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Summary

for people ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Nitish Badhwat

Description

Summary

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.

Keywords

Sudden Cardiac Death Heart Failure Patient Education ICD Implantable Cardioverter Defibrillator Video Decision Decision making

Eligibility

You can join if…

Open to people ages 21 years and up

  1. Non-hospitalized patients with ejection fraction ≤35%
  2. New York Heart Association class I-III heart failure,
  3. Age >21
  4. Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death
  5. Self-identified race as black
  6. Provision of informed consent to participate in the study.

You CAN'T join if...

  1. Life expectancy <12 months
  2. Listed for Orthotropic Heart Transplantation (OHT)
  3. Transplant (OHT) or OHT imminent within 12 months,
  4. History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes
  5. ICD already implanted
  6. Myocardial infarction within the last 40 days,
  7. Coronary revascularization within the last 3 months,
  8. Patients who are unable to understand the study procedures due to cognitive or language barriers.
  9. Inpatients will be excluded from the study because decision-making processes are thought to be appreciably different in inpatients as compared with outpatients.
  10. . Plan for subcutaneous ICD (Sub-Q ICD)

Locations

  • Jackson Heart accepting new patients
    Jackson, Mississippi, 39216, United States
  • Henry Ford Hospital accepting new patients
    Detroit, Michigan, 48202, United States
  • Georgia Arrhythmia Consultants and Research Institute accepting new patients
    Macon, Georgia, 31201, United States
  • South Carolina Heart accepting new patients
    Columbia, South Carolina, 29204, United States
  • Duke University Medical Center accepting new patients
    Durham, North Carolina, 27710, United States
  • Medstar Washington Hospital Center accepting new patients
    Washington, District of Columbia, 20010, United States
  • Medstar Health Research Institute accepting new patients
    Baltimore, Maryland, 21237, United States
  • Drexel University College of Medicine accepting new patients
    Philadelphia, Pennsylvania, 19102, United States
  • Cooper University Hospital accepting new patients
    Camden, New Jersey, 08103, United States
  • Rutgers Robert Wood Johnson Medical School accepting new patients
    New Brunswick, New Jersey, 08901, United States
  • Montefiore Medical Center accepting new patients
    Bronx, New York, 10467, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT02819973
Lead Scientist
Nitish Badhwat
Study Type
Interventional
Last Updated
November 1, 2016
I’m interested in this study!