disclosures u dr. spertus discloses that he is a founder of health outcomes sciences () that...
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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
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.
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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- HL096624Disclosures: Dr. Spertus has equity in Health Outcomes Sciences (www.h-outcomes.com)
AHA Late Breaking Clinical Trials – November 14, 2011
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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
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ePRISM: Clinical Risk Modeling at the Point-of-Care
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Risk Models Decision Support Tools
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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
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Implementing PRISM Informed Consents
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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?
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********
Henry Ford Hospital Detroit, MI
Mayra Guerrero, MDMayra Guerrero, MD
**
Baylor HealthPlano Heart Hospital
Plano, TXBradley Leonard, MDBradley Leonard, MD
Washington UniversityBarnes-Jewish Hospital
St. Louis, MORichard Bach, MDRichard Bach, MD
**
Bay State Medical CenterSpringfield, MA
Aaron Kugelmass, MDAaron Kugelmass, MD
Yale New Haven HospitalNew Haven, CTJeptha Curtis, MDJeptha Curtis, MD
****
Prairie HeartSt. John’s Hospital
Springfield, ILMarc Shelton, MDMarc Shelton, MD
Kaiser-PermanenteSan Francisco, CA
Ed McNulty, MD
**
**
**
Mayo ClinicRochester, MNHenry Ting, MDHenry Ting, MD
Integris Heart HospitalOklahoma City, OK
Charles Bethea, MDCharles Bethea, MD
Sites Participating in PRISM Study
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Site Enrollment, Characteristics & Process
HospitalA B C D E F G H I
Number of patients surveyedOriginal consentPRISM consent
101101
100101
6543
6265
6651
6862
4121
3939
4844
Reading level (School grade)Original consentPRISM consent
15.78.6
11.09.0
9.59.0
12.59.1
12.79.14
12.39.5
9.78.0
13.79.1
13.19.0
Number of interventionalists 23 19 21 5 52 12 11 15 17
PRISM replaced original form
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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
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8080
6060
4040
2020
00
Per
cent
Per
cent
Original ConsentOriginal Consent PRISM ConsentPRISM Consent
100100
Percent of Patients Who Reviewed the Consent FormPercent of Patients Who Reviewed the Consent Form
Study averageIndividual sites
Large Site Variability
Required statistical analyses to be site-adjusted
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Patients’ Experiences of the Consent Process
0%10%20%30%40%50%60%70%80%90%
100%
Reviewed consentform
Completelyunderstood theinformation*
Consent was easy toread*
Original Consent (n=590) PRISM Consent (n=527)
p=0.04
p=0.04 p=0.01
*Among those who reviewed consentAll p-values from hierarchical models adjusting for site
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Knowledge Transfer
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Correctly identifiedpurpose of the procedure
Recalled being told %risk of death
Recalled being told %risk of bleeding
Original Consent (n=590) PRISM Consent (n=527)
p=0.02 p=0.09 p=0.08
All p-values from full, site-adjusted models
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Discussed Stent Type with Doctor before Treatment
0%
20%
40%
60%
80%
100%
Discussed Stent Type with Doctor
Original Consent (n=590) PRISM Consent (n=527)
Average OR = 2.7, p=0.02
All p-values from full, site-adjusted models
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Participation in Shared Decision-MakingWho Should Decide your Treatment? Who Decided to Use a DES or BMS?
p=0.43 p=0.05
All p-values from full, site-adjusted models
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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
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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
– 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
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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.
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