Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)
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.
|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|
- 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.
- 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 ]
- 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)
|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)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969240
|Contact: Erik Hess, MD, MScfirstname.lastname@example.org|
|Contact: Laurie Pencille, CCRPemail@example.com|
|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.firstname.lastname@example.org|
|Principal Investigator: Deborah B Diercks, MD, MSc|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Contact: Carlos Torres, MD 904-783-1498 email@example.com|
|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|
|Rochester, Minnesota, United States, 55905|
|Contact: Erik Hess, MD, MSc 507-284-7221 firstname.lastname@example.org|
|Contact: Laurie Pencille, CCRP 507-538-6801 email@example.com|
|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|
|Principal Investigator:||Erik Hess, MD, MSc||Mayo Clinic - Rochester, MN|