Participant Enrollment Research Articles

Resource Requirements for Participant Enrollment From a University Health System and a Federally Qualified Health Center Network in a Mobile Health Study: The myBPmyLife Trial.

Resource Requirements for Participant Enrollment From a University Health System and a Federally Qualified Health Center Network in a Mobile Health Study: The myBPmyLife Trial.

An Introduction and Practical Guide to Strategies for Analyzing Longitudinal Data in Clinical Trials of Smoking Cessation Treatment: Beyond Dichotomous Point-Prevalence Outcomes.

Conceptualizing tobacco dependence as a chronic relapsing condition suggests the need to use analytic strategies that reflect that premise. However, clinical trials for smoking cessation typically define the primary endpoint as a measure of abstinence at a single timepoint distal to the intervention, typically 3-12 months. This reinforces the concept of tobacco outcomes as a dichotomous state-one is, or is not, abstinent. Fortunately, there are several approaches available to handle longitudinal data that reflect the relapsing and remitting nature of tobacco use during treatment studies. In this paper, sponsored by the Society for Research on Nicotine and Tobacco's Treatment Research Network, we present an introductory overview of these techniques and their application in smoking cessation clinical trials. Topics discussed include models to examine abstinence outcomes (eg, trajectory models of abstinence, models for transitions in smoking behavior, models for time to event), models that examine reductions in tobacco use, and models to examine joint outcomes (eg, examining changes in the use of more than one tobacco product). Finally, we discuss three additional relevant topics (ie, heterogeneity of effects, handling missing data, and power and sample size) and provide summary information about the type of model that can be used based on the type of data collected and the focus of the study. We encourage investigators to familiarize themselves with these techniques and use them in the analysis of data from clinical trials of smoking cessation treatment. Implications Clinical trials of tobacco dependence treatment typically measure abstinence 3-12 months after participant enrollment. However, because smoking is a chronic relapsing condition, these measures of intervention success may not accurately reflect the common trajectories of tobacco abstinence and relapse. Several analytical techniques facilitate this type of outcome modeling. This paper is meant to be an introduction to these concepts and techniques to the global nicotine and tobacco research community including which techniques can be used for different research questions with visual summaries of which types of models can be used for different types of data and research questions.

Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial.

There is a need for cost effective interventions that increase surgical preparedness in urogynecology. We performed an ancillary prospective economic evaluation of the Telehealth Intervention to Increase Patient Preparedness for Surgery (TIPPS) Trial, a randomized multicenter trial that evaluated the impact of a preoperative telehealth call on surgical preparedness in women undergoing urogynecologic surgery. A within-trial analysis from the health care sector and societal perspective was performed. Cost-effectiveness was computed from health care sector and societal perspectives, with an 8-week time horizon. A total of 126 women were included in our analysis. QALYs gained were similar between groups (telehealth 0.1414 + 0.0249; usual care 0.1409 + 0.0179). The cumulative mean per-person costs at 8 weeks from the healthcare sector perspective were telehealth call: $8696 +/- 3341; usual care: $8473 +/- 3118 (p = 0.693) and from the societal perspective were telehealth call: $11,195 + 5191; usual care: $11,213 +/- 4869 (p = 0.944). The preoperative telehealth call intervention was not cost effective from the health care sector perspective with an ICER of $460,091/QALY (95%CI -$7,382,608/QALY, $7,673,961) using the generally accepted maximum willingness to pay threshold of $150,000/QALY (Neumann et al. N Engl J Med. 371(9):796-7, 2014). From the societal perspective, because incremental costs per QALY gained were negative $-35,925/QALY (95%CI, -$382,978/QALY, $317,226), results suggest that preoperative telehealth call dominated usual care. A preoperative telehealth call is cost effective from the society perspective. Registered with http://ClinicalTrials.gov . Date of registration: March 26, 2019 Date of initial participant enrollment: June 5, 2019 URL: https://clinicaltrials.gov/ct2/show/record/NCT03890471 Clinical trial identification number: NCT03890471.

Development and utility of a clinical research informatics application for participant recruitment and workflow management for a return of results pilot trial in familial hypercholesterolemia in the Million Veteran Program.

The development of clinical research informatics tools and workflow processes associated with re-engaging biobank participants has become necessary as genomic repositories increasingly consider the return of actionable research results. Here we describe the development and utility of an informatics application for participant recruitment and enrollment management for the Veterans Affairs Million Veteran Program Return Of Actionable Results Study, a randomized controlled pilot trial returning individual genetic results associated with familial hypercholesterolemia. The application is developed in Python-Flask and was placed into production in November 2021. The application includes modules for chart review, medication reconciliation, participant contact and biospecimen logging, survey recording, randomization, and documentation of genetic counseling and result disclosure. Three primary users, a genetic counselor and two research coordinators, and 326 Veteran participants have been integrated into the system as of February 23, 2023. The application has successfully handled 3367 task requests involving greater than 95000 structured data points. Specifically, application users have recorded 326 chart reviews, 867 recruitment telephone calls, 158 telephone-based surveys, and 61 return of results genetic counseling sessions, among other available study tasks. The development of usable, customizable, and secure informatics tools will become increasingly important as large genomic repositories begin to return research results at scale. Our work provides a proof-of-concept for developing and using such tools to aid in managing the return of results process within a national biobank.

Rural service coordination programming for women using substances and their families.

Women experiencing substance use during their pregnancies or after the birth of a child report being fearful of losing their children based on care, stigmatized when seeking assistance, and barriers to care such as having to provide the same information to different providers, and having to repeat their lived experiences with substance use in detail. Particularly these service barriers can be confusing, complicated, and difficult to follow, which could lead to non-compliance or not seeking services. We evaluated components of a service coordination program for women experiencing substance use, their children, and larger families who help with caregiving. We examined stakeholder interest in the program, feasibility providing services over time, and initial program effectiveness. Participant enrollment and outcomes as well as service coordination activities provided over a 4-year period was gathered across three demonstration site locations (a birthing hospital, reunification program, and home visiting program). Program information was gathered from needs assessment data, health survey data from enrolled caregivers and infants, training evaluations, and budget recordings of direct aid. In this mixed method design, we examined potential differences between baseline and the last assessment for women and children enrolled in the program. We also utilized univariate analyses of variance to examine the main effects of maternal and infant characteristics on final maternal and infant outcomes. Three sites enrolled 182 women and families for program services. Patient navigators provided direct aid, training, goal setting, and service coordination and planning. Families remained in the program, on average, 655 days and were satisfied with the services received. Respondents thought the program elements were easy to implement within the rural setting. The program effectively addressed basic needs, violence (p < 0.001; η2 = 0.34 (0.05-0.53)), infant development (p < 0.02; η2 = 0.51 (0.13-0.61)), and maternal depression (p < 0.05; η2 = 0.9 (0.00-0.22)). Select outcomes did differ by site. A service coordination model utilizing a patient navigator role to coordinate client services coupled with an approach that serves the infant and caregiver needs was feasible and desirable by all stakeholders within a rural setting. Service coordination effectively impacted select caregiver and infant outcomes.

Comparison of Mixed Reality-Assisted Spinal Puncture with Landmark-Guided Spinal Puncture by Novice Practitioners: A Pilot Study.

Performing spinal anaesthesia in elderly patients with ligament calcification or hyperostosis is challenging for novice practitioners. This pilot study aimed to compare the effectiveness of mixed reality-assisted spinal puncture (MRasp) with that of landmark-guided spinal puncture (LGsp) by novice practitioners in elderly patients. In this pilot study, 36 patients (aged ≥65 years) scheduled for elective surgery under spinal anaesthesia by anaesthesiology residents were included. Patients were randomly assigned to the MRasp group (n = 18) or the LGsp group (n = 18). The outcomes included the number of needle insertion attempts, redirection attempts, passes, the rate of successful first-attempt needle insertion, the rate of successful first needle pass, the spinal puncture time, the total procedure time, and the incidence of perioperative complications. The median number of needle insertion attempts was significantly fewer in the MRasp group than in the LGsp group (1.0 vs 2.0, P = 0.023). The proportion of patients with successful first-attempt needle insertion was 72.2% in the MRasp group and 44.4% in the LGsp group (P = 0.176). The incidence of perioperative complications did not significantly differ between the two groups. This pilot study found that novice practitioners made significantly fewer needle insertion attempts in the MRasp group compared to the LGsp group when performing spinal anaesthesia on elderly patients. A future randomized controlled trial (RCT) is warranted to validate its effectiveness. This trial was registered at https://www.chictr.org.cn/showproj.html?proj=178960 (ChiCTR-IPR-2300068520). Public title: Mixed reality-assisted versus landmark-guided spinal puncture in elderly patients: a randomized controlled pilot study. Principal investigator: Lei Gao. The registration date was February 22, 2023. The date of the first participant enrolment was February 27, 2023.

Feasibility and acceptability of FOotpaths foR adolescent MAternal mental HeAlth (FOR MAMA): A co-designed intervention for pregnant adolescents in Malawi.

This study aimed to assess feasibility, acceptability and potential for impact of FOotpaths foR Adolescent MAternal Mental HeAlth (FOR MAMA), a co-designed intervention for pregnant adolescents in Malawi. We used a mixed-methods interventional pre-post cohort design. We recruited pregnant adolescents from a rural health centre in Zomba district, Malawi, all of whom were offered a five-session psychosocial intervention delivered by community healthcare workers. Quantitative feasibility indicators related to participant enrolment, session attendance and intervention completion. Feasibility of intervention delivery was explored using in-depth semi-structured interviews with healthcare workers. Acceptability was investigated through in-depth semi-structured interviews with intervention participants and a service user satisfaction questionnaire. Intervention outcomes were assessed using standardised measures of common mental disorders, financial distress and poor mental health and perceived social support. 19 adolescents aged 15-19 years (mean=17.21, SD=1.18) started the intervention, with 18 (94.7%) completing the programme. Significant improvements (p<0.05) were reported across all outcome measures, with moderate to high pre-post effect sizes. Intervention participants reported high levels of service satisfaction, although healthcare workers (n = 6) reported that some feasibility challenges emerged during recruitment and delivery. The FOR MAMA intervention proved to be an acceptable and feasible psychosocial intervention for pregnant adolescents in Malawi.

Implementation of Session Zero as a Recruitment Strategy in the National Diabetes Prevention Program's Lifestyle Change Program.

The purpose of the study was to understand the extent to which organizations offering the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program (National DPP) lifestyle change program implement session zero (a pre-enrollment session designed to recruit, engage, and enroll participants in programs), the stated purpose(s) for offering session zero, the content of session zero, and best practices for using session zero for recruitment. Researchers conducted a survey of all organizations offering the National DPP lifestyle change program that were registered with the CDC's Diabetes Prevention Recognition Program and their affiliated delivery locations. Most (79.5%) delivery locations reported implementing session zero; of these, most used session zero as a recruitment strategy (81.1%) and orientation session (72.8%), whereas few (17.7%) used session zero solely to complete participant enrollment paperwork. Most (60.7%) delivery locations that implement session zero offer all their sessions at the same location, offer one session per upcoming participant cohort (66.7%), and use a consistent agenda (83.0%). Out of a list of activities informed by behavior change theory, the most common was offering an opportunity to enroll in the year-long lifestyle change program at the end of session zero (71.1%). Most National DPP delivery locations implement session zero as a recruitment and orientation session. Most delivery locations reported including some activities informed by behavior change theory, but delivery locations could offer more theoretically informed activities during their session zero. The findings provide practice-based considerations for implementing session zero for recruitment into lifestyle change programs.

Testing a Culturally Tailored Advance Care Planning Intervention (MY WAY) for an American Indian Tribe: Protocol for a Quasi-Experimental Waitlist Control Design.

American Indian and Alaska Native peoples experience poor end-of-life care, including more hospitalizations and lower use of hospice and do-not-resuscitate orders. Although advance care planning (ACP) can improve end-of-life care, ACP rates are disproportionately low in American Indians and Alaska Natives. We culturally tailored and delivered an existing evidence-based ACP program for an American Indian tribal community. Here, we present the protocol for assessing the intervention's feasibility and efficacy. We measured feasibility via participant recruitment, participants' evaluation (acceptability, appropriateness, comprehension, and satisfaction), and intervention fidelity. Recruitment was measured with participant screening, eligibility, enrollment, and retention. Participant's evaluation of the intervention was measured with surveys. Fidelity was measured with direct observation and the Make Your Wishes About You (MY WAY) Fidelity Checklist Tool. To assess the intervention's efficacy, we used a quasi-experimental waitlist control design with 2 cohorts who were surveyed each on three separate occasions. The intervention's efficacy was assessed by the following: ACP barriers and facilitators as well as ACP self-efficacy, readiness, and completion. A total of 166 participants were screened for eligibility; 11 were deemed ineligible, and 155 participants were enrolled in the study. Of those enrolled, 113 completed the intervention and will be included in subsequent analyses. We finalized data collection in January 2023, and analyses are underway. Study enrollment was successful, and we expect that participants will report high levels of acceptability, appropriateness, comprehension, and satisfaction with the intervention. We expect that the intervention was implemented with fidelity and will demonstrate decreases in ACP barriers and increases in ACP facilitators, self-efficacy, readiness, and completion. Enrolling over twice as many participants as we had hoped suggests that members of this tribal community are willing to engage in end-of-life ACP. We were able to implement a waitlist study design to show that a culturally tailored ACP program for a tribal community is feasible. ClinicalTrials.gov NCT05304117; https://clinicaltrials.gov/study/NCT05304117. DERR1-10.2196/50654.

Development and implementation of an on-demand competency-based onboarding program for clinical research professionals in academic medicine.

Over the past 7 years, Duke has implemented competency-based job classifications for clinical research professionals (CRPs) with a defined pathway for career advancement. The workforce is defined specifically as the collection of staff employed across the clinical research enterprise to operationalize clinical research and human participatory protocols through the hands-on conduct of protocol activities including participant enrollment, regulatory coordination, study documentation, data collection and management, and sponsor engagement. The competency framework for this critical workforce laid the foundation for a centrally developed on-demand onboarding program at Duke. The self-paced program is designed to engage learners through competency-based learning modules, guided mentor/manager discussions, and applied learning activities. Consisting of an initial E-Learning orientation to clinical research at Duke, called Express Start, followed by a 90-day role-based Onboarding Learning Plan, our onboarding program includes training in foundational pre-defined core competency areas and customizable learning paths. Associated Engagement Activity Packets for many clinical research competencies encourage mentor and/or manager involvement and hands-on learning for the employee through suggested enrichment activities. The program has been widely adopted for CRPs within the Duke University Schools of Medicine and Nursing, and newly hired CRPs and their managers have expressed satisfaction with these centrally offered tools. In this paper, we describe the methods used to develop and implement our competency-based onboarding program. We will share an evaluation of the program and planned next steps for expanding the suite of onboarding resources.

INCREASING THE REPERTOIRE FOR DEPRESSION CARE: PEER SUPPORT AS DEPRESSION CARE FOR VULNERABLE OLDER ADULTS

Abstract Despite facing greater risks for poorer health, low-income White and BIPOC older adults underutilize mental health services even when they have indicated need. Increasing the repertoire for depression care that is community-based and uses paraprofessionals has potential to increase access and engagement. We are testing the effectiveness of a peer support intervention called Peer Enhanced Depression Care (PEERS) which is an 8-week community-based intervention that uses trained peer mentors to deliver emotional, appraisal and informational support in addition to encouraging self-care skills to depressed low-income white and BIPOC older adults. Enrolled participants are randomized to either the peer support intervention (PEERS) or to the social interaction control and followed for 12 months. The primary outcome is depression and secondary outcomes include engagement, mental health service use, and social, emotional, and physical functioning. Challenges related to the onset of the COVID-19 pandemic and social isolation required a shift from recruitment initially focused on the health care system to community-based organizations serving older adults. Required contactless recruitment strategies eg. flyers and newspaper ads, led to self-referral of community-dwelling older adults to the study. Challenges to participant enrollment included barriers related to communication, stigma related to help-seeking, distrust and unfamiliarity with research. Recruitment of peer mentors was facilitated by a robust infrastructure supporting the employment of the peer support workforce. Continued PM supervision after initial training, review of skills and evaluation of performance were important in maintaining quality and fidelity to the intervention.

Recruitment Barriers of an mHealth Pediatric Asthma Pilot Study.

Successful participant recruitment for pediatric studies can be challenging and even result in study discontinuation. In conducting a 2-year pilot study for a pediatric mobile health (mHealth) asthma intervention, a group of researchers experienced multiple barriers and failures in all 4 areas of recruitment: generating initial contacts, screening, consenting, and enrollment and retention. The main failures that resulted in minimal participant enrollment were poor participation, communication issues, and difficulties related to recruiting in an emergency department during a pandemic. The following is a report on this study's recruitment efforts, including preliminary and adapted strategies, the results of these strategies, and considerations for researchers who conduct studies with children. The research team concluded that frequent and clear communication, flexibility, and a willingness to alter initial recruitment plans are essential elements for recruitment success in pediatric studies.

Offering recovery rather than punishment: Implementation of a law enforcement–led pre-arrest diversion-to-treatment program for adults with substance use disorders

BackgroundThe opioid epidemic has strained the US criminal justice system. Law enforcement frequently encounters persons with substance use disorder (SUD). Law enforcement–led, pre-arrest diversion programs linking individuals with SUD to addiction treatment instead of arrest and prosecution has the potential to reduce crime, overdoses, and other community harms. We implemented a pre-arrest diversion-to-treatment program—the Madison Addiction Recovery Initiative (MARI)—from September 2017 to August 2020, and describe the key components of MARI's effective implementation. MethodsAdults who committed an eligible, drug use–related crime were offered a 6-month MARI participation with referral to treatment in lieu of arrest; criminal charges for that crime were “voided” upon the successful MARI completion. Formative evaluation, with stakeholder feedback and team meeting minutes, assessed key factors influencing implementation. Process evaluation consisted of tracking participant referrals, enrollment, and engagement. Police officers, MARI participants, and treatment center staff members were surveyed about program experiences and attitudes. The study used descriptive statistics to describe quantitative survey responses; thematic qualitative analysis identified major themes in qualitative responses. ResultsOf 263 participants, 160 initiated program engagement, with 100 successfully completing MARI. Interim evaluations and community partner feedback informed program protocol adjustments to increase participant enrollment, retention and diversity, streamline the referral processes, and transition to telehealth during the COVID-19 pandemic. ConclusionRigorous evaluation and community partner feedback are essential components of effective implementation and sustainability of a law enforcement–led pre-arrest diversion-to-treatment program, which has the potential to both reduce crime and overdose, and change the lives of people with SUD.

Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol

BackgroundThis paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. MethodsParticipants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. ConclusionThis trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. Clinical trials registrationClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study.

Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called "ChatV," based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider-informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes. This study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial. We will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use "stop, amend, and go" progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method. Participant enrollment for the study will begin in January 2024. By using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot. ClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901. PRR1-10.2196/53556.

Impact of the COVID‐19 pandemic on enrollment at United States Alzheimer’s Disease Research Centers

AbstractBackgroundImpacts of the COVID‐19 pandemic have been disproportionate by race/ethnicity and sex. We aimed to characterize the impact of the pandemic on enrollment in US Alzheimer’s Disease Research Centers (ADRCs) overall and by race/ethnicity and sex using National Alzheimer’s Coordinating Center (NACC) data.MethodsWe included data on N = 8875 participants (mean age, 69.4 years; 59% female; 9% Hispanic/Latino; 14% Black/African American) from 29 ADRCs with ≥5 years of data and study visits after 2020 (e.g., baseline visits from January 2017‐December 2021). We used interrupted time series (ITS) analyses to assess the relationship of the pandemic on enrollment and calculated projected date of recovery of pre‐pandemic enrollment overall and by race, ethnicity, and sex.ResultsEnrollment dropped to 0% of pre‐pandemic levels in April 2020; through December 2021, enrollment recovered to only 46% of pre‐pandemic levels. Participants enrolled during the pandemic (vs pre‐pandemic) were less likely to be: women, cognitively normal, and able to live independently. They were slightly younger, slightly more educated, and more likely to: be married, be referred by a doctor, nurse, or other professional, and come in for a clinical or mixed clinical and research study evaluation (p’s&lt;0.05). The two groups did not vary by race, ethnicity, living situation (alone or with others), or co‐participant characteristics. ITS demonstrated that the pandemic caused an immediate 79% drop in enrollment rate, with an estimated post‐pandemic increase in enrollment of 0.92%/month, leading to a projected recovery date of January 2026. Due to parallel pre‐ and post‐pandemic enrollment slopes among Black/African American participants, we could not predict a recovery date for this group. Projected recovery varied by ethnicity with Hispanic participant enrollment recovering earlier than non‐Hispanic participant enrollment (January 2022 vs. April 2027), largely because Hispanic participant enrollment was declining nearly 1.5%/month pre‐pandemic. Recovery date projections also varied by sex, with female participant enrollment recovering sooner than male participant enrollment (June 2025 vs. May 2027).ConclusionsStrategies to speed enrollment recovery should be developed and implemented, with special attention given to Black/African American and Hispanic enrollment. Funders and researchers should be aware of and account for ongoing COVID‐19 impact on ADRD research enrollment.

The Minority and Rural Coronavirus Insights Study: Design and Baseline Characteristics of a Minority Cohort.

The Minority and Rural Coronavirus Insights Study (MRCIS) is an ongoing prospective cohort study examining health disparities associated with SARS-CoV-2 infection among medically underserved populations. This report describes procedures implemented to establish the MRCIS cohort and examines the factors associated with the molecular and serological assessment of SARS-CoV-2 infection status at participant enrollment. Participants were recruited from 5 geographically dispersed federally qualified health centers between November 2020 and April 2021. At baseline, participants completed a detailed demographic survey and biological samples were collected for testing. SARS-CoV-2 infection status was determined based on the combined molecular and serological test results. Chi-squared and logistic regression analyses were conducted to examine associations between sociodemographic factors, COVID-19 safety measures, existing comorbidities, and SARS-CoV-2 infection status. The final cohort included 3238 participants. The mean age of participants was 50.2 ± 15.8 years. Most participants identified as female (60.0%), heterosexual or straight (93.0%), White (47.6%), and Hispanic or Latino (49.1%). Approximately 26.1% of participants had at least one positive SARS-CoV-2 test result. The main effect model included age, sex, and race/ethnicity. Compared with adults ≥65 years, participants in all other age groups had ∼2 times increased odds of a positive SARS-CoV-2 test result. In addition, racial/ethnic minorities had ∼2 times increased odds of a positive SARS-CoV-2 infection status compared with non-Hispanic Whites. A unique cohort of a traditionally medically underserved minority population was established. Significant racial and ethnic disparities in SARS-CoV-2 infection status at baseline were discovered.

Advancing Engagement and Enrollment of Older Black Americans in Alzheimer’s disease and Dementia‐Related Research

AbstractBackgroundThe under‐enrollment of racial and ethnic minorities in clinical trials limits the development of culturally tailored disease treatments and preventative strategies. For example, African Americans experience a greater risk of Alzheimer’s disease (AD), yet they remain woefully underrepresented in AD research. This limits understanding of how AD may operate differently in black populations, who have a higher burden of socio‐structural determinants of health. To improve older black American enrollment, The NYU Healthy Brain Aging and Sleep Center (HBASC) team developed a method tailored toward increasing minority enrollment in clinical trials by collaborating with community‐based organizations and minority populations to reexamine barriers to trial participation.MethodHBASC conducted a single‐site (New York Metropolitan Area) longitudinal study examining sleep and AD in healthy black adults (aged 60‐75). From the study, barriers to trial enrollment were evaluated on a systemic and individual level. The degree to which each level directly or indirectly contributed to barriers to enrollment was further explored using a series of steps and practices seeking to engage underrepresented communities in research. In doing so, team members established and implemented a community‐focused method called FEED. Study personnel demonstrated the feed method by Finding groups, organizations, and trusted community members to collaborate with, Educating community members, Engaging community members through events and educational seminars, and Delivering resources to the community.ResultThrough collaborations with community leaders and organizations, the study team performed community outreach events, raising disease awareness, sustaining trustful relationships, and providing educational resources. The study team saw ∼50% increase in black participant enrollment through the FEED method. Increased engagement in medical research was accomplished when underrepresented communities were empowered with the tools and resources to make knowledgeable decisions.ConclusionDiverse populations of patients face complex and multifaceted barriers to enrollment in clinical trials. A FEED framework will help address these barriers at an individual and systemic level.

Strategies for recruiting African Americans into aging research: The Health and Aging Brain Health Disparities (HABS‐HD) Study.

AbstractBackgroundDespite the increase in Alzheimer’s disease (AD) research among ethnic and racial minority populations, they are underrepresented in research and successful recruitment of diverse cohorts remains challenging. Culturally specific recruitment strategies and community engagement are needed to increase diverse participant enrollment in aging research. In 2020, we designed and implemented a strategy to recruit 1,000 African Americans (AA), 50 years and older into the Health &amp; Aging Brain Study‐ Health Disparities (HABS‐HD) project. In this study, we examined the effectiveness of recruitment strategies among this group.MethodHABS‐HD is an epidemiological study of cognitive aging among diverse communities. The team recruited an initial cohort of 1,000 non‐Hispanic whites and 1,000 Mexican Americans using a community‐based approach. This foundation was expanded to reach the AA community through the engagement of key stakeholders and the use of an integrated marketing and outreach strategy. Recruitment methods included an integrated approach combining traditional marketing (print, radio); social media (influencers and online ads), and in person community recruitment and education events at local churches, barbershops, health fairs, etc. The reach and enrollment data were collected and analyzed.ResultOut of 4066 participants that were interested in HABS‐HD, 1362 (33.5%) identified as AA. While recruiting the AA cohort outreach team participated in over 140 community events, ranging from state fairs, barbershops, and church events. Enrollment data indicated participants heard of us through word of mouth (35%); community events (21.6%); news (12.7%); refer a friend program (6.8%); print media (6.4%) radio (4%); and social media (3.6%). In terms of traditional marketing and overall general study awareness, the social media approach reached 179,200 individuals. Of this number12.1% of people interacted with the landing site and then a further 747 clicked to sign up. The reach of our radio advertising was 2,200,000 listeners.ConclusionRecruiting diverse communities into research involves targeting the recruitment techniques and materials to the target population. The creation of a culturally appropriate media campaign and utilizing community based methods such as outreach, engagement, and collaboration between the research team and key stakeholders in the community led to the successful recruitment of AA into our study.

Advancing Engagement and Enrollment of Older Black Americans in Alzheimer’s disease and Dementia‐Related Research

AbstractBackgroundThe under‐enrollment of racial and ethnic minorities in clinical trials limits the development of culturally tailored disease treatments and preventative strategies. For example, African Americans experience a greater risk of Alzheimer’s disease (AD), yet they remain woefully underrepresented in AD research. This limits understanding of how AD may operate differently in black populations, who have a higher burden of socio‐structural determinants of health. To improve older black American enrollment, The NYU Healthy Brain Aging and Sleep Center (HBASC) team developed a method tailored toward increasing minority enrollment in clinical trials by collaborating with community‐based organizations and minority populations to reexamine barriers to trial participation.MethodHBASC conducted a single‐site (New York Metropolitan Area) longitudinal study examining sleep and AD in healthy black adults (aged 60‐75). From the study, barriers to trial enrollment were evaluated on a systemic and individual level. The degree to which each level directly or indirectly contributed to barriers to enrollment was further explored using a series of steps and practices seeking to engage underrepresented communities in research. In doing so, team members established and implemented a community‐focused method called FEED. Study personnel demonstrated the feed method by Finding groups, organizations, and trusted community members to collaborate with, Educating community members, Engaging community members through events and educational seminars, and Delivering resources to the community.ResultThrough collaborations with community leaders and organizations, the study team performed community outreach events, raising disease awareness, sustaining trustful relationships, and providing educational resources. The study team saw ∼50% increase in black participant enrollment through the FEED method. Increased engagement in medical research was accomplished when underrepresented communities were empowered with the tools and resources to make knowledgeable decisions.ConclusionDiverse populations of patients face complex and multifaceted barriers to enrollment in clinical trials. A FEED framework will help address these barriers at an individual and systemic level.