Approaches to screening and enrollment in clinical trials for seriously ill older adults in rural Appalachia.

backgroundRecruiting participants for clinical trials in rural regions is challenging due to geographic isolation, transportation barriers, limited healthcare infrastructure, and longstanding mistrust of research. An NIH-funded randomized controlled trial (RCT) is underway to evaluate a nurse-led home care intervention for patients with advanced heart failure (HF) in rural Appalachia. PURPOSE: This paper describes systematic strategies for screening, recruitment, and enrollment of older adults with HF and their primary caregivers in rural settings.

methodsRecruitment occurs through outpatient HF clinics and referrals from faith-based nurses native to rural counties in West Virginia. Strategies emphasize cultural sensitivity and community engagement, including comprehensive staff training, proactive outreach, flexible scheduling, and IRB-approved incentives.

resultsEight months after IRB approval and staff training, 66 families have enrolled, representing 64.7% of the target enrollment goal. Enrollment is ongoing and progressing as planned. Challenges include unclear HF diagnoses in medical records, missing caregiver contact information, and communication barriers such as outdated phone numbers and reluctance to answer unfamiliar calls. These issues are addressed through systematic documentation, repeated follow-up, and leveraging trusted community networks. DISCUSSION: Culturally tailored, community-based approaches effectively mitigate enrollment barriers in rural populations. Collaboration with local clinic staff and faith-based nurses fosters trust, improves access, and supports retention of participants with serious illness. Structured processes grounded in cultural understanding and local partnerships are essential for successful trial implementation in rural Appalachia.