the chest pain choice decision aid: a randomized trial isdm conference maastricht, june 2011
TRANSCRIPT
The Chest Pain Choice Decision Aid: a Randomized
Trial
ISDM Conference
Maastricht, June 2011
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
MNFoundation for Informed Medical
Decision Making
AHA Fellow-to-Faculty Transition Award
Background• Chest pain 2nd 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
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
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
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
Objectives
(1) To design a DA for use in patients at low risk for ACS
(2) To test the DA in a randomized trial
Methods
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
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
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
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
Results
Baseline Characteristics
Variable Intervention
(n=101)
Control
(n=103)
P-value
Mean age 54.5 54.9 0.81Female 59% 61% 0.97HTN 45% 28% 0.01Hyperlipidemia 45% 39% 0.46Family history of premature CAD
14% 12% 0.61
Mean PTP of ACS 3.2% 3.3% 0.81
Knowledge and Participation
Variable Intervention
(n=101)
Control
(n=103)
Mean diff (95% CI)/ p-value
6 knowledge questions
3.6 3.0 0.67
(0.34, 1.0)OPTION score 51.4 32 < 0.0001
Decisional Conflict* and Physician Trust
Variable Intervention
(n=101)
Control
(n=104)
Mean diff (95% CI)
Decisional conflict (DCS)
22.3 43.3 -13.6
(-19.1, -8.1)Trust in physician (TPS)
83.4 79.3% 4.1
(-1.4, 9.6)
*Conflict related to feeling uninformed
Acceptability to Patients
Variable Intervention
(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
Provider experience
Variable Intervention
(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
Safety
Variable Intervention
(n=101)
Control
(n=104)
P-value
Revascularization 3% 2% 0.68MI 1% 0% 0.49Death 0 0 NAMACE within 30 days of discharge
0 0 NA
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
Limitations
• Single center
• Insufficient power to demonstrate safety
Conclusions
Summary of impact of DA
Variable Direction of differencePatient knowledge ↑Patient participation
↑
Decisional conflict ↓Physician Trust ↔Acceptability ↑Safety ↔Resource use ↓
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
Future Directions
• Identification of factors that promote or inhibit uptake of SDM in acute setting
• Prospective multicenter randomized trial