Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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.

Exclusion Criteria

  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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Educational Video 1
African American/ Black Video
  • Other: Educational Video1
Experimental
Educational Video 2
Caucasian Video
  • Other: Educational Video 2
Experimental
Usual Care (no video) 3
Standard Care/ No video
  • Other: Usual Care 3

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Veronica Day

More Details

NCT ID
NCT02819973
Status
Recruiting
Sponsor
Duke University

Study Contact

Laura Webb
9196688977
laura.webb@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.