Chest PainCPCNCT01969240
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial
A study testing Chest Pain Choice Decision Aid in people with Chest Pain and Acute Coronary Syndrome, run by Mayo Clinic at 5 sites in United States.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome
- What is being tested?
- Chest Pain Choice Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 898 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Indiana University Hospital: IU
Indianapolis, Indiana, 46202
Mayo Clinic
Jacksonville, Florida, 32224
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
University of California, Davis
Sacramento, California, 95817
About this study
Official title: 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:
- 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.
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Being tested
- Chest Pain Choice Decision Aid
- Keywords
- Chest Pain, Decision Aid, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes, Shared Decision Making, Unnecessary hospital admissions
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Pain Choice Decision AidOther
Also called CPC DA
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.
| Study group | Role | What they receive |
|---|---|---|
| Chest Pain Choice Decision Aid | Active comparator | Patients randomized to the decision aid arm. Receives: Other: Chest Pain Choice Decision Aid |
| Usual Care | No intervention | Patients randomized to the usual care arm (no decision aid used) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Directly following intervention (on day 1)
Secondary outcomes (6)
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.
Measured: Within 30 days of study enrollment
Test if the Decision Aid Safely Improves Patient Engagement.
- 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.
Measured: Immediately after the intervention (on day 1)
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.
Measured: within 30 days of enrollment
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.
Measured: 45 days
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.
Measured: Immediately after the visit (day 1)
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.
Measured: Immediately after the visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 898 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Indiana University, University of California, Davis, Thomas Jefferson University
- Responsible party
- Principal investigator, Erik P. Hess, Mayo Clinic
- Investigators
- Erik Hess, MD, MSc, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969240
- Sponsor's protocol ID
- 13-001359
- Acronym
- CPC
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2013
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27919865Anderson 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.
PubMed 24884807
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
- ClinicalTrials.gov ID
- NCT01969240
- Acronym / sponsor ID
- CPC / 13-001359
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- Chest Pain, Decision Aid, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Indiana University, University of California, Davis, Thomas Jefferson University
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest Pain Choice Decision Aid | Active comparator | Other: Chest Pain Choice Decision AidPatients randomized to the decision aid arm. |
| Usual Care | No intervention | –Patients randomized to the usual care arm (no decision aid used) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Pain Choice Decision AidAlso: CPC DAThe 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. | Other | Chest Pain Choice Decision Aid |
Primary outcome
Test if Chest Pain Choice Safely Improves Patient Knowledge.
Time frame: Directly following intervention (on day 1)
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.
6 secondary outcomes
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
Time frame: Within 30 days of study enrollment
Test if the Decision Aid Safely Improves Patient Engagement.
Time frame: Immediately after the intervention (on day 1)
Major Adverse Cardiac Event (MACE)
Time frame: within 30 days of enrollment
Total Testing Within 45 Days (a Component of Healthcare Utilization)
Time frame: 45 days
Decisional Conflict
Time frame: Immediately after the visit (day 1)
Physician Trust
Time frame: Immediately after the visit (day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27919865Hess 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.
- Derived from this study: PubMed 24884807Anderson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Hess, MD, MSc principal investigator
Mayo Clinic, Rochester, MN
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Pain Choice Decision Aid in people with Chest Pain and Acute Coronary Syndrome, run by Mayo Clinic at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test if Chest Pain Choice Safely Improves Patient Knowledge. (time frame: Directly following intervention (on day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01969240, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.