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OpenTrials
Completed

NCT Number: NCT00918125

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alamance Regional Medical Center, Burlington, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: VIVID-01

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 11, 2009
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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