- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674021
Use of Visual Decision Aid for Shared Decision Making in Chest Pain
The Use of a Visual Decision Aid for Shared Decision Making Among Patients With Chest Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
Chest pain is a common presenting complaint in the Emergency Department (ED). Cardiac testing in low-risk patients poses unnecessary costs and resource utilisation, which may in part be due to clinicians adopting a very-low-risk threshold for discharge without testing.
The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain, and has shown to be effective in increasing patient knowledge and decreasing the rate of admission to an observation unit for cardiac testing, among patients with chest pain who are at low risk for acute coronary syndromes. Shared decision making with the use of this visual aid has been shown in other centres to be associated with greater patient knowledge, greater patient involvement in decision making and less frequent admissions, with no increase in major adverse cardiac events (MACE) due to the intervention.
The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available. The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.
This study aims to assess if using a visual decision aid for shared decision making between physician and patient can safely help to decrease unnecessary admissions to the ED observation unit, as well as its impact on patient knowledge, satisfaction, as well as 30-day and 60-day Major Adverse Cardiac Events (MACE).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Central
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Singapore, Central, Singapore, 119074
- Mui Teng Chua
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 21 years and above
- Have low risk chest pain as defined by the HEART score (0-3 points)
- Be English-literate
- Have an initial serum troponin that is less than the 99th centile of the normal reference population
- Have an initial electrocardiogram that is not suggestive of cardiac ischaemia
Exclusion Criteria:
- Have a HEART score of 4 or more
- Are not English-literate
- Have an elevated initial serum troponin
- Have an initial electrocardiogram that is suggestive of cardiac ischaemia (ST-segment depression or elevation, new onset left bundle brunch block, T-wave inversions, etc.)
- Have known coronary artery disease
- Have a prior plan for cardiac intervention or admission
- Have barriers to outpatient follow-up
- Are prisoners
- Are pregnant
- Are hearing or visually impaired, or are otherwise unable to use the clinical decision aid
- Do not consent to participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
Patients in the intervention arm will receive the Chest Pain Choice visual aid prior to discussion with their primary physician regarding disposition.
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The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain.
The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available.
The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.
|
No Intervention: Control Arm
Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Admission to the Emergency Department Observation Unit
Time Frame: Index visit
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Admission to the Emergency Department Observation Unit during index emergency department visit
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Index visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Cardiac Events (MACE) at 30 days
Time Frame: 30 days after index visit
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MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
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30 days after index visit
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Major Adverse Cardiac Events at 60 days
Time Frame: 60 days after index visit
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MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
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60 days after index visit
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Emergency Department Attendance at 30 days
Time Frame: 30 days after index visit
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Repeat attendance to the emergency department
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30 days after index visit
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Emergency Department Attendance at 60 days
Time Frame: 60 days after index visit
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Repeat attendance to the emergency department
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60 days after index visit
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Stress treadmill electrogram at 30 days
Time Frame: 30 days after index visit
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The presence of stress treadmill electrocardiogram at 30 days post index visit
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30 days after index visit
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Stress treadmill electrogram at 60 days
Time Frame: 60 days after index visit
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The presence of stress treadmill electrocardiogram at 60 days post index visit
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60 days after index visit
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Stress myocardial perfusion imaging at 30 days
Time Frame: 30 days after index visit
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The presence of stress myocardial perfusion imaging at 30 days post index visit
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30 days after index visit
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Stress myocardial perfusion imaging at 60 days
Time Frame: 60 days after index visit
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The presence of stress myocardial perfusion imaging at 60 days post index visit
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60 days after index visit
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Stress echocardiogram at 30 days
Time Frame: 30 days after index visit
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The presence of stress echocardiogram at 30 days post index visit
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30 days after index visit
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Stress echocardiogram at 60 days
Time Frame: 60 days after index visit
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The presence of stress echocardiogram at 60 days post index visit
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60 days after index visit
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Computed tomography of the coronary arteries (CTCA) at 30 days
Time Frame: 30 days after index visit
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The presence of computed tomography of the coronary arteries (CTCA) at 30 days post index visit
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30 days after index visit
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Computed tomography of the coronary arteries (CTCA) at 60 days
Time Frame: 60 days after index visit
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The presence of computed tomography of the coronary arteries (CTCA) at 60 days post index visit
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60 days after index visit
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Collaborators and Investigators
Publications and helpful links
General Publications
- Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):251-9. doi: 10.1161/CIRCOUTCOMES.111.964791. Epub 2012 Apr 10.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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