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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. |
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| Country: | United States |
| State: | Missouri |
| Zip Code: | 64108 |
| UI: | 20143512 |
| CTgovId: | NCT02046902 |
| Project Status: | Completed |
| Record History: | ('2017: Project extended to 2018.',) |