Disclosures u Dr. Spertus discloses that he is a founder of Health Outcomes Sciences ( that disseminates and supports the PRISM tool. u All other authors – None u 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 Forms to Improve Patients' Experiences with PCI 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- HL Disclosures: Dr. Spertus has equity in Health Outcomes Sciences ( AHA Late Breaking Clinical Trials – November 14, 2011

Conceptualizing an Improved Consent Process PCI Patients Informed Consent Patient Factors: - Socio-demographics - Clinical Factors - Disease Severity Feedback of Predicted Outcomes DES BMS Outcomes: Restenosis Need for DAPT Medical Decision- making PCI Complications: Bleeding Death Informing Patients Shared Decision- making: - Therapeutic options - Evidence of benefit - Patient preferences Requires Delivering Evidence-based Prediction Models

e PRISM : Clinical Risk Modeling at the Point-of-Care Risk Models Decision Support Tools

Valid Risk Models for PCI Outcomes u ACC NCDR Mortality Model –Built on 588,398 procedures at 465 sites –J Am Coll Cardiol 2010; 55: u ACC NCDR Bleeding Risk Model –Built on 302,152 procedures at 440 sites –Circ Cardiovasc Intervent 2009; 2: u ACC NCDR 1-year Target Vessel Revascularization Model for DES and BMS –Built on 27,107 procedures in all Massachusetts hospitals –Circulation 2011; 124:

Implementing PRISM Informed Consents

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

Sites Participating in PRISM Study

Site Enrollment, Characteristics & Process Hospital ABCDEFGHI Number of patients surveyed Original consent PRISM consent Reading level (School grade) Original consent PRISM consent Number of interventionalists PRISM replaced original form

Baseline Characteristics u 590 surveyed with original consents, 527 with PRISM u Comparable in >30 demographic, literacy/numeracy and comorbidity characteristics, except… u 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) u All differences adjusted for in hierarchical models

Percent Original Consent PRISM Consent 100 Percent of Patients Who Reviewed the Consent Form Study average Individual sites Large Site Variability u Required statistical analyses to be site-adjusted

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

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

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 Who Should Decide your Treatment?Who Decided to Use a DES or BMS? p=0.43p=0.05 All p-values from full, site-adjusted models

Limitations u Non-randomized study –Difficult given fundamental changes in structure/process of care u Which components of PRISM consents – lower reading level, individualized risks – lead to outcomes unknown u Site characteristics associated with benefit unknown –Ongoing qualitative research on implementation

Conclusions u It is feasible to implement evidence-based decision aids within the routine flow of patient care u Personalized, evidence-based consents support… –Improved informed consent –Better knowledge transfer –More engagement in shared decision-making u Marked variability in benefits observed across sites –The consent form is only 1 component of the consent process

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