Implementation and evaluation of Employee Health and Wellness Program using RE-AIM framework

PurposeThe study describes the design, implementation and evaluation of an employer-sponsored health screening program – Employee Health and Wellness Program (EHWP) – in an academic healthcare system in Pakistan.Design/methodology/approachOne year after implementation, RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework was used to evaluate and report participant- and organizational-level indicators of success.FindingsOf the 5,286 invited employees, 4,523 (86%) completed blood work and 1809 (34%) completed health risk assessment (reach). Of the 915 (51%) who required referrals, 3% were referred for new diagnoses of diabetes, hepatitis C or severe anemia; 63% for elevated 10-year risk of cardiometabolic diseases (cardiovascular disease and diabetes); and 25% for counseling for depression, obesity or smoking cessation (effectiveness). Employees' barriers to enrollment were explored (adoption). While institutional costs were considered nominal (USD 20/employee), organizational barriers were identified (implementation). Finally, 97% of users reported interest in enrollment if EHWP was offered again (maintenance).Originality/valueIn a country with minimal focus on adult preventive care, the study reports the impact of an employer-offered wellness program that identified new risk factors and offered a referral for ongoing care. Employees reported a positive experience and were willing to re-enroll. Using the RE-AIM framework, the study has defined indicators in the real-world setting that can be used effectively by other institutions to start such a program.

Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants

Amid the growth of addiction medicine randomized controlled trials (RCTs), scholars have begun examining participants’ study experiences, highlighting facilitators and barriers to enrollment. However, this work can overlook the interplay between trial participation and social-structural dimensions among people with substance use disorders linked to the social nature of use, socioeconomic marginalization, and time demands of substance procurement and use. To effectively conduct RCTs with this unique population, it is necessary to examine the broader social context of study participation. We conducted nested qualitative interviews with 22 participants involved in an RCT testing a treatment for alcohol and opioid use disorders in HIV clinics. Thematic analyses revealed social-structural circumstances shaping RCT participation as well as how participation constitutes a turning point, prompting individuals to reconfigure social networks, reorient to spatial environments, and reorganize day-to-day life—with implications for how substance use disorder RCTs should be approached by researchers.

Federal Nutrition Programs after the Pandemic: Learning from P-EBT and SNAP to Create the Next Generation of Food Safety Net Programs

It is thought that childhood food insecurity rates increased to 18 million impacted children in 2020. In response, innovative policy solutions from the Supplemental Nutrition Assistance Program (SNAP) and the Pandemic Electronic Benefit Transfer (P-EBT) were swiftly implemented. These innovations must serve as catalysts to create the next generation of food safety net programs. These include the removal of administrative barriers to enrollment, the use of streamlined procedures to access food, the expansion of P-EBT to daycare and childcare centers, and the uncoupling of receipt of benefits from physical presence in schools. Critical gaps also remain. SNAP benefit amounts are often too low, leaving many families ineligible. More realistic benefit amounts are needed, such as those used in the USDA’s Moderate Cost Food Plan. Eligibility cut-offs exclude many food insecure families. Better alignment of SNAP eligibility with income levels that substantially increase food insecurity risk are critical. Lastly, creating slower phase-out periods for benefits as incomes rise is essential. Additionally, food insecurity continues to disproportionately impact racial and ethnic minority populations and low-income households. These deeply rooted inequalities in access to nutrition play an important role in driving health disparities, including obesity, hypertension, diabetes, and other chronic comorbidities and must be further examined. Changes to SNAP and the P-EBT program illustrate how innovative, broad-scale policy solutions can expeditiously support the nutritional needs of families with children. While pandemic-inspired innovation offers critical lessons for designing the next generation of nutrition assistance, there remain gaps that can perpetuate disparities in access to food and health. As a community of medical providers, we must advocate for broader, more inclusive policies to support those facing food insecurity. The future depends on it.

Assessing Alzheimer’s Disease Specific Barriers to Enrollment in an Observational Actigraphy Study

There are unique challenges to recruit and enroll individuals with Alzheimer’s disease (AD) into research studies, and typical barriers to participation include the need for study partner involvement, use of invasive procedures (e.g., lumbar punctures), and lack of awareness of ongoing research. Failure to enroll this population impacts generalizability and external validity of results. The current study sought to explore reasons for non-participation in individuals with AD enrolled in the University of Kansas Alzheimer’s Disease Center (ADC) Registry. Participants were approached at their annual registry visit and asked to participate in an observational sub-study that utilized wrist-worn actigraphy to measure physical activity and sleep over a one-week period. Of the thirty-six non-participation encounters that were recorded over a 2.5 year data collection period, 28% were never recruited due to appointment cancellation, rescheduling, or no-show. Of the remaining encounters, the three most common reasons for non-participation included: physical limitations of individuals with AD (15%), unknown (28%), and study partner concerns regarding use of technology in individuals with impaired cognition due to AD (25%). Multiple study partners were concerned that the individual with AD would lose the watch, remove the watch from the wrist, or become irritated while wearing it. Findings suggest that the use of technology such as actigraphy presents an additional barrier to enrollment that is unique to individuals with AD. Future studies should consider potential interventions to address study partner concerns regarding use of technology in individuals with AD.

978. Barriers to Recruitment of Latino Men who Have Sex with Men and Transgender Women to Behavioral HIV Seroprevalence Studies

Background Chicago’s HIV epidemic disproportionally affects people of color. Almost a quarter (23%) of these infections occur in Hispanics. It is important to understand sexual behaviors and HIV risk in Latino MSM and transgender women (TGW) to create targeted culturally sensitive harm reduction interventions. However, participation of minority MSM and TGW in survey-based studies is low. The main objective of the study was to understand the sexual health and of Latino MSM and TGW residing in Chicago, Illinois, United States. We herein report subject’s attitudes towards participating in the study and qualitative observations about perceived barriers to enrollment of this population. Methods This study was a cross sectional analysis of a behavioral/HIV seroprevalence survey administered during 2017-2020 to presumed HIV negative, Latino identifying, MSM and TGW individuals. The survey included questions on sexual risk, HIV knowledge and depression scores. We categorized recurrent themes of the most common reasons participants provided for declining to participate in the study. We generated descriptive statistics. Results A total of 48 community organizations assisted with recruitment. Of 149 participants screened, only 18 (12%) agreed to complete the survey. Among those who declined to complete the survey (n=131), the most common reasons given were: participants were uncomfortable answering some questions (n=59, 45.0%), participant’s did not have the time to initiate or complete the survey (n=41, 31.3%) and survey was deemed long (n=16, 12.2%). We categorized barriers to successful recruitment into the following general themes: 1) Participants were unwilling to discuss their sexual history; 2) Participant’s felt uncomfortable taking a rapid oral HIV test; 3) Participant’s lacked transportation; and 3) Participants didn’t have time to complete the survey or thought it was too long. Conclusion Despite extensive community networking, we found barriers to recruitment of high-risk Latino MSM and TGW into an HIV seroprevalence study. Further research is needed to better understand and address these barriers, and thus, increase representation of this key population in prevention studies. Disclosures All Authors: No reported disclosures

Barriers to Participation in Therapeutic Clinical Trials as Perceived by Community Oncologists

PURPOSE: Despite considerable research on the barriers to enrollment in cancer therapeutic trials, few studies have elicited barriers from the perspective of community physicians, who provide the majority of cancer care. The purpose of this study was to characterize barriers to and facilitators of cancer therapeutic trials as perceived by oncologists in community practices. METHODS: Twenty semistructured interviews were conducted with oncologists at six community sites affiliated with City of Hope National Medical Center from March to June 2018. Responses were recorded digitally and transcribed. Data were analyzed using qualitative content analysis. RESULTS: Of the 20 participants, 4 (20%) were women, 13 (65%) had > 10 years of practice experience, and 16 (80%) reported that < 5% of their patients were enrolled in a therapeutic trial. Participants identified four system-level barriers: lack of appropriate trials for community-based settings, insufficient infrastructure support, restrictive eligibility criteria, and financial limitations; three physician-level barriers: lack of awareness of available trials, lack of knowledge of trial details, and lack of time; and two patient-level barriers: patient burden and negative beliefs/attitudes toward research. Efforts aimed to increase trial availability, clinical trial support personnel, and physician knowledge were identified as major facilitators. CONCLUSION: Community oncologists face numerous complex, multifaceted barriers to cancer therapeutic trial enrollment. Although expanding clinical research beyond the academic setting allows access to a larger and more diverse patient population, increasing generalizability and relevance of trial findings, there remains a substantial need for new strategies to improve cancer research delivery in the community.

Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network’s Marfan Trial experience

Background/Aims: The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies. Methods: Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence. Results: Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation’s resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence. Conclusion: Overall adherence was excellent for this trial conducted within a National Institutes of Health–funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.

Factors associated with enrollment into a clinical trial of caregiver-implemented intervention for infants at risk for autism spectrum disorder

Early intervention has been established as efficacious in addressing developmental delays in young children with autism spectrum disorder. Evidence that caregiver-implemented interventions are feasible and effective for young children with autism spectrum disorder is emerging, yet research suggests there are barriers to enrollment in clinical trials of these interventions for infants at risk for autism. This study identifies factors associated with enrollment in a clinical trial of a caregiver-implemented intervention for 12-month-old infants at risk for autism spectrum disorder. As part of a large longitudinal study, fifty-seven infants were deemed eligible for intervention based on several converging indicators of autism risk. Of these eligible infants, 44% declined enrollment in the intervention study. Examination of factors associated with families who declined enrollment compared to those who agreed to enroll revealed maternal full-time work status, household income, and distance to the clinic as significant predictors. In contrast, autism red flags and parental concern were not significantly associated with enrollment. These results highlight the need for more research on how parental understanding of, and willingness to act on, early social-communication delays impacts intervention study enrollment. Future research can then examine how to address these barriers to enrollment in caregiver-implemented intervention studies. Lay abstract Early intervention helps to address developmental delays in young children with autism spectrum disorder. Yet, research suggests there are barriers to enrollment into research studies that test the effectiveness of these interventions for infants at risk. This study identifies family characteristics that were associated with agreement to enroll in a clinical trial of early intervention for 12-month-old infants at risk for autism spectrum disorder. As part of a large longitudinal study, infants were evaluated for early signs of autism spectrum disorder at 1 year of age. Of the fifty-seven infants who were showing signs of autism and deemed eligible for the early intervention trial, 44% declined enrollment. Results suggest that families were more likely to decline enrolling into the intervention study if the mother was working full time, the total household income was between US$60,000 and US$100,000, and they lived further from the clinic. In contrast, infant autism symptoms and parental concern at 12 months were not significantly associated with enrollment. These findings highlight the need for intervention studies that are more accessible to parents, for example, intervention that takes place in the home, in addition to more research on how parental understanding of, and willingness to act on, early social-communication delays impact intervention study enrollment. Future research can then examine how to address these barriers to enrollment in early intervention studies. Such findings will shed light on best practices for dissemination of early identification and intervention strategies.