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 decisio...
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BMC
2022-08-01
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Online Access: | https://doi.org/10.1186/s12913-022-08399-z |
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author | Angela Sivly Haeshik S. Gorr Derek Gravholt Megan E. Branda Mark Linzer Peter Noseworthy Ian Hargraves Marleen Kunneman Chyke A. Doubeni Takeki Suzuki Juan P. Brito Elizabeth A. Jackson Bruce Burnett Mike Wambua Victor M. Montori for the Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators |
author_facet | Angela Sivly Haeshik S. Gorr Derek Gravholt Megan E. Branda Mark Linzer Peter Noseworthy Ian Hargraves Marleen Kunneman Chyke A. Doubeni Takeki Suzuki Juan P. Brito Elizabeth A. Jackson Bruce Burnett Mike Wambua Victor M. Montori for the Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators |
author_sort | Angela Sivly |
collection | DOAJ |
description | 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). |
first_indexed | 2024-04-13T13:03:07Z |
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institution | Directory Open Access Journal |
issn | 1472-6963 |
language | English |
last_indexed | 2024-04-13T13:03:07Z |
publishDate | 2022-08-01 |
publisher | BMC |
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series | BMC Health Services Research |
spelling | doaj.art-9c24b5c507684320ae89f384ac043ead2022-12-22T02:45:51ZengBMCBMC Health Services Research1472-69632022-08-012211810.1186/s12913-022-08399-zEnrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trialAngela Sivly0Haeshik S. Gorr1Derek Gravholt2Megan E. Branda3Mark Linzer4Peter Noseworthy5Ian Hargraves6Marleen Kunneman7Chyke A. Doubeni8Takeki Suzuki9Juan P. Brito10Elizabeth A. Jackson11Bruce Burnett12Mike Wambua13Victor M. Montori14for the Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial InvestigatorsKnowledge and Evaluation Research Unit, Mayo ClinicHennepin HealthcareKnowledge and Evaluation Research Unit, Mayo ClinicKnowledge and Evaluation Research Unit, Mayo ClinicHennepin HealthcareKnowledge and Evaluation Research Unit, Mayo ClinicKnowledge and Evaluation Research Unit, Mayo ClinicKnowledge and Evaluation Research Unit, Mayo ClinicMayo Clinic Center for Health Equity and Community Engagement Research, Mayo ClinicIndiana University School of MedicineKnowledge and Evaluation Research Unit, Mayo ClinicDivision of Cardiovascular Disease, University of Alabama at BirminghamHealth PartnersHennepin HealthcareKnowledge and Evaluation Research Unit, Mayo ClinicAbstract 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).https://doi.org/10.1186/s12913-022-08399-zDiversityMinoritiesEquityEnrollmentPractice-based trialsComplex interventions |
spellingShingle | Angela Sivly Haeshik S. Gorr Derek Gravholt Megan E. Branda Mark Linzer Peter Noseworthy Ian Hargraves Marleen Kunneman Chyke A. Doubeni Takeki Suzuki Juan P. Brito Elizabeth A. Jackson Bruce Burnett Mike Wambua Victor M. Montori for the Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial BMC Health Services Research Diversity Minorities Equity Enrollment Practice-based trials Complex interventions |
title | Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial |
title_full | Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial |
title_fullStr | Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial |
title_full_unstemmed | Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial |
title_short | Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial |
title_sort | enrolling people of color to evaluate a practice intervention lessons from the shared decision making for atrial fibrillation sdm4afib trial |
topic | Diversity Minorities Equity Enrollment Practice-based trials Complex interventions |
url | https://doi.org/10.1186/s12913-022-08399-z |
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