Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sudden Cardiac Death, Heart Failure

Intervention / Treatment
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* Other: Educational Video1
* Other: Educational Video 2
* Other: Usual Care 3


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Video 1<br>African American/ Black Video | Other: Educational Video1<br> <br> |
| Experimental: Educational Video 2<br>Caucasian Video | Other: Educational Video 2<br> <br> |
| Experimental: Usual Care (no video) 3<br>Standard Care/ No video | Other: Usual Care 3<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, Patient Education, Implantable Cardioverter Defibrillator, Video, Decision, Decision making