Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

Heart Failure Clinical Trial

— VIVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819973
• Other study ID #: Pro00071154
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: April 30, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Other:
• Educational Video1

• Educational Video 2

• Usual Care 3

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Medstar Health Research Institute	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	South Carolina Heart	Columbia	South Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Jackson Heart	Jackson	Mississippi
United States	Georgia Arrhythmia Consultants and Research Institute	Macon	Georgia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	University of California at San Francisco	San Francisco	California
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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