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

NCT01383382 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1399

Last updated 2012-09-10

No results posted yet for this study

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.

Conditions

  • Non-emergent Percutaneous Coronary Intervention (PCI)

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • Baylor Research Institute

    collaborator OTHER

  • Baystate Medical Center

    collaborator OTHER

  • Henry Ford Health System

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • Prairie Education and Research Cooperative

    collaborator INDUSTRY

  • Saint Luke's Health System

    lead OTHER

Principal Investigators

  • John A Spertus, MD, MPH · St. Luke's Hospital, Kansas City, Missouri

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-10-31
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383382 on ClinicalTrials.gov