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

Completed

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

• Registration Number: NCT01383382
• Lead Sponsor: Saint Luke's Health System

Brief Summary

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.

Detailed Description

This study will test the impact of a new mechanism for eliciting informed consent from patients undergoing percutaneous coronary intervention (PCI) on 1) patients' comprehension of procedural risks/benefits and participation in shared decision-making; and 2) upon clinicians' use of effective strategies to minimize the risk of bleeding at the time of PCI. To facilitate these goals, we will prospectively provide each patients' risks for bleeding at the time that the informed consent document is generated. This will be accomplished by transforming the infrastructure of the informed consent process at participating study centers using a novel, web-based system - the Personalized Risk Information Services Manager (PRISM) - to generate individualized consent forms with estimates of risks and outcomes using validated multivariable models from the American College of Cardiology's NCDR. The goals of this study are to 1) identify barriers in implementing individualized consent forms in clinical care and to test whether this novel consent process 2) improves the quality of the informed consent process, 3) supports the more rational use of Bleeding Avoidance Therapies (BATs), 4) reduces bleeding events after PCI, and 5) supports a more cost-effective PCI procedure. This will be done using a pre-post design at 6 enrolling hospitals and comparing changes in practice with contemporaneous controls matched from the broader NCDR Cath/PCI registry.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2011-10
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1399

Inclusion Criteria

• All patients receiving a PCI in a participating institution

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Kaiser Permanente; 🇺🇸 Oakland, California, United States

Prairie Education and Research Cooperative; 🇺🇸 Springfield, Illinois, United States

Baylor Research Institute; 🇺🇸 Plano, Texas, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Barnes-Jewish Hospital/Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States