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

NCT00918125 | Completed Results

• 2 other identifiers: Pro000111171U18HS016964
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Sudden Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Decisional Conflict Scale

  one week post intervention

• Receipt of an ICD

  3 months

Other Outcomes (1)

• Mean Knowledge Scores About ICD Therapy One Week Post Intervention.

  one week post intervention

Study Arms (3)

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.

Usual care

Patients will receive counseling about their condition and treatment options.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Medtronic: collaborator

Study Sites (2)

Alamance Regional Medical Center

Burlington, North Carolina, 27215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27715, United States

Location

Related Publications (1)

• 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.

  PMID: 23816035 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study terminated early and thus only 59 out of the proposed 90 patients were enrolled.

Results Point of Contact

• Title: Dr. Kevin Thomas
• Organization: Duke University Medical Center

kevin.thomas@dm.duke.edu

919-668-7857

Study Officials

• Eric D Peterson, MD, MPH

  DCRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 19, 2015
• Results First Posted: April 5, 2013

Record last verified: 2013-04

Locations

US (2)