(1132) Adapting a Methods-motivational Interviewing Approach in Enrolling and Retaining Black Adults with Diabetes in a Pilot Behavioral Clinical Trial

Objectives: Suboptimal enrollment and retention efforts can compromise randomized controlled trial (RCT) quality. Recruiting historically marginalized populations is challenging because of barriers such as mistrust of healthcare and/or research, and low awareness/education about clinical trials and how they work. Methods-Motivational Interviewing (MMI) approach is a patient-centered approach that integrates interactive and educational sessions in providing trial information and engages participants in discussions about participating in a clinical trial before enrollment in the trial. Previous studies have found the MMI approach to be an effective strategy to enhance recruitment and retention rates in clinical trials. This study utilized an adapted MMI approach in enrolling Black adults with type 2 diabetes into a pilot trial, investigating their facilitators and barriers to trial enrollment.

Methods: An adapted MMI approach, including a prerequisite orientation was implemented in the recruitment stage of a pilot trial assessing the feasibility and signal of change in outcomes of a culturally tailored diabetes self-management intervention versus a standard diabetes program for Black adults. The orientation occurred prior to informed consent with a 20-minute interactive presentation led by the principal investigator and a 10-minute small group discussion led by the study coordinator. The presentation discussed five main components: (1) to the meaning of research and the purpose of clinical trials, (2) an introduction to randomization and the process of randomization, (3) an overview of the clinical trial and differences between the two trial arms, (4) the study timeline including assessments, time involvement, and incentive schedule, and (5) an explanation about the scientific rationale for completing assessments. The orientation content and language used health literacy principles, i.e., vivid examples, infographics and a pictorial roadmap. The visual aids and key points in the interactive presentation and discussion were demonstrated in Table 1. Following the presentation, potential participants were separated into small groups to discuss the pros and cons related to trial participation and two different trial arms. The study coordinator facilitated the small group discussion and led the large group discussion. Discussion notes taken by research assistants were documented during the small group discussion. After the trial started, two focus groups were conducted to explore participants’ perceptions of the enrollment process. Trial recruitment and retention rates were analyzed using descriptive statistics. Focus group transcripts were analyzed using inductive content analysis to capture their overall feedback of the prerequisite orientation session.

Results: Fifteen participants attended a 30-minute orientation prior to the trial. Fourteen participants enrolled in the trial after the orientation, representing a 93% enrollment rate from all eligible participants. The time from screening to enrollment was 13 days (47 days faster than anticipated), and there were no dropouts after randomization. The current retention rate in this 6-month trial is 100% (intervention), and 93% (control). In discussing trial participation pros and cons, potential participants valued having healthier lifestyles, supplementing provider information with intervention educational content, and having the ability to share diabetes self-management information with family members (Table 2). Participants perceived time commitment and conflicts with schedules as negatives. Positive experiences of the orientation were reported in the focus group because of a better understanding of the study information and expectations and rationale behind the randomization process.

Conclusions: Implementing an adapted MMI approach may improve trial enrollment and retention rates. A prerequisite orientation to diffuse ambivalence about participating in trials may be essential for recruiting marginalized populations. Being explicit about the differences in the intervention components of trial arms may address concerns about participation before enrollment. Future studies should examine the key MMI components associated with better enrollment and retention rates in marginalized populations and expand on how a prerequisite orientation may impact research literacy and trust.