The Diversity Study: Factors Influencing Clinical Research

ABSTRACT The Diversity Study is a two-pronged study which evaluates both clinical research professionals and patient populations eligible to participate in studies. The focus of this paper is on patient populations. Specific aims regarding the patient population of this study seek to identify how widespread participation in clinical studies is within the Lehigh Valley Health Network (LVHN) community. Additionally, opinions regarding promotional tools which may more effectively entice women to participate in clinical research were evaluated in a 0-4 Likert scale. An overarching goal to improve diversity in research aligns with LVHN triple aim (better health, cost, and care) and touches on community involvement aspect of health. Outcomes indicate that women in Obstetrics clinics of all races and cultures are open to participation in clinical studies given the right approach and resources. BACKGROUND It was hypothesized that the interest in and significance of promotional tools (for example, video explanations, medical interpretation, and support groups) is high among women, providing the potential to lessen the disparity within clinical research. Education and socioeconomic status are thought to influence openness to participation. In addition, it was hypothesized that the majority of subjects who speak a language other than English at home will not have participated in clinical studies. What prevents these women from participating? Disparity on the participant level was initiated in part by the Food and Drug Administration (FDA) more than 30 years ago when pregnant women were classified as unable to participate in Phase I drug trials. Generalization of this exclusion led to a noticeable absence of women participants in all phases of clinical studies.1 In fact, a report reviewing 19 randomized and controlled cardiovascular clinical trials in 2009 revealed a low participation of 27% by females.2 Previous clinical trial recruitment at the same location in which this study was conducted reported a 40% decline rate.3 Through The Diversity Study it is hoped that factors influencing women’s participation in clinical trials, or lack thereof, will be better understood. Furthermore, the deeper disparity including minority women is hoped to be better understood through this project. Presently, the demographics of the United States of America do not match accordingly to clinical research, even though studies have demonstrated that minorities are in fact not less willing overall to participate in clinical studies than are white subjects.4 Literature suggests that mistrust of physicians and lack of participation is rooted in an overrepresentation of minorities in Phase I clinical trials and an underrepresentation of minorities in Phase III trials.4 Unfortunately, this dearth of women participants results in skewed conclusions from clinical trials due to physiological variability between men and women.1 It is crucial to unravel the factors which will result in the inclusion of more women participants in clinical studies. METHODS The Diversity Study is a two-pronged study which evaluates disparity both on the level of research professionals and the participant pool. This paper refers only to the administration of surveys to patients in LVHN centers for women’s medicine. Surveys were professionally translated into Spanish so that both English and Spanish copies were available. An eight-page consent combined with a survey was administered to 400 LVHN patients age 18 years and older over the course of five weeks. Research Scholars distributing surveys were able to describe the survey, consent participants, and answer questions regarding the survey to participants in both Spanish and English. Patients were informed of the voluntary nature of the survey and given an opportunity to ask questions. The survey was piloted and reviewed by 15 non-research and non-clinical staff of LVHN prior to its distribution in clinics. A screening log was kept of all individuals approached regarding the survey, and all changes and developments of this study have been approved by LVHN’s Institutional Review Board. Data entry was performed by the Research Coordinator, Lauren Semler, and data analysis was completed by the author using Microsoft Excel.5 RESULTS Participant Information Average Response Age 25-34 Percent with Children 76.80% Previously Participated in Research Study 8.35% Rating of Tools For Understanding Research Studies 3 Table 1: a sample of descriptive statistics of the 400 women who completed surveys. More descriptive statistics referenced in Discussion. Figure 6 displays average rating of language tools for all survey subjects, stratified by income. Figure 5 displays the average ratings of openness to language tools for all survey subjects, stratified by educational background. Figure 2 displays the percentage of participants who participated in clinical studies previously, stratified by occupation. Figure 1 displays the percentage of respondents who had previously participated in clinical studies by race. Figure 4 displays ratings of interest in support of subjects who had previously participated in clinical research, stratified by income. Figure 3 displays ratings of interest in support of subjects who had previously participated in clinical research, stratified by educational background. Figure 9 displays average ratings of helpfulness of explanations for all subjects, stratified by education. Figure 10 displays average ratings of helpfulness of explanations by subjects, stratified by income. Figure 8 displays average rating of support tools for all survey subjects, stratified by income. Figure 7 displays average rating of support tools for all survey subjects, stratified by education. DISCUSSION AND CONCLUSION The average age range of the women surveyed was 25-34 (p=0.0029), 76.75% of patients had children, and the education level of this population is “some college or 2 year degree” (p=0.01421). Of the 395 participants who responded to the question asking about heritage, 42.27% were of Hispanic descent (Table 1). However, given that the subject had participated in a clinical trial previously, 84.85% of subjects spoke a language other than English at home. This is indicative of a population which participates in clinical studies and has not been barred from participation in trials due to cultural or language differences. The average language spoken at home was Spanish (p=0.014264), and subjects responded on average that they speak and understand English “very well” (p=0.016). The majority of subjects self-reported good health (median response, “Very Good,” p While one of the locations in which the study was conducted boasts bilingual physicians and staff in addition to heavy involvement in research, only 8.35% of survey subjects indicated participation in a research study previously. Of the participants who had previously been part of clinical studies, only one woman had participated in more than one study in the past five years. Average ratings by women who had previously participated in clinical studies of support tools were overall lower compared to the whole population of women who took the survey (Figures 3 and 4). There was high variation in veteran participant responses (not statistically significant to a 95% confidence interval), indicating that decision-making regarding study participation may be more autonomous given prior exposure to clinical studies. One additional piece of information which may add to this project is how many times the survey population had been asked to participate in a study over the past year. In rating tools by helpfulness in terms of deciding whether or not to participate in clinical studies, more personal options such as support groups and opportunities to speak with prior participants were rated slightly higher than written explanations or video support by the whole survey population. The median for each tool was rated at 3 on a 0-4 Likert scale, with 4 being the most helpful. The highest rating median of 4 was given to “Having material provided in my own language,” however; the average rating was 3.21 (similar to other option responses) with a p-value of 0.0547, which is not statistically significant (Figures 5-10). Given that the subject had previously participated in clinical studies, 17% of those subjects were employed in health care or science fields. The women who had previously participated in clinical studies identified as 20% Hispanic, 50% white/Caucasian, and 20% black or African American and the average education was “some high school” (Figures 1 and 2). It could be said that the group which previously participated was somewhat diverse in educational, ethnic, and socioeconomic background. The trend based on education follows that the subjects with the most and least education rated less importance on supportive tools to improve openness to clinical studies than those in the middle of the educational spectrum (high school or some college). The average respondent was of an income $30,000 or less, which is reflective of the area in which the study was conducted. The highest importance of promotional tools was rated by the lowest income subjects who had previously participated in clinical studies (Figures 3, 4). Limitations to this study include several confounders and logistical challenges. The survey was available in English for more days during the study than Spanish. Confounding factors of incompleteness due to a lack of comfort with the question type or the subject’s English fluency could have influenced responses. A final confounder could lie in the responses in English surveys versus Spanish surveys given the subject’s English fluency. Outcomes of this study suggest that women are in fact open to educational and supportive resources which may increase openness to participation in clinical studies. It can be said that the hypothesis regarding interest and openness to promotional tools and clinical studies is high among women was correct. Education and socioeconomic status relatively influenced openness to participation. Between video and written explanation ratings, written was rated higher overall. Between the option to speak with a prior participant of the study and to have a support group, the option to speak with a prior participant was rated higher. Between the option for materials in the subject’s own language and access to a medical interpreter, materials in the subject’s own language were the highest and clearest preference. These three preferred tools would make for a good base in further testing. The final hypothesis that the majority of subjects who speak a language other than English at home would not have participated in clinical studies was not accepted. Results indicate that over 80% of the participants of clinical studies did in fact speak a language other than English at home. The largest factor which may improve openness to clinical studies may lie in the approach and provision of support to participants. Further research directions include identifying a consensus of openness to materials of reference and in-person support which is positive and able to be implemented. Utilization of discrete materials at various enrollment sites and comparison between outcomes given the support tool as a sole variable could help better identify which tool is best for the women and minority population within LVHN

Connection Between Education and Relationship with Doctor in Female Clinical Research Participation: A Multi-Center Study Investigating the Factors that Influence Female Participation in Clinical Research

Connection Between Education and Relationship with Doctor in Female Clinical Research Participation: A Multi-Center Study Investigating the Factors that Influence Female Participation in Clinical Research Lauren Crawford; Anita Kurt PhD, RN Abstract Women, particularly those in racial and ethnic minorities, have long been underrepresented in clinical research. There are many barriers that prevent women from participating. This study aims to determine some of the less recognized factors and barriers faced in women’s decisions, specifically trust of and relationship with doctors. It is hypothesized that trust of doctors varies by level of education and that female participants in research believe these factors to be more important than those who do not participate. The study conducted was an anonymous, IRB-approved survey in which women ranked influencing factors on a scale of 0 to 4. Preliminary data do not support either hypothesis, suggesting that factors other than education influence trust and that importance of relationship with the doctor does not vary across women who have and have not participated in clinical research. Study results provide insight into how best to increase female participation in clinical research to allow for more comprehensive studies with wider applications. Background Historically, there has been seen a discrepancy between genders in participation in clinical research. The discrepancy widens across people with a lower level of education. More barriers seem to exist preventing women, particularly those with little education, from participating in clinical studies and trials. Rothenberg (1996) suggests that gender roles and ignorance about women’s health issues have prevented outreach to women for clinical studies. Additionally, previous FDA regulations on women with the potential to become pregnant limited the participation of many women; although these regulations have changed, continuing misunderstanding has created and continues to create further barriers to participation. A lack of participation by women in clinical research limits the span of application of this research. This study aims to determine some of the lesser-recognized barriers that prevent women from participating in research. Correction or adjustment of these barriers could allow for further application of clinical research, particularly early phase trials in which women are most underrepresented. One potential barrier studied in this trial is relationship with and trust (or distrust) of doctors. Good doctor-patient relationships and improved trust in doctors improves health outcomes for patients (McKinstry, Ashcroft, Car, Freeman, and Sheikh 2006). Trust is also likely to be influential in a patient’s decision to participate in clinical research. Improving relationships and trust between doctors and patients could help increase female participation in clinical research. It is hypothesized that women who do participate in clinical research will rank their relationship with or trust of their doctors as more important than those who do not, and that differing education levels will cause changes in the importance of these values. It is predicted that this trend will be reflected in higher survey self-scores of “my relationship with my doctor” or “my distrust of doctors” for women with lower levels of education. Research by Corbie-Smith, Thomas, and St. George (2002) determined that African American patients are less likely than their white counterparts to trust their doctors. This study corrected for social markers such as socioeconomic class. These markers, specifically education level, are likely also influential in a woman’s trust of her doctor. A lack of trust translates to less participation in clinical research and studies (Shavers, Lynch, and Burmeister 2002). Determining factors that influence women’s trust in their doctors could provide a path to more participation by women in clinical research. Methods A Lehigh Valley Health Network IRB-approved survey was conducted at the Center for Women’s Medicine at LVHN’s 17th Street site. Surveys included questions regarding demographics, participation in clinical research, and motivating factors or barriers to participation in clinical research. No identifying information was collected. The research team approached patients to briefly explain the study and confirm meeting eligibility requirements (female, age 18 or older, a patient of the site, and able to fully understand the survey and give informed consent in one of four available languages). Consent was confirmed verbally with research team members; patients were then presented surveys in English, Spanish, Traditional Chinese, or Simplified Chinese, and provided an informed consent information sheet in their language of choice. A screening log was maintained to record each patient’s gender, language of survey and consent, and age eligibility. Surveys were also presented at other LVHN sites and outside of LVHN; however, these surveys were not analyzed in this report. Data from 400 collected surveys were entered into a password-protected Microsoft Excel database by research associates. Data analysis was performed with Excel by the author. Results Factors analyzed were “Did you ever participate in a clinical research study?” “What is the highest grade or level of school you completed?” “What factors would motivate you to participate in a clinical research study? : My relationship with my doctor,” and “What factors would prevent you from participating in a clinical research study? : My distrust in doctors.” Education levels were ranked as shown in Table 1. Table 1. Education levels and numerical values. Numerical Value Descriptive education level 1 8th grade or less 2 Some high school, but did not graduate 3 High school graduate or GED 4 Some college or 2 year degree 5 4-year college graduate 6 More than a 4-year college degree 7 Masters degree (for example, MA, MS, MSN, MEng, Med, MBA) 8 Professional degree (for example, RN, MSW, MD, DDS, DVN, LLB, JD) 9 Doctoral Degree (for example, Ph.D, EdD, DSW, DNP) Participants were asked to choose their highest level of education. No participants analyzed selected 9 (Doctoral Degree). Other factors were ranked numerically on a 0 to 4 scale from least to most impact. 356 surveys were analyzed. Mean education level was 3.476 (between high school graduate/ GED and some college/two year degree). Median education level was 3 and mode education level was 3. Mean ranking for importance of “my relationship with my doctor” across all education levels was 2.466. Mean ranking for “my distrust in doctors” was 2.087. Average values of other factors surveyed ranged from 0.905 to 2.946. Table 2. Average score for importance of relationship and distrust by level of education. Ed. Level n Relationship Distrust 1 5 2.200 0.600 2 53 2.491 2.019 3 132 2.538 2.114 4 130 2.346 2.154 5 21 2.667 2.476 6 5 3.400 1.400 7 6 2.667 2.333 8 4 3.000 2.250 Headings represent average survey scores for “my relationship with my doctor” (heading title: relationship) and “my distrust of my doctor” (heading title: distrust). Sample size represented by n. Education level 9 (Doctoral degree) was excluded as no patients analyzed chose this option. Both aspects were analyzed for correlation with education level. Correlationvalues between variables were determined with Excel. The correlation of education and relationship had values R2=0.00172 and r=0.0415. The correlation of education and distrust had values R2=0.00441 and r=0.0664. Mean values of factors were compared using Students’ t-tests. Means were calculated for education levels 1-3 (up to and including high school education or GED) and 4-8 (some college/ 2 year degree through advanced degrees). Mean values for education levels 1-3 were 2.516 and 2.047 for relationship and distrust. For education levels 4-8, means were 2.446 (relationship) and 2.181 (distrust). Student t-tests performed to compare rankings between education tiers gave t value for relationship 0.604 and p value 0.547. T value for distrust was 0.392 and p value was 0.696. Factors were also analyzed by participation (or lack of participation) in clinical research. Comparison of means between survey participants who had versus had not previously participated in clinical research gave t-test values of 0.278, 0.306, and 0.246 for education level, relationship with doctor, and distrust of doctor, respectively. P values were 0.785, 0.764, and 0.809 for these same factors. Table 3. Comparison of factors by participation. Education Relationship Distrust Yes 2.167 1.833 3.889 No 2.492 2.131 3.450 t value 0.278 0.306 0.246 p value 0.785 0.764 0.809 “Yes” indicates survey participant has previously participated in clinical research. “No” indicates participant has not. “Relationship” corresponds to “my relationship with my doctor” and “distrust” corresponds to “my distrust of my doctor.” Conclusion The p values for “my relationship with my doctor” and “my distrust of my doctor” between education levels 1-3 and 4-8 were 0.547 and 0.696, respectively. These values indicate that there was not a statistically significant difference in mean rankings of trust between participants of different education levels. Correlation coefficients r=0.0415 and r=0.0664 indicate that the overall correlation between education and relationship with doctor and between education and distrust of doctors is very weak. These values suggest that education level does not largely impact the importance of relationship and trust of doctors. Although it was hypothesized that education would, like race, influence trust of medical professionals, there seems to be little relationship between these factors. It is likely that other factors have more influence on trust of doctors than does education. Other factors that may be influential in the importance of trust include race, which has been studied extensively (Murthy, Krumholz, and Gross 2004), religion, age, and childbearing potential. These factors and others will be analyzed in the future of this study. Future studies could investigate other influences, such as history of health issues or time constraints. Additionally, it is likely that even though education is not a motivating factor in trust and relationship with doctors, it affects other aspects of the decision to participate in clinical research. This study considers deciding factors such as gender or race of participants’ doctors, provision of educational materials, and future benefit of the research. Going forward, these aspects could be analyzed with regard to education levels to determine what aspects are most affected by education level. The differences in rankings for “my relationship with my doctor” and “my distrust of my doctor” were not statistically significant between women who had and had not previously participated in clinical research, with p values 0.764 and 0.809. This indicates that women who participate in clinical research are not relying any more or less on their relationship with their doctors than their non-participating counterparts. As there is no statistically significant difference in rankings between participants and non-participants, it is likely that trust is not a major barrier preventing women from participating in clinical research. The range of average rankings for the factors studied was 0.905 to 2.946. Both “my relationship with my doctor” and “distrust of my doctor” had rankings in the top half of values, suggesting that both factors were more important than other factors studied (such as doctor’s gender or race, or whether money is offered for participation) but less important than factor JIII (how well the research was explained). This information provides a framework for LVHN to increase women’s participation in clinical research. Initial data collected in this study has determined that women most value how well a study is explained to them in deciding whether or not to participate in clinical research. Given this information, LVHN and partner sites could work to improve the information that is provided about clinical studies to ensure that women (and all participants) sufficiently understand the studies. Additionally, fostering trust of doctors and improving doctor-patient relationships may help to increase participation. As this study was completed by self-reported surveys, data may be skewed due to self-report biases. Response rate for surveys at the Center for Women’s Health is about 66%, so there may exist nonresponse bias in the data. Because several members of the research team gave surveys, some participants may have completed more than one survey. If survey participants took surveys in a language with which they were less comfortable, responses could be altered. These shortcomings of the survey may have slightly altered results. Data analyzed in this paper were preliminary data of 400 surveys gathered at one site. The study will continue at this site (Center for Women’s Medicine) and at other sites. Completed study results may not reflect these findings. Preliminary results and conclusions may not apply to complete study results at the conclusion of the study. The continuation of this study will provide additional insight into the lesser-known factors that influence women’s decisions to participate (or to choose not to participate) in clinical studies and trials. Addressing these issues will provide prospects for improvement in creating future research opportunities and ensuring representative participation across all genders, races, and more. References Corbie-Smith, G., Thomas, S.B., St. George, D.M.M. (2002). Distrust, Race, and Research. Arch Intern Med 162(21):2458-2463. McKinstry, B., Ashcroft, R., Car, J., Freeman, G.K., Sheikh, A. (2006). Interventions for improving patients\u27 trust in doctors and groups of doctors. Cochrane Database of Systematic Reviews (3). Murthy, V.H., Krumholz, H.M., Gross, C.P. (2004). Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities. Journal of the American Medical Association 291(22):2720-2726. Rothenberg, K.H. (1996). Gender Matters: Implications for Clinical Research and Women’s Health Care. Houston Law Review 32:1201-1272. Shavers, V.L., Lynch, C.F., Burmeister, L.F. (2002). Racial Differences in Factors that Influence the Willingness to Participate in Medical Research Studies. Annals of Epidemiology 12(4):248-256

The Influence of Education and Religion on the Perceived Benefit of Two Resources for Enrollment in Clinical Trials

Abstract This study presents the data gathered from surveying 187 individuals and compares the answers to two questions using religion and education as qualifiers. Individual patients were surveyed at four different Family Practice clinics and completed surveys were collected and data was analyzed. The mean, median, and mode were taken for two questions regarding possible available information sources during clinical trials questions 2L3 and 2L6 (Appendix 1). Each question allowed survey takers to select from 0 to 4. Further statistical analysis was done to see possible differences in choice based on religion and level of education from questions 3P and 3S (Appendix 1).Religious choices were summarized into two possibilities as was level of education. Student t-tests were done to ascertain whether or not significant differences were present. For question 2L3 the mean was found to be 3.49, the median was found to be 3 and the mode was found to be 4. For question 2L6 the mean was found to be 2.75, the median was 3 and the mode was 4. The t-tests found that there were no significant differences between Christian and non-Christian and between having less than four years or college and four years of college or more. The Influence of Education and Religion on the Perceived Benefit of Two Resources for Enrollment in Clinical Trials Background As innovations in medicine become more and more common, the practice of conducting clinical trials does as well. There is however an imbalance in said studies regarding the diversity of enrollees (Ciuliano et al. 2000). Women as well as those of a minority race often do not participate in clinical trials in correct numbers to accurately represent the population. These disparities result from influences they may stem from the patient or the provider. Many studies have been done regarding how race and gender factor into recruitment for trials (Noah, 2003; Murphy, Krumholz, & Gross, 2004; Coakley, Fadiran, Parrish, Griffith, Weiss, & Carter 2012). Often patients are afraid of trials and prefer not to take part. Doctors have been found to select preferentially for their trials as well. However, much less attention has been placed on other demographic factors such as education and religious belief. This is what the study incorporates in part; to understand what previously ignored factors may be truly important. An important factor in whether or not patients are willing to participate in clinical trials is availability of resources. After experiments such as the Tuskegee Syphilis study, there are many people who approach clinical trials warily especially African Americans (Corbie-Smith et al. 1997). Having different forms of resources available affects whether or not some people are willing to enroll in a clinical trial. Possible resources include brochures, DVDs, support groups, and translated materials. Learning more about the procedures involved in clinical research increases knowledge and often promote enrollment in trials (Butler, 2007). The study includes two other resources; the availability of a former clinical trial enrollee and whether or not there is a medical interpreter. From this, further steps are taken to utilize the previously mentioned demographics and compare their choices. Methodology Surveys were handed out by summer research scholars at 4 locations, Bethlehem Family Medicine, Community Health and Wellness Center, Lehigh Valley Family Center, and Lehigh Family Medicine Associates. The surveys were available in both English and Spanish. Chinese surveys in both traditional and simplified were also created but none were yet collected. Patients 18 years of age and older were asked to participate in this survey that also served as consent. Eligible participants were limited to patients of the practices. This survey was purely voluntary, refusal was permitted and acceptance or refusal was documented. In total, 198 surveys were collected from the four locations. Omitting surveys with too multiple incomplete portions, 187 were used for analysis. The mean, median, and mode were found for the questions regarding contact with a former participant and availability of a medical interpreter. The data for the questions was then further analyzed based on answers to the questions regarding level of education and religious beliefs. T-tests were done after categorizing the education choices into reaching less than 4 years of college and reaching 4 or more years of college. The religious beliefs were grouped into the broad categories of Christianity and Other. The T tests were then applied to determine if any significant differences existed when comparing the answers to the questions by the two different groups. Results The mean, median, and mode for the results of the 2L3 regarding the benefit of having the opportunity to speak to a past enrollee and 2L6 regarding the benefit of having a medical interpreter are shown below in Table 1. Figure 1 and Figure 2, show the level of education and religious beliefs held by participants respectively. Table 1 Mean, Median, and Mode for Two Questions Question Number Question Mean Median Mode 2L3 Opportunity to speak to a patient who has participated in a clinical research study 3.25 3 4 2L6 Access to a medical interpreter throughout the study 2.75 3 4 Figure 1 Distribution of answers to question 3P from 187 answers Figure 2 Distribution of answers to question 3S from 187 answers When the answers were analyzed they were categorized into two answer groups, less than two indicating that the topic would be of no help, and two or greater which indicates that it would help. The number of patients who took the survey and answered question 2L3 (Appendix 1) in the categories are tabulated below in Table 2. The data was further analyzed and separated into those who had reached less than 4 years of college education (8th grade or less, some high school, high school graduate or GED, and some college or 2 year degree) and those who had reached at least 4 years of college education (4 year college graduate, more than a four year college degree, masters degree, professional degree, or doctoral degree). Similarly the data was also looked at in terms of choices of religion. The religious groups were categorized into Christian covering Catholic, Evangelical, Pentecostal, Jehovah\u27s Witness, and Protestant or Other covering Buddhist, Hindu, Jewish, Muslim, non religious, and other religions. Table 2 Answers to question 2L3 separated by category Category Education Category Religion Answer \u3c2 \u3e2 Answer \u3c2 \u3e2 Did not reach four years of college 31 103 Christian 27 113 Had at least four years of college 6 47 Other Religion 10 37 Total 37 150 Total 37 150 Table 3 shows the results for question 2L6 (Appendix 1) analyzed in similar fashion to question 2L3. Table 3 Answers to question 2L6 separated by category Category Education Category Religion Answer \u3c2 \u3e2 Answer \u3c2 \u3e2 Did not reach four years of college 50 82 Christian 42 97 Had at least four years of college 18 37 Other Religion 16 22 Total 68 119 Total 37 150 Tabulated below in Table 4 are the results of a T-Test done on answers for question 2L3 chosen by those who had reached than 4 years of college education and those who had at least 4 years of college education. Whether or not there is significance between the two sets of data is shown below. Also included are the answers of those who are Christian or belong to the Other category evaluated in the same fashion. T-tests were unpaired, two tailed, with unequal variance, and utilized a 95 percent confidence value. Table 4 T-Tests for comparison of answers for two different subcategories of two categories for question 2L3 Categories for comparison T-Test p value Significance Categories for comparison T-Test p value Significance Less than 4 years of college education 0.185 No significant difference Christian 0.533 No significant difference Had at least four years of college Other Religion Table 5 T-Tests for comparison of answers for two different subcategories of two categories for question 2L6 Categories for comparison T-Test p value Significance Categories for comparison T-Test p value Significance Less than 4 years of college education 0.746 No significant difference Christian 0.599 No significant difference Had at least four years of college Other Religion Conclusion The results show that on average people feel that having the chance to meet a person who had taken part in a clinical trial would be more influential in helping them decide to take part in a clinical trial when compared with having the aid of a medical interpreter. Though the study is limited to the population of the four clinics, the data shows that in general people feel more comfortable talking about the experience with someone who was inside the clinical research trial process than having someone trained to interpret the medical data. This depicts the distrust that still exists between the enrollee and the medical professionals. As mentioned before Tuskegee remains a firm memory, particularly in the minority population. Increasing the number of opportunities to interact with past enrollees would help increase recruitment numbers as the prospective participants become more confident and comfortable with clinical trials. While having a medical interpreter was ranked below meeting a past participant in ability to help decide patients to enroll in clinical trials, it was still rated as beneficial in helping decide whether or not to participate. Again, a deeper understanding of the trial fosters comfort and willingness to join. It should be noted that the majority of people chose 4 for both questions indicating that the resource in the inquiry would play a large part in helping the participant join a clinical trial. Furthermore, the T-Tests show that although they are considered factors in clinical trial enrollment, religious beliefs and education have no significant differences when comparing the answers found by separating each category into two different groups. While this data seems to contradict the idea that these two factors are in fact influential to choosing whether or not a person will enroll, it must be taken into consideration that these two questions in general do not rely on religion or education. The acceptance or desire for information is not affected by what level your education is. While it is possible that religious beliefs may stop a person from taking part in a trial, unless their religion prohibited obtaining information it is unlikely that it will factor into a person’s opinion on what is helpful in convincing them of joining a trial. Similarly, a basic understanding of the trial is needed, which can be obtained with increased learning. However, it is also unlikely that a person’s level of education will influence whether or not they wish to obtain further information. While this particular sample did not show the influence of education level and religion, the willingness to enroll is very often affected. A limitation to this study can be seen in the fact that only four clinics were selected to participate and were located in close vicinity to each other. While a total of 400 surveys were desired, the goal has not yet been reached thus limiting the population further. The limited population may have skewed the results as less opportunity was available for trends to become significant. Another limitation is that not all surveys were answered completely, further changing the results. The study looked at religion and education but missing answers from minority groups in both categories cause even less distinction to appear when analyzed using a T-test. Because this study is a subdivision of another broader study there are many parts that will be covered. Future research could add an additional question such as whether or not having a contract explicitly stating the processes that will occur will help participants decide to enroll. The contract would serve to hold the doctors to standards and allay issues that the patient may have towards possible deviations from what they had signed up for. Yet another opportunity for further research lies in location, specifically by increasing the number of clinics all over the United States from the east to west coast. The different areas with different populations to pull from would give a chance for any underlying trends to be seen. References Butler, K. L. (2007) African Americans’ participation in clinical research: importance, barriers, and solutions. The American Journal of Surgery, 32-39. Coakley, M., Fadiran, EO., Parrish, L.J., Griffith, R. A., Weiss, E., &Carter, C. (2012). Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trial. Journal of Women’s Health, 21 (2), 713-716 Corbie-Smith, G., Thomas, S. B., Williams, M. V., & Moody-Ayers, S. (1999). Attitudes and beliefs of african americans toward participation in medical research. Journal of General Internal Medicine, 14(9), 537-546. Giuliano, A., MoKuau, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R., & McDCaskill- Stevens, W. (2000). Participation of minorities in cancer research: the influence of structural, andlinguistic factors. Annals of Epidemiology, 10(8 Supply), S22-S34 Noah, B.A. (2003). The participation of underrepresented minorities in clinical research. American Journal of Law & Medicine, 29:221-245 Murthy, V.H., Krumholz, H.M. & Gross, C..P. (2004) Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA. 291 (22), 2720-2726 Appendix PARTICIPANT INFORMED CONSENT, AUTHORIZATION AND SURVEY Title of Study: Factors Influencing Participation in Clinical Research Principal Investigator: Anita Kurt, PhD, RN Address: Lehigh Valley Health Network 1240 South Cedar Crest Boulevard, Suite #212 Allentown, Pennsylvania 18103 Telephone: 610-402-7666 You are being asked to participate in a survey which will help us understand the factors that influence participation in clinical research (for example: doctors testing a new medication or device and collecting data to see whether the new medication or device is working). If you are 18 years of age or older, you are eligible to take the survey. This survey is completely anonymous; in other words, any personal identifying information or your signature will not be collected. Also, your participation in this survey is completely voluntary; it is up to you to decide whether or not you want to participate. Completing the survey should take no more than 8 to 10 minutes of your time. If you start the survey and change your mind about participating, you may stop at any time. If any of the questions make you uncomfortable, feel free to skip them. This project is funded by the Anne and Carl Anderson Trust, a non-profit philanthropic trust. If you would like to discuss any issues, have complaints, and/or address concerns or questions, you may contact the Research Participant Protection Office at Lehigh Valley Health Network, 1255 South Cedar Crest Boulevard, Suite #3500, Allentown, Pennsylvania, 18103, telephone, 610-402-2760. If you were asked to participate before and completed this survey at another location, please do not fill out another survey. If you wish to know the results of this survey after the data are analyzed (likely by the end of 2016), please call Anita Kurt, PhD, Principal Investigator, at 610-402-7666. Please take this page with you for future inquiries. Thank you for taking the time to complete this survey Section 1: General questions about your health and previous participation in clinical research studies: Are you here today as a patient? A1. Yes A2. No In general, compared to other people your age, how would you rate your overall health? Excellent Very Good Good Fair Poor About how often would you say you make decisions about obtaining the medical care you need (as opposed to someone else making the decision for you)? All of the time Most of the time Some of the time Rarely Never Have you ever participated in a clinical research study (a study where a doctor tests a new medication or device to see how it improves your health)? Yes No Which family member would play the MOST important role in deciding whether another member of your family can participate in a clinical research study? (Please select one) My mother My father My spouse or significant other My brother My sister Other; please specify_______ How many clinical research studies have you participated in within the last FIVE years? F1. None F2. One F3. More than one Please list the health condition that was the focus of the MOST RECENT study you participated in. G1. ____________ G2. ___ I did not participate in any. Using any number from 0 to 10, where 0 was the worst experience possible and 10 was the best experience possible what number would you use to rate the MOST RECENT study you participated in? H1. ______________ H2. _____ I did not participate in any. Some studies are able to offer participants money to participate. Would you prefer to participate if you are paid? I1. Yes I2. No I3. Does not matter Section 2: Factors that relate to participating in clinical research studies: What factors would motivate you to participate in a clinical research study? Please rate the following from NO MOTIVATION (0) to MOST (4) motivating factor. Motivating factors 1 2 3 4 My relationship with my doctor 1 2 3 4 Doctor’s reputation in the community 1 2 3 4 How well the research study is explained to me 1 2 3 4 My desire to please the doctor 1 2 3 4 Money offered for my participation 1 2 3 4 A friend or family member participating in the same study 1 2 3 4 The doctor conducting the research is the same gender (sex) as me 1 2 3 4 The doctor conducting the research is the same race/ethnicity as me 1 2 3 4 The doctor conducting the research speaks the same language as I do 1 2 3 4 Knowledge learned from my participation will benefit someone in the future 1 2 3 4 What factors would prevent you from participating in a clinical research study? Please rate the following from NO BARRIER (0) to GREATEST (4) barrier. Potential barriers 1 2 3 4 My distrust in doctors 1 2 3 4 Time commitment 1 2 3 4 My family’s concern 1 2 3 4 My religious beliefs 1 2 3 4 Clinical research studies are too hard to understand 1 2 3 4 Study related phone calls for follow-ups 1 2 3 4 Multiple follow-up visits related to the study 1 2 3 4 Risk of unknown side effects 1 2 3 4 Access to transportation 1 2 3 4 What would help you decide whether to or not to participate in a clinical research study? Please rate the following from NO HELP (0) to MOST (4) helpful resource. Helpful Resources 1 2 3 4 Written material explaining the research study 1 2 3 4 DVDs or electronic material explaining the research study 1 2 3 4 Having opportunity to speak to a patient who has participated in a clinical research study 1 2 3 4 Having access to a support group of patients who have participated in clinical research 1 2 3 4 Having all material provided in my own language 1 2 3 4 Having access to a medical interpreter throughout the study 1 2 3 4 Section 3: Information about you: What is your age? M1. 18-24 M2. 25 to 34 M3. 35 to 44 M4. 45 to 54 M5. 55 to 64 M6. 65 to 74 M7 75 or older What is your gender? _____Male ______Female Do you have any children? _______Yes _______No What is the highest grade or level of school you completed? 8th grade or less Some high school, but did not graduate High school graduate or GED Some college or 2 year degree 4 year college graduate More than a 4 year college degree Masters degree (for example, MA, MS, MSN, MEng, Med, MBA) Professional degree (for example, RN, MSW, MD, DDS, DVN, LLB, JD) Doctoral Degree (for example,Ph.D, EdD, DSW, DNP) Are you of Hispanic or Latino origin or descent? Yes No What is your race (circle all that apply)? White or Caucasian Black or African American Asian Native Hawaiian or Other Pacific Islander American Indian or Alaska Native Other: Please specify: ______________ What is your religious preference? Buddhist Catholic Christian Evangelical/Pentecostal Hindu Jehovah’s Witness Jewish Muslim Not religious/None S10. Protestant S11. Other; please specify: __________ What language do you speak at home? T1.English_____________ T2.Spanish T3. Other: please specify: ___________________ How well do you speak and understand English? Very well Pretty good Can understand English, but have a hard time speaking it Cannot speak English What category best describes your CURRENT employment status. Employed Full-Time Employed Part-Time Unemployed and looking for work Unemployed but not looking for work Student Retired Other; please specify: _____________ If you said you are employed, what category best describes the industry you work in? Not applicable (I am either unemployed or retired) Military. Education. Transportation. finance/banking Service industry (for example, food services, retail, sales). Health care/science. Construction. W9. I work in another industry (please list here :_____________________________) What category best describes your TOTAL income in 2013? Less than $30,000$30,001-$50,000$50,001-$75,000$75,001-$100,000$100,001 or more I‘d rather not answer. Thank you!

Implementation of a Rapid Assessment Unit (Intake Team): Impact on Emergency Department Length of Stay

Implementation of a Rapid Assessment Unit (Intake Team): Impact on Emergency Department Length of Stay Richard S. MacKenzie, MD, David B. Burmeister, DO, Jennifer A. Brown, RN, Melissa Teitsworth, RN, BSN, Christopher J. Kita, MEd, Megan J. Dambach, DO, Shaheen Shamji, DO, Anita Kurt, PhD, RN , Susan Friend, Marna Greenberg, DO, MPH Acknowledge: Clare M. Lenhart, PhD, MPH Objective: Emergency Department (ED) crowding is an on-going formidable issue for many EDs. A Rapid Assessment Unit (RAU) is a potential solution. This process involves the use of a team approach to convert the current “series” type evaluation to a more “parallel” evaluation and treatment of patients. The RAU concept of evaluating and treating ED patients radically changes the current methods utilized in today’s standard emergency care area. The RAU concept offers a process in which the patient walks into the ED and is seen in a unit by an intake team composed of a nurse, registrar, and provider (physician assistant, nurse practitioner, or physician) that provides evaluation and emergent treatment. This removes the redundancy of a patient giving the same information several times before they are treated. Simultaneously, the team decides whether the patient would be better served by remaining seated or requires a recumbent position. This is referred to as allowing “vertical flow” versus the default “horizontal flow” where all patients recline on a stretcher whether they need it or not. Certainly, having construction that specifically supports these processes is an innovation as well (having an area where patients can be seated and remain “vertical”). The team structure itself is unique. The nurses and providers are not assigned geographically by room but rather are defined by their function. We set out to determine if the addition of the RAU process would decreases the LOS of the discharged ambulatory arrival patient. Methods: After IRB approval, this retrospective, pre- and post intervention, observational comparison study was conducted from August 2011-March 2012 at a suburban teaching hospital in central Pennsylvania with an annual ED census of approximately 54,000. The inclusion criteria were all ambulatory discharged patients. The exclusion criteria were all patients that arrived by ambulance and admitted patients. Data points captured included: time of arrival in triage , time in triage to ED entry, time of ED entry until seen by a provider, time from ED entry to discharge, total length of stay (LOS). The data were uploaded to Horizon Business Insight™ (HBI), a cumulative data manager and exported to an Microsoft excel file for analysis. Mann-Whitney U tests were used to demonstrate differences in Median LOS. All statistical tests were 2-sided; probability values \u3c0.05 were considered significant. Results: 11, 994 pre and 10814 post-RAU patients were included in analysis. Median LOS was shorter during the post-RAU period in each subcategory of LOS with the exception of the interval from being seen in the ER to discharge which is a result of provider seeing the patient earlier in the ED encounter. Results, Table 1. Conclusions: The RAU process decreases the LOS of the discharged ambulatory arrival patient and deserves further exploration as an innovative model in the ED that improves flow

Gender Differences in Emergency Department (ED) Patient Mechanical Fall Risk and Openness to Communication with Providers

Gender Differences in Emergency Department (ED) Patient Mechanical Fall Risk and Openness to Communication with Providers Bryan G Kane, MD, Michael C Nguyen MD, Robert D Barraco, MD MPH, Brian Stello MD, Arnold Goldberg MD, Clare M Lenhart, PhD MPH, Bernadette G Porter BA ,Anita Kurt PhD, RN, Marna Rayl Greenberg DO, MPH Objectives: The CDC reports that among older adults (≥65), falls are the leading cause of injury-related death and rates of fall-related fractures among older women are more than twice those for men. We set out to determine ED patient perceptions (analyzed by gender) about their personal fall risk compared to their actual risk and their comfort level in discussing their fall history or a home safety plan with their healthcare provider. Methods: After IRB approval, a convenience sample of ED patients (50 years or older) was surveyed at a suburban Level 1 Trauma center with an annual ED census of approximately 75,000. The survey included demographics, the Falls Efficacy Scale (FES), and questions about fall risk. The FES is a validated survey measuring concern of falling. Analysis included descriptive statistics and assessment of fall risk and fear of falling by gender using chi-square and t-tests as indicated. Significance was set at 0.05. Results: Of the 150 surveys collected, 149 indicated gender and were included in this analysis. Fifty-five percent of the sample was female (n=82); 45% (n=67) were male. Most (98%) were Caucasian and 22% reported living alone. There was not a difference in the mean age of female participants 69.79 years (SD=12.08) vs. males 68.06 (SD=10.36; p=0.355). See Table 1 for distribution of reported fall risk factors between genders. Collectively, these variables resulted in a mean risk of falling score of 3.37(SD=1.62) out of 9. On average, female participants had a significantly higher objective risk of falling than did male participants (3.65 vs. 3.02 p=0.018). Similarly, females also reported greater fear of falling than did males (FES score 12.33 vs. 9.62; p=0.005). Significantly more females (41.5%) than males (23.9%, p=0.037) reported having fallen in the past year. Of the 50 participants reporting past-year falls, only 19 (12 female and 7 male, p=0.793) sought treatment. The correlation between actual fall risk and fear of falling were greater among females (p The majority of patients (76.4%) were willing to speak to a provider about their fall risk. No significant difference was noted in willingness to discuss this topic with a provider based on gender (p=0.619), objective fall risk (p=0.145) or FES score (p=0.986). Similarly, many respondents indicated a willing to discuss a home safety evaluation with a provider (58.1%) and responses did not vary significantly by gender (p=.140), objective fall risk (p=0.168) or FES score (p=.584). Conclusion: In this study, female ED patients reported a greater fear of falling, had a significantly higher objective risk of falling, and had a higher correlation between their perceived risk and actual risk of falling than did males. The majority of both genders were amenable to discussing their fall risk and a home safety evaluation with their provider