NCT01383382|Completed
Transforming PCI Informed Consent Into an Evidence-based Decision-making Tool
PRISM
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PRISM
Sponsor study identifier
NIH
observational
1,399
1 country
7
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
September 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 27, 2011
Actual (reported)June 28, 2011
Actual (reported)October 2011
Actual (reported)September 2012
Actual (reported)Cardiac patients undergoing a non-emergent percutaneous coronary intervention (PCI) procedure for their heart disease.
Kaiser Permanente
Oakland, California, 94612, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Barnes-Jewish Hospital/Washington University School of Medicine
St Louis, Missouri, 63130, United States
Baylor Research Institute
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.
John A Spertus, MD, MPH
St. Luke's Hospital, Kansas City, Missouri
1,399 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2011
First Posted
June 28, 2011
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Plano, Texas, 75204, United States
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.
Primary Completion
October 2011
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
September 10, 2012
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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