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Information about ongoing health services research and public health projects

Optimizing health outcomes in patients with symptomatic aortic valve disease
Investigator (PI): Brennan, James Matthew
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: 2014
Final Year: 2020
Record Source/Award ID: PCORI/CER-1306-04350
Funding: Total Award Amount: $1,913,610
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision making tools that will help patients understand the risks and benefits of each treatment alternative in the setting of their individual characteristics. The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The cornerstone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries that has been linked to Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR; and 2) create and evaluate personalized decision assistance tools for all patients considering AVR. This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination. Specifically, we will achieve the following three research aims: (specific aim 1) compare recent health outcomes with surgical versus transcatheter AVR among patients who are eligible for surgical AVR in the United States; (specific aim 2) create and assess a personalized decision assistance tool to evaluate expected health outcomes with surgical versus transcatheter AVR for patients who are eligible for surgical AVR; and (specific aim 3) develop and assess a personalized risk assessment tool to evaluate expected health outcomes with transcatheter AVR for patients who are not eligible for surgical AVR. Additionally, we will create and evaluate web- and print-based educational resources for targeted dissemination to patients with aortic stenosis, their caregivers, and their health care providers. The proposed research will help match patients with the treatment that most closely aligns with their value systems, and it will empower patients to actively participate in their own health care decisions. In this way, this study will improve the care of patients with aortic valve disease and reduce overall health care expenditures. In addition, this study will serve as a model to promote personalized medicine across all medical disease states.
MeSH Terms:
  • Aortic Valve /*pathology
  • * Cardiac Surgical Procedures
  • Catheterization
  • Decision Making
  • Heart Valve Diseases /*therapy
  • Humans
  • Medicare
  • * Outcome Assessment, Health Care
  • Risk
  • Societies, Medical
  • United States
Country: United States
State: North Carolina
Zip Code: 27705
UI: 20143549
CTgovId: NCT02266251
Project Status: Completed
Record History: ('2019: Project extended to 2020. \n2018: Project extended to 2019\n2017: Project extended to 2018',)