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Developing and testing a personalized, evidence-based, shared decision-making tool for stent selection in percutaneous coronary intervention (PCI)
Investigator (PI): Spertus, John
Performing Organization (PO): (Current): University of Missouri-Kansas City, School of Medicine, Department of Internal Medicine / (816) 404-5032
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/CE-1304-6448
Funding: Total Award Amount: $1,725,651
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Patients undergoing percutaneous coronary intervention (PCI) to open up blocked heart arteries have a choice to receive either drug eluting (DES) or bare metal stents (BMS) to keep the artery open. This is an important decision because while DES reduces the risk of needing a repeat procedure, patients receiving a DES must take a "super-aspirin" for at least one year, as compared with a month for BMS. This medicine can increase the risk of bleeding, delay elective surgeries, and increase patients' medication costs. Currently, 80% of patients receive drug-coated stents, but less than a third discuss stent choices with their doctors. Objectives: We will create a shared decision making (SDM) tool that will describe the benefits, drawbacks, and costs associated with DES and BMS. Importantly, the benefits of avoiding a repeat procedure will be individualized for each patient, based upon a validated prediction model. We will use this SDM tool at two U.S. hospitals and train hospital staff to improve SDM. We will then find out whether the use of the SDM tool increases the frequency and quality of the discussions between patients and their doctors about stent choices. Methods: To create the SDM tool, we will interview patients and health care providers to identify the most important information and optimal presentation mode for SDM discussions. After developing the tool, we will introduce it into routine clinical care. Patients undergoing PCI, before and after introduction of the tool, will complete questionnaires to measure the frequency and quality of their discussions with their doctors about stent choice. If successful, we will be able to rapidly disseminate our tool, and the accompanying staff training materials, to increase its use among the 600,000 PCI procedures performed each year in the US.
MeSH Terms:
  • Algorithms
  • Aspirin /adverse effects
  • Decision Making
  • * Decision Support Systems, Clinical
  • Drug-Eluting Stents
  • Evidence-Based Medicine
  • Humans
  • Metals
  • Percutaneous Coronary Intervention /*methods
  • Program Development
  • Reoperation
  • * Stents
  • United States
Country: United States
State: Missouri
Zip Code: 64108
UI: 20143512
CTgovId: NCT02046902
Project Status: Completed
Record History: ('2017: Project extended to 2018.',)