Disclosures

1. 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 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.

2. 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)

3. Conceptualizing an Improved Consent Process Requires Delivering Evidence-based Prediction Models Feedback of Predicted Outcomes • Outcomes: • Restenosis • Need for DAPT Medical Decision-making DES BMS 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

4. ePRISM: Clinical Risk Modeling at the Point-of-Care Risk Models Decision Support Tools

5. 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

6. Implementing PRISM Informed Consents

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

8. Mayo Clinic Rochester, MN Henry Ting, MD Henry Ford Hospital Detroit, MI Mayra Guerrero, MD Bay State Medical Center Springfield, MA Aaron Kugelmass, MD Kaiser-Permanente 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

9. Site Enrollment, Characteristics & Process

10. 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

11. 100 80 60 Percent 40 20 Study average Individual sites 0 Original Consent PRISM Consent Large Site Variability Percent of Patients Who Reviewed the Consent Form • Required statistical analyses to be site-adjusted

12. Patients’ Experiences of the Consent Process p=0.04 p=0.04 p=0.01 All p-values from hierarchical models adjusting for site *Among those who reviewed consent

13. Knowledge Transfer p=0.02 p=0.09 p=0.08 All p-values from full, site-adjusted models

14. Discussed Stent Type with Doctor before Treatment Average OR = 2.7, p=0.02 All p-values from full, site-adjusted models

15. Participation in Shared Decision-Making Who Should Decide your Treatment? Who Decided to Use a DES or BMS? p=0.05 p=0.43 All p-values from full, site-adjusted models

16. Limitations 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

17. Conclusions It is feasible to implement evidence-based decision aids within the routine flow of patient care Personalized, evidence-based consents support… • Improved informed consent processes • 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

18. 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 prevention? Extend this paradigm to other conditions • Shared decision-making tools for stable CAD treatment • Other medical conditions – orthopedics, cancer, etc.

20. Back-up Slides

21. Implementing PRISM within Routine Care ‘Informed Consent’ is mandatory before PCI, but is poorly done Standard Consent Forms PRISM Consent Forms Simple to understand Educational for patients Embed Personalized Estimates of Outcome from Validated NCDR Models Support bidirectional discussions for stent choice: DES vs. BMS Provide actionable data on bleeding risk for safer, more cost-effective care • Written in ‘legalese’ • Not read by patients • Vague and uninformative • Do not educate patients • No support for shared medical decision-making • Miss opportunity to engage patients in treatment decisions • Don’t support clinicians in tailoring treatment to patients’ risks/benefits

22. Site Variation in PRISM Effect Participation in Informed Consent Knowledge Transfer SDM

23. Loss of Power Due to Site Variation

24. The President’s Commission… …for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research concluded that… • “ethically valid consent is a process of shared decision-making.” • “health care institutions, such as hospitals…, have important roles to play in assisting health care professionals obtain informed consent by providing the infrastructure to support the process” • They cannot replace the “part of that process [that] is human interaction.” President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Washington DC: Library of Congress; 1982. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med 1996;156:2521-6