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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborators:
Patient Centered Outcome Research Institute
Indiana University
University of California, Davis
University of Pennsylvania
Information provided by (Responsible Party):
Erik P. Hess, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01969240
First received: October 17, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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: March 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier: NCT01969240

Contacts
Contact: Erik Hess, MD, MSc 507-255-6501 hess.erik@mayo.edu
Contact: Laurie Pencille, CCRP 507-538-6801 pencille.laurie@mayo.edu

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Deborah B Diercks, MD, MSc    916-734-4052      
Contact: Toni Harbour       Toni.harbour@ucdmc.ucdavis.edu   
Principal Investigator: Deborah B Diercks, MD, MSc         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Carlos Torres, MD    904-783-1498    torres.carlos@mayo.edu   
Contact: Shannon L. Kennedy       Kennedy.Shannon@mayo.edu   
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      
Principal Investigator: Jeffrey Kline, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Erik Hess, MD, MSc    507-284-7221    hess.erik@mayo.edu   
Contact: Laurie Pencille, CCRP    507-538-6801    pencille.laurie@mayo.edu   
Principal Investigator: Erik Hess, MD, MSc         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Judd E Hollander, MD    215-662-2767      
Contact: Katie O'Conor    410-698-2001    Katie.OConor@uphs.upenn.edu   
Principal Investigator: Judd Hollander, MD         
Sponsors and Collaborators
Mayo Clinic
Patient Centered Outcome Research Institute
Indiana University
University of California, Davis
University of Pennsylvania
Investigators
Principal Investigator: Erik Hess, MD, MSc Mayo Clinic - Rochester, MN
  More Information

No publications provided

Responsible Party: Erik P. Hess, MD, MSc, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01969240     History of Changes
Other Study ID Numbers: 13-001359
Study First Received: October 17, 2013
Last Updated: March 4, 2014
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
Cardiac
Emergency Department
Cardiac Testing
Healthcare Utilization
Patient Centered Outcomes
Shared Decision Making
Unnecessary hospital admissions

Additional relevant MeSH terms:
Chest Pain
Emergencies
Acute Coronary Syndrome
Pain
Signs and Symptoms
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014