TY - JOUR
T1 - Enrolling people of color to evaluate a practice intervention
T2 - lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial
AU - for the Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators
AU - Sivly, Angela
AU - Gorr, Haeshik S.
AU - Gravholt, Derek
AU - Branda, Megan E.
AU - Linzer, Mark
AU - Noseworthy, Peter
AU - Hargraves, Ian
AU - Kunneman, Marleen
AU - Doubeni, Chyke A.
AU - Suzuki, Takeki
AU - Brito, Juan P.
AU - Jackson, Elizabeth A.
AU - Burnett, Bruce
AU - Wambua, Mike
AU - Montori, Victor M.
AU - Montori, Victor M.
AU - Fleming, Kirsten
AU - Gorr, Haeshik
AU - Hess, Erik
AU - IV Hamilton, James
AU - Noseworthy, Peter A.
AU - Haffke, Alexander
AU - Muegge, Jule
AU - Poplau, Sara
AU - Simpson, Benjamin
AU - Vang, Miamoua
AU - Anderson, Joel
AU - Behnken, Emma
AU - Bellolio, Fernanda
AU - Cabalka, Renee
AU - Ferrara, Michael
AU - Giblon, Rachel
AU - Inselman, Jonathan
AU - LeBlanc, Annie
AU - Lee, Alexander
AU - Montori, Victor
AU - Olive, Marc
AU - Organick, Paige
AU - Shah, Nilay
AU - Spencer-Bonilla, Gabriela
AU - Stier, Amy
AU - Thota, Anjali
AU - Ting, Henry
AU - Vanmeter, Derek
AU - Zeballos-Palacios, Claudia
AU - Abullarade, Carol
AU - Harvey, Lisa
AU - Keune, Shelly
AU - Smith, Timothy
AU - Stephens, Shannon
AU - Barksdale, Bryan
AU - Hickey, Theresa
AU - Peters, Roma
AU - Price, Memrie
AU - Watson, Connie
AU - Wolfe, Douglas
AU - Guyatt, Gordon
AU - Haynes, Brian
AU - Tomlinson, George
AU - Daniels, Paul
AU - Gersh, Bernard
AU - Jaeger, Thomas
AU - McBane, Robert
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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).
AB - 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).
KW - BIPOC
KW - Complex interventions
KW - Diversity
KW - Enrollment
KW - Equity
KW - Minorities
KW - Practice-based trials
KW - Shared decision-making
UR - http://www.scopus.com/inward/record.url?scp=85136343237&partnerID=8YFLogxK
U2 - 10.1186/s12913-022-08399-z
DO - 10.1186/s12913-022-08399-z
M3 - Article
C2 - 35962351
AN - SCOPUS:85136343237
SN - 1472-6963
VL - 22
JO - BMC health services research
JF - BMC health services research
IS - 1
M1 - 1032
ER -