학술논문
Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial
Document Type
Report
Author
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.; Fleming, Kirsten; Gorr, Haeshik; Hess, Erik; IV Hamilton, James; Noseworthy, Peter A.; Haffke, Alexander; Muegge, Jule; Poplau, Sara; Simpson, Benjamin; Vang, Miamoua; 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
Source
BMC Health Services Research. August 12, 2022, Vol. 22 Issue 1
Subject
Language
English
ISSN
1472-6963
Abstract
Author(s): Angela Sivly[sup.1] , Haeshik S. Gorr[sup.2] , Derek Gravholt[sup.1] , Megan E. Branda[sup.1,3] , Mark Linzer[sup.2] , Peter Noseworthy[sup.1,4] , Ian Hargraves[sup.1] , Marleen Kunneman[sup.1,5] , Chyke A. Doubeni[sup.6] [...]
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: Diversity, Minorities, Equity, Enrollment, Practice-based trials, Complex interventions, Shared decision-making, BIPOC
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: Diversity, Minorities, Equity, Enrollment, Practice-based trials, Complex interventions, Shared decision-making, BIPOC