TY - JOUR
T1 - Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) trial
T2 - Rational, design and methodology
AU - Thomas, Kevin L.
AU - Sullivan, Lonnie T.
AU - Al-Khatib, Sana M.
AU - LaPointe, Nancy Allen
AU - Sears, Sam
AU - Kosinski, Andrzej S.
AU - Jackson, Larry R.
AU - Kutyifa, Valentina
AU - Peterson, Eric D.
N1 - Funding Information:
Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (AD-1503-29746).Patient enrollment was calculated to allow a sufficient number of subjects to provide 80% power for testing the primary outcomes. Based on the results of our pilot study,29 we estimated a 17%-20% increase in the proportion of patients accepting ICD implantation in the combined video groups compared with usual care with an overall acceptance rate of 60% with video. Additionally, we estimated a 20% higher acceptance of ICD implantation in the racially concordant video group compared with the discordant group. The type 1 error was adjusted to account for 2 co-primary comparisons ? = .025?=??.5/2 (Bonferroni correction). We calculated sample sizes across different effect sizes. For the first co-primary outcome, estimating a video effect size of 20% and the proportion of patients viewing the video accepting an ICD of 60%, to achieve 80% power, the sample size in each video and the usual care arm should be 89 (20%) (Table IIA). For the second component of the primary outcome, we postulated a 60% ICD acceptance rate for individuals viewing the video; thus, an absolute difference of 20% implies that acceptance of ICD implantation in the concordant video would be 70% and 50% in the discordant video. For 80% power, the sample size needed is 115 subjects in each video group, necessitating an overall study sample size of 345 (115 black video, 115 white video, 115 usual care) (Table IIB). Computations were done with SAS 9.2 statistical software (PROC POWER). Enrollment will conclude December 2019, and currently, 307 patients have been enrolled. Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (AD-1503-29746). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.? 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. 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: http://www.dcri.duke.edu/research/coi.jsp for Dr Peterson's disclosures.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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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U2 - 10.1016/j.ahj.2019.10.011
DO - 10.1016/j.ahj.2019.10.011
M3 - Article
C2 - 31785550
AN - SCOPUS:85075556250
SN - 0002-8703
VL - 220
SP - 59
EP - 67
JO - American Heart Journal
JF - American Heart Journal
ER -