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Trial record 1 of 1 for:    Pro00071154
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Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs (VIVID)

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ClinicalTrials.gov Identifier: NCT02819973
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Sudden Cardiac Death Heart Failure Other: Educational Video1 Other: Educational Video 2 Other: Usual Care 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. proportions of patients saying "yes" to ICD [ Time Frame: 3 months ]
  2. proportions of individuals saying yes to ICD implant in the racially concordant video [ Time Frame: 3 months ]

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

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

  3. ICD receipt within 90 days of the decision for ICD implantation. [ Time Frame: 3 Months ]
    Phone Interview

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

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

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

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

  8. Study coordinators will assess the time spent with patients by providers in each arm of the study [ Time Frame: Baseline ]
    Baseline questionnaire timer

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

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

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

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

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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)
Contacts and Locations

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


Contacts
Contact: Laura Webb 9196688977 laura.webb@duke.edu

Locations
United States, California
University of California at San Francisco Completed
San Francisco, California, United States, 94143
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kim Shine         
Principal Investigator: Zayd Eldadah, MD         
United States, Georgia
Georgia Arrhythmia Consultants and Research Institute Recruiting
Macon, Georgia, United States, 31201
Contact: Justin Jackson         
Principal Investigator: Daniel Haithcock, MD         
United States, Maryland
Medstar Health Research Institute Recruiting
Baltimore, Maryland, United States, 21237
Contact: Cynthia Yashinski         
Principal Investigator: Glenn Meininger, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Angela Budai         
Principal Investigator: Claudio Schuger, MD         
United States, Mississippi
Jackson Heart Recruiting
Jackson, Mississippi, United States, 39216
Contact: Lisa Milner         
Principal Investigator: Byron Colley, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Julie Field         
Principal Investigator: Andrea Russo, MD         
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Nora Cosgrove         
Principal Investigator: Archana Patel, MD         
United States, New York
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Wolfgang Jorde         
Principal Investigator: Luigi Di Biase, MD, Ph.D         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan Gerstl         
Principal Investigator: Larry Jackson, MD         
United States, Pennsylvania
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Shawn Cone         
Principal Investigator: John Fontaine, MD         
United States, South Carolina
South Carolina Heart Recruiting
Columbia, South Carolina, United States, 29204
Contact: Judith Brown         
Principal Investigator: Venk Gottipaty, MD         
Sponsors and Collaborators
Duke University
Patient-Centered Outcomes Research Institute
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02819973     History of Changes
Other Study ID Numbers: Pro00071154
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
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:
Heart Failure
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden