Back to resultsShared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)
Primary Purpose
Chest Pain, Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chest Pain Choice Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Chest Pain focused on measuring Chest Pain, Decision Aid, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes, Shared Decision Making, Unnecessary hospital admissions
Eligibility Criteria
Inclusion Criteria:
- 18+ years of age (at least 18).
- Admitted to emergency department for chest pain.
- Being considered by the treating clinician for admission for cardiac testing.
Exclusion Criteria:
- Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
- Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
- Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 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).
- Cocaine use within the previous 72 hours by clinician history.
- Pregnancy.
- Referral to the emergency department by a personal physician for admission.
- Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
- Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
- Homelessness, out-of-town residence or other condition known to preclude follow-up.
- Patients in police custody or currently incarcerated individuals.
- 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).
Sites / Locations
- University of California, Davis
- Mayo Clinic
- Indiana University Hospital: IU
- Mayo Clinic
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Chest Pain Choice Decision Aid
Usual Care
Arm Description
Patients randomized to the decision aid arm.
Patients randomized to the usual care arm (no decision aid used)
Outcomes
Primary Outcome Measures
Test if Chest Pain Choice Safely Improves Patient Knowledge.
Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
Secondary Outcome Measures
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
Test if the Decision Aid Safely Improves Patient Engagement.
1) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
Major Adverse Cardiac Event (MACE)
A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
Total Testing Within 45 Days (a Component of Healthcare Utilization)
In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
Decisional Conflict
Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
Physician Trust
The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
Full Information
NCT ID
NCT01969240
First Posted
October 17, 2013
Last Updated
November 10, 2017
Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute, Indiana University, University of California, Davis, Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT01969240
Brief Title
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
Acronym
CPC
Official Title
Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute, Indiana University, University of California, Davis, Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Acute Coronary Syndrome
Keywords
Chest Pain, Decision Aid, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes, Shared Decision Making, Unnecessary hospital admissions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
898 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chest Pain Choice Decision Aid
Arm Type
Active Comparator
Arm Description
Patients randomized to the decision aid arm.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients randomized to the usual care arm (no decision aid used)
Intervention Type
Other
Intervention Name(s)
Chest Pain Choice Decision Aid
Other Intervention Name(s)
CPC DA
Intervention Description
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 emergency department 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.
Primary Outcome Measure Information:
Title
Test if Chest Pain Choice Safely Improves Patient Knowledge.
Description
Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
Time Frame
Directly following intervention (on day 1)
Secondary Outcome Measure Information:
Title
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
Description
We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
Time Frame
Within 30 days of study enrollment
Title
Test if the Decision Aid Safely Improves Patient Engagement.
Description
1) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
Time Frame
Immediately after the intervention (on day 1)
Title
Major Adverse Cardiac Event (MACE)
Description
A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
Time Frame
within 30 days of enrollment
Title
Total Testing Within 45 Days (a Component of Healthcare Utilization)
Description
In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
Time Frame
45 days
Title
Decisional Conflict
Description
Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
Time Frame
Immediately after the visit (day 1)
Title
Physician Trust
Description
The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
Time Frame
Immediately after the visit (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18+ years of age (at least 18).
Admitted to emergency department for chest pain.
Being considered by the treating clinician for admission for cardiac testing.
Exclusion Criteria:
Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 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).
Cocaine use within the previous 72 hours by clinician history.
Pregnancy.
Referral to the emergency department by a personal physician for admission.
Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
Homelessness, out-of-town residence or other condition known to preclude follow-up.
Patients in police custody or currently incarcerated individuals.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Hess, MD, MSc
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Indiana University Hospital: IU
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A link to the pre-test probability web tool and the Chest Pain Choice decision aid (DA) can be accessed at the Mayo Clinic Shared Decision Making National Resource Center at http://shareddecisions.mayoclinic.org/decision-aid-information/chest-pain-choice-decision-aid/. De-identified patient level data and statistical code can be requested from the corresponding author at hess.erik@mayo.edu and provided to investigators who agree to adhere to a signed research data use agreement with the Mayo Clinic after 12/31/2017.
Citations:
PubMed Identifier
27919865
Citation
Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165.
Results Reference
derived
PubMed Identifier
24884807
Citation
Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.
Results Reference
derived
Learn more about this trial
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
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