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

Mayo Clinic

Status: Completed

Conditions: Acute Coronary Syndrome; Chest Pain

Treatments: Other: Chest Pain Choice Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT01969240

13-001359

Details and patient eligibility

About

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.

Enrollment: 898 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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898 participants in 2 patient groups

Chest Pain Choice Decision Aid

Active Comparator group

Description:

Patients randomized to the decision aid arm.

Treatment:

Other: Chest Pain Choice Decision Aid

Usual Care

No Intervention group

Description:

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