Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000539538p
Ethics application status
Submitted, not yet approved
Date submitted
11/04/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a prehospital model of care involving risk assessment, point-of-care troponin, and virtual emergency department to accelerate the provision of definitive care for chest pain
Scientific title
A pragmatiC Cluster randomised trial to Evaluate a prehospitaL model of carE involving Risk Assessment, point-of-care Troponin, and virtual ED to accelerate the provision of definitive care for adults with Chest Pain
Secondary ID [1] 311933 0
None
Universal Trial Number (UTN)
Trial acronym
ACCELERATE-CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest pain 333527 0
Condition category
Condition code
Cardiovascular 330206 330206 0 0
Other cardiovascular diseases
Public Health 330207 330207 0 0
Health service research
Emergency medicine 330208 330208 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
When a patient attended by Ambulance Victoria for chest pain meets all inclusion criteria and no exclusion criteria, additional components will determine which clinical pathway a patient will take:

1. Risk score calculation embedded within the Ambulance Victoria Clinical Practice Guideline (CPG) mobile phone app.
- Risk assessment will involve calculation of the Early Chest pain Admission, myocardial infarction (MI), and Mortality (ECAMM) risk score that was developed and validated by the Investigators and determines the risk of cardiac and non-cardiac causes of chest pain. It will take approximately 5 minutes to complete the risk assessment.
- The ECAMM risk score is a measure of early all-inclusive risk, predicting the risk of hospital admission for any diagnosis (other than non-specific pain), 30-day MI, and 30-day all-cause mortality among patients with undifferentiated chest pain. It provides a numerical risk assessment not limited to coronary diagnoses alone.
- The score categorises patients into low, intermediate, or high risk according to cut-off scores.
- The score calculator will be embedded within the current CPG mobile app on phones carried by all paramedics as part of the chest pain CPG.
**If the patient is deemed to be intermediate risk or high risk via the ECAMM score, patients will be transported to hospital as is the current standard of care.

2. Prehospital point-of-care (POC) high-sensitivity troponin testing performed by paramedics.
- Measurement of high-sensitivity troponin at the point of patient care will determine the next steps in the new pathway of care.
- Paramedics will collect capillary blood via finger prick for testing and apply a sample to the test cartridge that is then inserted into the POC device for measurement. It will take 1-2 minutes to collect the blood and insert the cartridge into the device for troponin measurement. The device takes 8 minutes to analyse the sample and return the troponin result.
- The POC device to be used is Australian Government Therapeutic Goods Administration approved.
- Real-time results will be provided in 8 minutes and will be the same quality as laboratory results.

**If the POC troponin test is positive, the patient will no longer be considered at low risk, and will be transported by ambulance to the nearest hospital for further investigation and care.

**Only when the risk score defines the patient as being at low risk AND the troponin test is negative, will the VVED be considered for use by paramedics.

3. Victorian Virtual Emergency Department (VVED) consultation
If a patient meets the criteria for low risk via the ECAMM Score and the POC troponin test is negative, paramedics will call VVED to arrange a consultation (available 24 hours per day, 7 days per week) which will be conducted whilst paramedics are still on scene and with the patient, as per usual Ambulance Victoria processes. A VVED clinician will provide a telehealth consultation (approximately 15 minutes in length) and confirm that the patient is suitable for outpatient follow-up and provide referrals where appropriate. If the VVED clinician feels the patient is not fit for prehospital discharge and still requires ED assessment, paramedics will transport them to the nearest hospital. Patients will also be able to request transport to ED at any time prior to paramedic departure.

Paramedic training: As with the introduction of all new Ambulance Victoria CPGs, training will be provided to all paramedics in the form of an online learning package that will include demonstration videos. Training paramedics to use the POC device will occur via a train the trainer model with the device company providing face-to-face training to a group of paramedics who will then provide face-to-face training to the remining paramedic workforce.

Monitoring of intervention adherence and fidelity: Adherence to the new CPG and fidelity of the intervention will be monitored by reviewing the patient care records for all patients who are treated by paramedics according to the new CPG and patients who meet the eligibility criteria but for whom the intervention was not provided (including following up the reasons why the intervention wasn't provided).
Intervention code [1] 328397 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator/control treatment will be the standard care of patients presenting to Ambulance Victoria for chest pain according to the current Clinical Practice Guideline. Patients randomised to the control arm will not undergo any further risk stratification (i.e. ECAMM score calculation or high-sensitivity troponin testing) at any time and will only be managed as per the current Clinical Practice Guideline for chest pain. This involves the transport of all patients presenting with chest pain to the closest ED.
Control group
Active

Outcomes
Primary outcome [1] 337960 0
Post-discharge myocardial infarction (i.e. heart attack) and all-cause mortality.
Timepoint [1] 337960 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [1] 433888 0
Proportion of suspected low-risk patients transported to hospital following VVED assessment.
Timepoint [1] 433888 0
At the time of Ambulance Victoria attendance for chest pain.
Secondary outcome [2] 433892 0
Total prehospital time.
Timepoint [2] 433892 0
At the time of Ambulance Victoria attendance for chest pain.
Secondary outcome [3] 433893 0
Total Victorian Virtual Emergency Department time.
Timepoint [3] 433893 0
At the time of Ambulance Victoria attendance for chest pain.
Secondary outcome [4] 433894 0
Rates of outpatient follow-up testing for computed tomography coronary angiography (CTCA).
Timepoint [4] 433894 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [5] 433895 0
Reoccurrence of chest pain for which patients call Triple Zero (000) or self-present to a hospital ED.
Timepoint [5] 433895 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [6] 433896 0
Major Adverse Cardiovascular Events (MACE) defined as any of: i) all-cause mortality, (ii) development of an acute coronary syndrome (ACS), (iii) requirement for revascularisation (PCI or coronary artery bypass graft surgery [CABG]).
Timepoint [6] 433896 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [7] 433897 0
Diagnoses of patients who are transported to hospital following VVED consultation.
Timepoint [7] 433897 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [8] 433898 0
Re-presentation to ambulance for any reason.
Timepoint [8] 433898 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [9] 433899 0
Final discharge diagnosis for low-risk patients with a positive prehospital troponin.
Timepoint [9] 433899 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [10] 433900 0
Post-discharge MI and all-cause mortality for low-risk patients with a positive prehospital troponin.
Timepoint [10] 433900 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [11] 433901 0
Patient experience.
Timepoint [11] 433901 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [12] 433902 0
Patient quality of life.
Timepoint [12] 433902 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [13] 434390 0
Rates of outpatient follow-up testing for stress echocardiography.
Timepoint [13] 434390 0
30-days of presentation to ambulance for chest pain.
Secondary outcome [14] 434391 0
Rates of outpatient follow-up testing for stress myocardial perfusion imaging (MIBI).
Timepoint [14] 434391 0
30-days of presentation to ambulance for chest pain.

Eligibility
Key inclusion criteria
- Undifferentiated chest pain with a complete assessment, including 12-lead ECG.
- Meets low risk criteria according to the ECAMM risk score (score <=7).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy.
- Unable to obtain a troponin measurement in patients who are attended by a vehicle randomised to the intervention group.
- Altered conscious state (GCS<14).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation using computerised sequence generation with stratification for geographical location (metropolitan versus regional).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
4/01/2027
Actual
Date of last data collection
Anticipated
3/02/2027
Actual
Sample size
Target
5600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316279 0
Government body
Name [1] 316279 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 316279 0
Australia
Funding source category [2] 316282 0
Government body
Name [2] 316282 0
Victorian Medical Research Acceleration Fund
Country [2] 316282 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318468 0
Government body
Name [1] 318468 0
Ambulance Victoria
Address [1] 318468 0
Country [1] 318468 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315098 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315098 0
Ethics committee country [1] 315098 0
Australia
Date submitted for ethics approval [1] 315098 0
02/05/2024
Approval date [1] 315098 0
Ethics approval number [1] 315098 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133670 0
Prof Dion Stub
Address 133670 0
Centre of Cardiovascular Research and Education in Therapeutics (CCRET), School of Public Health and Preventive Medicine, Monash University, Level 4, 553 St Kilda Road, Melbourne VICTORIA 3004
Country 133670 0
Australia
Phone 133670 0
+61 412104644
Fax 133670 0
Email 133670 0
[email protected]
Contact person for public queries
Name 133671 0
Dion Stub
Address 133671 0
Centre of Cardiovascular Research and Education in Therapeutics (CCRET), School of Public Health and Preventive Medicine, Monash University, Level 4, 553 St Kilda Road, Melbourne VICTORIA 3004
Country 133671 0
Australia
Phone 133671 0
+61 412104644
Fax 133671 0
Email 133671 0
[email protected]
Contact person for scientific queries
Name 133672 0
Dion Stub
Address 133672 0
Centre of Cardiovascular Research and Education in Therapeutics (CCRET), School of Public Health and Preventive Medicine, Monash University, Level 4, 553 St Kilda Road, Melbourne VICTORIA 3004
Country 133672 0
Australia
Phone 133672 0
+61 412104644
Fax 133672 0
Email 133672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Following publication with no end date determined.
Available to whom?
Requests will be assessed on a case-by-case basis at the discretion of the Principal Investigators.
Available for what types of analyses?
Any purpose approved by the Principal Investigators and approved by a Human Research Ethics Committee.
How or where can data be obtained?
Access subject to approvals by Professor Stub ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.