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

NCT ID: NCT00918125

Last Updated: 2015-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Sudden Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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White educational video

Patients will view an educational video that contains White physicians and patients.

No interventions assigned to this group

African-American educational video

Patients will view an educational video that contains African-American physicians and patients.

No interventions assigned to this group

Usual care

Patients will receive counseling about their condition and treatment options.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric D Peterson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

DCRI

Locations

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Alamance Regional Medical Center

Burlington, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23816035 (View on PubMed)

Other Identifiers

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1U18HS016964

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

Pro00011117

Identifier Type: -

Identifier Source: org_study_id

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