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

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).

Reversal of direct oral anticoagulants: Highlights from the Anticoagulation Forum guideline.

The 2019 guideline from the Anticoagulation Forum provides clear instructions on how to use 2 agents for reversing the effects of direct oral anticoagulants (DOACs): idarucizumab for dabigatran-associated bleeding and andexanet alfa for bleeding associated with rivaroxaban and apixaban. The guideline also discusses off-label use of andexanet alfa for bleeding associated with edoxaban and betrixaban and the use of hemostatic agents such as activated prothrombin complex concentrate and 4-factor prothrombin complex concentrate. Lastly, it offers approaches for building and managing stewardship programs at the health system level.