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Addressing racial disparities in implantable cardioverter defibrillator therapy via innovative designs (VIVID)
Investigator (PI): Thomas, Kevin
Performing Organization (PO): (Current): Duke University, School of Medicine, Department of Medicine, Division of Cardiology / (919) 668-2520
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2021
Record Source/Award ID: PCORI/AD-1503-29746
Funding: Total Award Amount: $2,006,825
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Sudden cardiac death (SCD) is a significant public health problem; it is the leading cause of death in the United States, accounting for more deaths annually than breast cancer, lung cancer, and HIV/AIDS combined. SCD is an "electrical problem" caused primarily by an irregular heartbeat called ventricular fibrillation that renders the heart incapable of pumping blood to the rest of the body. People who are at high risk for SCD may be treated with implantable cardioverter defibrillators (ICDs), devices that are implanted under the skin and connected to wires placed in the heart. ICDs monitor the heart's rhythm and automatically deliver a shock when a dangerous, fast irregular heartbeat is detected. Studies have shown that ICDs are the best way to prevent SCD in high-risk patients. Despite having the highest rates of SCD, black individuals are significantly less likely than white individuals to receive an ICD. The reasons for this racial disparity in ICD use are poorly understood. Racial differences in preferences for procedures may explain, in part, ICD disparities. Research has shown that black patients recommended to undergo the same invasive cardiac procedure are more likely than white patients to refuse. This racial difference in preference could reflect variances in personal beliefs, but it may also be a result of poor communication between minority patients and their health care providers. Ineffective patient-provider communication often leads to uninformed medical decision making, mistrust, and low-quality care. Additionally, racially concordant relationships between black doctors and black patients yield greater patient satisfaction and more participatory decision making. Nontraditional alternatives to health care education models are needed to help patients make informed decisions that are consistent with their values. Videos can be attractive decision aids because they simplify complex information and stimulate patients to be more active in decision making. In an effort to understand which interventions may best facilitate decision making for ICDs in black patients, and based on feedback from patients, their families and other relevant stakeholders, we propose a 480-patient randomized trial that compares the effectiveness of a patient-centered educational video with traditional health care provider counseling on the following outcomes: 1) the knowledge of SCD and ICD therapy; 2) the decision for ICD implantation and associated decisional conflict, and ICD receipt within 90 days; and 3) the impact of racial concordance between patients viewing the video and individuals (health care providers and patients) in the video on decisional conflict, the decision for ICD implantation, and ICD receipt within 90 days. This study addresses a modifiable contributor to racial disparities in the receipt of ICD therapy by focusing on patient provider communication and its impact on medical decision making.
MeSH Terms:
  • Comparative Effectiveness Research
  • Death, Sudden, Cardiac /prevention & control
  • Decision Making
  • Decision Support Techniques
  • Defibrillators, Implantable
  • Ethnic Groups
  • * Healthcare Disparities
  • Heart Rate
  • Humans
  • Patient Education as Topic /*methods
  • Patient-Centered Care
  • Professional-Patient Relations
  • Quality of Health Care
  • Randomized Controlled Trials as Topic
  • Risk
  • United States
  • Video Recording
Country: United States
State: North Carolina
Zip Code: 27710
UI: 20162015
CTgovId: NCT02819973
Project Status: Ongoing
Record History: ('2019: Project extended to 2021',)