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... Running head: OLDER ADULTS AND SMARTPHONE USE 1 Exploring the Fit Between Older Adults and Smartphone Use to Inform Design and Practical Application Natalie Azzarito, Kelsey Brown, Darian Burchfield, Kaytlyn Eberly, Nicole Meert, and Molly Sears December 15th, 2017 A research project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the research advisor: Beth Ann Walker, PhD, OTR Running head: OLDER ADULTS AND SMARTPHONE USE A Research Project Entitled Exploring the Fit Between Older Adults and Smartphone Use to Inform Design and Practical Application Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Natalie Azzarito, Kelsey Brown, Darian Burchfield, Kaytlyn Eberly, Nicole Meert, and Molly Sears Approved by: Research Advisor (1st Reader) Date 2nd Reader Date Accepted on this date by the Chair of the School of Occupational Therapy: Kate E. DeCleene Huber, OTR, MS, OTD Chair, School of Occupational Therapy Date 1 OLDER ADULTS AND SMARTPHONE USE 2 Abstract Background: Smartphones have become a valuable tool on which many rely to complete a myriad of tasks on a daily basis, and occupational therapists have begun to consider them as possible tools to support the daily occupations of older adults. While the capabilities of smartphones and available applications appear endless, older adults may not fully understand the mobile phone they are using or understand how smartphones might be used to support occupational performance. In order for occupational therapists to effectively incorporate the use of smartphone technology to support the occupational needs of the aging population, a greater understanding of older adults acceptance and use of smartphone technology is needed. Purpose: The purpose of this study was to explore older adults acceptance and use of smartphone technology and check for redundancy of Walker et al.s (2015) preliminary model. Methodology: Investigators utilized a focus group design to collect qualitative data on older adult acceptance and use of smartphone technology. Participants included eight older adults aged 60-78 who were selected through purposive, convenience, and nominative sampling. Verbatim transcription was analyzed using a constant comparative approach. Findings: Findings of this study were consistent with Walker et al.s (2015) preliminary study. Five factors contributed to participants ability to successfully operate their smartphone: physical characteristics of the device, past experience, effort expectancy, available resources, and selfefficacy. Overall, smartphone use was collectively explained by the constructs of ability, attitude, perceived need, and social influence. Conclusion: Occupational therapists can use this model to thoroughly examine and consider the fit between older adults, smartphones, and related applications in order to provide client-centered recommendations to effectively support the occupational performance of their older adult clients OLDER ADULTS AND SMARTPHONE USE using smartphone technology. Further, this model may also be used to inform the future design of smartphone technology and related applications aimed to support the needs of older adult consumers. 3 OLDER ADULTS AND SMARTPHONE USE Acknowledgements The authors would like to thank the eight participants for their time and insights on their experiences with smartphone technology. We would also like to thank Dr. Brenda Howard for taking time to provide an in-depth review of this paper prior to submission. 4 OLDER ADULTS AND SMARTPHONE USE 5 Exploring the Fit Between Older Adults and Smartphone Use to Inform Design and Practical Application Smartphones have become a valuable tool on which many rely to complete a myriad of tasks on a daily basis. They are capable of offering an endless array of options aimed to promote autonomy and independence in activities of daily living (ADLs), instrumental activities of daily living (IADLs), rest and sleep, education, work, play, leisure and social participation (American Occupational Therapy Association [AOTA], 2014). Occupational therapists can consider smartphone technology as a tool to increase independence and participation in occupation for older adults through productive aging. Productive aging refers to aging in a safe and healthy environment, while continuing to participate socially in the community regardless of living in home or a long term living facility (National Institute for Occupational Safety and Health, 2015). Occupational therapists strive to support productive aging by providing services targeted at preserving meaningful roles and occupations, such as promoting engagement in managing personal health and wellness, personal finance, transportation, community, and maintaining or increasing participation in meaningful occupations within a community context (National Aging in Place Council, n.d.). While it is evident that smartphones provide a variety of options that support productive aging, a better understanding of the factors that contribute to older adults acceptance and use of this technology is needed to inform how occupational therapists incorporate them as a tool to influence functional outcomes. It is apparent that more and more older adults are using smartphones; however, it is evident that they use their phones differently when compared to younger generations. As of 2014, 77% of older adults owned a cell phone; however, only 27% of adults 65 and older owned a smartphone (Smith, 2014 b). Older adults attitudes and use of technology, such as OLDER ADULTS AND SMARTPHONE USE 6 smartphones, are influenced by their personal, social, and physical situations (Peek et al., 2016). Individuals from different age groups utilize smartphones differently. For example, individuals ranging from 19 to 21 years of age typically used cell phones for texting, while individuals over the age of 65 primarily used them for security (Pedlow, Kasnitz, & Shuttleworth, 2010; Van Volkom, Stapley, & Amaturo, 2014). According to M. Martinez-Pecino, R. Martinez-Pecino, and Lera (2012), cell phones have helped older adults remain in communication with their families, which has brought them a sense of security. According to McLeod (2009) and Gitlow (2014), older adults reported using cell phones every day for personal calling, texting, checking voicemails, and for emergencies, whereas functions such as setting alarms, taking pictures, and checking the time were used less frequently. Most older adults did not use cell phones for playing games or using the internet as often as other features (McLeod, 2009). Smartphone technology can be utilized to support many IADLs that occupational therapists address with their clients. Instrumental activities of daily living include communication management, community mobility, home establishment and management, religious observation or spirituality, shopping, education, leisure and social participation (Lauer, 2013). Examples of applications that can assist with such IADLs for communication management include social media applications such as Easy Facebook for Seniors, which allows for communication with friends and family with less clutter compared to the basic Facebook app (18 unexpectedly innovative apps for seniors, 2017). Community mobility can be supported through apps such as Lyft, which is a user-friendly application for transportation within the community by simplifying the process of obtaining a ride (Derrick, 2017). Applications pertaining to home establishment and management such as Mint, which allows for the organization of finances to maintain a monthly budget and pay bills (18 unexpectedly OLDER ADULTS AND SMARTPHONE USE 7 innovative apps for seniors, 2017). Religious observation or spirituality can include an app called Sermon Audio, which provides audio sermons and addresses religious observations (The 25 best Bible apps, n.d.). Shopping can be supported through an application called Instacart, which assists with delivery of groceries after being ordered via the application (Mears, 2016). Education can include Goodreads, which allows the user to rate and share books online before purchasing. Leisure can include applications such as iBooks, which is an application used for educational and leisurely reading; Skype allows individuals to connect with family and friends within a virtual context (18 unexpectedly innovative apps for seniors, 2017). In addition to smartphones supporting applications for IADLS, they also support applications that enhance or adapt client factors (AOTA, 2014). Smartphone applications can be used to record body functions and send important medical readings to doctors and other health professionals such as blood sugar levels, pacemaker data, caloric intake, and even physical activity (Kim, H-S., Lee, Kim, H., & Kim, J. H., 2014; Pedlow et al., 2010). For example, the application, Blood Pressure Monitor, sends blood pressure readings and weight changes instantly to a physician (18 unexpectedly innovative apps for seniors, 2017). Smartphones may also be used to accommodate memory limitations by setting reminders for medical visits (Kim et. al., 2014). Users are also able to take notes, create voice memos, and set alarms using their smartphone to assist with their memory. Memory can be supported through apps such as Pillboxie to remind individuals to take medications at specific times (18 unexpectedly innovative apps for seniors, 2017), Evernote, an application used for creating audible reminders (Belval, 2015), and Lumosity, a memory game including over one-hundred games and puzzles (18 unexpectedly innovative apps for seniors, 2017). Vision can be supported through applications including EyeReader, which serves as a magnifying glass with a bright light for OLDER ADULTS AND SMARTPHONE USE 8 reading; and Silver Surf, which offers zoom, larger buttons, and adjustments to contrast for easier reading (Derrick, 2017; 18 unexpectedly innovative apps for seniors, 2017). Hearing can be supported by an application called BioAid, which works as a hearing aid by using a microphone to process sound and deliver to headphones for enhanced sound (Useful apps for hearing loss, n.d.). Although the capabilities of smartphones and available applications appear endless, older adults may not fully understand the mobile phone they are using (Ziefle & Bay, 2005), let alone understand how they might be used to support productive aging. Many adults do not use functions beyond personal calling and texting (McLeod, 2009). It is important to uncover barriers to smartphone use to maximize the fit between the older adult user and smartphone technology. According to McLeod (2009), ease of use is the most important feature of a cellphone among older adults. Complex phones have many different menus that may cause older adults to become lost within the menu and may seek assistance from younger users (Ziefle & Bay, 2005). Also, many of these menus may not seem necessary to the user (Plaza, Martn, Martin & Medrano, 2011). This requires that older users build a mental map of the location of the different menus, but also memorize the names of the menus (Ziefle & Bay, 2005). If the device is too small, an older adult may have difficulty holding the phone comfortably in their hand, and applications within the cell phone will be small as well (Plaza et al., 2011). It can be difficult for older adults to think of the action they are trying to do, such as calling, when many icons appear arbitrary to the task at hand (Kim et al., 2014). Small text size can hinder older adult's smartphone use if the text size is hard to read regardless of corrective lens use (Plaza et al., 2011). On the other hand, if the text size is too large, the phone many only OLDER ADULTS AND SMARTPHONE USE 9 display a few words on the screen at a time and becomes difficult to read or scroll through entire messages (Zhou, Rau & Salvendy, 2014). In an effort to better understand the factors that influence or hinder mobile phone use by older adults, Walker et al. (2015) described a preliminary comprehensive model (Appendix B) to explain the acceptance and use of mobile phone technology by older adults. The main findings of this study suggested that older adults use of mobile phones was determined by a combination of ability, social influence, perceived need, and attitude. According to this model, the factors which contributed to older adults ability to use a mobile phone included the design of the device itself, effort expectancy, experience, available resources, and self-efficacy. Effort expectancy was defined as the anticipated degree of ease associated with mobile phone use. Experience referred to the amount of previous use and knowledge an individual has with a smartphone. Available resources referred to the aid, support, or person an older adult sought out when guidance was needed to perform a function on their smartphone. Self-efficacy was defined as the participants belief in their ability to successfully perform needed tasks and functions on a smartphone device. Social influence was defined as the effect important people in an older adults life had on their acceptance and use of mobile phones and was primarily influenced by younger generations, family, friends and colleagues. Attitude was defined as older adults positive or negative feelings about using the mobile phone. Attitude was affected by the understanding, convenience, and benefit of device as well as effort expectancy and generational attitude. Perceived need was defined as the degree to which an older adult believed they needed a mobile phone and was comprised of the following constructs: communication, safety, caregiving, work and cost (Walker et al., 2015). OLDER ADULTS AND SMARTPHONE USE 10 In order for occupational therapists to effectively meet the needs of the aging population, a greater understanding of older adults acceptance and use of smartphone technology is needed to minimize the gap between the user and smartphone technology. This understanding will serve as the precipice to maximize the fit between the person and the occupational task at hand to facilitate productive aging. Research is needed to further test Walker et al.s (2015) preliminary model for redundancy over time and ever-changing smartphone technologies. In effort to inform occupational therapy practitioners on how to best optimize the fit between older adults and smartphone technology used to support occupational performance, the purpose of this study was to explore older adults acceptance and use of smartphone technology and check for redundancy of Walker et al.s (2015) preliminary model. Methodology A phenomenological approach was used to explore older adults acceptance and use of smartphones. This design was utilized to understand participants perceptions, perspectives, and experiences of a phenomenon (Lester, 1999). A focus group method was selected due to its popularity in academic qualitative studies and applicability of results for the generalization of a larger population (Cheng, 2007). The University of Indianapolis Institutional Review Board (IRB) granted approval for this study. Sampling A combination of purposive, convenience, and nominative sampling was used to recruit participants. Purposive sampling is commonly used for qualitative research and is defined as the selection of participants based on specific characteristics that relate to a certain phenomenon (Palinkas et al., 2013). According to Palinkas et al. (2013), purposive sampling is best used to uncover both differences and similarities with regards to phenomenological interest when two OLDER ADULTS AND SMARTPHONE USE 11 different types of purposive sampling are used. Convenience sampling is a method of data collection that relies on participants that are available to participate in the study due to location, availability, or personal acquaintances (Palinkas et al., 2013). Convenience sampling was used to recruit older adults within the Indianapolis and surrounding region that met the inclusion criteria. Nominative sampling occurs when participants are asked to recruit others that meet the criteria of the study (Palinkas et al., 2013). The most frequently utilized type of purposive sampling is criterion inclusion, which identifies specific, predetermined criteria that must be met before participation may occur (Palinkas et al., 2013). Inclusion criteria for participation included being between the ages of 60 and 80, own a smartphone, English speaking, living independently in the community, and ability to get to and from the focus group site on the designated date. An ideal focus group should consist of 5-12 members (Cheng, 2007). The exact number of participants varies based on the purpose of the focus group. According to Cheng (2007), focus groups with four or less participants provide fewer opinions than an eight-person group, while a large group can become too difficult to moderate thereby diminishing the opportunity for participants to provide opinions. Data Collection The focus group session was held September 2016 over a two-hour period in a private room at the University of Indianapolis. The goal of the focus group session was to investigate older adults acceptance and use of smartphone in regards to changing technologies to check for redundancy of Walker et al.s (2015) preliminary model. A semi-structured interview with openended and non directive questions was used to guide group discussion (see Appendix A). The interview guide was developed to investigate ability, social influence, perceived need, usefulness, and attitude. Question topics included participants perceptions of their ability to use OLDER ADULTS AND SMARTPHONE USE 12 their smartphone, the most influential person that impacted their decision to get a smartphone, the social effects of smartphone use, how and why participants use their smartphone, and their overall feelings and beliefs about smartphones. An explanation of the focus group procedures, including the objective and time frame, was provided to the participants. The participants selected an unidentifiable pseudonym for recording purposes in order to remain anonymous. Seven investigators were present during the focus group session. The principal investigator reframed questions, repeated items as needed, and used probing questions to increase the depth of discussion among participants to ensure complete coverage of content. The moderator of the focus group session emphasized there were no right or wrong answers and all opinions were welcome. Another investigator took notes regarding topics of conversation via computer. In order to ensure accuracy of the transcript, the remaining investigators took hand-written notes of facial expressions, body language, and any aspects not otherwise detected via audio-recording or transcription. The data was collected via a voice recorder. The voice recording was then transcribed verbatim. Data Analysis Each member of the research team listened to the audio recording individually, then read and re-read the transcripts and field notes to orient themselves to the data and took notes recording reflexive thoughts and insights (Johnson & Christensen, 2014). The research team completed an open coding process in which the researchers read through the transcripts line by line, placed the information into categories, and created tentative labels (Khandkar, n.d.). Initial codes (60) were reviewed as a group and condensed into 34 codes once a consensus was reached. Axial coding consisted of using deductive and inductive reasoning to relate the codes and identify relationships among the open codes (Bhm, 2004). Selective coding was then employed OLDER ADULTS AND SMARTPHONE USE 13 by the research team to identify the core construct of use and systematically relate it to the categories which emerged from axial coding (Bhm, 2004). Using a constant comparative technique, the data was also compared to previous data collected by Walker et al. (2015). Validity Credibility was ensured through reflexivity, investigator triangulation, member checking, peer examination, and interview technique (Krefting, 1991). Reflexivity was established by reviewing field notes and openly discussing the possible influence of each researchers background, interests, and perceptions on how data was interpreted (Krefting, 1991). For example, researchers identified potential biases through reflection of the generational gap between themselves and the research participants and its potential influence on perceptions of smartphone use. Investigator triangulation was ensured in this study through individual and collaborative efforts of the seven-member research team. The principal investigator, an expert in qualitative research, utilized an interview technique called member checking throughout the session to frequently ask the participants to confirm her interpretation of what was being said. Peer examination was provided by an impartial outside reviewer who is an expert in qualitative research, to ensure that the findings accurately reflect the participants experience (Birt, Scott, Cavers, Campbell, & Walter, 2016). Transferability of results was achieved through nominative sampling, which is the process of gathering participants by the use of a panel of people currently participating in the study to select additional participants that represent the phenomenon being investigated (Krefting, 1991). The gathering of dense background information about the participants served to enhance the transferability of findings. Dependability was strengthened through the coding and recoding method previously mentioned in conjunction with stepwise replication in which OLDER ADULTS AND SMARTPHONE USE 14 tasks were completed by at least two members of the research team. Dense description of research methods supported a stepwise replication. Confirmability was ensured through external reviewer, triangulation, and reflexivity. A confirmability audit was completed in which a third party individual reviewed the interview guide, field notes, raw data, data reduction and analysis procedures, and synthesis process (Krefting, 1991). Triangulation of theoretical perspectives was employed by the open and axial coding processes as well as a follow-up procedure including a priori coding using the core constructs from the Walker et. al. (2015) model to develop preliminary themes. A priori coding is used to increase methods triangulation in which codes from a previous study were identified and used to assist in writing an interview guide and preliminary codes (Stuckey, 2015). Reflexivity, already discussed in detail, also served to strengthen confirmability. OLDER ADULTS AND SMARTPHONE USE 15 Findings The participants provided information about themselves including participant type, gender, marital status, age, occupation and type of smartphone (Table 1). There were three married couples and two individuals who did not bring a partner for a total of eight participants. Table 1 Description of Participant Demographics Participant Gender Marital Status Age Occupation Smartphone Operating System 1 Male Married 75 Retired: farmer Android 2 Female Married 75 Retired: school teacher Android 3 Male Married 78 Retired: consultant Android 4 Female Married 67 Retired: homemaker iOS 5 Male Married 67 Retired: corporate manager iOS 6 Female Married 76 Retired: office worker Android 7 Male 60 Current: maintenance worker iOS 8 Female Single 67 Current: hospital insurance Android specialist Couples Individuals Married Four main factors were found to drive the use of smartphones by the older adults in this study: ability, social influence, attitude, and perceived need (Table 2). Ability was the largest and most complex of the these factors and was comprised of the following categories: smartphone device, effort expectancy, experience, available resources, and self-efficacy. Social influence was composed of categories including younger generation, family influence and peer pressure. OLDER ADULTS AND SMARTPHONE USE 16 Attitude included categories of societal concern, social acceptability, and privacy concern. Perceived need included categories of communication, safety, caregiving, work, and cost. Usefulness included categories of frequency of use, convenience, and apps used. Table 2 Factors affecting use of smartphones by older adults Theme Category Subcategory Ability Smartphone device Physical limitations Phone design Phone features Effort expectancy Ease of use Mistakes Experience Paired use Shared use Evolution of use Frequency of use Available resources Training resources Training Learning When in doubt Self-Efficacy Not smart enough Fear of misuse Decisions Training retention Social Influence Younger Generation Family Influence Peer Pressure OLDER ADULTS AND SMARTPHONE USE Attitude 17 Societal acceptability Social concern Privacy concern Perceived Need Communication Safety Caregiving Work Cost Use Frequency of use Convenience Apps used Ability Ability refers to a persons skills or competence using a smartphone given their current physical, cognitive, and psychosocial status. Ability to use a smartphone was influenced by features of the smartphone device, effort expectancy, experience, available resources, and selfefficacy. Smartphone device. The smartphone device refers to the physical features, capabilities, and complexities associated with the actual device. Features of smartphones devices, which had an influence on participants ability to use a smartphone, included the screen size, display, and icons. Features that contributed to ease of use included a stylus for easier screen selection, adequate display size, and touchscreens. While there was a consensus that phone size display may be slightly too small to clearly see and push buttons accurately, others mentioned features exist to change the keyboard settings to make letters larger or easier to select. Issues related to selecting items on the phone were due to touch screen sensitivity, size of the phone, small text size, or the complexity of the device. Participants reiterated phone size was an important feature OLDER ADULTS AND SMARTPHONE USE 18 contributing to ease of use and ability to use the smartphone. In reference to his mother, one participant stated: We tried to find something bigger with bigger keys and something she could read and theres almost nothing available. So as we get arthritis or you know, become less nimble, I think using the current phones or if they get smaller it will become more and more difficult, plus the eyesight type thing. Certain procedural tasks and functions available on smartphones were challenging to remember, such as how to access settings or contacts. Multi-step tasks often led to confusion and difficulty navigating the smartphone. The need for devices to be user friendly for all individuals became apparent with participants reports of confusion and frustration. Many participants found that the icons used to delineate functions did not make sense to them, and reported having difficulty locating the settings icon and navigating the lists of choices within it. I think for seniors the keyboard, or the symbols, it becomes harder and harder to navigate through those. I know for my mother it was difficult. The complexity of menus was not the only aspect of smartphones that caused participants difficulty. Pre-set settings such as the limit of volume a smartphone can produce and text sizes that only go so large were noted to not always be loud enough or large enough for comfortable use. One participant stated about their mother, And [we needed something] louder; it wasn't an iPhone, obviously, but you know she still couldn't hear it ring. Effort expectancy. Effort expectancy is the anticipated degree of ease associated with smartphone use. The more difficult the participant perceived the device or application, the less likely they would be to use itusing some of the applications are more difficult than theyre worth. Participants found that working toward completing a task on their smartphone could be OLDER ADULTS AND SMARTPHONE USE 19 challenging. In reference to completing a task on her smartphone, one participant stated, Well I just get frustrated sometimes and just quit. When trying to understand their smartphone and seek help, the help desks that you call sometimes are more frustrating than they are helpful. Directions to increase ease of use were not readily available or simple to follow, leading to frustration and a decrease of use. Experience. Experience is the amount of previous use and knowledge an individual has with a smartphone. The extent of experience using a smartphone had a direct influence on the participants ability to use smartphones. With more experience, participants had greater success and confidence when using their smartphones. Regarding incorrectly pressing buttons, one participant stated when asked about making mistakes when using their phone, ...I think as users, getting more experience, you kind of grow out of that. However, participants emphasized that with experience and repetitive use, they were more likely to remember how to complete the desired task. If I dont use it then I forget it. People will show me things and if I don't use it, then two weeks later I am like how did they show me that. I don't remember. But if I use it then I am fine. Available resources. Available resources refer to the aid, support, or person an older adult seeks out when guidance is needed to perform a function on their smartphone. Older adults typically asked family members or friends for assistance with their smartphone. Other common resources accessed when in need of assistance with smartphones included referring to the user manual, watching YouTube videos, contacting a help desk, attending a class, or visiting the mobile phone provider. One participant stated, If there were some instructions, I would try to read the instructions first and then go to a family member. Similar ideas were shared when OLDER ADULTS AND SMARTPHONE USE 20 seeking available resources, I might go back to the store I bought my phone, more than likely I would talk to my son-in-law. As participants encountered difficulties with their smartphones, they preferred one-onone instruction and often turned to a younger family member for support. When asked who the participants turn to when they ran into difficulties using their smartphone, one participant responded with, anybody younger: students, daughter, grandkids, while another stated, We have a young guy at work and he is a techie and he does all sorts of things. He is like 25, so I have learned a lot from him actually. He has shown me how to do all sorts of things. Self-efficacy. Self-efficacy is defined as the participants belief in their ability to successfully perform needed tasks and functions on a smartphone device. Low self-efficacy negatively impacted ability to use the smartphones correctly, I hit buttons a lot for something in settings that I am trying to find and I just go through all the different choices until I find what I am looking for. Once in a while I call my son and ask him something; hell say wait a minute, this one is for the books, like its a really stupid question. Some participants felt inadequate or experienced lower levels of self-efficacy in their ability to solve problems encountered during smartphone use. These participants did not feel comfortable with open exploring on their phone when they ran into a problem, one participant did experiment some with their smartphone to figure out the intended function, I do three things. I play with it for a while and then if I dont figure it out I might Google it or call our son. Throughout the focus group, when there was a lack of confidence, there was a decreased ability to successfully use their smartphone. OLDER ADULTS AND SMARTPHONE USE 21 Another factor that contributed to self-efficacy was a fear of misusing or damaging the smartphone device during use. A fear of misuse can be defined as an individuals belief that they do not have the ability to perform certain functions on their smartphone. Thus, they believe they will perform an unintended or irreversible task, You know, Im afraid of what if I touch that and its going to do something wrong or call somebody I dont want to call. It was mentioned that performing complicated tasks such as closing out an application influenced this notion of messing something up due to not being able to reverse what was done. ...I really have a mess sometimes, I dont do things right, so then I think I have to learn how to get myself out of it because I havent ruined anything Participants mentioned they felt uncomfortable clicking icons and pushing buttons when they were unfamiliar with what the icon did. For example, I watched my little granddaughter get on my iPad and I thought she was going to crash the thing and I found out that she cant do anything to hurt it so I dont suppose I can either. Overall, in fear of making a mistake that they would be unable to fix, participants did not click icons or buttons for which they did not know the purpose. Social Influence Social influence refers to the impact other individuals have on how the participants use their smartphone. Participants felt there was a push from their children, grandchildren and peers to obtain and use smartphones. When asked about who influenced their smartphone use, one participant responded with, I think family is the biggest influence... Another agreed by saying, I guess our son-in-law is our big influence and our grandkids. I said if I could keep a grandkid with me all the time I wouldnt need a smartphone. When older adults were asked why they got their smartphones, they stated, My daughter insisted that I have a phone... Some participants did not originally believe there was a need for a smartphone, but got one to appease their family OLDER ADULTS AND SMARTPHONE USE 22 members. I think [there was] some family pressure and peer pressure to upgrade... It was expressed, if their cell phone still worked, they felt there was no need to replace it with a smartphone. One participant remarked that a phone representative stated ...if I was a vet and this is your pet, I would say its time to put it down, when her phone was taken in for maintenance. After the encounter, she was still reluctant to purchase a new phone because she did not feel there was a need, but felt she was expected to. Some participants mentioned feeling that friends and family expected them to be available to communicate at all times, but believed it was a personal choice whether they wanted to be connected or not. Participants noted social expectation to have their phones on them and be accessible at all times: Some expectation in the world and in the environment, now, that you have a smartphone and can be reached and things like that. A little bit of peer pressure, but if people need to reach us there is that expectation. Though they may not want to be reached at all times, a few participants mentioned the influence of family, friends, peers, and members of younger generations on how they use their smartphones. Attitude Attitude is defined as the participants positive or negative feelings toward smartphone use. Older adults attitudes and values influenced how they used their smartphone in everyday life. Components of attitude which emerged in this study included social acceptability, societal concern, and privacy concern. Social acceptability. Several participants conveyed that it was not socially acceptable to be on your smartphone in public; however, they did note that it is becoming more acceptable in OLDER ADULTS AND SMARTPHONE USE 23 todays society. One participant stated, Several years ago you heard a lot about people in restaurants complaining about phones, but you don't hear anything about that anymore and people are constantly on phones, and it is very rare that people complain about it anymore. However, another participant disagreed when discussing smartphone use in public by stating, It is still rude and annoying. Overall, the remaining participants agreed that the social acceptability of smartphone use has increased with the generational tide. Societal concern. Several participants noted societal concerns regarding smartphone use by younger generations. These concerns included being constantly preoccupied with smartphones, disengaged in conversations while using their devices, and a decrease in critical thinking skills due to smartphone use. Older adults felt that their generation placed less importance on smartphone use and instead, focused on other forms of communication. Participants felt that increased smartphone use has contributed to decreased social skills for individuals of younger generations. A participant supported this concept by stating, There should be mutual respect that you put down your phone and be a part of the group versus texting... One older adults agreed with younger generations having decreased social skills by saying, They go for their job interview, then they don't know how to have a conversation with a professional...my grandson doesn't know how to do that and to his detriment, because he's on his phone all the time and he's 18 years old. Another participant expressed, I think now, we as a generation, we have more conversations. The younger generations, they all have their phones. They'll be sitting in the same room, but I dont know if they are talking to each other. Another agreed with this statement, Yeah I mean they do not even pay attention to what is going on around them, let alone who they are next to or OLDER ADULTS AND SMARTPHONE USE 24 where they're at or anything. Lack of awareness. Older adults combatted this by not using their smartphones in social situations to ensure the quality of time spent with others. Older adults felt less immediacy for smartphone use compared to younger generations. One participant discussed his thoughts and frustrations about this expectation of use when he said, I think it is becoming more acceptable, just like work is texting me right now [eyebrows raised and hands thrown in air]...I think it is kind of rude that my phone is ringing right now in this atmosphere, but I think it's becoming more acceptable because that is just the way it is anymore. He continued to state his frustration about younger generations being disengaged with their surroundings and lacking social skills by intensely stating, ... I am around students a lot at [work] and its very annoying because when they walk out of class, immediately they are on the phone Students will pay absolutely no attention to what is around them. Zero. I frequently travel on the sidewalks with a pick-up truck or some kind of motorized vehicle... and I have literally had to stop on the sidewalk because there is a student coming towards me, face in the phone, and has no idea that I am sitting there with a pickup truck. They have literally gotten within 5 feet of me before they have realized that I am there. Another participant commented positively regarding this new expectation saying, I think one of the positive things about all of this is it teaches young people how to respond very quickly to things that they do see, and I know that military likes to get gamers and things like that because theyre used to getting things on screen and responding quickly. Concern was expressed over the growing dependence of younger generations on their smartphones. Participants felt their generation was not reliant on their phones as compared to OLDER ADULTS AND SMARTPHONE USE 25 younger generation smartphone use. I keep saying Im not married to my phone. I check it maybe twice a day and my family they all know if they want to get ahold of us, call. Another agreed by saying, Im not attached to my phone and I dont want to be, so if somebody really needs to get ahold of me theyll text me, or theyll leave me a message, or theyll call me." Some older adults did convey that dependence on smartphones may be necessary at some point in their lives. One participant supported this by stating, I think for seniors, if you had a medical condition, a really severe medical condition, it would probably enhance your independence by being able to go out and if you had an episode you could contact someone. That doesnt apply to use now but eventually it may. Participants were adamant that they did not want to be tied to their phones and did not feel the urgency of smartphone use as compared to younger generations. Older adults also explained that younger generations lacked critical thinking skills and expected immediate gratification due to instant access to information at all times through smartphones. Regarding societal concerns, one participant contributed, I think it creates lack of critical thinking. You know, instead of having to figure something out they just Google it. They get the information just like that. They don't have to ponder and think this was like this, and this was like that, then what would be the result. They just get the answer instead of figuring something out. One participant challenged this notion of people being tied to their phones and engaging less in conversations by stating, I think it depends on the situation. I could see that sometimes in a conversation it would be helpful to know and Google something and there could be other times when it's not; the urgency is not there. OLDER ADULTS AND SMARTPHONE USE 26 Privacy concern. Participants expressed they did not store sensitive information on their smartphones due to having concerns about privacy. We dont put anything on the phone thats sensitive, we dont store passwords, and we dont store accounts. Participants provided advice about storing information on smartphones, Dont put things on there that are that critical. I mean if its that critical you dont put it on there because I dont think it is private. I mean I think that if somebody wants to find out what is going on, some people have capabilities...I mean who knows for sure who has access to our information. Perceived Need Perceived need can be defined as the degree to which the older adult participants perceived they needed to use a smartphone. The factors that influenced perceived need included communication, safety, caregiving, work, and cost. Communication. Communication refers to the need participants have to connect with others through the use of their smartphone. Communication was a popular reason for smartphone use. The main reasons that communication was important included the need of being reachable away from home, by work, family, or friends in case of emergencies and for socialization purposes. All participants expressed the importance of having a phone for safety. One participant stated, Its really nice when you are out there working on the tractor and something goes wrong and you can just [call] right then and say I need help. Participants discussed the need to communicate during medical emergencies. One participant expressed this by stating I think for seniors, if you had a medical condition...it would probably enhance your independence by being able to go out and if you had an episode you could contact someone. That doesnt apply to us now but eventually it may. OLDER ADULTS AND SMARTPHONE USE 27 Safety. A popular thread when discussing the necessity of a smartphone was the aspect of driving. Three participants stated they got their phone for safety while driving, including being able to contact someone in case of car trouble or emergencies. One participant stated, I just mainly have it with me for actually safety, if I was driving and I need to call... Three participants discussed they used their phones for navigation while driving, since it updates traffic conditions including accidents and a standard navigation system does not. Regarding the navigation system, one participant said, We can put the app in and it really almost tells you your location and theres especially the traffic, and if theres accidents or traffic and its helpful when you are traveling. Caregiving. Another theme which emerged as a reason participants needed a smartphone was tied to the role of caregiver. One participant expressed her need for continuous accessibility while others are providing care for her adult daughter with special needs, We also have a special needs daughter and it was nice to be able to be available. They could reach me if they ever had a problem at her program so its still that way. The participant explained that games were also important to have on her smartphone as a source of entertainment for her daughter, stating, She [daughter with special needs] likes to do matching games and all that and she has an iPad, but if we are out some place, then she can do it on my phone. So, I have a few of them loaded on here so she can play some of the matching games. Gives her something to do. Another participant expanded on the use of smartphones within the role of caregiver for an aging parent, I think for family support, emergencies, for medical reasons, I know I mentioned my mother, when she was living, you know, to make sure we could be contacted if she needed help. OLDER ADULTS AND SMARTPHONE USE 28 Work. Many participants were influenced by their current or previous employment to have a smartphone. Two participants stated that they first received their phones through work. One man stated that while he was employed, You had to try to find an internet connection to get to do some of the work that I had. And a laptop and a lot of times a paid telephone booth so I got a phone to start out with and then you know just the flip phone and then went to the smart. An additional participant explained, I probably got mine in the late 80s, mid 80s, and it was really because of my work at the time and the company provided the phones to me or to all of our managers. For the remaining participants, work was not a driving force on their decision to purchase a smartphone. One participant still currently working, explained she was unable to use her smartphone within her profession, One of the reasons I dont use mine at work is because of the MRI machine just eats up the life of the battery, so I keep it in my purse tucked away and it doesnt go away quite so quickly. But, inside of a hospital is not a good place to use a cell phone. Cost. The cost associated with purchasing and maintaining use of a smartphone appeared to influence use. When discussing the process of purchasing a smartphone, cost was found to be a substantial factor. Half of the participants noted that the only reason they got a smartphone was either that it was free through work, or that a family member pays for their phone and phone service. One participant explained, Well because my daughter insisted that I have a phone and she pays for it, so thats even better. Other participants stated that store deals allowed them to upgrade for free, or other specials were available which helped them when making the decision to purchase a smartphone. One deal was described as, ...it said if you have a workable smartphone and you want to come in we will give you $200 for it and you can get an S7 and all it OLDER ADULTS AND SMARTPHONE USE 29 costs you is sales tax for a new phone. Additionally, one participant commented on the rising costs of smartphones, yet he continues his services. He stated, The expense of it too, I mean it can start adding up you know what I mean I can remember back when we spent 30-40 dollars a month for phone and thats all we did. Now we spend you know its easy to spend 200-300-400 a month on phone service of all kinds. Use Use is defined as the way in which a smartphone is utilized. Collectively, the participants discussed their use of smartphones including: frequency of use, convenience, and apps used. Frequency of use. The participants frequency of smartphone use was inconsistent and varied between each individual. When asked how frequently participants used their smartphones throughout the day, some participants conveyed that they used their smartphones frequently, and others expressed using their smartphone only minimally. When asked how often participants used their phone, one participant replied, Constantly. From the time I get up in the morning, about 6-6:30, I check it to see if I have any messages, like from our daughters driver, or what the news is of the day. I have an app for one of the local stations and it gives me breaking news. I use it all day long; if I get a bill in the mail, I pull up our bank and pay a bill, and go shopping. I text everybody back and forth instead of calling them, I google things. I use it all day until I go to bed at night. In contrast, another participant stated, I have my phone with me in case someone needs to get a hold of me, but Im not attached to my phone and I dont want to be. Participants expressed a general consensus of a desire to not use their phones constantly. OLDER ADULTS AND SMARTPHONE USE 30 I use [my smartphone] throughout the day probably hourly or half hourly but I havent become addicted to it like I think some people have and I dont play games I probably only use 10-15% of its capacity because you know I dont want to become tied to it. I use it for the basics, I dont use it, very rarely, when I drive so there are times of the day when I dont depend on it and dont use it and resist the temptation to use it. Convenience. Convenience refers to the reduction in effort to carry out various functions. Every participant alluded to the convenience that is created by owning a smartphone. One participant stated, You go to the grocery store and somebody forgot to tell you to get something, you get back home and [they say] we needed this too. And I mean that really does come in handy a lot of times. And then work, I just use it, I use it all the time for work. Participants discussed several positives aspects of the convenience provided by using a smartphone. One opinion was, Yeah to be available at any time. Thats been probably the best thing about having one, again, I just I use it for everything. Another participant stated, If we are going somewhere, you used to get out the atlas and look at it, and spend a half an hour mapping out a route. Now you punch it up on your phone and it tells you exactly where to go. And if it's somebodys birthday next week, its one of my grandkids birthday next week, what day is it on, oh it's this day.... It's just, it's more convenient to have the information. It was also beneficial for the participants to be able to take their smartphones with them wherever they went: It is convenient, it is light, it is a nice size. Apps used. Participants discussed the various apps they used for communication, navigation, time management, data storage, social media, shopping, financial management, OLDER ADULTS AND SMARTPHONE USE 31 information exploration, and entertainment apps. Apps commonly used for communication management included text messages, video calls, voice calls, voicemails, and emails. Participants discussed using these apps to communicate with family, friends, and work. One participant enjoys the benefits of video calls, Now its nice to be able to FaceTime and see what the kids are doing the grandkids and if they have done something special in school theyll send you a picture of what theyve done or you know theyll call you and tell you something. Its nice. Another participant discussed managing his emails via smartphone, I get a lot of emails and Im always checking my computer and I just scan down and if they look like something I had to respond to I would; otherwise, I would just leave them on there...One thing I found on the cell phone when they come in, they are easy to delete and I keep much more up to date on that now. Navigation was another app discussed for use while traveling: We can put the app in and it really almost tells you your location and theres especially the traffic, and if theres accidents or traffic and its helpful when you are traveling. One application that was discussed, which would be in considered in the occupation of time management, was the calendar app. In reference to this app, one participant expressed, I keep things in it that I need to keep track of. Participants also discussed using their phone apps for data storage like the photo album for picture storage, and storing documents and recipes via cloud storage apps. One participant expressed using cloud storage: ...some of the clouds and the store information back and forth and we follow those apps. It was expressed by another participant that she desired to learn how to specifically save her recipes via Dropbox. The only app discussed relating to social media was OLDER ADULTS AND SMARTPHONE USE 32 Facebook. One participant mentioned social networking as a way for sharing information by stating, No one has mentioned Facebook...people send stuff all the time and you can see the pictures and things. Several participants discussed using their smartphones for shopping, with apps like Costco, JoAnn Fabrics, Cartwheel (Target), Michael's. One participant stated, hmm I cant think of what else, but I have a lot. A few participants reported using banking and stocks apps for financial management. One participant stated, I use a lot of it for like your stock the PNC apps for grain markets and oil, so on and so forth what the current standing is. Google, weather apps, and news apps were heavily used by the participants to access information and keep up with current events. One participant expressed his feelings towards the app stating, Google is really handy though, if I want to know something its fast and I cant believe how fast it is. Three participants indicated that they use their phones for entertainment with games. One participant expressed, I play games occasionally, but my granddaughter is on hers all the time. In reference to the perceived use of smartphones for entertainment, one participant stated, As parents, when all of our kids were little you know, we would park them in front of the TV at times to entertain them... and now I think they have all these other things that the parents use...theres just so much more available than when our kids were little and entertainment. Many participants used and liked the applications, however, one participant expressed negative feelings and felt that many of the apps were not beneficial to him, ...theres no benefit to a lot of the applications in my opinion. Discussion The purpose of this study was to explore older adults acceptance and use of smartphone technology to check for redundancy of the Walker et al. (2015) preliminary model in order for OLDER ADULTS AND SMARTPHONE USE 33 occupational therapists to optimize the fit between older adults and smartphones used to support daily occupations. The preliminary model created from the previous study consisted of four constructs which included ability, attitude, perceived need, and social influence. Factors within the Walker et al. (2015) model found to influence an individuals ability to use a smartphone included physical aspects of the device, available resources, effort expectancy, and self-efficacy. Findings confirm the primary constructs of the original model (Walker et al., 2015); however, investigators found inconsistencies among contributing factors. Ability Ability was found to have a substantial impact on smartphone use. The participants ability to use their smartphone was influenced by physical features of the device, effort expectancy, experience, available resources, and self-efficacy. Smartphone device. Participants preferred smartphones that had a large display screen, were lightweight, and could easily fit into pockets or purses. Participants in this study also reported a desire for smartphones to be durable, have the capability to take clear pictures, and allow easy access to their important information stored on the device. Plaza, Martn, Martin and Medrano (2011), found that older adults experienced difficulties operating phones with small screens due to the decreased size of the information presented on the screen. Plaza, Martn, Martin and Medrano (2011), support the findings of this study, as it is recommended that smartphones continue to be designed with larger screens, simple menus, and universally representative icons to promote use by users of all ages. Occupational therapists are positioned well to provide educational resources to assist older adult consumers in selecting appropriate smartphones to reduce effort expectancy with smartphone use as well as increase independence while using this as a tool within their daily life (Fletcher & Jensen, 2015). Occupational OLDER ADULTS AND SMARTPHONE USE 34 therapists can also recommend adaptations to smartphone settings to increase size of onscreen buttons and inform clients of shortcuts for use of menus and icons to assist with older adults integrating use of their smartphone device into their daily routines. By providing recommendations, occupational therapists can reduce the impact of many barriers between physical design and productive use of smartphones. Effort expectancy. Findings indicated older adults were less likely to use their smartphone devices if viewed as difficult or unfamiliar. Participants noted they were less likely to use an app or smartphone feature if they perceived the associated steps were difficult to remember or if menus were too complex and confusing. The participants discussed challenges associated with various apps and functions Participants reported they would start a task on their smartphone then becoming frustrated and quit the task entirely. A study conducted by Zhou, Rau, and Salvendy (2014), identified a strong correlation between perceived ease of use and an older adults ability to operate their smartphone successfully, whereas the amount of effort needed to complete a task on the participants smartphone directly influenced the likelihood of completing the task successfully. Nagle and Schmidt (2012), found that older adults accepted technology when the system gave the impression it was easy to master, provided immediate technical support, and allowed for simple communication between family and friends. Older adults often experience an increase in effort with smartphone use due to possible changing in their physical, cognitive, or sensory functions as well as, acceptance of use or the advanced design of the smartphone (Fletcher & Jensen, 2015). When an occupational therapist makes recommendations, which require smartphone use, hands-on, repetitive training, with opportunities for practice should be incorporated into the treatment plan as well as follow-up to OLDER ADULTS AND SMARTPHONE USE 35 ensure carry-over of skill in order to increase confidence in hopes to also decrease anxiety and effort expectancy. Experience. Participants relayed that the more experience they had, the greater success and confidence they experienced when using their smartphones, therefore enhancing their ability to use their smartphone with less mistakes. According to Grindrod, Li, and Gates (2014), older adults were more likely to become frustrated and make more mistakes when they were first time smartphone users. As older adults experiment and use their smartphones more often they can manipulate their phone successfully. According to Mori and Harada (2010), older adults who lived with a grandchild were more likely to be able to perform complicated tasks on their smartphone due to more opportunities for older adults to have supervised practice with their grandchild, enhancing their overall experience with smartphone use (Mori & Harada, 2010). As a result of these findings, it is evident that within occupational therapy practice we have a role to not only provide recommendations to assist with smartphone use but also assist with step by step practice with clients in order to ensure carryover. It is also important for the occupational therapist to encourage family and friends to guide older adults through procedures rather than completing the tasks for them. Having the individual complete tasks themselves will ensure greater learning retention. Available resources. When seeking support or assistance using their smartphone, participants reported use of the internet or a training manual on occasion, but did not find these methods to be near as helpful as training from friends or family members. The most commonly used resource for technological support shared by participants were friends and family members, specifically those of younger generations. Individuals who received smartphone assistance from their grandchildren were more likely to be advanced in using their device when compared to OLDER ADULTS AND SMARTPHONE USE 36 others (Mori & Harada, 2010). According to Loorbach, Karreman, and Steehouder (2013), older adults prefer learning how to use their device from other users personal stories rather than using a training manual. Given the frequent reliance on family and friends for technological support, when learning how to use applications on a smartphone, it is essential for occupational therapy practitioners to collaborate with key friends and family and include them in aspects of training. Self-efficacy. Self-efficacy was found to have a significant contribution to the participants ability to successfully use their smartphones. Most participants indicated a fear of misusing or breaking the device, or not being able to properly close specific applications. Participants also expressed that feelings of incompetence with operation, which negatively impacted their overall ability. Previous evidence from Zhou et al. (2014), found that when older adults were unsure how to use a new smartphone application they experienced a fear of breaking the device. Research from Grindrod, Li, and Gates (2014), related to these findings by conveying that older adults did not feel comfortable using their smartphones to integrate use of specific applications until after a period of training. It is evident that older adults often experience lack of confidence using their smartphones which negatively impacts on the way they use their smartphones. Occupational therapists can promote self-efficacy for smartphone use through stepby-step training while older adults are learning to use novel applications. Occupational therapists can also use graded practice opportunities, support, and education to facilitate carryover and confidence with use. Social Influence Findings indicated participants children, grandchildren, younger generations, and peers/friends were the main reasons for acquiring and using smartphone technology. Purchasing and using smartphone technology was connected to being pressured to be available at all times OLDER ADULTS AND SMARTPHONE USE 37 from family members. Participants relied on friends and family for input on purchasing a mobile phone, but also upgrading to smartphones. Zhou et al. (2014) noted that family members frequently advised older adults to obtain cell phones so they could be conveniently and that older adults rarely made their own decisions when buying smartphones. It is important for occupational therapists to understand the importance of the role of family within the social context when recommending applications for older adults. Recommending smartphones and applications already used by multiple family members or easily accessed and understood by family members will enhance carryover and provide a source of available support as needed. Attitude Participants felt that younger generations spend an excessive amount of time using smartphone technology, affecting their social skills and critical thinking. Participants conveyed more accepting attitudes toward smartphone use than demonstrated in previous literature. According to Mitzner et al. (2010), older adults believed the positives of using technology outweighed the negatives, especially when the technology encouraged independence and continued socialization. While some older adults have positive perceptions of smartphone technologies, others worried that it may replace human interaction (Harrefors, Axelsson, & Savenstedt, 2010). Older adults have had positive attitudes toward smartphones used for cases of emergency (Zhou et al., 2014). Attitude, as a factor that influences use, can be influenced by occupational therapists to support client occupations using smartphone technology. It is important for occupational therapists to assess older adults attitudes on smartphone technology that may influence use. For older adults who have negative attitudes toward smartphone technology, occupational therapists need to educate clients on the benefits of use, importance of improved occupational performance, weigh pros and cons related to use, address possible OLDER ADULTS AND SMARTPHONE USE 38 barriers to use. It is also essential for practitioners to understand that smartphone technology may not be the best tool to enhance occupational performance and should consider alternative means to facilitate optimal outcomes. Social acceptability. While the expectation from society was to constantly have smartphones on hand and readily available, participants were able to discuss related positive and negative outcomes. Regardless of positive or negative perceptions of the way society views smartphone use, participants recognized the use of smartphones becoming progressively more accepted, especially for younger generations. There was still a general consensus that smartphones were heavily used by the younger population and that use in public was considered rude, but becoming more accepted by society. Forma and Kaplowitz (2012) agreed that cell phone conversations were perceived as being more rude than face-to-face conversations, thus confirming negative stigma of use. Therefore, it is important for occupational therapists to consider how clients view the acceptability of smartphone technology when recommending applications, as acceptance may influence use. Societal concern. The older adults in this study believed that the increase of smartphone use has decreased social skills in younger generations. There was also a less perceived immediacy for smartphone usage as compared to younger generations. Older adults also expressed the lack of critical thinking skills in younger generations due to using smartphones and the sense of instant gratification that is produced from smartphone use. These findings are similar to a study that by van Deursen, Colle, Hegner, and Kommers (2015), that found older adults are less likely to become dependent on cell phone use as young people. In this study, compared to younger generations, older adults felt they placed less significance and experienced less dependency on using smartphones. There was limited research regarding older adults OLDER ADULTS AND SMARTPHONE USE 39 societal concern regarding smartphone use of younger generations. Occupational therapists can utilize this information to increase their awareness of how differently older adults may view smartphone technology and allow them to validate older adults societal concerns related to use. Privacy concern. Older adults did not store sensitive information on their smartphones, so they were not concerned about unintended dispersion of sensitive information. However, older adults would be concerned with sensitive information if they had it stored on their phones. McLeod (2009) also found that found older adults felt distressed and had negative feelings toward smartphones when storing personal information. McLeod (2009), found that smartphone capability of storing personal or sensitive information may cause older adults to worry that unauthorized distribution of their information may occur. Thus, occupational therapists need to consider and respect this generation's privacy of personal and sensitive information to better recommend applications and promote aging in place. Occupational therapists can also use this information to reduce barriers in order to increase positive attitudes toward smartphone use. Perceived Need Perceived need was a main theme consisting of the following categories: communication, safety, caregiving, work, and cost. Peek et al. (2016), determined that older adults do not use technology unless they see a need for it, and identified one of the three major attitudes of older adults that influence their use of technology as the perceived need for technology. All participants in this study confirmed that smartphones are useful, and they perceived a need to own one. Previous research showed that older adults will only adopt smartphones after they have perceived that it was useful (Reneau, 2013). Mobile technology allows individuals to monitor their overall well-being, retrieve up to date information, and seek out ongoing support for their health or chronic disease management (Joe & Demiris, 2013). Due to the convenience and access OLDER ADULTS AND SMARTPHONE USE 40 to medical information, mobile technology has become more frequently used by older adults (Joe & Demiris, 2013). Health professionals, including occupational therapists, may influence the perceived need of older adults to use smartphones, through providing education on the benefit of tracking medications and medical appointments electronically (Fletcher & Jensen, 2015). It is important to emphasize to older adults how smartphones can be used to support occupation (Fletcher & Jensen, 2015). Communication. Participants described the perceived need of smartphone use for communication purposes. They explained that the appeal of a smartphone in regard to communication is the ability to be reached by family, friends, and work while away from landlines. These findings agree with Gitlow (2014), who determined social communication was one of the most common reasons older adults use cell phones. While participants felt that communication was more convenient with use of a smartphone, they also expressed the expectation to constantly be available. According to McLeod (2009) and Gitlow (2014), most older adults use their cell phone every day for socialization including personal calling, texting, checking voicemails, and emergencies. As participants engaged in socialization through the use of smartphones occurred through video/voice calling, texting, and social media, it is important for practitioners to highlight the benefits of older adults remaining in contact with family and friends to reduce depression and loneliness (Fletcher & Jensen, 2015). Safety. Findings indicated that older adults value the security provided by owning a smartphone in case of emergencies. Finding are in agreement with Kubik (2009) and Zhou et al. (2014), who recognized that older adults typically valued the usefulness of cell phones during emergencies. Another aspect of safety that was discussed was the need for a smartphone while driving for safety and navigation. Participants expressed the convenience of utilizing navigation OLDER ADULTS AND SMARTPHONE USE 41 features of their smartphone for traveling purposes. Lin and Da Young (2015) stated that more and more drivers are using navigation applications on their smartphones even if there is an invehicle system available. Participants discussed how smartphone use while driving can impact safety and emphasized that smartphones could decrease safety if used while operating a vehicle. This idea was heavily supported by the National Safety Council, and known as driver distraction while forcing the brain to multitask. Occupational therapists can present the benefits of using a smartphone by framing it as a tool to increase Older adults safety due to their ability to contact someone in an emergency or find a route when traveling in unfamiliar areas (Fletcher & Jensen, 2015). Caregiving. Participants described the importance of communication in the role of caregiver, whether caring for parents, children with disabilities, or grandchildren. There are an estimated 29.2 million people that are currently caring for a family member over 18 years of age with a disability or chronic illness (Family Caregiver Alliance, 2010). Family caregivers are the largest source of long-term care services and it is predicted that the number of family caregivers will increase to 37 million by 2050 (Family Caregiver Alliance, 2010). The need for caregivers is increasing as the baby boomer population ages. When occupational therapists are discussing the role of being a caregiver, a smartphone can be a useful solution for caregivers when they need to be away from home to run errands. Caregivers can also use smartphones to communicate with the person they are caring for through text messages or video calls to monitor how the person is doing. Work. This study determined that two of the eight participants adopted smartphones because of work requirements. According to Mcleod (2009), sometimes, older adults decided to purchase a cell phone specifically used for employment. As the baby boomer population OLDER ADULTS AND SMARTPHONE USE 42 continues to age, work may become a more predominant factor in smartphone adoption. Since work is considered a main occupation (AOTA, 2014), it is important for occupational therapists to discuss technology use at work and the benefits of similar technology that can be used at home to assist in the productive aging process. Cost. During this study, when discussing the factors, the participants considered when purchasing a smartphone, cost was the most common consideration. One participant alluded to the rising costs of smartphones and service, yet still purchased and used a smartphone. Mallenius, Rossi, and Tuunainen (2007) stated the current baby boomer generation is concerned with high prices of technology. An interesting aspect of this study was that most of the participants received their smartphones at little to no cost due to various sources (i.e., work, family, or store deals), these findings may indicate a need for further research on the topic of how older adults afford smartphones. It is important for practitioners to make feasible and affordable recommendations for smartphones and applications, given many older adults consider cost as a barrier to smartphone adoption/use (Wallace, Graham, & Saraceno, 2013). Use While the frequency of use varied from minimum to maximum use between participants, reasons for use included personal use, communication management, navigation, time management, data storage, accessing social media, shopping, financial management, information exploration, and entertainment. Depending on how a client uses his or her smartphone may depict how well it might work as a tool to support occupational performance. Although sample size is not a limitation for a qualitative study, the generalizability of these findings is limited. Researchers interpretations of findings may be influenced by the generational gap between the participants and the researchers. Another limitation includes OLDER ADULTS AND SMARTPHONE USE 43 researchers prior exposure to Walker et al. (2015) study and preliminary model depicting a similar topic. Participants also may have been hesitant to fully express their thoughts as they were in front of a group of people. In the context of this study, the Walker et al. (2015) preliminary model is a practice framework that can also be applied to implement client-centered occupational therapy services with regards to smartphone technology. According to AOTA (2014), holistic occupational therapy interventions address virtual environments, functional communication, and the ability to access information as related to participation in occupations. Holistic occupational therapy services include overarching instrumental activities of daily living (AOTA, 2014). Through this evidence, occupational therapists could advocate for change in practice regarding technology and promote holistic care. Continued research to investigate the applicability and implications of smartphone technology use by older adults is crucial for occupational therapists to effectively support productive aging. To advance the future of smartphone design to assist with independence for older adults, there is a need for more research in global applications to capture both the needs of older adults and standard smartphones users in order assist with ADLs. This will facilitate the introduction of a global design, so that smartphone applications are simple enough to comprehend for users across the lifespan. A cross-generational design would eliminate the need to design applications specifically for older adult users as all applications would encompass this approach. Research should also include efforts to test the Walker et al. (2015) model on a large population to ensure redundancy of the model. Researchers should also aim to investigate comparisons in applications designed for use across the lifespan utilizing universal design versus OLDER ADULTS AND SMARTPHONE USE 44 applications designed specifically for older adults in order to assess the strengths and limitations of both designs. Conclusion Five factors contributed to participants ability to successfully operate their smartphone: physical characteristics of the device, past experience, effort expectancy, available resources, and self-efficacy. Smartphone use was collectively explained by the constructs of ability, attitude, perceived need, and social influence. Occupational therapists can use this model to thoroughly examine and consider the fit between older adults, smartphones, and related applications in order to provide client-centered recommendations to effectively support the occupational performance of their older adult clients using smartphone technology. Further, this model may also be used to inform the future design of smartphone technology and related applications aimed to support the needs of older adult consumers. OLDER ADULTS AND SMARTPHONE USE 45 References American Occupational Therapy Association. (2008). Occupational therapy practice framework: Domain and process. (2nd ed.). American Journal of Occupational Therapy, 62, 625 683. doi:10.5014/ajot.62.6.625 American Occupational Therapy Association. (2014). Occupational therapy practice framework: Domain and process (3rd ed.). 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Retrieved from Pew Research Center, Internet and Technology website: http://www.pewinternet.org/2014/04/03/attitudes-impacts-and-barriers-to-adoption/ Smith, A. (2014b). Older adults and technology use (Report). Retrieved from Pew Research Center, Internet and Technology website: http://www.pewinternet.org/2014/04/03/olderadults-and-technology-use/ Stuckey, H. (2015). The second step in data analysis: Coding qualitative research data. Methodological Issues in Social Health and Diabetes Research,3(1), 7-10. The 25 best Bible apps. (n.d.). Retrieved from http://www.theologydegrees.org/best-bible-app/ Useful apps for hearing loss. (n.d.). Retrieved from https://www.hearinglink.org/living/loopsequipment/useful-apps-for-hearing-loss/ Van Deursen, A. J., Bolle, C. L., Hegner, S. M., & Kommers, P. A. (2015). Modeling habitual and addictive smartphone behavior: The role of smartphone usage types, emotional intelligence, social stress, self-regulation, age, and gender. Computers in Human Behavior, 45411-420. doi:10.1016/j.chb.2014.12.039 Van Volkom, M., Stapley, J. C., & Amaturo, V. (2014). Revisiting the digital divide: Generational differences in technology use in everyday life. North American Journal of Psychology, 16(3), 557-574. OLDER ADULTS AND SMARTPHONE USE 52 Venkatesh, V., L. Thong, J. Y., & Xu, X. (2012). Consumer acceptance and use of information technology: Extending the unified theory of acceptance and use of technology. MIS Quarterly, 36(1), 157-178. Wallace, S., Graham, C., & Saraceno, A. (2013). Older adults use of technology. Perspectives on Gerontology, 18(2), 50-59. Walker, B. A., Thompson, T., Kessler, K., Ausberger, B., Nields, S., France, K., & Zornes, S. (2015). A comprehensive model for understanding acceptance and use of technology by older adults. Poster presented at the Gerontological Society of America 68th Annual Scientific Meeting, Orlando, FL. Zhou, J., Rau, P. P., & Salvendy, G. (2014). Older adults use of smartphones: An investigation of the factors influencing the acceptance of new functions. Behaviour & Information Technology, 33(6), 552-560. doi:10.1080/0144929X.2013.780637 Ziefle, M., & Bay, S. (2005). How older adults meet complexity: Aging effects on the usability of different mobile phones. Behaviour & Information Technology, 24(5), 375-389. OLDER ADULTS AND SMARTPHONE USE Appendix A Interview Guide 1. Please share with the group when and why you got your first mobile phone a. Prompt what type of phone was that? 2. Why did you decide to convert to upgrade to a smartphone? 3. What did you take into consideration before getting a smartphone? 4. Who was the most influential person in your decision to get a smartphone and why? 5. How often do you use your smartphone? 6. What do you typically use your smartphone for? 7. What apps do you use and why? 8. For those of you who still have a landline, what do you use each phone for? 9. What are the benefits of having a smartphone? 10. How did you learn to operate your current phone? a. Did anyone show you how to use any of the features? 11. What do you like about the design of your smartphone? 12. What do you not like about your current phone? a. Is there anything hard to do? b. Any features you do not understand? c. Do you avoid any features on your phone? 13. If you could wave a magic wand, what would you change about the design of your smartphone? 14. For those of you who have had multiple phones, what did you like better about your old phone over your new phone? 53 OLDER ADULTS AND SMARTPHONE USE 15. What do you do when you dont know how to use a feature on your phone? a. Who helps you the most 16. In what ways do you rely on your phone on a day to day basis? 17. How do you feel your mobile phone contributes to your independence? 18. Do you have any privacy concerns regarding the information on your phone? 19. What is the difference between how you use your phone versus younger generations? a. Do you feel you use your phone as intended? b. Why do you think this gap exists? 20. Do you have any other suggestions or comments regarding your experience with mobile phone technology? 54 OLDER ADULTS AND SMARTPHONE USE Appendix B 55  ...

... Running head: EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 1 Exploring Early Intervention and Parent Perceptions Addie Williams, OTS May 2018 A capstone project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the faculty capstone advisor: Alison Nichols, OTR, OTD EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS A Capstone Project Entitled Exploring Early Intervention and Parent Perceptions Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Addie Williams Occupational Therapy Student Approved by: Faculty Capstone Advisor Date Doctoral Capstone Coordinator Date Accepted on this date by the Chair of the School of Occupational Therapy: Chair, School of Occupational Therapy Date 2 EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 3 Abstract The purpose of this study was to examine parent perceptions of early intervention services in the Fort Wayne area. After the completion of a needs assessment, it was determined there was a lack of communication among therapy service providers and caregivers providing and receiving early intervention services. Ten parents and caregivers completed a questionnaire related to satisfaction of early intervention services. The questionnaire focused on receiving adequate resources, comfort level with their therapist, the childs progress, treatment inclusion, and their overall confidence in the therapists skills. The questionnaires were completed face-to-face at the end of the early intervention session within a two-week span. All questionnaires were anonymously collected and analyzed for an increased understanding of parent perceptions. Overall, results indicated high parent satisfaction of those families receiving early intervention services, thereby demonstrating positive parent perceptions. Future recommendations include the implementation of the questionnaire every three months alongside the completion of a progress report to initiate increased communication among early intervention professionals within this setting. Keywords: Early intervention, parent satisfaction, occupational therapy EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 4 The Exploration of Early Intervention Services and Parent Perceptions Project Introduction Early intervention emphasizes the importance of family-centered care to promote positive outcomes for the child and family. While all therapists hope they are providing high quality services to their families, it is critical to address this topic as it plays a vital role in the outcome of services. Whether parental perceptions of early intervention services are positive or negative, articulating these parental insights can assist therapists with providing services that better equip families for success. The purpose of this Doctoral Capstone Experience (DCE) was to examine parent perceptions of early intervention services in Fort Wayne and the surrounding areas through Possibilities Northeast Pediatric Therapies and Autism Services. Literature Review Occupation Based Model: Person-Environment-Occupation-Performance Models can be viewed as a way to organize, structure, and provide a basis for creating and implementing client-centered interventions. The model used for this DCE is the PersonEnvironment-Occupation-Performance Model (PEOP). This is a model that is used along the lifespan which identifies occupational performance as the outcome when taking the person, occupation, and environment into consideration (Cole & Tufano, 2008). The PEOP emphasizes occupations as the focal point, which includes the individuals roles, tasks, or values. Through this model, the person identifies which occupations are most important to successfully complete in their natural environment (Cole & Tufano, 2008). For this DCE, the focus is on the child successfully performing occupations that are vital to their lives such as age appropriate play, feeding, eating, and meeting developmental milestones. The person identifying these important occupations is typically the client being EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 5 treated. In this case, the person identifying meaningful occupations for the child is their family or caregiver, as these individuals are responsible for the childs care and advocate for the child. The children will learn to complete the identified meaningful occupations in their natural environments to assist in the longevity of skill carryover. This model best fits the early intervention setting as it identifies all the important aspects when working with the pediatric population. Occupational Therapists Role Early intervention services can play an important role in the lives of infants, toddlers, and the families involved. Occupational therapists working within this realm provide one-on-one services to children as well as education and training to their families (Kingsley & Mailloux, 2013). More specifically, occupational therapists work on a childs occupations including play, feeding, bathing, toileting, leisure, and social interactions (Fishers, 2017). According to the American Occupational Therapy Association (2017), the role of an occupational therapist is to address family concerns, provide appropriate and relevant resources, create outcomes and interventions through family and therapist collaboration, and assist in the transition process after early intervention services cease. Legislature In 1986, the Individuals with Disabilities Education Act (IDEA) included Part H comprised of early intervention services to infants and toddlers (Epley, Summers, & Turnbull, 2011). Later in 1997, this became known as Part C which specifically state services are provided to children who are at risk for developmental delays from birth until their third birthday (Fisher, 2017). These services should be implemented in natural locations including the childs home, day care, or community. Initially, Congresss hopes for establishing an early intervention EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 6 program was to allow infants and toddlers to bridge the developmental gap between themselves and their peers, reduce the costs in schools that would be put towards special education, and provide opportunities and resources for families to feel better equipped to help their child succeed (Early Intervention, Then and Now, 2014). Since then, the core elements of early intervention services have remained the same, with the addition and implementation of new and improved regulations in 2011. Parent Involvement Family-Centered Practice. Under traditional services, the American Occupational Therapy Association (2014) highlights the use of a client-centered approach when describing an occupational therapists role in service provision. While providing early intervention services, the child theoretically is identified as the client, and therefore services would be centered around their needs. This is only a portion of what early intervention encompasses as it focuses on creating a family-centered practice (FCP) (Fingerhut et al., 2013). FCP is used within this setting because the family unit is described as a constant in the childs life. Members of the family will be incorporated throughout the entirety of the intervention process (Fingerhut et al., 2013). Maintaining family-centered care while providing quality occupational therapy services is a focal point in early intervention. Fingerhut et al. (2013) completed an interview-based study with occupational therapy practitioners to better understand FCP within the home, clinic, and school-based settings. Results indicated therapists understood the term FCP but were unable to identify how it was being implemented into their daily services. Barriers to achieving FCP were identified as cultural incompetence, lack of communication, decreased collaboration with the families, and lack of time (Fingerhut et al., 2013). The researchers also identified that although literature EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 7 provides evidence of the positive outcome FCP has in early intervention, some therapists were not willing to use the FCP principles. This was due to a lack of support from colleagues, a gap in current literature and practice delivery, and/or decreased education on the implementation of FCP (Fingerhut et al., 2013). Ensuring proficiency with the implementation of FCP principles implies therapists understand the concept of family-centered services. This means therapists can identify the occupations meaningful to the family unit, assess the changes being made in the family, and assist the family unit with participating in their meaningful occupations (Degrace, 2003). Another way in which FCP can be implemented within practice is by listening and providing support to families (Case-Smith & OBrien, 2015). Support can include mental and emotional assistance as completing typical daily tasks can become difficult with an infant or toddler requiring additional developmental needs. For example, suggestions on how to make daily routines flow easier for the family is a form of support. Another example is by creating interventions based around already existing family routines so that additional work is not placed on the family (Case-Smith & OBrien, 2015). Goal Setting. Parent involvement incorporates a variety of components. This can consist of discussing what the family identifies as most important to address while receiving early intervention services. During the initial evaluation, goals will be discussed and outcomes created in the Individualized Family Service Plan (IFSP) resulting in a starting point for treating therapists to begin intervention during therapy sessions (Epley, Summers, & Turnbull, 2011). Outcomes and interventions are based upon the current circumstances of the family with an emphasis on the familys strengths, routines, and ways of living. This is to promote positive results for the child receiving services (Rodger, OKeefe, Cook, & Jones, 2012). Rodger, EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 8 OKeefe, Cook, and Jones (2012) completed a study on the Family Goal Setting Tool identifying four characteristics that assisted in a positive perception of early intervention services. This included the Family Goal Setting Tool aiding with collaboration of creating goals, maintaining focus on the childs strengths, ensuring a family-centered approach, and giving a sense of control to the family (Rodger, OKeefe, Cook, & Jones, 2012). These characteristics were identified as improving the overall perception of services. Parent Perceptions. Meeting the needs of the family is an important aspect to consider when promoting the success of the child. Ridgley and Hallam (2006) addressed a disconnect between early intervention providers and families receiving services. The researchers found that many IFSPs did not address the needs of the family but instead addressed the needs the professionals observed during the evaluation. In result, outcomes were created without collaboration and were not focused on what is important to the family (Ridgley & Hallam, 2006). This may create a negative disposition of early intervention services, and therefore parents are less likely to be involved in influencing the overall outcome. While providing direct care to the child is crucial, maintaining a positive therapist and parent relationship is also important, as the parent is the individual providing the carryover throughout day to day activities. Little research has been completed on parental perceptions of early intervention services, as the focus has been on ensuring FCP is occurring. When FCP is not occurring during the implementation of services, the perception of services from families may be more negative. Summary Understanding the dynamics of legislature, early intervention services, and ensuring family-centered practice can be a difficult task to accomplish. All components discussed must come together for quality care in this setting. Recognizing legislature surrounding occupational EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 9 therapy in early intervention ensures the safety of the child and therapist, as well as provides the means for ample resources and opportunities through the state. Literature demonstrates that providing quality family-centered services provides the family with opportunities to succeed. Currently, early intervention service providers through Possibilities Northeast Pediatric Therapies and Autism Services do not have a tool to assess parent perceptions of services and therefore are unable to gain an objective parental insight. Screening and Evaluation The screening and evaluation process of the DCE entailed two components. Semistructured interviews were completed with early intervention providers face-to-face as well as via telephone. A questionnaire was also developed to gain an insight of parent perceptions of early intervention services. According to Rodger, OKeefe, Cook, & Jones, (2012), a parent provides an expert insight into what the child needs and assists with directing therapy intervention. The interviews and questionnaires were means of gathering data from both early intervention providers and parents receiving services. The development of the questionnaire was based on existing literature in addition to the analysis of service provider responses from the semi-structured interviews to enhance understanding of what is lacking from early intervention providers. Needs Assessment Based on the current literature, parent perceptions and satisfaction can determine the outcomes of early intervention services. To assess whether this was a problem within Possibilities Northeast Pediatric Therapies and Autism Services, a needs assessment was completed via semi-structured interviews with current early intervention therapists. Based on information from the Family and Social Services Administration website, IN.gov, as well as EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 10 semi-structured interviews, a Quarterly IFSP Review is set in place and is completed every 3 months with families while early interventions services are being provided. This is given to the family by the Service Coordinator and is a 9-question conversation parents are to complete discussing topics such as finances, ensuring family is being provided with face-to-face sheets after each service is complete, discussion on how comfortable family is with the service provider, and overall parent satisfaction (Family and Social Services Administration, n.d.). Finally, a re-evaluation takes place every 6 months by the Evaluation Team to assess the skills and outcomes of the child receiving services. Once services cease, the Indiana First Steps Early Intervention System Exit Summary is sent to the family to complete regarding their overall experience. This summary includes the identification of information and resources provided on the transition process as well as the Family Outcomes Survey. This is illustrated in Appendix A. The survey includes questions regarding parent rights, communication with service providers, and how helpful service providers were with needed resources (Family and Social Services Administration, n.d.). Both forms are quick and simple methods to address state requirements but lack personal insight throughout the service provision process. Although state forms are used to provide parent insight at the end of services, no specific tool is being used by individual service providers to gain information based on parent satisfaction of services. Interviews were completed with several early intervention therapists from a variety of disciplines through Possibilities Northeast Pediatric Therapies and Autism Services, including occupational therapists, speech language pathologists, developmental therapists, and physical therapists. The questions from the semi-structured interview can be located in Appendix B. Based on discussion through the interviews one theme was evident: a lack of communication EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 11 among all early intervention providers. One individual explained she felt she had a good relationship with the family she was providing services to, but the family had been expressing concerns to their service coordinator. The service coordinator did not keep the therapist up-todate, and therefore the therapist was unaware of the familys dissatisfaction. With the lack of interdisciplinary communication and collaboration among service coordinators and service providers, there could be a decrease in overall parent satisfaction in early intervention services. Other early intervention providers expressed similar encounters with a lack of communication including unknown requests to transfer therapists, unknown outcomes wanting to be addressed by family, and lack of collaboration among service providers treating the same child. When working in early intervention, a personal relationship is built with families as the therapist is typically providing services within their home. This can create a closer relationship between therapists and families, as therapists can observe how day-to-day activities occur in the home. This may be different from individuals who receive services in other settings like an outpatient clinic because they are not receiving services in their natural environment and may not have the opportunity to get to know the family and their routines. Connecting emotionally with therapists allows parents to find strength in the challenging times (Scaffa, Reitz, & Pizza, 2010). Although a closer personal relationship may be built in the familys home, interview discussions demonstrated that it makes it more difficult to express dissatisfaction with services. Understanding personal experiences from the service providers assisted with the development of a questionnaire assessing parent satisfaction. Development of Questionnaire After research was completed, one questionnaire was used as a basis in the development of the Early Intervention Parent Satisfaction Questionnaire. This questionnaire was developed to EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 12 assist therapists in the understanding of parent perceptions of early intervention services. Broggi & Sabatelli (2010) completed a study using a self-created parent satisfaction questionnaire, along with other forms of data collection, to gain a better understanding of parent satisfaction of early intervention services provided by physical therapists. Through this questionnaire, parents were asked about a variety of topics ranging from satisfaction, how comfortable they were with the therapist, resources, and how considerately the therapist treated them. These statements were answered using a 5-point Likert scale (1 being strongly disagree to 5 being strongly agree) (Broggi & Sabatelli, 2010). This questionnaire can be viewed in Appendix C. Statements from the questionnaire created by Broggi &Sabatelli (2010) were modified for overall use of early intervention providers and the purposes of this study. It was then used in the development of the questionnaire used for this project focusing on parent satisfaction, interdisciplinary communication, and parent overall perception of early intervention services. Appendix D provides the modified questionnaire. These statements include feeling confident about the therapists skills, available resources provided to families, collaboration about intervention decisions, flexibility and willingness to work with the family, overall satisfaction, being comfortable with the therapist, and satisfaction with the progress being made. The questionnaire created contains 10 qualitative questions all assessing the satisfaction of early intervention services. The short questionnaire assisted in the understanding of parent perceptions of the services their family is receiving. To answer, a 5-point Likert scale was implemented to allow a simple way for parents or caregivers to gauge their satisfaction by. The 5-point Likert scale ranges from the individual scoring a 1 to 5 with a lower score indicating the individual strongly disagreed with the statement and a higher score indicating the individual strongly agreed with the statement. EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 13 Other Areas of Occupational Therapy There are many similarities and differences among the practice areas that encompass the field of occupational therapy. When working with all clients, occupational therapists strive to assist with engaging in meaningful occupational participation. For this DCE, a needs assessment was completed by developing a questionnaire and completing semi-structed interviews with other therapists working as treating therapists in early intervention. These are two forms of gathering data that are commonly used when assessing an individuals meaningful occupations. Throughout the project, information was gathered for two different entities including service providers and parents. Unlike traditional services, for this project the semi-structured interviews were completed with other early intervention service providers and not a specific client. Traditionally, an occupational profile would be used as an interview to gather information about the client (American Occupational Therapy Association, 2014). This could be viewed as individually client-based rather than population-based. However, throughout the DCE the purpose of the interview was to better understand the difficulties early intervention providers were experiencing causing dissatisfaction from parents as a population. The questionnaire was then developed with the emerging interview discussion topics in mind to assess parent satisfaction. For this project, the questionnaire was developed to be completed by parents. This concept contrasts other areas of practice such as home health in which the questionnaire is completed by the client receiving services. Overall Identification of Needs The overall needs assessment and evaluation process for the DCE allowed the researcher to better understand and implement the Early Intervention Parent Satisfaction Questionnaire. The data collected from the semi-structured interviews provided a basis for the development of EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 14 the questionnaire. The interviews ensured critical topics were addressed throughout the questionnaire to allow service providers to obtain parental insight needed to understand positive parent perceptions and overall satisfaction with intervention services. Overall satisfaction from parents can promote positive outcomes for the child receiving services. Implementation Phase Program planning and implementation that occurred throughout the DCE included taking the developed questionnaire and identifying the best way to distribute the questionnaires to parents and caregivers. I discussed several options for distribution with several early intervention providers, including the use of a paper copy of the questionnaire to be completed face-to-face, or an electronic copy to be completed during the session, or on the parent or caregivers own time. It was also important to consider the most effective way to maintain anonymity of the participants, as well as receive the questionnaires back in a timely manner. For this DCE, the implementation phase of this project included the distribution and the collection of a short questionnaire which assessed overall parent satisfaction of early intervention services. The questionnaire was distributed in-person at the location in which services were being provided including the home, care providers home, daycare, or community center. It was determined to distribute the questionnaire face-to-face as it provided the parent or caregiver an opportunity to complete it during a time of the day that would not seem stressful. The questionnaire was given prior to the start of the early intervention session. This ensured the parent or caregiver was provided with enough time to complete it as well as have time to interact throughout the session. A brief overview of the questionnaire was provided including the description of the purpose and an explanation of the evidence found in the literature. After the early intervention session and documentation was completed and signed by the parent, the EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 15 collection of the questionnaire took place. It was then placed in a folder upside down in no specific order by the parent or caregiver containing no identifying factors on the questionnaire. This ensured all responses remained anonymous throughout the implementation process. The distribution was completed by the researcher as well as the site mentor at the clinic. Leadership Skills A variety of leadership skills were essential to demonstrate throughout the implementation phase of the DCE. These skills were required as completing this phase of the project required independence and structure to achieve goals and outcomes. After assessing my strengths via Strengthsfinder 2.0, the results identified my top strengths as achiever, developer, discipline, empathy, and responsibility (Rath, 2017). These strengths have translated into practice throughout the DCE and proved to be my main form of leadership skills. The project has required skills such as communication, discipline, responsibility, feedback, and positivity. While completing different portions of the implementation phase, I was required to have discipline and communicate to remain on a timeline and complete specific goals and tasks for that week. During the distribution of the questionnaires, I utilized organization and discipline to ensure all families receiving services were provided with a description and the opportunity to participate in the completion of the questionnaire. The families also had the option to decline the questionnaire after a description was provided. Communication and responsibility were both used to gain the trust of parents and caregivers prior to the distribution of the questionnaires and in turn they were trusting that all responses remained anonymous throughout the project. These two characteristics were also utilized while creating a schedule. This required trial and error as the day-to-day schedule over the 16-week project were unknown. Communication was used EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 16 frequently while explaining the purpose of the questionnaire and the entirety of the DCE with parents, caregivers, and early intervention providers. During this time, I used effective communication to build rapport with those individuals that played a significant role throughout this experience including parents, caregivers, and early intervention providers. Accepting constructive feedback was also a leadership skill required to succeed throughout this phase of the project. The individuals who completed the questionnaires, as well as early intervention providers, were vital in providing me with feedback throughout this process. This feedback was toward both the DCE as well as early intervention services in Fort Wayne. Discussing both positive and negative feedback with a variety of individuals assisted in the understanding of the overall parent perception of early intervention services on a more personal level. Reviewing the feedback and reflecting on what I could learn from the responses was important, as it was key to learn from my mistakes and enhance my understanding of early intervention services. Staff Development Rapport was built early on with early intervention providers, parents, and caregivers based on the completion of the needs assessment at the beginning stages of the project. During this time, the 16-week DCE was discussed and the purpose behind the project was identified. While this occurred, the early intervention providers at the clinic expressed their personal experiences and voiced their support of this project. Future use of this questionnaire was informally discussed with early intervention providers to use as an individual self-assessment to ensure parent satisfaction of services. This is one way in which staff development can be promoted throughout early intervention providers at Possibilities Northeast Pediatric Therapies and Autism Services. EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 17 Another way in which staff development occurred was through the adaptation process for the satisfaction questionnaire. This included further informal discussions with early intervention providers within the Possibilities Northeast Pediatric Therapies and Autism Services clinic. During these discussions, therapists felt there could be a variety of statements on the questionnaire specific to each discipline utilizing the tool. Through the multiple conversations with other early intervention providers, I discussed the purpose of the questionnaire and educated therapists on the importance it has in the early intervention setting. In result, it was determined the most effective way to address parent perceptions and satisfaction of services in a more effective manner was to develop a questionnaire specific to each discipline. Discontinuation and Outcome Phase Results In all, ten questionnaires were completed by parents or caregivers receiving early intervention services in the Fort Wayne area. The demographics of the participants who participated in the data gathering process included seven mothers, two foster mothers, and one father. Ten out of ten individuals asked to participate in the study completed the questionnaire. The results of the data collected via questionnaires indicated all participants were satisfied with early intervention services and therefore demonstrated a positive perception of the overall early intervention experience. Table 1 provides a depiction of the percent of individuals who responded with strongly agree to questionnaire statements. Table 1 Percentage of individuals who responded with Strongly Agree on the Early Intervention Parent Satisfaction Questionnaire Statement 1. I am confident in the skills of my childs therapist. Percent (%) Strongly Agree 100% EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 2. I have been given appropriate resources by my childs therapist. 3. I am a part of the decision making regarding treatment outcomes. 4. I am well informed of any changes made to the intervention program. 5. My childs therapist is flexible and willing to work with the family. 6. I am satisfied with the progress my child is making. 7. I am comfortable speaking with my childs therapist about concerns. 8. My childs therapist includes the family into the treatment sessions. 9. I am satisfied with the services being provided. 10. Overall, I am satisfied with my childs therapist. 18 80% 90% 100% 80% 100% 100% 100% 100% 100% Overall, the questionnaire identified parent satisfaction of the early intervention services being received by all participants indicating they either agreed or strongly agreed with the statements provided. By analyzing the results of the parent satisfaction questionnaire, I can associate their satisfaction with perceptions and gain an increased understanding of parent perceptions of early intervention services. Continuous Quality Improvement Once data was collected and analyzed from the questionnaire, I completed a SWOT analysis to identify the questionnaires strengths, weaknesses, opportunities, and threats (Bonnel & Smith, 2018). This form of analysis can be used to ensure continuous quality improvement is occurring once the implementation process has occurred. The questionnaire displayed many strengths that have the potential to benefit individual early intervention providers in the future. The SWOT analysis identified a strength of the questionnaire as providing therapists with a simple and effective way to initiate communication between all individuals involved in the case. Implementing the questionnaire within the first few months of services also allows the therapist EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 19 to address problems the family may be experiencing that the therapist is unaware of. The questionnaire also assists with building rapport with parents and caregivers as it demonstrates the therapist is willing to address problems arising and modify services to best fit the family. Overall, the questionnaire can be utilized as a form of self-development to assess individual strengths and weaknesses as an early intervention therapist as well as build rapport and communication among families. By completing the SWOT analysis, I also identified weaknesses that could be adapted for more effective use in the future. Based on the observations made during the implementation phase, one adaptation includes creating a separate questionnaire for each discipline providing early intervention services. This was identified as an area of weakness as the questionnaire used for the DCE encompassed all early intervention services. It became difficult for parents and caregivers to generalize their overall satisfaction regarding all early intervention services they have received. Several individuals reported having varying satisfaction levels based on the different disciplines and the varying early intervention providers on the case. Along with separating the disciplines, the statements on the questionnaires will have to be adjusted to be more discipline specific. By altering the statements, it would allow the therapist to gain a better parent perception of each early intervention discipline, understand parent satisfaction of their childs skills in that area, and promote discipline specific concerns necessary to address during the session. Opportunities and threats were also identified as a portion of the SWOT analysis. An example of an opportunity acknowledged throughout this experience was the initiation of discussion among early intervention providers. Discussion was focused on the overall lack of communication between all parties involved within early intervention services. This not only EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 20 includes the providers and service coordinators but also the families involved. It can become easy to get into a routine and complete an early intervention session without connecting with families and addressing the difficulties occurring at home. Although the results displayed parental satisfaction with early intervention services, it promoted communication and provides therapists a chance for a reflection of their services in the future. This form of analysis also considers external threats. Overall, the early intervention providers varied in their agreement with the questionnaire. A threat identified after the completion of the questionnaire was the buy-in from other early intervention providers. Although many providers saw the benefit from completing the parent satisfaction questionnaire, a couple providers felt it may take up valuable treatment time and displayed less interest than their colleagues. By assessing the questionnaire via SWOT analysis, changes could be made for continuous quality improvement. To ensure continuous quality improvement and sustainability, the adapted questionnaires will be distributed via email to the early intervention providers working within Possibilities Northeast Pediatric Therapies and Autism Services clinic. A binder will also be created and placed in the clinic including hard copies of the questionnaire for individual use in the future. The questionnaire allows early intervention providers with the opportunity to check in with the families while they receive services on a more frequent basis. This can be used as a stepping stone to enable increased communication between provider and family. By providing copies of the questionnaire to other early intervention therapists at the clinic, it will increase the use of the questionnaire and allow for continuous feedback to occur. It can also be used as an individual professional development tool to assess which areas need the most improvement in regards to the provision of services and which areas the provider is excelling in. The most important aspect is to ensure positive parent perceptions of early intervention services. EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 21 Lastly the needs of society are continually changing, more specifically for the parents, caregivers, and the children being served within this setting. These societal needs can be identified and then addressed by implementing the developed questionnaire to families receiving early intervention services. This promotes overall increased communication among all individuals participating in therapy. Once the needs are identified, the results can assist with improved early intervention services and overall improved outcomes. By developing and implementing the parent satisfaction questionnaire, early intervention providers can continually receive parent satisfaction feedback of their changing needs, resulting in the promotion of an improved early intervention experience. Based on observation and professional opinion, it is recommended that the questionnaire is completed with the family every three months at the time of each progress report. By continually receiving feedback via questionnaire, the early intervention provider is initiating the assessment of their own performance. Overall, the continual updates from parents allow early intervention therapists to adapt their services as the needs of society are changing. Whether these societal changes include changed environments, new diagnoses, or altered family dynamics, the therapists will be able to meet the needs of the parents, caregivers, and children through the questionnaire feedback. Overall Learning Learning took place in a variety of settings throughout the Doctoral Capstone Experience. These settings included homes, daycares, community play areas, and libraries. In these locations I interacted with early intervention providers, biological parents, foster parents, daycare providers, aunts, siblings, and grandparents. One form of interaction used was effective verbal communication. This was important to initially build rapport so we could then discuss the childs medical history, recent hospitalizations, pediatrician appointments, educate the parents EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 22 and caregivers, and communicate with other early intervention providers on the case. The verbal interactions were an important aspect of early intervention as it assisted with building the parenttherapist relationship needed to be an effective occupational therapist. Once a relationship was established, effective verbal communication was used to educate families on important developmental milestones their child was working towards and ways in which the parents could address these skills in their everyday lives. Effective verbal communication with other early intervention providers on the case was also a necessity in order to relay important information in a timely manner or to discuss strategies with other disciplines. Effective nonverbal communication goes hand-in-hand with verbal communication within this setting. Some days, the best form of therapy I could provide to the family was to be a listening ear, display empathy, and offer education to the parents or caregivers. During these sessions, the role of the occupational therapist was to use therapeutic use of self and to assist the parent or caregiver as best as I could. This seemed prevalent as the population served over the DCE included children in foster care, single parents, first-time parents, medically fragile children, children with severe developmental delays, severe feeding difficulties, Autism spectrum disorders, and genetic malformations. It was also important to demonstrate effective nonverbal communication while parents or caregivers are trialing new techniques and skills given to them by the therapist. Parents and caregivers rely on an encouraging and supportive therapist to teach them strategies to improve the childs daily life. Nonverbal communication is key during these teaching moments as parents and caregivers feel they should be perfect at implementing the strategies and often feel overwhelmed. Written communication was used each session during the documentation process. Within this setting, documentation occurred at the end of the session and incorporated education for EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 23 parents and caregivers as well as a brief synopsis of what was completed throughout the session. The face-to-face documentation also included specific skills or activities the early intervention therapist would like the family to work on until the next session. Documentation within this setting also looks different than other areas of practice as it focuses on using family-centered language. This provided parents and caregivers with an understanding of what occurred during the session, what to work on, and when to expect services next. This form of communication is also important when services are provided at a daycare or when only one parent can be present at the time of the session. Clear and concise family-centered language is the best way for other family members to read and understand what occurred during the early intervention therapy session that day. While both effective verbal and non-verbal communication with the parents and caregivers are important, these forms of communication are also imperative to the success of the child receiving services. Through verbal and non-verbal communication, the therapist can build a trusting relationship with the child to promote successful outcomes. By developing this relationship, the therapist can make the early intervention experience as positive as possible through engaging interventions for each individual child. Through this Doctoral Capstone Experience, I have been provided with a variety of opportunities to learn and grow from. The experiences and knowledge gained over the 16-week Doctoral Capstone Experience have contributed to the therapist I have become and the therapist I aspire to be in the future. This is due to the experiences I have been provided with and the mentors I have had along the way. My confidence in both collecting data and treating young children has increased exponentially. These opportunities have expanded my hands-on experience within the pediatric population, specifically younger children aged six months to EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 24 three years of age. I have gained experience when working with a variety of diagnoses including autism spectrum disorder, developmental delay, feeding difficulties, Sensory Processing Disorder, Down Syndrome, and prematurity. Through these hands-on experiences, I have gained clinical skills needed to address developmental delays in young children in the future. Not only did I gain hands-on experience working with children, I was able to work oneon-one with families on a personal level. This occurs in early intervention due to therapists treating within homes, working alongside family members, and following their routines. I observed the importance of gaining parents and caregivers trust, as early intervention providers can be vital to the development of young children. Through the literature reviewed, data collected, and statements analyzed throughout this experience, the theme of parent satisfaction and positive parental perceptions have been determined to be a key factor in the success of the child. I have observed firsthand that when parents begin to establish a relationship with the therapist and begin to trust them, parents increase their carryover at home, which results in increasing the childs overall outcome. EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 25 References American Occupational Therapy Association. (2017). Guidelines for occupational therapy services in early intervention and schools. American Journal of Occupational Therapy, 71(Suppl. 2), 7112410010. doi:10.5014/ajot.2017.716s01 American Occupational Therapy Association. (2014). Occupational therapy practice framework: Domain and process (3rd ed.). American Journal of Occupational Therapy, 68 (Suppl. 1), S1-S48. Bonnel, W. & Smith, K. V. (2018). Proposal writing for clinical nursing and DNP projects, Second edition. New York: Springer Publishing Company. Broggi, M. B. & Sabatelli, R. (2010). Parental perceptions of the parent-therapist relationship: Effects on outcomes of early intervention. Physical & Occupational Therapy in Pediatrics, 30(3), 234-247. doiL10.3109/01942631003757602 Case-Smith, J., & OBrien, J.C. (2015). Occupational therapy for children and adolescents. (7th ed.). St. Louis, MO: Elsevier Mosby. Cole, M. B., & Tufano, R. (2008). Applied theories in occupational therapy: A practical approach. Thorofare, NJ: SLACK, Inc. Degrace, B. W. (2003). Occupation-based and family-centered care: A challenge for current practice. American Journal of Occupational Therapy, 57(3), 347-350. doi:10.5014/ajot.57.3.347 Early intervention, then and now. (2014) Retrieved from http://www.parentcenterhub.org/ei-history/#now Epley, P. H., Summers, J. A., & Turnbull, A. P. (2011). Family outcomes of early interventions: Families perceptions of needs, services, and outcomes. Journal of Early Intervention, EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 26 33(3), 201-219. Family and Social Services Administration. (n.d.) Retrieved from http://www.in.gov/fssa/4655.htm Fingerhut, P. E., Piro, J., Sutton, A., Campbell, R., Lewis, C., Lawji, D., & Martinez, N. (2013). Family centered principles implemented in home-based, clinic-based, and school-based pediatric settings. American Journal of Occupational Therapy, 67, 228-235. http://dx.doi.org/10.5014/ajot.2013.006957 Fishers, T. (2017). Occupational therapy early intervention in Indiana and contiguous states. Health Science Journal, 11(1), 1-11. Kingsley, K. & Mailloux, Z. (2013). Evidence for the effectiveness of different service delivery models in early intervention services. American Journal of Occupational Therapy, 67, 431-436. Rath, T. (2017). Strengthsfinder 2.0. New York: Gallup Press. Ridgley, R. & Hallam, R. (2006). Examining the IFSPs of rural, low-income families: Are they reflective of family concerns? Journal of Research, 21, 149-162. Rodger, S., OKeefe, A., Cook, M. & Jones, J. (2012). Parents and service providers perceptions of the Family Goal Setting Tool: A pilot study. Journal of Applied Research in Intellectual Disabilities, 25, 360-371. Scaffa, M.E., Reitz, S.M., & Pizzi, M. A., (2010). Occupational therapy in the promotion of health and wellness. Philadelphia, PA: FA Davis Company. EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS Appendix A 27 EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS Appendix A Continued 28 EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS Appendix B Question from the semi-structured interviews: 1. How long have you been working as an early intervention therapist? 2. What type early intervention service do you provide? 3. What is a positive aspect of working in a childs natural environment? 4. What is a negative aspect of working in a childs natural environment? 5. Do you feel you implement family-centered services? 6. Do you provide services to parent/s families? a. What type of services do you provide to the parents/ families? 7. In your opinion, what makes working within early intervention difficult? 8. How would you describe the relationship with your families? 9. Do you feel you know how satisfied families are with your services? 10. Do you use a tool to assess parent satisfaction? 29 EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 30 Appendix C Satisfaction Survey This questionnaire is designed to assess how satisfied you are with the physical therapy your child has received. You are asked to answer each item on a scale from 1 (not true of you and/or your experience) to 5 (very true of you and/or your experience). 1 Strongly disagree 2 3 Agree 4 5 Strongly agree I have confidence in the skills and expertise of my childs physical therapist. I trust my childs physical therapist. I like how the physical therapist interacts with my child. I am comfortable discussing my questions and concerns with my childs physical therapist. I feel at ease with my childs physical therapist. I have been given helpful resources by my childs physical therapist. Overall, I am satisfied with the progress my child is making in physical therapy. Physical therapy helps both my child and our family. My childs physical therapist helps us to be optimistic about the future. My childs physical therapist points out what my family and I do well. My childs physical therapist is considerate of our familys other responsibilities. EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 31 Appendix D Parents/ Caregivers, I am currently a Doctoral student at the University of Indianapolis completing my Doctoral Capstone Experience. I am spending 16 weeks learning and working alongside early intervention providers to gain clinical skills in this setting. I am also gathering data on the perceptions parents have of the early intervention services their child is receiving. I have created a short questionnaire to assess parent satisfaction of services as literature identifies increased parent satisfaction promotes positive outcomes in services. Thank you in advance for your consideration in taking part in this survey. Sincerely, Addie Williams, OTS EXPLORING EARLY INTERVENTION AND PARENT PERCEPTIONS 32 Appendix D Continued Early Intervention Parent Satisfaction Questionnaire Answer all of the questions to the best of your ability. Answer 1 (strongly disagree) to 5 (strongly agree). All responses will remain anonymous. (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, (5) Strongly Agree 1. I am confident in the skills of my childs therapist. 1 2 3 4 5 2. I have been given appropriate resources by my childs therapist. 1 2 3 4 5 3. I am a part of the decision making regarding treatment outcomes. 1 2 3 4 5 4. I am well informed of any changes made to the intervention program. 1 2 3 4 5 5. My childs therapist is flexible and willing to work with the family. 1 2 3 4 5 6. I am satisfied with the progress my child is making. 1 2 3 4 5 7. I am comfortable speaking with my childs therapist about concerns. 1 2 3 4 5 8. My childs therapist includes the family into the treatment sessions. 1 2 3 4 5 9. I am satisfied with the services being provided. 1 2 3 4 5 10. Overall, I am satisfied with my childs therapist. 1 2 3 4 5  ...

... 1 Exploring Benefits of Hippotherapy Through Implementation of a Volunteer Protocol Kelsy Tracey May, 2018 A capstone project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the faculty capstone advisor: Jennifer Fogo, PhD , OTR 2 A Capstone Project Entitled Exploring Benefits of Hippotherapy through Implementation of a Volunteer Protocol Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Kelsy Tracey, OTS Exploring Benefits of Hippotherapy Through Implementation of a Volunteer Protocol Approved by: Faculty Capstone Advisor Date Doctoral Capstone Coordinator Date Accepted on this date by the Chair of the School of Occupational Therapy: Chair, School of Occupational Therapy Date HIPPOTHERAPY BENEFITS 3 Exploring Benefits of Hippotherapy through Implementation of a Volunteer Protocol Kelsy Tracey University of Indianapolis School of Occupational Therapy HIPPOTHERAPY BENEFITS 4 Abstract Section I Hippotherapy is a unique treatment tool used by occupational, physical, and speech therapists to meet patients functional goals. Hippotherapy requires several individuals to facilitate a successful and safe session and provides a multitude of benefits to patients with a variety of diagnoses due to its ability to impact multiple body systems simultaneously. The various physical, sensory, and psychological benefits of hippotherapy are explained utilizing evidence based literature to support these benefits. This paper was written to explain the benefits of hippotherapy, responsibilities of hippotherapy team members, and to justify the importance of ensuring each member of the hippotherapy team is knowledgeable regarding hippotherapy benefits, responsibilities when assisting with a hippotherapy session, and Health Insurance Probability and Accountability Act (HIPAA) guidelines. The researcher implemented a volunteer protocol at a nonprofit hippotherapy clinic to improve volunteers knowledge and ensure patient safety. The results were assessed using the Goal Attainment Scale following a pre- and post-survey. Succeeding implementation of the volunteer protocol, approximately 40% of post-survey participants showed improved knowledge regarding hippotherapy and 50% demonstrated improved knowledge of HIPAA regulations. This translates into increased efficiency and safety of a hippotherapy session. Therefore, the volunteer protocol can be viewed as a valuable resource implemented at this hippotherapy clinic. Keywords: occupational therapy, benefits of hippotherapy, hippotherapy and Sensory Integration, Hippotherapy and Model of Human Occupation, HIPAA regulations for volunteers, quality improvement model HIPPOTHERAPY BENEFITS 5 Exploring Benefits of Hippotherapy through Implementation of a Volunteer Protocol A 16-week doctoral capstone experience (DCE) was completed by a Doctor of Occupational Therapy student (OTS) at the Childrens TherAplay Foundation, Inc. in Carmel Indiana. Requirements for the DCE included conducting a needs assessment to create and implement a program based off of the priority populations needs. Below is an introduction to hippotherapy, detailed needs assessment, and explanation of program implementation at Childrens TherAplay. Section II Occupational therapists often utilize a variety of treatment tools in order to help patients meet functional goals. One unique treatment tool that occupational therapists can utilize is hippotherapy. Hippotherapy can be integrated into physical, occupational, and speech therapy that utilizes the natural gait and movement of a horse to provide motor, and sensory input (Koca & Ataseven, 2016, p. 247). The term hippotherapy derived from ancient Greek literally means horse hippos (Koca, & Ataseven, 2016, p. 247). Winston Churchill once stated, there is something about the outside of a horse that is good for the inside of a man (Govender, Barlow, & Ballim, 2016, p.31). Churchill proposed this thought many years ago introducing what would become an integral part of modern hippotherapy sessions. The horse was not incorporated into therapy until the 1960s in Germany, Switzerland, and Austria (American Hippotherapy Association, 2015). Hippotherapy was introduced into the United States in the 1970s. Several therapists joined together to create the American Hippotherapy Association (AHA) in 1992, to develop a standardized hippotherapy curriculum for use among therapy disciplines (AHA, 2015). Despite the implementation of the HIPPOTHERAPY BENEFITS 6 American Hippotherapy Association nearly 25 years ago, there is still limited evidence based literature regarding hippotherapy services. Additionally, many community members, healthcare workers, and families that could benefit from these services are still unaware of the benefits hippotherapy can provide. Existing resources support benefits that hippotherapy can offer children with a variety of diagnoses including but not limited to: developmental delays, Autism Spectrum Disorder (ASD) diagnosis, Cerebral Palsy, and Down Syndrome. The purpose of this paper is to introduce the various benefits of hippotherapy, explain the importance of the hippotherapy team, and describe the implementation of a volunteer protocol developed to ensure safety and efficacy of hippotherapy services. What is Hippotherapy? Hippotherapy involves the purposeful manipulation (AHA, 2015, p. 3) of the horse in order to facilitate a response in the patient riding the horse. These reactions affect many different body systems at the same time such as musculoskeletal, circulatory, respiratory, nervous system, and cognitive functions. Hippotherapy has the unique ability to simultaneously impact multiple body systems and functions throughout one treatment session making it beneficial for many patients. Physical benefits of hippotherapy. Although evidenced based literature is limited regarding hippotherapy services, there is literature discussing the anatomy of the horse and the human and how the two correlate to create a unique therapy experience. The movement of the horses pelvis is similar to the movement in a humans pelvis. Movement in both occurs in three dimensional planes. A human pelvis moves through a sagittal plane producing flexion and extension movements, a frontal plane producing abduction, adduction, and lateral movements, HIPPOTHERAPY BENEFITS 7 and lastly a transverse plane producing rotational movements. While a patient is seated on the horse, he or she will be exposed to similar movements required for human gait because the pelvis of the horse is moving in the same three planes (AHA, 2015). The movement pattern of the horse is repetitive and rhythmic and therefore can provide many physical benefits to the patient by translating those motor movements directly through the horses pelvis to the patients pelvis (Koca & Ataseven, 2016). The patient is constantly responding to the horses movements to readjust to midline, maintain center of gravity while on a dynamic surface, and activate various trunk muscles to maintain an upright position (AHA, 2015). Koca and Ataseven (2016) reviewed effectiveness of hippotherapy and concluded that hippotherapy improves balance and muscle control of the patient (p. 248). The impact of direct contact from the horses moving pelvis on the patients pelvis and spine has twice as strong (Koca & Ataseven, 2016, p. 248) effect on the patient than normal human gait. Researchers concluded that hippotherapy can improve mobility and posture of the patient faster and more effectively than traditional therapy approaches (Koca & Ataseven, 2016). These improved motor and balance skills can help enhance each patients occupational performance in various activities off the horse as well. Hippotherapy not only has a positive impact on postural control and mobility, but it also plays a role in the overall improvement of fine motor and gross motor skills (Ajzenman, Standeven, & Shurtleff, 2013). These results can be beneficial for individuals with different diagnoses such as Autism Spectrum Disorder (ASD). Children with this diagnosis often have decreased postural stability (Ajzenman, Standeven, & Shurtleff, 2013, p. 654). Commonly seen deficits, such as decreased gross and fine motor skills, in children with ASD affect their ability to participate in daily activities. Ajzenman et al., (2013) found that when incorporating hippotherapy sessions into a 12-week treatment plan for children with ASD there was HIPPOTHERAPY BENEFITS 8 improvement in overall postural control and motor coordination. Researchers analyzed how these changes affected participation in daily activities, and found a correlation between improved postural control and motor coordination with improved participation in daily activities such as, self-care tasks, leisure activities, and social interaction (Ajzenman et al., 2013). Zadnikar and Kastrin (2011) researched the benefit of hippotherapy on children with Cerebral palsy (CP) and the benefits of hippotherapy services. Children with CP often present with limited postural control and various motor deficits that ultimately impacts the childs ability to complete daily tasks, that require some degree of postural control. Hippotherapy can improve postural control in many ways. For example, a therapist may ask the patient to sit anteriorly on the horse and reach for different objects above his or her head or reach laterally in different planes. This movement facilitates motor coordination and strength from the dorsal side of the body when the child reaches forward. Occasionally, the therapist will have the child reach inferiorly and laterally to retrieve an object which will facilitate contraction of the muscles on the ventral side of the body. These various activities in addition to initiating core strength to maintain balance while on the horse, help to improve postural control in multiple ways. The therapist may also ask the horse handler to guide the horse in trotting or completing patterns such as a figure eight that will facilitate righting and equilibrium responses, which enable development of dynamic postural stabilization and control (Zadnikar & Kastrin, 2011, p.687). These improvements in postural control can facilitate progression towards the patients increased independence with self-care tasks such as putting a shirt on independently, sitting at a desk at school with no assistive device, or engaging in leisure activities for a longer period of time before fatiguing. HIPPOTHERAPY BENEFITS 9 Hippotherapy impacts many client factors throughout one therapy session. There are benefits to the respiratory and circulatory system. The concussive forces created from the horses movement have been found to initiate more breaths from the patient, requiring increased exhalation/ inhalation that helps relax and normalize the diaphragm. This is very important for patients who have respiratory difficulties because the concussive forces help loosen secretions in the lungs making breathing easier for patients following a hippotherapy session (AHA, 2015). The concussive forces elicited during a hippotherapy session will also improve blood flow throughout the patients body and can facilitate a relaxation response to potentially decrease blood pressure (AHA, 2015, p. 53). The positioning of the patient while seated on the horse encourages an elongation of the trunk, which can aid in improving the respiratory system as well (AHA, 2015). Along with the continual elongation of trunk, the patient may be asked to cross midline and reach for a ring on the left side then pass it to the right side. This may seem like a simple task, but this task encourages the patient to initiate trunk rotation and lateral flexion, while requiring the patient to cross midline and maintain balance on the horse (AHA, 2015). The vast amount of physical benefits hippotherapy has to offer can make it a life changing therapy tool for children with physical disabilities. Along with all of the physical benefits hippotherapy has to offer, there are several sensory benefits that are notable as well. Sensory benefits of hippotherapy. Sensory processing involves input from the environment that is processed and organized to elicit behaviors. Sensory processing is regulated through auditory, visual, gustatory, olfactory, tactile, pain, vestibular, proprioceptive, and kinesthetic systems (AHA, 2015, p. 53). Even though hippotherapy provides sensory stimuli to all sensory systems, the impact on the vestibular and proprioceptive systems will be highlighted in this paper. HIPPOTHERAPY BENEFITS 10 Children with developmental delays, ASD, or Sensory Processing Disorder (SPD) struggle to participate in daily tasks due to decreased ability to process stimuli. A child that has a sensory processing disorder often struggles to learn new tasks and perform motor coordination tasks, making it difficult for that child to participate in daily tasks such as dressing, bathing, or brushing teeth (Case- Smith & OBrien, 2015). The information below details how vestibular and proprioceptive input provided through hippotherapy, stimulates multiple sensory systems which can benefit a child with an ASD or SPD (Granados & Ags, 2011). Vestibular input is nearly constant during a hippotherapy session because the horse is continually moving or changing directions. The horses change in speed and direction stimulates the patients vestibular system, which is sensitive to change in movement. These changes in movement and gravitational pull will elicit a stimulus in the inner ear to relay information to the brain of the patient, informing him or her of their position in space (Granados& Ags, 2011). The processing of this vestibular input affects the patients posture, balance, movement, and coordination (North Shore Pediatrics Therapy, 2017). As the child is exposed to additional sensory input the child will become more successful at organizing this input appropriately and this will translate into goal- directed actions which is called an adaptive response (Case- Smith & OBrien, 2015, p.259). Therefore, increased vestibular stimulation is important for overall sensory regulation because the patient will begin to elicit an adaptive response to changes in vestibular information. As the patient learns to adaptively respond to sensory input, this leads to a more efficient sensory integration system (Case- Smith & OBrien, 2015). A more efficient sensory integration system can translate into more effective participation in daily activities. For example, the vestibular system and bilateral coordination are closely related. The vestibular system and our body's ability to register information and integrate it into movements enables HIPPOTHERAPY BENEFITS 11 bilateral coordination and body awareness of the upper and lower body (The OT Toolbox, 2016, p. 1). Bilateral coordination is a vital skill for many daily tasks that often require the concurrent use of both sides of the body. If a child lacks bilateral coordination, his or her daily actions will appear clumsy and disorganized. (The OT Toolbox, 2016). Hippotherapy provides an influx of vestibular stimuli that, when organized in the body appropriately, can promote improvement in the childs posture, balance, fine and gross motor skills. Proprioception is another sensory system stimulated during a hippotherapy session. Proprioception is provided through the concussive forces and rhythmic movement the horse is transferring to the patient. The increased proprioceptive input will elicit an increased sense of self for the patient (Mathews, 2012). Much like vestibular input, proprioceptive input works to inform the body of its position in space (North Shore Pediatrics Therapy, 2017, p. 1). When a child receives increased proprioceptive input and learns to adaptively respond to this input, he or she will gain a better understanding of where and what his or her body is doing. This understanding translates into more organized and efficient participation in daily activities (North Shore Pediatrics Therapy, 2017). Case- Smith & OBrien (2015) used Jean Ayers Sensory Integration theory to explain the importance of a childs sensory system being in harmony in order for a child to effectively participate in daily activities. Ayers explained sensory integration as the brains ability to organize sensory information received from the body and the environment, and to produce an adaptive response (Cole & Tufano, 2008, p.229). Ayers stressed the importance of all sensory systems working in harmony in order to successfully organize input and respond to the stimulus properly. Nearly all daily activities a child participates in involves the integration of one or more of the sensory systems listed above. An occupational therapist can utilize hippotherapy as a tool to impact many sensory systems HIPPOTHERAPY BENEFITS 12 simultaneously. This influx of sensory input will elicit the patients adaptive response mechanism which results in an even more efficient sensory system (Case- Smith & OBrien, 2015). Psychological benefits of hippotherapy. Not only does hippotherapy offer physical and sensory benefits to patients, its influence extends to the mind. Taylor et al. (2009) examined volitional change in children with ASD who were participating in hippotherapy. Researchers studied a convenient sample of children who participated in hippotherapy weekly utilizing the Pediatric Volitional Questionnaire. After 16 sessions, all three children showed improvement in their motivation to engage in everyday activities (Taylor et al., 2009, p. 198). Even though the researchers had a small number of participants, the results revealed that hippotherapy can provide a motivational change for children with ASD. Taylor et al., (2009) utilized the theory Model of Human Occupation (MOHO) to guide their research study. MOHO was created by Gary Kielhofner (Cole & Tufano, 2008) and had three main components. The first component focuses on volition. Kielhofner defined volition as the motivation for occupation, (Cole & Tufano, 2008, p.95). The second term is habituation which is the process by which occupation is organized into patterns or routines (Cole & Tufano, 2008, p.95). The last component is performance capacity which is comprised of a persons ability to complete skilled occupations (Cole & Tufano, 2008). These three primary components of the MOHO align well with the psychological benefits evident hippotherapy treatment. The horse can be used as a motivational tool for the child. A child fond of the horse will begin to build a relationship with the horse and look forward to hippotherapy sessions. The child can also participate in opportunities to care for the horse, such as grooming or feeding the HIPPOTHERAPY BENEFITS 13 horse. These opportunities can also be seen as motivating factors for the child (AHA, 2015). As the child sees himself or herself improving in therapy, this translates to the child gaining confidence in other aspects of life (Taylor et al., 2009). This improved confidence can transform into self-assurance to participate in social groups at school, complete home-work assignments on time, and work towards increasing independence in tasks such as instrumental activities of daily living (IADL). Occupational therapists utilize hippotherapy in many ways to improve motor control, fine motor coordination, gross motor coordination, overall balance, attention to task, and to help integrate sensory processes (AHA, 2015). Some degree of motor planning, balance, and attention to task are necessary skills in order for a patient to be able to participate in daily activities. Since hippotherapy provides a holistic approach to therapy (AHA, 2015) it can be utilized to help improve a patients occupational performance in many ways when compared to strictly clinic based occupational therapy. Hippotherapy Compared to Clinic Based Therapy According to American Occupational Therapy Association (AOTA) hippotherapy is not classified as an emerging area of practice however, some researchers still classify it as emerging due to lack of public awareness regarding hippotherapy services (Baker, 2015). Hippotherapy when compared strictly to clinic based therapy inevitability has higher risks due to it requiring the use of a large animal (AHA, 2015). However, this unique treatment tool has shown to have outstanding effects on various body systems, allowing patients to meet functional goals quicker than traditional approaches (AHA, 2015). Occupational therapists working in a hippotherapy setting create functional goals that can be achieved on and off the horse. The therapists at HIPPOTHERAPY BENEFITS 14 Childrens TherAplay utilize a variety of pediatric assessments such as Peabody Developmental Motor Scales Second Edition (PDMS 2), Sensory Profile II, and Bruininks-Oseretsky Test of Motor Proficiency, Second Edition and (BOT-2) OT Short Form to assess patients functional goals. These pediatric assessments are also used in standard pediatric clinics. The results of the assessments help justify the patients need for occupational therapy services, and provide a quantifiable means to document progress (L. Van Antwerp, personal communication, January 24, 2018). Some hippotherapy clinics utilize hippotherapy assessments to assess patient function specifically related to hippotherapy goals. Thompson, Ketcham, and Hall (2014) studied how hippotherapy impacted patients with developmental delays (DD). Researchers utilized several assessments to look at changes in participants physical and psychological function after participation in 8-12 weeks of hippotherapy. Therapists used the Gainesville Riding through Equine Assistive Therapy (G.R.E.A.T.) Postural Scale assessment to assess postural changes in participants along with a parent questionnaire to assess changes in self-esteem and overall quality of life. The results revealed that approximately half of the participants showed improvement in fine motor coordination, and approximately 62% demonstrated improvements in the gross motor assessment, specifically related to postural control (Thompson, Ketcham, & Hall, 2014). The parent surveys indicated a significant increase in each childs quality of life and overall self-esteem following the hippotherapy treatment. Researchers concluded that equine assisted therapy can be seen as a effective therapeutic protocol for children with a variety of developmental delays (Thompson, Ketcham, & Hall, 2014, p. 67). HIPPOTHERAPY BENEFITS 15 Assessments such as the G.R.E.A.T Postural Scale, can be beneficial to use in a hippotherapy setting in order to provide further quantitative data supporting the benefits of hippotherapy services. However, these assessment tools, much like most assessment tools, are expensive and difficult to administer (L. Van Antwerp, personal communication, January 24, 2018). Occupational therapists at Childrens TherAplay focus on using assessments that are commonly used in clinical pediatric settings to help justify skilled occupational therapy needs to insurance companies and to doctors to ensure continued services for each patient (L. Van Antwerp, personal communication, January 24, 2018). Despite similar assessment tools and goals for therapy, the main difference between hippotherapy and clinic based therapy is the horses ability to provide physical, sensory, and psychological benefits simultaneously to a patient throughout one hippotherapy session, which would take several clinic based sessions to see similar results (AHA, 2015). In order for hippotherapy sessions to be safe and effective it requires trained individuals that are dedicated to helping each patient achieve functional goals. Hippotherapy Team The hippotherapy process is unique and requires several individuals in order for the therapy session to be successful and safe. A well- trained occupational or physical therapist is an important factor in successful hippotherapy implementation. A therapist utilizing hippotherapy must understand the anatomy of the horse, the connection between the horses movement and the patient in order to utilize this therapy tool most appropriately. It is also imperative for the therapist to understand the anatomy of the patient and the symptoms of the patients diagnosis at hand. This knowledge helps the therapist create the most effective treatment plan for the patient. Therefore, it is highly encouraged that all therapists working in a AHA certified hippotherapy HIPPOTHERAPY BENEFITS 16 clinic attend Treatment Principle trainings created by the AHA to ensure best practice (AHA, 2015). Hippotherapy can look different dependent upon the area of the world where the therapy is provided. Typically, in the United States hippotherapy sessions include three individuals that play a vital role in ensuring safety of all team members and the patient throughout the hippotherapy session. The team members roles and responsibilities are described below. Horse handler. A horse handler is responsible for understanding the specific behaviors and movements of the horse and utilizing these to guide the horse to achieve specific patterns and movements as requested by the therapist to facilitate appropriate adaptive responses from the patient. The horse handler can be a well-trained volunteer or an instructor/ trainer who has had advanced experience in horse handling techniques. The horse handler utilizes his or her advanced equine knowledge to collaborate with the therapist to select the best horse to fit the patients needs. The horse handler must always be aware of potential safety risks. The horse handler must identify when the horse is in distress and inform the therapist in order for him or her to perform an emergency dismount to ensure safety of the patient and team members involved in the session (AHA, 2015). Primary side walker. The primary side walker is usually an occupational or physical therapist guiding the session. This person is labeled as the primary sider walker because he or she is the primary person responsible for the childs safety. The primary side walker will be on one side of the horse with a hand on the patients thigh or ankle for safety. Occasionally the therapist will place a hand on the patients lower back to promote maintenance of midline position throughout the session. The therapist constructs short term and long term goals for the HIPPOTHERAPY BENEFITS 17 patients plan of care and utilizes different activities on the horse to help the patient achieve those goals. During the hippotherapy session, the therapist must direct the horse handler to manipulate the horse in specific patterns and movements that will help facilitate development of skills necessary for the patient to achieve the established short and long term goals (AHA, 2015). Secondary side walker. The third individual is the secondary side-walker who is on the other side of the horse with a hand placed on the patients thigh or ankle to ensure patient safety. The secondary side walker is often a student or volunteer. The secondary side walker may assist with interactive activities as directed by the therapist throughout the hippotherapy session. The secondary side walker is responsible for horse preparation, patient preparation, and following directions from the therapist to maintain patient position while the patient is on the horse. The secondary side walker aides the therapist in safely transitioning the patient on and off the horse, which is the riskiest time for the horse and therefore requires trained individuals to aide in this process (AHA, 2015). All of these individuals play important roles to ensure the childs safety, the horses safety, and the success of the hippotherapy session (AHA, 2015). Therefore, it is vital to certify that all members of the hippotherapy team understand and are comfortable with their responsibilities to maximize the patient benefits. At Childrens TherAplay a mandated volunteer protocol was put into place to ensure these expectations were understood by volunteers and ensure patient safety and confidentiality. HIPPOTHERAPY BENEFITS 18 Screening and Evaluation Section III Needs Assessment The Childrens TherAplay Foundation Inc. in Carmel, Indiana. Childrens TherAplay provides hippotherapy sessions to approximately 170 children a year, ages 18 months to 13 years old (Childrens TherAplay Foundation, 2018). The DCE focused on the occupational therapy student (OTS) performing a needs assessment in order to implement some type of program that would benefit the organization the student was partnered with. Scaffa & Reitz (2014) described the purpose of a needs assessment as the identification of the most prominent needs of a specific population. A needs assessment includes using resources to discover the needs of the population and establishing goals and objectives to meet the identified needs. The OTS set up a face-to-face meeting with an occupational therapist on staff and the volunteer coordinator to assess the priority population and the needs of that population at Childrens TherAplay. The occupational therapist and the volunteer coordinator determined the most immediate need was to further develop the existing volunteer training protocol, specifically requesting for the OTS re-make the current side walking video that was created in 2013, and implement Health Importability Accountability Act (HIPAA) standards into the new volunteer protocol. Therefore, the OTS identified the volunteers and students at Childrens TherAplay, specifically focusing on the group of volunteers who help with side walking responsibilities, as the priority population. The OTS reached out to the rest of the therapy staff at Childrens TherAplay for input on the new volunteer protocol. The OTS requested the therapy staff send suggestions via email by 2/8/18. HIPPOTHERAPY BENEFITS 19 The OTS utilized a variety of resources to further explore the needs of the organization. One of the most beneficial resources was The American Hippotherapy Association Level I Treatment Principles Course Manual which helped justify the need to expand on the current volunteer protocol materials. The OTS completed a systematic search online to compile resources for the creation of the HIPAA training PowerPoint. Lastly, the OTS completed a systematic search on the American Hippotherapy Association website to identify any other hippotherapy clinics in the Indiana area; to compare and contrast Childrens TherAplay volunteer protocol to other facilities in Indiana and the surrounding area. According to the American Hippotherapy Association, Childrens TherAplay Foundation, Inc. is the only AHA identified hippotherapy clinic in Indiana. A systematic search identified two therapeutic riding centers in Indiana, Morning Dove and Agape (AHA, 2018). The student reached out to both facilities during the needs assessment process to gain a better insight on volunteer protocols in other settings. The OTS sent an email to Indiana University (IU) Healths Volunteer Coordinator to explore volunteer protocols in a larger medical setting as well. Morning Dove. Morning Dove is a therapeutic riding clinic located in Zionsville, Indiana. Morning Dove offers a variety of equine programs such as, therapeutic riding, hippotherapy, and equine learning programs (Sadler, 2018). It is important to note the difference between hippotherapy and therapeutic riding. Hippotherapy includes a trained occupational, physical, or speech therapist that utilizes the horse as a therapeutic tool in order for patients to meet functional goals (Zadnikar & Kastrin, 2011). Whereas, therapeutic riding is a broad term that includes recreational use of a horse. Therapeutic riding involves trained instructors who teach the rider how to direct the horse and care for the horse (Zadnikar & Kastrin, 2011). Since HIPPOTHERAPY BENEFITS 20 hippotherapy is directed by a skilled therapist the volunteers main responsibility is to assist in keeping the child safe throughout the session. In therapeutic riding volunteers could act as the instructor and therefore require a more intensive orientation session. Individuals interested in volunteering at Morning Dove are required to attend a two-and-a-half-hour orientation provided by the volunteer coordinator, prior to their first volunteering shift. This orientation includes an informational PowerPoint teaching volunteers about his or her responsibilities, safety requirements, and expectations. (N. Graper, personal communication, February 5, 2018). Indiana University Health. An individual who volunteers at IU heath is required to attend an orientation session/ tour of the facility prior to starting. During this initial session, the volunteer will be given a detailed handbook explaining expectations of volunteers, appropriate patient interaction, and a list of volunteer responsibilities. The handbook includes specific HIPAA regulations along with a confidentiality agreement form singed by all volunteers. The handbook states strict guidelines for anyone who does not follow HIPAA compliance standards to be dismissed from the IU Health volunteer list. All IU Health volunteers are required to read through the packet, initial, and return to the volunteer coordinator upon beginning their first shift (D. Hunt, personal communication, February 5, 2018). IU Healths detailed handbook served as a valuable resource in the creation of the new volunteer protocol at Childrens TherAplay. Horse Feathers. The other therapeutic riding clinic contacted was Horsefeathers, located in Illinois. The information was received via email from an occupational therapist on staff at Horsefeathers. The therapist sent a YouTube video that volunteers are asked to watch regarding responsibilities, safety guidelines, and what to expect when volunteering. The therapist reported HIPPOTHERAPY BENEFITS 21 I'd love to create our own video like this but we don't have the time or resources right now (P. Lundell, personal communication, February 9, 2018). Childrens TherAplay. The OTS analyzed the existing volunteer protocol materials prior to the implementation of the new volunteer protocol. Childrens TherAplay required volunteers and students to watch a short five-minute video regarding side walking responsibilities, participate in a tour of the facility, and sign a confidentiality waiver before volunteers began working. There were no specific guidelines regarding HIPAA and its importance in this medical setting. Results of Needs Assessment The results of the needs assessment were revealed through interviews, systematic searches, and analysis of evidence based materials. The literature supported the results of the needs assessment. In order to continue to provide the most effective and quality hippotherapy services to each patient, it was essential all volunteers and students understand the responsibilities and regulations expected in this setting. AHA (2015) explains All team members MUST have training in the application of equine movement, safety procedures, and confidentiality as determined by Health Insurance Portability and Accountability Act (HIPAA) regulations. It is ideal if all team members are knowledgeable about the expected outcomes of the therapy session (AHA, 2015 p. 35). Following the needs assessment, goals of the priority population were set in place to ensure adequate knowledge and safety at Childrens TherAplay. The volunteer protocol included an educational video to explain to volunteers and students the responsibilities of side walking along with a brief overview of the benefits of hippotherapy. To ensure best practice it was essential that each hippotherapy team member had an understanding HIPPOTHERAPY BENEFITS 22 of the importance of hippotherapy, patient goals, and safety regulations. The second component of the volunteer protocol was an educational PowerPoint on HIPAA guidelines. Hughes (2005) clarified the importance of making sure volunteers at nonprofits are adequately trained in HIPAA regulations. HIPAA medical privacy rule must train all member of its workforce on the organizations policies and procedures for protecting patient information this includes volunteers (Hughes, 2005, p. 1). Hughes explained healthcare organizations are expected to train employees (and volunteers) on HIPAA regulations, but have the freedom to do so in their own format. Hughess article validated the importance of including the HIPAA PowerPoint as a component of the volunteer protocol. Program Model A Logic Model is a tool that can be used by any individual to evaluate the effectiveness of a program (McCawley, n.d.) A Logic Model can be utilized in a systematic manner to visually display the components of a program. This model breaks down the issue at hand and then incorporates potential inputs and outputs into the intervention plan. The resulting impact is seen as the outcomes. External influences are also considered in the model diagram (McCawley, n.d.). The Logic Model was used to organize the ideas for the volunteer protocol in a methodical and visual manner. By organizing the volunteer protocol with this model it provided increased validity and potential for yielding data (McCawley, n.d.). The inputs included individuals who participated in the creation of the volunteer protocol; the OTS, occupational therapist, and volunteer coordinator. The resources used to create the volunteer protocol included evidence based literature, American Hippotherapy Association Manual, and online resources from various websites. The outputs included an updated volunteer HIPPOTHERAPY BENEFITS 23 protocol including a new side walking video and a HIPAA compliance PowerPoint distributed to existing and new volunteers by the volunteer coordinator as they came in for their volunteer shift. The effectiveness of the updated volunteer protocol was analyzed using pre and postsurveys. The outcomes included short term and long term goals. The short term goal was to increase volunteers awareness, knowledge, and skills regarding hippotherapy safety regulations. The long term goal was improved compliance with HIPAA regulations and continued safe practice to increase validity and awareness of hippotherapy services and benefits. The Logic Model was used to organize ideas for the volunteer protocol (see Appendix A). Further analysis of results was done on an individual level, by the OTS utilizing the Goal Attainment Scale (GAS), (see Appendix B). The GAS is often used in both clinical work and research to assess the effectiveness of an intervention (Kransy-Pacini, Evans, Sohlberg, & Cgevignard, 2016, p. 157). The student used the GAS to assess the outcomes of four specific goals related to participation in a pre- and post-survey, increased knowledge regarding hippotherapy, and knowledge regarding HIPAA compliance. The GAS uses an ordinal scale to assess the success of an intervention, in this case the volunteer protocol (see Appendix B for a descpriton of each GAS goal) (Kransy-Pacini, Evans, Sohlberg, & Cgevignard, 2016). Implementation Phase Section IV Participants The participants of the DCE project included any individual in the volunteer database that had participated in side walking responsibilities, no matter the amount of time he or she had been a volunteer. The volunteer coordinator sent a complete list of the participants who met this HIPPOTHERAPY BENEFITS 24 criteria to the DCE student. Participants ages varied from 19 years old to 65 plus years old, with varied backgrounds. The majority of participants resided in Hamilton County (K. Stratman, personal communication, February 20, 2018). Approximately 53 volunteers were sent information regarding the DCE project, detailing the purpose of the pre- and post-survey, and the necessity of a volunteer protocol. Procedure Following the needs assessment, a pre-survey was developed. The pre-survey questions included specific details regarding side walking responsibilities, safety guidelines, and HIPAA regulations. Pre-survey questions were reviewed by an occupational therapist and volunteer coordinator on staff. The final draft of the pre-survey questions included nine multiple choice items, and one open-ended question. The post-survey consisted of the same nine questions in the pre-survey, and one open-ended question. The questions were put into Survey Monkey; a copy of the survey questions with intended answers labeled in bold were sent to all staff (see Appendix C for a copy of the survey). An initial email was sent to all 53 volunteers on 2/20/18 which included the Survey Monkey link. A statement of consent was included, informing participants that their responses would be used to assess the quality of the materials included in the volunteer protocol. The DCE student participated in a face-to-face meeting with the occupational therapist, volunteer coordinator, and Equine Program Manager to collaborate on the development of a detailed video script on 2/20/18. The video was filmed on 3/16/18 by a media specialist who was outsourced by the occupational therapist assisting with the DCE project. HIPPOTHERAPY BENEFITS 25 Along with the creation of an updated side walking video, a HIPAA Training PowerPoint was created by the DCE student (see Appendix D for a copy of the PowerPoint). The occupational therapist and volunteer coordinator provided feedback throughout the development of the PowerPoint. The HIPAA PowerPoint was created utilizing resources from other therapeutic riding centers, IU Health, and online resources. The PowerPoint included a definition of HIPAA, details regarding Protected Health Information (PHI), and an explanation of Treatment, Payment, and Operation (TPO). The HIPAA PowerPoint included a slide titled Confidentiality Statement that all participants were asked to sign and return to the volunteer coordinator, confirming his or her understanding of the HIPAA guidelines. Data Collection The research design was a quantitative quasi-experimental pre-survey/post-survey design. The data collection process included the pre- and post-survey results that allowed the OTS to assess the impact of the newly instated volunteer protocol had on participants knowledge. The participants responses were assessed utilizing the Goal Attainment Scale (GAS). The scores for questions seven, eight, and nine were compared from the pre to post-survey to assess for improved knowledge regarding hippotherapy. The scores for questions five and six were assessed for improved knowledge from pre to post-survey regarding HIPAA compliance.. Results are discussed in further detail in Section V. Leadership Skills The OTS acted as a consultant for the therapists and volunteer coordinator during the 16week DCE. Staff collaboration was required throughout the needs assessment process. The OTS demonstrated leadership skills by taking on a role that was outside of her comfort zone, acting as HIPPOTHERAPY BENEFITS 26 a consultant, rather than strictly working as an OTS learning clinical skills. This role included creating and maintaining a schedule of tasks and time frames for task completion, independently working on the HIPAA training PowerPoint, and developing a video script, which were not skills that the student had utilized in previous fieldwork settings. The level of independence during this experience, required the student to stay on task and be organized to ensure that the volunteer protocol materials were completed on time. The DCE student received regular feedback from the volunteer coordinator and occupational therapist, but was expected to work on projects independently, and report to the two advisors as work was completed. Leadership skills were also required to explain the role as a DCE student. Since this was a new experience for the site and the university, proper advocacy skills were required to explain the importance of the DCE experience. The OTS had to advocate for herself in order to ensure adequate amount of time could be spent developing the project and the DCE Summary Paper outside of other projects requested by the Childrens TherAplay staff. The service provision model that guided this DCE included consultation. The Executive Council of Physical Therapy and Occupational Therapy Examiners define consultative service provision as the consultant seeks to create solutions that remediate the presenting problemsconsultation services may be given to students, staff, and administration (Definitions for direct service and consultation, 2015, p.1) The needs assessment revealed the issue at hand. It was important for the OTS to consult the Childrens TherAplay staff, volunteers, and students on the needs assessment results and reiterate the importance of implementing a volunteer protocol. HIPPOTHERAPY BENEFITS 27 Staff Education Staff was educated on the importance of the volunteer protocol throughout the entire DCE process The OTS sent an email to all therapists and selected administration staff to explain the DCE project along with requesting any input be sent via email by 2/9/18. It was important to ensure all staff were on board with the project and understood the necessity of implementing a volunteer protocol. Lastly, it was important to collaborate and receive feedback from staff in order to ensure the materials would be used for an extended period of time after completion of the DCE. Discontinuation and Outcomes Section V Pre- Survey. The OTS sent the pre-survey on 2/20/18 to 53 volunteers. Twenty- three volunteers completed the survey, of whom 20 were females, and three were males. The presurvey was available to participants from 2/20/18-3/10/18. The average time to complete the presurvey was three minutes. The OTS assessed the results of the pre-survey using the first GAS goal (see Appendix B). The final score was zero, meaning the expected outcome as outlined by the GAS was met. Approximately 43% of volunteers who were sent the pre-survey email completed the survey; the baseline goal was 40% completion rate. Post- Survey. The OTS sent the post-survey via email on 4/02/18. The post-survey was available to participants from 4/02/18-4/11/18. The email included the link to the Survey Monkey post-survey and the new side walking video that was approximately five minutes in length, with updated information including benefits of hippotherapy, responsibilities of the hippotherapy team, and reference to HIPAA guidelines. The OTS sent the HIPAA PowerPoint as HIPPOTHERAPY BENEFITS 28 well, which included a confidentiality statement slide that requested all volunteers sign and return to the volunteer coordinator, indicating his or her understanding of HIPAA compliance guidelines. The OTS only sent the post-survey link to volunteers who had completed the presurvey in order to validate the use of the GAS to assess the participants gained knowledge after viewing the video and the PowerPoint. Ten individuals completed the post-survey, of whom nine were females and one was a male. Approximately 43% of volunteers completed the post-survey out of the 23 that participated in the pre-survey. This met the baseline goal of 40%. Results Quantitative results. The OTS assessed the quantitative results using the GAS scale (see Appendix B for GAS goals). Forty-three percent of individuals who were sent the pre-survey participated in it resulting in a score of zero for the first GAS goal. Forty-three percent of participants completed the post-survey as well, ensuing a score of zero for the second GAS goal. Knowledge gained from viewing the video and PowerPoint were assessed by comparing the individual scores on the pre-and post-survey. Forty percent of the 10 post-survey participants showed improved knowledge regarding hippotherapy and hippotherapy services as assessed by questions #7,8,9 on the pre- and post-survey, resulting in a score of zero for the the third GAS goal. Fifty percent of post-survey participants demonstrated improved knowledge in HIPAA regulations as shown through responses on questions #5,6 on the pre-and post-survey, ensuing a score of zero for GAS goal number four. Qualitative results. The OTS requested on question number 10 that all volunteers include his or her name and email along with any suggestions on the side walking video. On the pre-survey, several volunteers submitted questions that were valuable to ensure improved clarity HIPPOTHERAPY BENEFITS 29 on the new side walking video. Please not all names have been changed to maintain confidentiality. For example, one volunteer stated: I would like more information on emergency dismounts. Luckily, I have never been faced with this situation, and split second reaction is needed and everyone needs to be on the same page, it seems like there could be different scenarios- generally I think the child should go to the therapist, but what if the horse jumps in the direction of the therapist for example? P.S. this is a great idea! (M. Smith, personal communication, February, 21, 2018). The OTS collaborated with the occupational therapist and volunteer coordinator to respond to this participants question appropriately along with clarify that the emergency dismount procedure would be clear in the new video. Another beneficial suggestion from the pre-survey was regarding side walking responsibilities, It might be helpful to include information regarding how and/or if a side walker should help with verbal and/or visual cues to help the therapist, or simply walk alongside. Does it depend on the therapist? (T. Hanson, personal communication, February 20, 2018). The OTS sent an informational email to this participant to further explain what was expected of a side walker. The new video thoroughly explained that with all transitions, changing hand placements, and cueing for the child to listen to the therapist who will instruct the volunteer on what to do in each scenario throughout the hippotherapy process. Following implementation of the volunteer protocol, post-survey qualitative results were very positive. Qualitative results were collected from participants, therapists on staff, and administrative staff. On the post-survey several of the volunteers left comments on the video HIPPOTHERAPY BENEFITS 30 many saying great video very helpful. One volunteer stated, Fantastic work on the new video and PowerPoint! Video was very thorough, and PowerPoint was very informative and easy to follow (S. Wilson, personal communication, April 3, 2018). One of the fairly new occupational therapists on staff reported, Great job! Starting off as a side walker, I appreciate the narration and video graphic timing (S. Hudson, personal communication, April 4, 2018). All qualitative results were reassuring of the value of the newly instated volunteer protocol materials. Discussion Despite the small sample size for the post-survey, the qualitative and quantitative results demonstrated increased knowledge regarding HIPAA and safety procedures when assisting with hippotherapy sessions. The implementation of the volunteer protocol, will reassure therapists and administrative staff of the volunteers knowledge regarding patient confidentiality and hippotherapy, which will enable them all to work together as a team for delivery of best practice. The volunteer protocol was implemented for a variety of reasons to enable continuous quality improvement at Childrens TherAplay. Quality improvement is defined as a focus on measuring change, consists of systematic continuous action that lead to measurable improvements in healthcare services and the status of a target patient group (Malnutrition Quality Improvement Initiative, 2016, p. 1). The volunteer protocol aided in ensuring constructs of quality improvement were met by certifying that all members of the hippotherapy team were knowledgeable about benefits of hippotherapy, importance of patient confidentiality, and responsibilities regarding side walking. Since hippotherapy services require several individuals for the therapy session to be effective, the materials provided in the volunteer protocol assisted in ensuring best practice of the entire hippotherapy team. Ensuring best practice is one of the key HIPPOTHERAPY BENEFITS 31 components for continuous quality improvement (Malnutrition Quality Improvement Initiative, 2016). In order to use the volunteer protocol as a resource for continuous quality improvement, it was important to create a protocol that could be adjusted easily as societal needs change. The OTS created the volunteer protocol in a way that made it versatile to promote use for an extended period of time, even after completion of the DCE. The OTS revised the volunteer protocol materials several times with assistance from the therapists on staff and the volunteer coordinator to ensure that the questions on the pre-and post-survey aligned well with the goals of the project. Collaboration was necessary to ensure the video script contained all of the necessary information and the HIPAA PowerPoint utilized evidence based resources and was easy for the target population to understand. The OTS focused on creating materials that were adaptable for the different generations and education levels to properly encompass the wide age range in the target population. The OTS saved all of the materials used on the share drive, in a folder titled Volunteer Protocol Materials to enable Childrens TherAplay staff to make changes to the volunteer protocol as needed. Since all employees have access to the share drive, any necessary changes can be made to the existing materials as needs change. The OTS sent an informational email to all staff to present the volunteer protocol resources and to promote program sustainment. The implementation of the volunteer protocol, assisted in reassuring therapists and administrative staff in the volunteers knowledge regarding patient confidentiality and hippotherapy, which will enable them all to work together as a team for delivery of best practice. HIPPOTHERAPY BENEFITS 32 Overall Learning Section VI The DCE experience was unique in many ways. This experience allowed the student to expand beyond the generalist level of OT and learn more about this specialty area of practice, hippotherapy. This experience required the OTS to become more independent, assertive, and further develop professional communication skills. The original focus of the DCE was to further develop clinical skills along with improve advocacy skills. By the end of 16 weeks the DCE focus included a variety of opportunities that enabled the student to grow as a future OT practitioner. Clinical Skills The DCE allowed the student to further develop clinical skills in a pediatric hippotherapy setting. The student became proficient in the electronic medical record system Practice Perfect. The student administered the PDMS-2 to three children and the Sensory Profile II to two parents. The student developed interpersonal and professional communication skills with parents of the children on her caseload. These skills were demonstrated when the student was required to explain evaluation scores to parents and explain the childs progress in daily treatment. The student provided communication through the use of layman terms while also explaining the clinical importance of equine movement and therapy interventions. The student collaborated with other therapy disciplines to discuss shared patient progress and to seek advice for effective intervention plan ideas. Since this was the students first long pediatric experience, she learned that pediatrics requires upbeat energy, creativity, and patience. The student demonstrated flexibility, creativity, and further developed assertive communication skills to enhance success of HIPPOTHERAPY BENEFITS 33 the interventions provided. All of these skills were valuable in the development as a future OT practitioner. Advocacy Advocacy was the second focus of the DCE experience. The student created a volunteer protocol that required advocacy skills to ensure follow through and efficiency of the materials. The student utilized communication through the company email to address all faculty requesting input on the volunteer protocol. The student also utilized Survey Monkey to collect responses from volunteers regarding input for the new video. The student used a variety of communication outlets to connect with staff, participants of the project, and community members in order to create and implement a sustainable and valuable volunteer protocol. The student participated in a variety of advocacy projects along with the main project of the volunteer protocol. The students first advocacy project was focused on assisting with the United Way Alignment report write up. The student reached out to United Ways Vice President, Christina Hage, to discuss Indianas regulations and policies regarding treatment of children with disabilities. This provided an opportunity for the OTS to use professional communication to connect with an individual involved in legislation, and provided an opportunity for advocacy of occupational therapy and Childrens TherAplay organization. The student received detailed information from Ms. Hage regarding organizations in the Indiana area that financially assist families who have children with disabilities. These resources were then relayed to the Childrens TherAplay Executive Director to ensure distribution of this knowledge to TherAplay staff and families. This experience was beneficial for the OTS because it required her to step outside her comfort zone and promote OT along with a nonprofit organization. HIPPOTHERAPY BENEFITS 34 Another area of advocacy and leadership that the student had an opportunity to participate in was the Taste of Chamber 2018 event. This was an outreach opportunity that required the student to assist with setting up a Childrens TherAplay display table and educate attendees on TherAplays mission, vision, and fundraising opportunities. The attendees included other nonprofit agency employees, restaurant mangers, and large business personnel throughout the Indianapolis area. This was a great opportunity to network and advocate for the OT profession and Childrens TherAplay Foundation. These two experiences, were a small sample of the multiple advocacy opportunities that the OTS participated in during this 16-week experience. The student gained valuable professional communication, advocacy, collaboration, and clinical skills throughout this experience. HIPPOTHERAPY BENEFITS 35 References Ajzenman, H., Standeven, J., & Shurtleff, T. (2013). Effect of hippotherapy on motor control, adaptive behaviors, and participation in children with autism spectrum disorder/ A pilot study. The American Journal of Occupational Therapy, 67(2), 653-663. doi: http://dx.doi.org/10.5014/ajot.2013.008383 American Hippotherapy Association, Inc. (2018). AHA Member Facilities in the United States. Retrieved from http://www.americanhippotherapyassociation.org/hippotherapy/find-afacility/ American Hippotherapy Association, Inc. (2015). Level I treatment principles. Course Manual Fifth Edition. (pp 30-39). American Occupational Therapy Association. (2014). Occupational therapy practice framework: Domain and process (3 rd ed.). American Journal of Occupational Therapy, 68(Suppl. 1), S1-S48. Baker, S. (2015). Emerging practice areas: Occupational and hippotherapy. Australia Occupational Therapy, 12(5), 14-15. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26726326 Case-Smith, J., & OBrien, J.C. (2015). Occupational Therapy for Children and Adolescents (7th ed.). St. Louis, MO: Elsevier Inc. Cole, M. B. & Tufano, R. (2008). Applied theories in occupational therapy: A practical approach. Thorofare, NJ: Slack Incorporated. HIPPOTHERAPY BENEFITS 36 Definition for direct service and consultation. 2015. Retrieved from https://www.saisd.net/main/documents/2015/Section504/def_direct_service_consult.pdf Govender, P., Barlow, C., & Ballim, S. (2016). Hippotherapy in occupational therapy practice. South African Journal of Occupational Therapy, 46(2), 31-36. doi:10.17159/2310-3833/2016/v46n2a6 Granados, A. C., & Ags, I. F. (2011). Why children with special needs feel better with hippotherapy sessions: A conceptual review. Journal of Alternative & Complementary Medicine, 17(3), 191-197. doi:10.1089/acm.2009.0229 Hughes, L. (2015) HIPAA compliance for volunteers? Medscape. Retrieved from https://www.medscape.com/viewarticle/504205 Koca, T. T., & Ataseven, H. (2016). What is hippotherapy? The indications and effectiveness of hippotherapy. Northern Clinics of Istanbul, 2(3), 247252. http://doi.org/10.14744/nci.2016.71601 Kransy-Pacini A., Evans, J., Sohlberg, M., Chevignard, M. (2016). Proposed criteria for appraising Goal Attainment Scales used as outcome measures in rehabilitation research. American Congress of Rehabilitation Medicine. (97), 157-169. http://dx.doi.org/10.1016/j.apmr.2015.08.424 Malnutrition Quality Improvement Initiative. 2016. Principles and models of quality improvement. Retrieved from http://malnutrition.com/static/pdf/mqii-principles-andmodels-of-quality-improvement.pdf HIPPOTHERAPY BENEFITS 37 Mathews, A. (2012). What is proprioception and why is it important? North shore Pediatric Therapy. Retrieved from https://nspt4kids.com/parenting/what-is-proprioception-andwhy-is-it-important/ McCawley, P. (n.d.). The Logic Model for program planning and evaluation. University of Idaho Extension. Retrieved from https://www.d.umn.edu/~kgilbert/educ5165731/Readings/The%20Logic%20Model.pdf North Shore Pediatric Therapy. 2017. What is vestibular system? Vestibular Processing. Retrieved from https://nspt4kids.com/healthtopics-and-conditions-database/vestibularprocessing/ Sadler, Elizabeth. (2018) Morning Dove Therapeutic Riding. Retrieved from http://morningdovetrc.org/volunteering/ Scaffa, M.E. & Reitz, S.M. (2014). Occupational therapy in community-based practice settings (2nd ed.). Philadelphia, PA: F.A. Davis Company. Shirvastav, N. (2014). Occupational therapy intervention to combat stress levels of mothers of children with Autism. The Indian Journal of Occupational Therapy 46(2), 55-60. Retrieved from http://web.a.ebscohost.com.ezproxy.uindy.edu/ehost/pdfviewer/pdfviewer?vid=7&sid=89 1c1c5d-8dc5-48bd-83a5-007915d97a27%40sessionmgr4006 Taylor, R., Kelhofner, G., Smith, C., Butler, S., Cahill, S., Ciukaj, M., & Gehman, M. (2009). Volitional change in children with autism: A single-case design study of the impact of hippotherapy on motivation. Occupational Therapy in Mental Health, 25(2), 192-200. doi:10.1080/01642120902859287 HIPPOTHERAPY BENEFITS 38 The Childrens TherAplay Foundation, Inc. (2018). Who We Are. Retrieved from http://www.childrenstheraplay.org/who-we-are The OT Tool Box. 2016. Bilateral coordination activities. Bilateral Coordination. Retrieved from http://www.theottoolbox.com/p/bilateral-coordination-activities.html Thompson, F., Ketcham, C., Hall, E. (2014). Hippotherapy in children with Developmental Delays: Physical function and psychological benefits. Advances in Physical Education, 4, 60-69. Retrieved from http://dx.doi.org/10.4236/ape.2014.42009 Zadnikar, M., & Kastrin, A. (2011). Effects of hippotherapy and therapeutic horseback riding on postural control or balance in children with cerebral palsy: a metaanalysis. Developmental Medicine & Child Neurology, 53(8), 684-691. doi:10.1111/j.1469-8749.2011.03951.x HIPPOTHERAPY BENEFITS 39 Appendix A Evidenced based literature & AHA manual Video equipment / Powerpoint Updated volunteer video HIPAA compliance powerpoint Pre and post surverys Distrubuted to volunteers at Children's TherAplay Outcomes OTD student, therapy staff, volunteer coordinator, marketing coordinator Outputs Lack of knowledge of hippotherapy benefits & Need for implementation of a volunteer protocol to ensure efficacy and safety of hippothearpy sessions. Inputs Situation Logic Model for Volunteer Protocol Implementation Short term -> Increase volunteers awareness, knowledge, and skills regarding hippotherapy safety and regulations Long term ->Improved compliance with HIPAA regulations and continued safe practice to increase validity and awareness of hippotherapy services External Influences * AHA Manual * HIIPPA Regulations Collaboration with other Hippotherapy clinics, other volunteer clinics on their protocols Figure 1. Logic Model graphic detailing volunteer protocol components (McCawley, n.d.). HIPPOTHERAPY BENEFITS 40 Appendix B Goal Attainment Scale Goals for Volunteer Protocol Score Levels of Attainment Pre-survey Participation Goal #1 80% of the 65 volunteers will participate in the pre-survey test Post-survey Participation Goal #2 80% of the volunteers who completed the pre-survey will participate in the post-survey test Post-survey Results Goal #3 80% of volunteers will demonstrate improved knowledge in hippotherapy services identified by responses on questions #7,8,9 +2 Much more than expected outcome +1 Somewhat more than expected outcome 60% of the 65 volunteers will participate in the pre-survey test 60% of the volunteers who completed the pre-survey will participate in the post-survey test 60% of volunteers will demonstrate improved knowledge in hippotherapy services identified by responses on questions #7,8,9 0 Expected outcome 40% of the 65 volunteers will participate in the pre-survey test 40% of the volunteers who completed the pre-survey will participate in the post-survey test 40% of volunteers will demonstrate improved knowledge in hippotherapy services identified by responses on questions #7,8,9 -1 Somewhat less than expected outcome 20% of the 65 volunteers will participate in the pre-survey test 20% of the volunteers who completed the pre-survey will participate in the post-survey test 20% of volunteers will demonstrate improved knowledge in hippotherapy services identified by responses on questions #7,8,9 -2 Much less than expected outcome 10% of the 65 volunteers will participate in the pre-survey test 10% of the volunteers who completed the pre-survey will participate in the post-survey test 10% of volunteers will demonstrate improved knowledge in hippotherapy services identified HIPAA Training Goal #4 80% of volunteers will demonstrate increased knowledge regarding HIPAA identified by responses to questions #5, 6 on the survey 60% of volunteers will demonstrate increased knowledge regarding HIPAA identified by responses to questions #5, 6 on the survey 40% of volunteers will demonstrate increased knowledge regarding HIPAA identified by responses to questions #5, 6 on the survey 20% of volunteers will demonstrate increased knowledge regarding HIPAA identified by responses to questions #5, 6 on the survey 10% of volunteers will demonstrate increased knowledge regarding HIPAA identified by responses to HIPPOTHERAPY BENEFITS 41 by responses on questions #7,8,9 questions #5, 6 on the survey Figure 2. Goal Attainment Scale (GAS). This scale was used to assess each participants outcomes and results related to goals following the pre and post-surveys. The scale assessed participation in pre- and post-surveys along with increased knowledge in pre- vs. post-surveys following the implementation of the volunteer protocol. The results were based off of an ordinal scale with the score of zero being the baseline and therefore expected outcome. Detailed results of the GAS can be found in Section V of the paper (Shirvastav, 2014). HIPPOTHERAPY BENEFITS 42 Appendix C Side walking Pre- and Post- Survey Please circle the following option that you feel is most accurate. 1) How long have you been a volunteer at Childrens TherAplay Foundation? a) 0-3 months b) 3-6 months c) 6-12 months d) 1-year plus Answer Varies 2) Please rate your agreement with the following statement: I am comfortable with the responsibilities involved with side walking a) Strongly Agree b) Agree c) Neutral d) Disagree e) Strongly Disagree Answer Varies 3) Please rate your agreement with the following statement: I have the necessary knowledge of horse safety. a) Strongly Agree b) Agree c) Neutral d) Disagree e) Strongly Disagree Answer Varies 4) Please rate your agreement with the following statement: I have the necessary knowledge about patient safety. a) Strongly Agree b) Agree c) Neutral d) Disagree e) Strongly Disagree Answer Varies 5) Please rate your agreement with the following statement: I understand the Health Insurance Portability and Accountability Act (HIPAA) and how it applies to this clinical setting. a) Strongly Agree b) Agree HIPPOTHERAPY BENEFITS 43 c) Neutral d) Disagree e) Strongly Disagree Answer Varies 6) According to HIPAA regulations, which of the following violates HIPAA compliance? a) Discussing a childs diagnosis with another volunteer b) Talking to someone other than the therapist about a child using their first and last name, age, or diagnosis c) Asking if a specific child receives treatment at the Childrens TherAplay Foundation d) All the above 7) What is the best way to aid a primary side walker in the case of an emergency dismount? a) b) c) d) Follow directions from the horse handler Push the child into the therapists arms and follow directions from the therapist Grab the child off the horse immediately Push the child into the therapists arms and follow directions from the horse handler 8) Please rate your agreement with the following statement: I understand the various physical, mental, and sensory benefits hippotherapy can provide to children with special needs? a) b) c) d) e) Strongly Agree Agree Neutral Disagree Strongly Disagree Answer Varies 9) Which of the following best describes hippotherapy? a) The child learns how to ride a horse b) The child gains overall strength to participate in daily activities c) The use of a horse for therapeutic treatment to aid the child in meeting functional goals d) It is a treatment that is covered by insurance 10) Do you have any suggestions to improve the side walking video? HIPPOTHERAPY BENEFITS 44 Appendix D Health Insurance Portability and Accountability Act Training HIPPOTHERAPY BENEFITS 45 HIPPOTHERAPY BENEFITS 46 HIPPOTHERAPY BENEFITS 47 HIPPOTHERAPY BENEFITS 48 HIPPOTHERAPY BENEFITS 49 HIPPOTHERAPY BENEFITS 50  ...

... Running head: PEDIATRIC THERAPY IN A RURAL COMMUNITY Expanding Pediatric Therapy in a Rural Community: A Doctoral Capstone Experience Michaela Wadsworth May, 2018 1 PEDIATRIC THERAPY IN A RURAL COMMUNITY 2 A capstone project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the faculty capstone advisor: Brenda Howard, DHSc, OTR PEDIATRIC THERAPY IN A RURAL COMMUNITY A Capstone Project Entitled Expanding Pediatric Therapy in a Rural Community: A Doctoral Capstone Experience Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Michaela Wadsworth Occupational Therapy Student Approved by: Faculty Capstone Advisor Date Doctoral Capstone Coordinator Date Accepted on this date by the Chair of the School of Occupational Therapy: Chair, School of Occupational Therapy Date 3 PEDIATRIC THERAPY IN A RURAL COMMUNITY 4 Abstract The purpose of this Doctoral Capstone Experience was to expand the pediatric program at a rural outpatient center by increasing awareness of the role occupational therapy plays with children, increasing appropriate referrals, creating relationships with other entities, and hosting a community event to serve the families of the community. A SWOT (strengths, weaknesses, opportunities, and threats) analysis was conducted as well as a community needs assessment comparing pediatric services currently offered and service still needed in the area. The results of this assessment confirmed the desire of the center to host a developmental screening day, which 35 children in the community attended. Collaboration and education with schools, physicians, daycares, and early intervention occurred, resulting in increased awareness of services offered at this outpatient center and increased referrals. Promotional materials were created specifically for primary care providers, schools, and caregivers and were distributed to current or possible stakeholders. A 166.67% increase in caseload occurred within the 16 week capstone experience, indicating possible benefits of increased means of advocacy. PEDIATRIC THERAPY IN A RURAL COMMUNITY 5 Background Information and Literature Review Rural health professionals face many challenges including professional isolation, large and diverse caseloads, scarce numbers of service providers, limited availability of resources, and reduced opportunities for continuing professional development or specialization (Weilandt & Taylor, 2010). A small outpatient center in a rural Midwestern town faces many of these challenges, and desires to expand a niche in pediatric therapy. At the beginning of the Doctoral Capstone Experience (DCE), the occupational therapy pediatric caseload was six children, approximately 6% of the occupational therapy departments caseload and not representative of the communitys pediatric population (Daviess Community Hospital, 2016). The occupational therapist in the school system typically has a caseload of about 80 children (S. Saladin, personal communication, January 23, 2018). One occupational therapist provides early intervention within the surrounding three counties. One outpatient occupational therapy clinic exists within a 35mile radius of this outpatient center, which provides occupational therapy services only. Many therapists in the community have agreed that pediatric services in this rural area are inadequate compared to the need (E. Johnson, personal communication, January 23, 2018). The outpatient center which is the focus of this DCE desires to provide accessible multidisciplinary services to children in the community (A. Hawthorne, personal communication, January 8, 2018). The purpose of this DCE was to educate physicians, caregivers, and therapy providers in the community about pediatric services available at this outpatient center, the CORE Center, and ensure that the center is equipped to adequately meet the needs of this pediatric population by assessing their resources and advocating for any unmet needs. The theoretical basis for this project was the Diffusion of Innovations Model. While pediatric outpatient therapy is not a novel practice in the realm of occupational therapy, the PEDIATRIC THERAPY IN A RURAL COMMUNITY 6 definition of innovation according to this theory is a practice thought to be new by an organization or community (Rogers, 2003). According to Scaffa, Reitz, and Pizzi (2010), the actual age of the innovation is irrelevant; it is the perception of newness that characterizes an innovation (p. 49). A pediatric department was new to this rural hospital and community, therefore could be considered innovative according to this theory. The social system, also known as adopters, time, and communication channels are all vital components to this theory (Rogers, 2003). For this project, adopters could be considered anyone in the community who may benefit or are in contact with those who would benefit from these services, including pediatricians, family practice physicians, parents, caregivers, school staff, and other therapy providers. Time is described as the length of time it takes to adopt the innovation, which is dependent on the characteristics of the innovation, the adopter, and the organization. Communication channels, or the means of transmitting the new idea from one person to the other, are essential to reaching these adopters and making the community aware of the pediatric services offered at this outpatient center (Rogers, 2003). According to a community health needs assessment conducted by the hospital, 68.9% of respondents learned about available healthcare services by word of mouth, and only 40.4% of respondents learned of these services by referral from physicians (Daviess Community Hospital, 2016). Referrals are a key component to developing this program, and Glennon (2007) suggests that parents drive the system when creating a referral base for a pediatric practice (p. 1). Glennon (2007) also describes many avenues for disseminating information to parents, including many opportunities for educating via word of mouth as indicated by the community health needs assessment. This information will guide the implementation of communication according to the Diffusion of Innovations Model. PEDIATRIC THERAPY IN A RURAL COMMUNITY 7 Eight conditions are described by the Diffusion of Innovations Model which will facilitate the adoption, implementation, and institutionalization of this program. These eight conditions include: dissatisfaction with status quo, knowledge and skills, resources, time, rewards, participation, commitment, and leadership (Ely, 1990). Dissatisfaction with status quo is evident as the therapy department is dissatisfied with the low number of referrals received for pediatric clients, as well as parents and other providers dissatisfaction with the lack of options for treatment in the community outside of services offered in schools and early intervention. Occupational therapists at this outpatient center possess the knowledge and skills to treat the pediatric population, however would benefit from continuing education to ensure quality of care and marketable skills. The center now possesses two pediatric rooms complete with a bolster swing, tools, and a couple pediatric assessments, but would benefit from advocacy for increased resources. Participation and commitment from the therapy staff, referral sources, and families is essential to creating a sustainable program. Finally, leadership among the therapy staff promoted the institutionalization of this program to continue serving the pediatric population in this community. Pediatric occupational therapy services are valuable to all communities, and lack of access to these services in a rural community could be considered an issue of occupational justice. Taking care of personal needs such as dressing, hygiene, eating, and sleep are essential skills for children to develop independence and autonomy. For children with special needs, mastering these skills is especially important, (AOTA, 2016). This project will ensure that children in this community will have access to services which promote skill mastery and independence. Occupational therapists enhance development and skill acquisition in motor coordination, social interaction, and problem solving to facilitate independence in occupational PEDIATRIC THERAPY IN A RURAL COMMUNITY 8 routines and active participation in these routines across the lifespan (AOTA, 2016). Research indicates that when children and their families participate successfully and independently in meaningful daily routines in the home, school, and community environments, they experience a greater sense of satisfaction and their health and wellness outcomes increase (Fingerhut, 2013). Developing a pediatric program for this outpatient center will provide the opportunity for familycentered service delivery that has proven to strengthen the family and improve satisfaction, wellbeing, social support, child performance, and parenting skills (Frolek Clark & Kingsley, 2013). The well-established research on occupational therapys influence on children and families will supplement the diffusion of this innovative program in a rural community. Screening and Evaluation Process A needs assessment is an essential component to confirming the expressed need of an organization. In order to determine the feasibility of expanding the pediatric program at this center, both formal and informal needs assessments were conducted. Jacobs and McCormack (2011) explained the purpose of a needs assessment in the realm of occupational therapy as to explore the area of service provision as an appropriate fit for the context to address the needs and capacities of a specific population in a specific context (p. 317). The authors described many possible sources for this needs assessment including: interviews with staff members, medical records, service data, reviewing current literature, and exploring demographic and area statistics (Jacobs & McCormack, 2011). I elected to include each of these components as well as interviews with relevant community members or stakeholders such as school therapists, early intervention therapists, parents, teachers (both special education and mainstream), pediatricians, and social workers in the needs assessment. Literature has indicated that inclusion of service providers in the diagnosis of issues and initiation of projects has elicited a shared vision which PEDIATRIC THERAPY IN A RURAL COMMUNITY promotes organizational success and sustainable changes (Camden, Swaine, Ttreault, & Bergeron, 2009; Fleming-Castaldy & Patro, 2012). Therefore, the formal needs assessment focused principally on the feedback of the service providers within the center. The screening and evaluation process for this DCE included the implementation of a strength, weakness, opportunity, and threat (SWOT) analysis. The analysis focuses on internal strengths and weaknesses and external opportunities and threats of an organization in order to gather information about the current situation of the organization and develop a clear path of action for quality improvement (Hazelbaker, 2006). Although this analysis tool originated for change management in business planning, its use has spread to a variety of sectors, including a recent emergence in health care (Camden, Swaine, Ttreault, & Bergeron, 2009). Jacobs and McCormack (2011) described the SWOT analysis as the most clear-cut and readily recognized approach used in assessing the environment (p. 105). The authors described the approach of a SWOT analysis as flexible, enabling the occupational therapy practitioner to explore opportunities or challenges at any time, whether that is initial strategic planning or ongoing program development (Jacobs & McCormack, 2011). Another benefit of the SWOT analysis is the opportunity to incorporate all service providers and other stakeholders in sharing information. Literature indicated that a SWOT analysis was well suited for participatory evaluation because it facilitates the development of a shared vision, increasing feelings of ownership among service providers and empowering then as change agents (Camden, Swaine, Ttreault, & Bergeron, 2009). For this project, a SWOT analysis was completed via two means. Initially, I took notes from interviews with stakeholders and community members and categorized each item into the relevant SWOT category. Then, I posted a large chart in the staff office with definitions and 9 PEDIATRIC THERAPY IN A RURAL COMMUNITY 10 examples of strengths, weaknesses, opportunities, and threats. I educated staff on the purpose of this analysis and engaged in conversation regarding correct placement of items. This chart remained in the office for one week, with five service providers contributing to the chart. Table 1 illustrates the results of the SWOT analysis from service providers and stakeholders within the community. The common themes which arose when discussing the strengths of this outpatient center regarding pediatric care included the family centered, holistic, and interdisciplinary approach offered from occupational, speech, and physical therapy, as well as the lack of outpatient pediatric services in the surrounding area. When discussing internal weaknesses, frequent themes included difficulties with insurance coverage and certifications, limited time to allocate to program development, and insufficient resources for a growing caseload. Opportunities which existed included the support of parents and therapists to increase service availability for the children in this community and creating a presence in the community for parent support and education. Threats which may have influenced the growth of the pediatric program at this center included issues relevant with a low socioeconomic status community, limited knowledge of occupational therapists scope of practice with the pediatric population, and poor referral pathways. Many of the threats and weaknesses expressed in the SWOT analysis of this pediatric program are consistent with challenges expressed in other practice areas of occupational therapy. Literature documents the high cost of medical services for families of children with medically complex diagnoses, which influences access to services, especially outpatient pediatric services, in a low SES community (Parsons, 2017). Setting up appropriate referral pathways is a challenge for many areas of practice, particularly the emerging area of driving programs (AOTA, n.d.). 11 PEDIATRIC THERAPY IN A RURAL COMMUNITY However, some pediatric outpatient centers cite difficulty with addressing long waiting periods for evaluations due to high referral rates, whereas the organization in this project relays frustration about low referrals (Phoenix, Rosenbaum, Watson, & Camden, 2016). Overall, the results of the SWOT analysis is consistent with difficulties expressed in both established and emerging areas of practice because outpatient pediatric services are well established as an area of practice, but are emerging in this rural community. Implementation Phase In order to plan the implementation stage, I created a list of possible action items which arose from the needs assessment and SWOT analysis. This list was comprised of 10 items, which a team of service providers ranked into three tiers of importance. See Table 2 for the delineation of these items. The initial implementation phase focused on addressing the three action items in the first tier of importance including: marketing to local pediatricians and family practice providers, hosting an event for families in the community, and increasing communication with therapists in the schools and early intervention to promote collaboration and referral pathways. Tier two items addressed include advocating for the purchase of new assessments, resources, and continuing education/specialty certifications. Tier three items include the development of protocols for insurance, documentation, aquatics, and evaluations. As part of the community needs assessment, I established relationships with the pediatric occupational therapists in the community outside of the outpatient center, including school and early intervention services. These therapists recommended other individuals within their organizations with whom to discuss referral patterns. I investigated referral patterns and pathways with First Steps transition coordinators and individuals within the special education cooperative for the surrounding counties to further investigate referral patterns and pathways. 12 PEDIATRIC THERAPY IN A RURAL COMMUNITY Therapists from the school and early intervention organizations expressed interest in forming a relationship with therapists at the CORE Center to promote increased communication about common clients and potential referrals. I facilitated the building of this relationship by sharing contact information and encouraging collaboration on both educational opportunities and common clients. Service providers and I collaborated to identify pediatrician and family practices within the community which have the potential to serve as referral sources. This collaboration resulted in a list of nine potential practices to market services. Each practice was contacted to set up a brief meeting with therapists from the CORE Center. Marketing materials were provided to each practice as well as the opportunity to elicit discussion about pediatric therapies offered at the CORE Center and appropriate referrals. These meetings also served as an opportunity to distribute flyers and promote the developmental screening day the center hosted. The CORE Center hosted a developmental screening day open to children from birth to six years old in order to identify children who require further evaluation for therapy intervention. The needs assessment revealed a lack of services available to children between early intervention and school services, so the preschool age range remained the focus of advertising. The focus was also to reach the many children who may not qualify for these services, or are not receiving the frequency of services required for optimal progress. The screening day was a free resource for families who were curious or concerned about their childs development. Interdisciplinary teams including occupational, physical, and speech therapy practitioners employed by the CORE Center conducted brief screenings for the children and discussed potential needs with parents and caregivers. The screenings were adapted from the Hawaii Early Learning Profile and Peabody Developmental Motor Scales and translated into parent-friendly terms (Folio & Fewell, 2000; PEDIATRIC THERAPY IN A RURAL COMMUNITY 13 Parks et al., 1994). The practitioners recommended if further evaluation was warranted based on the results of the initial screening. The practitioners provided materials with steps to obtain a physician referral appropriate for the family. This project focused on providing services to an organizational client, or a center as whole, rather than individuals, which requires leadership skills considered beyond entry level for occupational therapy practitioners. In order to effectively lead during this project, I employed the five key leadership characteristics described by the Leadership Challenge Model (Kouzes & Posner, 2002). Fleming-Castaldy & Patro (2012) described the Leadership Challenge Model as the most applicable model relating to the current occupational therapy practice environment. The five characteristics include: challenging the process, inspiring a shared vision, enabling others to act, modeling the way, and encouraging the heart (Kouzes & Posner, 2002). Each of these characteristics were considered during the planning, developing, organizational, and marketing stages while serving the organization in this project. I challenged the current processes of the pediatric department and referral pathways in the community. Encouraging the staffs current capabilities was a priority to build confidence and direct progress towards strengths. I emphasized forming relationships, creating a sense of teamwork, and most importantly, inspiring a shared vision. I practiced modeling the way by practicing what I encouraged others to do, especially by creating relationships with various therapy and medical providers in the community. Finally, I maintained a client-centered approach by focusing on the vision of the organization and the staff, and communicating enthusiasm for this vision becoming a reality. Staff development is a means of enabling others to act (Fleming-Castaldy & Petro, 2012). While the staff at the CORE Center is competent in providing pediatric services, they would benefit from continuing education to develop niches and provide advanced intervention PEDIATRIC THERAPY IN A RURAL COMMUNITY 14 techniques. One therapist recently attended a course in pediatric kinesio-taping which has already proved beneficial to clients served at the center. Other interests in continuing education or specialty certifications include behavior modification and feeding and eating. The staff development portion of this project includes advocating for continuing education courses for current staff. Another aspect of staff development includes the creation of protocols to promote uniform evaluation methods, documentation, and insurance tracking as the center is not currently equipped to address the unique needs of the pediatric population in these administrative aspects. The final component of staff development includes training all staff participating in the developmental screening day on the use of the screening tool to ensure competency prior to administering this screening during the event. Discontinuation and Outcome The evaluation method for this project was selected in order to promote a continuous assessment of quality improvement. The SWOT analysis introduced in previous sections is intended for continual use, for initial and consequent assessment. The strengths, weaknesses, opportunities, and threats of an organization are evolving regularly, therefore should be assessed regularly. At the end of this project, the original SWOT analysis was updated based on the outcomes of the action items to assess growth and gaps which remain or have been newly identified. The results of the updated SWOT analysis will direct further administrative changes past the end of this project. The staff at the CORE Center is now equipped to conduct their own SWOT analysis for any program at their site. A means of ensuring the quality of services offered by the student in this project is administration of a survey to the therapists at the outpatient center. This survey addressed satisfaction and perceptions of each action item implemented including: marketing to local pediatricians and family practice providers, hosting an event for families in the community, and PEDIATRIC THERAPY IN A RURAL COMMUNITY 15 increasing communication with therapists in the schools and early intervention to promote collaboration and referral pathways. Emphasis was placed on the efficacy of the Developmental Screening Day and whether this would be an effective means to continuously serve the community. The staff had the opportunity to indicate opportunities to improve this event in the future. This survey was administered in the week following the developmental screening day so that the center was equipped with improvements and details to replicate the event. Objective outcomes of the doctoral capstone project were assessed by scoring the goal attainment scale created at the commencement of the project. See Table 3 for the outcomes of each goal. Overall each goal achieved a +1 (somewhat more than expected) or +2 (much more than expected) level, determining that each goal was adequately met through the course of the experience. Resources advocated for to benefit the growth of the pediatric program included three assessment tools, six intervention tools, and one additional therapist. Marketing materials were delivered to six pediatric or family practices in the community, and meetings were scheduled for therapists to market to an additional four practices. Promotional handouts were created and delivered to the special education cooperative which includes seven elementary schools. Handouts were also delivered to three preschools and two daycares. Over the course of the DCE, the occupational therapy pediatric caseload increased from six children to sixteen children, demonstrating a 166.67% increase in caseload. Finally, twenty-four families attended a developmental screening day at the CORE Center, which was provided as a community event to promote support for parents and pediatric services offered at the center. Thirty-five children attended a developmental screening day hosted at the CORE Center. Each child was screened by a team of occupational, physical, and speech therapists to display the interdisciplinary strength of the CORE Center. Of these children ages birth to six years, 41% were recommended for further evaluation. Within one week after the event, four of these PEDIATRIC THERAPY IN A RURAL COMMUNITY 16 children had received orders from their primary care physician and scheduled an evaluation. The report that 76.47% of parents/caregivers of the children who attended did not know that the CORE Center offered pediatric services confirmed the need for advocacy. One therapist stated that the event was one of the biggest returns on investment this clinic has had for a community event (B. Johnson, personal communication, April 12, 2018). All eight therapists involved in the screening day indicated the desire to make this event an annual occurrence. Overall, the developmental screening day was successful in advocating for pediatric services and increasing caseload. The community where this DCE takes place reports a higher prevalence of autism spectrum disorder and parents reporting concern about behavioral difficulties (A. Waggner, personal communication, February 6, 2018). Interviews with school personnel in the community also identify difficulty with behavior regulation as one of the largest barriers to participation in the classroom (M. Brothers, personal communication, February 21, 2018). In order to enable occupational therapists to respond to the changing needs of this community, I advocated for the role of occupational therapy in addressing the cited needs. I utilized the occupational therapy practice framework to support the role of occupational therapists in addressing the needs of children experiencing difficulty with behavior regulation (AOTA, 2014). I collaborated with the therapists at the CORE Center to research current behavior regulation interventions and continuing education opportunities so they feel confident in serving the needs of the children and their families. The CORE Center possesses the unique capability to intervene with children and their families who are not qualifying for services in the school system and early intervention due to stringent qualification criteria and large caseloads. In order to meet the needs of families who are falling through the cracks in the community, the CORE Center is advertising services offered PEDIATRIC THERAPY IN A RURAL COMMUNITY 17 by all therapies to physicians, school personnel, and families in the community. The CORE Center offered, and will continue offering, developmental screenings for families who are concerned about their childs development to promote early identification and intervention. Overall Learning Effective communication with stakeholders was an integral component to my DCE. I interacted with my client, the community, colleagues, and health providers orally as often as possible, whether that was over the phone or in person. I went to many of these stakeholders to demonstrate interest in how they served the community. I met with social workers, therapists, and behavioral consultants in the schools; nurse practitioners and physicians in their offices; and childcare providers in their daycares. When meeting with or observing any of these stakeholders, I implemented the same approach. My approach was to gain an understanding of what the stakeholders do, what they perceive as needs for children in the community, and discuss how collaboration with the CORE Center could potentially meet these needs. This approach proved beneficial as it valued the distinct role of each of these stakeholders and promoted collaboration rather than overstepping boundaries. Written communication served as a means to interact with the entire community, particularly as a means of advocacy. I passed out over 800 flyers in the community to advertise for the developmental screening day, as well as created an event on Facebook through the hospitals Facebook page. This advertising served a dual purpose, for people who were not interested in the developmental screening day could also learn that the CORE Center serves the pediatric population. Another means of advocacy was creating a cheat sheet for providers in knowing what deficits to refer to which therapy at the CORE Center, see Figure 1 for more information. This was distributed to eight practices in the area including pediatricians and family PEDIATRIC THERAPY IN A RURAL COMMUNITY 18 physicians, with many physicians expressing that this will be a helpful tool and they did not realize that the CORE Center treated children with these difficulties. One barrier to communication that I experienced was the existence of a tense relationship between the CORE Center and the schools. This was due to a contract falling through a number of years ago. While my supervisor did make me aware of this situation, it was more difficult than I expected collaborating with the occupational therapist in the school. I learned that I should have communicated how services at the CORE Center differed from the school-based services rather than discussing the similarities. Discussing similarities expressed threat to the school therapist that the CORE Center wanted to take her caseload instead of supplementing services with a medical-based model. There are also regulations in place at the schools not to mention outside services for fear of the school having to pay for outpatient services. Therefore, I had to get creative in developing an information sheet which demonstrated the value of outpatient therapy to families and teachers without placing responsibility on the school. It became very important to distinguish medical-based outpatient services from education-based services for children in oral and written communication to preserve the focus on collaboration. In future practice, I will need to consider the history between two entities when approaching a collaborative experience. I will also need to maintain an awareness of the boundaries between differing areas of practice in occupational therapy. From my colleagues at the CORE Center, I learned the importance of an interdisciplinary model, advocacy, and continuous improvement. The teamwork exhibited within the occupational therapy team was truly incredible at the CORE Center, as the occupational therapy practitioners constantly learned from each other and problem solved together. The teamwork did not stop within occupational therapy. The entire staff of occupational therapists, physical therapists, PEDIATRIC THERAPY IN A RURAL COMMUNITY 19 speech therapists, and athletic trainers were constantly seeking to collaborate with other disciplines to provide the best quality of care possible. The speech therapist and occupational therapist that work with children frequently co-treat children and demonstrate a good understanding of each others roles. All of the practitioners focus on advocating for their profession in interactions with physicians and clients. They also are good advocates for themselves with professional development and goals for improving services. I learned that a SWOT analysis is an effective means to determine feasibility of improvement and set achievable goals on a continuous basis. The Leadership Challenge Model enabled me to utilize a framework in interacting with my site and the community (Kouzes & Posner, 2002). I was emboldened to challenge the processes at the CORE Center and within the community even though this was a new setting to me. The model provided me with the steps to inspire a shared vision, enable others to act, model the way, and encourage the heart (Kouzes & Posner, 2002). I believe it is easy to forget about these important components to leadership, so I appreciated this framework guiding me back to these essential approaches. It was important to me to initially take the time to understand what I was advocating for, and have a good understanding of the unique strengths the CORE Center possesses to meet the needs of society. This permitted me to effectively and accurately advocate for the the CORE Centers pediatric program within the community, and to have an idea of how this site could potentially meet the needs of children in the community. Through this approach to leadership, I increased awareness of the CORE Centers pediatric services within the schools, physician practices, and general community, as well as hosting a community event. The purpose of DCE was to expand the pediatric program at a rural outpatient center by educating physicians, caregivers, and therapy providers in the community about available PEDIATRIC THERAPY IN A RURAL COMMUNITY 20 services. Through advocacy and conducting a community event, the pediatric caseload has increased by 166.67%, and marketing materials have been distributed to ten family or pediatric practices, seven schools, three preschools, and four daycares in the surrounding area. The outpatient center is equipped to complete a SWOT analysis, conduct a developmental screening day, identify resources which would benefit practice, and continue marketing to physicians, schools, and the community. The CORE Center is positioned to continue expanding a valuable service and offering high quality, family-centered, interdisciplinary care to the children of their community. PEDIATRIC THERAPY IN A RURAL COMMUNITY 21 References American Occupational Therapy Association (n.d.). Setting up referral pathways. Retrieved from http://www.aota.org/Practice/ProductiveAging/Driving/Practitioners/Toolkit/pathway.asp x American Occupational Therapy Association (2016). Children & youth: Resource for administrators and policy makers. Retrieved from http://www.aota.org/~/media/Corporate/Files/Secure/Practice/Children/distinct-valuepolicy-makers-children-youth.PDF Camden, C., Swaine, B., Ttreault, S., & Bergeron, S. (2009). SWOT analysis of a pediatric rehabilitation programme: A participatory evaluation fostering quality improvement. Disability and Rehabilitation, 31(16), 1373-1381. Daviess Community Hospital (2016). Community health needs assessment and implementation strategy. Retrieved from https://www.dchosp.org/AboutUs/News/2017/November/Community-Health-Needs-Assessment-Update-from-Da.aspx Ely, D. P. (1990). Conditions that facilitate the implementation of educational technology innovations. Journal of research on computing in education, 23(2), 298-305. Fingerhut, P. E. (2013). Life participation for parents: A tool for family-centered occupational therapy. American Journal of Occupational Therapy, 67, 3744. Fleming-Castaldy, R. P., & Patro, J. (2012). Leadership in occupational therapy: Selfperceptions of occupational therapy managers. Occupational therapy in health care, 26(2-3), 187-202. Folio, M. R., & Fewell, R. R. (2000). Peabody developmental motor scales: Examiner's manual. Pro-ed. PEDIATRIC THERAPY IN A RURAL COMMUNITY 22 Frolek Clark, G., & Kingsley, K. (2013). Occupational therapy practice guidelines for early childhood: Birth through 5 years. Bethesda, MD: AOTA Press. Glennon, T. (2007). Pediatric private practice: Perks and pitfalls. Administration and Management Special Interest Section Quarterly, 23(2), 1-4. Hazelbaker, C. B. (2006). The SWOT analysis: Simple, yet effective. Athletic Therapy Today, 11(6), 53-55. Jacobs, K., & McCormack, G. (2011). The occupational therapy manager (5th ed.). Bethesda, MD: AOTA Press. Kouzes, J. M., & Posner, B. Z. (2002). The leadership challenge (3rd ed.). San Diego: JosseyBass. Parks, S., Furono, S., OReilly, K., Inatsuka, T., Hoska, C. M., & Zeisloft-Falbey, B. (1994). Hawaii early learning profile (HELP). Palo Alto, Calif.: VORT. Parsons, H. (2017). Four things pediatric practitioners need to know about health care reform. Bethesda, MD: AOTA Press. Phoenix, M., Rosenbaum, P., Watson, D., & Camden, C. (2016). The 5Rs of reorganization: A case report on service delivery reorganization within a pediatric rehabilitation organization. Physical & Occupational Therapy in Pediatrics, 36(2), 217-228. Rogers, E. M. (2003). Diffusion of innovations. Free Press. New York, 551. Scaffa, M. E., Reitz, S. M., & Pizzi, M. (2010). Occupational therapy in the promotion of health and wellness. Philadelphia, PA: FA Davis Company. Wielandt, P. M., & Taylor, E. (2010). Understanding rural practice: Implications for occupational therapy education in Canada. Rural and remote health, 10(3), 1488. PEDIATRIC THERAPY IN A RURAL COMMUNITY Table 1 SWOT Analysis Strengths: Knowledge of Sensory Integration Individualized Plans- Focused on the child and the family Interdisciplinary Model and communication Holistic approach- NDT, nutrition, environmental Adequate Environment- 2 rooms dedicated to pediatric clients Location Communication with outside stakeholders (schools) Opportunities: Screening Day Parent Support Family events/Respite Need expressed by parents, teachers, and therapists in varying settings Use of social media to advertise Use of student to market services and complete projects Need for behavior modification and feeding services Weaknesses: Limited marketing opportunities due to decreased time Timeframe for insurance approvals Limited pediatric specializations No standard documentation (EMR and intake forms) Limited assessment resources Incontinent children do not have access to aquatic therapy Tracking certifications and recertifications with insurance (not letting kids fall through the cracks) Threats: Low SES Community Home contexts/environmentsdrug epidemic Transportation difficulties Parent/client compliance Low referrals from area physicians School therapists restricted from offering referrals to outside services Limited knowledge of pediatric scope of practice for OT in community Low reimbursement rates Limited visits approved by insurance Note. The SWOT (strengths, weaknesses, opportunities, and threats) analysis conducted at the outpatient center with the therapists as a component of the needs assessment. 23 PEDIATRIC THERAPY IN A RURAL COMMUNITY 24 Table 2 Action Items Tier 1 Market to local pediatricians and family practice providers Host an event for families in the community Increase communication with therapists in the schools and early intervention to promote collaboration and referral pathways Tier 2 Advocate for the purchase of new assessments Advocate for the purchase of new resources Advocate for the purchase of new continuing education/specialty certifications Tier 3 Develop protocols for insurance tracking Develop documentation structure for pediatrics Note. These items illustrate the goals ranked by importance by the practitioners at this doctoral capstone site. The item were addressed within the sixteen week timeframe in the order presented in this table. 25 PEDIATRIC THERAPY IN A RURAL COMMUNITY Table 3 Goal Attainment Scale Level of Expected Outcome Goal 1 Goal 2 Goal 3 Goal 4 Goal 5 +2 I will request 8-10 resources which would benefit the growth of the OT program from CORE Center administrati on including assessment tools, treatment tools, or continuing education. A team from the CORE Center will visit 5 or more pediatricians offices to educate staff about pediatric services offered at the CORE Center and request referrals. 8-10 families will attend an event hosted by the CORE Center for families in the community in order to provide parent support and promote the CORE Center. I will create promotional handouts that educate caregivers about pediatric services/prov iders at the CORE Center and deliver them to 11-12 schools/dayc ares in the area. The CORE Center will track an increase in pediatric caseload >80% from January 8, 2018 to April 27, 2018. +1 I will request 6-7 resources which would benefit the growth of the OT program from CORE Center administratio n including assessment tools, treatment tools, or continuing education. A team from the CORE Center will visit 4 pediatrician s offices to educate staff about pediatric services offered at the CORE Center and request referrals. 6-7 families will attend an event hosted by the CORE Center for families in the community in order to provide parent support and promote the CORE Center. I will create promotional handouts that educate caregivers about pediatric services/provi ders at the CORE Center and deliver them to 9-10 schools/dayca res in the area. The CORE Center will track a 6080% increase in pediatric caseload from January 8, 2018 to April 27, 2018. 26 PEDIATRIC THERAPY IN A RURAL COMMUNITY 0 I will request at least 5 resources which would benefit the growth of the OT program from CORE Center administratio n including assessment tools, treatment tools, or continuing education. A team from the CORE Center will visit 3 pediatricians offices to educate staff about pediatric services offered at the CORE Center and request referrals. 5 families will attend an event hosted by the CORE Center for families in the community in order to provide parent support and promote the CORE Center. I will create promotional handouts that educate caregivers about pediatric services/provi ders at the CORE Center and deliver them to 8 schools/dayca res in the area. The CORE Center will track a 4060% increase in pediatric caseload from January 8, 2018 to April 27, 2018. -1 I will request 3-4 resources which would benefit the growth of the OT program from CORE Center administratio n including assessment tools, treatment tools, or continuing education. A team from the CORE Center will visit 2 pediatricians offices to educate staff about pediatric services offered at the CORE Center and request referrals. 3-4 families will attend an event hosted by the CORE Center for families in the community in order to provide parent support and promote the CORE Center. I will create promotional handouts that educate caregivers about pediatric services/provi ders at the CORE Center and deliver them to 6-7 schools/dayca res in the area. The CORE Center will track a 2040% increase in pediatric caseload from January 8, 2018 to April 27, 2018. 27 PEDIATRIC THERAPY IN A RURAL COMMUNITY -2 I will request 1-2 resources which would benefit the growth of the OT program from CORE Center administratio n including assessment tools, treatment tools, or continuing education. A team from the CORE Center will visit 1 pediatricians offices to educate staff about pediatric services offered at the CORE Center and request referrals. 1-2 families will attend an event hosted by the CORE Center for families in the community in order to provide parent support and promote the CORE Center. I will create promotional handouts that educate caregivers about pediatric services/provi ders at the CORE Center and deliver them to 4-5 schools/dayca res in the area. The CORE Center will track <20% increase in pediatric caseload from January 8, 2018 to April 27, 2018. Note. This goal attainment scale indicated the level of expected outcome expected and achieved within this doctoral capstone experience. Levels are determined as follows: +2 = much more than expected, +1 = somewhat more than expected, 0 = Patient achieves the expected level, -1 = somewhat less than expected, -2 = much less than expected. The levels achieved are shown in boldface. PEDIATRIC THERAPY IN A RURAL COMMUNITY Figure 1. Referral information distributed to surrounding pediatric and family practices to promote appropriate referrals to the pediatric services offered at the outpatient center. 28  ...

... Examining the Acute Effects of Weighted Vest Post-Activation Potentiation in Division II Track and Field Athletes for Competitive Application By Chelsea Wieland An Honors Project submitted to the University of Indianapolis Strain Honors College in partial fulfillment of the requirements for a Baccalaureate degree with distinction. Written under the direction of Dr. Richard Robinson. March 20, 2017 Approved by: __________________________________________________________________ Dr. Richard Robinson, Faculty Advisor ______________________________________________________________ Dr. James B. Williams, Interim Executive Director, Strain Honors College ______________________________________________________________________ First Reader ______________________________________________________________________ Second Reader C. Wieland 2 Abstract Recent studies have shown potential for acutely improving athletic performance utilizing post-activation potentiation (PAP) activities. When sets, repetitions, recovery, and intensity are specified, PAP may result in more successful force production by affecting the contractile history of the active muscle fibers. Though research has been performed testing these mechanisms, few protocols have paired practical warm-ups with a competitive simulation. The purpose of the current study was to examine the effects of warm-up strides (relaxed sprints), with and without a weighted vest, on 15 meter dash performance in Division II Track and Field Athletes. Though the results were not significant, there was a trend towards the non-weighted vest protocol eliciting a quicker sprint time. It is possible that the repetitions performed with the vest could have led to fatigue instead of potentiation. However, rest time and intensity (amount of weight/effort given) could also have caused the results to differ from previous PAP studies. The physiological difference of individual athletes should also be considered with the understanding that one certain warm-up procedure may not benefit all. Further research should be conducted altering the different variables that affect PAP in order to identify a protocol that supports optimal performance. C. Wieland 3 List of Tables Table 1: Population Demographics 14 Table 2: Athlete Weight Sprint Time Comparison 21 Table 3: Athletic Event Sprint Time Comparison 21 C. Wieland 4 Table of Contents Cover Page 1 Abstract 2 List of Tables 3 Statement of Purpose 5 Introduction 6 Method/Procedure 14 Results 18 Analysis/Conclusion 19 Reflection 27 References 31 Appendices 34 Appendix A: Style Guidelines 34 Appendix B: CITI Training 39 Appendix C: IRB Submission 41 Appendix D: IRB Letter of Approval 42 Appendix E: Informed Consent 44 Appendix F: Recruitment Email 48 C. Wieland 5 Statement of Purpose The purpose of this honors project was to investigate the effects of post-activation potentiation (PAP) on sprinters and jumpers in the track and field program. This study was designed to reveal how particular acute warm-up protocols may affect the performance of a forceful skill (15 m dash) in athletes that are trained for speed and power. C. Wieland 6 Introduction Coaches and athletes are constantly adapting their warm-up protocols to fit the newest research for performance benefits. Warm-ups function to raise body temperature, increase nerve conduction velocity, increase muscle enzymatic activity, and open the blood vessels to allow for increased oxygen transport (Pojski et al., 2015). All of these mechanisms operate to improve readiness for exercise. From static stretching to dynamic stretching, athletes share the common goal of wanting to prepare their bodies for the maximum performance. There has been recent interest in exploring a new form of warmup, post-activation potentiation (PAP). Post-activation potentiation relies on the contractile history of the muscle fibers to facilitate the development of force and power in movements. This preliminary stimulation of the central nervous system aids in motor unit recruitment, and thus force production (Sygulla & Foutaine, 2014). Though PAP can be applied in different contexts with different techniques, it can more generally be defined as a method of preconditioning the muscles through loaded exercises in order to allow temporary improvements in performance of often power-related events (i.e. sprinting, running, weightlifting, jumping, etc.) (Barnes, Hopkins, McGuigan, & Kilding, 2015). At a physiological level, it is hypothesized that PAP is the result of short-term adaptations that happen at the actin-myosin binding site. There is an increased sensitivity to calcium that allows the binding of the myosin head and actin filaments in the muscle fiber to occur more rapidly, thus increasing the rate at which force can be developed in the performance activity. The twitch contraction-relaxation time decreases significantly C. Wieland 7 with effective use of PAP, thus causing an increased frequency of motor unit firing and resultant force. In addition to this physiological adaptation, PAP also allows for increased synchronization of the motor units due to the muscle preparation through the simulation of the target activity (Matthews, Matthews, & Snook, 2004). However, not just any form of exercise will elicit the PAP effects and there are variables that need to be taken into account when determining the characteristics of a PAP warm-up. For example, the number of sets or repetitions that are performed, the rest time that is allocated between exercises, the intensity of the PAP exercise, the type of PAP exercise, individual traits of the athlete, and the type of activity the athlete is trying to potentiate are important considerations when outlining a study of PAP or PAP warmup protocol (Tillin & Bishop, 2009). Ways to test the success of PAP include weightvest warm-ups, back squats, use of resistance bands, loaded jump squats, and dynamic warm-ups (high knees, sprints, power skips, etc.). Through the performance of PAP warm-ups, there could be three possible outcomes: no increase in performance, increase in performance due to the successful PAP mechanism, or a decrease in performance due to fatigue. A major consideration when utilizing PAP in training is the awareness of fatigue that could occur and how to avoid it. Fatigue and PAP are related in the aspect that in order for muscular performance to increase through PAP, it must prevail over fatigue (Batista et al., 2007). The interval of time that is dedicated to rest between the PAP exercise and the target exercise is key to whether or not fatigue will be present. The rest period needs to be long enough to avoid fatigue, but short enough to utilize the benefits of PAP before they dissipate (Weber, C. Wieland 8 Brown, Coburn, & Zinder, 2008). There have been numerous studies performed that examine the success of PAP through force produced, decreased time in performance, or other objective measures of athletic success. Studies have also investigated the effects of different lengths of rest in the attempt to find the optimal time interval of PAP, rest, and ultimate performance. However, there have been few studies that specifically apply to a competitive sport situation. Though past research has led researchers to believe that PAP could benefit athletic performances, it has rarely been transferred to a practical athletic competition situation. One study performed by Weber et al. (2008) examined the acute effects of a heavy-loaded squat on consecutive squat jump performance in Division I male track and field athletes. They completed a control, characterized by a set of jumps followed by unloaded squats and then another set of jumps, and an experimental trial, which required five repetitions of back squat at 85% of their max between the two sets of jumps. The peak and mean heights of the vertical jumps were recorded, as well as peak and mean ground reaction forces. The results of the study declared that the experimental trial utilized PAP to a greater extent than the control, thus improving the performance of the vertical jump. Though this protocol of PAP was successful within this population, it must be considered that improvement could have been due to the numerous amounts of fast twitch fibers present in the muscles of the athletes, which allows for proliferation of PAP (Weber, Brown, Coburn, & Zinder, 2008). Coaches and athletes must be aware that the success of PAP is dependent on the population and the characteristics of the process C. Wieland 9 that is being followed. They must also consider the idea that though track and field athletes may perform types of jumps, a purely vertical jump is not characteristic of any events, thus there should be speculation in studies that are more applicable to real-life competitive situations. Faigenbaum, McFarland, Schwerdtman, Ratames, Jie, and Hoffman (2006) came closer to developing a protocol of PAP that could be transferred to a pre-competition warm-up situation. Though the sport was not specified, the population for the study was characterized by high school female athletes. They studied the effects of four warm-up protocols with and without a weighted vest and how they affected long jump, vertical jump, seated medicine ball toss and a 10-m sprint. They found that the dynamic warm-up with the weighted vest with two percent of body mass added improved long jump performance in comparison to six percent of added mass. Vertical jump also experienced similar benefits from two percent of body weight being added. Though there were not any significant differences with the sprints, the current study serves to explore this finding deeper with a more clearly pertinent population. As stated before, the success of different PAP protocols is dependent on the specific training of the subject base, as well as how well it lines up with the experience of the participants. A study designed by Kmmel et al. (2016) was performed to test PAP, but not so much in a practical sense. Though the study did not directly mimic a competitive setting, it was able to elicit positive effects of PAP with the chosen population of track and field athletes. The researchers decided to test ten maximal repetitive hops, with a ten second rest, as a way to mimic the performance drop jump, yet not cause fatigue. They argued C. Wieland 10 that other types of conditioning plyometrics may produce too much ground reaction force, thus stating that reactive jumps are the most favorable form of PAP activity for this type of performance. They found that the conditioning stimulus had significant potentiating effects, and thus caused an increase in performance of the drop jump that was performed subsequently. The researchers stated that this sort of stimulus was allotted to provide ground reaction forces that would prepare the legs to produce a stretch-reflex during the countermovement. However, despite these significant findings, coaches and athletes may be skeptical due to the lack of direct correlation to their sport. No event in track and field involves the specific skill of a drop jump, which leads performers to question what warm-up is best for them. Regardless of the moderate impracticality of these findings, this study continues to support the ability to obtain PAP results within the population of power athletes, such as elite sprinters (Kmmel et al., 2016). Another recent study performed by Seitz et al. (2016) supports that idea that PAP will be provoked more effectively in individuals with significant muscle size, muscle volume, and percentage of type II myosin heavy chain isoforms. The study suggests that training methods that promote a higher myosin heavy chain concentration may allow increased magnitudes of PAP to be attained (Seitz et al., 2016). Due to the fact that the chosen population for the current study will be athletes that participate in both power and strength building routines (sprinting and weightlifting), it can be concluded that the researchers of the current study may have success in stimulating resultant PAP with a structured and researched protocol. C. Wieland 11 In addition to the types of exercises being performed, the rest interval is important to allow potentiation, rather than fatigue, to occur. Once again, the recovery time will be dependent on the subject base and the intensity of the potentiating exercise. In the analysis of Division II female athletes (basketball, volleyball, and softball), they were allowed a five minute rest between each part of the study; however, they did not find significant differences all-around, only certain individual cases (Sygulla & Fountaine, 2014). In the study of jump, sprint, and agility performance of collegiate level soccer players, a two minute rest was allowed following warm-up interventions, with a minute between each performance test. The study found that a prolonged intermittent lowintensity isometric exercise using 30% of body weight positively affected speed and agility with the given rest intervals (Pojski et al., 2015). Kilduff et al. (2008) focused more specifically on varying rest times. They sought to find the optimal recovery time between a heavy resistance squat protocol and a countermovement jump for professional rugby players. Their study included rest times of 4, 8, 12, 16, 20, and 24 minutes, with the optimal recovery time that produced the best results being 8 minutes (Kilduff et al., 2008). Weber, Brown, Coburn, and Zinder (2008) found that among Division I male track athletes, three minutes rest between the initial jumps, the performance of the heavyload squats, and performance jump allowed for improvement in acute jump height and force. Though the current study will be analyzing sprint performance as opposed to vertical jump height, the population in the study performed by Weber, Brown, Coburn, and Zinder most closely matches the population of the current study, thus the three C. Wieland 12 minute rest time will be utilized in the current study. The results in the meta-analysis performed by Seitz and Haff (2015) aligned with the previously discussed studies by reinforcing that the degree of potentiation relies on the strength characteristics of the individual as well as the components of the potentiation protocol. One relevant discussion in the study was that though back squat was not able to potentiate a greater response in a timed short-distance sprint, a sled resistance sprint was able to elicit positive effects. The study also stated that though stronger individuals are able to gain larger benefits from PAP, even weaker individuals may find some success. Though the current subject base should have experience in weight lifting and resistance exercises, the ability for weaker individuals to have improved results should still promote some success in the research findings. Also, even moderately weaker athletes will have had some experience with resisted training, based on observation of practices. The study also points out that plyometric style conditioning activities (jumping and short sprinting) may be more successful than traditional activities (heavy lifting) due to the assumption that type II muscle fibers are recruited more effectively with a lesser amount of resultant fatigue. This decreased amount of fatigue also allows the participant to follow with their performance activity with less of a rest interval. The study suggests that with plyometric style PAP, the individual may see effects as soon as 0.3-4 min preceding the activity; whereas, with heavy traditional warmups, the individual may have to wait more than five minutes; however, a range of 3-7 min was noted across several studies as successful (Seitz & Haff, 2015). The findings in regards to warmup style and rest interval length are consistent with the needs of a sprinter or jumper in track and field. These individuals C. Wieland 13 may not have access to a squat rack a few minutes before their race, and it would be more difficult to time this warmup correctly to elicit the effects when the gun is fired. It is important to analyze information that may be applicable to an athlete when it matters most, on the runway or at the start line. Information gained from this meta-analysis can help develop a proposed protocol for athletes preparing to compete. Thus, taking the past research into consideration, the current study serves to build on past knowledge but with a focus targeted on benefitting a specific population for a practical, competitive setting. Through this study, the research will examine if PAP deserves a place in the pre-competition warm-up rituals of collegiate track and field athletes, and what procedures should characterize the potentiating warm-up. Based on successes of previous research, it is hypothesized that the weighted vest/post-activation potentiation protocol will prepare the participant for the sprint trial to a greater extent, thus resulting in a faster completion time. C. Wieland 14 Method/Procedure Participants The participants for this study included 10 Division II Collegiate Track and Field athletes from the University of Indianapolis, particularly long jumpers (n = 2), high jumpers (n = 1), pole vaulters (n = 2), hurdlers (n = 1), and heptathletes (n = 4). The athletic population was chosen due to the possibility of greater muscular potentiation and less fatigue (Chiu et al., 2003). The age of the participants ranged from 19 to 21 years. Other participant information is summarized in Table 1. Table 1. Population Demographics. Number of Age (years) Participants 10 Track Experience Weight (lbs) (years) 20.31.06 8.43.34 157.724.92 Participants were asked not to engage in strenuous strength or endurance training, abstain from caffeine and alcohol consumption at least 24 hours before each test, and there were at least five days separating the two warm-up protocols (Barnes, Hopkins, McGuigan, & Kilding, 2015). Testing took place during competition season, thus replicating the fitness level of the athletes if the protocol were to be transferred to a meet setting. The participants completed testing at approximately the same time to avoid timeof-day effects. Though the testing occurred at the same time of day, the protocols were counterbalanced to avoid order effects. Due to the limited subject base, both genders were included (Male: 6; Female: 4); however, differences due to gender were considered C. Wieland 15 in the analysis, despite that this was not the overall goal of the study. All participants were required to fill out an informed consent document to ensure that they were aware of the procedures and time commitment (two days of testing). General Warm-up Each athlete was familiar with the equipment used during testing. Prior to each test all participants completed a 400m run at about 60% effort to mimic a typical running warmup for this population. They were led through a short series of dynamic stretches to complete the pre-test general warm-up, taking approximately five additional minutes (Sygulla & Fountaine, 2014). The stretches included 30m spans of skipping forward/backward with backward/forward swimming arm circles, knee to chest pulls, foot to gluteal runs, and forward leaning scoops (a hamstring stretch). For the purpose of this study, the general warm-up served to get the body ready for exercise and prevent injuries, was not intended to directly enhance athletic performance. Non-Weighted Vest Potentiation Warm-Up Participants performed six repetitions of a ten-second stride pattern, defined as a submaximal sprint with elongated strides (Barnes et al., 2015). Barnes et al. (2015) found success using a PAP protocol in which participants performed six 10-second strides with a weighted vest. Thus, the current researchers selected six repetitions of strides in an attempt to produce potentiating effects. Recovery time consisted of the time it took to walk back to the start of the stride (around 60s). Barnes et al. (2015) requested C. Wieland 16 that the runners perform the strides at a 1500m race pace. For the current study, in order to provide an appropriate speed for sprinters and jumpers, participants performed the strides at around 70% of a 200m race pace. There was five minutes of recovery before the first 15 m sprint trial was performed. Weighted Vest Potentiation Warm-Up Participants were asked to perform six repetitions of a ten-second stride pattern, but for the final three repetitions, participants wore a weight vest with 20% of their body weight (Barnes et al., 2015). Though the researchers of the previous study utilized six weighted vest strides, the population for the current study did not have the same inherent endurance capabilities, thus the number of strides that were weighted was reduced. There was a five minute of recovery before the first 15 m sprint trial was performed. Sprint Testing The participants underwent the sprint testing under two conditions: one following the control warm-up without the weighted vest, and the other to assess sprint performance after the weighted-vest potentiation protocol. Participants received 5 minutes of recovery after the warm-ups before completing each sprint. Sprint distances of 10-20m have been studied, but the pre-activation techniques did not mimic the act of sprinting or use weighted vests to add a load (Maloney, Turner, & Fletcher, 2014). Thus, a sprint distance of 15m was selected with a more specific potentiating stimulus. The Brower TC-Timing System with Touchpad (TC, Brower Timing Systems, Draper, Utah, USA) C. Wieland 17 was utilized for data collection. Participants started with one hand on the touchpad (pressure sensor), in either a three- or four-point stance. After lifting the hand off the touchpad, the timer was automatically started as the individual initiated the maximum speed sprint. As the participants ran through the TC-PhotoGate (infrared light beam) at the end of the 15 meters, the completion time was recorded on the TC-Timer. The Brower TC-Timing System was selected in order to determine the effectiveness of the particular pre-sprint warm-up without the influence of reaction-time on the part of the participant and a person timing the sprint. Participants completed two sprint trials with three minutes of recovery between trials. The averages of the two trials were analyzed for significant differences. C. Wieland 18 Results A repeated measures ANOVA (SPSS 24.0, Chicago, IL) determined there were not significant differences (p > 0.05) between the effects of the warm-up protocols on sprint times, F(1,9) = 3.24, p = 0.105. However, there was a trend for the length of sprint time to be shorter in the case of the non-weighted vest protocol compared to the weighted vest protocol (2.700.13 sec.; 2.730.10 sec., respectively). C. Wieland 19 Analysis/Conclusion The aim of the study was to discover if a previously used potentiation protocol would be successful if adapted for the use of power athletes, as opposed to endurance athletes. A successful protocol would elicit beneficial potentiation and allow the athletes to perform the 15m dash with a faster time, as compared to the control trial. The study conducted by Barnes et al. (2015) examined runners used to running further distances in a race setting (1500m compared to 200m). The protocol for the endurance athletes was able to increase leg stiffness and thus elastic energy usage, which are mechanisms functioning alongside PAP. Due to the nature of chronic adaptations for power athletes, compared to endurance athletes, it is possible that there was not as much room for improvement when it comes to leg stiffness and short sprint running economy for the population. Other researchers have examined PAP protocol relationships with the power athletes of track and field; however, as far as it is known, none have examined a protocol that could be used in preparation for competitive events. Through examination of past studies, it was determined that potentiation protocols have allowed athletes to attain more successful power production than non-weighted scenarios (Faigenbaum et al., 2006; Kmmel et al., 2016; Weber, Brown, Coburn, & Zinder, 2008). The performance of Type II, fast-twitch muscle fibers benefit from pre-loading the muscles due to a primed contractile history, which was the basis of the hypothesis for the current study (Seitz et al., 2016). However, determining the perfect balance between maximizing potentiation and minimizing fatigue (Batista et al., 2007) proved to be a challenge due to the fact that there has not been a study performed with this specific population with these specific C. Wieland 20 performance measures. It is possible that the potentiation protocol proved to be too much for the athletes to handle, thus they approached the sprint testing in a less than optimal condition. Negative overloading could have occurred through too much intensity or volume. Intensity could be varied through decreasing the percentage of weight added to the vest or decreasing the percentage of effort that is placed into the warm-up activity (Seitz & Haff, 2015). However, some individuals still found success with the current protocol, so it is important to investigate why different variables may lead to beneficial potentiation in some cases and not others. Though not statistically analyzed, there was a trend for a few of the individuals who were high/long jumpers and weighed relatively less than the other athletes to have more success in the weighted vest trial (Table 2 and Table 3). Though the weighted vest addition was based on a percentage of the athletes total mass, there is room for speculation that the athletes that weighed less were at the same level of fitness as the other athletes, but had more lean/functional mass. This could mean that athletes who weighed less had a better force-to-body mass relationship allowing them to more successfully handle the potentiation protocol. C. Wieland 21 Table 2. Athlete Weight Sprint Time Comparison Weight Categories (lbs) Protocol Time (sec) Non-Weighted Weighted 125-148 2.830.06 2.820.02 149-171 2.680.15 2.720.12 172-194 2.600.03 2.640.03 Table 3. Athletic Event Sprint Time Comparison Long Jump High Pole Vault Heptathlete Hurdler Jump NonWeighted Weighted 2.8130.074 2.865 2.6950.247 2.6330.06 2.575 2.8080.025 2.830 2.7350.198 2.6710.047 2.650 Further research into this speculation would be necessary; however, with more conclusive data, the use of body composition measurements to determine levels of potentiation loading could be beneficial. However, the technique behind high/long jumping could also be analyzed as a reason for success in this subgroup. For example, high/long jumpers are required to convert horizontal momentum to vertical momentum (high jumpers more so than long jumpers), and thus may be particularly impacted by added mass. The completion of the high jump is dependent on the force impulse that is the C. Wieland 22 result in the change of momentum directed upward. In one particular study, researchers observed that the horizontal component of the take-off must be at a maximum, but also with the ability to deliver a high vertical reaction force and quick ground contact time (on, 2010). The fact that the forces that the body feels are several times that of the actual mass, unnecessary mass has the potential to complicate these two variables, and thus affects the success of the jump. Long jump is similar in nature, but with more horizontal velocity and less vertical velocity, and may be subject to the same variables affecting success. The other events do not involve quite the same application of force, and thus may not be as prepared to handle the potentiation protocol (i.e. pole vault uses an assistive device to gain the vertical change in direction, hurdling discourages vertical movement, etc.) However, within the constraints of the current study, it is difficult to deduce an exact relationship between weight of the athlete, specific athletic event, and potentiation success. Further research should be performed to separate these components and examine more accurate causation. Balancing the variables behind PAP can be a challenge due to the need to consider the goals of the athlete. Decreasing the potentiation protocol effort percentage could lead to a straying from the power output optimization for some. During competition season, the athletes of the population experience a tapering effect that focuses on decreasing the volume, but increasing the intensity. Thus, it may be more effective to rewrite a protocol with fewer repetitions of the stride patterns, as opposed to decreasing the effort or weight. Conversely, with this decrease in volume, there may be a need to increase the speed of the strides (intensity) to better simulate the speed of C. Wieland 23 acceleration in a race or runway approach. The protocol utilized by Barnes et al. (2015) that was considered in the development of this study involved distance runners, who rarely reach the speeds of power athletes. Thus, it may be more relevant to structure the intensity based on studies that examined more similar populations, such as in the case of Weber, Brown, Coburn, and Zinder (2008) who utilized 85% max effort of the task they were analyzing. The other side of fatigue is the amount of recovery between warm-up repetitions, the warm-up and the sprints, and between sprints. It is possible that the individuals did not receive a long enough recovery time; however, this aspect is more difficult to analyze because too much of a recovery could result in dissipation of the potentiation effects (Weber et al., 2008). Fitness level and muscular composition of the athletes are determinants of optimum recovery time and will be variables for consideration in individual cases. Another potential cause for deviation from the past findings could be due to the difference in the athletes analyzed. Each athlete is accustomed to performing some measure of running and power exercise; however, some of the individual events involve less running, and thus may lead to variance in the results. Past research has emphasized that the individual physiological characteristics of the athletes is an important consideration for potentiation protocols (Tillin & Bishop, 2009). Thus, future success may be found by tailoring the protocol for each athlete, through adjusting added weight and rest time. Instead of adopting one protocol from a synthesis of past literature and applying it towards multiple athletes, determining the best method of priming the C. Wieland 24 neuromuscular system may need to be established over multiple trials for each individual, using the guidelines of what has and has not worked for other researchers. There was also the presence of uncontrollable variables that occurred throughout the research activities. For example, there could have been a learning curve for the starting position of the sprints for some of the athletes. Though all of the athletes had experience starting a sprint from a three- or four-point position, those that are primarily jumpers may not encounter this starting position as frequently. The weighted vests may also have proved to be cumbersome to the athletes. Though they are familiar with activities that involve moving extra weight, there were reports that the vests were mildly constricting and awkward while running. This discomfort could have led to the athletes developing atypical running gaits, which could have led to a decrease in running economy, and thus increased, unnecessary effort. Expending energy in this manner would lead to not properly priming the muscles, and potentially skewing the results. A difference in the weekly structure for each individual was also an uncontrollable variable. For instance, because many of the athletes were on different workout schedules, it was possible that some were fatigued from previous workouts, and did not report it. Though the athletes were informed of the guidelines and procedures, it is difficult to control the activities the athlete had participated within the same day or during the week preceding the testing sessions. An area of further investigation could be examine the speed of the sprint following only the general warm-up, without the strides. Though this would be a slight risk for the athlete if their muscles were not warmed up enough, it could determine if C. Wieland 25 both the weighted and non-weighted protocols had an effect, even if one was not more significant than the other. The stride patterns themselves were of higher intensity than the general warm-up, thus there could be the possibility that they had a potentiating effect, regardless of the presence of extra weight. Competition setting recovery time could also be more individualized for the athletes; however, many researchers have found differing optimal recovery times, thus it may be up to each athlete to deduce what rest period is ideal for them. There is also the potential for recovery time to be based on heart rate; however, with the variables of adrenaline or uncontrollability of the precise start time of the race, this measure could be unpractical and less relevant to sprint performers. Coaches are constantly trying to determine what workouts and warmups will best prepare their athletes for competition day. However, due to individual physiological differences, uniformly priming athletes may not be possible. Though research is critical to produce guidelines for building successful training programs, there cannot be a single approach towards securing athletic performance. It is important to analyze the fitness of the athlete and build a successful warm-up protocol from experience by varying the intensity, volume, and rest that is incorporated. Further research or individual experimentation should be performed with a protocol similar to the current study in order to identify the ideal levels for each variable in order to make an application to a practical competition setting. Athletes in different events may have different musculature and anthropometric measurements rendering individual consideration. For example, high jumpers are generally taller because of the elevated center of mass advantage; pole vaulters balance height and muscle mass to have enough power to successfully convert C. Wieland 26 energy into the pole, yet proceed in an upward pattern; heptathletes participate in multiple, varied events, and thus need to have an overall sound fitness, but may excel in some areas more than others (i.e. the 1000m run versus 60m hurdles). There is also the consideration of fatigue between different events. For example, heptathletes often have multiple events back-to-back; long jumpers have the opportunity to continue on to finals and gain more attempts; high jumpers and pole vaulters theoretically have unlimited attempts as long as they keep clearing bars. On the other hand, it is also important to recognize that some athletes may not have the ideal form when it comes to each event. For example, some short high jumpers and pole vaulters are able to overcome their vertical disadvantage with better power and technique, which could mean that these athletes may need a different potentiation protocol than their taller counterparts. In order to differentiate between specific athletes within the single sport of track and field, future studies could focus on measuring biomechanical and neuromuscular variables (i.e. stride length/rate and leg stiffness, respectively). The use of PAP as an acute warm-up technique and the research to back the concept is still relatively new and further examination needs to be performed so all athletes can benefit. Though past research has found success in various potentiation protocols, it is important to remember the context and the ultimate goal to improve athletic performance when it matters the most. C. Wieland 27 Reflection Research has always been a passion of mine, particularly in areas that are relatable. Being an exercise science student has given me multiple opportunities to look into the research that is currently being performed around the world, but to also experiment with my own research ideas. Until this research project, I have not been involved in the process of getting a research protocol approved by the IRB. This process proved to be extensive with plenty of details that I would have overlooked without guidance. Though I recognize the importance to keeping the participants safe and confidential, I never realized the extent of which a researcher has to document all of the whys and hows. This experience has greatly developed my appreciation for larger scale research and the process that those involved went through to get the procedure from proposal to actual data. Another difficult element to the research process is through recruiting attempts. If I did not have a connection with the University of Indianapolis Track and Field team, I do not think I would have been able to gather the participants that I needed. Though the athletes were willing to participate in the beginning, many forgot or had schedules that became increasingly busy. I would have liked to include more participants in my study; however, logistically it proved to be very difficult. Through this process, I have also acknowledged the importance of a pilot study, in some cases. Because there were many articles in this field of study, but none that incorporated all of the elements that I was looking for, I was forced to synthesize different elements of each research study and at times, make knowledgeable assumptions. This lack of resources in the specific area that I wanted to C. Wieland 28 examine proved that there was a need for research to be performed, yet made the process more challenging. A pilot study can serve to determine if the methods are on the right track or if there are certain variables to be accounted. Ideally, I would have liked to have had the chance to perform a pilot study so I could have a base of research to tweak and adjust for a new round of testing. I would have hoped for this opportunity so I could potentially find significant results the second time around; however, this is just another realization of the amount of time and commitment that goes behind developing significant data. It was also challenging to rely on the resources of others when attempting my research protocols. This experience again opened my eyes to cost that can go behind extracting significant data. Whether that be through actually paying the participants, allocating technology, or funding other resources, it is clear why there is a necessity for organizations dedicated to providing grants for researchers. The whole process of developing an Honors Project was more challenging than I anticipated in general. Due to extenuating circumstances, I had the opportunity to work with several advisers and see the perspectives of each professor and how they approach research. Though at first this was a slight obstacle, it ended up being an opportunity for me to work with different people and experience different styles of approaching the process. This experience also taught me to be flexible, as I know in the real world I will often be a part of situations that I cannot control, and I need to know how to handle them and find success as a result. As I continue on to Physical Therapy graduate school and pursue more research interests, I will have a deep appreciation for the work in which I will be involved. Even C. Wieland 29 if I end up joining the professor after the research is underway, I will have personal experience with handling the start-up process, which will increase my engagement. This experience with the research process will also be an advantage as I compete for the few positions of research involvement offered to my large cohort of students. I will be a knowledgeable resource, familiar with the process and accompanied with the determination to provide new and interesting research to the medical community. Also, looking back, I have to remind myself that all research is important, even if the hypothesis is not proven correct or the data is not significant. All research builds on one another, and it is necessary to develop each building block in order to know where to proceed from there. Research studies contain literature reviews for a reason, as proof that the investigators looked into every aspect of the subject before developing a new or improved path of study. I have greatly enjoyed my studies and learning from the fantastic faculty here at UIndy and the opportunities that I have been offered to apply my knowledge in a practical setting. Learning through lectures and classroom settings has developed the knowledge base that I need to continue to build on my education through applied research. It is important for students to recognize the value in taking ownership of their education and to do personal research to see what is new in their field of study. This research process has taught me how to take information that I have read from other sources, synthesize it, find areas of improvement, and then develop my own ideas and test them in a similar manner. This research process will indirectly help me as a therapist as I encounter new patient scenarios and seek new information to apply to each patient C. Wieland 30 and problem solve to make each encounter more successful. Through improving my skills of analyzing past research, I was able to take my education to the next level and contribute to the body of research. More specifically, I was able to examine an important aspect of my life, track and field, and investigate a potential route for the performance improvement for my teammates and myself. Though I was not able to find significant relationships, I was able to report past information and more insight for athletes to structure their competitive approach. Through this Honors Project, I have continued to build my belief in the value of current research and developing our fields of interest. C. Wieland 31 References Barnes, K.R., Hopkins, W.G., McGuigan, M.R., & Kilding, A.E. (2015). Warm-up with a weighted vest improves running performance via leg stiffness and running economy. Journal of Science and Medicine in Sport, 18, 103-108. Batista, M.A., Ugrinowitsch, C., Roschel, H., Lotufo, R., Ricard, M.D., & Tricoli, V.A. (2007). Intermittent exercise as a conditioning activity to induce post-activation potentiation. Journal of Strength and Conditioning Research, 21(3), 837-840. Chiu, L.Z., Fry, A.C., Weiss, L.W., Schilling, B.K., Brown, L.E., & Smith, S.L. (2003). Postactivation potentiation response in athletic and recreationally trained individuals. Journal of Strength and Conditioning Research, 17(4), 671-677. on, M. (2010). Biomechanical characteristics of take off action in high jump A case study. Serbian Journal of Sports Sciences, 4(4), 127-135. Faigenbaum, A.D., McFarland, J.E., Schwerdtman, J.A., Ratamess, N.A., Jie, K., & Hoffman, J.R. (2006). Dynamic warm-up protocols, with and without a weighted vest, and fitness performance in high school female athletes. Journal of Athletic Training, 41(4), 357-363. Kilduff, L.P., Owen, N., Bevan, H., Bennett, M., Kingsley, M.I., & Cunningham, D. (2008). Influence of recovery time on post-activation potentiation in professional rugby players. Journal of Sports Sciences, 26(8), 795-802. Kmmel, J.L, Bergmann, J., Prieske, O., Kramer, A., Granacher, U., & Gruber, M. (2016). Effects of conditioning hops on drop jump and sprint performance: A randomized crossover pilot study in elite athletes. BMC Sports Science, Medicine C. Wieland 32 and Rehabilitation, 8(1), 1-9. Matthews, H.P., & Snook, B. (2004). The acute effects of a resistance training warmup on sprint performance. Research in Sports Medicine, 12, 151-160. Pojski, H., Pagaduan, J.C., Babaji, F., Uianin, E., Muratovi, M., & Tomljanovi, M. (2015). Acute effects of prolonged intermittent low-intensity isometric warm-up schemes on jump, sprint, and agility performance in collegiate soccer players. Biology of Sport, 32(2), 129-134. Seitz, L.B., & Haff, G.G. (2015). Factors modulating post-activation potentiation of jump, sprint, throw, and upper-body ballistic performances: A systematic review with meta-analysis. Sports Medicine, 46(2), 231-240.. Seitz, L.B., Trajano, G.S., Haff, G.G., Dumke, C.C., Tufano, J.J., & Blazevich, A.J. (2016). Relationships between maximal strength, muscle size, and myosin heavy chain, isoform, composition and postactivation potentiation. Applied Physiology, Nutrition, and Metabolism, 10, 1-7. Sygulla, K.S., & Fountaine C.J. (2014). Acute post-activation potentiation effect in NCAA Division II female athletes. International Journal of Exercise Science, 7(3), 212-219. Tillin, N.A., & Bishop, D. (2009). Factors modulating post-activation potentiation and its effect on performance of subsequent explosive activities. Sports Medicine, 39(2), 147-166. Weber, K.R., Brown, L.E., Coburn, J.W., & Zinder, S.M. (2008). Acute effects of heavyload squats on consecutive squat jump performance. Journal of Strength & C. Wieland 33 Conditioning Research, 22, 726-730. C. Wieland 34 Appendices Appendix A: Style Guidelines Page setup Use letter size (8-1/2 by 11 inch). Margin must be 1.5 inches on the top and 1.5 inches on the left. One inch on the right, and one inch on the bottom. When using the MS template, be sure to delete EVERYTHING that is typed in RED. Except for the title page, everything should be double-spaced. Exceptions would be: Table of Contents, footnotes and end notes, captions/explanatory notes on charts, graphs, and/or tables, appendices, and references (single-spaced within a reference and double spaced between entries). Please consult your discipline-specific style manual, such as MLA or APA. Style In APA style, quotations over three lines long should be in block quotation, singlespaced, and double indented (one inch) on the left and right. Do not use quotation marks in the block quote except when indicating quotations within the block quotation. In MLA style, quotations four or more lines should be in block quotation (three or more lines for poetry), double-spaced, and double-indented (one inch) on the left side only. Do not use quotation marks in the block quotation except when indicating quotations within the block quotation. Please follow the guideline within your discipline. Font, etc. An Honors thesis is not the place to experiment with funky fontsthey do not enhance your work. They only distract your readers. Unless there is an artistic reason for using a non-standard font or multiple styles, please use a single 12 point standard font style, such as Times New Roman. Appendices that include documents prepared by others, copies of invoices, recruitment flyers, or other promotional materials are exceptions to this rule. Title/title page Type the title in all bold letter and in font size 16 on the first page of the manuscript. Be sure to center the title. By line and your name should also be centered. Use the MS template. This page should NOT have the page number. The following statement must be centered also: An Honors Project submitted to the University of Indianapolis Honors College in partial fulfillment of the requirements for a Baccalaureate degree with distinction. Written under the direction of your advisors name here. C. Wieland 35 Date It is very likely that you will be asked to revise and resubmit your honors project. Every time you submit your project, be sure to change the date and type in the ACTUAL date of submission. Signatures BEFORE you submit your manuscript to the Honors College Committee, be sure to have your advisor sign your manuscript. This means that you must complete your manuscript and give it to your advisor at least two weeks in advance so that your advisor will have ample time to read your manuscript. You may submit your manuscript ONLY AFTER your advisor signs the title page, indicating that your advisor have read and approved the project and that your manuscript is ready to be read by the HCC. The Director of Honors College will sign AFTER your manuscript has been approved by the HCC. Abstract The second page of your manuscript should be the abstract page. Type the heading, Abstract, in the font size 12 and on the first line in the center. Your abstract should be somewhere between 150 words to 200 words, and from this portion on, your thesis must be double-spaced. Acknowledgment (optional) The third page of your manuscript should be the acknowledgment page. However, if you received a grant for this project, you should acknowledge that here. This page should be typed in double-space. List of Table If you decide not to have an acknowledgment page, AND if you have tables in your manuscript, then this page should be the third page. If you did not use any tables, then skip this page and move on. The title should be centered while the list of tables should use both right and left justifications. Do not leave extra line between the List of Tables and Table 1. Include a brief title of table after Table 1: with all major words capitalized. The brief title of table must match the way it is presented in the body of the text. Make sure the page numbers line up straight on the right side. In the body of the manuscript, you must place the table titles ABOVE the tables. List of Figures If you used any figures in your manuscript, this page comes next. The title, List of Figures should be centered, whereas the list itself should use both right and left justifications. Do not leave out a line between List of Figures and Figure 1.) Figure 1: etc. should be followed by a brief figure caption. Figure captions must be placed C. Wieland 36 BELOW the figure in the body of the manuscript, capitalizing only the first word and any proper noun or adjective. Keep the figure captions brief, and make sure that the figure captions in the body of the manuscript matches how they appear in the list of figures. Table of Contents Unlike list of tables and figures, which may be included in your manuscript ONLY IF you do have tables and figures in your manuscript, you MUST have the table of contents. The title, Table of Contents, should be centered, where as the rest should use both left and right justification so that the page number will line up strainght on the right. List of Appendices Again, the title should be centered, whereas the list itself should use both left and right justification in order to align the page numbers on the right. Copy of your CITI training should be in the Appendices. If you have a project that was research with human participants, your IRB submission and the approval letter from IRB is REQUIRED. If you applied for external funding, a copy of the grant application should be included. If you had a budget, a complete budget comparing projected with actual costs should be included in the Appendices, too. Appendices are organized in the order they are discussed in the manuscript; therefore, the first appendix mentioned in the manuscript would be Appendix A. Statement of Purpose Arabic numeral starts from this page on. Use Header (click on View, select Header/Footer) and make sure this is Section 3; otherwise, Header, etc. will appear on the cover page. This running head should be on one line and aligned to the right. Type your first initial (because sometimes there are several Honors students with the same last name), and last name, one space. Then, click on format page number to select 1, 2, 3. And click insert page number. This page should be page 1. The title, Statement of Purpose, should be centered. The text itself should use the left alignment. Be sure to revisit your statement of purpose from your project proposal. Be sure to use the past tense now that your project is done. This should reflect what you actually investigated or did, especially IF the project changed substantially from what was originally proposed. Body of Manuscript Follow the guideline within your discipline. Keep in mind that all components that publishable article within your discipline have must be included in your Honors Manuscript. Subheadings should be typed in the center in font size 12. Introduction You probably read some more books, articles, etc. as you worked on your project. Be sure to revise your literature review from your proposal and include works C. Wieland 37 youve read while working on your project. Method/Procedure Write out the description of actual project procedure. Be sure to revisit your proposal and feedback from the committee to see if there were works that needed to be included in the project. Now that your project is done, write in the past tense. Product Produced This section can be in appendix. Results This section is only for empirical studies. This is where you present data from your study. Analysis/Conclusion Analysis section is important for creative Honors project also (for empirical studies, this is where you analyze the data). To demonstrate your learning and understanding of your art in creative Honors project, you need to analyze your own work based on the historical/critical knowledge you gained, and this is where you do NOT place your work in historical/critical context but actually analyze your own works merit. Conclusion is where you can address what needs to be done in the future, so it is more future-looking. Reflection Reflection is to record the student learning and making connections between text/literature and the activity, so it is more past-looking and more personal piece. References Follow the format of your discipline. This could be Bibliography, Works Cited, Works Consulted, etc. The table titles in the body of the manuscript must be placed ABOVE the tables, and the titles must match how they are presented in the list of tables. Figure captions in the body of the manuscript must be placed BELOW the figures, and the titles must match how they are presented in the list of figures. Be sure to include citations in the body of the manuscript (but not in the list of figures) if figure is reproduced from another source. Figures must be sharp, high resolution. Full color is allowed. Appendices This comes at the end. Copy of your CITI training should be in the Appendices. If you have a project that was research with human participants, your IRB submission and the approval letter from IRB is REQUIRED. If you applied for external funding, a copy of the grant application should be included. If you had a budget, a complete budget comparing projected with actual costs should be included in the Appendices, too. Appendices are organized according to the order they are discussed in the manuscript (The first appendix mentioned in the manuscript would be Appendix A, for example). C. Wieland 38 Margins on all Appendices must be 1.5 inch on the top and the left, one inch on the right and the bottom. Appendices must be paginated and consistent with the body of the manuscript. Submission of Manuscript for Review to Honors College Committee Three copies signed by advisor(s) Submission of Camera-Ready Manuscript After the project is approved by Honors College Committee, submit one hard copy with advisors signature, one electronic copy, and a clean copy of the cover page. All macros must be removed from the electronic copy, and manuscript must be in a single file. The extension on the electronic copy must be either doc. or docx. C. Wieland 39 Appendix B: CITI Training C. Wieland 40 Appendix B: CITI Training (Continued) C. Wieland 41 Appendix C: IRB Submission C. Wieland 42 Appendix D: IRB Letter of Approval C. Wieland 43 Appendix D: IRB Letter of Approval (Continued) C. Wieland 44 Appendix E: Informed Consent C. Wieland 45 Appendix E: Informed Consent (Continued) C. Wieland 46 Appendix E: Informed Consent (Continued) C. Wieland 47 Appendix E: Informed Consent (Continued) C. Wieland 48 Appendix F: Recruitment Email  ...

... Enhancement of Anti-Cancer Efficacy through Combination Chemotherapy of Ciprofloxacin with either 5-Fluorouracil or Gemcitabine By Katie M. Beverley An Honors Project submitted to the University of Indianapolis Strain Honors College in partial fulfillment of the requirements for a Baccalaureate degree with distinction. Written under the direction of Dr. Dean A. Wiseman. March 13, 2016 Approved by: __________________________________________________________________ Dr. Dean A. Wiseman, Faculty Advisor ______________________________________________________________ Dr. James B. Williams, Interim Executive Director, Strain Honors College ______________________________________________________________________ First Reader ______________________________________________________________________ Second Reader K. Beverley ii Abstract Pancreatic cancer is one of the most lethal cancers, with most patients dying within the first 5 years after diagnosis. Frequently it arises from cells in the pancreatic ducts (pancreatic ductal adenocarcinoma) and often fails to be diagnosed until it has already metastasized to other organs and tissues in the body, and thus is significantly harder to treat. For these reasons, alternative therapy options should be investigated. Previously, we observed in our hands that ciprofloxacin selectively kills pancreatic ductal adenocarcinoma cells but not non-malignant human cells. 5-fluorouracil (5-FU) is a commonly used chemotherapeutic agent for pancreatic cancer which inhibits DNA replication in the S-phase of the mitotic cell cycle. Another front-line chemotherapeutic is the nucleotide analog gemcitabine (dFdC) which functions in a similar manner to 5-FU. Given that all three of these drugs appear to have both anti-cancer activity and act in the same cell cycle phase, we hypothesized ciprofloxacin would augment the cytostatic and/or cytotoxic effect of either 5-FU or dFdC. To test this hypothesis, MIA PaCa-2 human ductal adenocarcinoma cells were cultured and treated singly with 5-FU, or dFdC, or Cipro, or in simultaneous combination (either 5-FU or dFdC with Cipro) for 24 hour periods of time. As a result, we found that Cipro could significantly (p 0.05) and in dose-dependent fashion enhance the activity of both 5-FU and dFdC. We conclude that Cipro is a valid candidate as an adjuvant to standard forms of chemotherapy which involve use of 5-FU and/or dFdC. Furthermore, we propose that additional studies be ii K. Beverley iii conducted to further assess the validity of such combinations for human patients in the future. iii K. Beverley iv Acknowledgments This project is dedicated to my parents for always supporting my pursuit of science and for their continued encouragement, guidance, and love. They have taught me what it means to pursue my goals even though at times it will not be easy. This project is also dedicated to my dear family friend Edith Mossner who lost her battle with Pancreatic Cancer on June 19, 2015. Her perseverance continues to inspire my work on this project and reminds me of why this work is so important. I would like to acknowledge many people who have supported my project. I so appreciated the contributions of other students who worked alongside me in the lab on this project, Colton Starcher, Brandy Ploetner, Amanda Khan, and Kennedy Nies. Special thanks go to Dr. Patrick Fueger at Indiana University School of Medicine for allowing use of his equipment. This research would not have been possible without funding from the Strain Honors College at the University of Indianapolis and the Department of Biology. Finally, I would like to thank my Project Advisor Dr. Dean Wiseman for his constant patience, support, and assistance on this project. I have been so blessed to work in his lab over the past two years. I truly appreciate him motivating me when I needed it and being there for me during tough moments. He has taught me that research is about more than just the numbers on a report but about becoming a more independent thinker and a better student of the world. iv K. Beverley v List of Data Figures Figure 1: Dose-dependent inhibition of PaCa-2 cell viability by ciprofloxacin 14 Figure 2: 5-Fluorouracil Inhibits Pancreatic Ductal Adenocarcinoma Cell Growth15 Figure 3: The anti-cancer effect of 5-FU is enhanced when combined with ciprofloxacin 16 Figure 4: The anti-cancer effect of dFdC is enhanced when combined with ciprofloxacin. 18 Figure 5: Normalized isobologram analysis of the enhancement of the anti-cancer effect of 5-FU by ciprofloxacin 20 Figure 6: Normalized isobologram analysis of the enhancement of dFdC anti-cancer effect by co-administration of Ciprofloxacin 21 v K. Beverley vi Table of Contents Cover Page i Abstract ii Acknowledgement iii List of Figures iv Statement of Purpose 1 Introduction 2 Method/Procedure 11 Results 14 Analysis/Conclusion 19 Reflection 23 References 25 vi K. Beverley 1 Statement of Purpose Pancreatic cancer is one of the most lethal cancers, and most current chemotherapeutic agents are capable of providing only a slight increase in the life expectancy and/or improving the patients quality of life during that time (Hildago, et al., 2015). Given our initial observation that ciprofloxacin (Cipro) preferentially kills cancer cells but not non-cancer cells, the purpose of this honors project was to test the effectiveness of a potential (and unexpected) chemotherapeutic agent, the antibiotic ciprofloxacin, independently and in combination with two commonly used chemotherapeutics, 5-fluorouracil (5-FU) and gemcitabine (dFdC). The experiments in this study assessed viability and/or death of pancreatic cancer cells when exposed to either single-agent Cipro, 5-FU, or dFdC with Cipro. Our goal was to ascertain if ciprofloxacin can enhance the known anti-cancer efficacy of 5-FU and/or gemcitabine in a standard in vitro model of human pancreatic cancer. K. Beverley 2 Introduction This introduction will provide a brief survey of the important concepts presented within this thesis. Such important concepts include a general background of the disease of cancer, some specific aspects of pancreatic cancer, mammalian cell cycle, the drugs ciprofloxacin, 5-fluorouracil, and gemcitabine, adjuvant chemotherapy, and some background information on the condition of pancreatitis. Herein, each concept is explained through a literature review and/or detailed mechanism. I. Cancer According to the American Cancer Society (2016), cancer begins when cells grow uncontrollably and push out the healthy cells from a certain area of the body. Cancer can develop in a variety of organs and tissues including the skin, breast, lung, blood, colon, and pancreas. At the time of diagnosis, cancer is typically categorized in one of four possible stages, indicating the severity and spread of the cancer cells within the tissues of the body. Stages 1 and 2 indicate that the cancer has not spread from the specific tissue it arises from (i.e. breast, lung, skin, or other tissue/organ of origin). When a cancer reaches stage 3 and 4 it has spread from tissue of origin, and has proceeded to invade other tissue, or even distant regions of the body (metastasis). Generally speaking, patient prognosis deteriorates as the stage number increases. K. Beverley 3 II. Pancreatic Cancer The American Cancer Society (2016) explains that the pancreas is an organ located behind the stomach in the abdomen, with exocrine secretory roles in digestion, as well as endocrine regulatory roles in the bloodstream. The exocrine role involves the production of digestive enzymes to facilitate breakdown of food and nutrients, as well as bicarbonate ion (HCO3-) which is critical in neutralizing stomach acid as digestive products enter the small intestine. In terms of endocrine function, specific endocrine cells release hormones, including insulin and glucagon for proper regulation of blood sugar, while other endocrine cells secrete hormones involved in the coordination of digestive activity in other organs, such as the liver, small and large intestines. Epidemiological data indicates that most cancers of the pancreas develop within the cells which line the exocrine ducts; accounting for more than 90% of pancreatic cancer diagnoses (Hidalgo et al., 2015). According to the Mayo Clinic (2016) the vast majority of pancreatic malignancies are silent (asymptomatic), and not usually diagnosed until they have invaded other tissues and organs of the body. Unfortunately, if the stage of disease is 3 (spread to other organs in the same body region) or 4 (metastasized to distant tissues), it is highly likely that surgery is no longer a viable treatment option. K. Beverley 4 Pancreatic cancer was cited as the cause of death in 330,000 patients globally in 2012, and among all major cancer types pancreatic adenocarcinoma has the lowest survival rate. Moreover, fewer than 25% of patients even survive their first year following diagnosis (Jiang et al., 2014). These statistics illustrate that pancreatic cancer is a truly severe condition and should be a focus for further research. III. Cell Cycle The cell cycle is the combination of two fundamental processes: replication of the genome and the formation of two new daughter cells (Murray and Kirschner, 1989; Waldman et al., 1996; Wiseman, 2004). There are three primary phases of the cell cycle: the G phases in which cells are relatively inactive, the S phase is when the cell is producing a copy of its genome, and the M phase is when the cell is split into two daughter cells (see Figure 1 below). The cells enter the G1 phase when they have received a trigger to divide but has not yet fully committed to cell division (Wiseman, 2004). K. Beverley 5 Figure 1. Mammalian Cell Cycle Research has suggested that ciprofloxacin acts during S-phase and inhibits the duplication of the chromosomes preventing the cancer cells from increasing in number (Yadav et al., 2015). IV. Ciprofloxacin Ciprofloxacin is an existing FDA-approved antibiotic which is most often used for severe bacterial infections, and is generally considered to be a safe and effective treatment for acute infectious colitis (bacterial infections of the colon), and many other infections, particularly in hard-to-reach areas of the body. It is a synthetic K. Beverley 6 4-quinoline derivative and is a broad-spectrum, widely used antibiotic. Based on its chemical structure, ciprofloxacin is classified as a fluoroquinolone, many of which have been used as chemotherapeutics (Yadav et al., 2015). Figure 2. Chemical structure of Ciprofloxacin However, this drug in non-cancer patients has been known to cause drug-induced pancreatitis (Sung et al., 2014). Ciprofloxacin can also suppress the human immune system by killing off the T-cells, which is also a common characteristic of other chemotherapeutic agents. (Kaminski et al., 2010). V. 5-Fluorouracil 5-Fluorouracil is a compound that inhibits DNA replication in the S-phase of the cell cycle. It works as an enzyme the blocks the production of thymine, a K. Beverley 7 nitrogenous base in the DNA molecule. Due to this inhibition the cancer cells are no longer able to divide rapidly. Figure 3. Chemical structure of 5-fluorouracil 5-Fluorouracil has been the most commonly used regimen for esophageal cancer over the past 15 years (Almhanna et al., 2015). 5-Fluorouracil has also been found to be effective in inducing cell death in MIA PaCa-2 cell lines especially when used in combination with traditional radiation treatments (Mohiuddin et al., 2002). VI. Gemcitabine Gemcitabine is another nucleoside analog that inhibits DNA replication and has been commonly used as a chemotherapeutic against pancreatic cancer (Heinemann et al., 1988). K. Beverley 8 Figure 4. Chemical structure of gemcitabine Once Gemcitabine enters the cells it is phosphorylated and then inhibits DNA replication, in an interesting mechanism described as masked chain termination. Gemcitabine inserts itself into the DNA sequence and then two more nucleotides are added to mask it and the drug becomes stuck in the DNA (Plunkett et al., 1995). Figure 5. Metabolism of gemcitabine in mammalian cells (Kamada et al., 2014) K. Beverley 9 One key study which demonstrated the clinical effectiveness of gemcitabine showed that 23.8% of patients experienced what was termed a clinical benefit of gemcitabine therapy, where patients lived for longer periods of time, with less discomfort and less pain than with other front-line drug therapies (Burris et al., 1997). Gemcitabine has limited toxicity and therefore is a focus of investigation in combination chemotherapy (Araneo et al., 2003; Wiseman, 2004). VII. Adjuvant Chemotherapy Adjuvant chemotherapy is the term used to describe a combination of multiple drugs for chemotherapy, where one drug is enhancing the effect of another, or allowing a particularly toxic drug to be used effectively at lower doses. Adjuvant therapy has been shown to be effective in gastrointestinal, pancreatic, and breast cancers (Schwentner et al., 2014). It was recently shown that moxafloxacin and ciprofloxacin, when combined, had a synergistic effect on MIA PaCa-2 cells, meaning the two-drug combination was much more potent than a one plus one dose-to-effect prediction. Specifically, this treatment led to mitochondrial apoptosis and arrest in the S-phase of the cell cycle (Yadav et al., 2015). Currently approved forms of adjuvant chemotherapy increase the life expectancy of pancreatic cancer patients in clinical settings. However, it is typically only used for younger patients with more advanced stage cancers (Nagrial et al., 2014). In vivo, combination K. Beverley 10 chemotherapy significantly reduced pancreatic adenocarcinoma tumor size in mouse models (Conger, 2015). Figure 6. Example of a normalized isobologram plot for drug combinations (Seiwert et al., 2007) One graphical method of assessing the effective quality of drug combinations is termed a normalized isobologram (shown above, Figure 6). By plotting the effect of dose combinations in this manner, we get a rapid visual representation of the relative effectiveness of a drug combination versus known effect with each drug individually (Chou et al., 2005). As a final note, combination chemotherapy has yielded extraordinarily beneficial outcomes in certain highly metastatic and previously extremely lethal forms of K. Beverley 11 cancer. In particular, triple-adjuvant chemotherapy was used in Lance Armstrongs treatment for metastatic testicular cancer. Over time, this triple-adjuvant regimen has reversed what was originally a disease with a 90% mortality into one which is now 90% curable (Washington Post, 2002). VIII. Pancreatitis Pancreatitis is either acute or chronic inflammation of the pancreas, and can be caused by a number of different factors. Causes of pancreatitis may include, infection coming up through the pancreatic duct from the intestine, or microorganisms traveling through the lymph nodes into the pancreas, be the result of physical occlusion of pancreatic ducts, or in some cases an adverse reaction to certain drugs or pharmaceuticals (Ignatavicius et al., 2012). According to the National Institutes of Health, pancreatitis leads to a hospitalization in 1,000 in every 50,000 people. Ciprofloxacin has been observed to induce a form of acute pancreatitis (Sung et al., 2014), and we consider this side effect to be perhaps a harbinger of its unusual anti-cancer effect on pancreatic ductal adenocarcinoma cells. K. Beverley 12 Methods/Procedure I. Cell Culture The human pancreatic ductal adenocarcinoma cell line MIA PaCa-2 (CRL1420) was purchased from the American Type Culture Collection (Manassas, VA). Cells were maintained in Dulbeccos modified Eagles medium (DMEM) supplemented with 10% fetal bovine serum, 100 U/mL penicillin, 100 g/mL streptomycin, and 2 mM L-glutamine (Invitrogen, Carlsbad, CA) at 37C in humidified air and 5% CO2. Cells used in experimentation were between passages 5 (post-American Type Culture Collection) and 20. Four days before the MTS assay MIA PaCa-2 cells were seeded in 96-well culture plates at a density of 1.0 x 105 cells per mL. K. Beverley 13 Figure 7. General workflow of cell viability assays II. Drug Treatments 24 hours before MTS assay, MIA PaCa-2 cells were treated with 5fluorouracil (5-FU), gemcitabine (dFdC), or ciprofloxacin (Cipro) as single agents, or in combinations of either 5-FU or dFdC with Cipro. For single-drug exposures drug concentrations of 5-FU dissolved in DMEM ranged from 0.625-100 M and drug combinations of dFdC dissolved in DMEM ranged from 0-50 M, while concentrations of Cipro ranged from 25-800 M. In combination regimes, 5-FU concentrations varied as before (0.625-100 M) with either 200 or 400 M Cipro. dFdC concentrations varied from 0-50 M with 400 M Cipro. K. Beverley 14 III. MTS Assay In this assay, we optically measure the creation of a dark-colored formazan product (which is opaque to 490 nm wavelength light) created by mitochondrial enzymes within viable cells. Formazan is a dye which is converted by NAD(P)H-dependent dehydrogenase enzymes, which function in mitochondrial metabolism (Cory et al., 1991). This mitochondrial enzymatic activity is directly proportional to the number of living cells present in a given culture of cells. According to the manufacturers protocol (BioVision, 2015), cells were incubated in MTS solution and phosphate buffered saline (PBS) for 1-4 hours then the absorbance is measured at 490 nm using the Molecular Devices SpectraMax M2 microplate reader with the Softmax Pro 6 software. IV. Data Analysis Each individual experiment was conducted with an independent sample number, n=16. Statistical analysis was conducted using Students t-Test comparing the average absorbance of formazan product (A490), along with standard error of the mean (standard deviation divided by the square root of the number of samples) was calculated. For statistical significance, we considered a value of p 0.05 between experimental groups to be significant. K. Beverley 15 V. Graphs and Isobolograms All graphs were generated using Prism software by Graphpad. Isobolograms were constructed using CompuSyn software by Ting-Chao Chou and collegues (Chou et al., 2005). K. Beverley 16 Results I. Ciprofloxacin-mediated inhibition of pancreatic cancer cells. This first experiment involved single-agent Cipro in order to establish the relevant range of anti-cancer activity in our PaCa-2 cells. Using the MTS assay to quantify mitochondrial activity, we found that Cipro significantly inhibits PaCa-2 cell growth in a dose-dependent manner over a 24 hour period with concentrations ranging from 50 to 800 M (Figure 8, below). The approximate IC50 was determined to be 400 M. Figure 8. Dose-dependent inhibition of PaCa-2 cell viability by ciprofloxacin. MIA PaCa-2 human pancreatic adenocarcinoma cells were incubated under standard conditions for 24 hrs with 0-800 M ciprofloxacin. Following incubation, MTS reagent was added to the media, and the cells were incubated for an addition 1-4 hr, and colorimetric analysis of the mitochondrial conversion of MTS was performed. Graph represents the average A492 absorbance of samples (n=16), and error bars represent the standard error of the mean (SEM). * p 0.05 vs. untreated cells. K. Beverley 17 II. Anti-cancer effect of single-agent 5-FU. 5-Fluorouracil (5-FU) is classified as a fluoroquinoline antibiotic. It has been shown to inhibit DNA replication during the S-phase of the cell cycle, and several other less well-characterized mechanisms. In our hands, we found 5FU causes a significant dose dependent decrease in PaCa-2 cell viability after 24 hours in the range of 1.25-100 M (Figure 9, below). Figure 9: 5-Fluorouracil Inhibits Pancreatic Ductal Adenocarcinoma Cell Growth MIA PaCa-2 cell viability is presented as a function of 5-FU concentration over a 24 hour period. Data represent the mean SEM. * p 0.05 vs. untreated cells. K. Beverley 18 III. Simultaenous administration of ciprofloxacin and 5-FU have a superadditive anti-cancer effect on PaCa-2 cells. Given that both agents demonstrate reasonable effectiveness on our PaCa-2 cells, and that both agents appear to work primarily during the same phase of the cell cycle, we hypothesized that both agents would function with increased efficacy in a tandem combination. Using isobologram analysis (Figure 12) We found that, when used together, 5-FU and Cipro have a greater dosedependent effect than either 5-FU or Cipro alone as quantified by the MTS assay after 24 hours. K. Beverley 19 Figure 10: The anti-cancer effect of 5-FU is enhanced when combined with ciprofloxacin. MIA PaCa-2 cell viability is decreased when both drugs are used together and the combinatorial anti-cancer effect is dose-dependent at all but the very highest doses of 5-FU. Data represent the mean (n=16) SEM. * p 0.05 vs untreated cells; p 0.05 vs single-agent 5-FU; p vs. 5-FU+200 M combination. IV. Simultaenous administration of ciprofloxacin and gemcitabine (dFdC) also has a superadditive anti-cancer effect on PaCa-2 cells. Given that we found enhanced anti-cancer effect with a known DNA synthesis inhibitor in 5-FU, we elected to see if there is any additional benefit in using another known DNA synthesis antagonist. We found that this combination K. Beverley 20 was superior to single-agent dFdC administration in our cells. Using isobologram analysis (Figures 12 and 13) We found that, when used together, 5-FU and Cipro have a greater dose dependent effect than either 5-FU or Cipro alone as quantified by the MTS assay after 24 hours. Figure 11: The anti-cancer effect of dFdC is enhanced when combined with ciprofloxacin. MIA PaCa-2 cell viability is decreased when both drugs are used together and the combinatorial anti-cancer effect is dose-dependent at all but the very highest doses of 5-FU. Data represent the mean (n=9) SEM. * p p 0.05 vs single-agent dFdC. K. Beverley 21 Analysis/Conclusion I. Single Chemotherapeutic Agent Effectiveness It was important that we first treat pancreatic ductal adenocarcinoma cells with each agent independently in order to confirm that they actually decrease viability of cancer cells as well as establish a baseline reference for anti-cancer activity in our cellular model system. We found that Cipro effectively reduced pancreatic cancer cell viability in our 24-hour experiments, as evidenced by MTS colorimetric assay. Our data indicate that cell viability and mitochondrial metabolism are decreased in response to Cipro in a significant and concentration-dependent manner (Figure 8). In retrospect, while it was a surprising finding to us at the time, it turns out that Cipro has been recently shown to have therapeutic promise in treating models of human colorectal cancer. Importantly, a recent study demonstrated anti-cancer effects of combinations of fluoroquinolone drugs including ciprofloxacinin human pancreatic adenocarcinoma cell lines (Yadav, et al., 2015), strongly indicating that the drug does have a specific effect on cells of the pancreas. The chemotherapeutic agents 5-fluorouracil (5-FU) and gemcitabine (dFdC) also demonstrated effective suppression of viability in our 24 hour experiments (Figures 9 and 11). The colorimetric reaction in the MTS assay suggests that the mitochondrial metabolism is significantly decreased by increased doses of 5-FU and dFdC. K. Beverley 22 II. Effectiveness of Combination Therapy on Cancer Cell Viability Given that Cipro, 5-FU, and dFdC all appear to act primarily during DNA replication in the S-phase of the cell cycle (Yadav et al. 2015) with resultant reduction in cell viability, our MTS viability data supports our hypothesis that Cipro would enhance the anti-cancer effect of 5-fluorouracil. This suggests that the two drugs would be most effective in a simultaneous combination, though this is merely speculative, as we did not assess an alternative modality of sequential drug administration, which would be an important follow-up experiment to this work. Figure 12: Normalized isobologram demonstrates the enhancement of the anti-cancer effect of 5-FU by ciprofloxacin (400 M). Single-agent and combination dose vs. effect relationships were graphically analyzed as described previously. This graph represents of 5-FU (0-100 M) with a constant dose (400 M) Cipro for 24 hrs. Drug combinations are plotted versus what the predicted effect would be if a perfect additive relationship was present (i.e. EC50 Drug A + EC50 Drug B = EC100 Drug A or B). All combinations tested yielded improved effect over single-agent experimental effect. K. Beverley 23 Our data corroborates the work of others who have established a preliminary mechanism of action for Cipro, as well as effectiveness of Cipro and 5-FU drug combinations in the MIA PaCa-2 cell line and other malignant pancreatic cell lines in vitro (Yadav et al., 2015). In our hands, increased Cipro (from 200 M to 400 M) further decreased cancer cell viability, indicating a dose-dependent combinatorial effect (Figure 10), which another standard of evaluation of drug combinations. In summary, the drugs were enhancing each other in a synergistic fashion, rather than acting independently of one another or acting as antagonists to one another. K. Beverley 24 Figure 13: Normalized isobologram demonstrates the enhancement of the anti-cancer effect of dFdC by ciprofloxacin (400 M). Single-agent and combination dose vs. effect relationships were graphically analyzed as described previously. This graph represents of dFdC (0-50 M) with a constant dose (400 M) Cipro for 24 hrs. Drug combinations are plotted versus what the predicted effect would be if a perfect additive relationship was present (i.e. EC50 Drug A + EC50 Drug B = EC100 Drug A or B). All combinations tested yielded improved effect over single-agent experimental effect. We also tested the combination of Cipro with dFdC, another nucleotide analog which is more potent than 5-FU, and surpassing 5-FU as the frontline drug of choice. Like 5-FU, the combination was more effective in diminishing cell viability than the individual chemotherapeutic agents. Normalized isobolgram analysis further suggests that these drugs act in a synergistic manner (Figure 13), and indicates a strong opportunity for future combinatorial study in advanced models of the disease. K. Beverley 25 III. Conclusions We find that either 5-FU or dFdC administered in combination with Cipro leads to a significantly greater dose-dependent response in our pancreatic ductal adenocarcinoma cells. Both 5-FU and dFdC appear to act in a synergistic manner with Cipro, and we hypothesize that this is due to their primary mechanism of action occurring during the same phase of the cell cycle, though this also has yet to be fully examined. This research provides strong evidence for a novel treatment therapy for pancreatic cancer using currently approved FDA drugs and further investigation is strongly merited. K. Beverley 26 Reflection First of all, we determined ciprofloxacin (Cipro) and 5-fluorouracil (5-FU) do act synergistically in terms of their effect in comparison to each of the drugs independently (as illustrated in Figures 8 and 9). Hye et al. (2014) suggested that ciprofloxacin has been critical in the treatment of gastrointestinal cancers. Further, Almhanna et al. (2015) suggest that 5-FU and radiation work well in inhibiting cancers of the esophagus. Since, the pancreas functions within the digestive system it correlates that these drugs would be effective in treating cancers of the pancreatic duct. Congers (2015) work argues that use of drug combinations such as Cipro and 5FU could be the key to treating pancreatic cancer. We corroborated previous data in Yadav et al. (2015) in Figure 12 where both drugs together were had a greater anticancer effect than either drug independently. Our data, as a whole, we conclude supports the contention that these compounds could be used in drug combination strategies. Through the completion of this project, I was able to use the scientific method to investigate why it is that ciprofloxacin kills cancer cells but does not kill healthy cells. I was also able to corroborate the published work of Yadav, et al. (2015) and was able to better understand the physiological function of both 5-fluorouracil (5-FU), gemcitabine (dFdC), ciprofloxacin (Cipro) as inhibitors of DNA replication. As a result of this K. Beverley 27 inhibition, the pancreatic ductal adenocarcinoma cells have decreased viability as shown by the MTS assay for mitochondrial function. While the viability is decreased we are as of yet unsure of the specific mechanism of cell cycle inhibition. Further studies should be conducted to explain the mechanism of action of Cipro and 5-FU in combination and how it impacts mitochondrial metabolism as illustrated in the MTS assay. Another study could be conducted to better understand the most optimal concentrations within the combination. In addition to the knowledge that I gained in the field of cancer pharmacology, I was able to apply the skills I have gained in aseptic tissue culture and other basic laboratory techniques that I will be able to use in my future research endeavors. I feel that the opportunities that I had to mentor other students was an important part of this honors project. Ultimately, sharing skills with a laboratory colleague helps them develop their skillset and also allows the mentor to gain a better understanding and mastery of the skill by teaching it. K. Beverley 28 References Almhanna, K., S.Hoffe, J. Strosberg, W. Dinwoodie, K. Meredith, and R. Shridhar. 2015. Concurrent chemoradiotherapy with protracted infusion of 5-fluorouracil (5-FU) and cisplatin for locally advanced resectable esophageal cancer. J Gastrointest Oncol. 6: 3944. Araneo, M., Bruckner, H., Grossbard, M., Frager, D., Homel, P., Marino, J., DeGregorio, P., Mortazabi, F., Firoozi, K., Jindal, K., and Kozuch, P. 2003. Biweekly low-dose sequential gemcitabine, 5-fluorouracil, leucovorin, and cisplatin (GFP): a highly active novel therapy for metastatic adenocarcinoma of the exocrine pancreas. Cancer Invest, 21: 489-496. BioVision. 2015. MTS cell proliferation assay kit protocol. http://www.biovision.com/mts-cell-proliferation-colorimetric-assay-kit-8078.html. Date Accessed: 12 April 2016 Burris, H., Moore, M., Andersen, J., Green, M., Rothenberg, M., Modiano, M., Cripps, M., Portenoy, R., Storniolo, A., Tarassoff, P., Nelson, R., Dorr, F., Stephens, C., and Von Hoff, D. 1997. Improvements in survival and clinical benefit with gemcitabine as first- K. Beverley 29 line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol, 15: 2403-2413. Cancer research: Its worth the ride. The Washington Post. October 3, 2002. Chou, T. and Martin, N. 2005. Compusyn for drug combinations: PC software and users guide: a computer program for quantitation of synergism and antagonism in drug combinations, and the determination of IC50 and ED50 and LD50 values. Combosyn Inc. http://www.combosyn.com/ Date Accessed: 12 April 2016 Chou, T. 2010. Drug combination studies and their quantification using the Chou-Talalay method. Cancer Res.70(2): 440-446. Conger, K. 2015. Combination therapy could fight pancreatic cancer, say Stanford researchers. Stanford Scope Blog. http://scopeblog.stanford.edu/2015/09/21/combinationtherapy-could-fight-pancreatic-cancer-say-stanford-researchers/ Date Accessed: 12 April 2016 K. Beverley 30 Cory, A., Owen, T., Barltrop, J., and Cory, J. 1991. Use of an aqueous soluble tetrazolium/formazan assay for cell growth assays in culture. Cancer Commun. 3(7): 2017-212. Heinemann, V., Hertel, L., Grindey, G., and Plunkett, W. 1998. Comparison of the cellular pharmakinetics and toxicity of 2,2-difluorodeoxycytidine and 1-beta-Darabinofuranosylcytosine. Cancer Res, 48: 4024-4031. Hidalgo, M., S. Cascinu, J. Kleeff, R. Labianca, J. Lohr, J. Neoptolemos, F. Real, J. Van Laethem, V. Heinemann. 2015. Addressing the challenges of pancreatic cancer: Future directions for improving outcomes. Pancreatology. 15: 8-18. Hye, Y.S., J.I. Kim, H.J. Lee, H.J. Cho, D.Y. Cheung, S.S. Kim, S.H. Cho, and J.K. Kim. 2014. Acute Pancreatitis Secondary to Ciprofloxacin Therapy in Patients with Infectious Colitis. Gut Liver.8: 265-270. Ignatavicius, P., A.Vitkauskiene, J. Pundzius, Z. Dambrauskas, and G. Barauskas.2012. Effects of prophylactic antibiotics in acute pancreatitis. HPB (Oxford). 14: 396-402. K. Beverley 31 Jiang, J., C. Yu, M. Chen, H. Zhang, S, Tian, and C. Sun. 2014. Reduction of miR-29c enhances pancreatic cancer cell migration and stem cell-like phenotype. Oncotarget, Advance Publications. 6(5): 1-12. Kamada, M., Akiyoshi, K., Akiyama, N., Funamizu, N., Watanabe, M., Fujioka, K., Ikeda, K., and Manome, Y. 2014. Cholangiocarcinoma cell line TK may be useful for the pharmakinetic study of the chemotherapeutic gemcitabine. Oncology Reports. 32(2): 829834. Kaminski, M., S. Sauer, C. Klemke, D. Suss, J. Okun, P. Krammer, and K. Gulow. 2010. Mitochondrial reactive oxygen species control T cell activation by regulatibg IL-2 and IL-4 expression mechanism of ciprofloxacin-mediated immunosuppression. Journal of Immunology. 184(9): 4827-4841. Lents, N. and Hesterman, D. 2016. Cell division I: The cell cycle. 3(5). http://www.visionlearning.com/en/library/Biology/2/Cell-Division-I/196 Date Accessed: 13 April 2016 Mayo Clinic. 2016. Sandhya Pruthi (Editor). http://www.mayoclinic.org/diseasesconditions/pancreatic-cancer/basics/definition/CON-20028153. Date Accessed: 13 April 2016 K. Beverley 32 Mouhiuddin, M., Chendil, D., Dey, S., Alcock, R.A., Regine, W., Mouhiuddin, M., and Ahmed, M.M. 2002. Influence of p53 status on radiation and 5-Fluorouracil synergy in pancreatic cancer cells. Anticancer Research. 22: 825-830. Murray, A. and Kirschner, M. 1989. Dominoes and Clocks: the union of two views of cell cycle regulation. Science, 246: 614-621. Nagrial, A., D. Chang, N. Nguyen, A. Johns, L. Chantrill, J. Humphris, and A. Biankin. 2014. Adjuvant Chemotherapy in elderly patients with pancreatic cancer. British Journal of Cancer. 110(2): 313-319. National Institutes of Health. 2007. http://toxnet.nlm.nih.gov/cpdb/chempages/5FLUOROURACIL.html. Date Accessed: 13 April 2016 National Institutes of Health. 2009. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=13168. Date Accessed: 13 April 2016 Ocana, A., Amir, E., Yeung, C., Seruga, B., and Tannock, I. 2011. How valid are claims for synergy in published clinical studies? Annals of Oncology. K. Beverley 33 Plunkett,W., Huang, P., and Gandhi, V. 1995. Preclinical characteristics of gemcitabine. Anticancer Drugs, 6: 7-13. Schwentner, L., A. Wockel, J. Konig, W. Janni, M. Blettner, R. Kreienberg, and R. Van Ewijk. 2014. Assessing the impact of CMF-like/Anthracycline-based/AnthracyclineTaxane-based/dose-dense chemotherapy in dependency of positive axillary lymph nodes/hormone receptor-status/grading/T-stage survival A retrospective multi-centre cohort study of 3677 patients receiving adjuvant chemotherapy. European Journal of Cancer. 50(17). 2905-2915. Seiwert, T., Sadama, J., and Vokes, E. 2007. The concurrent chemoradiation paradigmgeneral principles. National Clinical Practice Oncology, 4(2): 86-100. Waldman, T., Lengauer, C., Kinzler, K., and Vogelstein, B. 1996. Uncoupling of S phase and mitosis induced by anticancer agents in cells lacking p21. Nature, 381: 713-716. What is pancreatic cancer?.2016. American Cancer Society. http://www.cancer.org/cancer/pancreaticcancer Date Accessed: 12 April 2016. Wiseman, D. A. 2004. Mechanism of action of, and combination chemotherapy with isoprenoids perillyl alcohol, farnesol, and geraniol. Ph.D. thesis, Purdue University. K. Beverley 34 Yadav, V., Varshney, P., Sultana, S., Yadav, J., and Saini, N. 2015. Moxifloxacin and ciprofloxacin induces S-phase arrest and augments apoptotic effects of cisplatin in human pancreatic cancer cells via ERK activation. BMC Cancer, 15: 581-596.  ...

... Enhancement of Anti-Cancer Efficacy through Combination Chemotherapy of Ciprofloxacin with either 5-Fluorouracil or Gemcitabine By Katie M. Beverley An Honors Project submitted to the University of Indianapolis Strain Honors College in partial fulfillment of the requirements for a Baccalaureate degree with distinction. Written under the direction of Dr. Dean A. Wiseman. March 13, 2016 Approved by: __________________________________________________________________ Dr. Dean A. Wiseman, Faculty Advisor ______________________________________________________________ Dr. James B. Williams, Interim Executive Director, Strain Honors College ______________________________________________________________________ First Reader ______________________________________________________________________ Second Reader K. Beverley ii Abstract Pancreatic cancer is one of the most lethal cancers, with most patients dying within the first 5 years after diagnosis. Frequently it arises from cells in the pancreatic ducts (pancreatic ductal adenocarcinoma) and often fails to be diagnosed until it has already metastasized to other organs and tissues in the body, and thus is significantly harder to treat. For these reasons, alternative therapy options should be investigated. Previously, we observed in our hands that ciprofloxacin selectively kills pancreatic ductal adenocarcinoma cells but not non-malignant human cells. 5-fluorouracil (5-FU) is a commonly used chemotherapeutic agent for pancreatic cancer which inhibits DNA replication in the S-phase of the mitotic cell cycle. Another front-line chemotherapeutic is the nucleotide analog gemcitabine (dFdC) which functions in a similar manner to 5-FU. Given that all three of these drugs appear to have both anti-cancer activity and act in the same cell cycle phase, we hypothesized ciprofloxacin would augment the cytostatic and/or cytotoxic effect of either 5-FU or dFdC. To test this hypothesis, MIA PaCa-2 human ductal adenocarcinoma cells were cultured and treated singly with 5-FU, or dFdC, or Cipro, or in simultaneous combination (either 5-FU or dFdC with Cipro) for 24 hour periods of time. As a result, we found that Cipro could significantly (p 0.05) and in dose-dependent fashion enhance the activity of both 5-FU and dFdC. We conclude that Cipro is a valid candidate as an adjuvant to standard forms of chemotherapy which involve use of 5-FU and/or dFdC. Furthermore, we propose that additional studies be ii K. Beverley iii conducted to further assess the validity of such combinations for human patients in the future. iii K. Beverley iv Acknowledgments This project is dedicated to my parents for always supporting my pursuit of science and for their continued encouragement, guidance, and love. They have taught me what it means to pursue my goals even though at times it will not be easy. This project is also dedicated to my dear family friend Edith Mossner who lost her battle with Pancreatic Cancer on June 19, 2015. Her perseverance continues to inspire my work on this project and reminds me of why this work is so important. I would like to acknowledge many people who have supported my project. I so appreciated the contributions of other students who worked alongside me in the lab on this project, Colton Starcher, Brandy Ploetner, Amanda Khan, and Kennedy Nies. Special thanks go to Dr. Patrick Fueger at Indiana University School of Medicine for allowing use of his equipment. This research would not have been possible without funding from the Strain Honors College at the University of Indianapolis and the Department of Biology. Finally, I would like to thank my Project Advisor Dr. Dean Wiseman for his constant patience, support, and assistance on this project. I have been so blessed to work in his lab over the past two years. I truly appreciate him motivating me when I needed it and being there for me during tough moments. He has taught me that research is about more than just the numbers on a report but about becoming a more independent thinker and a better student of the world. iv K. Beverley v List of Data Figures Figure 1: Dose-dependent inhibition of PaCa-2 cell viability by ciprofloxacin 14 Figure 2: 5-Fluorouracil Inhibits Pancreatic Ductal Adenocarcinoma Cell Growth15 Figure 3: The anti-cancer effect of 5-FU is enhanced when combined with ciprofloxacin 16 Figure 4: The anti-cancer effect of dFdC is enhanced when combined with ciprofloxacin. 18 Figure 5: Normalized isobologram analysis of the enhancement of the anti-cancer effect of 5-FU by ciprofloxacin 20 Figure 6: Normalized isobologram analysis of the enhancement of dFdC anti-cancer effect by co-administration of Ciprofloxacin 21 v K. Beverley vi Table of Contents Cover Page i Abstract ii Acknowledgement iii List of Figures iv Statement of Purpose 1 Introduction 2 Method/Procedure 11 Results 14 Analysis/Conclusion 19 Reflection 23 References 25 vi K. Beverley 1 Statement of Purpose Pancreatic cancer is one of the most lethal cancers, and most current chemotherapeutic agents are capable of providing only a slight increase in the life expectancy and/or improving the patients quality of life during that time (Hildago, et al., 2015). Given our initial observation that ciprofloxacin (Cipro) preferentially kills cancer cells but not non-cancer cells, the purpose of this honors project was to test the effectiveness of a potential (and unexpected) chemotherapeutic agent, the antibiotic ciprofloxacin, independently and in combination with two commonly used chemotherapeutics, 5-fluorouracil (5-FU) and gemcitabine (dFdC). The experiments in this study assessed viability and/or death of pancreatic cancer cells when exposed to either single-agent Cipro, 5-FU, or dFdC with Cipro. Our goal was to ascertain if ciprofloxacin can enhance the known anti-cancer efficacy of 5-FU and/or gemcitabine in a standard in vitro model of human pancreatic cancer. K. Beverley 2 Introduction This introduction will provide a brief survey of the important concepts presented within this thesis. Such important concepts include a general background of the disease of cancer, some specific aspects of pancreatic cancer, mammalian cell cycle, the drugs ciprofloxacin, 5-fluorouracil, and gemcitabine, adjuvant chemotherapy, and some background information on the condition of pancreatitis. Herein, each concept is explained through a literature review and/or detailed mechanism. I. Cancer According to the American Cancer Society (2016), cancer begins when cells grow uncontrollably and push out the healthy cells from a certain area of the body. Cancer can develop in a variety of organs and tissues including the skin, breast, lung, blood, colon, and pancreas. At the time of diagnosis, cancer is typically categorized in one of four possible stages, indicating the severity and spread of the cancer cells within the tissues of the body. Stages 1 and 2 indicate that the cancer has not spread from the specific tissue it arises from (i.e. breast, lung, skin, or other tissue/organ of origin). When a cancer reaches stage 3 and 4 it has spread from tissue of origin, and has proceeded to invade other tissue, or even distant regions of the body (metastasis). Generally speaking, patient prognosis deteriorates as the stage number increases. K. Beverley 3 II. Pancreatic Cancer The American Cancer Society (2016) explains that the pancreas is an organ located behind the stomach in the abdomen, with exocrine secretory roles in digestion, as well as endocrine regulatory roles in the bloodstream. The exocrine role involves the production of digestive enzymes to facilitate breakdown of food and nutrients, as well as bicarbonate ion (HCO3-) which is critical in neutralizing stomach acid as digestive products enter the small intestine. In terms of endocrine function, specific endocrine cells release hormones, including insulin and glucagon for proper regulation of blood sugar, while other endocrine cells secrete hormones involved in the coordination of digestive activity in other organs, such as the liver, small and large intestines. Epidemiological data indicates that most cancers of the pancreas develop within the cells which line the exocrine ducts; accounting for more than 90% of pancreatic cancer diagnoses (Hidalgo et al., 2015). According to the Mayo Clinic (2016) the vast majority of pancreatic malignancies are silent (asymptomatic), and not usually diagnosed until they have invaded other tissues and organs of the body. Unfortunately, if the stage of disease is 3 (spread to other organs in the same body region) or 4 (metastasized to distant tissues), it is highly likely that surgery is no longer a viable treatment option. K. Beverley 4 Pancreatic cancer was cited as the cause of death in 330,000 patients globally in 2012, and among all major cancer types pancreatic adenocarcinoma has the lowest survival rate. Moreover, fewer than 25% of patients even survive their first year following diagnosis (Jiang et al., 2014). These statistics illustrate that pancreatic cancer is a truly severe condition and should be a focus for further research. III. Cell Cycle The cell cycle is the combination of two fundamental processes: replication of the genome and the formation of two new daughter cells (Murray and Kirschner, 1989; Waldman et al., 1996; Wiseman, 2004). There are three primary phases of the cell cycle: the G phases in which cells are relatively inactive, the S phase is when the cell is producing a copy of its genome, and the M phase is when the cell is split into two daughter cells (see Figure 1 below). The cells enter the G1 phase when they have received a trigger to divide but has not yet fully committed to cell division (Wiseman, 2004). K. Beverley 5 Figure 1. Mammalian Cell Cycle Research has suggested that ciprofloxacin acts during S-phase and inhibits the duplication of the chromosomes preventing the cancer cells from increasing in number (Yadav et al., 2015). IV. Ciprofloxacin Ciprofloxacin is an existing FDA-approved antibiotic which is most often used for severe bacterial infections, and is generally considered to be a safe and effective treatment for acute infectious colitis (bacterial infections of the colon), and many other infections, particularly in hard-to-reach areas of the body. It is a synthetic K. Beverley 6 4-quinoline derivative and is a broad-spectrum, widely used antibiotic. Based on its chemical structure, ciprofloxacin is classified as a fluoroquinolone, many of which have been used as chemotherapeutics (Yadav et al., 2015). Figure 2. Chemical structure of Ciprofloxacin However, this drug in non-cancer patients has been known to cause drug-induced pancreatitis (Sung et al., 2014). Ciprofloxacin can also suppress the human immune system by killing off the T-cells, which is also a common characteristic of other chemotherapeutic agents. (Kaminski et al., 2010). V. 5-Fluorouracil 5-Fluorouracil is a compound that inhibits DNA replication in the S-phase of the cell cycle. It works as an enzyme the blocks the production of thymine, a K. Beverley 7 nitrogenous base in the DNA molecule. Due to this inhibition the cancer cells are no longer able to divide rapidly. Figure 3. Chemical structure of 5-fluorouracil 5-Fluorouracil has been the most commonly used regimen for esophageal cancer over the past 15 years (Almhanna et al., 2015). 5-Fluorouracil has also been found to be effective in inducing cell death in MIA PaCa-2 cell lines especially when used in combination with traditional radiation treatments (Mohiuddin et al., 2002). VI. Gemcitabine Gemcitabine is another nucleoside analog that inhibits DNA replication and has been commonly used as a chemotherapeutic against pancreatic cancer (Heinemann et al., 1988). K. Beverley 8 Figure 4. Chemical structure of gemcitabine Once Gemcitabine enters the cells it is phosphorylated and then inhibits DNA replication, in an interesting mechanism described as masked chain termination. Gemcitabine inserts itself into the DNA sequence and then two more nucleotides are added to mask it and the drug becomes stuck in the DNA (Plunkett et al., 1995). Figure 5. Metabolism of gemcitabine in mammalian cells (Kamada et al., 2014) K. Beverley 9 One key study which demonstrated the clinical effectiveness of gemcitabine showed that 23.8% of patients experienced what was termed a clinical benefit of gemcitabine therapy, where patients lived for longer periods of time, with less discomfort and less pain than with other front-line drug therapies (Burris et al., 1997). Gemcitabine has limited toxicity and therefore is a focus of investigation in combination chemotherapy (Araneo et al., 2003; Wiseman, 2004). VII. Adjuvant Chemotherapy Adjuvant chemotherapy is the term used to describe a combination of multiple drugs for chemotherapy, where one drug is enhancing the effect of another, or allowing a particularly toxic drug to be used effectively at lower doses. Adjuvant therapy has been shown to be effective in gastrointestinal, pancreatic, and breast cancers (Schwentner et al., 2014). It was recently shown that moxafloxacin and ciprofloxacin, when combined, had a synergistic effect on MIA PaCa-2 cells, meaning the two-drug combination was much more potent than a one plus one dose-to-effect prediction. Specifically, this treatment led to mitochondrial apoptosis and arrest in the S-phase of the cell cycle (Yadav et al., 2015). Currently approved forms of adjuvant chemotherapy increase the life expectancy of pancreatic cancer patients in clinical settings. However, it is typically only used for younger patients with more advanced stage cancers (Nagrial et al., 2014). In vivo, combination K. Beverley 10 chemotherapy significantly reduced pancreatic adenocarcinoma tumor size in mouse models (Conger, 2015). Figure 6. Example of a normalized isobologram plot for drug combinations (Seiwert et al., 2007) One graphical method of assessing the effective quality of drug combinations is termed a normalized isobologram (shown above, Figure 6). By plotting the effect of dose combinations in this manner, we get a rapid visual representation of the relative effectiveness of a drug combination versus known effect with each drug individually (Chou et al., 2005). As a final note, combination chemotherapy has yielded extraordinarily beneficial outcomes in certain highly metastatic and previously extremely lethal forms of K. Beverley 11 cancer. In particular, triple-adjuvant chemotherapy was used in Lance Armstrongs treatment for metastatic testicular cancer. Over time, this triple-adjuvant regimen has reversed what was originally a disease with a 90% mortality into one which is now 90% curable (Washington Post, 2002). VIII. Pancreatitis Pancreatitis is either acute or chronic inflammation of the pancreas, and can be caused by a number of different factors. Causes of pancreatitis may include, infection coming up through the pancreatic duct from the intestine, or microorganisms traveling through the lymph nodes into the pancreas, be the result of physical occlusion of pancreatic ducts, or in some cases an adverse reaction to certain drugs or pharmaceuticals (Ignatavicius et al., 2012). According to the National Institutes of Health, pancreatitis leads to a hospitalization in 1,000 in every 50,000 people. Ciprofloxacin has been observed to induce a form of acute pancreatitis (Sung et al., 2014), and we consider this side effect to be perhaps a harbinger of its unusual anti-cancer effect on pancreatic ductal adenocarcinoma cells. K. Beverley 12 Methods/Procedure I. Cell Culture The human pancreatic ductal adenocarcinoma cell line MIA PaCa-2 (CRL1420) was purchased from the American Type Culture Collection (Manassas, VA). Cells were maintained in Dulbeccos modified Eagles medium (DMEM) supplemented with 10% fetal bovine serum, 100 U/mL penicillin, 100 g/mL streptomycin, and 2 mM L-glutamine (Invitrogen, Carlsbad, CA) at 37C in humidified air and 5% CO2. Cells used in experimentation were between passages 5 (post-American Type Culture Collection) and 20. Four days before the MTS assay MIA PaCa-2 cells were seeded in 96-well culture plates at a density of 1.0 x 105 cells per mL. K. Beverley 13 Figure 7. General workflow of cell viability assays II. Drug Treatments 24 hours before MTS assay, MIA PaCa-2 cells were treated with 5fluorouracil (5-FU), gemcitabine (dFdC), or ciprofloxacin (Cipro) as single agents, or in combinations of either 5-FU or dFdC with Cipro. For single-drug exposures drug concentrations of 5-FU dissolved in DMEM ranged from 0.625-100 M and drug combinations of dFdC dissolved in DMEM ranged from 0-50 M, while concentrations of Cipro ranged from 25-800 M. In combination regimes, 5-FU concentrations varied as before (0.625-100 M) with either 200 or 400 M Cipro. dFdC concentrations varied from 0-50 M with 400 M Cipro. K. Beverley 14 III. MTS Assay In this assay, we optically measure the creation of a dark-colored formazan product (which is opaque to 490 nm wavelength light) created by mitochondrial enzymes within viable cells. Formazan is a dye which is converted by NAD(P)H-dependent dehydrogenase enzymes, which function in mitochondrial metabolism (Cory et al., 1991). This mitochondrial enzymatic activity is directly proportional to the number of living cells present in a given culture of cells. According to the manufacturers protocol (BioVision, 2015), cells were incubated in MTS solution and phosphate buffered saline (PBS) for 1-4 hours then the absorbance is measured at 490 nm using the Molecular Devices SpectraMax M2 microplate reader with the Softmax Pro 6 software. IV. Data Analysis Each individual experiment was conducted with an independent sample number, n=16. Statistical analysis was conducted using Students t-Test comparing the average absorbance of formazan product (A490), along with standard error of the mean (standard deviation divided by the square root of the number of samples) was calculated. For statistical significance, we considered a value of p 0.05 between experimental groups to be significant. K. Beverley 15 V. Graphs and Isobolograms All graphs were generated using Prism software by Graphpad. Isobolograms were constructed using CompuSyn software by Ting-Chao Chou and collegues (Chou et al., 2005). K. Beverley 16 Results I. Ciprofloxacin-mediated inhibition of pancreatic cancer cells. This first experiment involved single-agent Cipro in order to establish the relevant range of anti-cancer activity in our PaCa-2 cells. Using the MTS assay to quantify mitochondrial activity, we found that Cipro significantly inhibits PaCa-2 cell growth in a dose-dependent manner over a 24 hour period with concentrations ranging from 50 to 800 M (Figure 8, below). The approximate IC50 was determined to be 400 M. Figure 8. Dose-dependent inhibition of PaCa-2 cell viability by ciprofloxacin. MIA PaCa-2 human pancreatic adenocarcinoma cells were incubated under standard conditions for 24 hrs with 0-800 M ciprofloxacin. Following incubation, MTS reagent was added to the media, and the cells were incubated for an addition 1-4 hr, and colorimetric analysis of the mitochondrial conversion of MTS was performed. Graph represents the average A492 absorbance of samples (n=16), and error bars represent the standard error of the mean (SEM). * p 0.05 vs. untreated cells. K. Beverley 17 II. Anti-cancer effect of single-agent 5-FU. 5-Fluorouracil (5-FU) is classified as a fluoroquinoline antibiotic. It has been shown to inhibit DNA replication during the S-phase of the cell cycle, and several other less well-characterized mechanisms. In our hands, we found 5FU causes a significant dose dependent decrease in PaCa-2 cell viability after 24 hours in the range of 1.25-100 M (Figure 9, below). Figure 9: 5-Fluorouracil Inhibits Pancreatic Ductal Adenocarcinoma Cell Growth MIA PaCa-2 cell viability is presented as a function of 5-FU concentration over a 24 hour period. Data represent the mean SEM. * p 0.05 vs. untreated cells. K. Beverley 18 III. Simultaenous administration of ciprofloxacin and 5-FU have a superadditive anti-cancer effect on PaCa-2 cells. Given that both agents demonstrate reasonable effectiveness on our PaCa-2 cells, and that both agents appear to work primarily during the same phase of the cell cycle, we hypothesized that both agents would function with increased efficacy in a tandem combination. Using isobologram analysis (Figure 12) We found that, when used together, 5-FU and Cipro have a greater dosedependent effect than either 5-FU or Cipro alone as quantified by the MTS assay after 24 hours. K. Beverley 19 Figure 10: The anti-cancer effect of 5-FU is enhanced when combined with ciprofloxacin. MIA PaCa-2 cell viability is decreased when both drugs are used together and the combinatorial anti-cancer effect is dose-dependent at all but the very highest doses of 5-FU. Data represent the mean (n=16) SEM. * p 0.05 vs untreated cells; p 0.05 vs single-agent 5-FU; p vs. 5-FU+200 M combination. IV. Simultaenous administration of ciprofloxacin and gemcitabine (dFdC) also has a superadditive anti-cancer effect on PaCa-2 cells. Given that we found enhanced anti-cancer effect with a known DNA synthesis inhibitor in 5-FU, we elected to see if there is any additional benefit in using another known DNA synthesis antagonist. We found that this combination K. Beverley 20 was superior to single-agent dFdC administration in our cells. Using isobologram analysis (Figures 12 and 13) We found that, when used together, 5-FU and Cipro have a greater dose dependent effect than either 5-FU or Cipro alone as quantified by the MTS assay after 24 hours. Figure 11: The anti-cancer effect of dFdC is enhanced when combined with ciprofloxacin. MIA PaCa-2 cell viability is decreased when both drugs are used together and the combinatorial anti-cancer effect is dose-dependent at all but the very highest doses of 5-FU. Data represent the mean (n=9) SEM. * p p 0.05 vs single-agent dFdC. K. Beverley 21 Analysis/Conclusion I. Single Chemotherapeutic Agent Effectiveness It was important that we first treat pancreatic ductal adenocarcinoma cells with each agent independently in order to confirm that they actually decrease viability of cancer cells as well as establish a baseline reference for anti-cancer activity in our cellular model system. We found that Cipro effectively reduced pancreatic cancer cell viability in our 24-hour experiments, as evidenced by MTS colorimetric assay. Our data indicate that cell viability and mitochondrial metabolism are decreased in response to Cipro in a significant and concentration-dependent manner (Figure 8). In retrospect, while it was a surprising finding to us at the time, it turns out that Cipro has been recently shown to have therapeutic promise in treating models of human colorectal cancer. Importantly, a recent study demonstrated anti-cancer effects of combinations of fluoroquinolone drugs including ciprofloxacinin human pancreatic adenocarcinoma cell lines (Yadav, et al., 2015), strongly indicating that the drug does have a specific effect on cells of the pancreas. The chemotherapeutic agents 5-fluorouracil (5-FU) and gemcitabine (dFdC) also demonstrated effective suppression of viability in our 24 hour experiments (Figures 9 and 11). The colorimetric reaction in the MTS assay suggests that the mitochondrial metabolism is significantly decreased by increased doses of 5-FU and dFdC. K. Beverley 22 II. Effectiveness of Combination Therapy on Cancer Cell Viability Given that Cipro, 5-FU, and dFdC all appear to act primarily during DNA replication in the S-phase of the cell cycle (Yadav et al. 2015) with resultant reduction in cell viability, our MTS viability data supports our hypothesis that Cipro would enhance the anti-cancer effect of 5-fluorouracil. This suggests that the two drugs would be most effective in a simultaneous combination, though this is merely speculative, as we did not assess an alternative modality of sequential drug administration, which would be an important follow-up experiment to this work. Figure 12: Normalized isobologram demonstrates the enhancement of the anti-cancer effect of 5-FU by ciprofloxacin (400 M). Single-agent and combination dose vs. effect relationships were graphically analyzed as described previously. This graph represents of 5-FU (0-100 M) with a constant dose (400 M) Cipro for 24 hrs. Drug combinations are plotted versus what the predicted effect would be if a perfect additive relationship was present (i.e. EC50 Drug A + EC50 Drug B = EC100 Drug A or B). All combinations tested yielded improved effect over single-agent experimental effect. K. Beverley 23 Our data corroborates the work of others who have established a preliminary mechanism of action for Cipro, as well as effectiveness of Cipro and 5-FU drug combinations in the MIA PaCa-2 cell line and other malignant pancreatic cell lines in vitro (Yadav et al., 2015). In our hands, increased Cipro (from 200 M to 400 M) further decreased cancer cell viability, indicating a dose-dependent combinatorial effect (Figure 10), which another standard of evaluation of drug combinations. In summary, the drugs were enhancing each other in a synergistic fashion, rather than acting independently of one another or acting as antagonists to one another. K. Beverley 24 Figure 13: Normalized isobologram demonstrates the enhancement of the anti-cancer effect of dFdC by ciprofloxacin (400 M). Single-agent and combination dose vs. effect relationships were graphically analyzed as described previously. This graph represents of dFdC (0-50 M) with a constant dose (400 M) Cipro for 24 hrs. Drug combinations are plotted versus what the predicted effect would be if a perfect additive relationship was present (i.e. EC50 Drug A + EC50 Drug B = EC100 Drug A or B). All combinations tested yielded improved effect over single-agent experimental effect. We also tested the combination of Cipro with dFdC, another nucleotide analog which is more potent than 5-FU, and surpassing 5-FU as the frontline drug of choice. Like 5-FU, the combination was more effective in diminishing cell viability than the individual chemotherapeutic agents. Normalized isobolgram analysis further suggests that these drugs act in a synergistic manner (Figure 13), and indicates a strong opportunity for future combinatorial study in advanced models of the disease. K. Beverley 25 III. Conclusions We find that either 5-FU or dFdC administered in combination with Cipro leads to a significantly greater dose-dependent response in our pancreatic ductal adenocarcinoma cells. Both 5-FU and dFdC appear to act in a synergistic manner with Cipro, and we hypothesize that this is due to their primary mechanism of action occurring during the same phase of the cell cycle, though this also has yet to be fully examined. This research provides strong evidence for a novel treatment therapy for pancreatic cancer using currently approved FDA drugs and further investigation is strongly merited. K. Beverley 26 Reflection First of all, we determined ciprofloxacin (Cipro) and 5-fluorouracil (5-FU) do act synergistically in terms of their effect in comparison to each of the drugs independently (as illustrated in Figures 8 and 9). Hye et al. (2014) suggested that ciprofloxacin has been critical in the treatment of gastrointestinal cancers. Further, Almhanna et al. (2015) suggest that 5-FU and radiation work well in inhibiting cancers of the esophagus. Since, the pancreas functions within the digestive system it correlates that these drugs would be effective in treating cancers of the pancreatic duct. Congers (2015) work argues that use of drug combinations such as Cipro and 5FU could be the key to treating pancreatic cancer. We corroborated previous data in Yadav et al. (2015) in Figure 12 where both drugs together were had a greater anticancer effect than either drug independently. Our data, as a whole, we conclude supports the contention that these compounds could be used in drug combination strategies. Through the completion of this project, I was able to use the scientific method to investigate why it is that ciprofloxacin kills cancer cells but does not kill healthy cells. I was also able to corroborate the published work of Yadav, et al. (2015) and was able to better understand the physiological function of both 5-fluorouracil (5-FU), gemcitabine (dFdC), ciprofloxacin (Cipro) as inhibitors of DNA replication. As a result of this K. Beverley 27 inhibition, the pancreatic ductal adenocarcinoma cells have decreased viability as shown by the MTS assay for mitochondrial function. While the viability is decreased we are as of yet unsure of the specific mechanism of cell cycle inhibition. Further studies should be conducted to explain the mechanism of action of Cipro and 5-FU in combination and how it impacts mitochondrial metabolism as illustrated in the MTS assay. Another study could be conducted to better understand the most optimal concentrations within the combination. In addition to the knowledge that I gained in the field of cancer pharmacology, I was able to apply the skills I have gained in aseptic tissue culture and other basic laboratory techniques that I will be able to use in my future research endeavors. I feel that the opportunities that I had to mentor other students was an important part of this honors project. Ultimately, sharing skills with a laboratory colleague helps them develop their skillset and also allows the mentor to gain a better understanding and mastery of the skill by teaching it. K. Beverley 28 References Almhanna, K., S.Hoffe, J. Strosberg, W. Dinwoodie, K. Meredith, and R. Shridhar. 2015. Concurrent chemoradiotherapy with protracted infusion of 5-fluorouracil (5-FU) and cisplatin for locally advanced resectable esophageal cancer. J Gastrointest Oncol. 6: 3944. Araneo, M., Bruckner, H., Grossbard, M., Frager, D., Homel, P., Marino, J., DeGregorio, P., Mortazabi, F., Firoozi, K., Jindal, K., and Kozuch, P. 2003. Biweekly low-dose sequential gemcitabine, 5-fluorouracil, leucovorin, and cisplatin (GFP): a highly active novel therapy for metastatic adenocarcinoma of the exocrine pancreas. Cancer Invest, 21: 489-496. BioVision. 2015. MTS cell proliferation assay kit protocol. http://www.biovision.com/mts-cell-proliferation-colorimetric-assay-kit-8078.html. Date Accessed: 12 April 2016 Burris, H., Moore, M., Andersen, J., Green, M., Rothenberg, M., Modiano, M., Cripps, M., Portenoy, R., Storniolo, A., Tarassoff, P., Nelson, R., Dorr, F., Stephens, C., and Von Hoff, D. 1997. Improvements in survival and clinical benefit with gemcitabine as first- K. Beverley 29 line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol, 15: 2403-2413. Cancer research: Its worth the ride. The Washington Post. October 3, 2002. Chou, T. and Martin, N. 2005. Compusyn for drug combinations: PC software and users guide: a computer program for quantitation of synergism and antagonism in drug combinations, and the determination of IC50 and ED50 and LD50 values. Combosyn Inc. http://www.combosyn.com/ Date Accessed: 12 April 2016 Chou, T. 2010. Drug combination studies and their quantification using the Chou-Talalay method. Cancer Res.70(2): 440-446. Conger, K. 2015. Combination therapy could fight pancreatic cancer, say Stanford researchers. Stanford Scope Blog. http://scopeblog.stanford.edu/2015/09/21/combinationtherapy-could-fight-pancreatic-cancer-say-stanford-researchers/ Date Accessed: 12 April 2016 K. Beverley 30 Cory, A., Owen, T., Barltrop, J., and Cory, J. 1991. Use of an aqueous soluble tetrazolium/formazan assay for cell growth assays in culture. Cancer Commun. 3(7): 2017-212. Heinemann, V., Hertel, L., Grindey, G., and Plunkett, W. 1998. Comparison of the cellular pharmakinetics and toxicity of 2,2-difluorodeoxycytidine and 1-beta-Darabinofuranosylcytosine. Cancer Res, 48: 4024-4031. Hidalgo, M., S. Cascinu, J. Kleeff, R. Labianca, J. Lohr, J. Neoptolemos, F. Real, J. Van Laethem, V. Heinemann. 2015. Addressing the challenges of pancreatic cancer: Future directions for improving outcomes. Pancreatology. 15: 8-18. Hye, Y.S., J.I. Kim, H.J. Lee, H.J. Cho, D.Y. Cheung, S.S. Kim, S.H. Cho, and J.K. Kim. 2014. Acute Pancreatitis Secondary to Ciprofloxacin Therapy in Patients with Infectious Colitis. Gut Liver.8: 265-270. Ignatavicius, P., A.Vitkauskiene, J. Pundzius, Z. Dambrauskas, and G. Barauskas.2012. Effects of prophylactic antibiotics in acute pancreatitis. HPB (Oxford). 14: 396-402. K. Beverley 31 Jiang, J., C. Yu, M. Chen, H. Zhang, S, Tian, and C. Sun. 2014. Reduction of miR-29c enhances pancreatic cancer cell migration and stem cell-like phenotype. Oncotarget, Advance Publications. 6(5): 1-12. Kamada, M., Akiyoshi, K., Akiyama, N., Funamizu, N., Watanabe, M., Fujioka, K., Ikeda, K., and Manome, Y. 2014. Cholangiocarcinoma cell line TK may be useful for the pharmakinetic study of the chemotherapeutic gemcitabine. Oncology Reports. 32(2): 829834. Kaminski, M., S. Sauer, C. Klemke, D. Suss, J. Okun, P. Krammer, and K. Gulow. 2010. Mitochondrial reactive oxygen species control T cell activation by regulatibg IL-2 and IL-4 expression mechanism of ciprofloxacin-mediated immunosuppression. Journal of Immunology. 184(9): 4827-4841. Lents, N. and Hesterman, D. 2016. Cell division I: The cell cycle. 3(5). http://www.visionlearning.com/en/library/Biology/2/Cell-Division-I/196 Date Accessed: 13 April 2016 Mayo Clinic. 2016. Sandhya Pruthi (Editor). http://www.mayoclinic.org/diseasesconditions/pancreatic-cancer/basics/definition/CON-20028153. Date Accessed: 13 April 2016 K. Beverley 32 Mouhiuddin, M., Chendil, D., Dey, S., Alcock, R.A., Regine, W., Mouhiuddin, M., and Ahmed, M.M. 2002. Influence of p53 status on radiation and 5-Fluorouracil synergy in pancreatic cancer cells. Anticancer Research. 22: 825-830. Murray, A. and Kirschner, M. 1989. Dominoes and Clocks: the union of two views of cell cycle regulation. Science, 246: 614-621. Nagrial, A., D. Chang, N. Nguyen, A. Johns, L. Chantrill, J. Humphris, and A. Biankin. 2014. Adjuvant Chemotherapy in elderly patients with pancreatic cancer. British Journal of Cancer. 110(2): 313-319. National Institutes of Health. 2007. http://toxnet.nlm.nih.gov/cpdb/chempages/5FLUOROURACIL.html. Date Accessed: 13 April 2016 National Institutes of Health. 2009. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=13168. Date Accessed: 13 April 2016 Ocana, A., Amir, E., Yeung, C., Seruga, B., and Tannock, I. 2011. How valid are claims for synergy in published clinical studies? Annals of Oncology. K. Beverley 33 Plunkett,W., Huang, P., and Gandhi, V. 1995. Preclinical characteristics of gemcitabine. Anticancer Drugs, 6: 7-13. Schwentner, L., A. Wockel, J. Konig, W. Janni, M. Blettner, R. Kreienberg, and R. Van Ewijk. 2014. Assessing the impact of CMF-like/Anthracycline-based/AnthracyclineTaxane-based/dose-dense chemotherapy in dependency of positive axillary lymph nodes/hormone receptor-status/grading/T-stage survival A retrospective multi-centre cohort study of 3677 patients receiving adjuvant chemotherapy. European Journal of Cancer. 50(17). 2905-2915. Seiwert, T., Sadama, J., and Vokes, E. 2007. The concurrent chemoradiation paradigmgeneral principles. National Clinical Practice Oncology, 4(2): 86-100. Waldman, T., Lengauer, C., Kinzler, K., and Vogelstein, B. 1996. Uncoupling of S phase and mitosis induced by anticancer agents in cells lacking p21. Nature, 381: 713-716. What is pancreatic cancer?.2016. American Cancer Society. http://www.cancer.org/cancer/pancreaticcancer Date Accessed: 12 April 2016. Wiseman, D. A. 2004. Mechanism of action of, and combination chemotherapy with isoprenoids perillyl alcohol, farnesol, and geraniol. Ph.D. thesis, Purdue University. K. Beverley 34 Yadav, V., Varshney, P., Sultana, S., Yadav, J., and Saini, N. 2015. Moxifloxacin and ciprofloxacin induces S-phase arrest and augments apoptotic effects of cisplatin in human pancreatic cancer cells via ERK activation. BMC Cancer, 15: 581-596.  ...

... Emphasizing Functional Outcomes of Environmental Modifications Fiona Jones, OTS May, 2018 A capstone project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the faculty capstone advisor: Taylor McGann, OTR, MS, OTD A Capstone Project Entitled Emphasizing Functional Outcomes of Environmental Modifications Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Fiona Jones Occupational Therapy Student Approved by: Faculty Capstone Advisor Date Doctoral Capstone Coordinator Date Accepted on this date by the Chair of the School of Occupational Therapy: Chair, School of Occupational Therapy Date Running Head: FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS Emphasizing Functional Outcomes of Environmental Modifications Fiona Jones, OTS University of Indianapolis 2018 1 FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 2 Abstract The purpose of an occupational therapy student being placed within the home modification and assistive technology departments was to address the need regarding follow-up about the effectiveness of services and how products impact clients function. Outcome questionnaires were created to fill this gap in services. Separate questionnaires were created for each department due to their distinct needs. Questionnaires were based on research, previous outcome measures, and needs identified by Easterseals Crossroads. Data from the home modification outcome questionnaire is collected in person at assessment and inspection as well as over the phone at three, six, and twelve months after discharge. Data from the assistive technology outcome questionnaire is collected over the phone at three, six, and twelve months after discharge. Both questionnaires aim to provide information about staff development, use and effectiveness of products, as well as client safety and independence. Leadership skills to work within a multidisciplinary team and ability to advocate for and educate about occupational therapy were imperative while creating the outcome questionnaires for Easterseals Crossroads. Keywords: Outcome questionnaire, home modifications, assistive technology, occupational therapy FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 3 Emphasizing Functional Outcomes of Environmental Modifications Approximately 90% of older Americans intend to continue living in their current home for at least the next five to ten years due to several factors including: comfort within their own home, being close to family and friends, and a desire to age in place (American Association of Retired Persons [AARP], 2012). Despite the desire to age in place, many older adults live in homes that lack accessibility. Reports from the 2011 American Housing Survey showed that only 1% of United States housing units have all five universal design features including: no-step entry, single-floor living, extra wide doorways and hallways, accessible electrical controls and switches, and lever-style door and faucet handles (Joint Center for Housing Studies of Harvard University, 2014). Although the homes lack these features, costs of home renovation are typically lower than costs of extended stays in assisted living or skilled nursing facilities therefore, it is more cost effective to make changes to the home (Joint Center for Housing Studies of Harvard University, 2014). Literature Review Approximately 60% of the homes in the United States were built before 1979, and many present safety barriers and lack features that are helpful for aging in place, such as walk in showers, visual and verbal reminder systems, safety alarms, ramps, grab bars, and chair lifts (Lee, n.d.). As many adults age, their physical and cognitive function declines which affects their ability to complete daily functional tasks and presents barriers to aging in place (Stark, Landsbaum, Palmer, Somerville, & Morris, 2009). As individuals function declines, the environment becomes more difficult to navigate creating additional barriers. These individuals also have a lower level of self-rated health, higher degree of depression, and increased social isolation due to their inability to perform daily tasks (Petersson, Liljia, Hammel, & Kottorp, FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 4 2008). The goal of environmental modifications is to improve the fit between the person and their environment with the focus on maximizing safety, independence, and participation in daily activities (Fagan & Sabata, 2011). By increasing participation in client-centered occupations, individuals can improve their overall sense of well-being, quality of life, and health (American Occupational Therapy Association [AOTA], 2014; Law, 2002; Schwier, 2015). A modification is simply revising the environment or activity demand to support increased occupational performance (AOTA, 2014). Environmental modifications and interventions are all used with the goal of improving an individuals daily life and occupational performance (Petersson et al., 2008). Thinking of environmental modifications in terms of architectural modifications (home modifications) as well as adaptive equipment (assistive technology) increases the range of options from which an individual can choose (Petersson et al., 2008; Stark et al., 2009). There is extensive research to support the use of environmental modifications to decrease: dependency, risk of falls, self-rated difficulty of tasks, and the need for caregivers, as well as increase self-rated safety and caregiver self-efficacy (Petersson, Kottorp, Bergstrom, & Liljia, 2009; Petersson et al., 2008; Sanford, Pynnoos, Tejral, & Browne, 2002; Somerville et al., 2016; Stark et al., 2009; Stark et al., 2018). Environmental modifications not only increase an adults ability to age in place and continue functioning at a safe level within their own homes, but also lowers health care costs (Stark et al., 2009). Providing individuals with more than one option for removing barriers can increase the overall compliance and acceptance with the final modifications, because it allows the individual to exert control over their environmental changes (Stark et al., 2009). A client-centered approach places emphasis on the clients knowledge, experiences, strengths, and ability to choose, which in turn allows for overall autonomy (AOTA, FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 5 2014; Stark et al., 2009). This increases adherence to recommendations and changes, leading to an increase in functional outcomes (AOTA, 2014; Stark et al., 2009). Despite the research that supports the benefits of environmental modifications, the process for obtaining these modifications is difficult (Stark et al., 2018). Centers for Medicare and Medicaid fund occupational therapy home assessments and interventions, but they do not fund the actual physical environmental modifications (Stark et al., 2018). In Indiana, the most common ways to obtain home modifications or assistive technology modifications is through the Medicaid waiver or Vocational Rehabilitation systems (B. Norton & J. Kelly, personal communication, January 18, 2018). When using either of the two funding systems, a home modification specialist or an assistive technology specialist is referred to complete an initial assessment and make recommendations, from which the individual can choose. The recommendations are then sent to a case manager and once the devices or changes are made the state, if the wavier system is used, or vocational rehabilitation will pay for devices and/or modifications (B. Norton & J. Kelly, personal communication, January 18, 2018). The process to get in the wavier or vocational rehabilitation system can be extensive, but the services provided are efficient and effective for individuals (B. Norton & J. Kelly, personal communication, January 18, 2018). Another gap in terms of environmental modifications, especially in the United States, is the use of functional outcome measures for environmental modifications. Swedish researchers have developed a few studies addressing an individuals function after modifications and have shown that safety in the home and self-rated ability in everyday life increased and difficulty of tasks decreased (Petersson et al., 2008; Petersson et al., 2009). Although research in the United States shows the positive effect of environmental modifications, much of the current FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 6 documentation is based on structural changes to the home, which the state requires as feedback to prove their money was used as intended (J. Kelly, personal communication, January 18, 2018; Weeks, Lamb, & Pickens, 2010). For example, instead of focusing on how the person is moving on and off the toilet, the outcomes that are focused on during assessment and inspection per funding guideline are: replacing 14 toilet with 17 toilet and replacing 24 door with a 32 door (J. Kelly, personal communication, January 18, 2018). This doctoral capstone experience aimed to provide Easterseals Crossroads with observation-based and evidenced-based outcome questionnaires for the assistive technology and home modification departments. The focus of the outcome questionnaire is on client function, safety, and difficulty of tasks with regards to home modification and assistive technology services. Screening and Evaluation Prior to starting at Easterseals Crossroads I met with my site mentors, including the Vice President of Technology and Information Services and the Director of Assistive Technology, to discuss ideas to fill the sites current needs. Various ideas regarding the assessment process and department collaboration were discussed. During my first two weeks at Easterseals Crossroads I met with the clinical assistive technology team, home modification team, driving rehabilitation team, employment consultant team, and some aspects of the therapy team to help streamline an idea to address an identified need. After discussion, we discovered there was a gap in assistive technology and home modifications regarding follow-up about how products and services impact clients function. Easterseals Crossroads does not currently have a full-time occupational therapist on staff within the home modification or assistive technology departments (B. Norton & W. Wingler, personal communication, December 5, 2017). As an organization, they do not place a lot of FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 7 emphasis on research, but instead place greater emphasis on community outreach, grant funding, and providing individuals with programming to suit their needs (B. Norton & W. Wingler, personal communication, December 5, 2017). As a doctor of occupational therapy student with practice in providing research-based programs, interventions, and resources focused on functional performance, Easterseals Crossroads took the opportunity to partner with me. It is common for occupational therapists to go into homes and make recommendations about modifications, but the purpose of this capstone experience was for an occupational therapy student to serve as a consultant in conjunction with home modification and assistive technology specialists (Fagan & Sabata, 2011). For this project, the client was Easterseals Crossroads as an organization. Practice with whole organizations is important, because they are the mechanism through which individual clients are served (AOTA, 2014). The focus of this project was less on the individual clients and more on how Easterseals Crossroads can improve their performance in the areas of home modifications and assistive technology. To adequately implement outcome questionnaires, it was important to gain a broad understanding of how the organization performs in both the home modification and assistive technology departments. The outcome questionnaires created during this project will assist in providing a beneficial product for those served by Easterseals Crossroads. The feedback from the outcome questionnaires will provide the departments with knowledge about areas of improvement, areas of strength, and areas of possible growth (J. Kelly, personal communication, January 18, 2018). Project Origin Fnge and Iwarsson conducted a study in 1999 with a goal to construct and develop a self-administered assessment that studied clients own perceptions of accessibility and usability of their housing environment. The results of the study created a tool that was valid, reliable, and FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 8 included concepts of: accessibility, suitability, occupational performance, safety, privacy, flexibility, and social contacts (Fnge & Iwarsson, 1999). This study sparked staff at Easterseals Crossroads interest and brought awareness to the lack of function in Indianas current assessment and inspection process (J. Kelly, personal communication, January 18, 2018). Due to the focus on state and vocational rehabilitation funding, function, which is a focus of occupational therapy, cannot be emphasized during an assessment, because evaluation of functional performance is beyond the scope of a home modification specialist (J. Kelly, personal communication, January 18, 2018). The departments however, did not want this barrier to prevent them from gaining information about function. My site mentors and I decided I would work to create an assessment which measures a clients change in function. To stay within funding guidelines and a home modification specialists scope of practice, the outcome questionnaire needed to be self-administered, similar to the 1999 study by Fnge and Iwarsson (J. Kelly, personal communication, January 18, 2018). Although Fnge and Iwarssons (1999) study focused on constructional modifications to homes, assistive technology modifications can be included due to the goal of both modifications emphasizing increasing function, decreasing task difficulty, and increasing safety for the individual in their surrounding environment (Goodrich & Garza, 2015; Petersson et al., 2008; Stark et al., 2009). Like home modification specialists, assistive technology specialists are not authorized to follow up on function, but rather make recommendations and train individuals how to utilize the technology (B. Norton, personal communication, January 18, 2018). The outcome questionnaires created during this doctoral capstone project were made to collect information on client function as well as be utilized by specialists who do not have training in functional assessment. The outcome questionnaires were based on prior research regarding reliable outcome FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 9 tools and observation of current assessments completed by the home modification and assistive technology specialists. They aim to measure effectiveness of the Easterseals Crossroads home modification and assistive technology services (see Appendix A for the home modification questionnaire and Appendix B for the assistive technology questionnaire). Theoretical Basis An occupational therapy consultant was a beneficial resource for the home modification and assistive technology departments. Occupational therapists educational background revolves around finding occupations that fit an individuals interests and assisting individuals in making accommodations to reach maximal occupational performance (AOTA, 2014, p. S1). This aligns with assisting individuals to discover helpful home modifications and assistive technology. Due to the education in both areas, an occupational therapy consultant served as a good point of connection and communication for the home modification and assistive technology departments as they worked towards providing outcome questionnaires to show the effects of their products (AOTA, 2014). Collaborative consultation was best for this project as it allows all involved to play a role in the outcomes, uses a problem-solving method, and requires an equal relationship among all involved (Phillips, n.d.). As an occupational therapy consultant, a systems theory was beneficial for an overarching theme, because it focuses on the relationships between items to create a whole. An open system, specifically, means that there is a constant inter-change of information, energies, and materials within ones environment (Cole & Tufano, 2008, p. 40). Throughout this doctoral capstone experience at Easterseals Crossroads it was important to obtain information from both departments in order to increase overall knowledge. This assisted in making beneficial changes that helped the departments and the whole organization. It was important to be sure to keep the FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 10 focus equal between home modifications and assistive technology and have the mindset that no one part is greater than the sum of the team, which circles back to the concept of using a systems theory (Cole & Tufano, 2008). The Person-Environment-Occupation Model (PEO) was an appropriate theory when creating the outcome questionnaires to measure function for the home modification and assistive technology departments. The PEO model places equal importance on its three components: the environment, the person, and the occupation (Law et al., 1996). The focus of PEO is how well the three components overlap to promote optimal occupational performance (Law et al., 1996). When working with the home modification and assistive technology specialists to create the functional outcome questionnaires, the PEO is an ideal fit. As Fagan and Sabata (2011) mentioned, the goal of environmental modifications is to improve the fit between the person and their environment with a focus on maximizing safety, independence, and participation in daily activities. Although not intentional, the current assessment processes utilized by the home modification and assistive technology specialists follows the PEO model. Most of the time the overlap of these three components is minimal, which is why individuals are referred for a home modification or assistive technology assessment. The PEO model is suitable, not only because the components are already built into the process, but because it can be viewed overtime (Law et al., 1996). The goal of both the home modification and assistive technology departments is to increase the overlap of the person, occupation, and environment to increase occupational performance. Although the departments are looking at each of these three aspects, the focus on occupational performance is lacking. They are often unable to measure or obtain information about how changes to environment, occupation, or person have impacted the occupational FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 11 performance of individuals, which is where the goal of this doctoral capstone project comes into focus. Staff Roles Home modification specialists are specifically known as Certified-Aging-in-Place specialists (CAPS) and they are often remodelers or designers who do not practice as medical or health professionals (Age in Place, n.d.; AARP Livable Communities, 2015). Easterseals Crossroads has the great fortune to have a home modification specialist who has a background as a physical therapy assistant (PTA). This gives him the knowledge and ability to assess function with greater understanding (Easterseals Crossroads, n.d.b). However, this does not mean he can assess function under the title of CAPS, because funding sources do not allow CAPS to bill for a functional assessment (J. Kelly, personal communication, January 18, 2018). Similarly, assistive technology specialists do not focus on function during their assessment. Their focus is on ensuring clients can use the assistive technology appropriately and that it assists with their deficits (Easterseals Crossroads, n.d.a). The main role of a CAPS is to make/draw up recommendations based on assessment, then follow up with an inspection when the job is complete (J. Kelly, personal communication, January 18, 2018). The focus of an inspection is to prove to the funding source that the job was completed within the standards that are required for reimbursement (J. Kelly, personal communication, January 18, 2018). Due to the strict guidelines from the state that focus more on objective documentation, as mentioned above, the assessments and inspections lack a portion of subjective questions focused on understanding the feelings or attitudes of individuals regarding their level of function before and after the modifications. (J. Kelly, personal communication, January 18, 2018). FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 12 The role of an assistive technology specialist is to work with clients and vocational rehabilitation counselors to assist in reducing barriers and increasing clients function either in school, at a job, or during the job search. Assistive technology specialists perform evaluations to better understand clients needs, make recommendation and train clients to use the technology to assist in work, school, or the job search. Evaluations and trainings often lack a holistic view due to the funding source of vocational rehabilitation streamlining the clients goal to work related tasks (B. Norton, personal communication, March 15, 2018). Specialists are not given the opportunity to discover clients interest, values, and desires, but rather focus solely on ability to utilize technology effectively and efficiently for work tasks. Currently there is no follow up with clients if vocational goals change or technology no longer fits their needs (B. Norton, personal communication, January 18, 2018). The CAPS and assistive technology specialists do not currently have an effective way of documenting function, positive or negative, of the environmental recommendations modifications being recommended to individuals (B. Norton & J. Kelly, personal communication, January 18, 2018). Along with the gap in focus on function, funding sources only allow CAPS and assistive technology specialists to focus on short-term changes. Assistive technology specialists and CAPS are billed based on a flat fee to assess environmental modifications (AARP Livable Communities, 2015). CAPS are only required to lay eyes on the client at the initial meeting, and they are not required or trained to observe clients functional performance during any meeting (J. Kelly, personal communication, January 18, 2018). Assistive technology specialists are often only authorized for a few training and evaluation hours (A. Leung, personal communication, January 31, 2018). After the client has been trained and given time to use the product, funding sources do not authorize staff to go back and assess function. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 13 The assumption is once the client learns how to use the product, it will increase function (A. Leung, personal communication, January 31, 2018). Consequently, CAPS and assistive technology specialists are not provided with the tools, time, or knowledge to assess function. Conversely, occupational therapists emphasize function because their training focuses on how to identify an individuals function within the environment and how this impacts occupational performance (AARP Livable Communities, 2015; AOTA, 2014; Law et al., 1996). Also, occupational therapists are trained to view an individuals functional performance over time to gain an accurate picture of independence level. The occupational therapy process includes: evaluation and analysis of occupational performance, intervention planning, intervention implementation, intervention review, measurements of outcome, and comparing outcomes to goals (AOTA, 2014). This is not a linear process, but a circular process that is continually refined over time as a clients status changes (AOTA, 2014). Observing clients overtime is important for the home modification and assistive technology departments as well, because they commonly work with older adults or individuals with disabilities (B. Norton & J. Kelly, personal communication, January 18, 2018). As individuals age and disabilities progress, function changes, occupations change, and the environment often begins to present barriers. Many individuals who receive home modifications and assistive technology have progressive conditions, such as Parkinsons disease, vision loss, and multiple sclerosis, which is why it is important to look at function short and long term (J. Kelly, personal communication, January 18, 2018). Wilson, Mitchell, Kemp, Adkins, and Mann (2009) investigated the impact assistive technology and home modifications had on function in aging adults with disabilities by collecting data one and two years after environmental modifications were installed. Although the individuals still showed natural functional decline, the decline was slowed when FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 14 environmental modifications were used appropriately (Wilson et al., 2009). This was measured with a self-reported functional outcome tool that was filled out over the phone (Wilson et al., 2009). These results show the short-term and long-term benefits environmental modifications can have on an individual regardless of natural decline. Despite the funding and knowledge barrier for CAPS and assistive technology specialists, gaining information about how individuals are engaging and functioning within their new environment after environmental modifications is important. Providing individuals with a selfrated outcome questionnaire does not require increased knowledge, training, or assessment time for CAPS or assistive technology specialists. The outcome questionnaires will provide the departments with data about what is working well, what isnt working well, and how individuals are functioning within their environments regarding topics such as: dependency, risk of falls, self-rated difficulty of tasks, the need for caregivers, self-rated safety, and caregiver self-efficacy (Ahn & Hegde, 2011; Petersson et al., 2009; Petersson et al., 2008; Sanford et al., 2002; Somerville et al., 2016; Stark et al., 2009; Stark et al., 2018). Currently staffs time during visits includes asking questions to determine the correct fit of products and services to clients needs. For example, CAPS focus questions during home assessments on measurements of the space and how the space can be utilized to create the least restrictive environment for an individual (J. Kelly, personal communication, January 18, 2018). On the other hand, during home assessments, an occupational therapist may use a tool such as the Safety Assessment of Function and the Environment for Rehabilitation-Health Outcome Measurement and Evaluation (SAFER-HOME v.3), which measures functional performance in the home rather than the home characteristics, or the Cougar Home Safety Assessment, which measures environmental safety hazards in the home (Weeks et al., 2010). Similar to CAPS, FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 15 assistive technology specialists focus assessment questions on usability of a device and clients current interest in devices to meet their needs (A. Leung, personal communication, January 31, 2018). During an assistive technology assessment, an occupational therapist may use the Matching Assistive Technology and Child assessment (MATCH), the Framework for Modeling the Selective of Assistive Technology Device, or the Matching Person and Technology Model (MPT) to evaluate the correct fit between the person, environment, occupation, and device (Jenko & Zupan, 2010). The outcome questionnaires for Easterseals Crossroads will include common themes from the previously mentioned tools, to create generalized outcomes across a variety of situations. The fine line to draw with the outcome questionnaires is role bleed. It is important not to allow CAPS or assistive technology specialists to take over role of an occupational therapist. Occupational therapists receive foundational education in home modification and assistive technology, so they can tap into both services (AARP Livable Communities, 2015; AOTA, 2014). As mentioned previously, assistive technology specialists and CAPS do not receive education on measuring functional performance. Therefore, the ideal team is to have an occupational therapist working alongside a CAPS and an assistive technology specialist. This team could provide information about a clients occupational performance and how recommendations are enhancing a clients function based on a multitude of factors including: diagnosis, current level of ability, motivation, cognition, etc. (AARP Livable Communities, 2015; AOTA, 2014). This project mirrors the ideal team layout and will likely demonstrate the need for an occupational therapist within these departments. Each team member brought their knowledge and expertise to the group. Health outcomes for clients can improve through educating one another about each disciplines focus (Moyers & FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 16 Metzler, 2014). The occupational therapy student focused on maximizing health, well-being, and quality of life for all people, populations, and communities through effective solutions that facilitate participation in everyday living, which is occupational therapys vision 2025 (AOTA, 2017). An interdisciplinary team layout provides the clients with well-rounded, collaborative care focused on positive outcomes (Fewster-Thuente & Velsor-Friedrich, 2008). It is uncommon to have CAPS and assistive technology specialists in traditional therapy settings such as skilled nursing facilities, hospitals, and outpatient centers. In traditional occupational therapy settings, it is normally a team of therapists, nurses, and doctors working with an individual client towards increasing personal factors. Traditional therapy settings focus on the whole picture including: the occupation, environment, and personal factors. The current team at Easterseals Crossroads emphasizes assistive device use and the reduction of environmental barriers. Therefore, they lack the function perspective because they do not have an occupational therapist on staff (B. Norton, J. Kelly, & W. Wingler, personal communication, January 18, 2018). The current team is taking a piece of therapy, the environment, and exploring it in greater detail, but they are missing the whole picture. With an occupational therapist on staff, all the factors affecting functional performance could be emphasized to gain a complete picture of the clients situation. A possible solution to assist in gaining a full picture of an individual client could be for Easterseals Crossroads to contract a home health occupational therapy organization or explore the emerging area of telehealth. Telehealth is a service delivery model that transcends all practice areas, therefore it could be used to bridge the current gap that exists between these departments (AOTA, n.d.). Telehealth may not be ideal for CAPS or assistive technology specialists to utilize because their work includes hands-on training of tools and devices and measurements of spaces. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 17 However, telehealth could be used successfully by an occupational therapist to assist clients in increasing physical function and occupational engagement (Cason, Hartmann, Jacobs, & Richmond, 2013). Assistive technology specialists would be a great team member to utilize for telehealth service, because technology is the means of communication in telehealth (Cason et al., 2013). Use of an occupational therapist through telehealth would allow the team at Easterseals Crossroads to be more holistic when providing services to clients. Implementation After the need for an outcome questionnaire for each department was identified, I conducted several searches to gain information about current environmental modification questionnaires. Many questions needed to be answered prior to creating the outcome questionnaires. Boynton and Greenhalgh (2004), identify considerations that are important to address prior to creating a questionnaire. First it was important to consider if a questionnaire was appropriate for the information being collected. Questionnaires are appropriate when the participant can give meaningful answers (Boynton & Greenhalgh, 2004). The clients served by the assistive technology and home modification departments are either independent in their homes or have caregivers, who could assist with answering questions. It was also important to consider if there was already an existing instrument that could be used. Ideally a questionnaire that has already been constructed and tested is utilized, however due to the departments specific requirements, use of a previous questionnaire was not practical (Boynton & Greenhalgh, 2004). The questionnaires that were created are evidence-based and include themes other environmental modification questionnaires contain such as independence, safety, mobility, usability, and task difficulty (Ahn & Hegde, 2011; Jenko & Zupan, 2010; Petersson et al., 2009; Petersson et al., 2008; Sanford et al., 2002; Somerville et al., 2016; Stark et al., 2009; Stark et al., 2018; Weeks et FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 18 al., 2010). Overall, both departments wanted a tool that was self-rated, measured clients responses over time, addressed functional use of products, and didnt require clinical reasoning or extensive time to be completed. Presentation of questions was another consideration to think about when creating the outcome questionnaires (Boynton & Greenhalgh, 2004). Question presentation was important to allow clients to be able to understand what is asked and answers accurately. Questions can be presented as open or closed-ended. Closed-ended questions do not allow for much variance, which makes data easier to compare, however the richness of responses is lower (Boynton & Greenhalgh, 2004). Open-ended questions allow clients to explain their answer and provide variety and richness, but they also make data analysis more difficult (Boynton & Greenhalgh, 2004). In terms of the Easterseals Crossroads outcome questionnaires, questions are both openended and closed-ended in order to obtain comparable yet detailed responses. Lastly, it is important to have a valid and reliable measure (Boynton & Greenhalgh, 2004). Having validity and reliability allows the reader to be sure results represent information that is intended to be collected and there is consistency among the results (Boynton & Greenhalgh, 2004). Regarding the outcome questionnaires at Easterseals Crossroads, validity and reliability were not focused on during this project. The focus of this project was on creation of the outcome questionnaires, which can be measured for validity and reliability in the future. After analyzing other questionnaires and finding common themes to include, I created a draft of the outcome questionnaires. I proposed drafts to my site mentors and discussed the ways in which data could be collected including: in person, through the mail, over the phone, and through email. Previously, staff have noticed a lack of responses with mail-out surveys, therefore this method was not chosen (B. Norton & J. Kelly, personal communication, January 22, 2018). FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 19 Each department made different decisions based on how data would be collected upon completion of this project. The assistive technology department decided information would be collected by the administrative assistant using phone calls therefore, a trial for this questionnaire was completed over the phone. The home modifications department decided that in person and phone calls would be used to collect information. The CAPS can take the home modification questionnaire with him on assessments and inspections to be filled out in person, but the monthly follow ups will be completed over the phone by the administrative assistant. Therefore, both methods were trialed for the home modification questionnaire. Wilson et al. (2009) were successful in collecting analyzable data through use of monthly phone calls to individuals, which is why this method of data collection was trialed in both departments. Data collection at Easterseals Crossroads will be ongoing upon completion of this project. The plan for both departments is to collect long-term information at three, six, and twelve months after discharge. After my drafts were approved, I began a trial period and made phone calls for both departments and brought the home modification questionnaire to assessments and inspections. The purpose of the trial period was to collect feedback about how easy or difficult it is for clients to complete the tool either in person or over the phone. This feedback gave me information about changes or adjustments that needed to be made to the outcome questionnaires and allowed me to propose the updated outcome questionnaires to my site mentors. Various changes were made throughout the process of finalizing the outcome questionnaires. During the trial period, I received feedback from clients about questions, layout of the phone calls, and the purpose of the questionnaires. I used this information to make the outcome questionnaires more client-friendly, help the phone calls flow better, and ensure the questions were collecting the correct information. The outcome questionnaires went through five FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 20 to six drafts in which various questions were reworded or changed. Changes were made due to confusion from clients over the phone, inaccurate information being collected, or to clarify meaning of questions. Because the home modifications questionnaire is administered in-person and over the phone, a large portion of the questions were changed to increase understanding and eliminate any confusion during data collection. Both outcome questionnaires had to be written at a level where individuals of all educational levels could easily comprehend what was being communicated, which was a challenge when wording questions. Not only were changes made to be sure clients understood the outcome questionnaires, but also to ensure accurate information was being collected. During the trial period, I gathered information about questions that had multiple interpretations. While making changes to the questionnaires, I had to be certain the questions continued to meet the needs of the site. It was important to keep in mind that long-term the information collected needs to provide feedback that will assist in improvement of quality of services and staff knowledge. During the trial period, I proposed a solution to the question, how would data collection transition smoothly to the administrative assistants. To combat this barrier, I suggested a training period take place. When this solution was approved, training was designed and organized. The training that took place included details on department processes, how to introduce the outcome questionnaires, how to respond to red flag responses, and who to notify if assistance with clients responses is needed. The training also had a period of practice which allowed time for questions or concerns to be addressed. The CAPS received no extra training, because he was an active member in creating the outcome questionnaire. The training helped with staff development, because it assisted the administrative assistants in gaining a better understanding of the work that is being completed within their FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 21 department. When fully implemented, the outcome questionnaires I created will provide feedback about clients thoughts, feelings, and independence levels, as well as feedback about staff performance. The information collected from the questionnaires at three, six, and twelve months will measure clients subjective responses to what staff is doing well, areas where staff can improve, how products are received, and how individuals feel about safety, independence, and the usability of the products over time. It will allow the staff to know what products are perceived well at the beginning, what continues to work well, what takes time to work, and what doesnt work over time. This will allow staff to develop into stronger departments and make more appropriate recommendations as they gain information about the products they are providing to individuals. Overall, the outcome questionnaires will improve services provided to clients, because staff will be more knowledgeable about what products work well over time. It is the responsibility of the staff to continually use the information gained from questionnaires as feedback about their performance and the usability of the products they are providing. Discontinuation Providing detailed information and guidance prior to discontinuation was the most important phase of this project to ensure accurate carry-over. The training period with the administrative assistants was vital for carry-over and allowed sufficient time for implementation prior to the end of my project to address and answer any follow-up questions or concerns. I communicated weekly with the administrative assistants to converse about their comfort level with implementation. Overall, I received positive feedback about the ease of implementation. Both administrative assistants reported it was refreshing to have positive comments being made about departments and felt the questionnaires would provide excellent growth for the departments (Administrative Assistants, personal communication, March 1, 2018). FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 22 Data retrieved from the outcome questionnaires will be collected past the time allotted for this project. Both departments are collecting information for clients at least three, six, and twelve months following the environmental modifications, so I was not able to receive specific feedback regarding the questionnaires outcomes. Therefore, I conducted a satisfaction survey during week fourteen with the site mentors to gather feedback about my role as an occupational therapy consultant (see appendix C for the satisfaction survey). My site mentors rated their satisfaction on multiple aspects including the outcome questionnaires, implementation, carry-over, communication, and professionalism. This information provided me with feedback to know what changes needed to be made or where gaps still existed. Collecting this feedback in week fourteen allowed two weeks for changes to occur. Both site mentors rated each question as strongly agree indicating that all expectations for the project were meet, student was flexible and professional, and the project was beneficial for the departments. (B. Norton & J. Kelly, personal communication, April 12, 2018). After data collection from the outcome questionnaires occurs, the information will be analyzed. The sites long-term goal is for another student to follow-through with data collection and analysis. Proper analysis of qualitative and quantitative information will provide feedback about quality improvement and help answer the questions how are we doing or how can we improve (National Learning Consortium, 2013). Quality improvement is focused on making changes that lead to better client outcomes, better system performances, and better professional development (Batalden & Davidoff, 2007). The information collected by the outcome questionnaires relates directly to quality improvement. Analysis of the outcome questionnaires ensures the best quality of services are being provided to clients, allows staff to develop into stronger, more knowledgeable departments, and eliminates products that are not received well or FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 23 do not make a lasting difference in clients lives. Along with establishing quality improvement, the outcome questionnaires data will hopefully provide feedback to staff and funding sources that proves services are making a difference in clients lives, and overall warrant sustainability of the departments. Societys Needs Societys needs are continuously changing often resulting in more demands. As mentioned previously, there has been an increase in the number of older adults wanting to age in place as well as an increase in technology use to improve independence and daily participation in schools, homes, and communities (AOTA, 2011; Berry & Ignash, 2003). The outcome questionnaires created aim to provide staff with feedback to ensure they are addressing societys changing needs. The questionnaires also give clients the chance to speak out if their needs have changed or different needs need addressed. The clients served by the home modifications and assistive technology departments are all active members of a changing society. Oftentimes clients are reaching out for services from the departments because they wish to pursue a more active role in the community. Most of the clients served by the assistive technology departments are either employed, in school, or working to become employed. Assistive technology is recommended to help individuals be more efficient, effective, and independent members of society as they fulfill their roles (Berry & Ignash, 2003). Needs are continuously changing as individuals shift classes, jobs, and goals. The assistive technology questionnaire created will allow staff to reach out to clients to ensure the technology recommended is still serving the client as intended despite changing roles in society. The questionnaire will also assist in identifying if follow-up services are needed. Although the home modifications department is not focused on engagement in society FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 24 when providing services, the questionnaire created measures an individuals comfort and safety within their own home. With societys increasing trend for older adults to age in place, safety and comfort within ones home can ultimately result in more community engagement or increased feeling of self-worth (Petersson et al., 2008). Individuals presented with environmental barriers often have lower level of self-rated health, higher degree of depression, and increased social isolation due to their inability to perform daily tasks (Petersson et al., 2008). Ultimately this can affect their community engagement and participation in daily activities. Feedback from the home modifications questionnaire will allow staff to have a better understanding of clients ability to engage, which was not collected prior to this project. Overall as an occupational therapy consultant throughout this project, I have been able to help remind staff the importance of the person, the environment, the occupation, and the changes that take place within each of these components (Law et al., 1996). Throughout this process, I have been able to open staffs eyes to the different ways to view situations and offer a variety of solutions. I have increased staffs knowledge about the bigger picture individuals face, including societys changing demands (B. Norton, personal communication, March 2, 2018). I have received positive feedback regarding my ability to think holistically and relay that information to staff and clients (J. Kelly, personal communication, March 6, 2018). With increased knowledge about ways an occupational therapist may view a situation, staff will hopefully be able to improve their ability to offer helpful, creative, holistic solutions during their evaluations with the idea of societys changing needs in mind. Leadership Skills I used the consultative model of service provision to guide me during this project, because it allows individuals to understand roles of all involved, uses a problem-solving method, FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 25 and requires an equal relationship among those involved (Phillips, n.d.). I continually challenged staff to include the person and occupation when thinking of implementation rather than just the environmental changes (Law et al., 1996). At the same time, the staff consistently challenged me to think about how I would use my occupational therapy knowledge when working with their clients. This collaborative relationship, in which all involved worked to improve one anothers knowledge, increased my ability to step outside of my comfort zone. I had to be a confident leader when presenting my ideas to individuals who think and view situations from different perspectives. I learned a lot about the services that are provided to individuals by the assistive technology and home modifications departments which allowed me to improve my practice skills and knowledge of community resources. Collaborative or partnership consultation worked well for this project because everyone played a role in identifying the problem, planning a solution, and implementing the solution (Dudgeon & Greenberg, 1998; Phillips, n.d.). It was my job as the consultant to train, guide, and supervise staff during implementation and be there to remediate barriers and make necessary changes (Dudgeon & Greenberg, 1998, p. 802). During my time at Easterseals Crossroads, many leadership skills were needed to plan, develop, organize, and deliver the outcome questionnaires to meet the needs of each department. Completion of the CliftonStrengths assessment identified my top five strengths including: achiever, discipline, responsibility, learner, and developer (Gallup, 2012). Knowing these leaderships strengths assisted me in utilizing them during this project. Each of these has a component of achievement, structure, and improvement, which I used to learn quickly, set attainable goals, and take responsibility for my plan (Gallup, 2012). Although similar in foundation, the two departments I worked with had individual needs, different staff, and offer different products. Therefore, adaptability was also a skill I used a lot throughout this process. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 26 The two departments often came to me with opposing concerns, questions, and comments. I had to be flexible in my ability to change ideas as I switched between the departments and their focuses. Creativity and motivation were important when taking on this project, not only while working to expand my knowledge of the departments focus, but also while seizing as many hands-on learning opportunities as possible. Making responsible, professional, and educated decisions when identifying, researching, and pinpointing the information to include in the outcome questionnaires was vital. The two main leadership skills that assisted me in creating a well-received and wellrounded tool for each department was communication and responsibility. Active communication with mentors ensured that I obtained a holistic view of the needs. It also allowed me to discuss my ideas with staff to increase the positive response and adoption of the outcome questionnaires. I knew coming into this position I needed to be confident in my knowledge of occupational therapy and strong in my ability to advocate for the profession. Responsibility was important during this project, because I was the leader, creator, and manager of the project. I was able to make responsible and timely choices to be sure I completed the end goal to the standards that were set. Overall Learning Being the first occupational therapy student in the assistive technology and home modifications departments at Easterseals Crossroads provided many opportunities for growth. Communication was vital to ensure I was fulfilling my role as an occupational therapy consultant. There were no pre-set goals in place when I started, so it was important for me to come into this experience with an open mind. During the first two weeks, my site mentors and I had daily face-to-face meetings to discuss my interests along with the sites needs. It was FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 27 important for me to be confident in my occupational therapy knowledge during these meetings, because my site mentors relied on me to understand the role an occupational therapist would play in each project idea. To assist in my understanding of Easterseals Crossroads needs, my site mentors ensured that I had face-to-face communication with each department at the site and educated me about the main roles of all departments. During these initial meetings, non-verbal communication was vital. Not only was I making an impression of myself, but also the profession of occupational therapy. Along with professional verbal communication, non-verbal communication was important to show staff within each department that I was invested and interested. When the project idea was finalized, my site mentors had a hands-off role. They were available when I had questions or concerns and would come to me with ideas, but much of our communication was through email. My site mentor in the assistive technology department is very active around the site and in the community, and my site mentor in the home modifications department often works from coffee shops between visits, therefore approximately 75% of communication was completed through emails. Although this project was self-driven and it was up to me to determine my schedule, it was still important for me to email my weekly goals and plans to my site mentors. Weekly email updates ensured we were on all the same page and needs were being appropriately met. Based on feedback from site mentors, communication through email was done effectively, efficiently, professionally, and clearly (B. Norton & J. Kelly, personal communication, February 28, 2018). Despite busy schedules and working between offices and the community, both site mentors and I made sure to meet face-to-face at least once a week. During these meetings, we would discuss changes in relation to project development. I would often ask for feedback about FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 28 my performance and expectations to be sure I was continuing to meet their needs. Verbal, written, and non-verbal communication were often strengths mentioned by both site mentors in relation to my interactions with staff and clients (B. Norton & J. Kelly, personal communication, February 28, 2018). Because my time was split between two departments, it was important to not only touch base about projects within each department, but also update each site mentor about my project in the opposing department. This allowed my site mentors to know how I was using my time and aided their communication with one another about my performance. Not only was it important to communicate well with site mentors, but I also had to build rapport with staff within the departments. It was important to make sure staff members understood my role and why my project was necessary. During my first week at Easterseals Crossroads my site mentors discussed the working environment of Easterseals Crossroads and compared it to working in silos (B. Norton & W. Wingler, personal communication, January 9, 2018). Although teamwork and collaboration is important within each department, collaboration, communication, and teamwork between departments is not stressed at Easterseals Crossroads (B. Norton & W. Wingler, personal communication, January 9, 2018). My site mentors challenged me to explore the working environment of operating within silos. I made it a personal goal throughout my project to increase staffs knowledge about both assistive technology and home modifications. Building rapport with staff and working closely with both departments facilitated my ability to advocate for and teach about the opposing department. At least once a week I talked to staff about what I was learning in the opposing department. Not only was it was exciting to see staffs curiosity about the other department grow, but it also facilitated teamwork and respect for each other. At a one-day training conference, a staff member from the assistive technology FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 29 department and the CAPS both mentioned how they could utilize one anothers expertise when working with clients (A. Leung & J. Kelly, personal communication, March 2, 2018). This taught me about the importance of teamwork, collaboration, and communication in order to provide clients with the most well-rounded, knowledgeable care. The process of beginning to breakdown silos required leadership, advocacy, and communication, which helped me grow as a professional. The learning process throughout this project has taught me a lot about myself and my knowledge of occupational therapy. This project challenged me to step outside of my comfort zone and take on a role as an independent occupational therapy student without direct supervision from an occupational therapy mentor. Not only was this a new experience for me, but also for the departments and my site mentors. My site mentors were very open to my ideas, my thoughts, and what I had to offer, which was helpful as I explored the role of an occupational therapy consultant. It was important for me to be confident in my knowledge of occupational therapy, and this project made me realize that I have the skills and knowledge to utilize occupational therapy concepts in a non-traditional setting. At each client visit, I challenged myself to identify one way an occupational therapist could help the client. When given the time I explained to staff how an occupational therapist may view a clients situation in a slightly different manner compared to an assistive technology specialists or CAPS. It was encouraging to educate staff about the different ways to view situations. Many of the staff gave me positive feedback about how the information I provided could help with other clients in the future (Assistive Technology Clinical Staff & J. Kelly, personal communication, March 5, 2018). Throughout my project, I was an advocate for occupational therapy, which will help me in future practice. My time at Easterseals Crossroads has allowed me to understand the many FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 30 areas in which an occupational therapist can assist clients. I was challenged to think outside of the box when working with the assistive technology department. Assistive technology is something occupational therapists get a limited amount of education on in school, but when working alongside assistive technology specialists for sixteen weeks I could see the overlap between professions. Not only do both professions follow a similar process of client care with evaluation, training/intervention, outcomes/goals, and discharge, but both assistive technology and occupational therapy have the goal of making clients more independent and efficient in a desired occupation (AOTA, 2014; B. Norton, personal communication, February 28, 2018; Easterseals Crossroads, n.d.a). The approaches, interventions, and training information differs, but the two professions work well together when given the opportunity. This project gave me the chance to be an occupational therapy leader within a multidisciplinary team. Similarly, occupational therapy and home modifications go hand-in-hand. It is very common to hear of occupational therapists completing home evaluations or modifications. Although Easterseals Crossroads does not have an occupational therapist working full-time in the home modification department, my role as a consultant fit very well. I conversed with clients and caregivers about the important of balance, awareness, community engagement, strength, endurance, etc. Also, I educated the CAPS about holistic care and remind him of many community engagement opportunities to help improve individuals quality of life (J. Kelly, personal communication, March 6, 2018). This helped me learn to advocate for occupational therapy and educate individuals of all backgrounds about the role an occupational therapist can play in various settings. Overall, this opportunity to work independently as an occupational therapy consultant gave me confidence in my knowledge, ability, and leadership skills to successfully fill my future role as a registered occupational therapist. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 31 References Age in Place. (n.d.). Introduction to certified aging in place specialists (CAPS). 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Emerging niche: Telehealth. Retrieved from: https://www.aota.org/Practice/Rehabilitation-Disability/EmergingNiche/Telehealth.aspx American Occupational Therapy Association. (2014). Occupational therapy practice framework: Domain and process (3rd ed.). American Journal of Occupational Therapy, 68(Suppl. 1), S1-S48. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 32 American Occupational Therapy Association. (2017). Vision 2025. American Journal of Occupational Therapy, 71, 7103420010. https://doi.org/10.5014/ajot.2017.713002 Batalden, P. B., & Davidoff, F. (2007). What is quality improvement and how can it transform healthcare? Quality & Safety in Health Care, 16, 2-3. doi: 10.1136/qshc.2006.022046 Berry, B. E., & Ignash, S. (2003). Assistive technology: Providing independence for individuals with disabilities. Rehabilitation Nursing Journal, 28 (1), 6-14. Boynton, P. M., & Greenhalgh, T. (2004). Hands-on guide to questionnaire research: Selecting, designing, and developing your questionnaire. British Medical Journal, 328, 1312-1315. Cason, J., Hartmann, K., Jacobs, K., & Richmond, T. (2013). Telehealth. The American Journal of Occupational Therapy, 67(6). S69-S90. Cole, M., & Tufano, R. (2008). Applied theories in occupational therapy: A practical approach. Thorofare, NJ: SLACK Incorporated. Dudgeon, B. J., & Greenberg, S. L. (1998). Preparing students for consultation roles and systems. The American Journal of Occupational Therapy, 52(10), 801-809. Easterseals Crossroads. (n.d.a). Clinical services. Retrieved from: http://www.eastersealstech.com/about/clinical-assistive-technology-services/ Easterseals Crossroads. (n.d.b). Home modification. Retrieved from http://www.eastersealscrossroads.org/?page_id=318 Fagan, L. A., & Sabata, D. (2011). Home modifications and occupational therapy. Retrieved from https://www.aota.org/About-Occupational-Therapy/Professionals/PA/Facts/HomeModifications.aspx Fnge, A., & Iwarsson, S. (1999). Physical housing environment: Development of a selfassessment instrument. Canadian Journal of Occupational Therapy, 66(5), 250-260. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 33 Fewster-Thuente, L. L. & Velsor-Friedrich, B. (2008). Interdisciplinary collaboration for healthcare professionls. Nursing Administration Quarterly, 32(1), 40-48. doi: 10.1097/01.NAQ.0000305946.31193.61 Gallup. (2012). Strengths insight report. Retrieved from https://gx.gallup.com/services/pdf?v=pdfGeneration.prince.7.0.binPath Goodrich, B., & Garza, E. (2015). The role of occupational therapy in providing assistive technology devices and services. Retrieved from: https://www.aota.org/AboutOccupational-Therapy/Professionals/RDP/assistive-technology.aspx Jenko, M., & Zupan, A. (2010). Models and instruments for selection of assistive technology for computer access. Informatica Medica Slovenica, 15(2), 31-36. Joint Center for Housing Studies of Harvard University. (2014). Housing Americas older adults: Meeting the needs of an aging population. Retrieved from: http://www.jchs.harvard.edu/sites/jchs.harvard.edu/files/jchshousing_americas_older_adults_2014.pdf Law, M. (2002). Participation in occupations of everyday life. The American Journal of Occupational Therapy, 56(6), 640-649. Law, M., Cooper, B., Strong, S., Stewart, D., Rigby, P., & Letts, L. (1996). The personenvironment-occupation model: A transactive approach to occupational performance. Canadian Journal of Occupational Therapy, 63(1), 9-23. Lee, S. (n.d.). How old are Americas houses? The surprising results of our old house poll. Retrieved from http://www.oldhouseweb.com/how-to-advice/how-old-are-americashouses.shtml FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 34 Moyers, P. A., & Metzler, C. A. (2014). Interprofessional collaborative practice in care coordination. American Journal of Occupational Therapy, 68(5), 500505. http://dx.doi.org/10.5014/ajot.2014.685002 National Learning Consortium. (2013). Continuous quality improvement (CQI) strategies to optimize your practice. Retrieved from https://www.healthit.gov/sites/default/files/tools/nlc_continuousqualityimprovementprim er.pdf Petersson, I., Kottorp, A., Bergstrom, J., & Liljia, M. (2009). Longitudinal changes in everyday life after home modifications for people with aging with disabilities. Scandinavian Journal of Occupational Therapy, 16, 78-87. doi: 10.1080/11038120802409747 Petersson, I., Liljia, M., Hammel, J., & Kottorp, A. (2008). Impact of home modification services on ability in everyday life for people ageing with disabilities. Journal of Rehabilitation Medicine, 40, 253-260. Phillips, G. (n.d.). Related service consultation: Strategies for successful integrated practice [PowerPoint Slides]. Retrieved from: http://slideplayer.com/slide/5764887/ Sanford, J. A., Pynoos, J., Tejral, A., & Browne, A. (2002). Development of a comprehensive assessment for delivery of home modifications. Physical & Occupational Therapy in Geriatrics, 20(2), 43-55. https://doi.org/10.1080/J148v20n02_03 Schwier, E. (2015). Live strong, learn strong: Promoting mental health in school. OT Practice, 20(5), 913. Somerville, E., Smallfield, S., Stark, S., Seibert, C., Arbesman, M., & Lieberman, D. (2016). Occupational therapy home modification assessment and intervention. American Journal FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 35 of Occupational Therapy, 70(5), 7005395010p1- 7005395010p3. http://dx.doi.org/10.5014/ajot.2016.705002 Stark, S., Landsbaum, A., Palmer, J., Somerville, E. K., & Morris, J. C., (2009). Client-centered home modifications improve daily activity performance of older adults. Canadian Journal of Occupational Therapy, 76(Spec No), 235-245. Stark, S., Somerville, E., Conte, J., Keglovits, M., Hu, Y. L., Carpenter, C., & Yan, Y. (2018). Feasibility trial of tailored home modifications: Process outcomes. American Journal of Occupational Therapy, 72(1), 7201205020p1- 7201205020p10. https://doi.org/10.5014/ajot.2018.021774 Weeks, A. L., Lamb, B. A., & Pickens, N. D. (2010). Home modification assessment: Clinical utility and treatment context. Physical & Occupational Therapy in Geriatrics, 28(4), 369409. doi: 10.3109/02703180903528405 Wilson, D. J., Mitchell, J. M., Kemp, B. J., Adkins, R. H., & Mann, W. (2009). Effects of assistive technology on functional decline in people aging with a disability. Assistive Technology, 21, 208-217. doi: 10.1080/10400430903246068 FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 36 Appendix A Home Modification Questionnaire Functional activities performed in the bathroom: Individual filling out this form: CONSUMER/CLIENT CAREGIVER/FAMILY MEMBER *If caregiver/family member, please rate based on your understanding of consumer/clients average function Please rate how you currently feel based on your functional performance 1. How much help does consumer/client need to get on/off the toilet? None (0) Supervision (1) A little (2) Some (3) A lot (4) 2. Rate consumer/clients safety in transferring on/off toilet: Poor (0) Fine (1) Good (2) Very good (3) Excellent (4) 3. How much help does consumer/client need to get in/out of the shower? None (0) Supervision (1) A little (2) Some (3) A lot (4) 4. Rate consumer/clients safety in transferring in/out of the tub/shower: Poor (0) Fine (1) Good (2) Very good (3) Excellent (4) 5. How much help is required for: a. Bathing/washing body None (0) Supervision (1) A little (2) Some (3) A lot (4) b. Washing hands None (0) Supervision (1) A little (2) Some (3) A lot (4) c. Toilet hygiene None (0) Supervision (1) A little (2) Some (3) A lot (4) d. Brushing teeth None (0) Supervision (1) A little (2) Some (3) A lot (4) 6. How much help does consumer/client need for mobility in/around the bathroom? None (0) Supervision (1) A little (2) Some (3) A lot (4) 7. Rate consumer/clients safety for mobility in/around the bathroom: Poor (0) Fine (1) Good (2) Very good (3) Excellent (4) FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 37 8. Comments regarding current functional use of the bathroom: Stair lift accommodation: Individual filling out this form: CONSUMER/CLIENT CAREGIVER/FAMILY MEMBER *If caregiver/family member, please rate based on your understanding of consumer/clients average functionPlease rate how you currently feel based on your functional performance 1. How much difficulty does consumer/client have ascending/descending stairs None (0) Supervision (1) A little (2) Some (3) A lot (4) 2. How much time does consumer/client spend on one floor due to barriers to transferring between floors? None (0) A little (2) Some (3) A lot (4) 3. What is consumer/clients comfort/confidence in ability to safely navigate stairs? None (1) A little (2) Some (3) A lot (4) 4. How much confidence does consumer/client have in your ability to get out of house in an emergency? None (1) A little (2) Some (3) A lot (4) 5. Rate consumer/clients safety in transferring between floors: Poor (0) Fine (1) Good (2) Very good (3) Excellent (4) 6. Comments regarding current functional use of the stairs: Entering/exiting home: Individual filling out this form: CONSUMER/CLIENT CAREGIVER/FAMILY MEMBER *If caregiver/family member, please rate based on your understanding of consumer/clients average functionPlease rate how you currently feel based on your functional performance 1. What is consumer/clients confidence in ability to get out of house in an emergency? None (1) A little (2) Some (3) A lot (4) 2. What is consumer/clients comfort/confidence in ability to safely navigate stairs? None (1) A little (2) Some (3) A lot (4) FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 3. How much does the current entrance/exit affect consumer/clients participation in outings/activities? None (1) A little (2) Some (3) A lot (4) 4. Rate consumer/clients safety in entering/exiting the house: Poor (0) Fine (1) Good (2) Very good (3) Excellent (4) 5. How much help does consumer/client required to get in and out of the house None (0) Supervision (1) A little (2) Some (3) A lot (4) 6. Comments regarding current ability to get in and out of the home: 38 FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 39 Appendix B Assistive Technology Questionnaire 1. What assistive technology do you currently use and what needs does it assist with? 2. Are you currently working, in school, etc. a. Is the assistive technology used to help you meet those needs? YES NO 3. How often do you use your assistive technology? (ex: weekly, daily, 2x week, weekends only, etc.) 4. I am in using my assistive technology a. Not as confident as I would like b. Confident c. More confident than I expected 5. What is one thing that you wish you could change about your assistive technology? 6. I use my assistive technology __________ than I expected a. More often b. The same c. Less often Are there any current barriers you are experiencing? 7. I have found my assistive technology __________ to use a. Easy b. Medium difficulty c. Hard Did the training meet your needs? YES NO Would you benefit from more training? YES NO If yes, what could you use more training on?____________________________________ 8. My assistive technology _______ my needs. a. Exceeds b. Meets on average c. Is inferior to Provide a brief explanation to your answer: FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS 40 9. Since receiving my assistive technology my overall technology needs have a. Increased b. Decreased c. Stayed the same d. Changed completely If needs have changed (increased, decreased, or changed completely), is it a: e. medical change f. educational change g. vocational change h. Other: 10. Choose/finish the phrase that best fits your belief a. I adopted the technology into my lifestyle and it has assisted me as expected. b. I have adopted the technology into my lifestyle but I am still learning how to use it to its full extent. c. I have abandoned the technology due to my change vocational goal. d. I have abandoned the technology due it no longer meets my needs. FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS Appendix C Satisfaction Survey 1. The outcome questionnaire meets expectations. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 2. The outcome questionnaire is easy to implement. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 3. Student assisted with smooth implementation and carry over. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 4. Student responded well to feedback. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 5. Student kept open communication throughout the project. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 6. Student implemented project in timely manner. a. Strongly agree 41 FUNCTIONAL OUTCOMES OF ENVIRONMENTAL MODIFICATIONS b. c. d. e. Comments: Agree Neither agree or disagree Disagree Strongly disagree 7. Student fulfilled expectations of an OT consultant. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 8. Student was flexible with changes to project. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 9. Student was knowledge about OT and maintained professional behavior. a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: 10. I believe the doctoral capstone experience was beneficial to our department a. Strongly agree b. Agree c. Neither agree or disagree d. Disagree e. Strongly disagree Comments: Would you take another student? YES NO 42  ...

... Running head: DOCTORAL CAPSTONE EARLY MOBILIZATION 1 Early Mobilization Program in the Intensive Care Unit to Improve Patient Outcomes Natalie Azzarito, OTS May 2018 A capstone project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the faculty capstone advisor: Rebecca A. Barton, DHS, OTR, FAOTA DOCTORAL CAPSTONE EARLY MOBILIZATION A Capstone Project Entitled Early Mobilization Program in the Intensive Care Unit to Improve Patient Outcomes Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Natalie Azzarito Occupational Therapy Student Approved by: Faculty Capstone Advisor Date Doctoral Capstone Coordinator Date Accepted on this date by the Chair of the School of Occupational Therapy: Chair, School of Occupational Therapy Date 2 DOCTORAL CAPSTONE EARLY MOBILIZATION Abstract Background/Purpose: A need for an early mobilization program was identified at a large Midwest hospital. This hospital does not have an early mobility program, but is in the early program design phase. Therefore, the purpose of this project was to determine staff perceptions on perceived barriers to implementing an evidence-based early mobility program in the ICU/CCU to maximize patient outcomes. Essential Features: An evidence-based survey was designed and provided to staff in the ICU/CCU to understand current staff perceptions on the barriers to early mobility. A total of 59 (n=59) total surveys were returned. The student also held a series of in-services to educate nursing staff on general principles of passive range of motion, created a pamphlet describing occupational therapy and early mobility, and treated patients with a variety of conditions. Outcomes/Discussion: Survey outcomes supported the following barriers: an ICU culture that promoted bed rest, lack of understanding the benefits of early mobilization, lack of communication, patient safety, and lack of appropriate resources. An early mobility team was created to identify goals to address these barriers in order to move forward with a standardized early mobility program. Survey results were presented at the early mobilization meetings to establish a timeframe with appropriate goals to implement the program. The barriers to early mobilization identified through this survey provided the early mobilization team with areas for education, issues in the ICU/CCU, and thoughts/perceptions from staff. 3 DOCTORAL CAPSTONE EARLY MOBILIZATION 4 Early Mobilization Program in the Intensive Care Unit Literature Review The intensive care unit (ICU) is a special unit of a hospital that provides immediate intensive services with constant care by medical professionals, involves technological complexities, and severe diseases; therefore, making this the most stressful, tense, and aggressive environment in the hospital (Barbieri Bombarda, Lanza, Valente Santos, & Vitale Torkomian Joaquim, 2016). Each year, in the United States, there are about 4.1 million adults admitted to an ICU with an estimate cost of 8.7 billion dollars in 2005, totaling to an average of five percent of all national health care costs (Weinreich, Herman, Dickason, & Mayo, 2017; Mullins, Goyal, Pines, & Gerson, 2013). Due to an aging population in the United States, between the years 2000 and 2005, the average number of beds in the ICU increased to six and half percent and average amount of days spent in the ICU increased to ten and half percent (Mullins, Goyal, Pines, & Gerson, 2013). Patients in the ICU often experience muscle atrophy, pressure ulcers, ICU-acquired weakness (ICUAW), delirium, proximal muscle weakness, poor sitting tolerance, deep venous thrombosis (DVT), orthostatic hypotension, pneumonia, foot drop, fatigue, and poor endurance (Zomorodi, Topley, & McAnaw, 2012; Kress, 2009). These patients often experience extensive days of bed rest, are mechanically ventilated, and sedated, which can lead to deconditioning of organ functions (Zomorodi, Topley, & McAnaw, 2012). Thus, due to patients being medically complex and experiencing a variety of physiological issues, care is more focused on organ function recovery rather than on mobilization (Kress, 2009). Recent research showed that muscle strength declines three to eleven percent for every day a patient is on bed rest, and ranges between weeks or months to improve (Fraser, Spiva, Forman, & Hallen, 2015). According to DOCTORAL CAPSTONE EARLY MOBILIZATION 5 Zomorodi, Topley, & McAnaw (2012), mechanically ventilated patients can lose up to 25% of peripheral muscles and 18% of body weight at discharge. Furthermore, immobility and best rest has been shown to be associated with increased length of hospital stay, higher mortality and morbidity rates, physical weakness, functional decline, increased risk for aspiration, which in turn lead to a higher readmission rates to the ICU (Fraser, Spiva, Forman, & Hallen, 2015; Zomorodi, Topley, & McAnaw, 2012). Early mobility is the process of improving patient functional outcomes through active range of motion (AROM), active assisted range of motion (AAROM), passive range of motion (PROM), sitting, standing, rolling, functional transfers, and walking (Hodgson et al., 2014). There is currently no gold standard for specific early mobility protocols in most ICUs, despite the amount of research describing how immobility contributes to weakness and deconditioning of critically ill patients (Fraser, Spiva, Forman, & Hallen, 2015). Research has shown that early mobilization of patients in the ICU can improve patient outcomes and reduce ICUAW (dos Santos, Herridge, & Batt, 2016). In fact, early mobility with critically ill patients not only reduces overall hospital length of stay from 4.8 days to 4.1 days, duration of mechanical ventilation, and enhances the patients health outcomes and functional abilities, but also significantly increases hospital net cost savings (Dang, 2013; Sigler et al., 2016). There has also been evidence demonstrating that early mobility reduces ICU delirium, improves walk distance, and enhances muscle strength (Sigler et al., 2016; Fraser, Spiva, Forman, & Hallen, 2015). Aside from supporting evidence-based research on benefits of early mobility in the ICU, there are also barriers inhibiting the implementation of early mobilization programs and protocols. Barriers to developing an early mobilization program for an ICU include a culture that promotes strict bed rest, over sedation of mechanically ventilated patients, lack of understanding DOCTORAL CAPSTONE EARLY MOBILIZATION 6 the benefits of early mobilization, lack of patient referrals, decline in patient status, obesity, pain, weakness, and levels of delirium (Sigler et al., 2016). Thus, it is crucial to change behavior to prioritize early mobilization of critically ill patients through a collaborative team effort, motivating physicians on progressive practice, and having supportive staff and administrators in order to move forward with a standardized early mobility program (Fraser, Spiva, Forman, & Hallen, 2015). Another common barrier is concern about the ability to accommodate new staffing needs for a new program that requires a mobility team (Azuh et al., 2016). However, Azuh et al. (2016) found that training unlicensed professionals in combination with nurses and trained therapists can not only help reduce costs of hiring new employees, but also provide a safe and effective alternative to implement an early mobility program. In fact, since early mobility reduces average length of hospital stays and increases hospital net savings, this program would not cost the hospital additional money (Bakhru, Wiebe, McWilliams, Spuhler, & Schweickert, 2015). Thus, providing a justification to the cost of the program (Bakhru, Wiebe, McWilliams, Spuhler, & Schweickert, 2015). Therefore, less concern should be placed on cost considerations when designing an early mobilization program. Furthermore, research shows that hospitals across the United States are aware of early mobility in the ICU but are not following through and implementing the program (Azuh et al., 2016). Evidence-based research on early mobility indicates that implementing an early mobility program in the ICU is safe, feasible, and clinically beneficial; however, few detailed programs exist making it difficult to replicate and implement (Sigler et al., 2016). There are currently three published descriptions of early mobility programs at Wake Forest University, Johns Hopkins University, and the University of California-San Francisco created under a Plan-To-Do-StudyAct design that includes a multidisciplinary approach (Sigler et al., 2016). These members DOCTORAL CAPSTONE EARLY MOBILIZATION 7 included physical therapy (PT), occupational therapy (OT), respiratory therapy (RT), physicians, project managers, pharmacists, nursing, and nursing assistants to safely and efficiently implement the early mobility program (Sigler et al., 2016; Harris and Shafi, 2014). Early mobility programs are complicated and challenging to develop and require a progressive, cultural change in the ICU toward early mobility (Sigler et al., 2016). According to Burtin et al. (2009), who examined 90 critically ill patients, determined that having an established early mobility protocol in the ICU would improve patient recovery time and increase overall activity during hospital stay. Seventy-three patients who received early mobility during their ICU stay were able to walk independently at discharge, compared to the 55 patients in the control group who did not receive early mobility (Burtin et al., 2009). Researches noted that an early mobility protocol in the ICU can be safely carried out (Burtin et al., 2009). Occupational therapy has played a role in providing skilled services in the ICU for many years (Affleck, Lieberman, Polon, & Rohrkemper, 1986). According to a study from 2005 in Canada, about 27% of occupational therapists reported working full-time in the ICU (Foreman, 2005). Common deficits occupational therapists work with in the ICU includes sensory deprivations, social isolation, and immobilization (Affleck, Lieberman, Polon, & Rohrkemper, 1986). An important focus for occupational therapists in this setting is to help reverse the cycle of immobility and improve overall patient outcomes through evidence-based early interventions (Affleck, Lieberman, Polon, & Rohrkemper, 1986). Occupational therapy plays an important role for increasing independence and participation in activities of daily living (ADLs) through ADL programs that include sitting tolerance, simple self-care tasks, functional transfers, stress management activities, and bed mobility (Affleck, Lieberman, Polon, & Rohrkemper, 1986). DOCTORAL CAPSTONE EARLY MOBILIZATION 8 These interventions are appropriately upgraded or downgraded based on the patient's tolerance and vital signs (Affleck, Lieberman, Polon, & Rohrkemper, 1986). Currently, PT is an essential part of the ICU team, however there is lack of adoption related to OT (Weinreich, Herman, Dickason, & Mayo, 2017; Barbieri Bombarda, Lanza, Valente Santos, & Vitale Torkomian Joaquim, 2016). This lack of adoption of OT in the ICU may be due to the fact that many staff members in the ICU reported not understanding the role of OT and admitted to having a lack of knowledge about interventions performed by occupational therapists (Barbieri Bombarda, Lanza, Valente Santos, & Vitale Torkomian Joaquim, 2016). Similarly, there is lack of literature describing the role of occupational therapy in the ICU (Foreman, 2005). However, current research also shows that OT plays a part in activity programs for patients in the ICU paired with the use of functional activities and engagement in ADLs. Therefore, there is a justification for occupational therapy to be part of an early mobilization team to not only perform activity programs, but also incorporate evidence-based early interventions to promote functional outcomes of critically ill patients (Affleck, Lieberman, Polon, & Rohrkemper, 1986; Weinreich, Herman, Dickason, & Mayo, 2017). Additionally, Weineich, Herman, Dickason, & Mayo (2017) found that patients had positive outcomes when simultaneously receiving OT and PT in the ICU. Creating a standardized early mobilization program will require both PT and OT to work collaboratively with other members of the early mobility team using a progressive regimen (Kress, 2009). Sigler et al. (2006) further explains the collaborative role of OT and PT to improve function, mobility, create the ability to perform activities of daily living, and prevent disability. PT and OT leadership of an early mobility program are critical to the success and multidisciplinary involvement (Sigler et al., 2016). Fraser, Spiva, Forman, & Hallen (2015) also reports that a strength to their pilot early mobility program was having an interdisciplinary DOCTORAL CAPSTONE EARLY MOBILIZATION 9 approach. In another study, researchers trialed that ABCDEF Bundle (Awakening and Breathing Coordination, Delirium Monitoring/Management, Early Exercise/Mobility, and Family Involvement). The ABCDEF Bundle or A-F Bundle has specific protocols written for staff to follow. Balas et al. (2014) found that compared to routine care, patients receiving the A-F Bundle spent three more days off mechanical ventilation, had less delirium, and expected to be mobilized at a higher rate. This Doctoral Capstone Experience (DCE) will focus on providing early evidence-based occupational therapy interventions and using principles from evidence-based early mobility in the ICU at a large Midwest hospital. This hospital currently does not have an early mobility program, but is in the premature program design phase incorporating the ABCDEF Bundle. This hospital is currently having issues implementing this bundle and encountering many barriers. Therefore, the purpose of this DCE is to create an evidence-based survey on staff perceptions to the barriers on early mobility to identify gaps in implementing the ABCDEF Bundle in the ICU/CCU. The theory that will be guiding this DCE is the Person Environment Occupation Performance (PEOP). The PEOP specifically looks at the person, their environment, occupations and how it affects overall occupational performance (Cole & Tufano, 2008). This model is appropriate because the goal of the early mobility program through the lens of PEOP is to produce occupational performance and engagement in occupations; such as, simple ADL tasks, self-feeding, grooming, and functional transfers (Cole & Tufano, 2008). Furthermore, the Frame of Reference (FOR) that will be guiding this DCE is rehabilitative. This FOR focuses on physical disabilities, pain, endurance, and strength (Cole & Tufano, 2008). These are all important factors that impact early mobility in the ICU and influence participation and independence with ADLs DOCTORAL CAPSTONE EARLY MOBILIZATION 10 and simple functional tasks. Examples of occupational therapy interventions through the lens of rehabilitative FOR includes adapting activities, physical reconditioning, and energy conservation techniques (Cole & Tufano, 2008). Screening and Evaluation Occupational therapists hold a responsibility to educate, promote, protect, and advance overall health and wellbeing of the community (Baum & Law, 1996). According to Baum and Law (1996), occupational therapy practitioners are required to focus on long-term health needs of the client, rather than short-term needs. A needs assessment is used to identify gaps in a facility between a current implementation process of procedures and what a future desired outcome would be based upon recognizing an issue with the current procedures (Scaffa & Reitz, 2014). After the pre-planning stage, a needs assessment should be completed to screen and evaluate the needs of the facility and to prioritize the development of interventions to address these needs (Scaffa & Reitz, 2014). According to Witkin and Altschuld (1995), a needs assessment also assists with identifying appropriate resources, determines contributing factors to the problem, and facilitates addressing priorities related to the needs. Therefore, a needs assessment was done at a large Midwest hospital to determine gaps in the early design process for an early mobility program in the ICU/CCU abiding by current mobility standards at this hospital. The purpose of the needs assessment was to determine the facilities priorities about the implementation process of an early mobilization program to increase occupational performance and overall patient outcomes (Scaffa & Reitz, 2014). The early mobility program will also allow the facility to focus on long-term health needs not only increase healthy behaviors, but also decreases health care costs (Baum & Law, 1996). Data Collection DOCTORAL CAPSTONE EARLY MOBILIZATION 11 A combination of methods was used to gather and obtain information. First, archival data from previous studies and evidence-based research was used to provide information on current implementation process of early mobility programs (Scaffa & Reitz, 2014). Then, a community profile was completed on the social demographics of the ICU/CCU (Scaffa & Reitz, 2014). This included collecting data from the previous year on health statistics in the ICU/CCU compared with the year prior (Scaffa & Reitz, 2014). This information included ICU admissions rates, average length of stay (LOS), mortality rates, and days spent on a mechanical ventilator (Baptist Health, 2017). Data collected showed an increase in ICU admission rates, days spent in the ICU, sepsis cases, and days spent on a ventilator (Baptist Health, 2017). This information provided the researcher with understanding the current gaps in the ICU/CCU and gave statistical support for a service profile (Scaffa & Reitz, 2014). This service profile contributed data about the current unmet problem and description of the affected population. Statistical patient information is important when considering an early mobility program because it provides the facility with a baseline and allows them to see if the program impacts patient outcomes (Scaffa & Reitz, 2014). Direct contact included meetings with the nurse manager of the ICU/CCU, nursing staff, the director of inpatient rehabilitation, and the occupational therapy department manager. An initial meeting with the nurse manager and occupational therapy department manager was made to determine occupational therapys role in the design of this early mobility program. It is evident that physical therapy plays a vital role in mobilizing patients in the ICU, however OT has not played a large role in the ICU this far. Therefore, it is important that staff will be educated on the role of occupational therapy in the ICU and early mobility team. Evidence supports that skilled occupation therapy evidence-based early interventions promote functional outcomes of critically ill patients (Affleck, Lieberman, Polon, & Rohrkemper, 1986; Weinreich, Herman, DOCTORAL CAPSTONE EARLY MOBILIZATION 12 Dickason, & Mayo, 2017). The nurse manager also relayed the concerns and specific suggestions from the seven intensivists working at this facility to help facilitate discussion. Results of this this meeting concluded that it would be beneficial to create an early mobility phase program and present it to the facility. The nurse manager also felt it would be beneficial for the research to hold in-services to the nursing staff on their role of passive range of motion to all extremities, since most do not already do this. Observation of the current ICU/CCU units was also used to gather information. Observation included observation nursing duties at the nurses station, attending daily rounding on patients, following an occupational therapist in these units, and observing role of physical therapy and respiratory therapy. One-on-one interviews were also held for ICU/CCU staff to describe their current role and how their role would contribute to an early mobility program (Scaffa & Reitz, 2014). Results indicated that nurses felt like there was a time constraint on doing passive range of motion as well as their job duties. It was apparent that the culture of these units promoted bed rest and the nurses relied on therapies to get their patients out of bed. Physical therapy reported they hold therapy for the day if the patient had bed rest orders and do not always check to see if the patient is appropriate to see with nursing staff. Nursing staff would like therapy to check in with them because the bed rest orders may have expired. All disciplines agreed that there needs to be better interdisciplinary collaboration. Lastly, monthly intensivist meetings were attended to discuss the facilities current phase in the early mobility process and current barriers as to why they have not progressed. The seven intensivists agreed that they felt therapy did not want to be part of the early mobility team and would like to see a greater effort on their part. It was brought up that the hospital has a grant for an early mobility program, but still cannot get the program started. After this meeting, it was DOCTORAL CAPSTONE EARLY MOBILIZATION 13 decided that the facility does not want to create an early mobility phase program, but to implement the ABCDEF bundle that surrounding hospitals have done to be able to use their existing grant. The ABCDEF bundle would increase a collaborative interdisciplinary approach and ultimately increase desired patient outcomes, occupational performance, and participation in functional tasks (Balas et al., 2014). Additionally, Weineich, Herman, Dickason, & Mayo (2017) found that patients had positive outcomes when simultaneously receiving OT and PT in the ICU. The results of the needs assessment from this facility shifted from creating a phase program to desiring to determine barriers inhibiting the implementation of the early mobilization bundle. The hospital has an existing grant and would like to be able to use it before expires, and the expiration date of this grant is currently unknown. Based upon these new needs, a written survey was created to determine staff perceptions of the barriers of early mobilization in the ICU/CCU and will be given to all staff working in these units. Existing and Emerging Areas of Practice Occupational therapys role in acute care is similar to other settings that offer occupational therapy services. Traditional settings in which occupational therapy is seen are in hospitals, rehabilitation centers, pediatric centers, and orthopedic centers (American Occupational Therapy Association, 2018). Occupational therapy in acute care is similar to the traditional role because it focuses holistic practice to improve recovery, patient outcomes, and overall occupational performance. Occupational therapists evaluate the patient using both standardized and non-standardized methods to form a treatment plan to address desired goals. The treatment plan and goals are based on the patients physical, developmental, and psychosocial needs (American Occupational Therapy Association, 2017). It is important for the therapist to provide feedback from the evaluation to physicians and case managers, so discharge DOCTORAL CAPSTONE EARLY MOBILIZATION 14 planning can be appropriately planned for optimal patient outcomes (skilled nursing facility, home health, acute rehab, home independently with family). Occupational performance goals in acute care focus on activity tolerance, simple ADL tasks, sitting on the side of the bed to engage in ADLs, and functional transfers (Affleck, Lieberman, Polon, & Rohrkemper, 1986). This process looks similar to an inpatient rehabilitation setting, however the patient is typically not able to tolerate intense therapy at this point. The acute care setting requires the practitioner to be flexible as the patients do not typically have a scheduled therapy time. The therapist has a list of patients and is required to check on all patients on the list to provide therapy services if appropriate for that day. In other traditional settings, patients will be seen at a scheduled time. In an acute inpatient rehabilitation setting, patients are required to receive three hours of therapy per day to meet Medicare guidelines (Mediware Information Systems, 2017), which is not the case for therapy in the acute care setting. In acute care, billing for therapy services is based on a certain number of minutes spent with the patient which translates into units (Therapy Medlearn, 2002). Most traditional areas of practice are driven by productivity standards, which is true for acute care (AOTA, 2017). Occupational therapy is also in many emerging areas of practice. As society is evolving, it is important for occupational therapy to also evolve to meet the required needs of the community (American Occupational Therapy Association, 2018). The American Occupational Therapy Association has researched trends and categorized these emerging areas into six broad categories through the Centennial Vision process (American Occupational Therapy Association, 2018). These emerging niches include children and youth, health and wellness, mental health, productive aging, rehabilitation, work and industry, and education (American Occupational Therapy Association, 2018). Although occupational therapy has played a role in acute and DOCTORAL CAPSTONE EARLY MOBILIZATION 15 critical care units, occupational therapys role on an early mobilization team is considered an emerging area of practice. According to Rogers, Bai, Lavin, & Anderson (2017), skilled occupational therapy is the only discipline that has shown to reduce hospital readmission rates through early mobilization, restoring function, increasing patient outcomes, and increasing occupational performance. Depending on the setting, occupational performance goals may look very different in emerging areas. In a community-based setting working with homeless individuals, participation in occupation may be attending an occupation-based self-care group. Furthermore, an occupational therapy evaluation in a domestic violence shelter may be focused on identifying barriers to occupation, current occupational performance, and addressing psychosocial factors (Javaherian, Underwood, & DeLany, 2007). The goal for both traditional and emerging areas of practice are to provide holistic care to improve occupational performance and participation in daily tasks (AOTA, 2018). Overall the process of evaluating, synthesizing, analyzing, and diagnosing problems related to occupational performance in traditional and emerging areas should follow foundational roots that are grounded in the occupational therapy practice framework (AOTA, 2014). Implementation Phase The occupational therapy student attended bimonthly early mobility meetings which included seven intensivist critical care physicians, nurse managers of ICU/CCU, PT, RT, OT, and director of rehab services. As previously stated, the purpose of these meetings was to understand staff perceptions and barriers related to early mobilization in the ICU/CCU. Each team member was assigned to a section of the ABCDEF Bundle (Awakening and Breathing Coordination, Delirium Monitoring/Management, Early Exercise/Mobility, and Family Involvement) to discuss what the hospital is doing well, goals, themes, and gaps. There were four DOCTORAL CAPSTONE EARLY MOBILIZATION 16 overall established goals which included decrease length of stay, address pain, decrease patient self-extubation, and decrease delirium. These four goals will be measured from the baseline data from Baptist Hospital East Dashboard (Baptist Health, 2017). The timeline established for the implementation of the ABCDEF Bundle is currently unknown, but staff agreed to meet biweekly to continue to move through the design phase. The concerns and areas staff noticed a gap in care from each section of the ABCDEF Bundle was then compiled and put into a written and online survey via Google Forms. The purpose of this survey was to understand current staff perceptions of OT, PT, RT, and nursing staff in the ICU/CCU. The survey was categorized into three sections: staff barriers, patient barriers, and institutional barriers (see Appendix A). An ordinal 5point Likert scale was used to measure levels of agreement/disagreement ranging from 5 Strongly Agree, 4 Agree, 3 Neutral, 2 Disagree, and 1 Strongly Disagree (Armstrong, 1987). The occupational therapy student administered written surveys to staff in the ICU/CCU. To ensure surveys remained confidential, the staff then put the completed survey in a labeled envelope at the central nurses station. The written surveys were then collected by the student and manually entered in Google Forms. The online survey was the same survey as the written, but since the occupational therapy student does not work night shift, it was difficult to encompass all staff. So, the critical care nurse manager suggested creating both a written and online survey to appeal to a higher response rate. The online survey was sent via email to Baptist Hospital East (BHE) nurses working day shift and night shift in ICU/CCU, as well as techs and nursing aides in the ICU/CCU. The second part of the implementation and program development aspect included a series of in-services to nursing staff about passive range of motion (PROM). This presentation was given at five end-of-the month mandatory staff meetings throughout the course of one week. The DOCTORAL CAPSTONE EARLY MOBILIZATION 17 student was allotted fifteen minutes to educate nursing staff about general principles about PROM, proper technique to support joints through full range of motion, and appropriate exercises. Two PROM guidebooks were created using the paid application at Baptist Health East called BioEx Systems, Inc. The student chose to educated nursing staff on BUE PROM and PT was responsible for BLE PROM exercises. The packet consisted of fifteen BUE PROM exercises that included pictures with a description for shoulder, elbow, wrist, fingers, and thumb. One packet was designated to the ICU and the other packet to CCU. Lastly, since there was confusion on why occupational therapy would be on an early mobility team and there was a lack of understanding on the role of occupational therapy, the student created a pamphlet addressing these topics (see Appendix B). The pamphlet was created on a word document template. It was reviewed by the students supervisor for a second opinion and the final product was then printed. Stacks of these pamphlets were left in the waiting room of the ICU/CCU for family members to read. It was also presented to nursing staff in both critical care units using a one-on-one in-service technique. Leadership and Staff Development Leadership is an integral part of this DCE project. Leadership skills were needed during the duration of this DCE to promote staff development by educating staff on the purpose and benefits of early mobility in the ICU/CCU. The hospital currently has a grant to implement the ABCDEF Bundle, however there is a gap in starting the implementation process. Leadership was demonstrated by developing a survey and presentation for nursing staff and coordinating between a variety of different schedules between disciplines. The student was required to be motivated and make an extra effort to communicate between disciplines on the opposite side of the hospital to ensure continuity of care. Furthermore, leadership skills were also demonstrated DOCTORAL CAPSTONE EARLY MOBILIZATION 18 to communicate between a large variety of disciplines including OT, PT, PTA, nursing, nursing assistants, clinical care managers, rehab directors, and seven intensivist critical care physicians. The occupational therapy student had to market the benefits of the program to staff members currently working in the ICU/CCU and describe what an early mobility program was. Staff development was promoted at the five nursing staff meetings where a PROM presentation was given. Through this nursing staff was educated on the role of OT on an early mobility team, billable/nonbillable therapy interventions, and importance of collaborating with RT to ensure the patient has stable respiratory function for activity. Staff development was also promoted through educational in-services to OT staff through a short in-service on benefits of early mobility and collaborating with necessary disciplines of RT, OT, PT, and nursing. Furthermore, the monthly and biweekly meetings are an interdisciplinary approach that allow each discipline attending (OT, PT, RT, pharmacy, nursing, and MD) to talk and educate other members of the meeting on their section of the ABCDEF Bundle. These meetings require outside interaction and communication, as well as taking the goals discussed in the meetings and applying them into everyday practice. Discontinuation and Outcome Phase In January of 2018, the student established goals and outcomes for this DCE stated in a document called the Memorandum of Understanding (MOU). Throughout the DCE, the student updated and revised goals/outcomes as necessary in conjunction with the site mentor. Initial outcomes included creating a phase program and upon shifting to the ABCDEF Bundle, outcomes/goals were included for the Bundle. The student also became an active member on an early mobility team and outcomes were created for this. The goal of attending daily patient rounds in the ICU/CCU were revised to attending rounds between two and three times a week DOCTORAL CAPSTONE EARLY MOBILIZATION 19 secondary to productivity standards and census. The primary focus of this DCE was program development, followed by clinical practice skills. Survey Analysis and Outcomes As previously stated, a survey was created and administered to staff in the ICU/CCU. On Google Forms, statistics are given for each question that included the response rate per question and a bar graph of how each question was answered. The results from Google Forms were then downloaded into an excel spreadsheet and shared with the critical care manager, as well as the early mobilization team. The survey results were presented at the early mobilization biweekly meetings the first week of March to establish a timeframe with appropriate goals to implement the ABCDEF Bundle. The barriers to early mobilization in the ICU/CCU identified through this survey provided the early mobilization team with areas for education, issues in the ICU/CCU, and thoughts/perceptions from staff. Early Mobilization Survey There was a three-week period for completion of written and online surveys via Google Forms, then no more were analyzed. One-hundred-and-sixteen staff members working in the ICU/CCU were eligible to participate in the survey and sent an online link to the survey via email. Rate of response varied depending on if the survey was completed online or on written copy. A total of 59 (n=59) total surveys were returned, 36 (n=36) were completed using the written format and 23 (n=23) were completed online via Google Forms. The online survey had a feature which required participants to answer all the questions, as this was not the case for the written survey. Fifty written surveys were handed out to staff working in both the ICU and CCU, and 36 (n=36) were returned. Of these 36 returned surveys, 6 (n=6) were partially completed and 30 (n=30) were fully completed. Responses from staff included nursing (n=43), followed by OT DOCTORAL CAPSTONE EARLY MOBILIZATION 20 (n=7), PT (n=5), and nursing assistants (n=3). Virtually all staff that responded managed a clinical caseload (n=52), while (n=2) held a non-clinical position at BHE. Results showed that most of the staff had between one and ten years of experience. Thirty-seven percent had between 6-10 years of experience working in the ICU/CCU and 33.3% had between one and five years of experience. The first section of the survey addressed staff perceptions on barriers in the ICU using a 5-point Likert scale. When asked how comfortable staff were mobilizing patients with an external ventricular drain (EVD), 30% responded they did not feel comfortable at all. On the contrary, 30% also responded they felt comfortable. This was not a surprising response, as the clinical nurse manager stated that patients with an EVD drain would not get out of bed for three weeks. This supports that staff need further education on how to move patients with an EVD drain to increase mobility and endurance for these patients. Forty-four percent of responses showed that staff feels very comfortable mobilizing patients with multiple lines and mobilizing patients that require a two person assist. About 30% responded they did not feel comfortable mobilizing patients who are on a vent. This was also a concern brought up in initial early mobilization team meetings. The second section of the survey was based on a 5-point Likert scale on perceived barriers staff experience with early mobilization related to the patient. Overall, most responses were rated a four out of five, indicating the staff agrees that patients present with these perceived barriers. Forty percent of staff felt neutral that low activity tolerance impacted early mobility, followed by 38% that responded they agreed that low activity tolerance impacted early mobilization. When asked if staff felt patients were not safe to mobilize due to sedation, there was a variation in responses, 27.6% both agreed and disagreed. About forty percent DOCTORAL CAPSTONE EARLY MOBILIZATION 21 responded agreed that delirium, respiratory instability (i.e. poor oxygenation, mechanical ventilation), safety concerns (e.g. falls, adverse events of staff or patient), and hemodynamically instability was a barrier to early mobilization. The third section of the survey addressed institutional barriers to early mobility at BHE using a 5-point Likert scale. Responses were very varied in this section, especially compared to the two previous sections. Upon discussion with the clinical nurse manager and clinical supervisor, it was decided that staff does not have access to resource about most of the institutional barriers, therefore could be a lack of knowledge. However, the seven critical care physicians and early mobilization team was still interested in seeing how staff would respond to these questions. When asked if lack of appropriate staffing, staff willingness to assist, lack of necessary equipment was a barrier to early mobilization, 29.8% responded with agree. About 30% of staff disagreed or felt neutral is there was appropriate training provided on mobilization. Almost all respondents agreed (35.1%) or strongly agreed (33.3%) that time constraints were a barrier to early mobility. There has been discussion at the early mobility team meetings that there is a lack of PT and OT referrals, however 42.1% of nursing staff disagreed that were a lack of patient referrals to PT/OT. On the other hand, 90% of both PTs and OTs responded they agreed and strongly agreed that there is a lack of patient referrals to therapy. Therefore, this was brought to the clinical care nurse manager because most of the time nursing is putting in therapy orders for physicians. Thus, the student gave an in-service to nursing staff about the role of OT, but also the role of OT on an early mobilization team to hopefully increase understanding and patient referrals. Both nursing staff and therapies agreed (40%) that the ICU/CCU culture promotes early mobility, but does not make it a priority. Furthermore, 41.8% of responses agreed the culture of the ICU/CCU promotes bed rest. In the ICU/CCU therapies DOCTORAL CAPSTONE EARLY MOBILIZATION 22 are mostly getting patients out of bed, however it has been brought to the students attention that there is not always a clear time frame of when this is appropriate. Therapists will receive contradictory therapy orders for patient that will read: the patient is on strict bed rest, therapy must wait 24 hours before moving patient, and mobilize patient as soon as possible. So, therapy is unsure which order to follow. When ICU/CCU staff were asked if there is an unclear time frame of when mobilization is appropriate, 34% agreed and 22% strongly agreed. These results were brought the seven critical care intensivists and they are working with the clinical nurse manager to make clear orders in the EPIC system. Over 70% of neutral responses were related to knowledge of funding, early mobility grant, and familiarity with current early mobility literature. Finally, the last section of the survey consisted of two optional short answer responses. The first question asked to list any additional comments regarding perceptions and/or barriers to early mobilization of ICU patients that were not mentioned in the survey. Nursing reported they need more support from nursing technicians for mobilizations since most patients are medically complex and require assistance of two people. Occupational therapy stated they would like to cotreat with physical therapy to improve patient outcomes and address low activity tolerance to therapy, however physical therapy stated they do not want to co-treat. Other responses included lack of appropriate chairs, concerns about patient safety, inconsistent therapy staff, unclear expectations, and unclear therapy orders. The second open ended question asked staff to list any concerns/questions regarding early mobility of patients in the ICU/CCU. A response from nursing staff stated nurses have so many patient priorities to consider in the critical care setting. Unfortunately, early mobility loses priority to assessments, labs, drains, and charting. There just isn't enough time and staffing during a busy shift. Another nurse stated concerns about wear DOCTORAL CAPSTONE EARLY MOBILIZATION 23 and tear injuries on their bodies after moving weak patients. Physical therapy reported there is a lack of follow through after huge push for early mobility a few years ago. Lastly, a nursing staff reported they have walked patients on vents, however will not do early mobility at this time due to lack of equipment and staff. Overall, the consensus was there is a lack of appropriate equipment, lack of staffing, lack of education, and safety concerns. Early Mobilization Team Weekly and biweekly early mobilization meetings with the critical care intensivists, nursing, OT, PT, RT, and pharmacy were held to discuss how to implement the ABCDEF Bundle. These meetings will continue to be held until the ABCDEF Bundle is fully implemented at BHE. In terms of this DCE, the student has met the required outcome to attend meetings and play a role as an active member on the early mobility team. The outcomes from these meetings facilitated more interdisciplinary communication between staff working in the ICU/CCU. As a team, it allowed these staff members to communicate, as well as educate others about their specific section of the ABCDEF Bundle and how it can improve patient outcomes. BHE will continue to make an effort to increase patient outcomes by focusing on pain management, decreasing length of stay, utilizing standardized assessments (CAM-ICU), decreasing selfextubation, creating a clear time frame for mobilization, and increasing family involvement in care. The student has collaborated with the critical care nurse manager to schedule and reserve rooms for these meetings after the students allotted time for the DCE has expired. At these meetings it was made apparent that nursing staff in the ICU/CCU reported that they did not feel comfortable to perform PROM. Therefore, the student held five in-services demonstrating BUE PROM and general principles of PROM. The outcomes from this meeting showed that nursing staff felt more comfortable completing PROM and understood that PROM is the first step in the DOCTORAL CAPSTONE EARLY MOBILIZATION 24 ABCDEF Bundle. All nursing staff reported feeling comfortable doing PROM and understood the importance (L. Link, personal communication, 2018). Clinical Practice Skills As stated in the Memorandum of Understanding (MOU), the secondary focus of the students DCE was to become competent with clinical skills in the ICU/CCU. The student has managed a full caseload since the third week of the DCE and is independent with both evaluations and treatments. However, since the student is not a licensed occupational therapist, clinical supervision and a co-signature of documentation is required by the clinical supervisor. About 90% of the occupational therapy orders are due to neurological deficits, including stroke. The student has also treated orthopedic injuries, general weakness, respiratory issues, mechanically ventilated patients, and patients with cancer. During this DCE, the student has also created folders on orthopedic injuries treated in the ICU/CCU for clinical reference. Continuous Quality Improvement During this DCE, the student used Continuous Quality Improvement (CQI) to modify the early mobility program to ensure quality of services met the site needs. Starting an early mobilization program will take an effort from the whole hospital and require continued support even after the student has completed this 16-week DCE. CQI was used by incorporating a reflective component. The student made necessary modifications to the program during the course of this DCE. Originally, the student was planning on creating a phase program to present to BHE on how to implement an early mobility program, however after discussion with the facility, the plan was changed. The student then assisted on working on the evidence-based portion of the ABCDEF Bundle (Early Mobilization and Exercise) and also played an active role on the early mobilization team to assist with implementing the Bundle. Furthermore, DOCTORAL CAPSTONE EARLY MOBILIZATION 25 adjustments/challenges with the original plan were discussed at the monthly intensivist meeting, at daily rounds, and to the rehabilitation director. An evidence-based protocol and program were used to guide this program, however there is still a gap in understanding early mobility at this hospital. The student also compiled and presented a binder of best evidence on early mobilization in the ICU/CCU and to occupational therapy staff. The student highlighted important sections of these articles for a quick reference. Inside the binder, a reference sheet of all relevant evidence the student gathered while doing the DCE was also included. The new rehabilitation director is an outpatient PT by background, therefore, she reported she does not understand the role of OT on an early mobility team (K. Thompson, personal communication, 2018). Thus, the student also complied best evidence on occupational therapy role in the ICU/CCU and role on an early mobility team for the rehabilitation director. The student identified that there was a lack of understanding on early mobility for both nursing staff and family members. Therefore, the student created a pamphlet describing OT and early mobility. This pamphlet was presented to the nursing staff and copies were left in waiting room for family members to read. Although early mobility is not a new concept, it is not the culture of BHE. A hospital close to BHE recently implemented an early mobility program in the ICU and family members were asking about what BHE offers. Therefore, this program will not only increase patient function, reduce hospital readmission rates, and improve overall functions of patients upon discharge. Communication Communication was a very crucial part of this DCE. The student was required to have good written, verbal, non-verbal communication. The student was expected to have professional written communication to complete patient documentation, but also for scheduling meetings via DOCTORAL CAPSTONE EARLY MOBILIZATION 26 email for biweekly and monthly early mobilization meetings. The student learned the importance of working on an interdisciplinary team and the importance of communication written and verbal communication between interprofessional disciplines. At these meetings, the student remained professional when communicating with the team about the E component of the Bundle (exercise and early mobility). The student was required to use professional verbal communication and with PTs and nurse managers. The concerns of the therapy departments were required to be relayed to the team in a respectful verbal manner, but also in a written document submitted to the critical nurse manager. Respectful verbal communication was also used when the student interacted with patients on a daily basis. For example, the student performed evaluations and interventions and was expected to share the outcomes of these with the client/family. The student also had to have professional written communication when creating home exercise programs for the client and be able to explain how to complete the exercises in a way the client would be able to understand. Non-verbal communication was used to read facial expressions of the patients for pain, fatigue, and dizziness during treatment and interventions. A PROM in-service was held for nursing staff where the student gave a presentation on general principles of PROM, what PROM was, and a visual demonstration of how to administer PROM. A handout on PROM was also made to keep at the nurses station in the ICU/CCU. This in-service required the student to have good written communication on the handouts, as well as good verbal communication during the PROM presentation to ensure comprehension. Overall, the student feels very comfortable with both written and verbal communication that will be required/expected for a future occupational therapy position. Overall Learning DOCTORAL CAPSTONE EARLY MOBILIZATION 27 This DCE focused on both program development and clinical practice skills that immensely prepared the student for future practice. The student used critical thinking skills to adapt the original goals/outcomes as necessary throughout the DCE. Critical thinking skills will be needed in a future occupational therapy position for treatments/evaluations. Throughout this DCE, the student was required to remain flexible and adaptive to the changing needs of the facility. The original plan was to create an evidence-based early mobility phase program, however after learning nursing staff was in the process of implementing the ABCDEF Bundle, the student then began working on the Bundle. Duties for the student also expanded as the facility realized they are still in the early design phase for implementing an early mobility program. The student learned how to manage a complex patient case load, as well as assisting with implementing a program. Working on the early mobilization team also required the student to attend biweekly and monthly meetings discussing how to implement the Bundle. These meetings provided the student with knowledge about working on a large team to accomplish a goal, as well as how to advocate to implement change. The student also had to advocate for occupational therapy by describing the role of OT on an early mobility team to therapies, nursing, family, patients, and critical care physicians. Being flexible is a beneficial quality to have for future practice, especially when working in acute care. Regarding patient care, the student was not always able to see patients when planned due to labs, tests, medical decline, or the patient was with another discipline. Therefore, the student had to change the plan for the day to accommodate these changes. Another skill the student learned was the importance of screening patients charts before completing an evaluation to see if the patient is appropriate for therapy. The student used evidence-based practice principles grounded in the PEOP theory when treating patients. DOCTORAL CAPSTONE EARLY MOBILIZATION 28 References Affleck, A., Lieberman, S., Polon, J., & Rohrkemper, K. (1986). Providing occupational therapy in an intensive care unit. American Journal of Occupational Therapy, 40(5), 323-332. American Occupational Therapy Association (AOTA). (2014). Occupational therapy practice framework: Domain and process (3rd ed.). 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Occupational therapy practice: Focusing on occupational performance. The American Journal of Occupational Therapy, 51(4), 277-288. Burtin, C., Clerckx, B., Robbeets, C., Ferdinande, P., Langer, D., Troosters, T., & ... Gosselink, R. (2009). Early exercise in critically ill patients enhances short-term functional recovery. Critical Care Medicine, 37(9), 2499-2505. doi:10.1097/CCM.0b013e3181a38937 Cole, M. & Tufano, R. (2008). Applied theories in occupational therapy: A practical approach. Thorofare, NJ: SLACK Incorporated. Dang, S. L. (2013). ABCDES of ICU: Early mobility. Critical Care Nursing Quarterly, 36(2), 163-168. DOI: 10.1097/CNQ.0b013e318283cf45 dos Santos, C. C., Herridge, M., & Batt, J. (2016). Early goal directed mobility in the ICU: 'something in the way you move'. Journal of Thoracic Disease, 8(8), E784-E787. doi:10.21037/jtd.2016.05.96 DOCTORAL CAPSTONE EARLY MOBILIZATION 30 Fraser, D., Spiva, L., Forman, W., & Hallen, C. (2015). Implementation of an early mobility program in an ICU. The American Journal of Nursing,115(12), 49-58. doi:10.1097/01.NAJ.0000475292.27985.fc Foreman, J. (2005). Ways we work. Occupational therapists' roles in intensive care. Occupational Therapy Now, 7(2), 15-18. Harris, C. L., & Shahid, S. (2014). Physical therapy-driven quality improvement to promote early mobility in the intensive care unit. Baylor University Medical Center Proceedings, 27(3), 203-207. Hodgson, C., Needham, D., Haines, K., Bailey, M., Ward, A., Harrold, M., & ... Berney, S. (2014). Feasibility and inter-rater reliability of the ICU Mobility Scale. Heart & Lung: The Journal of Critical Care, 43(1), 19-24. doi:10.1016/j.hrtlng.2013.11.003 Javaherian, H. A., Underwood, R. T., & DeLany, J. V. (2007). Occupational therapy services for individuals who have experienced domestic violence (statement). The American Journal of Occupational Therapy, 61(6), 704-709. Kress, J. P. (2009). Clinical trials of early mobilization of critically ill patients. Critical Care Medicine, 37(10 Suppl), S442-S447. doi:10.1097/CCM.0b013e3181b6f9c0 Mediware Information Systems. (2017). 3-hour rule defining an IRF/U level of intense therapy services. Retrieved from https://www.mediware.com/rehabilitation/blog/3-hour-ruledefining-an-irf-u-level-of-intense-therapy-services/ Mullins, P. M., Goyal, M., Pines, J. M., & Gerson, L. (2013). National growth in Intensive Care Unit admissions from emergency departments in the United States from 2002 to 2009. Academic Emergency Medicine, 20(5), 479-486. doi:10.1111/acem.12134 DOCTORAL CAPSTONE EARLY MOBILIZATION 31 Rogers, A. T., Bai, G., Lavin, R. A., & Anderson, G. F. (2017). Higher hospital spending on occupational therapy is associated with lower readmission rates. Medical Care Research and Review, 74(6), 668-686. doi:10.1177/1077558716666981 Scaffa, M. E., & Reitz, S. M. (2014). Occupational therapy in community-based practice settings. Philadelphia, PA: F. A. Davis Company. Sigler, M., Nugent, K., Alalawi, R., Selvan, K., Jim, T., Edriss, H., & ... Tseng, J. (2016). Making of a successful early mobilization program for a Medical Intensive Care Unit. Southern Medical Journal, 109(6), 342-345. doi:10.14423/SMJ.0000000000000472 Therapy Medlearn. (2002). 11-part B billing scenarios for PTs and OTs. Retrieved from https://www.cms.gov/Medicare/Billing/TherapyServices/downloads/11_Part_B_Billing_ Scenarios_for_PTs_and_OTs.pdf Weinreich, M., Herman, J., Dickason, S., & Mayo, H. (2017). Occupational therapy in the Intensive Care Unit: A systematic review. Occupational Therapy in Health Care, 31(3), 205-213. doi:10.1080/07380577.2017.1340690 Witkin, B. R., & Altschuld, J. W. (1995). Planning and conducting needs assessments: A practical guide. Thousand Oaks, CA, US: Sage Publications, Inc. Zomorodi, M., Topley, D., & McAnaw, M. (2012). Developing a mobility protocol for early mobilization of patients in a surgical/trauma ICU. Critical Care Research and Practice, 2012964547. doi:10.1155/2012/964547 DOCTORAL CAPSTONE EARLY MOBILIZATION Appendix A Early Mobilization Survey 32 DOCTORAL CAPSTONE EARLY MOBILIZATION 33 DOCTORAL CAPSTONE EARLY MOBILIZATION 34 DOCTORAL CAPSTONE EARLY MOBILIZATION Appendix B Occupational Therapys Role in Early Mobility Pamphlet 35  ...

... Running head: BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS Early Detection of Performance Deficits in Patients Receiving Breast Cancer-Related Treatment Ellen Thomas May, 2018 A capstone project submitted in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree from the University of Indianapolis, School of Occupational Therapy. Under the direction of the faculty capstone advisor: Katie Polo, DHS, OTR/L, CLT-LANA BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 1 A Capstone Project Entitled Early Detection of Performance Deficits in Patients Receiving Breast Cancer-Related Treatment Submitted to the School of Occupational Therapy at University of Indianapolis in partial fulfillment for the requirements of the Doctor of Occupational Therapy degree. By Ellen Thomas Occupational Therapy Student Approved by: Faculty Capstone Advisor Date Doctoral Capstone Coordinator Date Accepted on this date by the Chair of the School of Occupational Therapy: Chair, School of Occupational Therapy Date BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 2 Abstract Surgical treatment for breast cancer can lead to decreased upper extremity range of motion and strength, and increased risk of developing lymphedema. These factors can hinder an individuals ability to perform necessary activities of daily living such as dressing, bathing, and grooming. Such side effects post-operatively may also impair a patients ability to receive lifeextending radiation treatment due to difficulty achieving appropriate shoulder positioning, as well as ability to maintain positioning throughout the duration of treatment. The purpose of this screening program was to detect upper extremity performance deficits and signs of lymphedema in patients receiving breast-cancer related treatment in order to obtain a referral to outpatient occupational therapy. This screening program aimed to serve to a population in need, as a large percentage of breast cancer patients did not receive an OT consultation post-operatively. Patients that participated in the program were screened pre- and post-operatively. Screenings included measurements of ROM, grip strength, arm circumference, and the administration of the Patient Specific Functional Scale (PSFS) to identify deficits in ADLs/IADLs. The Kwans Arm Problem Scale (KAPS) was also utilized post-operatively to assess upper extremity occupational performance factors. Results showed that one out of the three participants presented with upper extremity deficits that greatly impaired occupational performance. Thus, they were referred to outpatient occupational therapy services to receive a more comprehensive evaluation. Upon completion of the doctoral capstone experience, the upper extremity screening program was presented to the therapy manager. This program is being considered for future implementation within the outpatient therapy department. BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 3 Early Detection of Performance Deficits in Patients Receiving Breast-Cancer Related Treatment Literature Review According to the American Cancer Society (2018), an estimated 268,670 individuals, including both women and men, will be diagnosed with breast cancer in 2018. There are approximately 3 million women living with breast cancer currently in the United States, due to improvements in treatment and early detection (American Society of Clinical Oncology, 2017). As more women and men are battling this disease each year, there is a need to address impairments and symptoms related to receiving breast cancer-related treatment. This can be accomplished through utilization of the Health Promotion Applied Theory with a special focus on tertiary prevention. The Health Promotion Applied Theory focuses on enabling clients to increase control and to improve their health though a client-centered approach. Tertiary prevention relates to patients that are already in a state of ill health, and occupational therapy (OT) interventions are utilized to restore, remediate, maintain, and modify activities (Cole & Tufano, 2008). Occupational therapists can play an essential role in addressing occupational performance deficits created by the side-effects of cancer treatment. Research shows that treatment for breast cancer, including surgery and radiation therapy, can lead to a decrease in range of motion (ROM) and strength, increase in pain, and risk for developing lymphedema on the involved side which can all impact functional use of the upper extremity (Lattanzi et al., 2010; Lee, Kilbreath, Refshauge, Herbert, & Beith, 2008). Range of motion at the shoulder joint is necessary for activities of daily living (ADLs) such as combing hair, reaching overhead for objects, bathing, and feeding tasks (Rundquist, Obrecht, & Woodruff, 2009). These side effects post-operatively may also impair an individuals ability to receive radiation treatment due to inability to place the shoulder in the appropriate position. A common BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 4 position is 90 degrees flexion and abduction, as well as maximal external rotation for up to approximately 30 minutes (Campbell, El-Sayed, Graham, Noble, Riley, & Slattery, 2017). Limited ROM has been found to negatively influence functional capacity and quality of life in breast cancer patients, which can also lead to a decline in mental and emotional well-being (Cho, Do, Jung, Kwon, & Jeon, 2016). Current evidence suggests that assessment of shoulder impairments and referrals for occupational therapy treatment, even when limitations may seem subtle, are vital components of care for patients with breast cancer (Lattanzi et al., 2010; Levangie & Drouin, 2009; OToole et al., 2015). OToole et al. (2015) and Stout et al. (2012) identified a need for prospective screening regarding lymphedema, pain, ROM, strength, performance, and quality of life to enable early detection and intervention. Lattanzi and investigators (2010) conducted a research study to explore the experience of clients undergoing occupational therapy treatment for breast cancer-related impairments, as well as to identify recommendations for practice. A few themes that emerged included challenges with obtaining referrals, challenges regarding patient education, and improvements in functional impairments after participating in occupational therapy (Lattanzi et al., 2010). Many clients noted that they had to wait until they had swelling in their arm or loss of total ROM before obtaining a referral to therapy (Lattanzi et al., 2019). Other clients reported that they did not receive instructions regarding healing and functional use after surgery, and avoided shoulder movement to minimize pain without knowing the detrimental effects (Lattanzi et al., 2010). Lastly, participants stated that their limitations significantly affected their ability to perform ADLs, however, participation in therapy helped combat performance deficits. In conclusion, researchers recommend advocating for referrals for occupational therapy consultation (Lattanzi et al., 2010). BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 5 There is a lack of standardized screening for early detection of breast cancer-related lymphedema (BCRL) according to Sun et al. (2016). Assessing signs and symptoms of lymphedema is vital in patients receiving breast cancer-related treatment, as it is estimated that early-stage BCRL is one-fifth of the cost of late-stage BCRL (Sun et al., 2016). Though, there is lack of standardization in BCRL quantification, lymphedema is defined as a 2 centimeter or more increase of any circumference on the arm of the affected side compared to the arm on the non-affected side (Nesvold, Fossa, Holm, Naume, & Dahl, 2009). Sato, Ishida, and Ohuchi (2014) suggest measuring arm circumference at two points. Forearm circumference can be measured 10 centimeters distal to the lateral epicondyle and upper arm circumference can be measured 15 centimeters proximal to the lateral epicondyle (Sato, Ishida, & Ohuchi, 2014). There are also self-assessments that have been developed to address both lymphedema and upper extremity deficits, such as the Kwans Arm Problem Scale (KAPS; Nesvold, Fossa, Naume, & Dahl, 2009). The KAPS is a 13 item self-rating form with two subscales that was developed specifically for breast cancer patients (Nesvold, Fossa, Naume, & Dahl, 2009). The KAPS activities of daily living subscale includes questions regarding ability to brush hair, pull on a sweater, fasten a bra, complete a back zipper, and reach overhead. The KAPS problem subscale includes questions about pain, stiffness, swelling, numbness, and movement (Nesvold, Fossa, Naume, & Dahl, 2009). The total KAPS and both subscales have been tested to show high internal consistency. The KAPS has also been confirmed for concurrent validity when compared to the BR23, which is also an assessment specifically designed for this population (Nesvold, Fossa, Naume, & Dahl, 2009). In another study, the Kwans Arm Problem Scale also showed good psychometric properties with both convergent and discriminant validity, as well as high reliability in the sample of breast cancer survivors that participated (Nesvold, Fossa, Holm, BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 6 Naume, & Dahl, 2009). The Patient Specific Functional Scale (PSFS) is also a self-assessment that allows participants to select meaningful occupations and rate their performance in order to detect change regarding the effect of a treatment or intervention. The PSFS allows patients to identify up to three ADLs that they are having difficulty performing, as well as rate their level of difficulty on a scale of 0-10 (Campbell et al., 2012). Research suggests that the PSFS is valid and sensitive regarding measurement of change in breast cancer survivors post-operation, thus should be included in the model for prospective surveillance (Campbell et al., 2012). Campbell et al. suggests use of the KAPS or PSFS, as well as shoulder ROM and hand grip strength when using a prospective surveillance model. Goniometer-based measurements are commonly utilized to assess shoulder ROM (Levangie & Droulin, 2009; Nesvold, Fossa, Holm, Naume, & Dahl, 2009; Sato et al., 2014; Shamley et al., 2007). Levangie and Droulin (2009) completed a systematic review to explore the effects of breast cancer treatments on shoulder function where several studies indicated that a 20 degree difference from the contralateral arm or from full ROM were considered to be associated with decreased ability to participate in daily activities. Lee et al. (2008) also recommends use of standardized tools, such as dynamometers to measure strength, in order to assess impairments and measure outcomes as accurately as possible. Use of standardized assessments is important not only for detecting performance deficits, but also for the justification of occupational therapy services for third party payers (Harrington, Michener, Kendig, Miale, & George, 2014). In conclusion, implementation of a screening protocol for patients receiving breast cancer-related treatment allows for a proactive approach regarding lymphedema and early detection of upper extremity impairments that may hinder participation in desired occupations. Evidence concludes screenings should assess shoulder range of motion, strength, arm BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 7 circumference, and occupational performance (Campbell et al., 2012; OToole et al., 2015; Stout et al., 2012). Detection of physical impairments allows for early treatment via rehabilitation care, including occupational therapy services. Rehabilitation care can reduce short and long-term arm morbidity (Stout et al., 2012), allowing survivors to participate in meaningful occupations and activities in order to achieve the highest quality of life possible. Screening and Evaluation Individuals with breast cancer at this site are not screened for upper extremity deficits that may impair occupational performance throughout the course of treatment. Only patients who undergo general anesthesia for their procedure, which most often includes mastectomies, receive post-operation education as they are required to stay overnight in the hospital. These women and men receive an OT consult on the day of their discharge regarding education on exercises that will aid in restoring range of motion for participation in necessary daily activities, as well as education on the signs and symptoms of lymphedema. However, the portion of the breast cancer population that undergo breast-conserving surgery, including lumpectomy or partial mastectomy, leave the same day and do not receive any type of OT treatment in order to combat occupational performance deficits. Regardless of whether patients receive a mastectomy or breast-conserving surgery; baseline measurements regarding ROM, strength, or lymphedema are not obtained. Patients are not screened post-operatively at any point in their treatment to detect impairments in motor skills required for participation in activities of daily living. Through multiple assessments, a need for a screening protocol for early detection of impairments as well as lymphedema was identified. Current evidence suggests that implementation of a prospective surveillance model for patients with breast cancer regarding physical rehabilitation should be utilized as a more holistic BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 8 approach to survivorship health care (OToole et al., 2015; Stout et al., 2012). Stout et al. proposed a model where patients are assessed pre-operatively, early post-operatively, and at follow-up appointments for ongoing surveillance. Research concluded that common impairments after breast cancer-related surgery and treatment include pain, lymphedema, and reduced ROM and strength necessary for participation in meaningful occupations (Lattanzi et al., 2010; Lee, Kilbreath, Refshauge, Herbert, & Beith, 2008). Thus, a screening protocol should assess ROM, strength, arm circumference, pain, and occupational performance (Campbell et al., 2012; OToole et al., 2015; Stout et al., 2012). Campbell et al. also suggests use of standardized outcome measures such as the KAPS or PSFS. Both of these tools allow the patient to assess their performance skills to complete daily activities such as dressing, grooming, meal preparation, home management, etc. Service delivery would include a one-on-one model. Screenings would be performed on an individual basis within the breast cancer population specifically, and any indication of impairment would justify the need for a referral to occupational therapy services for a comprehensive evaluation. Though this site previously lacked a screening protocol for upper extremity impairments and lymphedema, there is a screening program utilized to assess cancer-related fatigue in the emerging area of practice of oncology. While receiving cancer-related treatment at the cancer center, patients are asked by a nurse to rate their fatigue on a scale of 0 to 10, with 0 indicating no fatigue and 10 indicating worst possible fatigue. Individuals that rate their fatigue at a 4 or above are contacted via the outpatient therapy center to offer a free screening in order to determine whether they are appropriate for the cancer-related fatigue program. The screening lasts approximately 30 minutes and consists of a variety of special tests including a 6 Minute Walk Test, 2 Minute Step Test, 30 Second Sit to Stand Test, and Gait Speed Test. The Patient BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 9 Specific Functional Scale is a self-assessment that is used as an outcome measure tool within the program. Impairments in one or more of the special tests validate the need for a referral to the program within the outpatient therapy clinic. The upper extremity screening program would contain similar characteristics to the fatigue screening, as the purpose of the screen would be to detect early signs of lymphedema and impairments in regards to patients abilities to perform daily activities in order to obtain a referral to outpatient therapy. The upper extremity screening program would also utilize standardized assessments in order to identify impairments and measure outcomes in individuals with breast cancer, such as PSFS or KAPS. This screening protocol would differ from the fatigue screening, as it would be conducted in two phases, including pre-operatively and postoperatively. Though, the upper extremity screening program would be geared towards only breast cancer patients versus the entire oncology population. An upper extremity screening program would greatly benefit this site in terms of increasing referrals to outpatient therapy, as well as helping patients served to achieve the highest quality of life possible through maximal occupational performance. Implementation Program Planning The implementation of the upper extremity screening program has included many phases of planning, organizing, and developing. The pre-planning portion of this upper extremity screening program included gathering evidence-based research regarding the need for occupational therapy within the realm of oncology, and specifically with breast cancer patients. Multiple needs assessments were performed by interviewing different members of the outpatient therapy team including a certified lymphedema therapist/occupational therapist and physical BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 10 therapist whom created a cancer-related fatigue (CRF) program at this site. The certified lymphedema therapist noted a need for referrals for breast cancer patients that showed any signs or symptoms of lymphedema in order to begin receiving treatment as early as possible. The physical therapist identified a need for screenings of upper extremity performance deficits for breast cancer patients, as many individuals who were referred to the CRF program were unable to participate due to a frozen shoulder on the affected side. Perspectives from a breast health navigator, social workers, radiation therapist, and palliative care nurse practitioner were also obtained. This was done in order to gain insights from multiple disciplines regarding needs and an appropriate timeline for a screening protocol for breast cancer patients. In conclusion, these health care professionals deemed a screening program appropriate pre- and post-operatively, as well as potentially further into treatment for breast cancer patients in order to increase occupational performance and quality of life throughout all stages of treatment and survivorship. Literature was gathered regarding detection of upper extremity impairments and lymphedema after receiving breast cancer related treatment including surgery and radiation therapy, where a large need for a screening program was identified (Lattanzi et al., 2010; Levangie & Drouin, 2009; OToole et al., 2015; Stout et al., 2012). Evidence was also collected regarding deficits that individuals who receive breast cancer-related treatment often exhibit, as well as appropriate outcome measures to assess performance deficits for inclusion within the screening program. Common deficits found in the literature included decreased range of motion and strength, lymphedema, and pain in the upper extremity on the affected side (Campbell et al., 2012; OToole et al., 2015; Stout et al., 2012). In conclusion, it was decided that range of motion, grip strength, and arm circumference measurements would be incorporated within the screening process. BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 11 The organizing phase consisted of obtaining the assessment tools for use within the screening program. The Kwans Arm Problem Scale and Patient Specific Functional Scale were identified as potential outcome measures, as they have all been considered reliable and valid tools when utilized with breast cancer patients (Campbell et al., 2012; Nesvold, Fossa, Naume, & Dahl, 2009; Stratford, Binkley, & Stratford, 2001). The PSFS was readily available online and was chosen for use within the screening program, as it allows participants to select meaningful occupations and is most time efficient. The KAPS was not available via the internet; however, the authors email was obtained via a research article. The author, Winkle Kwan, granted permission for use of the assessment tool within the screening program and provided an attachment with the tool itself. The KAPS will be utilized as a secondary outcome measure when screening patients post-operatively. Next, the development of this trial upper extremity screening program was completed through the use of Microsoft Excel and Microsoft Word in order to create the screening sheet. Pre-operative and post-operative range of motion, grip strength, arm circumference, and PSFS templates were created in Excel and merged within Word in order to easily record measurements throughout the screening process (See Appendix A). A participation waiver was also developed and approved through the legal department within the hospital to be utilized for the program (See Appendix B). Lastly, a proposal was developed in order to market the trial screening program and to gain permission from one of the breast surgeons within the hospital for implementation (See Appendix C). Implementation of the Upper Extremity Screening Program The pre-operation screenings took place within one of the breast surgeons offices, where patients with breast cancer attended their pre-operative appointments for surgical planning. A BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 12 nurse practitioner greeted the patient in the examination room and offered the free screening after vitals were obtained. If the patient was interested in being screened, the doctoral student and occupational therapist were then allowed to enter the room to begin the assessment. First, the patient was asked to read and sign a participation waiver for the legal department of the hospital. Next, the patient was seated on the exam table and asked to remove any long-sleeve garments to ensure accuracy of measurements. Range of motion measurements were obtained via a goniometer for shoulder flexion, abduction, external rotation, and internal rotation on both arms. Grip strength was then assessed using a dynamometer three times each hand in order to acquire an average for each arm. A tape measure was used to obtain circumference measurements on both arms at three different points each for a total of six measurements. Wrist girth, forearm girth (6 centimeters distal from the lateral epicondyle), and upper arm girth (9 centimeters proximal from the lateral epicondyle) were measured in centimeters. Lastly, the PSFS was utilized and patients were asked if they were having difficulty performing any necessary or desired activities due to their breast cancer at the time. The post-operation screening consisted of the same process as the pre-operation screening; however patients did not need to fill out another participation waiver. Range of motion, grip strength, and arm circumference were all re-measured for both arms. The PSFS was also completed once again regarding any activities of daily living patients were having difficulty participating in after their surgery. The Kwans Arm Problem Scale was also completed at this time. Pre-operation measurements, post-operation measurements, and pre- and post-operation PSFS scores were compared in order to identify any deficits or signs of lymphedema present. Noted impairments were communicated to the patients and an outpatient therapy clinic brochure was provided if deemed necessary. This was done in order to acquire an occupational therapy BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 13 referral to the outpatient therapy department at this site to reduce occupational performance deficits within these patients. Leadership Skills and Staff Development A variety of leadership skills were required for the planning and implementation of the upper extremity screening program. Communication skills were crucial for the planning phases in order to interview hospital personnel and collaborate with supervising occupational therapists within the inpatient therapy department. Much communication occurred via email in order to state the purpose of an interview as well as to set up meeting times, thus it was imperative that communication was clear and professional. Leadership skills were also important in order to advocate for the unique profession of occupational therapy, and how upper extremity impairments and lymphedema can affect occupational performance. Flexibility was another essential skill, as many individuals were only able to meet for brief periods of time throughout the day or on certain days of the week. Meeting times would change frequently at the last minute due to scheduling conflicts. Motivation and persistence were also demonstrated throughout this process, as it was difficult to make initial contact with the breast surgeons in order to gain permission for implementation. These doctors are very busy serving patients, thus multiple emails and follow up phone calls were required in order to set-up a meeting. Initially, staffing for implementation of the program included only the doctoral student and two supervising inpatient occupational therapists. However, the nurses at the breast surgeons office were educated on the purpose of the screening program, as they are the individuals initially offering the screening to patients. The upper extremity screening program was considered as a trial program at this facility. A proposal for continuation of the program was BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 14 formulated for this site upon completion and presented to the therapy department manager for future service provision. Outcomes and Discontinuation Program Results and Considerations The trial screening program allowed for assessment of three female participants pre- and post-operatively. The type of procedure, lymph nodes removed, body mass index (BMI), age, and hand dominance were all recorded for comparative data (See Appendix D). Results showed that one out of the three (approximately 33%) participants demonstrated upper extremity deficits which hindered ability to perform necessary daily tasks. This participant (participant 2) in particular exhibited a considerable loss in range of motion (60 degree decrease in flexion, 60 degree decrease in abduction), decreased grip strength (10 pounds), and decreased ability to perform daily tasks (6 point change in PSFS total score) with the affected upper extremity. Activities that participant 2 noted difficulties performing via the PSFS included completing laundry, unloading the dishwasher, and carrying out cooking tasks. Through utilization of the KAPS, this participant noted that her pain in the affected arm was a 4 when rated on a scale from 1 (no pain) to 5 (my arm is very painful). She indicated that brushing her hair and pulling a sweater overhead with the affected arm were a moderate problem. She also rated her ability to reach overhead as unable to perform. The other two participants (participants 1 and 3) showed minimal loss in range of motion and reported that they had no difficulty participating in desired roles and occupations when completing the PSFS. Both participants rated their ability to pull a sweater overhead as a slight problem when completing the ADL subscale of the KAPS. Participant 3 also rated numbness in her arm as a 2 on of a scale of 1 (no numbness) to 5 (my BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 15 arm is completely numb). None of the participants exhibited any signs or symptoms of lymphedema post-operatively when examining arm circumference (See Appendix E). Results from the trial screening program suggest that individuals who undergo a partial mastectomy or more extensive surgeries may be at a greater risk for upper extremity impairments than those who only undergo a lumpectomy. A potential factor that may be considered in the future for individuals who endure a partial mastectomy is hand dominance. The participant (participant 2) that exhibited decreased range of motion, strength, and occupational performance post-operatively noted that her surgery was performed on her non-dominant side. Thus, she was able to compensate when performing daily activities by using only her dominant arm. Another factor to consider for future implementation is BMI, as the participant with performance deficits also had a considerably higher BMI than the other participants. Potential Program Continuation The discontinuation phase of the program began as the post-operative screenings were completed for individuals who participated in the pre-operative screenings. As the program progressed to the outcome phase, a proposal was created for the continuation within the outpatient occupational therapy center at this site upon completion of the doctoral capstone experience (See Appendix F). Evidence-based research as to why a prospective surveillance model for patients with breast cancer is an essential component to survivorship care was included in the program proposal. The targeted population and logistics of this program were also clearly defined. The screening sheet and outcome measures utilized within the program were provided as well. Lastly, the proposal included estimated cost and forecasted revenue for the outpatient therapy clinic in order to prove the programs worth. This program proposal was presented to the therapy manager at this site in order to direct administrative changes appropriately. The therapy BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 16 manager was very receptive to this information and believed utilization of the upper extremity screening program would be a great way to maximize outcomes for patients with breast cancer, as well as to increase growth in regards to outpatient OT clientele. One future program change that will be made includes that all pre-operative and postoperative screenings will be performed at the outpatient occupational therapy center instead of the breast surgeons offices. This change in location is necessary in order to decrease staffing costs; however, it will be imperative for the breast surgeons to encourage their patients to schedule these screenings. It is not cost efficient for this site to hire personnel only to perform the screenings in the breast surgeons offices, as they are only in office on specific days and not all patients treated are breast cancer patients, thus screenings are not warranted each day. The outpatient therapy center already has the personnel to perform scheduling for these individuals, as well as occupational therapists qualified to perform the screenings. Therefore, this will improve the quality of services, as the outpatient therapy center already has the tools required such as mat tables, goniometers, dynamometers, and measuring tapes to perform the screenings. Tools that were used throughout the program were borrowed from the inpatient rehab center and had to be transported to the breast surgeons office for each screening, and then promptly returned. This location change will also assist with improving quality of services, as occupational therapists performing the screenings may also be the therapists providing treatment to patients if a referral is necessary. This will aid in establishing rapport with these potential patients, and the OT practitioners will be able to explain what a comprehensive evaluation and treatment interventions may look like depending upon the patients needs. This program is currently being considered for future implementation within the outpatient therapy clinic. BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 17 According to the American Occupational Therapy Association (AOTA), the Vision 2025 states occupational therapy maximizes health, well-being, and quality of life for all people, populations, and communities through effective solutions that facilitate participation in everyday living (AOTA, 2017). As more women and men are conquering breast cancer due to improvements in treatment and detection, survivorship care is becoming a routine component in healthcare in order to maximize well-being and quality of life (Stout et al., 2012). The upper extremity screening program is responding to the oncology societys needs by addressing upper extremity occupational performance deficits that may occur due to breast cancer-related treatment, such as surgery. The continuation of the screening program will allow for early detection of these impairments in order to receive occupational therapy treatment before deficits begin to hinder occupational participation and performance. Early detection will also focus on prevention of musculoskeletal disorders that are prevalent in individuals who receive breast cancer-related surgery, such as adhesive capsulitis, which can also impact ones ability to sleep or perform simple self-care activities (Jeong, Sim, Hwang, & Kim, 2010). By implementing this screening and referral process to occupational therapy at the outpatient center, patients with breast cancer will have the opportunity to restore their ability to participate in necessary roles and occupations. This may include participation in the cancer-related fatigue program or ability to receive life extending treatments, such as radiation therapy. In conclusion, the screening program aims to result in restoring participation in meaningful occupations which can overall impact quality of life in a positive manner in alignment with AOTAs Vision 2025. Overall Learning Verbal, written, and nonverbal interactions took place with multiple different individuals, including colleagues, fellow healthcare providers, patients, and patients families BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 18 throughout this doctoral capstone experience. Verbal communication was used primarily when interacting with colleagues, as they were readily available at all times while on site and were able to give immediate feedback. Weekly face-to-face meetings took place with the supervising occupational therapists in order to communicate items that had been completed, tasks that still needed to be accomplished, and a plan for the upcoming week. Both written and verbal communication was utilized when contacting other healthcare providers including the breast health navigator, palliative care nurse practitioner, radiation therapist, outpatient therapists, therapy managers, cancer center staff, social workers, breast surgeons and their nursing staff, and other disciplines. This was done through email, phone calls, and face-to-face meetings. Professional and concise communication was required in order to obtain and convey pertinent information, as many stakeholders had limited available time. Patients and their significant others/families were communicated with via nonverbal and verbal interactions. It was important to be aware of the patients and familys demeanor when walking into a room, as this was a difficult time learning of a new breast cancer diagnosis and discussing surgical treatment options. Nonverbal communication skills were used to provide emotional support, such as establishing good eye contact and offering a smile or rub on the back when appropriate. Nonverbal communication skills were also used via demonstration for proper positioning of the upper extremities throughout the screening process. These verbal, written, and nonverbal communication skills will continue to be utilized in future practice when working with clinicians, healthcare practitioners, patients, and management personnel. Other skills learned that will be useful in future practice regardless of setting includes research, clinical practice, and abilities regarding program development and implementation. Program development is a timely process and requires collaboration from many BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 19 disciplines in order to be successful. Program development and implementation also requires formation of a business plan in order to show forecasted revenue for sustainability, as well as creation of a proposal for marketing to stakeholders. Clinical practice skills that were gained through conducting these screenings will also be useful for identifying deficits and relating how they may be impacting occupational participation and performance. Lastly, occupational therapys role within the oncology population and survivorship care will continue to be advocated for within acute, outpatient, and community settings to help these individuals achieve the maximum quality of life possible. BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 20 References American Cancer Society. (2018). Estimated Number of New Cases for the Four Major Cancers by Sex and Age Group. Retrieved from https://www.cancer.org/content/dam/cancerorg/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/estimatednumber-of-new-cases-for-the- four-major-cancers-by-sex-and-age-group-2018.pdf American Society of Clinical Oncology. (2017). Breast Cancer: Statistics. Retrieved from https://www.cancer.net/cancer-types/breast-cancer/statistics Campbell, B., El-Sayed, A., Graham, K., Noble, C., Riley, N., & Slattery, A. (2017). Physiotherapy and cancer treatment. Physiopedia. Retrieved from https://www.physiopedia.com/Physiotherapy_and_cancer_treatment Campbell, K. L., Pusic, A. L., Zucker, D. S., McNeely, M. L., Binkley, J. M., Cheville, A. L., & Harwood, K. J. (2012). A prospective model of care for breast cancer rehabilitation: Function. Cancer, 118(8), 2300-2311. Cho, Y., Do, J., Jung, S., Kwon, O., & Jeon, J. Y. (2016). Effects of a physical therapy program combined with manual lymphatic drainage on shoulder function, quality of life, lymphedema incidence, and pain in breast cancer patients with axillary web syndrome following axillary dissection. Support Care Cancer, 24, 2047-2057. doi:10.1007/s00520015-3005-1 Cole, M. & Tufano, R. (2008). Applied theories in occupational therapy: A practical approach. Thorofare, NJ: SLACK Incorporated. BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 21 Harrington, S., Michener, L. A., Kendig, T., Miale, S., & George, S. Z. (2014). Patient-reported upper extremity outcomes measures used in breast cancer survivors: A systematic review. Archives of Physical Medicine and Rehabilitation, 95(1), 152-162. doi:10.1016/j.apmr.2013.07.022 Jeong, H. J., Sim, Y. J., Hwang, K. H., & Kim, G. C. (2010). Causes of shoulder pain in women with breast cancer-related lymphedema: A pilot study. Yonsei Journal of Medicine, 52(4), 661-667. Lattanzi, J. B., Giuliano, S., Meehan, C., Sander, B., Wootten, R., & Zimmerman, A. (2010). Recommendations for physical and occupational therapy practice from the perspective of clients undergoing therapy for breast cancer-related impairments. Journal of Allied Health, 39(4), 257-264. Lee, T. S., Kilbreath, S. L., Refshauge, K. M., Herbert, R. D., & Beith, J. M. (2008). Prognosis of the upper limb following surgery and radiation for breast cancer. Breast Cancer Research and Treatment, 110, 19-37. doi:10.1007/s10549-007-9710-9 Levangie, P. K., & Drouin, J. (2009). Magnitude of late effects of breast cancer treatments on shoulder function: A systematic review. Breast Cancer Research and Treatment, 116, 115. doi:10.1007/s10549-008-0246-4 Nesvold, I. L., Fossa, S. D., Holm, I., Naume, B., & Dahl A. A. (2009). Arm/shoulder problems in breast cancer survivors are associated with reduced health and poorer physical quality of life. Acta Oncologica, 49(3), 347-353. Nesvold, I. L., Fossa, S. D., Naume, B., & Dahl A. A. (2009). Kwans arm problem scale: psychometric examination in a sample of stage II breast cancer survivors. Breast Cancer Research and Treatment, 117(2), 281-288. BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 22 OToole, J. A., Ferguson, C. M., Swaroop, M. N., Horick, N., Skolny, M. N., Brunelle, C. L., Miller, C. L., Jammallo, L. S., Specht, M. C., & Taghian, A. G. (2015). The impact of breast cancer-related lymphedema on the ability to perform upper extremity activities of daily living. Breast Cancer Research and Treatment, 150, 381-388. doi:10.1007/s10549015-3325-3 Rundquist, P., Obrecht, C., Woodruff, L. (2009). Three-dimensional shoulder kinematics to complete activities of daily living. American Journal of Physical Medicine & Rehabilitation, 88(8), 623-629. doi:10.1097/PHM.0b013e3181ae0733 Sato, F., Ishida, T., & Ohuchi, N. (2014). The perioperative educational program for improving upper arm dysfunction in patients with breast cancer: A controlled trial. The Tohuku Journal of Experimental Medicine, 232, 115-122. Shamley, D. R., Srinanaganathan, R., Weatherall, R., Oskrochi, R., Watson, M., Ostlere, S., & Sugden, E. (2007). Changes in shoulder muscle size and activity following treatment for breast cancer. Breast Cancer Research and Treatment Journal, 106, 19-27. doi:10.1007/s10549-006-9466-7 Stratford, P. W., Binkley, J. M., & Stratford, D. M. (2001). Development and initial validation of the upper extremity functional index. Physiotherapy Canada, 53(4), 259-267. Stout, N. L., Binkley, J. M., Schmitz, K. H., Andrews, K., Hayes, S. C., Campbell, K. L., McNeely, M. L., Soballe, P. W., Berger, A. M., Cheville, A. L., Fabian, C., Gerber, L. H., Harris, S. R., Johansson, K., Pusic, A. L., Prosnitz, R. G., & Smith, R. A. (2012). A prospective surveillance model for rehabilitation for women with breast cancer. Cancer, 188(8), 2191-2200. doi:10.1002/cncr.27476 BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 23 Sun, F., Skolny, M. N., Swaroop, M. N., Rawal, B., Catalano, P. J., Brunelle, C. L., Miller, C. L., & Taghian, A. G. (2016). The need for preoperative baseline arm measurement to accurately quantify breast cancer-related lymphedema. Breast Cancer Research and Treatment Journal, 157, 229-240. doi.10.1007/s10549-016-3821-0 BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS Appendix A. Screening Sheet 24 BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 25 BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 26 Appendix B. Upper Extremity Screening Program Participation Waiver Upper Extremity Screening Program Participation Waiver I understand that my involvement in the Upper Extremity Screening program at The Christ Hospital is voluntary. I understand that I may be asked questions and to participate in certain tests to screen for signs of dysfunction. I understand that participation could pose the risk of injury. I understand it is my responsibility to seek and continue to receive medical evaluations from my personal physician to determine if there are any medication conditions, medications, or injuries that could limit my participation in the screening program or future therapy treatment interventions. I also understand that this program does not in any way constitute a comprehensive occupational therapy evaluation and/or treatment prescription procedures. I understand that I am voluntarily participating in an Upper Extremity Screening program and I assume the risk of any injury, loss, and/or adverse health consequences. I hereby release The Christ Hospital, Physical and Occupational Therapy Center locations, outpatient services and their offices, directors, employee, and their affiliated entities from any and all claims, liabilities, and demands of any kind arising from injury or adverse consequences related to my voluntary enrollment in the Upper Extremity Screening program at The Christ Hospital. Subject to these conditions, I affirm that I have read, understand, and agree to all the terms set forth above, and enroll voluntarily at my own risk. Name: (print)_______________________________________________________ Signature:__________________________________________________________ Date:______________________________________________________________ Date of Birth:_______________________________________________________ Clinical Staff Name:__________________________________________________ BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 27 Appendix C. Implementation Proposal Proposal: Prospective Surveillance for Detecting Upper Extremity Performance Deficits in Breast Cancer Patients By: Ellen Thomas, Doctoral Student of Occupational Therapy, University of Indianapolis Research concludes that treatment for breast cancer can lead to a decrease in active range of motion and strength, increase in pain, and risk for developing lymphedema (OToole et al., 2015; Stout et al., 2012). Rotator cuff tendonitis and adhesive capsulitis are also prevalent among individuals who undergo breast surgery (Mafu, September, & Shamley, 2018). Decreased range of motion and strength, pain, and lymphedema can hinder an individuals ability to perform necessary activities of daily living such as dressing, bathing, and grooming (Rundquist, Obrecht, & Woodruff, 2009). These side effects post-operatively may also impair a patients ability to receive radiation treatment due to difficulty achieving and maintaining appropriate shoulder positioning (Campbell, El-Sayed, Graham, Noble, Riley, & Slattery, 2017; Conneely & Weber, 2007). Early detection of these impairments is a vital component to survivorship care. Target population: Patients undergoing breast surgery as a result of breast cancer Goal: To detect upper extremity impairments in patients receiving breast cancer-related treatment in order to warrant the need for an OT referral to address limitations that may hinder occupational participation and ability to receive life-extending oncology treatments. Process: Patients will be assessed pre-operatively and approximately 2-4 weeks post-operatively in order to detect early impairments regarding range of motion, strength, occupational performance, and signs/symptoms of lymphedema. 1) Shoulder AROM via goniometer a. Measurements will be performed seated regarding flexion, abduction, IR, and ER of both affected and non-affected arm b. Impairment noted if 20 degrees difference between arms or 20 degrees from normal or baseline measurements c. Normal ROM includes: flexion 180 degrees, abduction 180 degrees, internal rotation 70 degrees, external rotation 90 degrees 2) Grip strength via dynamometer a. Average grip strength of 3 trials for each hand will be measured b. Impairment noted if below norm for age group BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 28 3) Arm circumference for detection of lymphedema a. Wrist: measure at wrist crease b. Forearm girth: 6 cm distal from elbow crease c. Upper arm girth: 9 cm proximal from elbow crease d. Compare both affected and non-affected, with possible signs of lymphedema if 2 or more cm difference 4) Patient Specific Functional Scale (PSFS) a. Clinical measure to assess change related to the effect of a treatment or intervention (i.e. surgery) for an individual b. Patients will identify 3 activities of daily living to rate difficulty on scale of 010 c. Research supports use of PSFS as a valid and sensitive tool to detect change in breast cancer survivors after surgery 5) Kwans Arm Problem Scale (KAPS) a. Self-assessment with problem subscale and ADL subscale b. Designed specifically for patients with breast cancer post-operatively c. Tested to show high internal consistency, reliability, and discriminant validity within this population Average time of screen: 13 minutes Contacts: Ellen Thomas, SOT Kristin Blackham, OTD, OTR/L, CLT Justin Gill, OTR/L, Supervisor of Occupational Therapy Department BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 29 Appendix D. Participant Factors Participant Factors Participant 1 Participant 2 Participant 3 Procedure Lymph nodes removed R lumpectomy + sentinal node biopsy L partial mastectomy + sentinal node biopsy + intraoperative radiation therapy L lumpectomy + sentinal node biopsy 2 1 1 Age BMI Dominant arm 51 y.o. 26.8 (overweight) 55 y.o. 47.4 (obese) 68 y.o. 31.6 (obese) R R R Appendix E. Program Results Comparing Pre- to Post- Screening Results Participant 1 Range of Motion No deficits noted Grip Strength No deficits noted Arm Circumference No deficits noted PSFS total score difference0 KAPS score 15/65 Referral to OT No Participant 2 Participant 3 flexion 60* decrease; abduction 60* decrease No deficits noted 10# decrease No deficits noted No deficit noted No deficits noted 6 0 34/65 15/65 Yes *PSFS 2 pt change in total score or 3 pt change in single activity is significant *KAPS (higher score = decreased function) No BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 30 Appendix F. Continuation Proposal Prospective Surveillance for Detecting Upper Extremity Limitations in Breast Cancer Patients By: Ellen Thomas, Student of Occupational Therapy The Need for an Upper Extremity Screening Program Research concludes that treatment for breast cancer can lead to a decrease in active range of motion and strength, increase in pain, and risk for developing lymphedema (OToole et al., 2015; Stout et al., 2012). Rotator cuff tendonitis and adhesive capsulitis are also prevalent among individuals who undergo breast surgery (Mafu, September, & Shamley, 2018). Decreased range of motion and strength, pain, and lymphedema can hinder an individuals ability to perform necessary activities of daily living such as dressing, bathing, and grooming (Rundquist, Obrecht, & Woodruff, 2009). These side effects post-operatively may also impair a patients ability to receive radiation treatment due to difficulty achieving and maintaining appropriate shoulder positioning (Campbell, El-Sayed, Graham, Noble, Riley, & Slattery, 2017; Conneely & Weber, 2007). Early detection of these impairments is a vital component to survivorship care. Program Overview This screening program will target patients undergoing breast surgery as a result of breast cancer. Patients will be assessed in the outpatient therapy center in order to detect early impairments regarding range of motion, strength, occupational performance, and signs of lymphedema. Goal: To detect upper extremity impairments in patients receiving breast cancer-related treatment in order to warrant the need for an occupational therapy referral. Provision of Services 1) Pre-operative screening obtain baseline measurements 2) Post-operative screening approximately two to four weeks after surgery 3) Recommend referral to outpatient OT 4) Outpatient OT evaluation 5) Outpatient OT treatment Screening Process: Shoulder AROM Grip strength Arm circumference Patient Specific Functional Scale (PSFS) Kwans Arm Problem Scale (KAPS) post-operatively only BREAST CANCER AND UPPER EXTREMITY PERFORMANCE DEFICITS 31 Forecasted Revenue Average pre-op screening time: 10 minutes Average post-op screening time: 10 minutes o Total screening time: 20 minutes Lowest OT practitioner hourly rate: $32.38 o $32.38/60 minutes = $0.54 per minute o $0.54 x 20 minutes = $10.80 per total screening Outpatient OT evaluation: $288.00 o $288.00 - $10.80= $277.20 revenue generated per referral made Outpatient OT treatment o Recommended treatment frequency of 2-3x/week for 6-12 weeks (Cheifetz & Haley, 2010; Conneely & Weber, 2007) Therapeutic activity unit: $131.00 Therapeutic exercise unit: $144.00 ADL unit: $131.00 o $ unit(s) x 2 x 6 = $1,572 minimum treatment generated revenue Marketing Strategies It is vital to gain support from the breast surgeons and their staff within The Christ Hospital network for the success of this potential program, as they will need to encourage their patients to schedule a pre-operative screening at the outpatient therapy center for obtaining baseline measurements. Dr. Kelly McLean and her staff have allowed for a trial period of the program within their office for the last ~6 weeks. Occupational therapists performing the pre-operative screenings will need to advise their patients to schedule a post-operative screening time approximately two to four weeks after their surgery date, which is also when the patient will return to the breast surgeons office for a post-operative appointment. Based on results of the post-operative screenings, a doctors referral for a comprehensive occupational therapy evaluation may be warranted if deficits are present. Summary of Proposal The above information is a brief outline of the importance of prospective surveillance screening for breast cancer patients. This upper extremity screening program aligns with The Christ Hospitals vision to be a national leader in clinical excellence, patient experience, and affordable care by providing patients with a preventative approach for upper extremity performance deficits in order to maximize outcomes and quality of life as a survivor. I believe this program will increase clientele volume through referrals to the outpatient occupational therapy department.  ...