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

September 7, 2012 updated by: Saint Luke's Health System
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1399

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente
    • Illinois
      • Springfield, Illinois, United States, 62701
        • Prairie Education and Research Cooperative
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • St. Louis, Missouri, United States, 63130
        • Barnes-Jewish Hospital/Washington University School of Medicine
    • Texas
      • Plano, Texas, United States, 75204
        • Baylor Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac patients undergoing a non-emergent percutaneous coronary intervention (PCI) procedure for their heart disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

Washington University School of Medicine
Henry Ford Health System
Kaiser Permanente
Baylor Research Institute
Baystate Medical Center
Prairie Education and Research Cooperative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01HL096624 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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