Acute Coronary SyndromeNCT03674021
Use of Visual Decision Aid for Shared Decision Making in Chest Pain
A study testing Chest Pain Choice visual aid in people with Acute Coronary Syndrome and Chest Pain, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain, Myocardial Infarction
- What is being tested?
- Chest Pain Choice visual aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2019to 3 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of a Visual Decision Aid for Shared Decision Making Among Patients With Chest Pain
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.
Read the 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).
- Being tested
- Chest Pain Choice visual aid
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Pain Choice visual aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chest Pain Choice visual aid |
| Control Arm | No intervention | Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to the Emergency Department Observation Unit
Admission to the Emergency Department Observation Unit during index emergency department visit
Measured: Index visit
Secondary outcomes (12)
Major Adverse Cardiac Events (MACE) at 30 days
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
Measured: 30 days after index visit
Major Adverse Cardiac Events at 60 days
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
Measured: 60 days after index visit
Emergency Department Attendance at 30 days
Repeat attendance to the emergency department
Measured: 30 days after index visit
Emergency Department Attendance at 60 days
Repeat attendance to the emergency department
Measured: 60 days after index visit
Stress treadmill electrogram at 30 days
The presence of stress treadmill electrocardiogram at 30 days post index visit
Measured: 30 days after index visit
Stress treadmill electrogram at 60 days
The presence of stress treadmill electrocardiogram at 60 days post index visit
Measured: 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
Measured: 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
Measured: 60 days after index visit
Stress echocardiogram at 30 days
The presence of stress echocardiogram at 30 days post index visit
Measured: 30 days after index visit
Stress echocardiogram at 60 days
The presence of stress echocardiogram at 60 days post index visit
Measured: 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
Measured: 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
Measured: 60 days after index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Mar 2019
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Why it stopped: Due to COVID pandemic and suspension of observation unit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674021
- Sponsor's protocol ID
- CPC
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22496116Anderson 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.
PubMed 24884807
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Visual Decision Aid for Shared Decision Making Among Patients With Chest Pain
- ClinicalTrials.gov ID
- NCT03674021
- Acronym / sponsor ID
- CPC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID pandemic and suspension of observation unit
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Chest Pain Choice visual aidPatients 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Pain Choice visual aidThe 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. | Other | Intervention Arm |
Primary outcome
Admission to the Emergency Department Observation Unit
Time frame: Index visit
Admission to the Emergency Department Observation Unit during index emergency department visit
12 secondary outcomes
Major Adverse Cardiac Events (MACE) at 30 days
Time frame: 30 days after index visit
Major Adverse Cardiac Events at 60 days
Time frame: 60 days after index visit
Emergency Department Attendance at 30 days
Time frame: 30 days after index visit
Emergency Department Attendance at 60 days
Time frame: 60 days after index visit
Stress treadmill electrogram at 30 days
Time frame: 30 days after index visit
Stress treadmill electrogram at 60 days
Time frame: 60 days after index visit
Stress myocardial perfusion imaging at 30 days
Time frame: 30 days after index visit
Stress myocardial perfusion imaging at 60 days
Time frame: 60 days after index visit
Stress echocardiogram at 30 days
Time frame: 30 days after index visit
Stress echocardiogram at 60 days
Time frame: 60 days after index visit
Computed tomography of the coronary arteries (CTCA) at 30 days
Time frame: 30 days after index visit
Computed tomography of the coronary arteries (CTCA) at 60 days
Time frame: 60 days after index visit
Results and safety
The study was stopped early (reason given: Due to COVID pandemic and suspension of observation unit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Results publication: PubMed 22496116Hess 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 publication: PubMed 24884807Anderson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Pain Choice visual aid in people with Acute Coronary Syndrome and Chest Pain, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID pandemic and suspension of observation unit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission to the Emergency Department Observation Unit (time frame: Index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674021, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.