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This study aims to evaluate the use of the chest pain choice (CPC) decision aid as a tool to facilitate discussion between the patient and his/her attending physician with regard to subsequent management plans. Patients aged 21 years and above with low-risk chest pain, as determined by the HEART score (HEART score 0-3), will be included. The investigator's hypothesis is that incorporating the Chest Pain Choice visual aid in shared decision making can help to reduce unnecessary admissions for low risk chest pain to the observation ward, as well as increase patient knowledge with regards to their own condition.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Patients in the intervention arm will receive the Chest Pain Choice visual aid prior to discussion with their primary physician regarding disposition. |
|
| Control Arm | No Intervention | Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest Pain Choice visual aid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Admission to the Emergency Department Observation Unit | Admission to the Emergency Department Observation Unit during index emergency department visit | Index visit |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) at 30 days | MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation. | 30 days after index visit |
| Major Adverse Cardiac Events at 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mui Teng Chua | Singapore | Central | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22496116 | Result | 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. | |
| 24884807 | Result |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2018 | Aug 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| D009203 | Myocardial Infarction |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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This is a randomized controlled trial where subjects are stratified by gender and then randomized 1:1 to the intervention (CPC) or control arm (usual care).
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The patient, attending physicians, and study team will not be blinded. Outcomes will be assessed through tracing electronic records as well as telephone calls for those whose electronic records are unobtainable. The outcome assessors will be blinded and will follow a telephone script for follow-up.
|
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
| 60 days after index visit |
| Emergency Department Attendance at 30 days | Repeat attendance to the emergency department | 30 days after index visit |
| Emergency Department Attendance at 60 days | Repeat attendance to the emergency department | 60 days after index visit |
| Stress treadmill electrogram at 30 days | The presence of stress treadmill electrocardiogram at 30 days post index visit | 30 days after index visit |
| Stress treadmill electrogram at 60 days | The presence of stress treadmill electrocardiogram at 60 days post index visit | 60 days after index visit |
| Stress myocardial perfusion imaging at 30 days | The presence of stress myocardial perfusion imaging at 30 days post index visit | 30 days after index visit |
| Stress myocardial perfusion imaging at 60 days | The presence of stress myocardial perfusion imaging at 60 days post index visit | 60 days after index visit |
| Stress echocardiogram at 30 days | The presence of stress echocardiogram at 30 days post index visit | 30 days after index visit |
| Stress echocardiogram at 60 days | The presence of stress echocardiogram at 60 days post index visit | 60 days after index visit |
| Computed tomography of the coronary arteries (CTCA) at 30 days | The presence of computed tomography of the coronary arteries (CTCA) at 30 days post index visit | 30 days after index visit |
| Computed tomography of the coronary arteries (CTCA) at 60 days | The presence of computed tomography of the coronary arteries (CTCA) at 60 days post index visit | 60 days after index visit |
| 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. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |