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

Not Applicable

Completed

Conditions: Chest Pain
Acute Coronary Syndrome

Interventions: Other: Chest Pain Choice Decision Aid

Registration Number: NCT01969240

Lead Sponsor: Mayo Clinic

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 898

Inclusion Criteria

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

Exclusion Criteria

Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
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).
Cocaine use within the previous 72 hours by clinician history.
Pregnancy.
Referral to the emergency department by a personal physician for admission.
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.
Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
Homelessness, out-of-town residence or other condition known to preclude follow-up.
Patients in police custody or currently incarcerated individuals.
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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chest Pain Choice Decision Aid	Chest Pain Choice Decision Aid	Patients randomized to the decision aid arm.

Primary Outcome Measures

Name	Time	Method
Test if Chest Pain Choice Safely Improves Patient Knowledge.	Directly following intervention (on day 1)	Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.

Secondary Outcome Measures

Name	Time	Method
Decisional Conflict	Immediately after the visit (day 1)	Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
Total Testing Within 45 Days (a Component of Healthcare Utilization)	45 days	In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
Test if the Decision Aid Safely Improves Patient Engagement.	Immediately after the intervention (on day 1)	1) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
Physician Trust	Immediately after the visit (day 1)	The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
Major Adverse Cardiac Event (MACE)	within 30 days of enrollment	A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.	Within 30 days of study enrollment	We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.

Trial Locations

Locations (4): Indiana University Hospital: IU
🇺🇸
Indianapolis, Indiana, United States
University of California, Davis
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Sacramento, California, United States
Mayo Clinic
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Rochester, Minnesota, United States
Thomas Jefferson University
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Philadelphia, Pennsylvania, United States