NCT02819973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 21, 2021

Completed
Last Updated

April 21, 2021

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

June 13, 2016

Results QC Date

February 24, 2021

Last Update Submit

March 25, 2021

Conditions

Sudden Cardiac DeathHeart Failure

Keywords

Patient EducationICDImplantable Cardioverter DefibrillatorVideoDecisionDecision making

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video

    7 days

  • Changes in Patient Knowledge (Pre and Post Intervention)

    Baseline preintervention and Baseline (approximately 20mins later) post intervention

  • Changes in Decisional Conflict (Pre and Post)

    Baseline pre intervention and 1 week post intervention

  • ICD Receipt Within 90 Days of Enrollment.

    3 Months

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

    Baseline

  • +1 more secondary outcomes

Other Outcomes (8)

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

    3 Month

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

    3 Month

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

    1 week

  • +5 more other outcomes

Study Arms (3)

Educational Video 1

EXPERIMENTAL

African American/ Black Video

Other: Educational Video1

Educational Video 2

EXPERIMENTAL

Caucasian Video

Other: Educational Video 2

Usual Care (no video) 3

EXPERIMENTAL

Standard Care/ No video

Other: Usual Care 3

Interventions

Educational Video1OTHER
Educational Video 1
Educational Video 2OTHER
Educational Video 2
Usual Care 3OTHER
Usual Care (no video) 3

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Georgia Arrhythmia Consultants and Research Institute

Macon, Georgia, 31201, United States

Location

Medstar Health Research Institute

Baltimore, Maryland, 21237, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Jackson Heart

Jackson, Mississippi, 39216, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

South Carolina Heart

Columbia, South Carolina, 29204, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • Thomas KL, Al-Khatib SM, Kosinski AS, Sears SF Jr, Allen LaPointe NM, Jackson LR 2nd, Matlock DD, Haithcock D, Colley BJ 3rd, Hirsh DS, Peterson ED. Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial. Ann Intern Med. 2023 May;176(5):615-623. doi: 10.7326/M22-2934. Epub 2023 Apr 4.

    PMID: 37011387DERIVED

  • 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.

    PMID: 31785550DERIVED

MeSH Terms

Conditions

Death, Sudden, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kevin Thomas, MD
Organization
Duke Clinical Research Institute
kevin.thomas@duke.edu
919-668-8700

Study Officials

  • Kevin Thomas, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 30, 2016

Study Start

July 1, 2016

Primary Completion

January 28, 2020

Study Completion

April 30, 2020

Last Updated

April 21, 2021

Results First Posted

April 21, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(14)