NCT01383382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 10, 2012

Status Verified

June 1, 2011

Enrollment Period

2.1 years

First QC Date

June 27, 2011

Last Update Submit

September 7, 2012

Conditions

Non-emergent Percutaneous Coronary Intervention (PCI)

Keywords

Heart DiseasesCardiovascular DiseasesAcute Myocardial InfarctionDecision MakingPercutaneous Coronary InterventionInformed ConsentQuality of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients receiving a PCI in a participating institution

You may not qualify if:

  • Previously enrolled in the PRISM
  • Does not speak English or Spanish
  • Dementia
  • Too ill to interview
  • Current prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kaiser Permanente

Oakland, California, 94612, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Barnes-Jewish Hospital/Washington University School of Medicine

St Louis, Missouri, 63130, United States

Location

Baylor Research Institute

Plano, Texas, 75204, United States

Location

Related Publications (3)

  • 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.

    PMID: 25805158DERIVED

  • 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.

    PMID: 25641532DERIVED

  • 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.

    PMID: 24259445DERIVED

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Study Officials

  • John A Spertus, MD, MPH

    St. Luke's Hospital, Kansas City, Missouri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

September 1, 2009

Primary Completion

October 1, 2011

Study Completion

September 1, 2012

Last Updated

September 10, 2012

Record last verified: 2011-06

Locations

US(7)