Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three
specific research questions. In black patients eligible for a primary prevention implantable
cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational
video compared with usual care (UC) on knowledge of SCD (Sudden Cardiac Death), associated
risk factors, and ICDs; 2) what is the effect of a patient-centered educational video
compared with UC on the decision for ICD implantation, decisional conflict, and receipt of an
ICD within 90 days of the decision; 3) what is the effect of racial concordance between study
patients and video participants (health care providers/patients) on the decision for ICD
implantation, decisional conflict and ICD receipt within 90 days of the decision. In
addition, in-depth qualitative interviews (IQI) with a sample of trial participants will be
conducted to determine the salient influences on their decision and explore the reasons for
their ultimate decision and subsequent implantation or non-implantation of an ICD.

Approximately 480 patients eligible for a primary prevention ICD will be enrolled at
approximately 12 hospitals in this study. Study sites selected for VIVID will be
geographically diverse and provide care to a significant proportion of racial and ethnic
minority patients. Patient's will be mailed a letter, regarding the study, prior to their
initial visit. At the initial visit, patients will be approached about participation in the
trial. For those interested, informed consent will be obtained and patients will be
randomized. The investigators will be utilizing electronic consents on an iPad. Black
patients will be randomized to one of 3 arms: educational videos presented in the same
format; one with black participants (patients and providers) or the other with white
participants (patients and providers); The third arm will be usual care (control) and the
provider can interact with the patient consistent with their typical/usual care. Notably, for
both intervention and control arms, all patient management decisions are completely at the
discretion of the care providers.