Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01969240|
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : January 13, 2016
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:
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.
- 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 or disease||Intervention/treatment||Phase|
|Chest Pain Acute Coronary Syndrome||Other: Chest Pain Choice Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||911 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
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)
- Test if Chest Pain Choice safely improves validated patient-centered outcome measures. [ Time Frame: Directly following intervention (on day 1) ]Test if the intervention significantly increases patient knowledge.
- Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment. [ Time Frame: Within 30 days of study enrollment ]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) ]
- Patient engagement in the decision-making process
- Decisional conflict
- Trust in the physician
- Patient satisfaction with the decision made
- Safety (major adverse cardiac events within 30 days)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969240
|United States, California|
|University of California, Davis|
|Sacramento, California, United States, 95817|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Indiana|
|Indiana University Hospital: IU|
|Indianapolis, Indiana, United States, 46202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Erik Hess, MD, MSc||Mayo Clinic - Rochester, MN|