Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819973
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Heart Failure Other: Educational Video1 Other: Educational Video 2 Other: Usual Care 3 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs
Study Start Date : July 2016
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of patients saying "yes" to ICD [ Time Frame: 7 days ]
    Proportion of patients who have decided by 7 days to receive an ICD


Secondary Outcome Measures :
  1. Proportion of individuals saying yes to ICD implant in the racially concordant video [ Time Frame: 7 days ]
    Proportion of patients who watched a racially concordant video and who have decided by 7 days to receive an ICD

  2. Changes in patient knowledge (pre and post intervention) [ Time Frame: Baseline preintervention and Baseline (approximately 20mins later) post intervention ]
    Knowledge Questionnaire

  3. Changes in decisional conflict (pre and post) [ Time Frame: Baseline pre intervention and 1 week post intervention ]
    Decisional Conflict Scale

  4. ICD receipt within 90 days of enrollment. [ Time Frame: 3 Months ]
    Phone Interview

  5. In-depth qualitative interviews focused on knowledge of SCD and ICD therapy [ Time Frame: 1 week ]
    In-depth phone interview

  6. In-depth qualitative interviews focused on influences on the decision to accept or decline an ICD [ Time Frame: 1 week ]
    In-depth phone interview

  7. In-depth qualitative interviews focused on impact of the video on the decision [ Time Frame: 1 week ]
    In-depth phone interview

  8. In-depth interview focused on barriers to ICD placement following the initial decision [ Time Frame: 1 week ]
    In-depth phone interview

  9. Time spent with patients by providers in each arm of the study [ Time Frame: Baseline ]
    Baseline questionnaire timer

  10. In-depth qualitative interviews focused on knowledge of SCD and ICD [ Time Frame: 3 Month ]
    In-depth phone interview

  11. In-depth qualitative interviews focused on influences on the decision to accept or decline an ICD [ Time Frame: 3 Month ]
    In-depth phone interview

  12. In-depth qualitative interviews focused on impact of the video on the decision [ Time Frame: 3 Month ]
    In-depth phone interview

  13. In-depth interview focused on barriers to ICD placement following the initial decision [ Time Frame: 3 Month ]
    In-depth phone interview

  14. Patient knowledge [ Time Frame: 1 week ]
    Knowledge Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819973


Locations
Layout table for location information
United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia, United States, 31201
United States, Maryland
Medstar Health Research Institute
Baltimore, Maryland, United States, 21237
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Mississippi
Jackson Heart
Jackson, Mississippi, United States, 39216
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
South Carolina Heart
Columbia, South Carolina, United States, 29204
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Duke University
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Kevin Thomas, MD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02819973    
Other Study ID Numbers: Pro00071154
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
Patient Education
ICD
Implantable Cardioverter Defibrillator
Video
Decision
Decision making
Additional relevant MeSH terms:
Layout table for MeSH terms
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden