Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use (VIVID-01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00918125|
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : April 5, 2013
Last Update Posted : October 19, 2015
|Condition or disease|
|Sudden Cardiac Arrest|
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|Official Title:||The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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.
- Decision to Receive an ICD [ Time Frame: 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.
- Decisional Conflict Scale [ Time Frame: 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 [ Time Frame: 3 months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|