Clinical trial NCT00918125: Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use
Official title: The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Arrest
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2009-06-11
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.

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.


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

Primary outcomes:
measure: Decision to Receive an ICD
timeFrame: 1 week post intervention
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: one week post intervention
measure: Receipt of an ICD
timeFrame: 3 months
Other outcomes:
measure: Mean Knowledge Scores About ICD Therapy One Week Post Intervention.
timeFrame: one week post intervention
Locations:
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: DCRI
name: Eric D Peterson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.