Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy (VIVID)

Duke University

Status: Completed

Conditions: Heart Failure; Sudden Cardiac Death

Treatments: Other: Usual Care 3; Other: Educational Video 2; Other: Educational Video1

Study type: Interventional

Funder types: Other

Identifiers

NCT02819973

Pro00071154

Details and patient eligibility

About

VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter defibrillators (ICDs); (2) the effect of an educational video on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days; and 3) 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.

Full description

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; 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. 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.

Enrollment: 343 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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343 participants in 3 patient groups

Educational Video 1

Experimental group

Description:

African American/ Black Video

Treatment:

Other: Educational Video1

Educational Video 2

Experimental group

Description:

Caucasian Video

Treatment:

Other: Educational Video 2

Usual Care (no video) 3

Experimental group

Description:

Standard Care/ No video

Treatment:

Other: Usual Care 3