Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial
Authors: Sivly Angela , Gorr Haeshik S. , Gravholt Derek , Branda Megan E. , Linzer Mark , Noseworthy Peter , Hargraves Ian , Kunneman Marleen , Doubeni Chyke A. , Suzuki Takeki , Brito Juan P. , Jackson Elizabeth A. , Burnett Bruce , Wambua Mike , Montori Victor M. ,   for the Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators, Montori Victor M. , Branda Megan E. , Brito Juan P. , Kunneman Marleen , Hargraves Ian , Sivly Angela , Fleming Kirsten , Burnett Bruce , Linzer Mark , Gorr Haeshik , Jackson Elizabeth A. , Hess Erik , Suzuki Takeki , IV Hamilton James , Noseworthy Peter A. , Haffke Alexander , Muegge Jule , Poplau Sara , Simpson Benjamin , Vang Miamoua , Wambua Mike , Anderson Joel , Behnken Emma , Bellolio Fernanda , Cabalka Renee , Ferrara Michael , Giblon Rachel , Inselman Jonathan , LeBlanc Annie , Lee Alexander , Montori Victor , Olive Marc , Organick Paige , Shah Nilay , Spencer-Bonilla Gabriela , Stier Amy , Thota Anjali , Ting Henry , Vanmeter Derek , Zeballos-Palacios Claudia , Abullarade Carol , Harvey Lisa , Keune Shelly , Smith Timothy , Stephens Shannon , Barksdale Bryan , Hickey Theresa , Peters Roma , Price Memrie , Watson Connie , Wolfe Douglas , Guyatt Gordon , Haynes Brian , Tomlinson George , Daniels Paul , Gersh Bernard , Jaeger Thomas , McBane Robert 
Published: August 2022

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).