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

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

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 Overview

• Status: Completed
• Conditions: Chest Pain; Acute Coronary Syndrome
• Intervention / Treatment: Other: Chest Pain Choice Decision Aid

• Study Type: Interventional
• Enrollment (Actual): 898
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital: IU
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chest Pain Choice Decision Aid; Patients randomized to the decision aid arm.	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.; Other Names: CPC DA
No Intervention: Usual Care; Patients randomized to the usual care arm (no decision aid used)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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
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)
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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Patient-Centered Outcomes Research Institute; University of California, Davis; Indiana University; Thomas Jefferson University
• Investigators: Principal Investigator: Erik Hess, MD, MSc, Mayo Clinic, Rochester, MN

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Emergency Department; Acute Coronary Syndrome; Decision Aid; Cardiac; Shared Decision Making; Chest Pain; Healthcare Utilization; Cardiac Testing; Patient Centered Outcomes; Unnecessary hospital admissions
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: 13-001359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A link to the pre-test probability web tool and the Chest Pain Choice decision aid (DA) can be accessed at the Mayo Clinic Shared Decision Making National Resource Center at http://shareddecisions.mayoclinic.org/decision-aid-information/chest-pain-choice-decision-aid/. De-identified patient level data and statistical code can be requested from the corresponding author at hess.erik@mayo.edu and provided to investigators who agree to adhere to a signed research data use agreement with the Mayo Clinic after 12/31/2017.