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Completed

NCT Number: NCT02819973

Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

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.

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California at San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-hospitalized patients with ejection fraction ≤35%
  • New York Heart Association class I-III heart failure,
  • Age >21
  • Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death
  • Self-identified race as black
  • Provision of informed consent to participate in the study.

Exclusion criteria

  • Life expectancy <12 months
  • Listed for Orthotropic Heart Transplantation (OHT)
  • Transplant (OHT) or OHT imminent within 12 months,
  • History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes
  • ICD already implanted
  • Myocardial infarction within the last 40 days,
  • Coronary revascularization within the last 3 months,
  • Patients who are unable to understand the study procedures due to cognitive or language barriers.
  • Inpatients will be excluded from the study because decision-making processes are thought to be appreciably different in inpatients as compared with outpatients.
  • Plan for subcutaneous ICD (Sub-Q ICD)

Treatment and study plan

Educational Video1

Other

Educational Video 2

Other

Usual Care 3

Other

Primary outcomes

  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 among patients randomized to the video intervention compared with health care provider counseling (usual care)

Secondary outcomes

  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 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

    Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs.

  3. Changes in Decisional Conflict (Pre and Post)

    Time frame: Baseline pre intervention and 1 week post intervention

    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.

  4. ICD Receipt Within 90 Days of Enrollment.

    Time frame: 3 Months

    Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review.

  5. Time Spent With Patients by Providers in Each Arm of the Study

    Time frame: Baseline

    Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer

  6. Patient Knowledge

    Time frame: 1 week

    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.

Other outcomes

  1. In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision

    Time frame: 3 Month

    In-depth phone interview

  2. In-depth Qualitative Interviews Focused on Impact of the Video on the Decision

    Time frame: 3 Month

    In-depth phone interview

  3. In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision

    Time frame: 1 week

    In-depth phone interview

  4. In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD

    Time frame: 3 Month

    In-depth phone interview

  5. In-depth Qualitative Interviews Focused on Impact of the Video on the Decision

    Time frame: 1 week

    In-depth phone interview

  6. In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD

    Time frame: 3 Month

    In-depth phone interview

  7. In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD

    Time frame: 1 week

    In-depth phone interview

  8. In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy

    Time frame: 1 week

    In-depth phone interview

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: VIVID

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2016
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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