Transforming PCI Informed Consent Into an Evidence-based Decision-making Tool

Completed

Conditions studied: Non-emergent Percutaneous Coronary Intervention (PCI)

In brief

Using individualized patient estimates of procedural risks and benefits, this project will transform the process of informed consent for coronary angioplasty into a dynamic educational tool for patients and physicians and is a direct response to the Institute of Medicine's call for a more evidence-based, efficient, patient-centered healthcare system. It is hypothesized that patients will develop a greater understanding of their individual risks and benefits from PCI, will be empowered to more actively engage in shared decision-making, as well as have improved awareness of their responsibility to adhere to dual anti-platelet therapy if treated with a drug eluting stent (risks for target vessel revascularization with bare metal and drug eluting stents are also provided in the new consent form). It is also anticipated that physicians, in turn, will use these individualized estimates to better discriminate between risks and benefits among different bleeding avoidance therapies so as to improve the safety and cost-effectiveness of PCI.

Key facts

Study ID

NCT01383382

Run by

Saint Luke's Health System

People needed

1399

Starts

2009-09-01

Expected to finish

2012-09-01

Last updated by the study team

2012-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients receiving a PCI in a participating institution

You may not qualify if…

• Previously enrolled in the PRISM
• Does not speak English or Spanish
• Dementia
• Too ill to interview
• Current prisoner

Where it is running

• Kaiser Permanente — Oakland, California, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Barnes-Jewish Hospital/Washington University School of Medicine — St Louis, Missouri, United States
• Baylor Research Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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