Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial.

BACKGROUND

Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates.

OBJECTIVE

To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD.

DESIGN

Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973).

SETTING

Fourteen academic and community-based electrophysiology clinics in the United States.

PARTICIPANTS

Black adults with heart failure who were eligible for a primary prevention ICD.

INTERVENTION

An encounter-based video decision support tool or usual care.

MEASUREMENTS

The 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.

RESULTS

Of 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.

LIMITATION

The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study.

CONCLUSION

A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation.

PRIMARY FUNDING SOURCE

Patient-Centered Outcomes Research Institute.