIT SERVICE (n = 2) SICKLE CELL PROGRAM (n = 1) Possible Participants N = 8,420 Excluded from Analysis Missing income for zip code (n = 96) Final Sample N = 8,324 DISCHARGE PREDICTORS 80 Appendix B "6-Clicks" AM-PAC Inpatient Short Form Boston University AM-PAC 6-clicks Basic Mobility Inpatient Short Form Please check the box that reflects your (the patients) best answer to each question. How much difficulty does the patient currently have 1. Turning over in bed (including adjusting bedclothes, sheets and blankets)? 2. Sitting down on and standing up from a chair with arms (e.g., wheelchair, bedside commode, etc.) 3. Moving from lying on back to sitting on the side of the bed? How much help from another person does the patient currently need 4. Moving to and from a bed to a chair (including a wheelchair)? 5. Need to walk in hospital room? Unable A Lot 1 2 3 4 1 2 3 4 1 2 3 4 Total A Lot A Little None 1 2 3 4 1 2 3 4 A Little None DISCHARGE PREDICTORS 6. Climbing 3-5 steps with a railing? 81 1 AM-PAC Short Form Manual (v. 3) 2007, Trustees of Boston University, under license to CREcare, LLC. All rights reserved. 2 3 4  ...

... The Concurrent Use of Intermittent Mechanical Cervical Traction and Neuromobilization Techniques in Patients with Cervical Radiculopathy Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Patrick J. Christianson PT, MHS, OCS, SCS Copyright April 22, 2021 By: Patrick J. Christianson PT, MHS, OCS, SCS All rights reserved Approved by: James W. Bellew, PT, EdD, MS Committee Chair ______________________________ Elizabeth S. Moore, PhD Committee Member ______________________________ Jeevan Pandya, PT, MHS, OCS, COMT, FAAOMPT Committee Member ______________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ Running head: CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY The Concurrent Use of Intermittent Mechanical Cervical Traction and Neuromobilization Techniques in Patients with Cervical Radiculopathy Patrick J. Christianson University of Indianapolis 1 CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 2 Abstract Background/Significance: Cervical radiculopathy (CR) is a common neck disorder involving injury to nerve roots which can lead to significant pain and disability. There is not consensus on the most effective strategy to treat CR. A recent physical therapy intervention using a concurrent treatment of intermittent cervical traction (ICT) and upper extremity neuromobilization techniques (NMTs) shows promise. However, this concurrent approach has not been compared to the standard multimodal approach using sequential ICT and upper extremity NMTs. Purpose: The purpose of the study was to determine if patients receiving the concurrent approach had differences in disability, neck pain, range of motion and treatment time compared to the sequential approach. Methods: Patients were randomized into either the concurrent ICT and NMTs or sequential ICT and NMTs treatment group. Patients were followed for up to four weeks. Pre-intervention and post-intervention measures for neck disability index, cervical range of motion (ROM), and the numeric pain rating scale were collected and analyzed for within and between group differences. Treatment time for each visit was compared between the concurrent and sequential groups. Results: There were significant differences in neck disability, cervical ROM, and pain within both groups from pre-intervention to post-intervention; however, no significant differences were found between the concurrent and sequential groups. The concurrent approach had a significant decrease in treatment time per visit compared to the sequential group. Conclusion: The concurrent approach was effective in reducing pain and improving function for patients with cervical radiculopathy. In addition, the concurrent approach used less time per session. Keywords: Cervical radiculopathy, neck pain, intermittent cervical traction, neuromobilization techniques CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 3 The Concurrent Use of Intermittent Mechanical Cervical Traction and Neuromobilization Techniques in Patients with Cervical Radiculopathy Cervical radiculopathy (CR) is a nerve root disorder typically caused by cervical disc herniation, spondylitic spur, or other space occupying lesion that can impinge or inflame the accompanying nerve root (Cleland, Whitman, Fritz, & Palmer, 2005). Most CR occurs unilaterally; however, bilateral symptoms can occur in rare instances (Eubanks, 2010). Common signs and symptoms are neck pain that radiates into the arm coupled with motor, sensory, and/or reflex changes (Rao, 2002). To date, the optimal treatment for CR remains unclear. Although surgical interventions continue to have a high incidence in its treatment (Marquez-Lara, Nandyala, Fineberg, & Singh, 2014; Oglesby, Fineberg, Patel, Pelton, & Singh, 2013), they have not been shown to be more effective than conservative management such as physical therapy in reducing pain or improving function (Engquist et al., 2013). Within the available physical therapy literature, there is no general agreement on how to best manage patients with CR. Current best evidence suggests that a multimodal treatment program consisting of exercise, manual therapy techniques including neuromobilizations, followed by mechanical traction may best reduce pain and improve function in patients with CR compared to the use of only one treatment type (Boyles, Toy, Mellon, Hayes, & Hammer, 2011; Cleland et al., 2005). Other studies demonstrated effectiveness when using cervical lateral glides with neuromobilizations, without mechanical traction (Coppieters, Stappaerts, Wouters, & Janssens, 2003, Rodrguez-Sanz et al., 2017). Despite evidence suggesting multimodal treatment to be effective in treating patients with CR, a standardized multimodal treatment protocol has not been established. A recent study involved the concurrent administration of manual cervical traction and upper extremity neuromobilizations in which CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 4 patients demonstrated improved range of motion and function compared to a control group (Savva Giakas, Efstathiou, Karagiannis, & Mamais, 2016). In addition, another study involved a concurrent approach with mechanical cervical traction and neuromobilizations and had good outcomes with regards to pain and function (Kumar, Kumar. Arjunan, & Thoufiq, 2017). These studies show promise in a concurrent approach to the treatment of patients with CR. However, in both studies the interventions were not used in conjunction with a multimodal approach. Additionally, it would be important to know if using mechanical cervical traction in a concurrent approach would benefit the patient and therapist with regards to a saving in time. Therefore, the current study looked at the use of concurrent mechanical traction and upper extremity neuromobilization techniques along with exercise and manual therapy in patients with CR compared to a treatment approach of exercise, manual therapy and sequential mechanical traction and upper extremity neuromobilization techniques. Both treatment protocols used for this study are expected to be effective in the treatment of CR and should improve patient function and pain. The benefits the concurrent approach may have over the sequential approach is that it may improve neural mobility under the force of traction and it may reduce treatment time for the patient and the therapist. The purpose of the study is to determine if a multimodal treatment protocol that includes mechanical traction concurrent with neuromobilization techniques offers any benefit over sequential mechanical traction and neuromobilzation techniques in treating patients with CR. To address this purpose, the following null hypotheses were tested: 1. There will not be a statistically significant difference in pain, measured by the numerical rating of pain score (NPRS), at the end of treatment between participants who receive the concurrent approach when compared to participants who receive the sequential approach. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 5 2. There will not be a statistically significant difference in functional outcomes, measured by the Neck Disability Index (NDI), and cervical range of motion (ROM) at the end of treatment between the concurrent approach and the sequential approach. 3. There will not be a statistically significant difference in mean treatment time measured in minutes for patients receiving the concurrent approach compared to participants who receive the sequential approach. This study should add to the knowledge base of how patients with CR are treated conservatively. No study to date has compared a sequential multimodal approach of treatment to a concurrent multimodal approach. If found to be more effective, the sequential approach may improve outcomes in this patient population. If less treatment time is required, therapist productivity may improve and the cost of care may decrease. Literature Review Cervical radiculopathy is one of the main reasons for neck pain (Goode, Freburger, & Carey, 2010). Neck pain has a prevalence of 34% in the general population (Bovim, Schrader & Sand, 1994). It is most prevalent in females and in the fourth and fifth decades of life (Goode, Freburger, & Carey, 2010; van Hulst,van Oostrom, Ostelo, Verschuren, & Picavet, 2016). It is estimated that 14% of the general population will have their first episode of neck pain in any given year (Cote, Cassidy, Carroll, & Kristman, 2004). For those with a new onset of neck pain, 14% (Bovim, Shcrader & Sand, 1994) to 24% (Cote et al., 2004) reported recurrent or persistent neck pain lasting greater than 6 months. The prevalence of CR has been estimated at 83 cases per 100000 persons (Radhakrishnan, 1999). Defining Cervical Radiculopathy CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 6 Classic symptoms of CR include one or all of the following: neck and or shoulder pain, diminished muscle stretch reflexes, sensory loss and/or motor loss (Cleland et al., 2005; Radhakrishnan, 1999; Wainner, 2000,). Electrodiagnostic studies, namely needle electromyography (EMG) are often used in diagnosing or ruling out radiculopathies (Dillingham et al., 2001, Hakimi & Spanier, 2013). Sensitivity values range between 50-71% (Hakimi and Spanier, 2013), to nearly 98% (Dillingham et al., 2001) depending upon the number of muscles assessed. Specificity of EMG for diagnosis of radiculopathy has been recorded at 77% (Narayanaswami et al., 2016). Needle EMG has been shown to be most sensitive when symptoms were less than three months from onset (Partanen, Partanen, Oikarinen, Niemitukia, & Hernesniemi, 1991). Since Needle EMG only detects motor changes in the axonal portion of the nerve, it has not been found to be beneficial in detecting radiculopathies with a sensory component or radiculopathies from demyelination (Hakims & Spainer, 2013). In a clinical review, Kuijper et al. (2009) recommended needle EMG for ruling out radiculopathy, but could not recommend it for diagnostic value. In their review, spiral CT was considered a better option for diagnosing CR from a degenerative standpoint whereas magnetic resonance imaging (MRI) was useful in detecting disc protrusions. However, diagnostic accuracy is not known on these two imaging techniques for patients with CR (Kuijper et al., 2009). Based on the available literature, diagnostic tests can be useful screening tools but should be used in conjunction with patient interview and physical examination. The clinical diagnosis of CR has been challenging due to low diagnostic accuracy of clinical tests (Rubinstein, 2007), and only a weak relationship between imaging findings and symptoms (Lee, 2013) In a review, Wainner and Gill (2000) discussed the lack of an agreed CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 7 upon criteria to diagnose CR and although specific provocative tests have been advocated, there were few prospective studies on the efficacy of such tests. However, attempts have been made to increase the likelihood of diagnosing CR (Wainner & Gill, 2000). Wainner et al. (2003), conducted a prospective diagnostic test study on 82 patients thought to have CR or carpal tunnel syndrome based on EMG and nerve conduction studies (NCS). Patients completed a subjective history, rated their pain on a visual analog scale (VAS) and completed the neck disability index (NDI). Patients then underwent a 34 item standardized clinical examination including cervical range of motion (ROM), neurological testing and provocative special tests. Initially, eleven variables were found to have acceptable diagnostic accuracy and were entered into a regression model. Upon analysis, the authors found the best test item cluster for a diagnosis of CR was; 1) positive upper limb tension test A (ULTT A), 2) cervical rotation less than 60 degrees to the involved side, 3) positive neck distraction test, and 4) positive Spurling A test. If all four variables were present, the specificity of diagnosis was 99% with a positive likelihood ratio (+LR) estimate of 30.3. And, when three of four variables were present, the specificity of diagnosis was 94% with a +LR of 6. Of the four tests, the ULTT was the most sensitive and therefore beneficial to rule out CR while Spurling A was the most specific and therefore, beneficial for ruling in CR (Wainner et al., 2003). More recently, Ghasemi et al. (2013) assessed the clinical utility of three tests in defining CR; shoulder abduction test (SAT), Spurling test (ST) and the upper limb tension test (ULTT). Clinicians performed the three tests on 100 patients and then using electrodiagnostic test results, determined if they had CR. Further separation was performed in determining if the patient had acute or chronic CR. Diagnosis of acute or chronic was based on electrodiagnostic tests versus time from onset. Sensitivity, specificity, and positive and negative predictive values were calculated. The SAT and ST were found to be highly CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 8 specific (85%) for both acute and chronic CR, making them appropriate tools to rule in the diagnosis of CR, while the ULTT was found to be most sensitive (65%) for acute CR and appropriate to rule out a diagnosis of CR. However, for sensitivity, no test in this study was found to be of significant value for those patients diagnosed with chronic CR (Ghasemi et al., 2013). Diagnosing between cervical and shoulder dysfunctions can be difficult as arm pain is common in both conditions. Spurlings test exhibits moderate specificity which can rule in CR (Tong, Haig, & Yamakawa, 2002, Wainner et al., 2003). Another test that is used to differentiate shoulder and neck symptoms is the Arm Squeeze Test. It involves squeezing the upper third of the involved arm with moderate force. Complaints of local pain is considered a positive test for cervicobrachial symptoms. It is hypothesized that this area of the upper arm includes the musculocutaneous, radial and ulnar nerves. It has been found to have high sensitivity and specificity (Gumina, Carbone, Albino, Gurzi & Postacchini, 2013). In review of the studies above, no single gold standard test has been established to effectively diagnosis CR. A combination of clinical examination that correlates with EMG or imaging study findings appears to be most beneficial. Mechanical Traction Mechanical traction is thought to have many physiological effects including increasing diameter of neuroforaminal openings, reducing disc protrusions, stretching of spinal and ligamentous structures, and straightening of spinal curves. Other benefits include muscle inhibition, muscle relaxation and pain reduction (Bellew, 2016). Mechanical traction forces can be applied via intermittent or continuous settings. Graham, Gross, Goldsmith, and the Cervical Overview group (2006) conducted a systematic review, which investigated the effectiveness of CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 9 types of traction on pain, disability and patient satisfaction. The pool of patients included mechanical neck pain, neck pain with headache, and neck pain with arm pain. Of the studies reviewed, the authors concluded most had design flaws and the evidence overall was inconclusive. However, based on the results of the studies, for clinical consideration, intermittent cervical traction (ICT) was more effective than continuous traction in the treatment of patients with neck disorders (Graham et al., 2006). A recent meta-analysis showed support for both manual and mechanical traction for short and intermediate effects on patients pain (Romeo et al., 2018). However, in a previous study, patients treated with mechanical traction had better outcomes with regards to pain and function when compared to manual traction (Bukhari, Rehamn, Ahmad, & Naeem, 2016). It would be beneficial to be able to identify a sub group of patients with neck pain who would respond to ICT. This would have the potential to improve outcomes by matching patients to interventions and furthermore, would demonstrate the effectiveness of ICT. Raney et al. (2009) developed a clinical prediction rule (CPR) to identify patients with neck pain who would benefit from ICT and exercise. After a standardized battery of tests, 68 patients with neck pain, with or without arm symptoms, were treated with ICT and an exercise program. Using logistic regression analysis, five variables were used in the final analysis: 1) age > 55, 2) patient reported peripheralization of symptoms with lower cervical (C4-C7) mobility testing, 3) positive shoulder abduction test, 4) positive neck distraction test, and 5) positive ULTT A. If 4 out of 5 variables were present, the +LR was 23. If 3 of 5 variables were present, the +LR was 4.8 (Raney et al., 2009). This study had similarities to the Wainner et al. (2003) study looking at defining CR. Two tests, neck distraction and ULTT A were found in each study and the positive shoulder abduction test was found to have high specificity (92%) in Wainner et al. (2003), although it did not make CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 10 the final analysis. It seems apparent that patients with CR, could be part of the sub group that would benefit from ICT. Effectiveness of Intermittent Cervical Traction In a case series by Moeti and Marchetti (2001), 15 patients with cervical radiculopathy were treated using ICT. Based on patient presentation some patients also received mobilization or manipulation to the cervical spine and all patients completed some form of exercise. The majority of patients reported decreased pain and disability. Patients with symptoms less than 12 weeks had even better outcomes (Moeti & Marchetti, 2001). More recently, 27 patients with CR were randomly assigned to one of two groups; exercise only or exercise with ICT mechanical traction. After 15 treatment sessions over a three-week period, the exercise and ICT demonstrated increased grip strength and decreased pain (Aydin & Yazicioglu, 2012). Bukhari et al. (2016), randomly assigned 42 patients (36 would complete the study) with cervical radiculopathy to either receive ICT or manual traction along with segmental mobilization and exercise. Each group had 18 treatment sessions. Both groups had statistically significant improvements in pain and disability, but the ICT groups numbers were found to be more clinically meaningful (Bukhari et al., 2016). In the study by Aydin and Yazicioglu (2012), follow- up was limited. These short-term results favor ICT, but a longer follow up would be more beneficial to determine duration of improvement. Fritz et al. (2014), looked at two different types of traction compared to an exercise only group. Eighty-six patients were randomly assigned to one of three groups; exercise only, exercise and over the door traction, and exercise and supine ICT. Follow up assessments were performed at 4 weeks, 6 months and 12 months after onset of the study. Both traction groups had better results on pain and disability than the exercise only group. Findings were most significant at six months. The authors also noted the CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 11 mechanical traction group performed in supine was superior to the over the door traction device (Fritz et al., 2014). Jellad et al. (2009) randomly assigned 39 patients into one of three groups: manual traction and standard rehabilitation, ICT and standard rehabilitation and standard rehabilitation alone. Follow-up included a 6-month assessment. Both groups of traction had decreased neck and arm pain and improved function lasting to the 6 month follow up (Jellad et al., 2009). Finally, Moustafa and Diab, (2014) performed a randomized controlled trial to examine the effectiveness of two ICT positions on patients with chronic (> 3 months duration) CR. Patients with positive findings for a C6-C7 radiculopathy were randomly assigned to one of three groups; a multimodal treatment of exercise, modalities, soft tissue and thoracic manipulation only, ICT in 24 degrees of ventroflexion and the multimodal treatment and ICT in 5 degrees of extension and the multimodal treatment. Patients were seen three times a week for four weeks and were followed for up to one year. Pain and disability were assessed using the VAS and NDI respectively. Results significantly favored the ICT in 5 degrees of extension and was still present at the one-year follow up. The ventroflexion group had improved significantly after the four-week intervention but results were not significant and were similar to the multimodal alone group at 1 year (Moustafa & Diab, 2014). It appears that ICT has a favorable impact on patients with CR. However, the heterogeneity of study designs reviewed impact the ability to draw conclusions or make a consensus on recommending the intervention. A Cochrane review by Graham et al. (2011) could not find evidence to support or refute the use of mechanical traction for neck pain. However, Vetroczky and Lauber (2017), in their critically appraised topic (CAT), found evidence to support the use of intermittent mechanical traction when used in a multimodal treatment approach. In addition, a case series by Cleland et al. (2005) found 10 of 11 patients treated with a CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 12 multimodal approach of manual therapy, exercise and ICT had improved pain and function at discharge and 6-month follow-up. Although a cause and effect relationship could not be inferred with a case series, it provided support for the approach (Cleland et al., 2005). There was heterogeneity in the studies reviewed. Studies varied on the amount of time on traction. For instance, in Jellad et al. (2009), patients had ICT for two 25 minute sessions with a 10-minute rest period. Patients in the study by Fritz et al. (2014) and Moustafa and Diab (2014) had one session for 15 minutes and one session for 20 minutes respectively. Additionally, studies also varied with regards to the device used, angle of pull, and the additional treatment interventions performed (Fritz et al., 2014; Jellad et al., 2009; Moustafa & Diab., 2014). Overall, based on the studies reviewed, ICT in the supine position in either ventroflexion or 5 degrees of extension, used in conjunction with a multimodal treatment regimen was found to be effective in reducing pain and disability in patients with acute (less than 3 months duration) CR. Neuromobilization Techniques In its healthy state, nerve tissue adapts to mechanical stress including tension, compression and elongation. With injury, such as CR, adverse effects such as neural edema, hypoxia, and fibrosis may occur (Butler 2000). The primary goal of neuromobilization techniques (NMTs) is to restore the normal mechanics between the injured nerve and surrounding tissue thus reducing edema, increasing nerve gliding, and reducing nerve adherence. There are three main types of NMTs; tensioning techniques, sliding techniques and lateral glides (Efstathiou, Stefanakis, Savva, & Giakas, 2015). Tensioning techniques use a combination of movements at multiple joints to elicit nerve lengthening via lengthening of the nerve bed. The nerve bed is made up of the surrounding tissues that provide the surface area where the nerve moves. The overall effect is one of nerve lengthening. However, increased pressure and strain on CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 13 the nerve has been demonstrated with tensioning techniques (Coppieters & Butler, 2006). In contrast, sliding techniques involve a combination of movements thought to elongate a nerve at one joint while simultaneously shortening it at an adjacent joint. The benefit of the sliding technique is the avoidance of increasing neural pressure and strain while producing excursion of the nerve (Coppieters & Butler, 2008; Dilley et al., 2005). In addition to sliders and tensioners, lateral glides are techniques that produce movement at the intervertebral foramen thought to reduce mechanosensitivity of the associated nerve root (Coppieters et al., 2003; Rodriquesz-Sanz et al., 2017). Effectiveness of Neuromobilizations Techniques Nar (2014) compared the use of NMTs and conservative treatment to only conservative treatment. Fifteen patients were assigned to each group and received electrical stimulation, ICT, isometric exercise and education. The experimental group also received NMT in the form of ULTT1 or otherwise called, ULTT A. This procedure places the involved limb in scapular depression, shoulder abduction and lateral rotation, elbow supination, and wrist and finger extension. For this study, once a barrier was appreciated, the clinician provided movement at the wrist component into the barrier making this a tensioning technique. Initial treatment was for a few seconds in duration and worked up to 20-30 seconds with adjustments to the amplitude of wrist movement and duration of oscillations. Results showed significant reduction in pain in both groups. A significant difference was also found between groups; the experimental group was more effective at reducing pain. Although not formally discussed, the follow up was only short term (Nar, 2014). Ragonese (2009), randomly assigned 30 patients with neck and arm pain into one of three groups; manual therapy only, exercise only, and manual therapy and exercise. Manual interventions included lateral glides, sliding techniques and tensioning techniques. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 14 Significant differences were found between treatment groups for a reduction in pain and improved scores on the NDI. The combination group exhibited the greatest improvement. For treatment using neural glides, the author used a sliding technique initially and then changed to a tensioning technique once symptoms had improved (Ragonese, 2009). Nee et al. (2012) randomly assigned patients with neck pain into one of two groups. One group received NMTs along with manual therapy and education while a control group was advised to continue their daily activities. Patients were treated for two weeks. Improvements were noted in pain scores and NDI scores in the treatment group (Nee et al., 2012). Allison and Hall (2002) randomly assigned 30 patients with cervicobrachial pain to one of three groups; NMTs that comprised of lateral glides and scapular oscillations, articular techniques aimed at shoulder and thoracic spine mobilizations, and a control group. The control group did not receive treatment for the duration of the study. Patients were treated for 8 weeks. Both manual therapy groups had significant improvements in pain and disability while the NMT group was found to be more significant at the 8-week assessment. However, the authors noted the difference between groups was statistically significant but not necessarily clinically significant (Allison & Hall, 2002). Efstathiou et al. (2015) performed a critical review on NMTs for spinal radiculopathy. Specific to CR, the authors review demonstrated positive findings from NMTs. However, due to the heterogeneity between studies, the results remained inconclusive (Efstathiou et al., 2014). Basson et al. (2017) performed a systematic review on the effectiveness of NMTs for a variety of neuromusculoskeltal conditions. For subjects with nerve related neck pain, they found that NMTs had a positive effect on pain and disability. However, the authors noted that the studies measurement techniques were not consistent and some studies did not list the specific interventions such as, slider, tensioner or lateral glide techniques (Basson et al., 2017). CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 15 The review for NMTs effectiveness is similar to the ICT review. Study heterogeneity impacted the ability to make specific statements on the effectiveness of the treatments. However, both interventions had a positive impact on the outcome of patients with CR. Concurrent Use of Intermittent Cervical Traction and Neuromobilization Techniques. Few studies reviewed looked at the concurrent use of traction and NMTs. In a case report, Savva and Giakis (2013) used intermittent manual traction simultaneously with a sliding technique. The patient presented with a 2-month history of neck and arm pain. The patient had positive neurological findings of impaired sensation and motor weakness. In addition, the patient tested positive on all four tests of the clinical prediction rule for patients with CR as described by Wainner et al., (2003). Treatment consisted of manual cervical traction with the head in neutral while the patient received a sliding technique administered by a second clinician. Six sets of 1minute duration interventions were performed at each session. The patient was seen for 12 visits over a four-week period. At the end of the twelfth visit, the patient had almost a complete reduction in pain and was completing household activities without symptoms. Improvements were also noted on NDI scores (Savva & Giakis, 2013). Although case studies cannot be used to infer cause and effect, this study presented an alternative treatment to patients with CR. Savva et al. (2016) followed this case study with a randomized control study. Forty-two patients diagnosed with CR were randomly assigned to either receive manual traction and NMTs or serve as a control. The control group was asked to avoid treatment and to stay active. As in the previous case study, patients were treated for 12 visits using a sliding technique during manual intermittent traction. Outcomes were assessed at baseline and at the end of the four weeks of treatment. The experimental group demonstrated significant improvements in pain, grip strength, function and cervical ROM. This study demonstrated the concurrent use of traction and NMTs to CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 16 be effective. However, follow up was limited to the time of intervention making long-term benefits of the treatment uncertain (Savva et al., 2016). Kim, Chung, and Jung (2017) randomized 30 patients; 15 received NMTs concurrent with manual traction and 15 received only manual traction. Those patients who received the concurrent approach had significantly better results on pain, disability, range of motion (ROM) and deep neck flexor strength when compared to the manual traction group (Kim et al., 2017). Recently, one study compared the concurrent approach of mechanical ICT with NMTs to a group who received NMTs and a group that received ICT (Kumar et al., 2017). This was the first study noted that used mechanical traction concurrently with NMTs. Twenty patients were randomized into each group and were followed for four weeks with a total of 12 treatment interventions. At the end of four weeks, the concurrent approach group had significant improvements in pain and disability when compared to the other two groups. The inclusion criteria was limited with regards to age range (45-55 years) and based on statistical analysis, it does not appear that the concurrent approach had a better outcome compared to the NMTs group, p = .097, 95% CI [-8.35, 0.55] (Kumar et al., 2017). To date, no study has looked at using the concurrent approach of ICT with NMTs to the sequential approach of ICT and NMTs. In addition, no study has looked at the inclusion of exercise into each group. In a clinical setting, patients routinely are treated with multiple approaches and it would be of benefit to know if the concurrent approach would be more effective. With this approach, the patient may experience reduced pain during the intervention, which could improve satisfaction and possibly compliance with the treatment program. In addition, the use of mechanical traction with NMTs could be performed with one clinician and reduce patient treatment time making it more efficient. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 17 Treatment Time In a fee for service model and escalating health care costs, the need to maximize therapist productivity and efficiency is paramount (Johnson et al., 2017). Krebs, Volpe, Aisen, and Hogan (2000) discussed three ways to improve productivity while not negatively impacting quality of care; 1) develop and practice evidence based therapy, 2) lessen the burden of non-clinical practices and 3) improve the productivity of individual clinicians. The concurrent use of ICT and NMTs could provide improved productivity in each of the three ways. Evidence does support the use of a multimodal approach, which includes ICT and NMT. In Savva et al. (2016), two clinicians were used to perform the treatment of manual traction and NMTs. Using one versus two clinicians during a treatment session would allow the second clinician time to treat other clients which in theory lessens the burden and allows more clients to be seen during a given period of time. Kumar et al. (2017) was able to demonstrate that the concurrent approach was effective. However, it was not included into a multimodal approach and treatment time was not discussed (Kumaar et al., 2017). When compared to other multimodal approaches, the concurrent approach may lessen the amount of time the client is being treated. If used, the therapist may be able to see more clients in a given time period making them more productive. No studies to date have looked at the value of treatment time saved when using a concurrent treatment approach compared to other multimodal approaches. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 18 Method Study Design This was an experimental study using a pretest-posttest randomized group design in which study participants with a diagnosis of CR were treated with either the concurrent use of ICT and NMTs with exercise or a multimodal approach using sequential ICT and NMTs and exercise. The experimental group was the concurrent use of ICT and NMT while the control group was the sequential approach. The study took place from July 2018 to June 2020. Prior to participant recruitment, the study was approved by the Institutional Review Board of the University of Indianapolis. Participants A convenience sample was recruited from the clinic that the primary researcher worked. Potential participants were referred by a physicians office or self-referred with a chief complaint of neck pain with arm symptoms of pain or numbness, a score of 10 or greater on the Neck Disability Index (NDI) and a score of 2 or greater on the numeric pain rating scale (NPRS). In addition, participants must be at least 18 years of age and diagnosed with CR. This diagnosis of CR was based on the clinical prediction rule determined by Wainner et al. (2003). Patients were excluded if they presented with one or more of the following: 1) evidence of cervical myelopathy, bilateral upper extremity involvement, or medical red flags (fracture, spinal tumor, rheumatoid arthritis, osteoporosis or long-term steroid use 2) currently pregnant, 3) recent history of cervical trauma, 4) evidence of instability, 5) evidence of vascular compromise, 6) previous surgery on the cervical spine, or 7) recent cervical injection in the past six weeks. These criteria have been used in similar studies (Cleland et al., 2005, Raney et al., 2009, Young et al., 2009). No restrictions were placed on gender or ethnic composition. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 19 Sample Size. An a priori sample size estimation was conducted using G*Power, version 3.1 (Faul, Erdfelder, Lang, & Buchner, 2009). The calculation was based on using a repeated measures ANOVA, within-between interaction test with two groups and two measurements and the following parameters, two-tailed test, alpha of .05, power of .80, and a small effect size of 0.15. From the calculation it was estimated that a minimum of 90 participants were needed for this study to be appropriately powered. Because this study was a student doctoral project the primary researcher did not have the time or resources to obtain a sample of that size in a reasonable and acceptable time period. Therefore, this study was underpowered. However, similar studies have used smaller sample sizes ranging from 27-60 (Jellad et al., 2009; Khatwani, Yadav, & Kalra, 2015; Kim, Chung, & Jung, 2017; Kumar et al., 2017; Lamba, Rani, Gauer, Upadhyay, & Bisht, 2012; Savva et al., 2016,). Based on the clinical population, it was estimated that a maximum sample size of 50 (25 in each group) would be recruited. To date, no study to date has looked at comparing the sequential approach and concurrent approach in the context of a multimodal treatment intervention; therefore, even an underpowered study should add significant information to the base of knowledge. Data Collection Data was collected from the initial visit (pre-treatment) and at the final visit after the last intervention (post-treatment). The primary researcher was responsible for all data collection. Each participant was assigned a unique study identification number and no participant identifiers were recorded in the Excel file. Data collected for both pre-treatment and post-treatment was extracted from the participants medical record and entered into the Excel spreadsheet as soon as possible after the initial evaluation and as soon as possible after the last treatment session. Data that was collected pre-treatment include the following demographics: age, gender, weight CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 20 (pounds), and duration of symptoms (less than 3 months duration or greater than 3 months duration). The following outcome data was be collected both pre-treatment and post-treatment: cervical ROM (flexion, extension, lateral flexion and rotation), Neck Disability Index (NDI) score, and numeric pain rating scale (NPRS) score. Results of the special testing of the clinical prediction rule (cervical ROM < 60, Spurling test, ULNTT A, and neck distraction test) was collected at the initial evaluation. Post-treatment the treatment time was also collected. Operationalization of variables. Pain was operationalized by scores on the NPRS. Patient function was operationalized by scores on the NDI and measurements of cervical ROM. Treatment time was defined by the average number of minutes the participant spends in the therapy (total number of minutes divided by number of sessions). A timer was started when a patient began their specific treatment session. The timer remained on until the therapist had ended the session. The timer could have been turned off during a session at the therapists discretion. Examples may include instances when the patient needed to stop and take a phone call or use the restroom. The timer was restarted once treatment resumed. The timers used for this study are common in clinics and are run on AAA batteries. Instruments and Equipment Neck Disability Index. The NDI is a 10 item self-reported measure that includes seven items related to activities of daily living, two items related to pain, and one item related to concentration. Maximum score is 50, but the result is typically expressed as a percentage (0100%) with higher scores indicating greater disability. For patients with neck pain, the NDI has been shown to have moderate test-retest reliability, ICC = .68; 95% CI [0.30, 0.90] and both minimal detectable change (MDC) and minimal clinically important difference (MCID) have been established, 10.2 and 7.0, respectively (Cleland et al., 2006). CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 21 Numeric pain rating scale. The NPRS is a self-reported pain questionnaire that uses an 11point scale (0 meaning no pain, and 10 worst pain imaginable). For patients with CR, it has been shown to have fair test-retest reliability, ICC = .59; 95% CI [0.14, 0.79] and a MDC of 4.0 and MCID of 2.2 have been established (Young, Cleland, Michener, & Brown, 2010). Inclinometer and goniometer. A bubble inclinometer was used to collect cervical flexion and lateral flexion and a standard goniometer was used to collect cervical rotation. Interrater and intrarater reliability of a single inclinometer has been found to be good (ICC = .84 - .94 for flexion/extension and ICC = .82 - .92 for lateral flexion (Hole, Cook & Bolton, 1995). For cervical rotation, the standard goniometer has strong intrarater reliability (ICC = .78 to .92), however, it was noted that its interrater reliability is poor (Youdas, Carey, Garrett, & Riddle, 1991). Procedures Screening examination. Patients who report to the clinic having neck pain and or arm symptoms were given a standard evaluation by the primary researcher as part of the patients initial evaluation. This examination is part of standard care at the clinic and no part of it was being done for research purposes only. During the evaluation, special tests were performed that determined a diagnosis of CR. The diagnosis was based on the following clinical presentation: patients who test positive in at least 3 of 4 criteria based upon the clinical prediction rule determined by Wainner et al. (2003). The tests are: 1) Spurling test A, 2) neck distraction test, 3) upper limb tension test A, and 4) cervical ROM. For Spurling Test A, the patient was seated with the therapist behind the patient. The neck was passively flexed toward the symptomatic side and the therapist provided a downward force of approximately 7 kg through the patients head. A positive test was reproduction of the patients symptoms. The neck distraction test; with the CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 22 patient supine, the therapist grasped the head and occiput and provided a distraction force of approximately 14 kg. A positive test was a reduction in the patients symptoms. For the Upper Limb Tension Test A, the patient was positioned supine and the examiner placed the patients upper extremity into (1) scapular depression, (2) shoulder abduction, (3) forearm supination, wrist and finger extension, (4) shoulder external rotation, (5) elbow extension, and (6) contralateral then ipsilateral cervical lateral flexion. A positive test included any of the following: symptom reproduction, greater than 10-degree difference in elbow extension when compared to the contralateral extremity, and an increase in symptoms with contralateral cervical side-bending or a reduction in symptoms with ipsilateral cervical side-bending. Finally, for cervical rotation measurement, the patient, in a seated position, was asked to rotate their head as far as they can. Using a standard goniometer, the researcher, with the goniometer above the patients head, measured the motion. Rotation right and left was measured. A positive test was cervical rotation less than 60 degrees on the symptomatic side. This rule has been used in other studies in this patient population (Cleland et al., 2005; Moustafa & Diab, 2014; Savva et al., 2016). Recruitment. Patients who met the inclusion criteria for the study were recruited by the primary researcher at the clinic he practices. Potential patients were those who presented to the clinic with a diagnosis of neck and or arm pain. Eligibility was determined after the initial examination and the patient was found to be positive on at least 3 of 4 special tests used for the inclusion criteria. After the examination the primary researcher verbally discussed the study with the patient. Informed consent. Individuals who meet eligibility criteria were asked to join the study. Willing participants were required to sign an informed consent. The primary researcher reviewed CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 23 the studys purpose, possible benefits and adverse reactions and what treatments the participant would receive and the anticipated number of treatment visits to expect. Patients were informed the treatments used in the study were considered the standard of care for this patient population and the time frame was be the same or very similar if they declined to be in the study but wanted to continue physical therapy. Patients were made aware the only difference between the sample groups was be if they receive a concurrent intervention of ICT and NMTs. Patients could elect to be in the study at that time and the interventions could begin the same day. However, patients were given until their next scheduled visit to make their decision. Involvement in the study did not require any extra time except for the informed consent (estimated to take 15 minutes) portion. Group assignment. Using Excel, a random number generator program with numbers 1 through 50 and with two groups (group 1 and group 2) was performed. 50 opaque envelopes, each with a unique study identification number and group assignment was produced. The primary researcher kept a log book by the envelopes. The logbook and envelopes were placed in a secure area with limited access. As participants were recruited, they opened up an envelope. The participants name assigned study identification number and group assignment was entered into the log book. At the end of each day, the envelopes and log book were stored in the primary researchers private office in a locked drawer in which only the primary researcher had a key. Data management. Participant information was entered into an Excel spreadsheet on a password protected laptop. Participant privacy was protected by using randomly generated numbers that were their study identification throughout the study. Intervention. Participants assigned to the control group received the sequential approach which included exercise, manual therapy, and ICT. The experimental group received the CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 24 concurrent approach which included exercise, manual therapy, and concurrent upper extremity NMTs and ICT. Treatments received by participants in both groups were considered standard care with the main difference being changed for research purposes was the order of the treatment received by the experimental group. Participants in both groups were to be seen two times a week for four weeks. The total of number of visits varied based on response to treatment. The therapist for each participant was the primary researcher. The primary researcher had over 24 years of experience in physical therapy, had completed an orthopedic residency, and has board certification in orthopaedic physical therapy. Control (sequential) group. Each control group participant received an active exercise program, thoracic spine manipulations, NMTs to the cervical spine in the form of lateral glides with the arm in median nerve bias, NMTs to the upper extremity using ULNTT A, and ICT. Exercises were focused on cervical deep neck flexors, middle and lower trapezius, and serratus anterior muscles. For cervical deep neck flexor strengthening, patients were supine and performed craniocerivcal flexion. The therapist provided supervision and cueing to ensure the patient was not eliciting muscle contraction of the sternocleidomastoid muscle. The goal of the exercise was to hold a contraction for 10 seconds and repeat 10 times. For middle and lower trapezius strengthening the patient was prone with the arm in 90 degrees of abduction for the middle trapezius and in 120 degrees for the lower trapezius. With the arm in external rotation the patient raised the arm off the table and slowly returned. The goal was two sets of 10 and progression included the use of weights at the therapist discretion. The final exercise was wall push-ups. The patient stood facing a wall with the arms at shoulder height on the wall. The patient was be asked to perform a push up plus by leaning toward the wall and then pushing away until elbows were fully extended and scapula were protracted. Initial goal was two sets of CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 25 10. These exercises were to become the patients home exercise program. Patients were asked to perform 1 time a day. In addition, the patient was instructed on cervical rotation to each side. In sitting, the patient placed a fist, thumb side up, in their sternal notch. With their chin resting on their thumb, they were asked to slowly turn their head side to side for 10 repetitions. They were instructed to do this two-times per day. The goal was for each patient were to complete all the exercises. The treating therapist used his discretion on when to implement and progress each exercise. These exercises have been used in other similar studies (Cleland, Childs, & Whitman, 2008, Ragonese , 2009, Young, Cleland, Michener, & Brown, 2010). After the exercise program, each participant received thoracic manipulations to the upper and mid thoracic spine. The technique has been described elsewhere (Cleland et al, 2005). These interventions were designed to address hypomobile motion segments of the thoracic spine. Based on examination findings, the therapist chose which specific segments were to be addressed. After each thrust technique, if an audible cavitation was not heard, the therapist could elect to perform it for a second time. For the upper thoracic manipulation, the patient had their arms clasped around their neck with the elbows close together in front. The therapist partially rolled the patient on their side and placed his manipulative hand over inferior vertebra of the motion segment to be addressed. The patient was then rolled back to supine. The therapist, using his upper body positioned over the patients arms, provide and high velocity, low-amplitude thrust. For the mid thoracic manipulation, the patient placed their hands across their chest. Using the similar technique through the patients elbow, the therapist provided a high velocity low amplitude thrust. For the mid thoracic spine, in order to localize the motion segment, the patient may be asked to flex their head off the table. Once the segment was stabilized, the therapist would support the head with their non-manipulative hand (Cleland et al., 2005). If the patient could not CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 26 tolerate the positioning or reported increased pain during the intervention, the therapist could elect to forgo this intervention for that session. It was the goal that each patient underwent these manipulations at each treatment session. After thoracic manipulations, the patient received NMTs to the cervical spine using lateral glides. This technique has been described elsewhere (Cleland et al., 2005). The patient was positioned supine with the therapist at their head. For this technique, the mobilizing hand was on the symptomatic side. The therapist first placed the symptomatic side arm in the position of median nerve bias; arm abducted, shoulder external rotation and wrist and fingers in extension. The specific position was varied based on the patients tolerance and avoidance of painful stimuli. Grasping and supporting the head of the patient with their non-mobilizing hand, the therapist then placed their mobilizing hand on the motion segment to be targeted and provided oscillatory translational glides away from the painful side (for example, if the right side was considered the involved side, the therapist placed their mobilizing hand on the right side of the neck). The goal was a grade IV mobilization up to 30 seconds at each targeted segment. The therapist performed 4-6 repetitions at each segment. (Cleland et al., 2005). The techniques purpose was to open the facet joint on the involved side (Vincenzio, Neal, Collins & Wrigth, 1999). This technique has been used in multiple studies with similar patient populations (Cleland et al., 2008, Ragonese, 2009) Next, the patient received upper extremity NMTs in the form of median nerve glides (Cleland et al., 2005). For median nerve mobilization the patient was supine while the therapist sequentially placed the arm to be treated in scapular depression, shoulder abduction, full external rotation, elbow flexion and wrist and hand extension. The initial treatment was a slider technique. As the therapist extended the arm, he moved the patients hand and fingers into less CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 27 extension. This technique has been shown to increase nerve bed motion but not increase strain on the nerve root (Coppieters & Butler, 2008; Dilley et al., 2005). The movements were slow and lasted for approximately 30 to 60 seconds. As the patient tolerated the motion without pain, the therapist changed to a tensioner technique which maintained the hand and fingers in full extension while the patients elbow was slowly extended. This progression of neuromobilization has been shown to be effective in the treatment of patients with CR (Cleland, Childs, & Whitman, 2008; Efstathiou et al., 2015; Ragonese, 2009). The final intervention the patient received was supine ICT. Each patient received ICT for 15 minutes. The machine was inworking order and had been calibrated on a yearly basis. For the initial session, the patients head was positioned in 25 degrees of flexion. The initial setting was 15 pounds and could be incrementally progressed each session to patients tolerance. The focus was on reduction of symptoms in the arm and or neck. The on off cycle time was set for 40 seconds on and 10 seconds off. Minor adjustments to neck angle were made based on patients preference. Studies have supported ICT for this patient population but the amount of pull, angle of pull and time on machine varied (Cleland et al., 2008; Fritz et al., 2014; Moeti & Marchetti, 2001; Moustafa & Diab, 2014). Therefore, the final adjustments were left to the therapists discretion on patient tolerance and impact on symptoms. Experimental (concurrent) group. The experimental group included the same exercises, thoracic manipulations, and cervical lateral glides. They were performed in the same order. The only difference was the experimental group had the concurrent use of upper extremity NMTS with ICT. After cervical lateral glide interventions, the participant was started on ICT as described in the control group section. During the pull cycle of ICT, the therapist performed the upper extremity NMTs described earlier in the control group section. The patient received CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 28 approximately 30 seconds of treatment during the on cycle with a 10 to 20 second rest period. The therapist performed up to 8 cycles during the ICT. As in the control group, the initial treatment consisted of sliding techniques. As patients tolerance improved, the treatment was progressed to a tensioning technique. A similar intervention has been done previously in the literature (Kumar et al., 2017). Data Analysis Descriptive statistics were conducted on the total sample and between and within groups. Nominal data are reported as frequencies and percentages. Nominal data were compared using Fishers exact tests. Interval and ratio data are reported as means and standard deviations. Interval and ratio data comparisons between groups were analyzed using independent t tests. Paired t tests were used to compare interval and ratio data within the concurrent approach group and within the sequential approach group. Effect sizes (ES) were calculated and interpreted based on recommendations by Cohen (1988) with an effect size 0 - .20 = small, .50 = medium; .80 and higher = large. That means an ES less than .20 is considered negligible. Data were analyzed using IBM SPSS Statistics for Windows, Version 24.0 (IBM Corp., Armonk, NY). Significance level of less than .05 was considered statistically significant. Results Fourteen participants; six in the concurrent group and eight in the sequential group were originally enrolled in the study. Two participants in the sequential group did not complete the study, citing work obligations and difficulty being compliant with therapy sessions so their results were not included in the final analysis. Therefore, the final sample size was 12. Seven (58.3%) males and 5 (41.7%) females participated in the study. The mean (standard deviation) age of participants was 60.67 (13.02) years, time from injury was 158.08 (218.57) days, and CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 29 number of visits per participant was 7.92 (2.78). The mean weight of participants was 200.75 (50.74) pounds and height was 66.58 (3.63) inches. Demographic and outcome descriptive statistics for each study participant is presented in Table 1. Group Comparisons Participant characteristics between groups. Independent t tests were conducted to determine if there were statistically significant differences in gender, age, weight, height, time since injury, and number of visits between the concurrent and sequential groups. There was not a statistically significant difference in sex between the concurrent and sequential group (males: 42.9%, 57.1%, respectively; p = 1.000). There was not a statistically significant difference between the concurrent group and the sequential group for age, t(10) = 1.02, p = .331, weight t(10) = -0.41, p = .690, height t(10) = -0.23, p = .824, time since injury t(10) = -1.55, p = .177, or number visits t(10) = -1.41, p = .189. Details of the results can be found in Table 2. Outcomes between groups. The mean time per visit, pre-intervention and postintervention NDI scores, and pre-intervention and post-intervention NRPS scores were compared between the concurrent and sequential groups using independent t tests. There was a statistically significant difference in the mean treatment time per visit between the concurrent and sequential groups, t(10) = 3.95, p = .007. However, there was not a statistically significant difference in NDI scores pre-intervention and post-intervention between the groups, t(10) = 1.13 p = .283, ES = 0.66; t(10) = 0.62, p = .547, ES = 0.40; respectively or pre-intervention and post-intervention for NPRS scores, t(10) = 0.69, p = .508, ES = 0.36; t(10) = 0.91, p = .384, ES = 0.53; respectively. Details of all comparisons and ES are found in Table 3. Outcomes within groups. NDI and NPRS scores along with cervical ROM measurements were compared within the concurrent group and within the sequential group using CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 30 paired t tests. There were statistically significant differences in NDI scores and NPRS scores over time for the concurrent group, t(5) = 3.94, p = .011, ES = 1.61; t(5) = 4.11, p = .009, ES = 1.68; respectively. The mean difference for NDI scores was 21.00 and the ES indicated a large effect of the intervention. This was greater than the MDC and MCID (10.2 and 7.0, respectively) making the improvement in function both statistically and clinically significant. The mean difference for the NPRS scores was 4.34 which is was greater than the MDC and MCID (4.0 and 2.2, respectively) making the improvements in pain clinically significant in addition to being statistically significant. With regards to cervical ROM, there were statistically significant differences from pre-intervention to post-intervention in the concurrent group for flexion, right lateral flexion and right rotation, t(5) = 2.98, p = .031; t(5), = 4.03, p = .010; t(5) = 3.43, p = .019; respectively. The ES ranged from 1.22 to 1.65 indicating a large effect for the intervention. The sequential group also had statistically significant change from pre-intervention to postintervention for NDI and NPRS scores, t(5) = 2.68, p = .044, ES = 1.10; t(5) = 5.11, p = .004, ES = 2.09 respectively. With mean differences in NDI scores of 17 and NPRS scores of 4.83, results were both clinically and statistically significant and the ES indicated a large effect of the intervention for the sequential group as well. The sequential group had statistically significant difference from pre-intervention to post-intervention ROM for only right rotation, t(5) = 3.58, p = .016, ES = 1.46. Details of the comparisons and ES are found in Table 4. Discussion The purpose of this study was to determine if the use of concurrent ICT and NMTs would be more effective in reducing pain and improving function based on NDI scores compared to the sequential use of ICT and NMTs when performed in a multimodal approach to patients with CR. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 31 An additional purpose of this study was to determine if there was a significant difference in treatment time between the two treatment approaches. Traction and more specifically ICT, has been shown to be effective in the treatment of patients with CR (Aydin &Yazicioglu 2012; Fritz et al, 2014; Moetti & Marchetti 2001). Along with other physiological effects, mechanical traction is thought to increase the diameter of neuroforaminal openings (Bellew et al., 2013). NMTs through joint positioning, specific maneuvers performed at the neck, or maneuvers performed to the involved upper extremity, are thought to restore normal mechanics between the involved nerve complex (nerve root and portion of the nerve involved) and surrounding tissue (Efstathiou, Stefanakis, Savva, & Giakas, 2015) causing a reduction in edema and improvement in nerve gliding. NMTs have been shown to reduce pain and improve function in patients with CR (Allison &Hall 2002; Nar 2014; Nee et al., 2012; Ragonese, 2009). It may be expected then, that when used concurrently, cervical traction would prepare the impaired cervical nerve root for mobility by increasing the diameter of the lateral foramen allowing the affected nerve root more space when NMTs are implemented. With this combined treatment, patients may have significant improvement in pain and disability. The current study results are in accordance with previous studies on the use of concurrent traction and NMTs (Khatwani, Yadav, & Kalra, 2015; Kim, Chung, & Jung, 2017; Kumar et al., 2017; Savva et al., 2016,). The overall treatment effect of the concurrent approach was not significantly different than the sequential treatment approach in cervical traction and neural mobilizations in patients with CR. However, results of this randomized control trial indicated the concurrent approach required less treatment time per visit compared to the sequential approach. Patients treated with a concurrent approach had significant reduction in pain and disability compared to other treatment interventions (Khatwani et al., 2015, Kim et al., 2017, CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 32 Kumar et al., 2017) or a control group (Savva et al., 2016). The NDI and NPRS were used in each of the studies making it easier to compare. However, a significant difference between the current study and the studies by Khatwani et al. (2015), Kim et al. (2017), and Savva et al. (2016) was the type of traction. In the three studies mentioned, manual traction was used with NMTs. The studies using manual traction with NMTs required two treating clinicians. In addition, manual traction was not able to precisely control for specific traction weight, angle of the pull, or on off cycle which are present in the use of ICT. Therefore, it was difficult to compare the current studys outcomes with those that used manual traction. The integration of using ICT with NMTs was a new intervention technique only seen in the study by Kumar et al. (2017). The current study closely resembles the study by Kumar et al. (2017) in that the researchers compared patients who underwent concurrent ICT and NMTs to another treatment group or groups. Also, Kumar et al. (2017) found that after 4 weeks and 12 treatment sessions, the group receiving concurrent ICT and NMTs had statistically significantly differences over the traction only group and NMTs group in pain and disability. Similarly, results from the current study found that the concurrent group had statistically significant decreased pain and disability. In addition to being statistically significant, the concurrent groups differences in pain and disability were clinically relevant and had large effect sizes (ES = 1.61, NDI; ES = 1.68, NPRS). The impact of the concurrent intervention provides clinical significance as well as statistical significance. As reported by Kumar et al. (2017), NDI scores for the experimental group had a 59.7% improvement (49.40 pretreatment to 19.90 posttreatment) and the current study had a 66% improvement in NDI scores (32.67 pretreatment to 11.00 posttreatment). For NPRS scores, Kumar et al. (2017) found a 71% improvement in scores (6.14 pretreatment to 1.76 posttreatment), whereas the current study had a 61% improvement in scores (7.17 CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 33 pretreatment to 2.83 posttreatment). Both the current study one and the one by Kumar et al. (2017) support the use of a concurrent approach in the treatment of patients with CR to reduce pain and improve function. While there are similarities between this study and the Kumar et al. (2017) study, there are also differences. One distinction is that the average age for the experimental groups differed by 14 years, current study 64.5 years, Kumar et al. study 50.5 years. A mostly likely reason for the difference in age is that the current study included individuals 18 years and greater while Kumar et al., (2017) included patients only between the ages of 45 to 55 years. Although the fourth and fifth decade of life is the most common age range for the diagnosis of CR (Goode, Freburger, & Carey, 2010; van Hulst,van Oostrom, Ostelo, Verschuren, & Picavet, 2016), researchers of the current study thought it was important to expand the age range as it more closely represents patients treated in an outpatient clinical setting. Results of the current study found significant improvement in pain and disability of patients which adds to the findings from Kumar et al. (2017). With no negative effects reported in the older study participants for either study, it may allay therapist concerns on the safety and tolerance of using these treatment techniques in this population. A second difference between Kumar et al.s (2017) study and this study is the treatment parameters used. Researchers have reported employing different parameters in their studies supporting ICT (Fritz et al., 2014; Jellad et al., 2009; Moustafa & Diab, 2014). Kumar et al. (2017) used a 15-degree angle of pull, an on/off cycle of 60:30sec, with a treatment time of 9 minutes. The current study used a 25-degree angle of pull, an on/off cycle of 40:10sec, and a 15minute treatment time. Both studies showed significant improvement in outcomes regardless of some of the parameters used, suggesting that treating clinicians may have options when CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 34 determining how to use ICT. The current study found that one optional parameter that seems to not negatively affect patient outcomes is the positioning patients for their comfort. It is also possible that increasing patient comfort may result in improved patient satisfaction. With regards to the parameters of NMTs techniques, both studies started with sliding techniques and progressed to tensioning techniques to patient tolerance. A third important difference between the two studies was the treatment provided to the groups not receiving the concurrent approach. For the current study, participants performed exercises and the treating clinician performed manual therapy to the cervical spine in the form of lateral glides and the thoracic spine in the form of manipulations. In contrast, Kumar et al. (2017) limited their participants to one specific parameter for the duration of the study; ICT group and an NMTs group. This makes comparisons difficult as, for the current study, there was an expectation of improvement in the control group. The concurrent group in the current study was able to demonstrate significant improvement in less treatment sessions when compared to the Kumar et al, (2017). The average number of visits in the concurrent group was 6.83 (range 3 to 10 visits). Kumar et al. (2017) had patients attend 12 visits. Patients in the concurrent group of the current study used 43% less visits per patient when compared to Kumar et al, (2017). This finding was also lower when compared to the sequential group in the current study (6.83 visits concurrent and 9.00 visits for the sequential group). Patients showing significant improvements in pain and disability in less time than other interventions may make the current study interventions valuable in the clinic setting. One benefit to participants in the current study was the addition of exercise and manual therapy. These additions may have increased the response and decreased the number of visits required. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 35 As reported, the current study was unable to detect a significant difference in pain and disability between the concurrent and sequential group. The sequential group, acting as the control group in the current study, was provided treatment interventions shown by several researchers to be effective in the treatment of patients with CR (Boyles, Toy, Mellon, Hayes, & Hammer, 2011; Cleland et al., 2005). The sequential group received the same interventions that the concurrent group. The multimodal approach used in the current study may be one reason that both groups significantly improved. A clinical impact based on ES for some variables could be argued. For the NDI, the pre-intervention scores were not significant (p = .283; ES = 0.66 [medium]). Post-intervention between group differences for the NDI was also not significant (p = .547; ES = 0.36 [small]). However, the ES change from medium to small indicates that the gap between the two groups closed with the concurrent group having a greater change in score (21point change for concurrent and 17 point change for sequential). A similar change was noted for a possible clinical relevance with regards to lateral rotation to the right and left. Pre-intervention ES for lateral rotation right and left were 0.93 (large) and 0.30 (small) respectively. Postintervention there was a decrease in ES from 0.93 to 0.66 (medium) for right lateral and from 0.30 to 0.10 (negligible) for left lateral rotation. These decreases in ES indicate that the concurrent groups participants had a greater increase in ROM compared to the sequential group. The concurrent group had multiple motions with improvement whereas the sequential group had one. One explanation for the multiple motions of improvement in the concurrent group compared to only one motion in the sequential group could be that the concurrent approach, using improvements in neuroforaminal opening simultaneous with NMTs to reduce pressure on the exiting nerve root, was more effective at reducing pain making it easier for the patient to move the neck. Studies looking at ROM as an outcome reported similar ROM improvements (Kim et CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 36 al., 2017; Savva et al., 2016). Savva et al. (2016) documented rotation and lateral flexion to the painful (ipsilateral) and non-painful (contralateral) sides. The current study used right and left labels without consideration of which was the involved side. One of the unique findings in the current study is the significant difference in time found between groups. The concurrent approach used less time per visit (41.83 minutes concurrent group to 49.17 minutes sequential group) which may be an aspect that makes it more desirable in the clinical setting. No previous studies in the published literature that were reviewed included treatment time as a parameter. Due to this, it is difficult to discuss what would be the amount of difference in time that would be considered a clinically significant difference. With so few participants in the current study, there are limitations to generalizing study results. However, there is a benefit to being able to describe specific differences between participants. For example, in the concurrent group, patients 3 and 5 had significant decreases in NDI scores (32 to 0 for patient 3 and 26 to 0 for patient 5), and NPRS scores (3 to 1 for patient 3 and 7 to 0 for patient 5) scores. Patient 3 and 5 also had the shortest time from injury (26 days for patient 3 and 14 days for patient 5) to the start of physical therapy interventions. This could indicate the benefits of initiating physical therapy soon after the onset of symptoms to achieve the greatest benefit. Horn, Brennan, George, Harman, and Bishop (2016) found patients with neck pain who received early physical therapy (within 4 weeks of onset) had better outcomes in NDI scores and NPRS scores compared to those having a delay in physical therapy. In contrast, patient 4 of the concurrent group had the longest time from injury (180 days). Patient 4 reported chronic neck issues, but had a recent exacerbation of symptoms which included pain in the right shoulder and scapular region. In addition, patient 4 was the only patient who tested negative on the distraction test in the concurrent group. Perhaps, a negative distraction test, may indicate a CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 37 lesser response to ICT. At time of discharge, patient 4 continued to report mild symptoms in his right upper extremity. Individuals in their 40s and 50s are considered the most at-risk age group for the onset of CR (Goode et al., 2010). Patients 1 and 5 were the youngest patients in the experimental group (42 and 57 years of age). They both had excellent outcomes including 0 out of 10 pain reported on the NPRS. Patient 6 was 71 years of age and showed least improvement in the concurrent group with regards to change in both NDI scores (no change) and NPRS scores (2-point change). Patient 6 reported having a prior injury to his upper back which resulted in chronic issues. Perhaps the impact of upper thoracic issues impacted the benefits of thoracic manipulation. After 4 visits, patient 6 requested to follow-up with his physician and was sent for further testing and imaging. Limitations A limitation to the current study is the small sample size, which increased that chances of making a type II error. Post hoc power calculations showed that none of the non-significant outcomes measured post-intervention were sufficiently powered with the highest power of 0.36 found for cervical ROM left rotation and the lowest power of 0.05 for cervical ROM left lateral rotation. For the primary outcomes of NDI and NPRS scores, post hoc power calculations were 0.09 and 0.13 respectively (Faul, Erdfelder, Buchner, & Lang, 2009). Not having been sufficiently powered, it is difficult to recommend the concurrent approach over the sequential approach. One advantage of the study was that participants were randomized in which treatment group they received. In addition, the treatment techniques are standardized and shown to be effective in the treatment of patients with CR. One drawback was the treating clinician and evaluating clinician were the same. Bias could have been a factor in testing procedures for CR. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 38 However, keeping to one clinician did improve internal validity Future studies should look to compare the concurrent approach to the sequential approach in an appropriately powered setting to determine if it is more effective than the sequential approach. Nevertheless, this study does add to the limited information currently known about the concurrent approach. In addition, the current studys novel analysis on treatment time difference may lead to future studies to report on benefits of reduced treatment time and its impact on therapist productivity or possible health care savings for the patient. Conclusion Although no significant differences were found in the current study on outcomes between group settings, within group differences in the concurrent approach exhibited statistically and clinically meaningful differences in pain and disability. In addition, the current study most closely resembled a clinical setting. Practitioners may look to these results more favorably and have more confidence on the effectiveness of the interventions. The results found is this study suggest that the concurrent approach may be an effective intervention in the treatment of patients with CR. CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 39 References Albayrak Aydin, N., & YazicioLu, K. (2012). Cervical intermittent traction: Does it really work in cervical radiculopathy due to herniated disc? Turkish Journal of Physical Medicine & Rehabilitation, 58(4), 277-282. doi:10.4274/tftr.44712 Allison, G. T., Nagy, B. M., & Hall, T. (2002). 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A critically appraised topic. International Journal of Athletic Therapy & Training, 22(3), 18-25. doi:10.1123/ijatt.2016-0071 Vicenzino, B., Neal, R., Collins, D., & Wright, A. (1999). The displacement, velocity and frequency profile of the frontal plane motion produced by the cervical lateral glide treatment technique. Clinical Biomechanics, 14(8), 515-521. Wainner, R. S., Fritz, J. M., Irrgang, J. J., Boninger, M. L., Delitto, A., & Allison, S. (2003). Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine, 28(1), 52-62. doi:10.1097/01.BRS.0000038873.01855.50 Wainner, R. S., & Gill, H. (2000). Diagnosis and nonoperative management of cervical radiculopathy. Journal of Orthopaedic and Sports Physical Therapy, 30(12), 728-744. doi:10.2519/jospt.2000.30.12.728 CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY Young, I. A., Michener, L. A., Cleland, J. A., Aguilera, A. J., & Snyder, A. R. (2009). Manual therapy, exercise, and traction for patients with cervical radiculopathy: A randomized clinical trial. Physical Therapy, 89(7), 632-642. doi:10.2522/ptj.20080283 Young, I. A., Cleland, J. A., Michener, L. A., & Brown, C. (2010). Reliability, construct validity, and responsiveness of the neck disability index, patient-specific functional scale, and numeric pain rating scale in patients with cervical radiculopathy. American Journal of Physical Medicine & Rehabilitation, 89(10), 831-839. doi:10.1097/PHM.0b013e3181ec98e6 47 CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 48 Table 1 Demographics and Pre-Intervention and Post Intervention Outcomes by Study Participants Study Age Participant (years) Sex Days from Pre Post Pre Post Number Injury NDI NDI NPRS NPRS of visits Concurrent 1 42 Female 60 46 8 8 0 8 2 73 Female 60 40 24 8 5 10 3 71 Female 26 32 0 3 1 8 4 73 Male 180 32 14 7 3 8 5 57 Male 14 26 0 7 0 3 6 71 Male 56 20 20 10 8 4 Sequential 1 51 Female 720 30 16 6 4 7 2 42 Male 28 14 0 4 0 5 3 42 Female 364 16 10 8 3 11 4 70 Male 21 16 8 5 1 9 5 68 Male 8 50 2 9 0 12 6 68 Male 360 24 12 6 1 10 Note. Pre = pre-intervention; post = post-intervention; NDI =neck disability index; NPRS = numeric pain rating scale CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 49 Table 2 Comparison of Descriptive Statistics Between Concurrent and Sequential Groups Concurrent Group Sequential Group n=6 n=6 M (SD) M (SD) p Age (years) 64.50 (12.58) 56.83 (13.40) .331 Weight (pounds) 194.50 (42.32) 207.00 (61.48) .690 Height (inches) 66.33 (3.62) 66.83 (3.97) .824 Time since injury (days) 66.00 (59.11) 250.17 (285.06) .177 Number of visits 6.83 (2.71) 9.00 (2.61) .189 Treatment time per visit (minutes) 41.83 (1.47) 49.17 (4.31) .007 Running head: CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 50 Table 3 Comparison of Outcomes Between Concurrent and Sequential Groups Treatment time Concurrent Group (n = 6) Sequential Group (n = 6) M (SD) M (SD) p Effect Size 41.83 (1.47) 49.17 (4.31) .007 2.28 (large) Pre-Intervention NDI score 32.67 (9.35) 25.00 (13.67) .283 0.66 (medium) NPRS score 7.17 (2.32) 6.33 (1.86) .508 0.40 (small) Flexion 47.17 (17) 49.00 (10.70) .574 0.34 (small) Extension 42.50 (15.41) 46.17 (13.32) .669 0.26 (small) Right lateral 24.83 (10.98) 33.33 (6.80) .138 0.93 (large) Left lateral 28.83 (6.91) 30.83 (6.46) .616 0.30 (small) Right rotation 49.00 (11.83) 57.50 (20) .367 0.55 (medium) Left rotation 49.00 (6.00) 52.83 (14.22) .556 0.35 (small) Post-Intervention NDI score 11.00 (10.10) 8.00 (6.07) .547 0.36 (small) NPRS score 2.83 (3.19) 1.50 (1.64) .384 0.53 (medium) Flexion 55.17 (7.65) 56.83 (7.31) .708 0.22 (small) Extension 48.33 (9.91) 51.17 (14.41) .700 0.23 (small) Right lateral 32.83 (9.17) 38.83 (9.04) .280 0.66 (medium) Left lateral 35.00 (6.69) 34.33 (6.41) .864 0.10 (negligible) Right rotation 56.17 (9.24) 65.17 (8.84) .115 1.00 (large) Left rotation 53.83 (9.07) 63.00 (8.94) .108 1.02 (large) Note. NDI = neck disability index, NPRS = numeric pain rating scale, Treatment time = minutes Running head: CONCURRENT TREATMENT FOR CERVICAL RADICULOPATHY 51 Table 4 Comparison of Outcomes Within the Concurrent Group and Within the Sequential Group Pre-Intervention (n = 6) Post-Intervention (n = 6) M (SD) M (SD) p Effect Size Concurrent Group NDI score 32.00 (9.35) 11.00 (10.10) .011 1.61 (large) NPRS score 7.17 (2.32) 2.83 (3.12) .009 1.68 (large) Flexion 45.17 (12.09) 55.17 (7.65) .031 1.22 (large) Extension 42.50 (15.41) 48.33 (9.91) .134 0.73 (large) Right lateral 24.83 (10.98) 32.83 (9.17) .010 1.65 (large) Left lateral 28.83 (6.91) 35.00 (6.69) .051 1.04 (large) Right rotation 49.00 (11.83) 56.17 (9.24) .019 1.40 (large) Left rotation 49.00 (6.00) 53.83 (9.06) .178 0.64 (medium) Sequential Group NDI score 25.00 (13.67) 8.00 (6.07) .044 1.10 (large) 6.33 (1.86) 1.50 (1.64 ) .004 2.09 (large) Flexion 49.00 (10.70) 56.83 (7.30) .082 0.89 (large) Extension 46.17 (13.32) 51.17 (14.41) .087 0.87 (large) Right lateral 33.33(6.80) 38.83 (9.04) .238 0.55 (medium) Left lateral 30.83 (6.46) 34.33 (6.41) .150 0.69 (medium) Right rotation 55.50(11.98) 65.17 (8.84) .016 1.46 (large) Left rotation 52.83 (14.22) 63.00 (8.94) .056 1.01 (large) NPRS score Note. NDI = neck disability index, NPRS = numeric pain rating scale  ...

... It Takes a Village: The Experience of Underrepresented Racial/Ethnic Minority Doctor of Physical Therapy Students Submitted to the Faculty of the College of Health Sciences University of Indianapolis In partial fulfillment of the requirements for the degree Doctor of Health Science By: Leslie Buckner, PT, MPT, NCS Copyright April 22, 2021 By: Leslie Buckner, PT, MPT, NCS All rights reserved Approved by: Lisa Borrero, PhD Committee Chair ______________________________ Laura Santurri, PhD, MPH, CPH Committee Member ______________________________ Bernadette Williams-York, PT, DSc, GCS Committee Member _____________________________ Accepted by: Laura Santurri, PhD, MPH, CPH Director, DHSc Program Chair, Interprofessional Health & Aging Studies University of Indianapolis ______________________________ Stephanie Kelly, PT, PhD Dean, College of Health Sciences University of Indianapolis ______________________________ Running Head: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE It Takes A Village: The Experience of Underrepresented Racial/Ethnic Minority Doctor of Physical Therapy Students Leslie M. Buckner University of Indianapolis 1 UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 2 Abstract Objective: Despite America becoming more diverse each year, minority students in the profession of physical therapy (PT), are, on average, outnumbered 3:1 by their White classmates. The American Physical Therapy Association has prioritized a goal to increase diversity in the profession to better meet the needs of the ever-changing demographic that physical therapists serve. Currently, limited research has been published on why diversity is lacking in PT, the qualitative perspectives of URM DPT students, and how such disproportion can be corrected. Method: In this study, the researcher sought to understand the experiences of underrepresented minority (URM) doctor of physical therapy (DPT) students. Twenty-two minority DPT students from four Midwest DPT programs, one Hispanic serving institution (HSI), and four historically Black colleges and universities (HBCUs) each participated in a single semi-structured interview to share their experiences as URM physical therapy students. Using the theoretical lens of Tintos theory of student retention, participant experiences were used to examine how to best recruit and retain minority students in physical therapy programs. Results: Three overarching themes were identified: (1) the importance of early exposure in bringing the URM student to the profession; (2) the unique experience of the URM DPT student; and (3) the role strong support plays in the retention of the URM DPT student. Conclusions: Support, both academically and socially, should be provided by the institution, family/friends, faculty, and other classmates. Future research should examine the most effective recruitment and retention strategies to increase minority representation in the field of physical therapy. Keywords: diversity, underrepresented minority, physical therapy, student, recruitment, retention UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 3 Acknowledgements There have been many people who have contributed to the successful completion of this project. I would like to begin with thanking my doctoral committee. My topic was not always the one that excited people, but they took such a great interest in it and were just excited as I was to see where the study would go. I am grateful for Dr. Lisa Borrero who served as committee chair. She always offered kind words and helped guide me through this process in such a caring way. I am thankful for Dr. Laura Santurri who took over the program partially through my studies. Both in her class, and from the time she agreed to be a part of my committee, she has been very supportive and offered great feedback for the data collection and overall completion of this project. I am grateful Dr. Bernadette Williams-York for her expertise she lent to this project as a subject matter expert. From the first time I heard her lecture, I knew I had to have her as part of my committee and I am happy to have joined her in the quest for improving the diversity of our profession. I absolutely cannot forget to thank my classmate and Belize roommate, Dr Maryleen Jones, who has served as not only a co-reviewer, but my sounding board throughout the end of my doctoral journey. I would like to thank all of the participants of this study who were willing to share their experiences as underrepresented minority DPT students. Their excitement to share their stories as a means to increase the diversity of our profession pushed me along throughout the completion of this study. I look forward to the day when, like them, we are able to see practitioners of physical therapy that look like the population we treat. Lastly, but definitely not least, I would like to thank my village. That village has been authored and directed by God. Without him there is no way I would have made it through this doctoral program and all the hills and valleys it brought over the past seven years, and for that I am eternally grateful. I am beyond indebted to my parents for their support and encouragement UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 4 throughout the entire process. I pray I make them proud as the first doctor in our family. I am thankful for my sister and my niece who have also walked this journey with me as I had to often find time to finish papers or interviews while we were supposed to be enjoying vacation. I hope that I inspire both of you to never settle in your careers, but to always strive for the best. I am thankful for all my aunts and uncles who are constant source of love and encouragement. My friends and all my sorority sisters who have fussed at me, never let me stop, encouraged me on my hardest days, offered advice on how to get through the completion of the manuscript and loved me through it all. They understood when I couldnt participate in things or at conferences or on vacation had to take an hour or two away to work on coursework. Special thank you to my friends from high school, Candace and Andrea, and my sorority sisters: Shellisa, Nikki, Jamila, Charise, Nikkia, Shatonya, Avis, and Robin. I would be remiss if I did not recognize my sorority sister Dr. Dani Coleman who, after completing her own dissertation, assisted me with finding Tintos theory which helped me shape the rest of my discussion section. I am appreciative as well to my friend Simir for being my constant voice of reason and pushing me to be the best I can be in my career. I am thankful for my church family who prayed for me and continually offered words of encouragement. Lastly, I am thankful for my coworkers who have been beyond supportive of my academic endeavors and who encourage me with their brilliance every day as they pour into our patients. The love and support that each of these people have shown me during the last seven years I will forever treasure. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 5 Table of Contents Problem Statement .......................................................................................................................... 8 Significance of Study ...................................................................................................................... 9 Purpose Statement........................................................................................................................... 9 Research Questions ......................................................................................................................... 9 Definition of Terms....................................................................................................................... 10 Predominately White Institution............................................................................................ 10 Historically Black College and University ............................................................................ 10 Hispanic Serving Institutions................................................................................................. 10 Literature Review.......................................................................................................................... 10 Importance of a Diverse Healthcare Workforce ........................................................................... 11 Underrepresented Minority Students ............................................................................................ 13 Recruitment Obstacles and Techniques ........................................................................................ 14 Minority Student Experiences in Professional Education Programs ............................................ 18 Retention Barriers and Strategies.................................................................................................. 22 Method .......................................................................................................................................... 24 Study Design ................................................................................................................................. 24 Bias Statement .............................................................................................................................. 25 Participants.................................................................................................................................... 25 Sampling ................................................................................................................................ 26 Procedures ..................................................................................................................................... 28 Recruitment ........................................................................................................................... 29 Informed consent ................................................................................................................... 30 Data collection ....................................................................................................................... 30 Data management and analysis.............................................................................................. 32 Study Rigor ................................................................................................................................... 34 Results ........................................................................................................................................... 34 Overview of Findings ................................................................................................................... 35 The Village Raises- Preparation for the DPT Program ............................................................. 36 UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 6 The Village Releases- The Minority Experience in the DPT Program ..................................... 44 The Village Reassures- Supporting the DPT Student Through the Program ............................ 64 Discussion ..................................................................................................................................... 71 Limitations .................................................................................................................................... 92 Future Research ............................................................................................................................ 92 Conclusion .................................................................................................................................... 94 References ..................................................................................................................................... 96 Appendix A ................................................................................................................................. 113 Appendix B ................................................................................................................................. 115 Appendix C ................................................................................................................................. 117 Appendix D ................................................................................................................................. 118 Figure1- The Village Model of Support for Underrepresented Minority DPT students ............ 122 Appendix F.................................................................................................................................. 123 Tables .......................................................................................................................................... 123 Table 1 ........................................................................................................................................ 123 Table 2 ........................................................................................................................................ 125 Theme Table- Preparing for the DPT Program: The Village Raises..................................... 125 Table 3 ........................................................................................................................................ 126 Theme Table- The Minority DPT Experience: The Village Releases..................................... 126 Table 4 ........................................................................................................................................ 130 Theme Table- Support for Retention in DPT Programs: The Village Reassures................... 130 UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 7 The Experience of Underrepresented Racial/Ethnic Minority Doctor of Physical Therapy Students The United States has seen a change in racial and ethnic diversity over the last 20 years. Per the 2010 census, the population is comprised of nearly 40% minority groups (e.g., African American, Hispanic/Latino, Asian, and Native Hawaiian/Pacific Islander; US Census Bureau, 2016). However, similar changes in racial and ethnic diversity have not occurred within the healthcare workforce. Seventy-two and a half percent of all students enrolled in professional physical therapy programs in 2019-2020 were White (The Commission of Accreditation in Physical Therapy Education, 2020, p. 14). Similar findings have been seen in other health profession programs (Brooklyn Health Disparities Center, 2011). The American Physical Therapy Association (APTA) and American Council of Academic Physical Therapy (ACAPT) do not at this time consider Whites and Asians as underrepresented in the profession of physical therapy based on their representation relative to the U.S. population (American Council of Academic Physical Therapy, 2016). Since 2016, there have been small gains in the number of URM students admitted into DPT programs with an increase of 0.8% African American students, 2.7% Hispanic/Latino students, and 1.3% multiracial students (The Commission of Accreditation in Physical Therapy Education, 2020, p.14). This data also goes on to show that the percentage of White students over the past eight years has decreased by 8.8%. While this is an improvement, the percentage of African Americans and Hispanic/Latinos in doctor of physical therapy (DPT) programs remain well below their census demographic. Having increased diversity in the healthcare professions increases cultural competence, increases patient satisfaction, improves access to healthcare, enhances patient-provider communication, decreases negative health outcomes for minorities, and is good business practice (The Sullivan Commission, 2004). UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 8 There are benefits to having diversity in the college setting as well. By students having the opportunity to be exposed to their colleagues of different ethnicities, races, and socioeconomic backgrounds, they expand the way they think and enhance their ability to work with others. Student body diversity assists in enriching multiple perspectives, promoting creative thinking, enhancing social skills, and preparing students for the global society in which they will work and live (Hyman & Jacobs, 2009). Saha, Guiton, Wimmers, and Wilkerson (2008) found that White medical students who attended schools with a greater percentage of underrepresented minority (URM) students felt better prepared than students at less diverse schools to care for racial and ethnic minority patients and had stronger attitudes about inadequate access to health care (p.1141). The learning experience is enhanced for students of color when diversity is increased as there is less likelihood of stereotyping and discrimination directed toward the students of color (Wells, Fox, & Cordova-Cobo, 2016). Problem Statement One goal of the current American Physical Therapy Associations (APTA) strategic plan for stewardship is to make APTA an inclusive organization that reflects the diversity of the society the profession serves (American Physical Therapy Association, 2019, p.3). As of 2019, the profession remained 76% percent White (Data USA, 2020). Although there has been a couple of more recent studies, much of the published research regarding diversity in the physical therapy profession was conducted prior to 2009. Yet as is evidenced above, there remain large discrepancies in the ethnic makeup of both practicing clinicians and students enrolled in DPT programs. In a 2015 taskforce survey of URM students, it was suggested that further research is needed to better understand how early exposure to the profession affects recruitment and how UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 9 student support and financial demands affect retention (American Council of Academic Physical Therapy, 2016). There have been numerous studies examining the experience of ethnic/racial URM student groups in the fields of nursing and dentistry (Amaro, Abriam-Yago, & Yoder, 2006; Evans, 2008; Veal, Perry, Stavitsky, et al, 2004; Zell, 2014). The research completed in these other professions acknowledge the challenges ethnic/racial URM face while enrolled in the academic program as well as the factors that help make these students successful. This suggests a more in-depth exploration of the ethnic/racial URM physical therapy student experience is needed. Significance of Study By exploring the lived experiences of underrepresented minority students in professional physical therapy programs, the researcher captured the voices of minority students and their perceived barriers as well as strategies for success. Through grounded theory inquiry, data elicited was used to develop theory to explain the process of pursuing a DPT for underrepresented racial/ethnic minority students. The theory generated will hopefully lead to the creation of initiatives aimed at increasing recruitment and retention of underrepresented racial/ethnic minority students in DPT programs. Purpose Statement The purpose of this study was to explore the personal experiences of underrepresented racial/ethnic minority DPT students to better understand the processes that draw URM individuals to the field of physical therapy and that contribute to successful matriculation in the DPT program. Underrepresented minority students at both predominately White universities and minority serving institutions were included in this study. Research Questions UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 10 The research question that was addressed in this study was: What is the process of pursuing a Doctorate of Physical Therapy for students from underrepresented ethnic/minority groups? Additional sub-questions were as follows: How do underrepresented racial/ethnic minorities become interested in the field of physical therapy? What factors led the underrepresented racial/ethnic minority student to choose the DPT program they did? How do underrepresented racial/ethnic minority students describe their successes and challenges while in their DPT program? Definition of Terms Predominately White Institution. Predominantly white institution (PWI) is the term used to describe institutions of higher learning in which Whites account for 50% or greater of the student enrollment (Brown & Dancy, 2009, para 1). Historically Black College and University. The Black College and University Act defined a historically Black college and university (HBCU) as one that existed before 1964 with a historic and contemporary mission of educating Blacks while being open to all (List of Historical Black Colleges, n.d.) Hispanic Serving Institutions. A Hispanic-Serving Institution (HSI) is defined as an institution of higher education that (A) is an eligible institution; and (B) has an enrollment of undergraduate full-time equivalent students that is at least 25 percent Hispanic students at the end of the award year immediately preceding the date of application (U.S. Department of Education, 2016). Literature Review UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 11 There is currently an underrepresentation of racial/ethnic minorities in the field of physical therapy. The reasons for that are multifaceted and there is a definite impact of the underrepresentation of minority therapists on the patients of underserved communities. This literature review was used to explore the importance of a diverse healthcare workforce, the obstacles and techniques for minority student recruitment in healthcare professions, the experiences of minority students while in professional level education programs, and the barriers and strategies used to help increase minority student retention and success. Importance of a Diverse Healthcare Workforce A diverse healthcare workforce can impact the delivery and accessibility of care for minority patient populations. Despite health disparities affecting minorities in greater numbers, minorities have limited access to preventative care and often feel they have limited access to the quality health care of their choice (Collins et al., 2002, Hernandez & Sparks, 2020). Pardasani and Bandyopadhyay (2014) identified that low-income Black and Latino patients were less likely than Caucasians to report that: there was culturally relevant pictures and patient education materials; providers reflected their racial/ethnic background; client-provider communication fostered feelings of trust, being understood, and respected; and that cultural beliefs were integrated into their plan of care. Research has shown most minority patients do not have access to healthcare providers who share their race or ethnicity (Kington, Tisnado, & Carlisle, 2001; Sullivan Commission, 2004; Traylor, Schmittdiel, Uratsel, Mangione, & Subramanian, 2010). Sweeney, Zinner, Rust, and Fryer (2016) found that 13.8% of African-American patients and 43.8% of Hispanic patients reported race/ethnic concordance with their primary healthcare provider compared to 94.4% of white patients. In a larger study by Traylor et al. (2010), only 9.7 percent of African American patients and 11.2 percent of Hispanic patients were UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 12 racially/ethnically matched while nearly 48 percent of white patients and 63 percent of Asian patients were racially/ethnicity matched (p. 797). These discrepancies further highlight the need for a diverse healthcare workforce. Minority practitioners have been found to be more likely to serve in minority and underserved communities, which may assist with increasing access to and utilization of healthcare for patients in these communities (Collins et al., 2002; Sullivan Commission, 2004; Toretsky, Mutha, & Coffman, 2018; U.S. Department of Health and Human Services, 2011). Additionally, minority providers influence health organizations and other clinicians to provide culturally sensitive care and appropriate care for minority patients (LaVeist & Pierre, 2014, p.129). Patient trust and ability to communicate with the healthcare provider can greatly influence the healthcare experience. When a patient trusts his/her healthcare provider, they are more likely to have greater patient satisfaction, improved communication, and compliance (Akbolat, Karakaya, Ugan, & Durmu, 2017; Hung & Oh, 2020; Sullivan Commission, 2004). This proved true as well when an ethnic concordant practitioner educated patients on improving health risk factors. Patients were found to have improved confidence in the provider, reduced reactance-related outcomes, and improved prevention-related knowledge transfer (Arendt & Karadas, 2018). Patient compliance with medication was improved in African Americans when there was race/ethnicity concordance (Traylor, Schmittdiel, Uratsel, Mangione, & Subramanian, 2010). Additionally, communication is improved when the provider speaks the patients native language. When the patient is unable to understand the instruction/education given by the healthcare provider, compliance decreases as do health outcomes (Brennan, 2015). Traylor et al. (2010) and Parker et al. (2017) found that medication compliance improved when there was language concordance. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 13 A diverse workforce and student body helps to improve cultural competence. Minority healthcare professionals help challenge systems, policies, and procedures that are not reflective of diversity, help educate others on culturally competent practice, and help bring a cultural affinity to practice that increases understanding of the patients experience (Valentine, Wynn, & & McLean, 2016; Sullivan Commission, 2004). A diverse student body allows students to experience new perspectives and interact with new cultures which may improve their communication skills and future patient interactions (American Council on Education, 2012; Kington et al., 2001). Additionally, in a culturally diverse classroom, students can better understand both their similarities and differences by dialoguing about how their culture shapes their belief systems and actions (Kachingwe, 2003). Allowing for the sharing of differing perspectives can allow for new innovations (Goethe & Colina, 2018). These interactions are valuable to the way students will approach the diverse patients they encounter over their career. Underrepresented Minority Students To increase diversity in healthcare, it is important to look at ways to understand which populations are most underrepresented in the healthcare fields. Educational organizations for nursing and dentistry define underrepresented minorities similarly to include African Americans, Hispanics, American Indians, and Alaskan Natives (American Association of Colleges of Nursing, 2015; Mertz et al., 2016). The American Association of Colleges of Nursing also includes Asians and men as underrepresented (2004). The Association of American Medical Colleges (2004) and the American Physical Therapy Association (e.g. APTA, 2014) however take a broader stance when defining who is considered an underrepresented minority. The APTA policy statement regarding underrepresented minority students is as follows: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 14 The American Physical Therapy Association defines Underrepresented in physical therapy education as the racial and ethnic populations that are underrepresented in physical therapy education relative to their numbers in the general population, as well as individuals from geographically underrepresented areas, lower economic strata, and educationally disadvantaged backgrounds. For the physical therapy profession, Asian Americans and males are not considered to be underrepresented. By knowing which racial/ethnic populations are considered underrepresented in a given discipline, that discipline is better able to address their specific issues concerning diversity. This may include finding solutions to ensure the diversity of the profession matches the diversity of the patients it serves. Recruitment Obstacles and Techniques There are numerous factors that affect minority students decisions to pursue a career in a health care profession. The decision to enter a healthcare career may be influenced by: the costs of the degree and ability to find funding, the academic program requirements, the support available for the student, previous experiences with the profession [good or bad], student knowledge about the profession, student personality, student exposure to the profession, intrinsic motivation to help others, and societal racism/discrimination (Boekeloo, Jones, Bhagat, Siddiqui, & Wang, 2015; Zayas & McGuigan, 2006). Holden, Rumala, Carson, and Siegel (2014) added that for URM students, factors that may negatively influence their decision to enter a health care career include: healthcare not having the status of careers in athletics or entertainment thus being viewed as not cool, lack of pre-requisites or skills needed, lack of self-confidence, parental influence when the parent has a lack of knowledge about healthcare careers, and poor school resources and promotion of healthcare careers by teachers. Similarly, Valentine et al. (2016) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 15 acknowledged that academic preparation, knowledge of health careers, and resources to pay for college impact students ability to enter a health care career. Among these influences, one of the largest factors that impacts recruitment and actual URM student enrollment is often the cost of the education. Racial/ethnic minorities are more likely to come from disadvantaged backgrounds than are majority groups. Kochhar and Cilluffo (2017) analyzing the 2016 Federal Reserve data found that the median wealth of white households was ten times greater than Black households and eight times greater than Hispanic households. Sharkey (2013, p. 38, Fig. 2.1) found that young African Americans (ages 13-28) were ten times more likely than young whites to live in poor neighborhoods. While the official poverty rate decreased in 2019 to 10.5%, there continues to be disparities in the distribution of poverty amongst African Americans and Hispanics (Semega, Kollar, Shrider, & Creamer, 2020). African Americans account for 13.2% of the population but 23.8% of those in poverty and Hispanics account for 18.7% of the population but 28.1% of those in poverty (Semega et al., 2020). In the 2018 census it was found that Native Americans had the largest poverty rate of all ethnicities at 25.4% (Poverty USA, 2021). Coming from a disadvantaged background may impact these URM students ability to afford a college and graduate level education. The cost to attend a 4-year college at public and private institutions has risen more than 400% in the past 20 years, while family incomes have remained relatively flat (Valentine et. al, 2016, p.139). Valentine et. al (2016) further noted that the federally funded Pell Grant, which helps students pay for college, has been scaled back. Some URM students assist their families financially by maintaining a job (Evans, 2008). However, students may not be able to hold a job while in the DPT program due to the rigorous coursework (American Council of Academic Physical Therapy, 2016). Additionally, as URM may incur more increased debt as compared to their UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 16 White counterparts and have greater need to contribute to the household, they may choose professions that have greater earning potential, such as medicine, dentistry, and pharmacy (American Council of Academic Physical Therapy, 2016, p. 9; Evans 2008; Wise et al., 2017). The American Council of Academic Physical Therapy diversity task force (2016) calls for institutions to creatively find ways to financially support students during their DPT program. Another factor that has affected URM recruitment is poor academic preparation. Students who come from schools with less financial resources may have difficulty meeting strict university admission standards (Duncombe, 2017; Evans, 2008). To expand the pool of quality URM applicants, there needs to be greater focus on providing quality education in the K-16 education system (U.S. Department of Health and Human Services, 2011). Students who live in underserved areas are less likely to have the resources and the courses to provide the necessary science, technology, engineering, and math (STEM) education (U.S. Department of Education, 2016). This often leaves gaps in the academic preparation of students needed for graduate health programs. Students of color may have difficulty with standardized testing (e.g. SAT and GRE) required of health professional program due to inequalities in the education system (Hardy, 2015; Valentine et al., 2016). ACAPT has recommended that DPT programs adapt more of a holistic admission strategy where factors other than just standardized test scores are considered (Wise et al., 2017). Haskins and Kirk-Sanchez (2006) reviewed recruitment techniques used by physical therapy programs; however, the review showed that there is still limited research on the effectiveness of each individual recruitment technique currently being used by DPT programs. Some of the techniques that have been used by DPT programs include participation in career fairs, having current minority students speak to high school students, hosting open houses, and UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 17 keeping in touch with potential minority students (Haskins & Kirk-Sanchez, 2006). Wise et al. (2017) noted that despite the work described above by Haskins and Kirk-Sanchez, little has been done since then to identify and promote best practices among professional PT programs (p.12). Despite recruitment efforts by DPT programs, there are still barriers the school faces for an URM student to select their institution. The three factors found to most influence the students choice of physical therapy education programs were costs, diversity of the student body, and program faculty (Wilcox, Weber, & Andrew, 2005; Wise et al., 2017). Johansen (2007) adds that minority students may also include positive interaction with current students as a factor in program selection. Barriers to recruitment include competition from other healthcare professions that provide better financial aid or greater earning potential, lack of exposure to the profession at a younger age, and admissions standards that focus on academic metrics only (Wise et al., 2017). The more exposure, experience, and support a student has, the more likely they are to pursue a healthcare career (Muncan, Majumder, & Tudose, 2016; Veal et al., 2004; Zayas & McGuigan, 2006). Many URM students are not aware of healthcare career opportunities (Valentine et al., 2016). Toretsky et al. (2018) noted many URMs may not have any health professionals within their families and may only know the health professionals they encounter when needing care (which may only include a doctor or nurse). Valentine et al. (2016) highlighted that pairing URM students with a mentor in the health professions can help with both recruiting and retaining these students. In addition to mentoring, others have expressed the importance of beginning to reach out to kids as early as elementary school using current URM DPT students so they can be exposed to people in the field who look like them (American Council of Academic Physical Therapy, 2016). Other avenues to increase exposure for URM students have included pipeline and summer enrichment programs. In the pipeline/enrichment UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 18 programs, high school or undergraduate students participate in science and health-related education, are exposed to health careers, and possibly participate in research. These programs have been successful at introducing students to the healthcare field and preparing them for admission (Alexander& Mitchell, 2010; Rashied-Henry et al., 2012; Toretsky et al., 2018). These findings point to the important role of teachers, guidance counselors, and advisors in supporting minority students and exposing them to healthcare careers early. Thus, it is important that they too be educated on how to successfully prepare the URM student for the DPT program (American Council of Academic Physical Therapy, 2016). Minority Student Experiences in Professional Education Programs There currently is limited research regarding the experience of the minority student while in a DPT program. However, there have been numerous studies on minority experiences at the graduate collegiate level and in the professions of pharmacy, nursing and dentistry (Diefenbeck, Michalec, & Alexander, 2016; Evans, 2008; Felder, 2010; Gasman, Hirschfield, & Vultaggio, 2008; Veal et al., 2004; Wong, Seago, Keane, & Grumbach, 2008; Zell, 2014). Each of these studies examined the unique experiences of the URM student as they pursue professional degrees. Many students highlighted the role that peer support played during their graduate health program. Hispanic nursing and African American graduate students noted one positive factor of their educational program was the relationship they shared with other minority students (AliceaPlanas, 2017; Gasman et al., 2008). In these studies, students turned to other minority students for support because they felt they were better understood in those peer circles based on shared experiences. On some campuses, students belonged to ethnically based student organizations with other like URM students. Ethnically diverse student organizations provide a support system to URM students and a safe venue for participants to identify with other students of their UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 19 ethnicity (Amaro et al., 2006, p. 252). Although URM students often turned to one another for support, they were able to forge support systems with their non-minority classmates as well. In South Africa, a country with similar race issues to America, URM physical therapy students sharing a room with another person provided a source of support and was a predictor of success (Mbambo-Kekana, Rothberg, Bruce, & Musenge, 2005). Dapremont (2011) found that Black nursing students felt peer support was important while in the nursing program. Although students in this study expressed an early need to identify with other Black students, as the program progressed, they appreciated the support of classmates regardless of race. Mbambo-Kekana et al. (2005) found that Black students who integrated into a group of fellow students were more successful due to the closer relationships and the support the group provided. Similarly, Zell (2014) identified that Hispanic students pursuing health careers identified peer support as a source of resilience and cooperative learning. Students in this study formed new peer systems and often used study groups to assist one another with learning and provide encouragement. Vaughan, Sanders, Crossley, ONeill, & Wass (2015) noted that by integrating with other students, particularly those who were White, minority students could gain access to different resources. Throughout review of the literature, there are a few challenges expressed by minority students in the various collegiate programs. One such challenge reflects the stress caused by financial concerns about the affordability of a program (Amaro, Abriam-Yago, &Yoder, 2006; Evans, 2008; Lim, Heckman, Letkiewicz, & Montalto, 2015; Mbambo-Kekana et al., 2005; Veal et al., 2004; Zell 2014). In a study of underrepresented minority nursing students, participants expressed concerns with not only affording, but being able to sustain the costs of the nursing program (Diefenbeck et al., 2016). Additionally, students noted it was financial support that UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 20 allowed them to persist in their program (Diefenbeck & Klemm, 2021). Graduate level students need funding for professional development opportunities (e.g. national conference, platform/poster presentations, etc.) to remain competitive and not having additional funds available for this can further create feelings of stress (Gasman et al., 2008). Some minority students expressed that they were unaware of grants and other funding sources to help offset financial costs (Veal et al, 2004). For some students with financial stressors, their academic performance or progress is impacted (Trombitas, 2015). Academics were noted to be challenging to some URM students as well. Amaro et al. (2006) found students were challenged by the workload, study demands, and complexity of information while in their nursing program. Students expressed they did not feel academically prepared for the rigor of the graduate health program, especially the sciences (Alicia-Plenas, 2017). In a study by Moore et al. (2003), forty-three percent of participants reported difficulty with time management, finding balance, and staying organized. In Evans (2008) study, participants verbalized fear of academic failure, saying the program was more difficult than they expected, yet it was hard for them to admit they needed help (p. 214). URM students in this study were also more likely to come from backgrounds where the secondary schools had limited resources to provide appropriate academic preparation needed for the program. Another challenge reported by URM students was in understanding how to effectively communicate with classmates, clinical instructors, and professors despite cultural differences or language barriers (Alicea-Planas, 2017; Amaro et al., 2006). Students in these studies acknowledged that when English is the students second language, they had greater difficulty with interpersonal communication and felt others became impatient with them. Some Hispanic students indicated the language barrier caused difficulty with understanding concepts (Alicea- UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 21 Planas, 2017). Clinical instructors surveyed reported that minority students had deficits in communication and interpersonal skills (Clouten, Homma, & Shimada, 2006). These communication issues included: accent, basic English skills, understanding directions, body language, writing skills impacting documentation, and professional use of the language. If faculty and clinical instructors perceive communication skills as a major barrier, this can impact a students success in the program and the way they are graded. Some URM students reported a lack of cultural awareness by classmates and professors as a challenge (Amaro et al., 2006; Bush, 2020; Evans, 2008; Gardner, 2005). URM students noted that other students and faculty were unaware of how lessons are taught using Eurocentrism where whiteness was used as the norm or benchmark against which others differences were measured (Evans, 2008, p. 213). Additionally, other students lack of cultural awareness left URM students feeling frustrated, misunderstood, discounted, or treated with insensitivity (Bush, 2020; Gardner, 2005). Black students often felt they had difficulty relating to classroom conversations and felt their voices were not fairly represented in course discussions (Gasman et al., 2008, p.134). There were important cultural challenges that affected minority students as well. Studies indicated that minority students could feel the lack of diversity represented in their educational program (across students and faculty) which limited the availability of ethnic role models, limited support available to the minority student, and created feelings of isolation (Amaro et al., 2006; Bush, 2020; Diefenbeck et al., 2016; Gasman et al., 2008; Veal et al., 2004; Wong et al., 2008). Gardner (2005) found that URM students often noted they felt different than their White classmates and due to having a different culture were at times unable to relate to common social practices. There have been studies that show URM students may experience minority status UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 22 stress that can lead to them feeling they do not belong and affect their ability to adjust to their college environment (Cokley, McClain, Encisco, & Martinez, 2012). Additionally, due to the paucity of minority professors, URM students had limited mentors or role models within their graduate programs (Amaro et al., 2006, Gasman et al., 2008). Due to this lack of diversity and feelings that both teachers and other students dont understand or dismiss them, minority students often reported feeling as though they did not fit in and that faculty did not support them (Gasman et al., 2008; Mbambo-Kekena et al., 2005; Veal et al., 2004). URM students expressed a desire for faculty to acknowledge they have different needs than their White counterparts and offer them support (e.g. educational, emotional, and motivational) and encouragement (Amaro et al., 2006; Dapremont, 2011; Gardner, 2005). Cultural expectations and self-imposed expectations were challenges that some students reported. Asian students may feel they must meet cultural expectations of perfection while other minority students (particularly women) may create high self-expectations both of which increase stress (Cokley et al., 2012; Yoon & Lau, 2008). Retention Barriers and Strategies To successfully recruit more URM students to the profession, DPT programs need to place more attention on retention strategies. One of the most influential factors impacting retention are the support services that are provided to the minority student. Support services that were most frequently identified as beneficial were academic support, assistance with finding financial support, and mentoring (Amaro et al., 2006; Felder, 2010; Gasman et al., 2008; Mellilo, Dowling, Abdallah, & Feindiesen et al., 2013). Other retention strategies that have been used by DPT programs include tutoring, study skills and test taking interventions, career and academic UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 23 advising, and allowing for cultural diversity discussions and integration into the program (Haskins & Kirk-Sanchez, 2006). Good mentorship/advising were identified as successful ways to help URM students navigate through new and difficult academic situations (Felder, 2010; Melillo et al., 2013; Zell, 2014). Gasman et al. (2008) found that African Americans who had good experiences with mentors felt these experiences contributed to their success while negative experiences led to low self-esteem and consideration of leaving the program. Mentoring relationships assist the URM student in navigating through the demands of the graduate program and prepares them for their professional roles (Gasman et al., 2008; Zell, 2014). Additionally, in a study by Felder (2010) of African American doctoral students, participants indicated that faculty mentors/advisors impacted their career development, promoted their research development, and ignited their persistence. URM students also show resilience in the strategies they employ during the challenges experienced throughout the professional program. One coping strategy minority students use during difficult times is drawing on peer/family support for encouragement and motivation (Amaro et al., 2006; Veal et al., 2004; Wong et al, 2008; Zell, 2014). For some Black students, family support extended to financial support or providing them a listening ear (Dapremont, 2011). Students acknowledged that having a family member in the health professions helped provide them inspiration to get through the challenging program (Diefenbeck et al., 2016). Another coping strategy some students used was to rely on their faith life. Students indicated that their spirituality was what helped them through challenging and frustrating situations (Diefenbeck et al., 2016; Gasman et al., 2008; Veal et al., 2004). In these studies, students noted their faith helped give them determination as did the support of their church family. Other UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 24 students relied on their own self-motivation and determination to get through the program (Amaro et al., 2006; Evans, 2013; Moore, 2003; Zell, 2014). URM students remained determined despite obstacles due to a desire to build a better future (Gardner, 2005). Hispanic study participants did not let setbacks and obstacles decrease their aspirations, instead keeping their long-term goal of a career in front of them served as motivation (Zell, 2014). Conclusion Minority representation in the healthcare professions does not mirror the current United States demographics. This literature review has shown that having a diverse healthcare workforce is of great benefit. Despite the APTA recognizing the need for increased diversity, there remains little research completed to help change the large discrepancy between Caucasian and minority therapists in the field of physical therapy. To better understand what is needed for improved recruitment and retention of minorities in the field of physical therapy, the experiences of minority student physical therapists need to be further explored (specifically challenges encountered and what support is needed). It is important to not only understand why there is such inequity in cultural/racial representation in the field of therapy, but also to work toward changing that inequity. Diversity is no longer optional but is critical to the future of the physical therapy profession. Method Study Design This qualitative study utilized a grounded theory approach to examine the experience of doctor of physical therapy (DPT) students. In grounded theory, the researcher derives a general, abstract theory of a process, action, or interaction grounded in the views of the participant (Creswell, 2014, p. 14). While individual experiences were examined, the grounded theory UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 25 approach was chosen to better understand the relationship between underrepresented minority students (URM) and other people/factors while pursuing or matriculating in a DPT program (Nichols, 2009). Each URM DPT student had a personal account of the emotions and experiences that they have had while in the DPT program, but it is the understanding of these collective experiences that may help shape future best practices in recruitment and retention of minority students. Bias Statement The primary researcher is an African American physical therapist who attended a predominately white institution (PWI) for her physical therapy studies, where there were only two African Americans total in her graduating class of sixty. She recognized the potential for bias due to her personal experiences with lack of diversity in the profession and the educational setting and, her desire to see more URM students enter the profession of physical therapy. However, strategies were included in the study design to mitigate bias during data collection and analysis including the use of a field journal for research reflection, use of broad, open-ended questions during interviews with participants, and a secondary coder to assist with objective development of a code book. The primary researcher engaged in critical reflection about her personal experiences through journal reflections to better understand how they may influence the research process. Self-reflective journals help identify the researchers values and facilitate reflexivity (Ortlipp, 2008). Thus, every effort was made to be non-directive and to ensure participants can talk openly about their experiences, both positive and negative. Participants The participants for this study were first-, second-, and third- year minority DPT students at PWIs, HBCUs, and HSIs. For this study, underrepresented minorities are defined as those UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 26 individuals who identify African American, Hispanic/Latinx, American Indians, and Alaskan Natives who are underrepresented in the profession of physical therapy relative to their numbers in the general population. Both male and female students were eligible for participation. There was no age limitation. Participants included 22 individuals who met the study criteria. Specifically, eight male and 14 female participants. Fifteen participants came from PWIs, one participant from an HSI, and six participants from HBCUs. There were 13 participants that identified as African American, five participants who identified as Hispanic/Latinx, and four who identified themselves as mixed ethnicity (Black or Hispanic/Latinx mixed with another race). Five students were in their first year of the DPT program, ten students were in their second year of the DPT program, and seven students were in their third year of the DPT program. Due to the representation of Whites and Asians (including Indian Americans) in physical therapy as compared to their representation in the general population, they were not included in this study (Commission on Accreditation of Physical Therapy Education, 2016; U.S. Census Bureau, 2014). Participants were excluded if they were not fluent in English (needed for interview). Sampling. The study utilized multiple sampling approaches to ensure the appropriate number of participants for saturation was reached. These approaches included: purposeful, snowball, and theoretical sampling. Purposeful sampling was used in the selection of schools that were chosen. Purposeful sampling is used when the researcher selects participants and sites because they purposefully add insight to the central phenomenon being studied (Creswell, 2013). It was the researchers aim to obtain views from students from different racial/ethnic backgrounds, males and females, and students from a variety of DPT programs. The researcher encouraged snowball sampling by inviting participants to recommend friends who meet criteria UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 27 to participate in the study (Harrell & Bradley, 2009). Per the tenets of grounded theory research, theoretical sampling was used to help with the generation of theory. Theoretical sampling is: the process of data collection for generating theory whereby the analyst jointly collects, codes and analyses his data and decides what data to collect next and where to find them, in order to develop his theory as it emerges (Glaser & Strauss, 1967, p.45). Therefore, through theoretical sampling, additional data was needed for theory development, outside of that attainable with the initial schools chosen. Additional schools were contacted when the need arose for further data collection. Additionally, the researcher purposefully sampled additional participants from minority based physical therapy social media groups. Final sample size was determined by saturation of answers where no further new information was obtained during the interviews and once the theory was full elaborated (Creswell, 2013; Siegle, 2002). Setting To recruit subjects for this study the primary researcher worked with the program directors/diversity directors at Marquette University, Governors State University, University of Indianapolis, Florida International University and Alabama State University. Schools were chosen because of researcher connection to these schools and their physical therapy programs. Additionally, three other schools were pursued, but program directors did not approve of their students participating in research. Participants participated in one semi-structured interview conducted via phone interview. Phone interviews were arranged at a time that coordinated with both the student and primary researchers availability. Marquette University is a Catholic, Jesuit university located in Milwaukee, WI. The school has 8,200 undergraduate and 3,000 graduate and professional students that originate from nearly every state and 72 countries (Marquette University, 2015). Marquette offers a variety of UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 28 bachelors, masters, and doctoral degrees. Healthcare professional programs at Marquette include athletic training, physical therapy, nursing, dentistry, speech therapy, physician assistant, and exercise science Governors State University (GSU) is a public university located in University Park, IL. The school has 5,500 students and offers a variety of bachelors, masters, and doctoral degrees (Governors State University, n.d.). Healthcare professional programs at GSU include occupational therapy, physical therapy, nursing, speech therapy, and health administration. University of Indianapolis (UIndy) is a private, Methodist university located in Indianapolis, IN. The school has 5,400 students and offers a variety of bachelors, masters, and doctoral degrees (University of Indianapolis, n.d.). Healthcare professional programs at UIndy include athletic training, physical therapy, nursing, occupational therapy, and health administration. Alabama State University is a Historically Black College/University (HBCU) located in Montgomery, AL. The school has 4,760 students and offers a variety of bachelors and masters degrees as well as four doctoral degrees (Alabama State University, 2017). Healthcare professional programs at Alabama State University include physical therapy, occupational therapy, and prosthetics and orthotics. Florida International University (FIU) is a Hispanic Serving Institution (HSI) located in Florida. The school has nearly 54,000 students and offers a variety of bachelors, masters, and doctoral degrees. Twenty-six percent of the students enrolled in the DPT program identify as Hispanic/Latinx. (Florida International University, n.d.). Healthcare professional programs at FIU include nursing, physical therapy, occupational therapy, and speech therapy. Procedures UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 29 Recruitment. A flyer was created which included: the purpose of the study, inclusion criteria, expectations of the student (one face to face interview and one review of interview summary), and contact information including name, phone number, and email of principal researcher (Appendix A). This flyer was then distributed to the diversity/program directors of Marquette University, Governors State University, University of Indianapolis, Alabama State University, and Florida International University. They were asked to pass this flyer along to second- and third- year DPT students in their respective programs. When saturation of data was not reached after interviewing students from these five schools, efforts were made by the primary researcher to reach out to minority PT students via racial/ethnic minority physical therapy groups on social media to assist with recruitment. Recommendations given by current participants and other physical therapists of potential students who met the criteria were also considered. When a recommendation was given, the primary researcher contacted the potential participant via email and provided them the flyer regarding what the research entailed. If the potential participant expressed interest the primary researcher conducted the same steps of communication as were completed with all other participants. Students were asked to contact the primary researcher via email or phone to arrange a time for a phone meeting or via email dialogue where the researcher could verify that they met inclusion criteria and provide further information about the study. As grounded theory research assists with developing theory, efforts to ensure balance in gender and racial/ethnic makeup of participants assists in developing a more comprehensive theory with greater transferability (Creswell, 2014; Henderson & Rheault, 2004; King & Horrocks, 2010). Participants were selected on a first come, first served basis with no more than five students from the same institution being selected and no less than three male students represented. Efforts were made to UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 30 secure students from more than one racial/ethnic group. Specifically, when there was not adequate representation of a specific racial/ethnic group, the primary researcher purposefully sought out students of that ethnicity at schools in which she had personal connections or via social media. For Native American students, calls were made to two health centers located on Indian reservations (in Arizona and in Wisconsin) who occasionally take Native American students. However, no students from this demographic were identified during the course of this study. Informed consent. Written permission to conduct the study was obtained from participating program directors and the University of Indianapolis Institutional Review Board (IRB). Each school was contacted to find out if approval was needed from the schools IRB or if the University of Indianapolis IRB is acceptable. All schools contacted were able to use the University of Indianapolis IRB. During the initial phone or email conversation with potential participants, further information was provided to the participant (orally or via email) about the purpose of the study, how data would be collected, and the estimated duration of the interview (30-45 min). If the subject agreed to participate, study information and informed consent forms were emailed to the participant for their review (Appendices B & C). Students were asked to give verbal consent at the start of each interview acknowledging that they had read and agreed to the informed consent document. Data collection. Qualitative data was collected via one semi-structured phone interview with each participant, conducted by the primary researcher. This interview occurred within one month from the initial phone or email contact by the primary researcher. Interviews were held via telephone with the participants in a location they deemed comfortable. A semi-structured UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 31 interview guide (see Appendix D) was used for every participant, comprised of open-ended questions that sought to gain information from the participant. This interview approach allowed participants to give as detailed an answer as they chose while still allowing the researcher to ask probing follow-up questions as needed (Turner, 2010, p. 756). Interviews were audio recorded (via Blackbox phone application) and the researcher took field notes during each interview. These notes included only observations of the participants responses (Mack, Woodsong, MacQueen, Guest, & Namey, 2005). The researcher observed the tone and inflection of the participants voice when responding noting when the participant appeared passionate about a topic, angered by subject matter, or frustrated by their experiences. Field notes further assist the research with developing meaning and an understanding of the phenomenon being studied (Schwandt, 2015). Initial notes written during the interview by the researcher were further expanded within twenty-four hours of interview completion (Mack et al., 2005). The researcher wrote initial thoughts/feelings that came to her mind while hearing the information to allow for reflection of her own personal biases. It was important to examine these notes while ideas are fresh, and this early review of field notes can provide important insights (Patton, 2002). The questions asked during the interview were used to explore the participants feelings, experiences, and beliefs regarding their experience with selecting the profession of physical therapy, choosing a DPT program, and during matriculation in the DPT program. Through the grounded theory framework, data elicited was used to develop theory to explain the process of pursuing a DPT for underrepresented racial/ethnic minority students. At the beginning of each interview, the study was explained again, and participants were notified that the interview would be recorded for future transcription. Additionally, participants were informed that interviews would be confidential and that identifying information would be removed from their UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 32 transcription. The semi-structured interview guide was used to gain more information about the participants reasons for choosing the profession, the level of support they have, the experiences they have had during the program, and participant demographics. The first component of the interview guide sought to develop rapport with the participants and ask basic factual questions including: gender, age, school demographic (PWI vs HBCU), participants family background, and ethnicity/race (McNamara, n.d.). The second component of the interview guide consisted of questions regarding the participants entrance to the program and selection of physical therapy as a career. The third component focused specifically on the participants experience in the DPT program. The fourth component explored the support systems and relationships that participants have during the program. The final component gathered information about the students personality and their recommendations to future URM students. A pilot interview was conducted prior to beginning the study to test the primary researchers interviewing skills, to practice audiotaping, and to assess if questions need to be adjusted. The pilot interview was used to identify weaknesses in the interview and should be conducted with participants that are similar in nature to those being studied (Turner, 2010). This interview was performed with two recent DPT program graduates. The pilot interview was critiqued by a Doctor of Health Science faculty member for feedback on adjustments that were needed to the interview guide and the interviewing technique. Data management and analysis. All interviews were audio recorded and transcribed verbatim. The entire interview was recorded following a brief introduction by the researcher to the participant. Audio recordings were transferred to a laptop and stored in password protected Cloud storage. The original recording was then destroyed. Each transferred recording was saved with a corresponding participant identification number given to each participant so that no UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 33 personal identifying information is present (Chandler & Reynolds, 2013). These participant identification numbers were random numbers assigned to each participant. The primary researcher transcribed the interview while listening to the recordings for accuracy. After completion of transcription, the primary researcher audited the transcription for accuracy. Transcribed data was then stored using Dedoose Version 8 and each transcription saved with the study code assigned to the participant to maintain confidentiality. Following transcription of data, all stored audio recordings were deleted. All participant consent was acknowledged within the recording and included within the interview transcription. All data was accessible to only the researcher, co-reviewer, and research advisor. Once the transcription process was complete, the primary researcher and one other coreviewer independently read the transcripts and perform coding using the constant comparison method. To reduce potential for bias, the co-reviewer chosen was of non-URM ethnicity and was proficient with the constant comparison method. The co-reviewer was a recent doctoral graduate of University of Indianapolis who recently completed coding of her own juried project interviews. Additionally, a research advisor provided oversight of the codebook at different time points to ensure better accuracy of the coding team. Each interview transcript was coded in several stages. The researcher and co-reviewer initially used open coding in which they read through data several times, assigned labels to concepts that emerged, and categorized those concepts. Then, axial coding was used to identify relationships between codes. Finally, selective coding was used to narrow down the codes to a central core variable. The emerging conceptual framework determines what is needed for subsequent data collection and coding (Holton, 2010). Data was constantly compared with emerging theory between participants (Creswell, 2013). Using theoretical sampling, the primary UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 34 researcher continued to obtain data and using that data selected if any additional participants were needed to complete development of the theory. The two researchers then meet to discuss key words, phrases, and the codes they individually compiled. Following coding of the interview, codes were compared with other interviews for similar codes to produce themes (Boeije, 2002). Upon review of the codes that each reviewer individually generated, the primary researcher and the assisting therapist searched for commonalities amongst answers and generated themes. As transcription analysis continued, themes and categories were continuously evaluated to gauge when saturation of data was reached and interviewing of participants could be terminated. Theory was generated based on the data from those who have experienced the process of being a DPT student (e.g. either through selective coding or by putting together implicit meanings, Creswell, 2013). Study Rigor The Rosalind Franklin Qualitative Research Appraisal Instrument (RF-QRA) assesses the rigor and trustworthiness of qualitative research (Henderson & Rheault, 2004). The RF-QRA was used as a measure to ensure the rigor of this study and the studys ability to be high level of trustworthiness. Triangulation, achieved by multiple coders, increased credibility and dependability as it reduces potential bias. The primary researcher and research assistant used an audit trail for both the coding and theme generation process. This process helped increase dependability. Efforts were made to attain diversity within the participants (gender and minority group) for increased transferability to similar populations across the United States. Lastly, the self-reflective journal of the interviewer increased credibility and confirmability as it also helped expose and reduce potential bias (Henderson & Rheault, 2004). Results UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 35 A total of 22 participants were interviewed for this study, characteristics of which are listed in Table 1. Participant identification numbers were assigned to each participant to protect the privacy of each participant. Participants were comprised of under-represented minority DPT students from predominately white institutions, historically black colleges and universities, and Hispanic serving institutions. While efforts were made to secure representatives from all underrepresented minority student groups, participants in this study included individuals who identified as African American, Hispanic, or mixed ethnicities. Student status in their respective DPT program ranged from those in their first year to those who had just completed their third and final year. Participants came from schools located on the East Coast, in the Midwest, and in the South. The age of participants interviewed in the DPT programs ranged from 23-36 years of age (with an average age of 26.4 years). There were thirty-six percent of participants who identified as male and sixty-four percent who identified as female. Fifteen participants came from PWIs, one participant from an HSI, and six participants from HBCUs. Interviews ranged from 30 minutes to one hour and were all conducted by phone. Overview of Findings Three major themes emerged that convey the process and experiences of the underrepresented minority students while pursuing a DPT degree: the village raises (Table 2), the village releases (Table 3), and the village reassures (Table 4). An African proverb is known to say, It take a village to raise a child. Much like this proverb infers, it takes a village to both prepare a minority student for and support a minority student during the DPT program. These three tables provide insight into the over-arching themes, subthemes, and sample quotations that were found during data analysis. The first overarching theme is the village raises which highlights the influence that parents, schools, and exposure to the profession have UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 36 on a student entering the profession of physical therapy (Table 2). The second overarching theme is the village releases which (Table 3). And, the third overarching theme, the village reassures, identifies the importance of the support that is given to the minority student during the program (Table 4). A conceptual model in Figure 1 demonstrates the relationship between exposure, minority student experience, and support given during the program to the success of the minority student in the DPT program. These major themes combined with additional subthemes highlight areas that need further investigation to improve URM student recruitment and retention in DPT programs. The Village Raises- Preparation for the DPT Program Throughout the study it became apparent that there were a number of factors that impacted a participant deciding to pursue the profession of physical therapy and the school in which they chose to pursue their DPT education. Exposure to the profession was highlighted as critical to a participants decision to enter the profession of physical therapy as well as the timing in which the participant came to the profession. Additionally, things like familial educational background and the guidance participants received in high school also impacted the participants decision to pursue a DPT degree. Lastly, a URM participants choice of which school/program to attend and the factors that led to that decision, are important for those interested in URM student recruitment to understand. Familial background. Participants in the study had parents with varying levels of education and diverse careers. There were a number of participants who had one parent with an educational level higher than that of the other parent. Of the participants in the study, one participant had at least one parent with no greater than a grammar school education, five participants had at least one parent with the highest level of education being high school, three UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 37 participants with at least one parents highest degree being an associate degree, nine participants with at least one parents highest degree being a bachelors degree, and four participants with at least one parents highest degree being an advanced degree. One participant stated that: So, my parents are from a small little village in Mexico. The highest education that they have is middle school. So they didnt really go into high school. After 8th grade, theyre pretty much done, yeah. (Participant #56) Parents and families can play a role in the professions and education that a student chooses to pursue. While the participant above went on to acknowledge her older siblings as responsible for guiding her into the health professions, another student had parents who worked in the medical field (father a physician and mother a nurse) and played a role in her decision to enter the profession. When asked what influenced her to pursue a career in physical therapy, she responded Well I think for sure it has to be my parents. I think because they both are in the medical field and I grew up around that. So, I was always fascinated, I was always asking questions (Participant 15). High school guidance. High school guidance appeared to impact a students exposure to the profession or other science-based fields. Guidance was not limited to the high school counselor, but also came from principals or teachers. Participants who had positive experiences noted that guidance by the academic staff in their high school helped them further pursue their areas of interest, enhanced areas where the student excelled, or provided opportunities for further learning or scholarships in their area of interest. One participant stated, I was really good at math and then in high school I had an awesome biology teacher and I started in class as a freshman. And he just kind of pushed me with science and so I really enjoyed that (Participant #98). However, several participants felt they had limited guidance in high school. They noted UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 38 there was a lack of exposure to pipeline programs or direct guidance toward the multitude of professions within the sciences for students who did not quite know which aspect of healthcare they wanted to enter. Some indicated they did not remember who their high school guidance counselor was, as their role in the students life left no lasting impact. One participant noted that she and her friend became one anothers sources of information and resources. Another participant described her experience with high school guidance counseling. She had to enter the field via the graduate level instead of the entry-level program despite knowing she wanted to be a physical therapist in high school: So in high school, I was always in honors classes or AP classes. So I took chemistry and physics. I had AP Biology. I was involved in all that I remember when I told my counselors in junior year of high school, senior year of high school when we had to talk to them, that I want to do physical therapy. That's the career I wanted to do and all my counselors said was to just apply. They didn't know anything about the field. So, when I was a senior applying to PT school I didn't realize that there were six-year programs so I ended up just going to community college and from there I just figured out my own. (Participant #33) Outlets of exposure. Throughout the study, participants noted a variety of ways in which they were exposed to the profession of physical therapy. One of the most common ways identified was through personal experience or familial experience of an injury that necessitated physical therapy services. They noted that actively going through rehabilitation or observing the care that a therapist provided to their loved one piqued an early interest in the profession. The connection they felt with their therapists was important to them. One participant described her exposure to physical therapy during her cousins therapy sessions: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 39 And then I found PT mostly through one of my cousins who needed therapy, so I was a translator for them and fell in love with it. I fell in love with how the therapist treated our family. You know having that my aunt didn't know English, so it was just a really great experience. And the more that I learned about the profession the more that I enjoyed what we do. (Participant #98) Other participants noted that their exposure came from experiences where they worked in a therapy clinic or in a profession where they were able to observe the role of a physical therapist (i.e., a CNA in a hospital). Still, others came to the profession secondary to shadowing a physical therapist or spending time with one discussing the profession. They noted through these shadowing and discussion experiences, they were able to see the profession in action or to learn more about the role of the physical therapists. One participant stated: I met an associate who was a physical therapist and he also told me to like if I ever wanted to come shadow him I could. I went and shadowed him at his job for a day and I kind of figured out that I really liked it (Participant #12) Three participants indicated opportunities in high school where they were able to shadow physical therapy classes, intern at a physical therapy clinic, or learn more about the profession at a college fair. However, there were several other ways that students came to the profession. For example, some participants mentioned their exposure to athletic training that later led to their interest in physical therapy. Parents and other family members also had some influence in their exposure to the profession whether by parental occupation or nudging of the family member to further research the profession. One participants brother, who later passed away, had spoken to her about the profession before he died as that was what he wanted to pursue. This conversation UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 40 stayed with her and led her to pursue the profession in his honor. Lastly, although not a conventional method of exposure, two participants indicated either a movie or a book that piqued their interest in the profession. One participant mentioned that what increased her interest was the movie, Just Wright, which showcases an African American woman playing the role of a physical therapist for an NBA basketball team. She stated: As far as what drove me to PT specifically I think ironically enough I saw a movie where Queen Latifah was a main character, and she was a PT for Common and I thought that's a really cool job. I felt like I had a strong connection with my PT and thats kind of a big deal for me. (Participant #15) Late entry to the profession. Unfortunately, due to late exposure or limited guidance, some participants had a delay in coming to the profession. As mentioned earlier, one participant was unable to do direct admit programs due to a lack of guidance and instead journeyed from junior college, to university, to the DPT program. Other participants worked in other professions before coming to the field of physical therapy. They either noted becoming unfulfilled in those professions or being exposed to physical therapy and deciding to change course. Some indicated they had once considered physical therapy but had not pursued a degree in the profession. One participant described how he came back to the thought of physical therapy as a career after not previously pursuing the profession due to his grades: So, I started off with a couple of odd jobs. I worked at a gym and then at a bank. And then I worked at an elementary school as a PE teacher for three years. Then after that, thats when I decided toobviously it was some gaps in my capabilities as a PE teacher to certain populations of students which really pushed me (and not for the salary, I was UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 41 like uhhh I dont know if this is going to cut it). It pushed me to revisit that thought of you know continued pursuit of PT. (Participant #46) He later returned to school to get a second bachelors degree so he could improve his GPA well enough to be able to apply to PT school. Students who came to the profession late (often switching professions), found that they had to complete several additional classes before they could apply to DPT school. One participant explained: Because I was a business major, I only had two classes I think that were able to transfer over and would count as prerequisites. I had to go back and take a year and a half and took about eleven pre-reqs (Participant #147) School selection. Participants indicated a variety of factors that impacted their decision on which school they chose to attend for their DPT program. Two of the most common factors that impacted participants decisions were program cost and location. Participants noted location to be important for proximity to their family, for access to childcare, or for being in a major city which allowed for increased opportunities. One participant explained the variety of factors he had to consider: Obviously the number one factor was loans and how much money I would take out for the actual schooling. So *my school* was always on top of my list for that factor itself. But then again, the type of program that it had to offer like whether it was ortho or neuro. And probably right up there most importantly was a staying home because Im part of a very traditional Mexican family. And you know leaving home is kind of like a big deal. My mom wanted me to stay back. Obviously, I have a whole bunch of family here so I'm always the one to get homesick so gotta try to stay home. (Participant #56) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 42 Other participants chose their specific school because of their undergraduate experience at the same school or familial traditions. For other participants, the schools reputation, research and contribution to healthcare, and respectability in the profession were more important than costs because the student felt it would benefit them in their career and their future networking opportunities. One participant stated: I had a tough time emotionally because a lot of the programs I applied to had a very good connection to hospitals in the area which was kind of the biggest thing to me because I wanted to see what the network was like in terms of you know was this a respectable institution, one that was well known for its research and contributions to healthcare. But I think a lot of it really did come down to that sort of reputation. I'm not gonnaI'll be honest, money was definitely a stressful thought process to deal with. But, I think I ultimately kind of sacrificed that fear over trying to maintain or I guess establish that sort of network for the thought that I would eventually have a network of colleagues that I could interact with. (Participant #15) Some participants closely reviewed academic requirements. They would not apply to a program if their academic background did not match the requirements of a school or if they would be required to take additional classes. One participant stated: The other factor was there were a couple of schools I would've applied to but I needed an extra psych course. And so I'm not going to do a whole nother semester just for one class and then miss a whole cycle of applying. Like forget that. (Participant #66) On the contrary, several participants shared the sentiment of this participant, I got accepted. That was about it. I didnt have options. It was where I got accepted so its where I went (Participant #14). These participants indicated that despite applying to a number of schools, they UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 43 were only accepted to one so that is how their school decision was made. A couple of additional students noted that they did not get accepted to any schools on their first attempts at entry into a DPT program and had to take additional classes and reapply the following year. Lastly, two students spoke about how diversity was an important factor in the consideration of which school to attend. One participant stated: So my main thing was diversity. Like that was my number one more thing. I wanted to be somewhere where my professors like understood different cultures and even the people that would become my future peers understood different cultures as well. And during my interviews like that was something I did stress and I would ask about the diversity at the school. And the school that I attend now, when I asked them during my interview they were all about it. My professors you know that I have now, most of them are minorities too. And their biggest message in the interview process was they just wanted a diverse group to understand different upbringings and stuff. (Participant #62) Another participant expressed why he chose an HBCU over a PWI: Throughout my process of trying to figure out where I wanted to go, I went and researched a lot of schools, I went to a couple of skills, but one thing I noticed was the lack of minorities in the program. And, I was like Im going to be in the program for 3 years. I also decided that I wanted to move away from home. So I decided if Im going to be away from home in a new environment that I needed to feel comfortable and be around people that look like me. And so I made the decision after visiting one of the top DPT programs, very large classes, and I looked at the pictures of each cohort on the wall and there would be like very little minorities out of all these people. And I decided I definitely wanted to go to an HBCU (Participant #67) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 44 The Village Releases- The Minority Experience in the DPT Program Once the village has poured into the under-represented minority student, they then enter the DPT program. Throughout the interviews, it became apparent that several factors were unique to the experiences that minority DPT students have had while in the DPT program. These experiences have impacted how they relate to classmates, balance their culture with the beliefs of others, combat a lack of program diversity, and the unique challenges they encounter due to them being a minority student. Additionally, the program challenges them both academically and personally as they seek to balance their personal considerations with academic challenges. Imposter syndrome. Imposter syndrome was initially defined by Clance and Imes (1978) as the struggle that some high achievers have to identify their successes being a product of their own hard work, but instead seeing them as the result of external forces. Evidence has shown that imposter syndrome is present on college campuses and that it can be present in collegiate students of color on both the undergraduate and graduate level (Cokley et al., 2017; Ewing, Richardson, James-Myers, & Russell, 1996; Parkman, 2016). Some participants spoke about noticing how few minority students there were in their classes and wondered why they were chosen to be there. These participants questioned if they were chosen for the program because they were a minority instead of their merit. They noted that they wondered if the nonminority students in their class thought about them that way as well. One student said: It still kind of makes you feel like well why did I actually get in? Was it because they needed to meet a quota for minority students? Or is it because I actually earned that spot? So, I was a little bit uncomfortable being one of the minority students. I think that's a psyche kind of thing that gets caught. Like I've spoken to a lot of my students who feel the same way. Because I know a lot of us have had experiences where someone at least UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 45 has told us at some point in life that they need to meet a quota. That's why you're there. So it kind of belittled our accomplishments so sometimes like you question you know if I be the person who was a straight A student and I can clinically reason somethings then its like OK, I do deserve to be here. But it still feels kind of weird. (Participant #33) One participant mentioned that the fact she had a visible external feature, her skin color, that was different from her classmates made her question if she should be there. She noted: I think that being a minority was a challenge in itself because I dont necessarily look like anybody else in my class and some of my habits or my word choice, or some of those things, it feels like its very disconnected. Hearing peoples biases is something that was difficult for me. And then I think that the imposter syndrome, I related to it more because I felt like there was an external factor where it did prove that I was different from everybody and maybe I shouldnt be here because of that. I know that everybody can relate to that (Participant #44) Pressure. Two participants spoke to the pressures that had externally been placed upon them or that they had put upon themselves as minority students. Specifically, they noted the pressure to succeed and to live up to their own expectations. Regarding the pressure to succeed, one participant wrote: So one of my biggest things when I came was kind of feeling like Oh the pressure of youre a black female, you have to try you know a hundred times harder than white kids. You get told that growing up. But yeah thats one of the things for me. I felt like I had that kind of pressure on me to perform a certain way. (Participant #62) Another participant spoke to both the pressure to work harder as a minority student and the internal conflict she faced with finding balance: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 46 But yeah just being willing to say no. And that's something that's really hard because I feel like if you're a minority you have to work three times as much to be considered about the same amount as somebody who's not and so like I feel like I always have to say yes. If I don't it seems like I'm not as good as some of my peers. And I know thats not what it's like, but that's what it feels like to me. (Participant #98) A third participant commented on the pressure they placed upon themselves saying, I guess with the success comes pressures, so I just have a fear of getting this far and not succeeding. Living up to my expectations I guess. (Participant #60) Familial factors. During the DPT program, a number of participants faced challenges related to that familial responsibilities. One example that was mentioned earlier was the example of the participant who had to care for her injured mom despite her challenging class work. Three participants faced challenges with parenting during the program. They noted that coordinating studying and caring for young children was very difficult. One participant described trying to balance being a mom and a student: Well just studying given the amount of time that it needs to actually be successful has been my biggest struggle. Mainly because of this little one (referring to her daughter in the background). And again I think Im the only one who has a child in this program, in my class. So, it is definitely a struggle when everyone else is up studying. I had to apologize to people because I go to bed at 8 so its like Im in bed at 8 so I can be up at 2am so that I can study. I only have this little window of time that I can actually be productive. I use those little 4 hrs in the morning. And if I cant get it done in those 4 hrs then thats like all I have. (Participant #147) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 47 Other participants noted the challenge of building relationships with other students when they were unable to stay on campus or hang out with the other students due to family commitments or long commutes from campus to home (due to efforts to save money). One participant explained her long-distance commute to school each day so she could still live at home with her family: The school that I go to is in Montgomery but I live in Birmingham so I travel to school every day I live with my boyfriend and my son class starts at 8, my day starts at five or five thirtyIf I have to pick him [her son] up from school then I probably get home around 6:30-7 oclock. (Participant #14) Exposure to similar professionals. Due to the lack of diversity in the profession of physical therapy, many participants noted that they rarely saw therapists who looked like them. This stretched across their academic career, observations, and clinical experience. One participant stated: I've never seen a Hispanic male physical therapist through observations or the clinical hours visits that we've been doing these past few semesters. Yeah so zero. Maybe Hispanic females but as I think about it, none of them come to mind. (Participant #56) Participants noted that whenever they encountered a practicing minority therapist, they wanted to engage them and talk about the profession because they felt like they had found someone who would understand them. One participant stated, So that front desk job I remember I went to a different clinic to cover somebody and I saw a black PT and I just had so many questions for her. Because, its rare, its rare. (Participant #46) Diversity. Participants often commented on how the lack of diversity in their program impacted them, their class discussions, and their experiences as compared to their non-minority counterparts. For some students, the lack of diversity in the program came as a surprise. In some UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 48 programs, a participant was the only person of their ethnic minority group in the class. Many participants had come from educational backgrounds that were diverse in nature. Upon entering the DPT program, they were disappointed to learn that there were not more minority students in the program. One participant stated: I think it's been a shock to my system just because I kind of mentioned with my high school and honestly undergraduate was extremely diverse as well. I'm used to seeing you know a lot of different people from different backgrounds and different skin colors and different et cetera which is not necessarily the case. So it was just kind of an adjustment to not be around that many people. (Participant #15) They indicated that despite the level of diversity, they still felt welcomed in the class, but that it did impact class discussions. One participant stated, It was like once the program continued and we got into certain courses, certain experiences, and discussions, I felt like the program was really lacking diversity and also lacking how they approached it and discussed it with students (Participant #77). This same sentiment was echoed by other participants who felt that education on health equity related to minority groups was lacking and the ethnic/racial minority perspectives were often missing. One participant stated: In terms of like education, I know that there is a section of our curriculum that's on like health and equity based on diversity like racial and ethnic diversity for minority groups. And we did have a few projects that talked about you know different perspectives. However, I didn't feel like it was that great of quality and it was something like me and a few other minority students talked about. You know just not feeling like it was a good quality education. There is you know, this is from lack of like an ethnic or racial minority perspective (Participant #21) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 49 While students expressed they did not want to be the token representative of their ethnicity, they struggled with the best way to correct what they felt were inaccuracies, fallacies, or areas of missing information from the perspective of a minority. Participants noted that the lack of diversity in classes sometimes led to things they enjoyed not being understood or their familial customs separating them substantially from their classmates. This could be as simple as music choices or experiences from their background (ex. slang or common cultural jokes/experiences) to the more complex situations where due to traditional beliefs, family is placed over their education. One participant provided an example of when her mother suffered an injury and the impact it had on her that her other classmates did not have to experience: Actually this past trimester, my mom fell on ice and broke her ankle. And again I picked the school partly because it was close to home and I do love being home and my parents are extremely supportive, but they also don't understand how much it takes for me to be in the program and how much in to it you need to be. So during especially the first three weeks (my mom had to be on crutches for six weeks), I was coming taking the train home from downtown Chicago, coming home making meals for my brother my sister, making sure I was there to pick up my sister on time and it was really, really hectic to go back and do that commute and it wasn't just the commute it was like coming home and not having any time to look over or study. It was get home, do meals, do laundry, like all the housework that needs to be done that my mom usually is on top of. And also, drive my sister to school, pick her up, drive her to band. make sure that my brother gets to tennis. It's like all those things that I was like trying to balance both. But that's also one thing with Hispanics is that we are very family oriented. And if something were to happen with UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 50 their families like that comes first. Even though we are working so hard for the program. (Participant #98) Minority participants expressed, at times, that the social options (outside the classroom) of their classmates were not things to which they could relate or in which they could participate. However, male participants indicated that despite the lack of diversity in their classes, the one thing that could bring them together with other classmates was sports because it defies cultural boundaries. Most participants agreed that despite the differences they had with their classmates, they could share commonalities in the struggles and experiences they share with their classroom experiences. Participants felt that having diversity in both the profession and the classroom were important to the care that their classmates would later provide to their patients. They felt that having more diverse practitioners was essential to enhance comfortability and trust of the minority patient when many do not trust or are fearful of the healthcare system. Participants felt that having more ethnically diverse clinicians allowed for patients to feel better understood. They also noted that by having more diverse classrooms, non-minority students could gain awareness of how to monitor cultural cues given by a patient and the cultural beliefs about healthcare held by the minority patient. One participant stated: So there needs to be more minorities in the field, especially in the hospital, to work with minority patients who understand the culture of minorities and communication patterns and gestures and so forth. Because, the reason why I feel this way is working with a CI, I experienced a situation where the CI could not read the cultural cues of the minority patient and understand the inherent distrust of the medical system that some minority patients have. Taking the extra step of empathizing and explaining to the patient family UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 51 would have helped the situation more and the CI could not pick up on this and was fired by the patients mother. (Participant #66) He discussed how the clinicians awareness of these cultural nuances or the lack thereof could impact the patients outcomes and the patients relationship with the healthcare provider. Another participant stated: I mean it's important especially with everyone when youre trying to build a relationship. It's hard when if youre from the North Side of Chicago and you come down here to these suburbs and youre trying to talk to someone about oh well hey how was your weekend and they say well my brother just got shot. And you don't know anything about that, you have never experienced stuff like that. I think when you speak to diversity, you're bringing people who share some of the same experiences with someone else, youre able to develop that rapport with them and improve patient care. A lot of people go to PT because, you know it's their only outlet so if they cant actually socialize and meet with you on different level what do you expect? I think that's the biggest thing that increasing diversity is going to mean a lot. Especially with the medical field a lot of people are scared to go to their physicians that they won't understand them, they wont get what theyre going through and thats why diversity is important. (Participant #33) Some participants noted they could see changes their university was trying to make in regarding diversity whether through full school diversity campaigns or increasing numbers of minority students in the classes behind them. However, many others echoed the sentiment that they did not see diversity recruitment efforts improving. Finding fit. Minority students found it difficult at times to find their fit in their DPT program. For most, it was difficult to find their fit amongst their fellow students. For a smaller UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 52 group of participants, it was complicated even further by coming to the program at an older age. Participants acknowledge that when in the company of non-minority students, they felt that their classmates did not always understand their experiences and cultural differences. For those who had other minority students in their class, they felt like sometimes they were understood better by fellow minority students due to common experiences. A participant noted, When I am feeling a certain way or having a certain experience I might reach out to one of my classmates who is a minority vs one whos not (Participant #15). One participant who did not have other minority students in his class expressed that at times class felt very lonely. Older participants in the classes expressed that while they were able to get along with their younger classmates, they struggled, at times, to connect with their fellow students. Some of this was due to feeling like they had different interests than their classmates, more life experiences than their classmates, or they considered their classmates to be immature. One participant acknowledged how she is not able to relate to her younger classmates: I think I limit my time with them. Im one of the older people and most of them are fresh out of college. Im one of the older classmates, so I know how to diplomatically deal with people. I probably wouldnt hang out with them on a regular basis, but while were in class and we have a project to do, Im fine with them. Its just I dont do a lot of hanging out after because I feel like its a lot of immaturity and Id just rather not deal with that. Thats pretty much it. While were doing school stuff Im fine but if you guys are hanging out at somebodys house, playing beer pong, Im like no thank you. (Participant #13) Clinical experiences. While most participants indicated positive clinical experiences, some expressed that they had frustrating experiences and were unsure if it was related to their race. One participant indicated that on her clinical, she was often automatically assumed to be a UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 53 CNA as opposed to a PT student. Another participant expressed that he was marked down for not being as social with the staff and that he did not understand how this factored into his performance of his job duties. A third participant noted feeling like he could do nothing right for his clinical instructor. He reported: But like everything I did was not good enough. She did say that I didn't address the physicians well or if physicians are in the room and I was asking the physician if it was ok if I saw the patient, she said it was unprofessional. And I was like I thought it was very professional. I had to start taking notes of everything she was telling me because I was like this dont make no sense. (Participant #54) When he questioned how she judged him he felt like he was being portrayed as the angry black dude. This same participant expressed how his experience with his clinical instructor made him uncomfortable with how some clinicians may view participants that look like him: I will say that my first CI said We are better than patients because we are more educated like we are doctors and all that. Which gave me insight into how she perceived me. You know we grew up with opportunities and we you know we got to do things they didn't get a chance to and I'm like well you dont know how I grew up I didn't grow up with those opportunities that youre talking about. You could easily be one of these patients that we treat here. Like my mom had me at sixteen. So I could have easily been a statistic like my friends and everyone else that was around me. I dont have any friends that have college degrees. I have a friend that didnt even graduate high school. So for her to say that really let me know kind of where her mindset was at. So shes kind of made me skittish to the PT world as a whole and Im thinking are these some of the professions and beliefs that the people who practice are holding? So I think that will always be in the UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 54 back of my mind. Hopefully I dont let it cloud my lens too much. But its something Im definitely aware of. (Participant #54) Introvert. Often participants mentioned the importance of creating a support system. However, for many of the participants, their introverted nature made it challenging to get to know others in their class. It often took increased time for them to grow comfortable with interacting with other students, especially those with whom they had less in common. Of the participants interviewed, eleven participants described themselves as introverts and an additional five saw themselves as both introverted and extroverted (initially introverted progressing to extroverted once they grow comfortable with others). One participant explained I kind of like to keep to myself and have my own personal time but especially in new situations, Im usually much quieter (Participant #12). Of the participants who indicated they were introverted, many noted that they preferred to sit back and observe first. Once they felt more comfortable, they would begin to interact with their classmates more. One such participant reflected: When I first got to school I was very quieted and introverted but as I kind of got more comfortable being there every day and being with the same 90 people. Im more outgoing and more willing to say hi and ask someone how theyre doing even though I might not necessarily hang out with them outside of school (Participant #15) Language concordance. For Hispanic students who spoke Spanish, they felt their Spanish speaking patients connected with them in a different way than they did with the clinicians that were supervising the students. They spoke of how patients were happy to see them in the clinic because they felt they could communicate with them. From the perspective of being a clinician, participants felt being able to communicate directly with the patient as opposed to UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 55 going through a translator or the patients family made communication easier. One participant said: When I work as tech a lot of people when we have a lot of Spanish speaking patients only and we know the PT can't communicate with them so Im there translating. And people are like oh Im happy you're going into the field because we need more people that look like you, that talk like you, and can relate to us so that kind of makes me hopeful. OK I can help, I can contribute more and try to help create improved patient care because I'll be able to communicate with the patient. I'll be able to build a better rapport with them. (Participant #33) Another participant highlighted that concept further: I look forward to helping the Hispanic community honestly. From what I've noticed just going into my observations and all that because I haven't seen too many Hispanic male therapists or therapists overall. When we do have a Hispanic patient that has to either communicate it through their son or through a translator interpreter its often times harder than they want it to be. So when I come into the office or to the clinic they often greet me with a really big smile and tell me like you know Spanish, obviously in Spanish theyre ok speaking to me now. So I feel like the conversation of being able to talk to a health care professional thats on the same level as them kind of they seem like they're just happier. So just that itself. (Participant #56) Program rigor. Nearly all of the participants expressed some adjustment to the rigor of the DPT program. They noted that the volume of information that needed to be learned in a short amount of time was difficult as was the workload. One participant described the workload as so UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 56 high that she just did not have enough hours in a day to do everything between class and studying. She noted: Well what I wasn't as prepared for I think was the workload. In undergrad it felt like the workload at the time felt like a lot but I was so busy with other things. And in PT school like all I really do is PT school and even then I feel like I just don't have the time that I need to go through all the readings, go through like everything that's required. Like I just am in class for so long that I run out of hours without sacrificing sleep. In PT school, all I do is to look forward to Friday to have a day to go to the gym and sit in a hot tub. I don't have enough time. (Participant #98) Another participant expressed how it was challenging to figure out precisely what should be studied and emphasized as he did not want to cram for a test, but learn the information that would be applicable to when he became a treating therapist. He acknowledged: I think that's the thing, I took so many tests in DPT school back-to-back to back-to-back to back, that it really, really disrupted my flow of studying. So I had to study faster, find some kind of way to study more efficiently, and my worry was that OK is this stuff actually going to stick or am I just cramming it into my head and the next week Im brain dead you know. So I had to pick and choose where somethings I was going to well what I ended up doing was I had to focus on, for one be very attentive in lecture about what the professor focused on and emphasized (made sure I knew that). And then for all the gray area stuff, learn it in a way that I think is going to be useful to me in the field and just let the grades work themselves out. That's what I ended up having to do and that strategy kept me more or less on a B, mid B path. And I just had to live with that. Id occasionally get an A, but for the most part, I was a B student. (Participant #66). UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 57 Still other participants noted that not previously having good study habits and not understanding what they needed to study to be successful was a great challenge as well. One participant shared his frustrations with his academic challenges in the program: So obviously Im not the ideal student. Me and school dont mix very well, but I have a goal and Im trying to accomplish it. And our program we have a probationary period. If you dont get a certain percentage on your exam grade then technically you failed the class no matter what your overall grade in the class is. And so I fell into that bracket with one of the classes. I was close to the [unintelligible] and I had to take a couple of semesters off until I could come back the following year and repeat that class again. I think obviously that whole adaptation component has been one of my challenges. Trying to figure out what do they want from me. Because, sometimes I feel like even though theyre preaching that they want us to learn the big picture and really develop an understanding of the material, I feel like I go away with that but when it comes time for the exam, its these minute details in the question that I couldnt recall. And then therefore, I get those questions wrong. So, thats definitely been a challenge of mine. Just really trying to figure out whats most important and delegate my time appropriately tobecause part of me is like I dont want to play this numbers game, I just want to make sure I pass. But yeah, thats where Im at right now. Taking a year off, you gotta do what you gotta do, pass, and move on with life. (Participant #46) Time management. To address the adjustment to the program rigor, participants had to improve in their time management. They noted that their schedule had to work for them even if it meant changing their studying time, sleeping habits, or building in time for themselves. One participant stated: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 58 I actually had to change my sleep schedule. Thats the biggest thing Ive had to do since Ive been in PT school so what I do now is usually my classes start anywhere between 8am-9. So, Ill wake up between 2:30-3:30 in the morning and I study before class. Go to school because usually its like a job like 8:30-4, 9-5 or something like that and Ill go to school all day and Ill come home and maybe like go to the gym, cook dinner, whatever I want to do to decompress mind. And then Ill maybe finish an assignment, but Im usually in bed by like 9-9:30. A lot of my classmates are the reverse like theyll stay up till 2:30 in the morning. But I find that my brain needs to rest. So Ill sleep like a couple of hours and then get up while my brain is fresh in the day, I can study more efficiently in the morning when I first wake up versus being in class all day, coming home, and trying to shove more information in my head. (Participant #13) Many have found that using a schedule or a calendar app helped them stay better organized with their time management. Other students cited their family and support system with helping them with their time management. Whether their family or significant others took on additional tasks or helped them with their studying, they noted that it allowed them to stay on task. When asked how she manages all her commitments, one participant who is a parent noted: Most days I cant. Thats why I rely a lot on my tribe: my mom, my dad, my brother, my husband, his dad, his aunt, like we have a huge network we reach out to that really helps out a lot. But, mainly its my husband who helps me balance. He takes on so much that I dont need to worry about it. Like working and balancing finances, thats huge so I dont have to spend time away from him or her working. (Participant #147) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 59 Some participants acknowledged the importance of building time into their day/week for the things they enjoy, time to decompress, or time to spend with family and friends. One participant stated: Scheduling out like personal time as well, scheduling out at least one to two nights a week with my partner and friends if I have time. Yeah. And I'm trying to think just like stress management. I make sure to have friends that are not in the program so I'm not always thinking about PT. So I get like a mental break from physical therapy and everything related to the program and etc.. (Participant #21) Academic preparation. Participants varied in how they felt their academic preparation for the DPT program was. For those who felt well prepared, they attributed it to their undergraduate major. Some participants felt their undergraduate major paralleled academic courses they would face again in the DPT program, thus making it easier to understand. Others noted their major (such as athletic trainer) prepared them for the non-academic related tasks of a therapist such as patient care skills. One participant stated: Uhhh I think my experience as a trainer kind of gives me practical experience with one on one working with a patient or working with a client. Thats been helpful with just like knowing how to conduct a session and how to build rapport and you know just overall how to conduct the session. My experience in undergrad just the didactic style knowing that kind of everything you are going to learn, you had to kind of just learn on your own and just having that mindset kind of helped me. Not looking for much help outside of just reading the book and kind of going on my own (Participant #54) Other participants had mixed views on their preparation. Due to previous work experiences, while they may have felt prepared for the non-book related skills (professionalism, UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 60 hands on skills, flexibility, communication, business acumen, and actual application to a real patient), they did not always feel as prepared for the academic coursework. This was noted mostly in students who had come to the DPT program later or as a career change. One participant stated: You know I feel like the thing I was best prepared in was like work ethic and professionalism based on my previous work experience. Just communicating with instructors and handling like a difficult caseload in a mature way and communication with peers and faculty members. Academically, I originally felt like I was a little behind because I was a non-traditional student. You know I hadn't majored in kinesiology or had a related major, but that was a very short-lived feeling. Probably within like a month I felt like I was up to par with my peers in terms of technical knowledge. (Participant #21) A final group of participants felt they were underprepared for the DPT program. Some of the participants who came to the profession after a career change felt that the course work they completed at junior colleges to meet DPT program requirements, did not prepare them well for graduate level course work. For some participants that did direct transition from undergrad to DPT programs, they acknowledged not having fully applied themselves during their undergraduate academics which they felt came back to hurt them. One participant noted: I don't feel likelike I knew that PT school was going to be hard, but like I was not prepared because I don't feel like I applied myself as much as I could have in college and that's why my GPA wasn't the highest so my study habits. I didn't know the best way for me to study. And I had to learn my first semester. I thought I was going to fail out. (Participant #65). UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 61 Perseverance. Four students mentioned losing minority classmates during their time in the program either due to grades or personal reasons. As retention of minority students is important, the concept of perseverance became important as well. Under-represented minority students interviewed for this study demonstrated multiple examples of perseverance during their DPT program. For some students it was persevering through academic struggles that they had never experienced in their academic career. One participant noted she was on academic probation after her first semester. Another participant explained her perseverance through failure: The greatest success Ive had (which was preceded by what I used to consider a failure) was that I failed an exam, and it was devastating to me. I never failed, like I haven't gotten a grade lower than a C since middle school. So I ended up failing a foundations exam last trimester and that was emotionally draining and upsetting. But I spoke with my grader and we set up things I could do to improve my study habits and change what I did for the next exam. And, for the following two exams, I got an A and a B. So to me the big success was kind of like and this has been like a complete change for me. This is my first time being on my own. I commuted from home to college so this was like huge. So I think a lot of it was just kind of establishing like oh hey it's okay to mess up and it's not the end of the world and you'll still be OK. But you can improve and you know you don't have to be sad about it. I think the biggest thing was just learning that I can overcome adversity. (Participant #15) Other participants spoke to how a particular class posed a challenge in that, if they failed the class they would not be able to continue. So, they had to learn how to modify study habits to turn their grades around. Two participants had to take off a full year of the DPT program and begin UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 62 again with class beneath them due to grades and personal injury respectively. One participant described challenges she faced and overcame in the program: I had a really rough first year. I was on academic probation by the third quarter. But I got off. And then I ruptured my Achilles the next quarter. So I had to take a leave of absence, a year off, so this is actually my 4th year. Im doing fine now. Everythings good. Its been a journey. (Participant #102) Giving back. Participants shared opportunities where they have been able to give back and share the profession with minority high school students. Other participants expressed that they would like to return to the communities from which they came to serve the patients and educate the youth of their community about the profession. To educate minority students about the profession, participants had the opportunity to either go out to high schools, video conference with high school students, or host students on campus. One participant remarked: So I am actually what they call the Diversity Committee student representative. So with that my main responsibility is to work with the community and try to get PT to be a career that students in (the youngest weve work with is middle school) usually either undergrad or high school were working with. Whether it's doing like video conferencing or having them come on campus to see the school and sit in on a couple classes. I think for me like having the whole aspect of being Hispanic, wanting to bring in people into the profession, or even just seeing them seeing like there are Hispanics getting higher education degrees has been really fulfilling for me. (Participant #98) Additionally, one participant noted that his minority classmates had created a mentoring group at his university for high school students interested in the health professions. One participant felt it important to expose high school students to the profession. She said: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 63 I have goals of going back home and trying to inspire some kids. My hometown we didnt have exposure to a lot of things. I cant think of anyone else in my graduating high school class who had their eyes set on becoming a physical therapist. (Participant #46) Some participants expressed a desire to return to their communities and to treat patients who may not have had someone who looked like them as a healthcare provider in the past. One participant noted Yes I would like to work with my population. The more I guess the more comfortable they see Ok, I have an African-American doctor who I can speak with and feel comfortable with and relate to. (Participant #60) Future racial fears. Some participants expressed the concerns they have as they enter the workforce. Their concerns center around knowing they may be the only person of color where they find employment and if they will find a good fit with their co-workers despite being a minority. They have fears about being their authentic self in a work environment and if they will face microaggressions. One participant stated: My concern about entering the profession is making sure being able to find a place that kind of allows me to be me, accepts me for who I am, how I look, my experiences, and the culture that I bring with me. Also, I dont expect them to just let me be ghetto or whatever, but I understand that I am unique to this profession, I bring different experiences and background, and I just need them to allow me to feel comfortable expressing those beliefs and behave in a way thats comfortable for me. So that's my biggest concern. Yeah and I feel like in the day if I can't find that kind of environment then I just have to create it myself. Create my own clinic. Do my own thing (Participant #54) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 64 Participants noted they think about how they will handle these situations that may arise due to their race/ethnicity and remain professional. Others were concerned about how they would be viewed in society and if their ability to perform their job would be questioned because of current racial tensions in America. One student expressed: Like I don't want people to my fear is that someone will belittle my accomplishments when I actually become a practicing PT. I don't want, especially in the climate that we live in right now, you never know who's going to say something and they're like I don't want to work with her because, you know, she's Mexican, I don't want to work with her or she doesn't know what shes doing because shes Mexican. That, I still kind of have like that fear that that might happen. But Im hoping everything turns out good. (Participant #33) The Village Reassures- Supporting the DPT Student Through the Program With the academic rigor of the DPT program, the need for adequate support systems for minority students becomes evident. Many participants noted that they did not have minority support groups on their campuses or designated resources for minority students to go to for additional support provided by the DPT program or university. The support that students did find came from a variety of sources including faculty, family/friends, significant others, fellow students, mentors, counselors, and faith traditions. Fellow students. Participants indicated their classmates served as a great support system and that they were able to bond over difficult coursework. Many participants noted they found support in their fellow classmates as they navigated classes together. Some participants found that having study groups with other students helped them do better in classes. Whether it be finding one person or a small group, most participants felt it was important to connect with other UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 65 students to succeed in the program. One participant stated I just attribute it to finding people that I study well with, a small group I would just say its about finding the people you work well with and struggle through it together. (Participant #14) However, there were some differences that minority students noted when interacting with their fellow minority students as opposed to non-minority students. Some participants indicated they had no other minority students in their classes, so they had a harder time finding a fit. Many other participants noted finding their closer friendship group in other minority students whether of the same ethnicity or another ethnic minority group. One student spoke about becoming a part of a Black Graduate Student Group at her school: We've been able to share things which has definitely been a nice experience just to kind of if there is something to bitch about there are people there who you know get it. You dont have to worry about what you say but it's kind of like I don't know it's almost like censoring myself. (Participant #15) A small number of participants expressed that despite having other minorities in their class, they did not always bond with those classmates and form close relationships. Reasons for this lack of bonding included differences in personal interests, personal conflicts between students, or natural factors that impact friendship formation. This was seen in both PWI and HBCU programs. Family and friends. Participants often noted the importance of the support of their family and friends. This support came in a variety of forms. For some students they were able to move back in with their parents or live with another family member which allowed them to both save money and have daily support within the home. Other participants spoke to the encouragement, listening ear, and advice that their family and friends provided: UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 66 I mean some emotional support like whether Im just venting or upset about something or stressed. Sometimes like it is I dont know what to call it but like stress where I have a specific problem and Im bringing it up and they help me troubleshoot through it (Participant #21) Participants who had begun young families spoke to the support system that allowed them to be a full-time student and a parent. Often time this support was comprised of their spouse or their parents. The support family provided them allowed them to focus on school and not have to be concerned with bills or childcare. One participant with a child who was 2 y.o. stated: Most days I cant [balance]. Thats why I rely a lot on my tribe: my mom, my dad, my brother, my husband, his dad, his aunt, like we have a huge network we reach out to that really helps out a lot. But mainly, its my husband who helps me balance. He takes on so much that I dont need to worry about it. Like working and balancing finances, thats huge so I dont have to spend time away from him or her working (Participant #147). In contrast some participants struggled at times with the support of family and friends. This difficulty arose from a lack of understanding by family or friends of the rigor of the PT program that made the participants less available for social activities. Often times the participant found that others did not understand the demands on their personal time that the program placed. One student reported, So I have a boyfriend hereIn the beginning it was a lot of just explaining, Im not blowing you off I literally cannot. I have a test, have a practicalonce we had that conversation it was fine (Participant #13) Faculty. The faculty for most DPT programs at PWIs was not noted to be diverse, with programs often having no minority professor or only one minority professor. Fourteen of the study participants commented on faculty diversity during their interviews. Of the programs at UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 67 PWIs, five of seven participants indicated having less than two professors of color. To the contrary, programs at HBCUs and HSIs tended to have the most diversity in the faculty as seven out of seven participants reported having two or more minority faculty on staff. Some participants believed that faculty played a role in their experience as a minority DPT students experience. Participants indicated they greatly appreciated faculty who were accessible and willing to help when they may have been struggling to understand a concept. Most noted that faculty were always available to answer questions or offered office hours to do so. When one participant was asked what aided in their success, they replied: Definitely my professors. Definitely their open-door policyThey're very beyond open door. They're very accessible. So like right now if I'm not understanding something, I can text my professor and he'll either give me a call or he'll text me back and respond so that I understand. So they do everything they can so they're like always accessible to us. (Participant #62) Some participants indicated there were professors with whom they were able to form special bonds because the professor truly cared about seeing them succeed. That was seen in a variety of ways whether it was taking extra time to ensure a student understood an area they were struggling in, helping a student obtain a tutor, being sensitive to a student who was having family or emotional issues outside of the classroom, or recognizing when the student needed extra encouragement and reassurance. Participants indicated feeling like they could connect with professors who were personable and relatable. One participant stated: I feel like they are very flexible. They are encouraging. We had a research presentation yesterday and I feel like the stress of that was kind of getting to me. But, they seen it in my body language. They asked me what was going on and if there was any way they UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 68 could help. And they kinda turned around my mood and brought my stress level down. Its things like that where they seem like they generally care about you. (Participant #54) Other participants, however, also noted some challenges with faculty. For those participants, they indicated that harsh tones in emails, indifference when delivering difficult messages to a student about academic performance, or apparent disinterest in a students concerns led them to not wanting to reach out to the academic staff for support. One participant stated: when I went to her office hours I just didn't feel like she wanted to help, so I never went back (Participant #65). Another participant shared his experience with faculty when he was having academic challenges: Nothing against them, but its been a little awkward. To an extent, I totally understand where theyre coming from. Its like ok youve made it this far, youve made it to a graduate program, some of these things youre gonna have to figure out on your own. And so I think thats the vibe that Ive gotten for the most part. Especially when I was going through that process of getting to the probationary period. We had a few meetings when grades were low and it was just kind of funny overtime after the second or third meeting it just got a little awkward. Because I felt theyre intent was to just make sure I was aware and to I dont know if it was to inspire me or help me to get things done (not to end up getting into the position I ended up in). But, I feel like those meetings didnt help and they hurt more than they helped. So they have an academic support system in place, but its not very strong. Thats something that I know somebody who works in the department wants to work on and I havent been able to foster a good relationship with any of the faculty. The relationships are all superficial. (Participant #46) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 69 Mentorship. Several participants highlighted the role mentorship played for them during the program. They indicated that they met their mentors through previous shadow experiences, work experiences, or an introduction by family or friends. They have been able to go back to these mentors when they have questions about the subject matter in class or for advice on navigating the profession as they progress toward graduation. One participant stated: But I go back to a lot of the PTs that I work with. A lot of them they're very open about, like I'll text them all the timeSo I reach out to a lot of my PTA friends from work and ask them like hey here's what I'm thinking can you give me your opinion and the same thing with the PTs that I work with a lot of them have specific certifications like OCS, Mackenzie, ummm like vestibular stuff. So Im constantly asking them. And like challenging what I learned in school and kind of regurgitate it to them so they can kinda tell me if I'm right or wrong and just ask them for advice. So, I look out to a lot of people I work with. (Participant #33) Some participants expressed the need for more mentorship for minority students from practicing clinicians, especially minority clinicians who look like them to help guide students and provide information in impoverished communities. One participant noted, I think where we really are lacking are things like mentorship programs and just access to information in general for students in like impoverished areas and just areas where school funding is just not up to par in general (Participant #) Coping strategies. Many participants indicated that coping strategies were needed to be able to get through the DPT program. They felt it was important to find a balance so that it was not just school all the time. Balance would include finding time for things like family/friends, UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 70 meditating, yoga, working out, or church. These things helped with managing stress. One participant stated: I just try to when I can, to balance what I enjoy doing. When I find time to do those things I do. And sometimes it may even be expense of studying, but I feel like its kind of important to give yourself that mental break or you wont make it through. (Participant#14) Other students have expressed that they needed to seek therapy to help them find ways to better cope during their time in the DPT program. One participant who attended counseling stated: Honestly, I have started going to counseling because I recently discovered through going to counseling that I have anxiety and social anxiety. So, the first thing was discovering that that was present and then from there we kind of started narrowing down things that were making me happy or less stress or things that I could do. So, one of the things is definitely working out, which is still hard to you know to do every day, but it's something I try and incorporate at least a few times a week. I also have found that one of the things that helps is yoga. But also like so when I'm sleeping, when I go to sleep I try and do yoga Nedra which is like a yoga practice with a deep breathing to help you fall asleep. That's something I do every once in a while. Yeah its a lot. But, I still go to counseling, I started taking medication and one of the other things is just keeping open communication. So Im really close with my roommate. I grew kind of apart from my parents. Not for anything that they did. I think it was just because I was so stressed. I think re-establishing that, being able to talk to my boyfriend, like those are all things that are kind of categorically reminded me that there are things in life other than school and you know in a few years time school will be done. (Participant #15) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 71 Discussion This study aimed to examine the lived experiences that underrepresented minority students have both before beginning and while pursuing their DPT degree. The account of these individuals experiences may provide further guidance for how the profession of physical therapy and DPT programs can better recruit underrepresented minority PT students to the profession and support them during both their application process and matriculation through the program to ensure their success. While the research has many implications, the study findings focused on the importance of early exposure to physical therapy on a students decision to pursue the profession, the factors that impact the students decision on which program to attend and the rigor they face upon program entry, the unique minority experience that underrepresented minorities have while in the program, and the important role of support to the success of the student in the DPT program. Tintos Theory The results of this study appear to align well with Tintos theory of student retention. His theory sought to conceptualize student departure in relation to how a student formed connections with individuals and their school environment (Tinto, 1975). The theory begins by acknowledging that a students commitment to their goal of completing an academic program is influenced by their family background, pre-college schooling, and their individual attributes. As they enter the academic program, they interact with the academic system as seen through grade performance and intellectual development (Aljohani, 2016). Simultaneously, the student also interacts with their social system which includes both peer group and faculty interactions (Aljohani, 2016). It is these interactions that lead to student integration both academically and socially. The level of integration the student experiences can impact their goal commitment and UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 72 institutional commitment either positively or negatively. If greater integration leads to a student having stronger goal commitment and institutional commitment, they are less likely to drop out of an academic program. While this theory was initially created for college student departure, it has been shown to be relevant in professional programs as well (Choi et al, 2019). Applying Tintos theory as it relates to this study, the importance of the concept of communal support for the URM student in a DPT program becomes apparent. As previously stated, there is an African proverb that states It takes a village to raise a child which means an entire community of people must interact with children for those children to experience and grow in a safe and healthy environment. (van der Rheede, 2010). Much like this proverb speaks toward supporting a child, it has been found in graduate level education that those who are able to develop relationships with faculty and other students are better able to work through social, emotional, and academic problems they may encounter (Figueroa & Hurtado, 2020). Community, in the context of Tintos theory, points to the community that is needed to help positively promote integration for the URM student and in turn strengthen not only the students sense of belonging, but also their goal commitment toward successful program completion. Various studies have examined academic resources and changes that schools can use to set students up for success. Additionally, a number of studies have been conducted that examine how to improve student relationships with other classmates and faculty for improved social integration. However, within the realm of healthcare disciplines, there appears to be just as much of a need for this communal effort both academically and socially prior to a student applying to or entering a professional healthcare program. The Pre-acceptance Community of Support UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 73 Tintos theory is primarily focused on student retention. However, as healthcare disciplines struggle to recruit minority candidates, it is just as important to focus on the communal effort that is needed to support the student prior to them getting accepted to a healthcare program. In 2019-2020, of the students accepted into DPT programs, 3.8% were African American, 7.1% Hispanic/Latino, and 3.4% students of mixed races (Commission on Accreditation on Physical Therapy Education, 2020, p.15). As the results of this study indicated, there are areas of opportunity that exists prior to acceptance in the DPT program. These opportunities include: exposing minority students to the profession early, mentorship of minority students once they express interest in the profession, the role guidance counselors play in connecting students with the resources needed, and opportunities for universities to create partnerships with minority serving institutions and bridge/pipeline program opportunities. Creating this community prior to acceptance in a program may help improve the acceptance rates of under-represented minority students in DPT programs as well as better prepare them for the academic rigor of the PT program. Exposure. Early exposure to the profession is critical in under-represented minority students knowledge about the profession and interest in pursuing the profession. The internal influences on young adults career choices are rooted in their early childhood experiences. These influences include the early exposure they had to potential future jobs, the development of their self-perception, feedback from their peers, and parental/familial influence (Messersmith, Garrett, Davis-Kean, Malanchuk, & Eccles, 2008). Participants who chose to pursue the physical therapy profession immediately post-undergraduate, often had personal experience as a patient or with a loved one who had undergone therapy. In other circumstances, the participant had been given the opportunity to shadow or have conversations with a physical therapist during their high school or UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 74 collegiate studies. Previous studies have shown that the more exposure, experience, and support a student has, the more likely they are to pursue a healthcare career (Veal et al., 2004; Zayas & McGuigan, 2006). One concern that remains an issue is how to better reach students who do not have personal experience with physical therapy. Brown et al. (2009) encouraged pipeline programs that start as early as elementary school through high school to both expose the students to health care professions and to ensure good preparation in the areas that would allow students to be successful in those health profession academic programs: math, science, and reading. The mentoring group Minorities in Medicine conducted a study of students and parents to better understand what strategies are most beneficial to expose students to healthcare careers and nurture a student into pursuing a healthcare career. The study found that participants desired a comprehensive, long-term program that provided exposure to various healthcare professions and practitioners, parent/student workshops, hands-on experiential learning, and mentoring by health care professionals (Holden et al., 2014). There were a number of programs that have been created to meet this need that are community based, school based, or virtual. Some high schools offer medical tracks while other organizations have created after school programming that include field trips to hospitals, area health profession programs, and labs (Holden et al., 2014). As students have the opportunity to learn more about health professions through the various programs, it is essential that physical therapy is represented. Practicing URM physical therapists and DPT students would be great representatives for the profession in program such as these. Their presence puts a relatable face to the profession which many may not often when they think of healthcare professions. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 75 Guidance. One new finding in this study was the number of students who came to the profession later in life due to the lack of early exposure or guidance toward the profession (Moerchen et al., 2018). For these students, many did not come to the profession until their late twenties or early thirties. Those students had worked in other professions, had started families, and had difficulty relating to younger students in the program. They found themselves having to take additional classes to qualify for the program and feeling slightly behind their classmates upon entering the DPT program. In some ways these students had become a double minority: both ethnically and in age. One student, despite knowing she wanted to go into physical therapy in high school, was unable to find the proper guidance on direct admit programs due to limited knowledge of her guidance counselor about the profession and no access to therapy mentors to help guider her through the process. This poses a concern as that lack of guidance caused her to take a longer path and more years in school to reach her goal of entering a DPT program. If students are not able to receive the guidance they need toward pursuing the profession, it may leave students underprepared for the program or more likely to pursue other majors. Due to a potential lack of exposure to health careers, the role of the high school or undergraduate advisor becomes more important for URM students. However, often advisors do not have much expertise in health care careers and may offer poor advice that may discourage a student from the health care professions (Toretsky et al., 2018) Mentorship. One way the village can nurture the pre-DPT student is through mentorship. Mentorship is a great support tool for students who are interested in the profession of physical therapy. Participants in this study spoke to the importance of mentorship for URM students interested in physical therapy by clinicians who look like them. This mentorship could provide students insight on what classes to take, how to prepare for the DPT applications and program, UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 76 how to choose a school, etc. Pipeline programs that have paired minority professionals with high school students interested in health professions found that when this pairing occurs, there was better understanding of the role culture plays on the guidance a student needs, mentors helped the student find their way, and they assisted the student with the career they choose (Henry-Noel, Bishop, Gwede, Petkova, & Szumacher, 2019). The hospital based mentoring program for high school students, The Reach One Each One Program early experience found that of the students mentored through the program 81% of participants expressed a likelihood to pursue health professions (87.5% actually went on to a health profession program) as opposed to only 30% of their classmates who did not go through the program (Danner et al., 2017). Danner et al. (2017) noted it was the direct interaction with the hospital personnel from diverse backgrounds that had the largest impact on program participants. Many participants of this current study expressed they want to return to their hometowns and serve as a mentor to future students who are interested in healthcare. URM physical therapists, especially recent graduates, would be great in the role of mentorship for URM students interested in pursuing the profession. The URM PT can provide guidance for the student on applying to and navigating through the program. But, even more beneficial, they can understand the unique challenges that the URM student may face and advise them how to work through them. They also serve as an example to URM students that completion of the program is possible for someone who looks like them. Role of the university. Universities also have opportunities to help foster community for URM students who are interested in the field of physical therapy. One key area is the effort they make with regard to recruiting URM students. Wise et al. (2017) found four themes that most influence the ability of PT programs to recruit and retain students which include: financial aid available to URM students, the characteristics of the institution (minority serving institution UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 77 [MSI] vs PWI, location, etc.), the institutions strategy surrounding recruitment, admission, and retention, and characteristics specific to the program such as reputation and competition with other health care professional programs. More specific challenges that could impact recruitment could be competition from other health professions, the lack of promotion of the profession to URM students at younger ages, admission criteria heavily reliant on GPA/GRE, the lack of a coordinated recruitment effort, and a student body not perceived as diverse by potential applicants (Wise et al., 2017). One participant in this study indicated diversity was important to her and played a large factor in the school she chose to attend. Other participants expressed choosing not to apply to certain programs based on their admission standards which they felt would make them a less considered applicant. There were a number of factors that played a role into how participants of this study selected a DPT program. The participants of this study identified cost, location, school reputation, program diversity, previous connection to a program, and program requirements as criteria that impacted their decision on which schools to apply to and which school they chose to attend. This aligns with a prior study that found the three factors most important to the choice of which physical therapy program a student chose to attend were costs, diversity, and program faculty (Wilcox, Weber, & Andrew, 2005). However, there were a number of participants who indicated that they only had one school accept them, so that is where they went. A couple of participants noted having to apply more than one year before they were accepted in any program. This brings about further questions on what can be put into place to better prepare students academically to meet competitive program pre-requisites and be highly appealing applicants to DPT programs. Many URM students often receive lower grades in math and science gateway courses on the collegiate level often due to fewer resources on the high school level leaving students under prepared. The UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 78 Healthforce Center at UCSF and the US Department of Health and Human Services found in their research the potential for universities to create strategic institutional partnerships with junior colleges, MSIs, or schools in areas with large minority percentages, in a direct effort to recruit a more diverse student body (Lundy-Wagner, Vultaggio, & Gasman, 2013; Toretsky et al., 2018). MSIs have shown great ability to prepare URM students for doctoral studies (LundyWagner et al., 2013). These strategic partnerships could include: identify and nurturing potential applicants to professional programs or creating bridging or summer enrichment programs. (Toretsky et al., 2018, p.10). Both components help increase students knowledge as well as expose them to and prepare them for a health professions career. Therapy programs can work with their universities to create pipeline or bridge programs (for high school or college students) that give students a chance to take additional science courses, test and study skill prep, as well as introduction to components of the profession (Brown, Flattau, &Altarum Institute, 2009; Toretsky et al., 2018). These programs not only increase exposure to the profession, but they also help increase the students ability to be a competitive applicant and have greater ability to cope with the academic rigor of the program once accepted. Only two participants indicated they had participated in programs in high school that exposed them to the profession of physical therapy. For the students that indicated they were only accepted to one school or who had to wait a year to apply to more programs due to not being accepted, it is unclear what the DPT programs they applied to used in their decision-making process for applicants (holistic vs GPA/GRE admission practices). There has been research to look at the benefits of using a more holistic approach to admissions as opposed to more strictly prioritizing GPA/GRE. Wise et al. (2017) found that, for those programs who did use holistic admissions, the most common noncognitive UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 79 factors they considered were communication, professionalism, and leadership. Not taking into account noncognitive attributes during the admissions process, could potentially exclude students from educationally disadvantaged backgrounds (Wise et al., 2017). Toretsky et al. (2017) noted that it is also important for those who sit on admission committees to undergo implicit bias training as implicit bias could exacerbate underrepresentation in health professions schools (p.15). There were a couple of studies completed that could impact African American acceptance in DPT programs as they indicated African Americans scored lower on standardized tests and that race, ethnicity, GPA and GRE scores were useful at predicting academic risk (Hardy, 2015; Utzman, Riddle, and Jewell, 2007). These studies could make programs leery about the students ability to pass the NPTE which is linked to a programs accreditation. Traditionally, HBCUs attempt to give students of color a chance when other universities will not. However, Howard University (an HBCU), after almost losing their accreditation for students not passing the NPTE had to review their acceptance criteria and boost their required GPA/GRE scores (Greene & Karavatas, 2018). This speaks to the delicate balance that has to be considered during program admissions to see the whole student while at the same time being realistic about the academic rigor that is required. However, studies have shown that despite lower standardized test scores, African American health professionals who scored lower still were able to perform at or exceeding that of other groups upon graduation (Capers & Way, 2015). The Post-acceptance Community As highlighted previously, Tintos theory focused on student retention. The earlier part of this discussion section examined how this model could be expanded to the community a URM student needs prior to acceptance into the program. However, this study also confirmed many of the elements within Tintos theory when it is applied to retention of the URM student in DPT UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 80 programs. The theory identified that students come to an academic program with their past educational history, family background, and individual attributes (Tinto, 1975). Many participants in this study came from very diverse high schools or undergraduate institutions. With this experience of coming from diverse learning environments, entering the DPT program where they were severely in the minority, left many students in a state of shock and concern. Morrison (2010) also found that minority students at times found themselves surprised by rude, ignorant, or politically incorrect statements made by their White counterparts (p. 998). While more than 50 percent of this studys participants had parents that attended college, there were still 41 percent of students whose parents had not attended college (with one participants parents only completing grammar school). Students with parents who did not have a college degree, were found less likely to persist through college due to their parents inability to emotionally/financially support them through challenges given the parents lack of experience in college (Bird, 2018). Although socioeconomic status was not examined during this study, a number of participants mentioned coming from lower middle-class homes. Ma (2009) found that students who can be categorized as a racial minority (regardless of socioeconomic background) or who come from lower socioeconomic backgrounds are more likely to choose a life/health field as a career because these careers generate more job opportunities and higher economic returns (p. 223). Each of these variables that may be a part of the URM students background are a factor that may influence their experience while in the DPT program. Following Tintos theory, it is critical that DPT programs help foster immersion into both the academic system and social system. Both systems will be impacted by the students previous experiences and internal motivations. But, it is imperative for DPT programs to find new ways to UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 81 address both systems as they both impact the URM students sense of belonging in the DPT program and will maximize their success in the program. Tinto stated: ...the more time faculty give to their students, and students to each other, the more likely are students to complete their education. Both academically and socially, such informal contacts appear to be essential components in the process of social and intellectual development of individuals and in the rewards they seek in entering higher education...institutions should encourage those contacts whenever and wherever possible (Tinto, 1982, page 697). Tinto and Pusser (2006) went on to create a model of actions the institution needs to take to aid in students success. This model illustrated five characteristics important to student success: institutional commitment, institutional expectations, support, feedback, and student engagement/involvement (p.6). The institution must have a commitment to student success that starts with academic leadership and trickles down to those who directly impact student performance. While there are multiple forms of support needed (academic, social, and financial), Tinto & Pusser (2006) list a few concrete ways institutions can provide support: financial aid; academic support in the form of advising, tutoring, study groups, and academic support programming (supplemental instruction); and social support in the form of counseling, mentoring, and ethnic student groups. Academic support. Academic programs need to be creative in their approach to strategies that help students succeed given the academic rigor of the DPT program. Once participants were accepted in DPT programs many expressed the challenges they had with the academic rigor of the program and their feelings of being unprepared. Amaro et al. (2006) found the same in nursing programs with some students being challenged by the workload, study UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 82 demands, and complexity of information. However, the participants in this study did not speak of any resources they were offered to assist with these challenges other than office hours of the professor. When Howard University sought to find ways to improve their DPT student success, they found that spreading out a compressed academic program to include a summer session at the start of the first year helped decrease the workload on students during the critical first academic year (Greene & Karavatas, 2018). To further support student success, tutoring may be beneficial (Toretsky et al., 2018). In addition to the Howard University DPT program spreading out their academic calendar, the program scheduled remediation sessions that were available twice a week for all students and required faculty members to participate in the remediation process by reaching out to students who scored less than 80% on exams (Greene & Karavatas, 2018). By implementing such programs, Howard University DPT program was able to see improvement in student success and National Physical Therapy Exam (NPTE) pass rates. Between 2013-2015, the NPTE pass rates were 55%, 70.1%, and 72.7% respectively which was below CAPTE standard of 85% (Greene & Karavatas, 2018, p. 54). However, following the interventions the program implemented, the NPTE pass rates over the 3 cohorts post intervention (between 2015-2017), saw improved scores to 90%, 100% and 100% respectively, (Greene & Karavatas, 2018, p. 57) Mentoring is just as important to the DPT student while they are in the program as it was prior to their acceptance in the program. In previous studies, good mentorship/advising was identified as a successful way to help students navigate through new and difficult academic situations (Felder, 2010; Melillo et al., 2013; Zell, 2014). Mentoring can also help develop social connections as well (Dickey, 1996). Those who serve as mentors may be faculty, peers, alumni, or others connected to the university or the student. Both hierarchical (faculty, advisor, etc..) and UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 83 peer mentoring have been shown to positively impact GPA and retention (Collier, 2017). Dickey (1996) found that: Mentoring systematically addresses causes of culturally diverse student attrition and delayed graduation by 1) promoting greater student/faculty contact, communication and understanding; 2) encouraging the use of university resources designed to aid students with nonacademic problems; 3) intervening promptly with academic difficulties; and 4) creating a culturally validating psychosocial atmosphere. (p. 12) Faculty mentors can help expose students to new research areas and inspire students especially if they share racial/ethnic concordance. But, often-times, programs lack mentors who are racially or ethnically concordant with the URM student due to the lack of minority faculty (Toretsky, 2018). It is suggested that when non-minority faculty participate in mentoring, they should seek out professional development opportunities that allow them to develop multicultural competence and participate in self-reflection and awareness (Thomas, Willis, & Davis, 2007). Some participants of this study expressed their desire to have more minority clinicians who look like them serve as mentors and to help guide them through the profession. Students who reported a clinician, teacher, or professor as someone whom they considered in their support network were found to be higher achievers (Vaughn et al., 2015). This further exemplifies the importance of that mentoring relationship to a students academic success. Peer mentoring has been found to be beneficial as well. The advantages of peer mentoring include it can be provided at a lower cost than faculty mentorship and there is an increased likelihood of the mentee following the advice of the mentor due to a shared common perspective (Collier, 2017). Peer mentorship also helps provide additional opportunities for socialization. The University of Mary Washington created the RISE program for first year URM students where they are paired with an upper UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 84 classman with similar background in an effort to provide connection and support during their transition onto campus (University of Mary Washington, 2020). In addition to mentoring, some health programs also used peer tutoring to provide support to their students (Torestsky, 2018). While some participants mentioned having a physical therapy mentor outside of the DPT program, no participant in this study mentioned having a teacher or peer mentor. This is an area for development that DPT programs should consider to help aide in student success. Participant intrinsics. Tintos theory of retention points to how students bring with them to the program their own sources of motivation to succeed (whether internal or external). Participants in this study expressed internal pressure they placed upon themselves due to advice they had been given by their parents that as a minority they would have to work two times as hard to be considered equal. A previous study noted that minority students may create high selfexpectations that increase stress (Cokley, McClain, Encisco, & Martinez, 2012). Most participants in this current study were high performers in high school and undergraduate. As such, participants indicated they at times put intense stress on themselves to do well or to carry the expectations of their family with them. For some students, parents can unknowingly create increased anxiety for their child to excel in school as well as may demonstrate poor coping strategies themselves when they experience stress which can be passed down to a student at a young age (Johnson & Descartes, 2016). Pressure to succeed whether internally or externally can serve as a source of stress for students as they navigate the academic rigor of the DPT program. It is important for students to learn how to manage their academic stress or it could potentially impact their academic performance (Pascoe, Hetrick, & Parker, 2020; Sakitri, 2020). In a similar way, some minorities may carry the burden of stereotype threat where they feel their professors and other students have preconceived negative stereotypes about their UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 85 capabilities and thus they stress to not live up to those negative stereotypes (Toretsky et al., 2018). While Tinto addressed what a student brings to the program, often times when participants were placed in classrooms that were not diverse, it also impacted them academically and socially. Previous studies indicated that minority students could feel the lack of diversity represented in their educational program (across students and faculty) which limited the availability of ethnic role models, limited support available to the minority student, and created feelings of isolation (Amaro et al., 2006; Coleman, 2006; Veal et al., 2004; Wong et al., 2008). A couple of participants mentioned feeling a type of imposter syndrome being an underrepresented minority student in their class. As was previously defined by Clines and Imes (1978) high achievers may struggle to see their success as due to their hard work, but instead as the result of external forces. In this case, URM students questioned if they were in the program because they deserved to be there academically or because they met a quota. This belief can both be impacted by the academic and social connections of the program and can impact the students ability to create connection in these two areas. If a student finds themselves struggling as they adjust to the academic rigor of the program, they may begin to doubt they belong in the program. Additionally, when they realize they are in such a non-diverse environment, they may struggle to believe they belong in the group and may worry about how their classmates perceive them. But, the feeling of imposter syndrome could also have negative impact on academics and social networks as the student may begin to under-perform academically or be less open to forming social networks with those who come from different backgrounds than them. This speaks to the importance of helping a student attain academic success as well as feel a part of a social network to both decrease the stress of expectations and feel that they belong in the program. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 86 Social support. The social systems students are able to form while in their programs is just as important to their integration into their DPT program as the academic system. Students who lack a sense of belonging are at greater risk of underperforming and of leaving the program early (Vaughn, Sanders, Crossley, ONeill, & Wass, 2015). Relationships are key to developing that sense of belonging. These relationships include those that are had with other minority students, those formed with non-minority classmates, and those formed with faculty. Participants in this study noted that if they had minority classmates, they tended to form tighter, closer friendships with those classmates. Students have been found more likely to be friends with those of same ethnicity or gender (Vaughn, Sanders, Crossley, ONeill, & Wass, 2015; Woolf et al., 2012). Some participants in this study indicated they felt more of a connection with other URM students in their program. Many participants noted they had some difficulty finding their fit amongst their non-minority classmates. In previous studies, due to the lack of diversity, and feelings that both teachers and other students dont understand or dismiss them, minority students often reported feeling as though they did not fit in and that faculty did not support them (Coleman, 2006; Gasman et al., 2008; Veal et al., 2004). Participants in this study noted due to their feelings of not being understood by non-minority classmates, they tended to gravitate toward other minority students. This too was found in previous research by Coleman (2006), Gasman et al. (2008), and Zell (2014). Additionally, participants spoke about the unique cultural experiences they had that separated them from their non-minority classmates. These experiences included familial commitments, self-induced standards, and lived cultural experiences that they felt fellow classmates could not understand. Participants felt non-minority students at times had difficulty understanding issues that impacted minorities in society. Consequently, many students formed relationships with other URM UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 87 students because they felt like students of similar ethnicities shared common experiences with them that made it easier to relate and have open conversations. Universities and DPT programs need to consider ways to help facilitate URM connection. One such way is peer support groups. One participant expressed that the first time she felt understood and comfortable sharing her feelings was when her school started a Black Graduate Student Group. The peer support component of programs is vital because it provides entering students with a cohort of peers with similar interests and backgrounds who understand the challenges they face and can offer practical advice for surmounting them (Torestsky, 2018, p. 21). The peer support group can also help students discuss concerns and build camaraderie (Brown et al., 2009; Morrison, 2010). Williams, Thakore, and McGee (2017) created a career coaching program to help provide social support to URM students. In that study, the biomedical science PhD students were separated into smaller coaching groups where a diverse mix of students (race, gender, institution, ethnicity) were guided by a faculty coach in a non-competitive environment. Discussions focused minimally on scientific topics, but primarily on issues related to career planning and professional development, as well as issues related to diversity, discrimination, and being different in science (Williams et al., 2017, p.4). These groups were found to provide a source of emotional, informational, and appraisal support where participants felt cared about, received support for professional development, and were able to validate and also normalize one anothers concerns (Williams et al., 2017, p.34). While it may not be possible to duplicate this model in all DPT programs, the formation of small diverse groups for class discussions and projects may be just as beneficial (Tinto and Prusser, 2006). Developing relationships with non-minority students in the program is just as important for URM students to do. By doing so, students may have the opportunity to be exposed to UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 88 additional resources (Vaughan et al., 2015). Tinto (2006) advocated for learning groups and problem-based learning strategies to foster active engagement of students, which subsequently helps with integration. In DPT programs, social systems can be formed as the result of academic integration that occurs during study groups and course work (Choi et al., 2019, Figueroa & Hurtado, 2013). Participants spoke to the support they received from fellow classmates as they navigated difficult times together. They often formed study groups with both minority and nonminority classmates. Zell (2014) found that students created peer networks which served as a source of support and resilience. When students develop these connections they have improved success in the classroom because of a culture of trust, inclusion, and acceptance (Choi et al., 2019, p. 2158). To foster that trust, inclusion, and acceptance, programs need to create strategies to incorporate discussions on diversity issues as well as provide experiences to work with diverse populations (Brown et al., 2009; Morrison, 2010). Some of the participants in this study spoke to how they felt discussions on diversity issues in their class did not go deep enough or were not completely accurate. This placed them in the uncomfortable position of if they should speak out about the inaccuracies and if they did so would they represent their entire race by doing so. It would be important for faculty leading the discussions to be culturally competent and participate in ongoing training to remain culturally competent (Brown et al., 2009). Additionally, having students recognize their own racial biases helps create more welcoming environments for the sharing of diverse perspectives by their classmates (Choi et al., 2019). By taking these measures, the URM student may feel more comfortable with engaging in challenging conversations with their non-minority classmates and feel more of a sense of belonging. One interesting finding from this study was the number of students that described themselves as introverts. Given that physical therapy is a profession where the clinician must UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 89 interact with others on a regular basis, this finding comes as a surprise. Having an introverted personality as a student may only further contribute to difficulty establishing social connections. Condon and Ruth-Sahd (2013) observed that introverted individuals tend to socialize less than extroverts because they prefer to spend substantial amounts of time alone (p. 506). Furthermore, introverts may not readily share their feelings or volunteer information (Condon & Ruth-Sahd, 2013). The lack of socializing with other classmates and the limited self-disclosure, may help limit a students ability to find fit with other members of their class. Introverted students may also have difficulty approaching faculty which can impact them asking for assistance or seeking clarification (Condon & Ruth-Sahd, 2013). This lack of communication with faculty may then impact their academic success. Faculty have been found to have an important role in the socialization of the doctoral student. Participants of this study found professors who made themselves available and who made students feel they genuinely cared about them served as a great source of support. Shaikh et al. (2004) noted that teaching faculty could help students dealing with stress by simply being interactive and friendly. Gardner (2010) however found that while doctoral program professors understood their role in student socialization as career preparation, not many considered the role they play in helping the students be socialized within the program itself. This could pose a problem as it could lead to professors not fully understanding the impact they have on students as well as possibly limiting efforts that encourage class interaction. Students who report having high interaction with faculty and staff generally continue to do so throughout the graduate program meanwhile students with low interaction continue to have low interaction if no targeted intervention occurs (Jeong, Litson, Blaney, & Feldon, 2020). For students who do show improvement from low interaction to higher interaction, they were more likely to do so with their UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 90 peers than with the faculty (Jeong, Litson, Blaney, & Feldon, 2020). OMeara et al. (2017) found that students relationships with their professors and mentors were one of the most important factors in increasing the graduate students sense of belonging. For URM students, finding this sense of connection with faculty may be a little more difficult. As has previously been noted, URM students often experience a lack of minority faculty role models which may leave them feeling isolated. This was evident during this study as participants attending PWIs often had only one to two minority professors in their DPT program. According to the U.S. Department of Education (2020), black males, black females, and Hispanic males account for only two percent of full-time professors in the United States while Hispanic females, American Indian/Alaska Native individuals, and individuals of two or more races account for less than one percent. Some participants noted that the lack of diverse faculty impacted their lectures on diversity because it was not presented from a diverse lens. In contrast, participants at HBCUs commented on the supportive relationships they had with staff in their program. Students have reported having greater academic validation when the faculty is diverse (Hurtado & Ruiz Alvarado, 2013). Brown et al. (2009) noted that faculty from the same URM background can serve as a source of support and that is why is important for academic programs to actively implement recruitment and retention strategies for minority faculty. Support plays a large role in participants success during their DPT program. That support came in a variety of different ways for study participants. Study participants often turned to family and friends for additional support in times when they were having difficulty or were frustrated. This is in alignment with previous studies where as a coping strategy, minority students used peer and family support; those who encourage and motivate them during difficult times so that they do not quit (Amaro et al., 2006; Veal et al., 2004; Wong et al, 2008; Zell, UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 91 2014). One area of support that was not spoken of however, was formal support programs created by the DPT program or university for minority students. DPT programs studied in the past have successfully employed retention strategies that included tutoring, study skills and test taking interventions, career and academic advising, and allowing for cultural diversity discussions and integration into the program (Haskins & Kirk-Sanchez, 2006). Having programs like these would appear to be beneficial to minority students going through a DPT program. Shaikh et al. (2004) noted that it may be beneficial to educate students in their first year on time management and stress management so that they are better prepared to deal with the stress that comes with managing the academic rigor of the program. Sakitri (2020) also highlighted that students should be given stress management principles to help with coping with stress. A few participants in this study mentioned seeking counseling to help them with coping during the DPT program. Brown et al. (2009) noted in addition to helping students adjust to academic demands and graduate experience, URM students may find the need for counseling to be able to deal with confronting negative stereotypes, having to explain their culture to majority students, and feeling obligated to support other members of their group facing similar struggles (p. 21). As such, Brown et al (2009) suggested schools should offer these counseling services by a diverse group of counselors. It is important that programs recognize the various types of support students may need to be successful. For students to have good retention and success in a program it is important that programs identify early when a student is not demonstrating academic and social integration (Choi et al., 2019). Once these issues are identified then intentional mentoring, facilitated study groups, selective peer tutoring, and increased positive faculty interaction may improve goal and institutional commitments (Choi et al., 2019, p. 2159). DPT programs would greatly benefit UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 92 from understanding the unique needs of the URM students. They also must be committed to putting in place both the academic and social supports that assist with student success. Limitations One area of limitation for this study was the recruitment phase of the study. Recruitment of participants through flyers (sent to college campuses) did not yield the desired number of participants. Due to the low number of minority students in PWI programs, it appeared to limit the available number of participants the flyer could reach at each of these schools. Social media proved to be a much more effective way to recruit students using student PT groups for minority students, speaking directly to professors at HBCU programs, and snowball sampling from students referring fellow minority students with whom they had relationships. Another limitation was the difficulty finding Native American students to participate in the study. Despite efforts to reach out to various reservations and two Native American physical therapists, no students were identified during this study to interview. The last limitation was being able to connect with Hispanic students in HSI PT programs. While an interview was conducted with one student from an HSI, she was not Hispanic and did not provide any additional classmate names for the study. Due to this limitation, further study with this population may be warranted. Future Research Data from this study revealed areas where additional research could be beneficial to the physical therapy profession. One such area of future research would be studying the role of high school guidance counseling and healthcare pipeline programs in exposing students to the profession and preparing them to be successful in a DPT program. Gaining better understanding on the influences of these two factors could provide better direction on how to recruit minority students at a younger age. It will also give insight in how to both prepare the students to be UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 93 competitive in application cycles and to be successful with managing the academic rigor of the DPT program. Another area that would benefit from further research is the use of holistic admissions in DPT programs. As further diversity is encouraged in the profession, it would be important to study if applicants who are reviewed holistically would be as successful in DPT programs as those where admission is highly weighted on GPA/GRE scores. If so, there may be a number of minority student applicants who could be given an opportunity for acceptance in DPT programs where previously they had been rejected for not having the desired test score. A third area that would benefit from further research is the support programming that DPT programs are able to offer students and more specifically underrepresented minority students. This may include support systems offered by either the university or the program itself. In doing so, it will help provide context on what things help underrepresented minority students feel better fit in their DPT program, cope with issues where they feel the impact of a lack of diversity, and assist with navigating the academic rigor of the program for successful matriculation through the program. A fourth area that would benefit from further research is understanding the lived experiences of under-represented minority PT clinicians. This research could provide further insight into the experiences under-represented minorities have with fellow medical colleagues and patients as they progress through their physical therapy careers. Information from such research may assist w/ ensuring diversity of hiring and understanding how to better prepare role models for URM students interested or matriculating through the DPT program. Lastly, some additional areas that may benefit from further research are not specifically related to only URM students, but may have an impact on those URM students who came to the UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 94 profession later in life. As some of the minority students came to the profession later due to lack of exposure, additional research understanding the experience of the older learner in DPT programs may be beneficial. One other area for future research in this category is understanding the lived experiences of students who have children while in the DPT program. Further research in this area may help guide support systems that are needed for this unique population to assist the student in successful matriculation. This research is need especially if more older students are entering the profession as opposed to the more traditional student going straight from undergraduate to the DPT program. Conclusion This study examined the reflections of lived experiences of under-represented minority students throughout their preparation and application for DPT programs as well as their matriculation through them. African American and Hispanic students in DPT programs on PWI, HBCU, and HSI campuses were engaged as participants. After reviewing the outcomes of 22 semi-structured interviews, our analysis resulted in the following conclusions (1) Early exposure to the physical therapy profession is critical to the recruitment of underrepresented minority students; (2) URM students experience unique challenges during the DPT program; and (3) Strong support systems are essential for underrepresented student retention and success in the DPT program. While these results are consistent with those of previous studies, this study additionally found that URM students benefit most when they receive support as they prepare for successful admission into a rigorous DPT program and throughout their professional DPT programs. Further research should examine the role of pipeline programs in preparing underrepresented minority students for DPT programs, the role that wholistic admissions play in UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 95 expanding the number of underrepresented minority students in DPT programs, and the various forms of support programming that DPT programs offer their students (especially the underrepresented minority students). The current social climate in the United States has shown more than ever the inequities that exist for minorities across various facets of life. With health disparities disproportionately impacting underrepresented minorities, it is critical to ensure that the members of the healthcare team are able to represent, through a culturally sensitive lens, the needs of the most vulnerable. Clinicians who originate from similar backgrounds are the best equipped and most likely to do so. With the ultimate goal of increasing diversity in the profession of physical therapy, this studys results point to the continued need for the profession to find creative and innovative ways to bring awareness to young URM students about physical therapy, but even more so to aide in their academic preparation for the profession. This will require DPT programs to examine their outreach, their admission processes, and their strategies for maximizing both recruitment and retention of the underrepresented minority students in their programs. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 96 References Akbolat, M., Karakaya, F., & Ugan, ., & Durmu, A. (2017). The effect of trust communication in patient-physician relationship on satisfaction and compliance to treatment. International Journal of Health Medicine and Current Research 2(4), 610-619. Alabama State University. (2017). ASU Quick Facts 2017. 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Retrieved from: http://www.nova.edu/ssss/QR/QR19/zell85.pdf UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 113 Appendix A Volunteer Recruitment Information SEEKING VOLUNTEERS FOR A RESEARCH STUDY The purpose of this research study is to explore the personal experiences of underrepresented racial/ethnic minority DPT students and what contributes to successful matriculation in the DPT program. To participate in this research, you must: Be a 2nd or 3rd year DPT student Be of the following race/ethnicity: Black, Native American, Hispanic, or Alaskan Native Participation in this study involves: A time commitment of 45-75 minutes Being available for an in-person (on campus) or web based interview One follow-up review of data via email To find out more information about this study, please contact Leslie Buckner at: Phone: 708-250-1654 Email: bucknerl@uindy.edu Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Experience of Underrepresented Racial/Ethnic Minority DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Experience of URM DPT Students Contact: Leslie Buckner Research Study: The Phone: 708-250-1654 Research Study: The Experience of URM DPT Students Contact: Leslie Buckner Study Title: The Experience of Underrepresented Racial/Ethnic Minority (URM) Doctor of Physical Therapy Students Principal Investigator: Leslie Buckner PT, MPT UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 114 Dear Student, My name is Leslie Buckner and I am a doctoral student at University of Indianapolis. I am currently seeking underrepresented minority students racial/ethnic minority doctor of physical therapy (DPT) students to participate in a research study. This would include DPT students who are: Black, Hispanic, Native American, or Alaskan Native. The purpose of this study is to explore the personal experiences of underrepresented racial/ethnic minority DPT students, the factors that led to them pursuing the physical therapy profession, and what things contribute to their successful matriculation in the DPT program. Participation in this study involves: A time commitment of 45-75 minutes Being available for an in-person (on campus) or web based interview One follow-up review of data via email For more information about this study, please contact the primary investigator, Leslie Buckner, by phone at 708-250-1654 or email at bucknerl@uindy.edu. Thank you, Leslie Buckner PT, MPT Primary Investigator Study Title: The Experience of Underrepresented Racial/Ethnic Minority (URM) Doctor of Physical Therapy Students UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 115 Appendix B Study Information sheet INFORMATION SHEET In-depth interviews Introduction Leslie Buckner and colleagues from University of Indianapolis are conducting a study to explore the lived experiences of underrepresented minority students in professional physical therapy programs. We are interested in learning about the things that interested you in the profession, the factors that influence the school you chose for your DPT, and the successes/challenges you have encountered while in the DPT program. Why is this study being done? The purpose of this study will be to explore the personal experiences of underrepresented racial/ethnic minority DPT students to better understand the processes that draw URM individuals to the field of physical therapy and that contribute to successful matriculation in the DPT program. Theory generated from this study will hopefully lead to the creation of initiatives aimed at increasing recruitment and retention of underrepresented racial/ethnic minority students in DPT programs What will happen today if I take part in this study? Today, we would like to ask you some questions about your experience as a DPT student. We will take notes of the discussion and a recording will also be made using a digital voice recorder (or video recorder for web-based interviews). After we ask these questions today, we will ask you to review our findings for accuracy within one week of your interview. You will be asked to complete this review with any additional feedback and return it to the researcher within one week from the date it is emailed. All information gathered will be treated as confidential by the study personnel, and records of the interviews will be kept securely in password protected Cloud storage and data analysis software. No personal identification information such as names will be used in any reports arising out of this research. How long will the study last? Today, the interview will last about 30-45 minutes. Can I stop being in the study? You can decide to stop participating at any time. Just tell the primary researcher right away if you wish to stop the interview. What risks can I expect from being in the study? Participation in any research study may involve a loss of privacy. Information you provide about your experiences and opinions will be recorded, but your name will not be used in any reports of the information provided. Participants information will be coded in order to keep their names confidential. The records of this study will be kept private. No words linking me to the study will be included in any sort of report that might be published. The researcher, Leslie Buckner, will transcribe audiotapes, and she will share the records with only two co-researchers who will assist in coding the interview transcripts. Potential other risks associated with this study may include anxiety or nervousness of the participant during the interview. Apprehension may be experienced by the participant when discussing uncomfortable situations during their DPT program. The information obtained from these interviews will only be used by the project researchers and will be secured via password protected storage. We will do our best to make sure that the personal information gathered for this survey is kept private. Are there benefits to taking part in the study? UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 116 There will be no direct benefit to you from participating in this study. However, the information that you provide will help provide the field of physical therapy with possible solutions for increasing minority representation in the field. Benefits may also include the development of a better recruitment and retention strategies to address minority representation in the allied health field What other choices do I have if I do not take part in this study? You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. What are the costs of taking part in this study? Will I be paid for taking part in this study? There are no costs to you for taking part in this study. You will not be paid for taking part in this study. What are my rights if I take part in this survey? Taking part in this study is your choice. You may choose either to take part or not to take part in the survey. If you decide to take part in this study, you may change your mind at any time. No matter what decision you take, there will be no penalty to you in any way. Who can answer my questions about the study? You can talk to the researchers about any questions or concerns you have about this survey. If I have any questions about the study, I can contact: Principal Researcher- Leslie Buckner PT, 708-250-1654; bucknerl@uindy.edu or Dissertation Chair- Lisa Borrero, 317-791-5944; borrerol@uindy.edu. If you have any questions, comments, or concerns about taking part in this study, first talk to the researchers. If for any reason you do not wish to do this, or you still have concerns about doing so, you may contact Dr. Greg Manship, Chair of the University of Indianapolis Institutional Review Board at 317-781-5774, via email at manshipg@uindy.edu Giving consent to participate in the study You may keep this information sheet if you wish. Participation in this survey is voluntary. You have the right to decline to participate in the study, or to withdraw from it at any point without penalty. If you do not wish to participate in the study, you should inform the researcher now. If you do wish to participate in this survey, you should tell the researcher now, or at the time of the interview if this is to take place in the future. If you do not agree to quotes or other results arising from your participation in the study being included, even anonymously, in any reports about the study, please tell the researcher now. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 117 Appendix C Consent Form CONSENT FORM Study Title: The Experience of Underrepresented Racial/Ethnic Minority Doctor of Physical Therapy Students Head of Research: Leslie Buckner PT, MPT The study has been explained to me in a language that I comprehend. All the questions I had about the study have been answered. I understand what will happen during the interview and what is expected of me. I have been informed that it is my right to refuse to take part in the interview today and that if I choose to refuse I do not have to give a reason, and that it will not impact the grade I receive now, or in the future. I have been informed that anything I say during the interview today will remain completely confidential: my name will not be used nor any other information that could be used to identify me. It has been explained that sometimes the researchers find it helpful to use my own words when writing up the findings of this research. I understand that any use of my words would be completely anonymous (without my name). I have been told that I can decide whether I permit my words to be used in this way. Circle response: I agree to take part in the study: Yes No I agree that my own words may be used anonymously in the report Yes No Signature of participant: NAME (in capital letters) SIGNATURE DATE OF SIGNATURE (in DD/MM/YYYY) Signature of study staff taking consent: I have discussed the study with the respondent named above, in a language he/she can comprehend. I believe he/she has understood my explanation and agrees to take part in the interview. NAME (in capital letters) SIGNATURE DATE OF SIGNATURE (in DD/MM/YYYY) UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 118 Appendix D Interview Guide Thank you for agreeing to be interviewed today. As we discussed before, the purpose of this study is to better understand what it is like to be a minority student in a DPT program. The questions that I will ask you today will be about your experiences with selecting a DPT program and while matriculating through the DPT program. The responses you provide during the interview are for the purposes of this study only and your responses will remain confidential. The timeframe for the interview will be 45-75 minutes. Your participation is voluntary. You may stop the interview at any time without consequence. If we come to a question that youd prefer not to answer, just let me know. Do you have any questions for me before we start? To ensure I note all of your responses correctly, I would like to audio record the interview. The recording will be deleted following its use for this study. Do you mind if I record the interview? (If they say yes). Great the recorder is now on. Interview Questions: (1) Basic Demographics Gender Age Ethnicity Location of Origin (e.g. hometown) Please describe you high school - What was the ethnic make-up? - Public vs private? General prompts: Help me understand. How did that impact. What were your feelings.. What are some examples of Tell me more. UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 119 Family background - Parents level of education and occupation (2) Pre-College Factors Can you tell be about who or what influenced you to pursue a career in physical therapy? Describe your academic journey prior to acceptance in the DPT program o Please describe your high school exposure to science classes, pipeline programs, and/or guidance counseling? Can you tell me about your exposure to the field of physical therapy in high school and/or college? Describe what extracurricular activities you were involved in during college? How did you make your decision on what school to attend for your DPT education? o Describe the factors that were the most important in that decision-making process. (3) Student Experience Tell me about how you are financing your DPT education How do you feel about your academic preparation for the DPT program? o Describe what areas you felt you were well prepared for? o Describe what areas you feel could have been improved in your academic preparation? o How do you feel your preparation compares to that of your fellow DPT students? How would you describe your experience as a minority student in the DPT program? o Further questioning will be asked based on the respondent answer Tell me about any successes you have had during the program o What things do you feel aided your success in the DPT program? UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 120 o Share what you consider to be your best moment in the program? Why? Tell me about any challenges you have had during the program o Share what you consider to be your most challenging moment? Why? How would you describe the diversity within your DPT program? Describe the extracurricular activities you are currently involved in? - Tell me how you manage school, work, activities, and all other commitments you may have? (4) Support What kinds of support have you experienced since beginning the program? o From academic staff? o From family/friends? o From others? How would you describe your relationship with other students in the program? o With non-minority classmates? o With other minority students? How would you describe your relationship with program faculty? (5) Other Considerations What would you recommend to other minority students interested in pursuing the field of physical therapy? Would you consider yourself an introvert or extrovert? And why? What do you look forward to once you begin your career? What fears do you have as you enter the profession? Is there anything else you would like to share on this topic? UNDERREPRESENTED MINORITY STUDENT EXPERIENCE Closing Paragraph Do you have any additional questions for me? Thank you for participating in this interview. 121 UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 122 Appendix E Figure1- The Village Model of Support for Underrepresented Minority DPT students Figure 1. Figure serves as the model created from the results section to show the relationship of the village to underrepresented DPT minority student success UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 123 Appendix F Tables Table 1 Participant Characteristics Participant Age School Type 147 33 PWI Gender Ethnicity Female African American Mixed (part AA or H/L) African American African American African American Hispanic/Latino 44 23 PWI Female 60 22 HBCU 13 27 PWI Female 48 26 HBCU Female 33 26 PWI Female 65 26 HBCU Female 54 29 HBCU Male 66 36 PWI Male 21 29 PWI Female 77 24 PWI Female 53 24 PWI Male 62 23 HSI Female 56 25 PWI 98 24 67 Male Year in Program 2 Parental Education Graduate Degree 3 Bachelors Degree Graduate Degree 1 2 1 3 Mixed (part AA or H/L) African American African American Hispanic/Latino 3 2 Male African American Mixed (part AA or H/L) African American Hispanic/Latino PWI Female Hispanic/Latino 2 28 HBCU Female 3 14 24 HBCU Male 15 24 PWI African American African American Mixed (part AA or H/L) Female 3 3 2 2 1 2 1 1 Bachelors Degree Highschool or Less Highschool or Less Associates Degree Associates Degree Bachelors Degree Bachelors Degree Graduate Degree Associates Degree Bachelors Degree Highschool or Less Highschool or Less Bachelors Degree Highschool or Less Graduate Degree UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 124 102 26 PWI Female African American 2 Bachelors Degree 80 24 PWI Female Hispanic/Latino 3 Grammar School 46 30 PWI Male African American 2 Bachelors Degree 12 27 PWI Male African American 2 Bachelors Degree Note. PWI=Predominately White Institution, HBCU= Historically Black College and University, HSI=Hispanic Serving Institution, AA=African American, H/L= Hispanic/Latino UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 125 Table 2 Theme Table- Preparing for the DPT Program: The Village Raises Category Personal Factors Subtheme Parental Education Social Factors Outlets of Exposure Academic Factors HS Guidance So in high school, I was always in honors classes or AP classes. So I took chemistry and physics. I had AP Biology. I was involved in all that I remember when I told my counselors in junior year of high school, senior year of high school when we had to talk to them, that I want to do physical therapy. That's the career I wanted to do and all my counselors said was to just apply. They didn't know anything about the field. So when I was a senior applying to PT school I didn't realize that there were six-year programs so I ended up just going to community college and from there I just figured out my own. (Participant #33) Late Entry into profession Because I was a business major, I only had two classes I think that were able to transfer over and would count as prerequisites. I had to go back and take a year and a half and took about eleven pre-reqs (Participant #147) Obviously the number one factor was loans and how much money I would take out for the actual schooling. So *my school* was always on top of my list for that factor itself. But then again, the type of program that it had to offer like whether it was ortho or neuro. And probably right up there most importantly was a staying home because Im part of a very traditional Mexican family. And you know leaving home is kind of like a big deal. My mom wanted me to stay back. Obviously I have a whole bunch of family here so I'm always the one to get homesick so gotta try to stay home. (Participant #56) School Selection Sample Quotation Well I think for sure it has to be my parents. I think because they both are in the medical field and I grew up around that. So, I was always fascinated, I was always asking questions. And then I found PT mostly through one of my cousins who needed therapy so I was a translator for them and fell in love with it. I fell in love with how the therapist treated our family. You know having that my aunt didn't know English, so it was just a really great experience. And the more that I learned about the profession the more that I enjoyed what we do. (Participant #98) Note: Quotes listed in table are a sample of a larger number of quotes for each subtheme UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 126 Table 3 Theme Table- The Minority DPT Experience: The Village Releases Category Personal Factors Subtheme Imposter Syndrome Sample Quotation It still kind of makes you feel like well why did I actually get in? Was it because they needed to meet a quota for minority students? Or is it because I actually earned that spot? So, I was a little bit uncomfortable being one of the minority students. I think that's a psyche kind of thing that gets caught. Like I've spoken to a lot of my students who feel the same way. Because I know a lot of us have had experiences where someone at least has told us at some point in life that they need to meet a quota. That's why you're there. So it kind of belittled our accomplishments so sometimes like you question you know if I be the person who was a straight A student and I can clinically reason somethings then its like OK, I do deserve to be here. But it still feels kind of weird. (Participant #33) Pressures the Student Has But yeah just being willing to say no. And that's something that's really hard because I feel like if you're a minority you have to work three times as much to be considered about the same amount as somebody who's not and so like I feel like I always have to say yes. If I don't it seems like I'm not as good as some of my peers. And I know thats not what it's like, but that's what it feels like to me. (Participant #98) Well just studying given the amount of time that it needs to actually be successful has been my biggest struggle. Mainly because of this little one (referring to her daughter in the background). And again I think Im the only one who has a child in this program, in my class. So, it is definitely a struggle when everyone else is up studying. I had to apologize to people because I go to bed at 8 so its like Im in bed at 8 so I can be up at 2am so that I can study. I only have this little window of time that I can actually be productive. I use those little 4 hrs in the morning. And if I cant get it done in those 4 hrs then thats like all I have. (Participant #147) Familial Factors Introvert Giving Back I kind of like to keep to myself and have my own personal time but especially in new situations, Im usually much quieter (Participant #12) So I am actually what they call the Diversity Committee student representative. So with that my main responsibility is to work with the community and try to get PT to be a career that students in (the youngest weve work with is middle school) usually either undergrad or high school were working with. Whether it's doing like video conferencing or having them come on campus to see the school and sit in on a couple classes. I think for me like having the whole aspect UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 127 of being Hispanic, wanting to bring in people into the profession, or even just seeing them seeing like there are Hispanics getting higher education degrees has been really fulfilling for me. (Participant #98) Future Racial Fears Like I don't want people to my fear is that someone will belittle my accomplishments when I actually become a practicing PT. I don't want, especially in the climate that we live in right now, you never know who's going to say something and they're like I don't want to work with her because, you know, she's Mexican, I don't want to work with her or she doesn't know what shes doing because shes Mexican. That, I still kind of have like that fear that that might happen. But Im hoping everything turns out good. (Participant #33) Language Concordance I look forward to helping the Hispanic community honestly. From what I've noticed just going in to my observations and all that because I haven't seen too many Hispanic male therapists or therapists overall. When we do have a Hispanic patient that has to either communicate it through their son or through a translator interpreter its often times harder than they want it to be. So when I come into the office or to the clinic they often greet me with a really big smile and tell me like you know Spanish, obviously in Spanish theyre speaking to me now. So I feel like the conversation of being able to talk to a health care professional thats on the same level as them kind of they seem like they're just happier. So just that itself. (Participant #56) Importance of Diversity So there needs to be more minorities in the field, especially in the hospital, to work with minority patients who understand the culture of minorities and communication patterns and gestures and so forth. Because, the reason why I feel this way is working with a CI, I experienced a situation where the CI could not read the cultural cues of the minority patient and understand the inherent distrust of the medical system that some minority patients have. Taking the extra step of empathizing and explaining to the patient family would have helped the situation more and the CI could not pick up on this and was fired by the patients mother. (Participant #66) Perseverance The greatest success Ive had (which was preceded by what I used to consider a failure) was that I failed an exam and it was devastating to me. I never failed, like I haven't gotten a grade lower than a C since middle school. So I ended up failing a foundations exam last trimester and that was emotionally draining and upsetting. But I spoke with my grader and we set up things I could do to improve my study habits and change what I did for the next exam. And, for the UNDERREPRESENTED MINORITY STUDENT EXPERIENCE Time Management Academic Factors Impact of Lack of Diversity on Classroom Academic Rigor Academic Preparation 128 following two exams, I got an A and a B. So to me the big success was kind of like and this has been like a complete change for me. This is my first time being on my own. I commuted from home to college so this was like huge. So I think a lot of it was just kind of establishing like oh hey it's okay to mess up and it's not the end of the world and you'll still be OK. But you can improve and you know you don't have to be sad about it. I think the biggest thing was just learning that I can overcome adversity. (Participant #15) I actually had to change my sleep schedule. Thats the biggest thing Ive had to do since Ive been in PT school so what I do now is usually my classes start anywhere between 8am-9. So, Ill wake up between 2:30-3:30 in the morning and I study before class. Go to school because usually its like a job like 8:30-4, 9-5 or something like that and Ill go to school all day and Ill come home and maybe like go to the gym, cook dinner, whatever I want to do to decompress mind. And then Ill maybe finish an assignment, but Im usually in bed by like 9-9:30. A lot of my classmates are the reverse like theyll stay up till 2:30 in the morning. But I find that my brain needs to rest. So Ill sleep like a couple of hours and then get up while my brain is fresh in the day, I can study more efficiently in the morning when I first wake up versus being in class all day, coming home, and trying to shove more information in my head. (Participant #13) In terms of like education, I know that there is a section of our curriculum that's on like health and equity based on diversity like racial and ethnic diversity for minority groups. And we did have a few projects that talked about you know different perspectives. However, I didn't feel like it was that great of quality and it was something like me and a few other minority students talked about. You know just not feeling like it was a good quality education. There is you know, this is from lack of like an ethnic or racial minority perspective (Participant #21) Well what I wasn't as prepared for I think was the workload. In undergrad it felt like the workload at the time felt like a lot but I was so busy with other things. And in PT school like all I really do is PT school and even then I feel like I just don't have the time that I need to go through all the readings, go through like everything that's required. Like I just am in class for so long that I run out of hours without sacrificing sleep. In PT school, all I do is to look forward to Friday to have a day to go to the gym and sit in a hot tub. I don't have enough time. (Participant #98) I don't feel likelike I knew that PT school was going to be hard, but like I was not prepared because I don't feel like I applied myself as much as I could have in college and that's why my GPA wasn't the highest so my study habitsI didn't know the best way for me to UNDERREPRESENTED MINORITY STUDENT EXPERIENCE Clinical Experiences Social Factors Lack of Like Professional Finding Fit 129 study. And I had to learn my first semester. I thought I was going to fail out. (Participant #65). But like everything I did was not good enough. She did say that I didn't address the physicians well or if physicians are in the room and I was asking the physician if it was ok if I saw the patient, she said it was unprofessional. And I was like I thought it was very professional. I had to start taking notes of everything she was telling me because I was like this dont make no sense. (Participant #54) So that front desk job I remember I went to a different clinic to cover somebody and I saw a black PT and I just had so many questions for her. Because, its rare, its rare. (Participant #46) I think I limit my time with them. Im one of the older people and most of them are fresh out of college. Im one of the older classmates, so I know how to diplomatically deal with people. I probably wouldnt hang out with them on a regular basis, but while were in class and we have a project to do, Im fine with them. Its just I dont do a lot of hanging out after because I feel like its a lot of immaturity and Id just rather not deal with that. Thats pretty much it. While were doing school stuff Im fine but if you guys are hanging out at somebodys house, playing beer pong, Im like no thank you. (Participant #13) Note: Quotes listed in table are a sample of a larger number of quotes for each subtheme UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 130 Table 4 Theme Table- Support for Retention in DPT Programs: The Village Reassures Category Social Factors Subtheme Students (minority) Students (all) Sample Quotation When I am feeling a certain way or having a certain experience I might reach out to one of my classmates who is a minority vs one whos not (Participant #15) I just attribute it to finding people that I study well with, a small group I would just say its about finding the people you work well with and struggle through it together. (Participant #14) Minority Student We've been able to share things which has definitely been a nice Support Group experience just to kind of if there is something to bitch about there are people there who you know get it. You dont have to worry about what you say but it's kind of like I don't know it's almost like censoring myself. (Participant #15) Family/Friends I mean some emotional support like whether Im just venting or upset about something or stressed. Sometimes like it is I dont know what to call it but like stress where I have a specific problem and Im bringing it up and they help me troubleshoot through it (Participant #21) Faculty Nothing against them, but its been a little awkward. To an extent, I totally understand where theyre coming from. Its like ok youve made it this far, youve made it to a graduate program, some of these things youre gonna have to figure out on your own. And so I think thats the vibe that Ive gotten for the most part. Especially when I was going through that process of getting to the probationary period. We had a few meetings when grades were low and it was just kind of funny overtime after the second or third meeting it just got a little awkward. Because I felt theyre intent was to just make sure I was aware and to I dont know if it was to inspire me or help me to get things done (not to end up getting into the position I ended up in). But, I feel like those meetings didnt help and they hurt more than they helped. So they have an academic support system in place, but its not very strong. Thats something that I know somebody who works in the department wants to work on and I havent been able to foster a good relationship with any of the faculty. The relationships are all superficial. (Participant #46) Mentorship But I go back to a lot of the PTs that I work with. A lot of them they're very open about, like I'll text them all the timeSo I reach out to a lot of my PTA friends from work and ask them like hey here's what I'm thinking can you give me your opinion and the same UNDERREPRESENTED MINORITY STUDENT EXPERIENCE 131 thing with the PTs that I work with a lot of them have specific certifications like OCS, Mackenzie, ummm like vestibular stuff. So Im constantly asking them. And like challenging what I learned in school and kind of regurgitate it to them so they can kinda tell me if I'm right or wrong and just ask them for advice. So, I look out to a lot of people I work with. (Participant #33) Coping Strategies I just try to when I can, to balance what I enjoy doing. When I find time to do those things I do. And sometimes it may even be at the expense of studying, but I feel like its kind of important to give yourself that mental break or you wont make it through. (Participant#14) Note: Quotes listed in table are a sample of a larger number of quotes for each subtheme  ...