Use of Visual Decision Aid for Shared Decision Making in Chest Pain
Primary Purpose
Acute Coronary Syndrome, Chest Pain, Myocardial Infarction
Status
Terminated
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Chest Pain Choice visual aid
Sponsored by
About this trial
This is an interventional other trial for Acute Coronary Syndrome
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
Sites / Locations
- Mui Teng Chua
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
Patients in the intervention arm will receive the Chest Pain Choice visual aid prior to discussion with their primary physician regarding disposition.
Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care.
Outcomes
Primary Outcome Measures
Admission to the Emergency Department Observation Unit
Admission to the Emergency Department Observation Unit during index emergency department visit
Secondary Outcome Measures
Major Adverse Cardiac Events (MACE) at 30 days
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
Major Adverse Cardiac Events at 60 days
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
Emergency Department Attendance at 30 days
Repeat attendance to the emergency department
Emergency Department Attendance at 60 days
Repeat attendance to the emergency department
Stress treadmill electrogram at 30 days
The presence of stress treadmill electrocardiogram at 30 days post index visit
Stress treadmill electrogram at 60 days
The presence of stress treadmill electrocardiogram at 60 days post index visit
Stress myocardial perfusion imaging at 30 days
The presence of stress myocardial perfusion imaging at 30 days post index visit
Stress myocardial perfusion imaging at 60 days
The presence of stress myocardial perfusion imaging at 60 days post index visit
Stress echocardiogram at 30 days
The presence of stress echocardiogram at 30 days post index visit
Stress echocardiogram at 60 days
The presence of stress echocardiogram at 60 days post 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
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
Full Information
NCT ID
NCT03674021
First Posted
August 26, 2018
Last Updated
April 12, 2022
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03674021
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID pandemic and suspension of observation unit
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Chest Pain, Myocardial Infarction, Angina Pectoris
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
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.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Patients in the intervention arm will receive the Chest Pain Choice visual aid prior to discussion with their primary physician regarding disposition.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care.
Intervention Type
Other
Intervention Name(s)
Chest Pain Choice visual aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Admission to the Emergency Department Observation Unit
Description
Admission to the Emergency Department Observation Unit during index emergency department visit
Time Frame
Index visit
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE) at 30 days
Description
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
Time Frame
30 days after index visit
Title
Major Adverse Cardiac Events at 60 days
Description
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
Time Frame
60 days after index visit
Title
Emergency Department Attendance at 30 days
Description
Repeat attendance to the emergency department
Time Frame
30 days after index visit
Title
Emergency Department Attendance at 60 days
Description
Repeat attendance to the emergency department
Time Frame
60 days after index visit
Title
Stress treadmill electrogram at 30 days
Description
The presence of stress treadmill electrocardiogram at 30 days post index visit
Time Frame
30 days after index visit
Title
Stress treadmill electrogram at 60 days
Description
The presence of stress treadmill electrocardiogram at 60 days post index visit
Time Frame
60 days after index visit
Title
Stress myocardial perfusion imaging at 30 days
Description
The presence of stress myocardial perfusion imaging at 30 days post index visit
Time Frame
30 days after index visit
Title
Stress myocardial perfusion imaging at 60 days
Description
The presence of stress myocardial perfusion imaging at 60 days post index visit
Time Frame
60 days after index visit
Title
Stress echocardiogram at 30 days
Description
The presence of stress echocardiogram at 30 days post index visit
Time Frame
30 days after index visit
Title
Stress echocardiogram at 60 days
Description
The presence of stress echocardiogram at 60 days post index visit
Time Frame
60 days after index visit
Title
Computed tomography of the coronary arteries (CTCA) at 30 days
Description
The presence of computed tomography of the coronary arteries (CTCA) at 30 days post index visit
Time Frame
30 days after index visit
Title
Computed tomography of the coronary arteries (CTCA) at 60 days
Description
The presence of computed tomography of the coronary arteries (CTCA) at 60 days post index visit
Time Frame
60 days after index visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mui Teng Chua
City
Singapore
State/Province
Central
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22496116
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.
Results Reference
result
PubMed Identifier
24884807
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.
Results Reference
result
Learn more about this trial
Use of Visual Decision Aid for Shared Decision Making in Chest Pain
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