Shared Decision Making in the Emergency Department: Chest Pain Choice Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

898 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-12-31

Brief Summary

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Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:

1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.

Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.

Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.

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Detailed Description

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Conditions

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Chest Pain Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Chest Pain Choice Decision Aid

Patients randomized to the decision aid arm.

Group Type ACTIVE_COMPARATOR

Chest Pain Choice Decision Aid

Intervention Type OTHER

The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.

Usual Care

Patients randomized to the usual care arm (no decision aid used)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chest Pain Choice Decision Aid

The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.

Intervention Type OTHER

Other Intervention Names

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CPC DA

Eligibility Criteria

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Inclusion Criteria

1. 18+ years of age (at least 18).
2. Admitted to emergency department for chest pain.
3. Being considered by the treating clinician for admission for cardiac testing.

Exclusion Criteria

1. Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
2. Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
3. Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
4. Cocaine use within the previous 72 hours by clinician history.
5. Pregnancy.
6. Referral to the emergency department by a personal physician for admission.
7. Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
8. Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
9. Homelessness, out-of-town residence or other condition known to preclude follow-up.
10. Patients in police custody or currently incarcerated individuals.
11. Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No