Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial

Abstract

Background: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF).

Methods: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation.

Analysis: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites.

Results: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. Eligible Black participants were significantly less likely (p < .001) to enroll (102, 11%) than trial-eligible White participants (185, 15%). The enrollment rate of BIPOC patients varied by site. The inclusion and prioritization of clinical practices that care for more BIPOC patients contributed to a higher enrollment rate into the trial. Specific efforts to reach BIPOC clinic attendees and prioritize their enrollment had lower yield.

Conclusions: Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed. This study suggests a high yield from enrolling BIPOC patients from practices that prioritize their care.

Trial registration: ClinicalTrials.gov (NCT02905032).

Keywords: BIPOC; Complex interventions; Diversity; Enrollment; Equity; Minorities; Practice-based trials; Shared decision-making.

Fig. 1

Proportion of BIPOC participants enrolled, by participating trial site. Proportion of Black, Indigenous and people of color (BIPOC) patients by enrollment status and main reasons for non-enrollment. Total enrollment of BIPOC patients was 147, 10 from University of Alabama at Birmingham (AL), 60 from Hennepin Healthcare (HCMC), 6 from Mayo Clinic, 30 from University of Mississippi (MS), and 41 from Park Nicollet (PN)

Fig. 2

Enrollment over time. The black line represents the cumulative enrollment of Black, Indigenous and people of color (BIPOC) patients. The arrows depict the start of enrollment at participating health systems: (1) Mayo Clinic (first quarter (Q1), 2017); (2) Hennepin Healthcare and Park Nicollet (Q2, 2017); and (3) University of Alabama at Birmingham and University of Mississippi (Q4, 2018)