1. The Chest Pain Choice Decision Aid: a Randomized Trial ISDM Conference Maastricht, June 2011

2. E Hess, M. Knoedler, N. Shah, J Kline, M Breslin, M Branda, L Pencille, B Asplin, D Nestler, A Sadosty, H. Ting, M. Montori Knowledge and Evaluation Research Unit Mayo Clinic College of Medicine MN Foundation for Informed Medical Decision Making AHA Fellow-to-Faculty Transition Award

3. Background Chest pain 2 nd most common complaint in U.S. Emergency Departments > 6 million patients annually 4% of ACS inappropriately discharged from ED Large #’s of low risk patients admitted for prolonged observation and cardiac stress testing False positive test results, unnecessary procedures,  cost Pope, NEJM, 2000

4. Background Kline and colleagues developed a quantitative pretest probability calculator Prospectively validated QPTP calculator in 3 Academic EDs Demonstrated efficacy of QPTP calculator in RCT 4 Kline JA, BMC Med Informed Decision Making, 2005 Kline JA, Annals of Emergency Medicine, 2009 Mitchell AM, Kline JA, Annals of Emergency Medicine, 2006

5. Background Decision Aids:  knowledge (by 15 of 100, 95% confidence interval 12-19%)  % patients with realistic perceptions of the chances of benefits and harms by 60% (40- 90%)  uncertainty related to feeling uninformed (by 8 of 100 (5-12)  % passive patients in decision making by 30% (10-50%)  % remaining undecided after counseling by 57% (30-70%) O’Connor, Cochrane Database of Systematic Reviews, 2009

6. Hypothesis Facilitating a patient-centered discussion regarding the short-term risk for ACS in otherwise low-risk chest pain patients will:  patient knowledge  patient engagement Safely  resource use

7. Objectives (1) To design a DA for use in patients at low risk for ACS (2) To test the DA in a randomized trial

8. Methods

9. Decision Aid Design Incorporate QPTP output in a literacy-sensitive DA, describe rationale of evaluation, list management options in value-neutral fashion Iteratively test DA in patient encounters Refine DA based on input from patients, clinicians, and investigative team  thematic saturation Breslin, Mullan, Montori Patient Educ Counseling 2008

10. Methods: Clinical Trial Design: single-center; allocation concealed by password-protected, web-based randomization Setting: Academic ED in Rochester, MN with 73,000 annual patient visits; 10-bed observation unit Eligibility: –Included: Adults with chest pain considered for EDOU admission –Excluded: +troponin, known CAD, cocaine use within 72 hrs, unable to provide informed consent or use decision aid

11. Outcome measures Decision quality –Patient knowledge** –Degree of patient participation (OPTION scale) –Decisional conflict (DCS) –Trust in physician (TPS) Quantitative –Safety endpoint: 30-day MACE* –Resource use Rate of cardiac stress testing in EDOU 30-day rate of stress testing

12. Statistical analysis Power: 200 patients –90% power to detect > 25% ↑ in mean knowledge –95% power to detect a 20% ↓ in proportion of patients who underwent stress testing in EDOU Hypothesis testing: chi-square, Fisher’s exact, t-test or Wilcoxon rank-sum as appropriate Intention-to-treat principle followed

13. Results

15. Baseline Characteristics VariableIntervention (n=101) Control (n=103) P-value Mean age 54.554.90.81 Female 59%61%0.97 HTN 45%28%0.01 Hyperlipidemia 45%39%0.46 Family history of premature CAD 14%12%0.61 Mean PTP of ACS 3.2%3.3%0.81

16. Knowledge and Participation VariableIntervention (n=101) Control (n=103) Mean diff (95% CI)/ p-value 6 knowledge questions 3.63.00.67 (0.34, 1.0) OPTION score 51.432< 0.0001

17. Decisional Conflict* and Physician Trust VariableIntervention (n=101) Control (n=104) Mean diff (95% CI) Decisional conflict (DCS) 22.343.3-13.6 (-19.1, -8.1) Trust in physician (TPS) 83.479.3%4.1 (-1.4, 9.6) *Conflict related to feeling uninformed

18. Acceptability to Patients VariableIntervention (n=101) Control (n=104) P-value Amount of information (just right) 93%80%0.0051 Clarity of information (extremely clear) 62%37%<0.0001 Helpfulness (extremely helpful) 53%34%<0.0001 Would recommend to others 75%45%<0.0001

19. Provider experience VariableIntervention (n=101) Control (n=104) P-value Strongly recommend way information was shared 59%20%<0.0001 Want to present other diagnostic information in same way 64%28%<0.0001

20. Safety VariableIntervention (n=101) Control (n=104) P-value Revascularization 3%2%0.68 MI 1%0%0.49 Death 00NA MACE within 30 days of discharge 00NA

21. Resource use Variable Intervention (n=101) Control (n=104) P-value Stress test in EDOU 58%77%<0.0001 Stress test performed within 30 days 75%91%0.02 Follow-up as outpatient 39%9%<0.0001

22. Limitations Single center Insufficient power to demonstrate safety

23. Conclusions

24. Summary of impact of DA VariableDirection of difference Patient knowledge ↑ Patient participation ↑ Decisional conflict ↓ Physician Trust ↔ Acceptability ↑ Safety ↔ Resource use ↓

25. Lessons learned Integration in process of care challenging Care process redesign required?? Feasibility of definitively demonstrating patient safety? Use of DA in emergency department requires reliable access to outpatient follow-up

26. Future Directions Identification of factors that promote or inhibit uptake of SDM in acute setting Prospective multicenter randomized trial