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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 29, 2014
Last verified: September 2014

October 17, 2013
September 29, 2014
October 2013
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01969240 on ClinicalTrials.gov Archive Site
  • 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)
  • Test if the decision aid has an effect on healthcare utilization within 45 days after enrollment. [ Time Frame: Within 45 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 45 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 45 days)
Not Provided
Not Provided
 
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Chest Pain
  • Acute Coronary Syndrome
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
  • Active Comparator: Chest Pain Choice Decision Aid
    Patients randomized to the decision aid arm.
    Intervention: Other: Chest Pain Choice Decision Aid
  • No Intervention: Usual Care
    Patients randomized to the usual care arm (no decision aid used)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
March 2016
March 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Erik Hess, MD, MSc 507-255-6501 hess.erik@mayo.edu
Contact: Melissa Kuntz (507)293-1239 Kuntz.Melissa@mayo.edu
United States
 
NCT01969240
13-001359
Yes
Erik P. Hess, Mayo Clinic
Mayo Clinic
  • Patient Centered Outcome Research Institute
  • Indiana University
  • University of California, Davis
  • University of Pennsylvania
Principal Investigator: Erik Hess, MD, MSc Mayo Clinic - Rochester, MN
Mayo Clinic
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP