N/A Completed N=59

Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use

Sudden cardiac arrest

Source: ClinicalTrials.gov NCT00918125 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Apr 2013

Primary outcomePrimary: Decision to Receive an ICD — 28; 14 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Decision to Receive an ICD	28; 14	—
SECONDARY Decisional Conflict Scale	35.0; 34.1	—
SECONDARY Receipt of an ICD	14; 33	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00918125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.