- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383382
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
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
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California
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Oakland, California, United States, 94612
- Kaiser Permanente
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Illinois
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Springfield, Illinois, United States, 62701
- Prairie Education and Research Cooperative
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Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital of Kansas City
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St. Louis, Missouri, United States, 63130
- Barnes-Jewish Hospital/Washington University School of Medicine
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Texas
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Plano, Texas, United States, 75204
- Baylor Research Institute
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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.
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
- Spertus JA, Decker C, Gialde E, Jones PG, McNulty EJ, Bach R, Chhatriwalla AK. Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks. BMJ. 2015 Mar 24;350:h1302. doi: 10.1136/bmj.h1302.
- Spertus JA, Bach R, Bethea C, Chhatriwalla A, Curtis JP, Gialde E, Guerrero M, Gosch K, Jones PG, Kugelmass A, Leonard BM, McNulty EJ, Shelton M, Ting HH, Decker C. Improving the process of informed consent for percutaneous coronary intervention: patient outcomes from the Patient Risk Information Services Manager (ePRISM) study. Am Heart J. 2015 Feb;169(2):234-241.e1. doi: 10.1016/j.ahj.2014.11.008. Epub 2014 Nov 15.
- Safley DM, Grantham JA, Hatch J, Jones PG, Spertus JA. Quality of life benefits of percutaneous coronary intervention for chronic occlusions. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):629-34. doi: 10.1002/ccd.25303. Epub 2013 Dec 19.
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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