Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use (VIVID-01)
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.
Sudden Cardiac Arrest
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)|
- Decision to Receive an ICD [ Time Frame: 1 week post intervention ] [ Designated as safety issue: No ]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.
- 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.
- 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:||November 2010|
|Study Completion Date:||April 2012|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918125
|United States, North Carolina|
|Alamance Regional Medical Center|
|Burlington, North Carolina, United States, 27215|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27715|
|Principal Investigator:||Eric D Peterson, MD, MPH||DCRI|