Clinical trial NCT03674021: Use of Visual Decision Aid for Shared Decision Making in Chest Pain
Official title: The Use of a Visual Decision Aid for Shared Decision Making Among Patients With Chest Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndrome
Chest Pain
Myocardial Infarction
Angina Pectoris
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Admission to the Emergency Department Observation Unit
timeFrame: Index visit
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE) at 30 days
timeFrame: 30 days after index visit
measure: Major Adverse Cardiac Events at 60 days
timeFrame: 60 days after index visit
measure: Emergency Department Attendance at 30 days
timeFrame: 30 days after index visit
measure: Emergency Department Attendance at 60 days
timeFrame: 60 days after index visit
measure: Stress treadmill electrogram at 30 days
timeFrame: 30 days after index visit
measure: Stress treadmill electrogram at 60 days
timeFrame: 60 days after index visit
measure: Stress myocardial perfusion imaging at 30 days
timeFrame: 30 days after index visit
measure: Stress myocardial perfusion imaging at 60 days
timeFrame: 60 days after index visit
measure: Stress echocardiogram at 30 days
timeFrame: 30 days after index visit
measure: Stress echocardiogram at 60 days
timeFrame: 60 days after index visit
measure: Computed tomography of the coronary arteries (CTCA) at 30 days
timeFrame: 30 days after index visit
measure: Computed tomography of the coronary arteries (CTCA) at 60 days
timeFrame: 60 days after index visit
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Mui Teng Chua
state: Central
Study officials:
References:
citation: 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.
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.