Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use (VIVID-01)

The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)

The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual care. Additionally, the investigators will look at whether racial concordance (physician and patient being of the same race) improves satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is that a video in which participants are of the same race as the patient will provide better education and more satisfaction with the treatment decision and may lead to more patients choosing ICD therapy.

Study Overview

• Status: Completed
• Conditions: Sudden Cardiac Arrest

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Alamance Regional Medical Center
    • Durham, North Carolina, United States, 27715
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.

Description

Inclusion Criteria:

• Class I primary prevention indications for an implantable cardioverter defibrillator (ICD). These include:
• Patients with ejection fraction <35% due to prior myocardial infarction (MI) who are at least 40 days post-MI and with New York Heart Association (NYHA) functional class II or III;OR
• Patients with nonischemic dilated cardiomyopathy (DCM) who have an LVEF < 35% and who meet criteria for NYHA functional class II or III; OR
• Patients with left ventricular dysfunction due to prior MI who are at least 40 days post-MI, have an left ventricular ejection fraction (LVEF) <30% and are in NYHA functional class I-III; OR
• Patients with nonsustained ventricular tachycardia (VT) due to prior MI, LVEF <40%, and with inducible ventricular fibrillation (VF) or sustained VT at electrophysiological study; AND
• Self identified race as black/African American or white/Caucasian

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
White educational video; Patients will view an educational video that contains White physicians and patients.
African-American educational video; Patients will view an educational video that contains African-American physicians and patients.
Usual care; Patients will receive counseling about their condition and treatment options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision to Receive an ICD	At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.	1 week post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict Scale	At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).	one week post intervention
Receipt of an ICD	Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Knowledge Scores About ICD Therapy One Week Post Intervention.	We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.	one week post intervention

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Eric D Peterson, MD, MPH, DCRI

Publications and helpful links

General Publications

• Thomas KL, Zimmer LO, Dai D, Al-Khatib SM, Allen LaPointe NM, Peterson ED. Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial. Am Heart J. 2013 Jul;166(1):157-63. doi: 10.1016/j.ahj.2013.03.031. Epub 2013 May 15.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: Pro00011117; 1U18HS016964 (U.S. AHRQ Grant/Contract)