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Disclosures. Dr. Spertus discloses that he is a founder of Health Outcomes Sciences ( www.h-outcomes.com ) that disseminates and supports the PRISM tool. All other authors – None

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
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Dr. Spertus discloses that he is a founder of Health Outcomes Sciences (www.h-outcomes.com) that disseminates and supports the PRISM tool.

All other authors – None

Management of COI – A complete raw set of data and analytic code provided to Harvard Clinical Research Institute for independent verification of all study results.


Testing Evidence-Based,Individualized Informed Consent Formsto Improve Patients' Experiences with PCI

AHA Late Breaking Clinical Trials – November 14, 2011

John Spertus MD MPH, Richard Bach MD, Charles Bethea MD,Adnan Chhatriwalla MD, Jeptha P. Curtis MD, Elizabeth Gialde RN,Mayra Guerrero MD, Kensey Gosch MS, Philip Jones MS, Aaron Kugelmass MD, Bradley M. Leonard MD, Edward J. McNulty MD, Marc Shelton MD,Henry H. Ting MD MBA, and Carole Decker RN PhD

Funding: AHA/PRT/David and Stevie Spina Outcomes Research Center, NHLBI R01- HL096624

Disclosures: Dr. Spertus has equity in Health Outcomes Sciences (www.h-outcomes.com)

conceptualizing an improved consent process
Conceptualizing an Improved Consent Process

Requires Delivering Evidence-based Prediction Models

Feedback of Predicted Outcomes

  • Outcomes:
  • Restenosis
  • Need for DAPT

Medical Decision-making



Informed Consent

PCI Patients

  • PCI Complications:
  • Bleeding
  • Death

Informing Patients

  • Patient Factors:
  • Socio-demographics
  • Clinical Factors
  • Disease Severity
  • Shared Decision-making:
  • Therapeutic options
  • Evidence of benefit
  • Patient preferences

ePRISM: Clinical Risk Modeling at the Point-of-Care

Risk Models

Decision Support Tools

valid risk models for pci outcomes
Valid Risk Models for PCI Outcomes

ACC NCDR Mortality Model

  • Built on 588,398 procedures at 465 sites
  • J Am Coll Cardiol 2010; 55:1923-32

ACC NCDR Bleeding Risk Model

  • Built on 302,152 procedures at 440 sites
  • Circ Cardiovasc Intervent 2009; 2: 222-9

ACC NCDR 1-year Target Vessel Revascularization Model for DES and BMS

  • Built on 27,107 procedures in all Massachusetts hospitals
  • Circulation 2011; 124: 1557-64
study design
Study Design

Design: 9-center pre/post survey of patients’experiences with traditional vs. PRISM-generated consent forms


  • Do patients engage in the consent process?
    • Do they read the consents? Do they understand them?
  • Is there effective ‘knowledge transfer’ of risks/benefits of PCI?
    • Are patients aware of risks of bleeding? Death?
  • Do patients participate in shared medical decision-making?
    • Do they discuss stent type with their doctors? Participate in the decision?

Mayo Clinic

Rochester, MN

Henry Ting, MD

Henry Ford Hospital Detroit, MI

Mayra Guerrero, MD

Bay State Medical Center

Springfield, MA

Aaron Kugelmass, MD


San Francisco, CA

Ed McNulty, MD









Yale New Haven Hospital

New Haven, CT

Jeptha Curtis, MD


Prairie Heart

St. John’s Hospital

Springfield, IL

Marc Shelton, MD

Integris Heart Hospital

Oklahoma City, OK

Charles Bethea, MD

Baylor Health

Plano Heart Hospital

Plano, TX

Bradley Leonard, MD

Washington University

Barnes-Jewish Hospital

St. Louis, MO

Richard Bach, MD

Sites Participating in PRISM Study

baseline characteristics
Baseline Characteristics

590 surveyed with original consents, 527 with PRISM

Comparable in >30 demographic, literacy/numeracy and comorbidity characteristics, except…

More PRISM patients with

  • History of prior smoking (42% vs. 33%, p=0.006)
  • History of depression (10% vs. 5%, p=0.001)
  • Stable CAD (51% vs. 34%, p<0.001)

All differences adjusted for in hierarchical models








Study average

Individual sites


Original Consent

PRISM Consent

Large Site Variability

Percent of Patients Who Reviewed the Consent Form

  • Required statistical analyses to be site-adjusted
patients experiences of the consent process
Patients’ Experiences of the Consent Process




All p-values from hierarchical models adjusting for site

*Among those who reviewed consent

knowledge transfer
Knowledge Transfer




All p-values from full, site-adjusted models

discussed stent type with doctor before treatment
Discussed Stent Type with Doctor before Treatment

Average OR = 2.7, p=0.02

All p-values from full, site-adjusted models

participation in shared decision making
Participation in Shared Decision-Making

Who Should Decide your Treatment?

Who Decided to Use a DES or BMS?



All p-values from full, site-adjusted models


Non-randomized study

  • Difficult given fundamental changes in structure/process of care

Which components of PRISM consents – lower reading level, individualized risks – lead to outcomes unknown

Site characteristics associated with benefit unknown

  • Ongoing qualitative research on implementation

It is feasible to implement evidence-based decision aids within the routine flow of patient care

Personalized, evidence-based consents support…

  • Improved informed consent
  • Better knowledge transfer
  • More engagement in shared decision-making

Marked variability in benefits observed across sites

  • The consent form is only 1 component of the consent process
future directions
Future Directions

Define impact on treatment and outcomes

  • Do they support more rational of drug eluting stents?
  • Do they reverse the risk-treatment paradox in bleeding management?

Extend this paradigm to other conditions

  • Shared decision-making tools for stable CAD treatment
  • Other medical conditions – orthopedics, cancer, etc.