Acute Coronary Syndrome, Angina Pectoris, Chest Pain, Myocardial Infarction
Conditions
Brief summary
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.
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).
Interventions
OTHERChest Pain Choice visual aid
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.
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Admission to the Emergency Department Observation Unit | Index visit | Admission to the Emergency Department Observation Unit during index emergency department visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) at 30 days | 30 days after index visit | MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation. |
| Major Adverse Cardiac Events at 60 days | 60 days after index visit | MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation. |
| Emergency Department Attendance at 30 days | 30 days after index visit | Repeat attendance to the emergency department |
| Emergency Department Attendance at 60 days | 60 days after index visit | Repeat attendance to the emergency department |
| Stress treadmill electrogram at 30 days | 30 days after index visit | The presence of stress treadmill electrocardiogram at 30 days post index visit |
| Computed tomography of the coronary arteries (CTCA) at 60 days | 60 days after index visit | The presence of computed tomography of the coronary arteries (CTCA) at 60 days post index visit |
| Stress myocardial perfusion imaging at 30 days | 30 days after index visit | The presence of stress myocardial perfusion imaging at 30 days post index visit |
| Stress myocardial perfusion imaging at 60 days | 60 days after index visit | The presence of stress myocardial perfusion imaging at 60 days post index visit |
| Stress echocardiogram at 30 days | 30 days after index visit | The presence of stress echocardiogram at 30 days post index visit |
| Stress echocardiogram at 60 days | 60 days after index visit | The presence of stress echocardiogram at 60 days post index visit |
| Computed tomography of the coronary arteries (CTCA) at 30 days | 30 days after index visit | The presence of computed tomography of the coronary arteries (CTCA) at 30 days post index visit |
| Stress treadmill electrogram at 60 days | 60 days after index visit | The presence of stress treadmill electrocardiogram at 60 days post index visit |
Countries
Singapore
Outcome results
None listed