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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00918125
First received: June 10, 2009
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Sudden Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Decision to Receive an ICD [ Time Frame: 1 week post intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Decisional Conflict Scale [ Time Frame: one week post intervention ] [ Designated as safety issue: No ]
    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).

  • Receipt of an ICD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.


Other Outcome Measures:
  • Mean Knowledge Scores About ICD Therapy One Week Post Intervention. [ Time Frame: one week post intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 59
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918125

Locations
United States, North Carolina
Alamance Regional Medical Center
Burlington, North Carolina, United States, 27215
Duke University Medical Center
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Duke University
Medtronic
Investigators
Principal Investigator: Eric D Peterson, MD, MPH DCRI
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00918125     History of Changes
Other Study ID Numbers: Pro00011117, 1U18HS016964
Study First Received: June 10, 2009
Results First Received: January 22, 2013
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
 Death, Sudden
Death
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013