Clinical trial NCT01969240: Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
Official title: Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Acute Coronary Syndrome
Keywords: Chest Pain
Decision Aid
Acute Coronary Syndrome
Cardiac
Emergency Department
Cardiac Testing
Healthcare Utilization
Patient Centered Outcomes
Shared Decision Making
Unnecessary hospital admissions
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Indiana University
name: University of California, Davis
name: Thomas Jefferson University
First posted: 2013-10-25
Enrollment: 898
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Test if Chest Pain Choice Safely Improves Patient Knowledge.
timeFrame: Directly following intervention (on day 1)
Secondary outcomes:
measure: Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
timeFrame: Within 30 days of study enrollment
measure: Test if the Decision Aid Safely Improves Patient Engagement.
timeFrame: Immediately after the intervention (on day 1)
measure: Major Adverse Cardiac Event (MACE)
timeFrame: within 30 days of enrollment
measure: Total Testing Within 45 Days (a Component of Healthcare Utilization)
timeFrame: 45 days
measure: Decisional Conflict
timeFrame: Immediately after the visit (day 1)
measure: Physician Trust
timeFrame: Immediately after the visit (day 1)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Hospital: IU
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Erik Hess, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165.
citation: Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.