Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:1/30/2019
Start Date:July 2016
End Date:January 2020
Contact:Laura Webb
Email:laura.webb@duke.edu
Phone:9196688977

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Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs

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.


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)
We found this trial at
14
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sharon Shen, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Principal Investigator: David Hirsh, MD
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Atlanta, GA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Luigi Di Biase, MD, Ph.D
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Baltimore, Maryland 21237
Principal Investigator: Glenn Meininger, MD
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Baltimore, MD
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Andrea Russo, MD
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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2001 Laurel Street
Columbia, South Carolina 29204
Principal Investigator: Venk Gottipaty, MD
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Columbia, SC
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Claudio Schuger, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Larry Jackson, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Jackson, Mississippi 39216
Principal Investigator: Byron Colley, MD
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Jackson, MS
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Macon, Georgia 31201
Principal Investigator: Daniel Haithcock, MD
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from
Macon, GA
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New Brunswick, New Jersey 08903
Principal Investigator: Archana Patel, MD
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New Brunswick, NJ
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Principal Investigator: John Fontaine, MD
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Philadelphia, PA
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San Francisco, California 94143
Principal Investigator: Nitish Badhwat, MD
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San Francisco, CA
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Washington, District of Columbia
Principal Investigator: Zayd Eldadah, MD
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Washington,
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