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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Mayo Clinic
Patient Centered Outcome Research Institute
Indiana University
University of California, Davis
Thomas Jefferson University
Information provided by (Responsible Party):
Erik P. Hess, Mayo Clinic Identifier:
First received: October 17, 2013
Last updated: May 5, 2015
Last verified: May 2015

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.

Condition Intervention
Chest Pain
Acute Coronary Syndrome
Other: Chest Pain Choice Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Test if Chest Pain Choice safely improves validated patient-centered outcome measures. [ Time Frame: Directly following intervention (on day 1) ] [ Designated as safety issue: No ]
    Test if the intervention significantly increases patient knowledge.

Secondary Outcome Measures:
  • Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment. [ Time Frame: Within 30 days of study enrollment ] [ Designated as safety issue: No ]
    Will evaluate if the intervention significantly reduces the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.

  • Test if the decision aid safely improves additional validated patient outcome measures. [ Time Frame: Immediately after the intervention (on day 1) and within 30 days (safety outcome) ] [ Designated as safety issue: Yes ]
    1. Patient engagement in the decision-making process
    2. Decisional conflict
    3. Trust in the physician
    4. Patient satisfaction with the decision made
    5. Safety (major adverse cardiac events within 30 days)

Estimated Enrollment: 1500
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ED 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 Name: CPC DA
No Intervention: Usual Care
Patients randomized to the usual care arm (no decision aid used)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 ED patients with potential ACS (≥ 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 ED 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01969240

Contact: Erik Hess, MD, MSc 507-255-6501
Contact: Melissa Kuntz (507)293-1239

United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Russell Jones, MD    916-734-8131      
Contact: Toni Harbour    916-734-8131   
Principal Investigator: Russell Jones, MD         
Principal Investigator: Kelly Owen, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Carlos Torres, MD    904-783-1498   
Contact: Shannon L. Kennedy   
Principal Investigator: Carlos Torres, MD         
United States, Indiana
Indiana University Hospital: IU Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jeffrey Kline, MD    317-944-5000      
Contact: Dana Musapatika, MS., MSc.    317-962-1190   
Principal Investigator: Jeffrey Kline, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Erik Hess, MD, MSc    507-284-7221   
Contact: Melissa Kuntz, CCRP    507-293-1239   
Principal Investigator: Erik Hess, MD, MSc         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Judd E Hollander, MD    215-662-2767      
Contact: Laura Costelloe    215-503-0988   
Principal Investigator: Judd Hollander, MD         
Sponsors and Collaborators
Mayo Clinic
Patient Centered Outcome Research Institute
Indiana University
University of California, Davis
Thomas Jefferson University
Principal Investigator: Erik Hess, MD, MSc Mayo Clinic - Rochester, MN
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erik P. Hess, MD, MSc, Principal Investigator, Mayo Clinic Identifier: NCT01969240     History of Changes
Other Study ID Numbers: 13-001359
Study First Received: October 17, 2013
Last Updated: May 5, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Chest Pain
Decision Aid
Acute Coronary Syndrome
Emergency Department
Cardiac Testing
Healthcare Utilization
Patient Centered Outcomes
Shared Decision Making
Unnecessary hospital admissions

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Angina Pectoris
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Signs and Symptoms
Vascular Diseases processed this record on November 27, 2015