Clinical trial NCT02819973: Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
Official title: Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Death
Heart Failure
Keywords: Patient Education
ICD
Implantable Cardioverter Defibrillator
Video
Decision
Decision making
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-06-30
Enrollment: 343
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Patients Saying "Yes" to ICD
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video
timeFrame: 7 days
measure: Changes in Patient Knowledge (Pre and Post Intervention)
timeFrame: Baseline preintervention and Baseline (approximately 20mins later) post intervention
measure: Changes in Decisional Conflict (Pre and Post)
timeFrame: Baseline pre intervention and 1 week post intervention
measure: ICD Receipt Within 90 Days of Enrollment.
timeFrame: 3 Months
measure: Time Spent With Patients by Providers in Each Arm of the Study
timeFrame: Baseline
measure: Patient Knowledge
timeFrame: 1 week
Other outcomes:
measure: In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision
timeFrame: 3 Month
measure: In-depth Qualitative Interviews Focused on Impact of the Video on the Decision
timeFrame: 3 Month
measure: In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision
timeFrame: 1 week
measure: In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD
timeFrame: 3 Month
measure: In-depth Qualitative Interviews Focused on Impact of the Video on the Decision
timeFrame: 1 week
measure: In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD
timeFrame: 3 Month
measure: In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD
timeFrame: 1 week
measure: In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy
timeFrame: 1 week
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants and Research Institute
state: Georgia
city: Baltimore
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart
state: Mississippi
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Heart
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Duke University
name: Kevin Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.