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Randomized Controlled Trial Multicenter Study
Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial.
- Kevin L Thomas, Sana M Al-Khatib, Andrzej S Kosinski, Samuel F Sears, Nancy M Allen LaPointe, Larry R Jackson, Daniel D Matlock, Daniel Haithcock, B Judson Colley, David S Hirsh, and Eric D Peterson.
- Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina (K.L.T., S.M.A.).
- Ann. Intern. Med. 2023 May 1; 176 (5): 615623615-623.
BackgroundRacial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates.ObjectiveTo assess the effectiveness of a video decision support tool for Black patients eligible for an ICD.DesignMulticenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973).SettingFourteen academic and community-based electrophysiology clinics in the United States.ParticipantsBlack adults with heart failure who were eligible for a primary prevention ICD.InterventionAn encounter-based video decision support tool or usual care.MeasurementsThe primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians.ResultsOf the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, -0.8 percentage point [95% CI, -13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, -2.6 [CI, -5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, -4.9 minutes [CI, -9.4 to -0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes.LimitationThe Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study.ConclusionA video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation.Primary Funding SourcePatient-Centered Outcomes Research Institute.
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