N/A
N=343
Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
Sudden Cardiac Death · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02819973 ↗Enrolled (actual)
343
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Proportion of Patients Saying "Yes" to ICD — 123; 60; 87; 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational Video1 (Other); Educational Video 2 (Other); Usual Care 3 (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Saying "Yes" to ICD |
123; 60; 87; 41 | — |
| SECONDARY Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video |
54; 69; 48; 39 | — |
| SECONDARY Changes in Patient Knowledge (Pre and Post Intervention) |
6.0; 6.1; 9.0; 8.4 | — |
| SECONDARY Changes in Decisional Conflict (Pre and Post) |
34.4; 37.5; 25.0; 25.0 | — |
| SECONDARY ICD Receipt Within 90 Days of Enrollment. |
142; 74 | — |
| SECONDARY Time Spent With Patients by Providers in Each Arm of the Study |
18.0; 20.0 | — |
| SECONDARY Patient Knowledge |
9.0; 8.0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02819973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.