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Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) trial: Rational, design and methodology - 05/02/20

Doi : 10.1016/j.ahj.2019.10.011 
Kevin L. Thomas, MD a, , Lonnie T. Sullivan, MD e, Sana M. Al-Khatib, MD, MHS a, Nancy Allen LaPointe, PharmD b, Sam Sears, PhD c, Andrzej S. Kosinski, PhD a, Larry R. Jackson, MD a, Valentina Kutyifa, MD, PhD d, Eric D. Peterson, MD, MPH a
a Duke Clinical Research Institute 
b Duke University Medical Center 
c East Carolina University, Department of Psychology, Greenville, NC 
d University of Rochester Medical Center, School of Medicine and Dentistry 
e Lonnie Sullivan Duke university medical center Durham, NC USA 

Reprint requests: Kevin L. Thomas, MD, Duke Clinical Research Institute (DCRI), 200 Morris St, Durham, NC 27705.Duke Clinical Research Institute (DCRI)200 Morris StDurhamNC27705

Abstract

Background

Despite a higher prevalence of sudden cardiac death (SCD), black individuals are less likely than whites to have an implantable cardioverter defibrillator (ICD) implanted. Racial differences in ICD utilization is in part explained by higher refusal rates in black individuals. Decision support can assist with treatment-related uncertainty and prepare patients to make well-informed decisions.

Methods

The Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) study will randomize 350 black individuals with a primary prevention indication for an ICD to a racially concordant/discordant video-based decision support tool or usual care. The composite primary outcome is (1) the decision for ICD placement in the combined video groups compared with usual care and (2) the decision for ICD placement in the racially concordant relative to discordant video group. Additional outcomes include knowledge of ICD therapy and SCD risk; decisional conflict; ICD receipt at 90 days; and a qualitative assessment of ICD decision making in acceptors, decliners, and those undecided.

Conclusions

In addition to assessing the efficacy of decision support on ICD acceptance among black individuals, VIVID will provide insight into the role of racial concordance in medical decision making. Given the similarities in the root causes of racial/ethnic disparities in care across health disciplines, our approach and findings may be generalizable to decision making in other health care settings.

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Mappa


 Clyde W. Yancy, MD, served as guest editor for this article
 Trial registration: ClinicalTrials.gov: NCT02819973
 Declaration of interest
Sam Sears: research grants from Medtronic, Larry R. Jackson II: consultant for Biotronik, Valentina Kutyifa: research grants from Zoll Medical Corporation and Boston Scientific Corp.
 Sources of funding
Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (AD-1503-29746).
 Conflict of interest disclosures
K. L. Thomas has no relevant disclosures to report.
Lonnie Sullivan has no relevant disclosures to report.
Sana Al-Khatib has no relevant disclosures to report.
N. Allen Lapointe has no relevant disclosures to report.
Sam Sears reports research grants from Medtronic.
Andrzej Kosisniski has no relevant disclosures.
Larry R Jackson II is consultant for Biotronik.
Valentina Kutyifa reports research grants from Zoll Medical Corporation and Boston Scientific Corp.
E. D. Peterson: Please see the DCRI Web site: coi.jsp for Dr Peterson's disclosures.


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