Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use (VIVID-01)
This study has been completed.
Information provided by (Responsible Party):
First received: June 10, 2009
Last updated: April 3, 2013
Last verified: April 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)
Primary Outcome Measures:
Secondary Outcome Measures:
- Decisional Conflict Scale [ Time Frame: one week post intervention ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.
Other Outcome Measures:
- Mean Knowledge Scores About ICD Therapy One Week Post Intervention. [ Time Frame: one week post intervention ] [ Designated as safety issue: No ]
We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2012 (Final data collection date for primary outcome measure)
White educational video
Patients will view an educational video that contains White physicians and patients.
African-American educational video
Patients will view an educational video that contains African-American physicians and patients.
Patients will receive counseling about their condition and treatment options.
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918125
|Alamance Regional Medical Center
|Burlington, North Carolina, United States, 27215 |
|Duke University Medical Center
|Durham, North Carolina, United States, 27715 |
||Eric D Peterson, MD, MPH
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 10, 2009
|Results First Received:
||January 22, 2013
||April 3, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Death, Sudden, Cardiac