Helping black patients decide on a treatment for chronic heart failure : the VIVID study / Kevin L. Thomas [and four others].

Format:

Book

Author/Creator:

Thomas, Kevin L., author.

Series:

Final research report (Patient-Centered Outcomes Research Institute (U.S.))

Language:

English

Subjects (All):

Decision making.

Physical Description:

1 online resource (122 pages) : illustrations.

Other Title:

Helping black patients decide on a treatment for chronic heart failure

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute, 2022.

Summary:

BACKGROUND: Sudden cardiac arrest (SCA) is the leading cause of death in the United States, accounting for approximately 450 000 deaths annually. Data from randomized clinical trials and systematic reviews have demonstrated the efficacy of implantable cardioverter-defibrillator (ICD) therapy to improve survival in patients with chronic systolic heart failure. However, despite guideline recommendations for ICD implantation for the primary prevention of SCA in at-risk populations, Black patients have lower rates of ICD implantation than do White patients. Reasons for racial disparities in ICD implantation remain enigmatic, but they are explained in part by higher refusal rates. A decision support tool may be an effective intervention to address barriers to ICD implantation in at-risk Black patients. OBJECTIVES: Using patient-centered, racially distinct educational videos on sudden cardiac death and ICDs, we compared the effects of video-assisted decision support with usual care on (1) patient knowledge of sudden cardiac death and ICDs, (2) assent for ICD implantation, (3) decisional conflict, and (4) ICD implantation within 90 days in Black patients. We explored the influence of racial concordance between study participants and actual clinicians and patients in the video on assent to ICD implantation, decisional conflict, and ICD implantation within 90 days. Last, we determined the impact of the decision support tool on time spent with the clinician during the study enrollment encounter. METHODS: From September 2016 to December 2019, we prospectively randomized 343 Black patients at 14 ambulatory electrophysiology clinics in academic and community practices to 1 of 3 arms in a 1:1:1 ratio: (1) video featuring actual Black clinicians and patients, (2) video featuring White clinicians and patients, or (3) usual care. The primary outcome was decision for ICD implantation. ICD implantation within 90 days of enrollment was a secondary outcome. For the outcomes assessment, the 2 video arms were combined and compared with usual care. We used the Pearson chi-square test to compare the combined video arms and the usual-care arm for the primary outcome and to assess the effect of racial concordance between a study participant and the clinicians and patients in the video on the decision for ICD implantation. We used adjusted linear regression to assess differences in knowledge questionnaire scores and Decisional Conflict Scale scores by treatment assignment. We conducted in-depth interviews in a purposively heterogeneous sample of study participants to better understand what variables influenced the decision for ICD implantation among assenters, decliners, and participants who were undecided at 7 days after study enrollment. RESULTS: Of the 343 patients enrolled, 330 were randomized; data for the primary outcome were available for 311 patients. The mean (SD) age was 59.6 (12.2) years, and 36.8% were women. The mean left ventricular ejection fraction was 24.9%, 94.2% of patients had New York Heart Association Class II or III heart failure symptoms, and 68.1% had a nonischemic etiology of their heart failure with reduced left ventricular function. Among those randomized to the video arm, assent to ICD implantation was 58.6%, compared with 59.4% in the usual care arm (P = .99). Compared with the usual care group, the video group had higher knowledge scores (adjusted coefficient, 0.66; 95% CI, 0.23-1.09; P = .03) and similar decisional conflict (adjusted coefficient, −2.643; 95% CI, −5.67 to 0.38; P = .09). Overall, the ICD implantation rate within 90 days was 65.7%, with no significant differences by intervention. Participants randomized to the video arm spent less time with their clinician than did those in the usual-care arm (22.1 (+/-) 17.0 minutes vs 27.0 (+/-) 20.8 minutes, respectively; P = .03). The videos were liked by all participants. Their clinicians' recommendations significantly influenced the decision for ICD implantation. CONCLUSIONS: Among Black patients eligible for an ICD, a video decision support tool increased patient knowledge but did not decrease decisional conflict or result in higher assent rates for ICD implantation (the primary outcome) compared with usual care. ICD implantation rates were similar in the intervention and control groups. A racially concordant decision support video did not result in higher assent to ICDs, lower decisional conflict, or higher ICD implantation rates than those with a racially discordant video. Decision support videos to promote shared decision-making were associated with less time spent by clinicians with patients. LIMITATIONS: It is plausible that a Hawthorne effect modified the behavior of clinicians in the usual-care arm that minimized the effect of the video by elevating the quality of usual care. We did not capture data on insurance status or health literacy, which may have influenced decision-making.

Contents:

Background

Methods

Results

Discussion

Conclusions

References

Related Publications

Acknowledgments

Appendices.

Notes:

Description based on publisher supplied metadata and other sources.