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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Sudden Cardiac Death
• Intervention / Treatment: Other: Educational Video1; Other: Educational Video 2; Other: Usual Care 3

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.

• Study Type: Interventional
• Enrollment (Actual): 343
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Macon, Georgia, United States, 31201
      • Georgia Arrhythmia Consultants and Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • MedStar Health Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Saying "Yes" to ICD	Proportion of patients who have decided by 7 days to receive an ICD among patients randomized to the video intervention compared with health care provider counseling (usual care)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video	Proportion of patients who watched a racially concordant video and who decided by 7 days to receive an ICD	7 days
Changes in Patient Knowledge (Pre and Post Intervention)	Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs.	Baseline preintervention and Baseline (approximately 20mins later) post intervention
Changes in Decisional Conflict (Pre and Post)	Difference in Decisional Conflict Scale score from baseline pre-intervention to 1 week post-intervention, range of 0-100 with higher value indicating greater conflict about the decision to receive an ICD.	Baseline pre intervention and 1 week post intervention
ICD Receipt Within 90 Days of Enrollment.	Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review.	3 Months
Time Spent With Patients by Providers in Each Arm of the Study	Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer	Baseline
Patient Knowledge	Assessment of knowledge retention at one week through re-administration of baseline Knowledge Questionnaire. Scale of 0-13, with higher score indicating more knowledge about ICDs.	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision	In-depth phone interview	3 Month
In-depth Qualitative Interviews Focused on Impact of the Video on the Decision	In-depth phone interview	3 Month
In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision	In-depth phone interview	1 week
In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD	In-depth phone interview	3 Month
In-depth Qualitative Interviews Focused on Impact of the Video on the Decision	In-depth phone interview	1 week
In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD	In-depth phone interview	3 Month
In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD	In-depth phone interview	1 week
In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy	In-depth phone interview	1 week

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Kevin Thomas, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Decision making; ICD; Video; Patient Education; Implantable Cardioverter Defibrillator; Decision
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: Pro00071154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO