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

Sudden Cardiac Arrest Clinical Trial

— VIVID-01  

Official title:

The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918125
• Other study ID #: Pro00011117
• Secondary ID: 1U18HS016964
• Status: Completed
• Phase: N/A
• First received: June 10, 2009
• Last updated: October 15, 2015
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest

Locations

Country	Name	City	State
United States	Alamance Regional Medical Center	Burlington	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Knowledge Scores About ICD Therapy 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.	one week post intervention	No
Primary	Decision to Receive an ICD	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.	1 week post intervention	No
Secondary	Decisional Conflict Scale	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).	one week post intervention	No
Secondary	Receipt of an ICD	Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.	3 months	No