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

Completed

• Conditions: Sudden Cardiac Arrest

• Registration Number: NCT00918125
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Study Start: 2010-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-01-22
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-03
• Results First Posted: 2013-04-05
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decision to Receive an ICD	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 Outcome Measures

Name	Time	Method
Decisional Conflict Scale	one week post intervention	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	3 months	Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.

Trial Locations

Locations (2)

Alamance Regional Medical Center; 🇺🇸 Burlington, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States