Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

NCT ID: NCT02819973

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-04-30

Brief Summary

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.

Detailed 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.

Conditions

Sudden Cardiac Death; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Educational Video 1

African American/ Black Video

Group Type: EXPERIMENTAL

Educational Video1

Intervention Type: OTHER

Educational Video 2

Caucasian Video

Group Type: EXPERIMENTAL

Educational Video 2

Intervention Type: OTHER

Usual Care (no video) 3

Standard Care/ No video

Group Type: EXPERIMENTAL

Usual Care 3

Intervention Type: OTHER

Interventions

Educational Video1

Intervention Type: OTHER

Educational Video 2

Intervention Type: OTHER

Usual Care 3

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

University of California at San Francisco

San Francisco, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Georgia Arrhythmia Consultants and Research Institute

Macon, Georgia, United States

Medstar Health Research Institute

Baltimore, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Jackson Heart

Jackson, Mississippi, United States

Cooper University Hospital

Camden, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

South Carolina Heart

Columbia, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Thomas KL, Al-Khatib SM, Kosinski AS, Sears SF Jr, Allen LaPointe NM, Jackson LR 2nd, Matlock DD, Haithcock D, Colley BJ 3rd, Hirsh DS, Peterson ED. Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial. Ann Intern Med. 2023 May;176(5):615-623. doi: 10.7326/M22-2934. Epub 2023 Apr 4.

Reference Type: DERIVED

PMID: 37011387 (View on PubMed)

Thomas KL, Sullivan LT 2nd, Al-Khatib SM, LaPointe NA, Sears S, Kosinski AS, Jackson LR 2nd, Kutyifa V, Peterson ED. Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) trial: Rational, design and methodology. Am Heart J. 2020 Feb;220:59-67. doi: 10.1016/j.ahj.2019.10.011. Epub 2019 Nov 11.

Reference Type: DERIVED

PMID: 31785550 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Pro00071154

Identifier Type: -

Identifier Source: org_study_id