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

N/ACompletedNCT01969240

Mayo Clinic898 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

898

Conditions

Chest Pain Acute Coronary Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (5)

University of California, Davis

Sacramento, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Indiana University Hospital: IU

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Test if Chest Pain Choice Safely Improves Patient Knowledge.

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.

Time frame: Directly following intervention (on day 1)

Secondary Outcomes

Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.

We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.

Time frame: Within 30 days of study enrollment

Test if the Decision Aid Safely Improves Patient Engagement.

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.

Time frame: Immediately after the intervention (on day 1)

Major Adverse Cardiac Event (MACE)

A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.

Time frame: within 30 days of enrollment

Total Testing Within 45 Days (a Component of Healthcare Utilization)

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.

Time frame: 45 days

Decisional Conflict

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.

Time frame: Immediately after the visit (day 1)

Physician Trust

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.

Time frame: Immediately after the visit (day 1)