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

NCT ID: NCT01383382

Last Updated: 2012-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1399 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

Non-emergent Percutaneous Coronary Intervention (PCI)

Keywords

Heart Diseases; Cardiovascular Diseases; Acute Myocardial Infarction; Decision Making; Percutaneous Coronary Intervention; Informed Consent; Quality of Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: collaborator

Baystate Medical Center

OTHER

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Prairie Education and Research Cooperative

INDUSTRY

Sponsor Role: collaborator

Saint Luke's Health System

OTHER

Sponsor Role: lead

Responsible Party

Saint Luke's Hospital of Kansas City

Principal Investigators

John A Spertus, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital, Kansas City, Missouri

Locations

Kaiser Permanente

Oakland, California, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Barnes-Jewish Hospital/Washington University School of Medicine

St Louis, Missouri, United States

Baylor Research Institute

Plano, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25805158 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25641532 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24259445 (View on PubMed)

Other Identifiers

R01HL096624

Identifier Type: NIH

Identifier Source: org_study_id

View Link