Transcript KER UNIT - Mayo Clinic Shared Decision Making National

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
MN
Foundation 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 Pope, NEJM, 2000
• Large #’s of low risk patients
admitted for prolonged
observation and cardiac stress
testing
• False positive test results,
unnecessary procedures,
cost
Background
• Kline and colleagues developed a
quantitative pretest probability calculator
Kline JA, BMC Med Informed Decision Making, 2005
• Prospectively validated QPTP calculator in 3
Academic EDs
Mitchell AM, Kline JA, Annals of Emergency Medicine, 2006
• Demonstrated efficacy of QPTP calculator in
RCT
Kline JA, Annals of Emergency Medicine, 2009
4
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% (4090%)
 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
Mean age
Female
HTN
Hyperlipidemia
Family history of
premature CAD
Mean PTP of ACS
Intervention
(n=101)
54.5
59%
45%
45%
14%
Control
(n=103)
54.9
61%
28%
39%
12%
P-value
3.2%
3.3%
0.81
0.81
0.97
0.01
0.46
0.61
Knowledge and Participation
Variable
Intervention Control
(n=101)
(n=103)
6 knowledge
questions
3.6
3.0
OPTION score
51.4
32
Mean diff
(95% CI)/
p-value
0.67
(0.34, 1.0)
< 0.0001
Decisional Conflict* and
Physician Trust
Variable
Decisional
conflict (DCS)
Trust in
physician (TPS)
Intervention Control
(n=101)
(n=104)
22.3
43.3
83.4
*Conflict related to feeling uninformed
79.3%
Mean diff
(95% CI)
-13.6
(-19.1, -8.1)
4.1
(-1.4, 9.6)
Acceptability to Patients
Variable
Amount of
information
(just right)
Clarity of
information
(extremely clear)
Helpfulness
(extremely helpful)
Would recommend
to others
Intervention Control
(n=101)
(n=104)
93%
80%
P-value
62%
37%
<0.0001
53%
34%
<0.0001
75%
45%
<0.0001
0.0051
Provider experience
Variable
Strongly
recommend way
information was
shared
Want to present
other diagnostic
information in
same way
Intervention Control
(n=101)
(n=104)
59%
20%
P-value
64%
<0.0001
28%
<0.0001
Safety
Variable
Revascularization
MI
Death
MACE within 30
days of discharge
Intervention
(n=101)
3%
1%
0
0
Control
(n=104)
2%
0%
0
0
P-value
0.68
0.49
NA
NA
Resource use
Variable
Stress test in
EDOU
Stress test
performed
within 30 days
Follow-up as
outpatient
Intervention Control
(n=101)
(n=104)
58%
77%
P-value
75%
91%
0.02
39%
9%
<0.0001
<0.0001
Limitations
• Single center
• Insufficient power to demonstrate safety
Conclusions
Summary of impact of DA
Variable
Patient knowledge
Patient
participation
Decisional conflict
Physician Trust
Acceptability
Safety
Resource use
Direction of difference
↑
↑
↓
↔
↑
↔
↓
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