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Clinical Trials/NCT00918125
NCT00918125
Completed
N/A

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

Duke University2 sites in 1 country59 target enrollmentNovember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sudden Cardiac Arrest
Sponsor
Duke University
Enrollment
59
Locations
2
Primary Endpoint
Decision to Receive an ICD
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
April 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Decision to Receive an ICD

Time Frame: 1 week post intervention

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 Outcomes

  • Decisional Conflict Scale(one week post intervention)
  • Receipt of an ICD(3 months)

Study Sites (2)

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