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

Acute Coronary Syndrome Clinical Trial

— CPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969240
• Other study ID #: 13-001359
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 898
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Emergencies

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Indiana University Hospital: IU	Indianapolis	Indiana
United States	Mayo Clinic	Jacksonville	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, Davis	Sacramento	California

Sponsors (5)

Lead Sponsor	Collaborator
Mayo Clinic	Indiana University, Patient-Centered Outcomes Research Institute, Thomas Jefferson University, University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Directly following intervention (on day 1)
Secondary	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.	Within 30 days of study enrollment
Secondary	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.	Immediately after the intervention (on day 1)
Secondary	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.	within 30 days of enrollment
Secondary	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.	45 days
Secondary	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.	Immediately after the visit (day 1)
Secondary	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.	Immediately after the visit (day 1)