Recruiting historically under-represented individuals into Project ECHO Diabetes: using barrier analysis to understand disparities in clinical research in the USA

Abstract

Objectives: Individuals under-recruited in diabetes research studies include those not seen at endocrinology centres and those from rural, low socioeconomic and/or under-represented racial/ethnic groups. The purpose of this descriptive analysis is to detail recruitment and retention efforts of Project ECHO Diabetes clinical sites affiliated with Stanford University and University of Florida.

Design: Prospective collection of participant engagement and qualitative analysis of barriers and facilitators of research engagement within Project ECHO Diabetes, a virtual tele-education programme for healthcare providers in the management of individuals with insulin-requiring diabetes.

Setting: Data were collected at the patient level, provider level and clinic level between 1 May 2021 and 31 July 2022.

Participants: Participants and study personnel were recruited from 33 Project ECHO Diabetes sites in California and Florida.

Outcomes: We report study completion rates for participants recruited into 33 Project ECHO Diabetes sites. Using barrier analysis, a methodology designed for the real-time assessment of interventions and system processes to identify barriers and facilitators, study personnel identified significant barriers to recruitment and retention and mapped them to actionable solutions.

Results: In total, 872 participants (California n=495, Florida n=377) were recruited with differing recruitment rates by site (California=52.7%, Florida=21.5%). Barrier analysis identified lack of trust, unreliable contact information, communication issues and institutional review board (IRB) requirements as key recruitment barriers. Culturally congruent staff, community health centre (CHC) support, adequate funding and consent process flexibility were solutions to address recruitment challenges. Barriers to retention were inconsistent postal access, haemoglobin A1c kit collection challenges, COVID-19 pandemic and broadband/connectivity issues. Additional funding supporting research staff and analogue communication methods were identified as solutions address barriers to retention.

Conclusions: Funded partnerships with CHCs, trusted by their local communities, were key in our recruitment and retention strategies. IRB consent process flexibility reduced barriers to recruitment. Recruiting historically under-represented populations is feasible with funding aimed to address structural barriers to research participation.

Keywords: Clinical Trial; DIABETES & ENDOCRINOLOGY; Health Equity; Patient Participation; STATISTICS & RESEARCH METHODS.

Figure 1

Map of community health centres participating in project ECHO diabetes in California and Florida. Florida is working with 14 centres (red) and California is working with 19 centres (green) as project ECHO diabetes research sites. All participating centres are either federally qualified health centres or are located in an area of high deprivation (online supplemental appendix A).

Figure 2

Barriers and solutions to recruitment. Four key barriers to recruitment were (1) lack of trust in the medical and research institutions (lack of trust), (2) inaccurate and outdated contact information (inaccurate contact info), (3) limitations in health literacy and language barriers (communication challenges) and (4) in-person consenting and limited access to technology (logistical issues) were barriers identified by study staff. Solutions (culturally congruent staff, partnerships with CHCs, funding and IRB flexibility) often addressed more than one barrier. CHCs, community health centres; IRB, institutional review board.

Figure 3

Barriers and solutions to retention of study activities. Four key barriers to retention included challenges in getting study materials to participants, difficulty in proper collection of A1c kits, the impact of COVID-19 and challenges with broadband connectivity to complete study activities.