Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001189112
Ethics application status
Approved
Date submitted
29/07/2019
Date registered
26/08/2019
Date last updated
14/09/2022
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving care by faster risk-stratification of patients with possible heart attacks in the emergency department using point-of-care blood biomarker measurements
Scientific title
Improving care by faster risk-stratification by use of next generation point-of-care troponin in patients presenting with possible acute coronary syndrome in the emergency department.
Secondary ID [1] 298537 0
HRC 19-234
Universal Trial Number (UTN)
Trial acronym
ICare-FASTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 313355 0
Condition category
Condition code
Emergency medicine 311794 311794 0 0
Other emergency care
Cardiovascular 311795 311795 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Title: This is measured implementation of a change in service delivery via a pragmatic multi-centre stepped-wedge cross-sectional implementation design.
Why: Early risk stratification can enable early discharge of low-risk patients.
What: The use of a next generation point-of-care (POC) troponin assay compared with central laboratory based troponin assay. They hypothesis is that the POC assay will enable earlier discharge in low-risk patients because the results are available earlier.
Who: Patients presenting to urban EDs with symptoms of possible acute coronary syndrome (ACS). These are patients who routinely have laboratory based troponin tests on presentation to the ED. The nurse or physician determines this on the basis of the presenting complaint which includes chest-pain. The attending nurse draws the clinical bloods and orders the laboratory troponin test. This will occur in both the usual care and intervention arm. The determination of who gets the blood test by the nurse is standard practice and will not change. In the intervention phase they will also place this blood on a point-of-care troponin measurement device to measure the troponin concentration which will be reported to the attending physician ~15 minutes later. There are no additional blood draws.
How: Each emergency department will have a minimum 4 month usual care (control) followed by a two month run-in and minimum 4 month intervention phase. The only difference between arms is that the usual-care arm will use a laboratory based troponin assay on the first blood draw whereas the intervention arm will use a point-of-care assay. There will be 5 steps with one month in between steps and two hospital sites at each step.
Where: Emergency departments (EDs) (~10)
Intervention code [1] 314786 0
Early detection / Screening
Intervention code [2] 315264 0
Treatment: Devices
Comparator / control treatment
Usual care (the control arm) is defined as the ‘existing daily practice (clinical pathway) of the attending clinical staff to diagnose a patient with chest pain.’ These pathways all incorporate a risk score, an electrocardiogram, and at least one, though usually two central laboratory troponin measurements.
Control group
Active

Outcomes
Primary outcome [1] 320469 0
The emergency department length of stay for all patients assessed for possible myocardial infarction. This will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [1] 320469 0
At initial emergency department presentation for each participant. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Primary outcome [2] 320470 0
The establishment of an optimal knowledge translation process for the amended clinical pathway.
This will be assessed through feedback from participating hospital sites (nurses, physicians, laboratory managers) obtained through semi-structured interviews and informally.
Timepoint [2] 320470 0
Over the duration of the study feedback from hospital sites will be sought both in the pre-intervention and post-intervention phases. No specific time points are established.
Secondary outcome [1] 371728 0
The length of hospital stay of low-risk patients without acute myocardial infarction stratified by hospital. The length of hospital stay will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [1] 371728 0
At initial emergency department presentation. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Secondary outcome [2] 371729 0
The length of hospital stay of low-risk patients without acute myocardial infarction stratified by ethnic group. The length of hospital stay will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [2] 371729 0
At initial emergency department presentation. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Secondary outcome [3] 371730 0
The length of hospital stay of low-risk patients without acute myocardial infarction stratified by sex. The length of hospital stay will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [3] 371730 0
At initial emergency department presentation. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Secondary outcome [4] 371731 0
The length of hospital stay of low-risk patients without acute myocardial infarction for first presentation only. The length of hospital stay will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [4] 371731 0
At initial emergency department presentation. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Secondary outcome [5] 371732 0
The rate of major adverse cardiac event (MACE) within 30 days for patients discharged directly from ED. These will be determined from the electronic health record of each patient using the ICD10 codes:
Arrythmia (VT) I47.2
Complete AV Block I44.2
Cardiac Arrest I46.0
Cardiac Arrest I46.1
Cardiac Arrest I46.9
Ventricular Fibrillation I49.0
Cardiogenic Shock R57.0
Non ST Elevation Myocardial Infarction: Acute myocardial infarction unspecified I21.9
Non ST Elevation Myocardial Infarction: Acute subendocardial myocardial infarction I21.4
Non ST Elevation Myocardial Infarction: Subsequent myocardial infarction of inferior wall I22.1
Non ST Elevation Myocardial Infarction: Subsequent myocardial infarction of other sites I22.8
Non ST Elevation Myocardial Infarction: Subsequent myocardial infarction of unspecified site I22.9
Non ST Elevation Myocardial Infarction:Subsequent myocardial infarction of anterior wall I22.0
ST Elevation Myocardial Infarction: Acute transmural myocardial infarction of unspecified site I21.3
ST Elevation Myocardial Infarction: Acute transmural myocardial infarction of anterior wall I21.0
ST Elevation Myocardial Infarction: Acute transmural myocardial infarction of inferior wall I21.1
ST Elevation Myocardial Infarction: Acute transmural myocardial infarction of other sites I21.2
Timepoint [5] 371732 0
30 days following emergency department presentation
Secondary outcome [6] 408977 0
The length of hospital stay of low-risk patients without acute myocardial infarction. This will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [6] 408977 0
At initial emergency department presentation for each participant. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Secondary outcome [7] 413856 0
The length of hospital stay of low-risk patients without acute myocardial infarction stratified by control assay. The length of hospital stay will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [7] 413856 0
At initial emergency department presentation. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.
Secondary outcome [8] 413857 0
The length of hospital stay of low-risk patients without acute myocardial infarction stratified by tube type used to draw blood samples (Serum-separating tube, SST, vs Lithium Heparin). The length of hospital stay will be determined by the routine electronic health record which records presentation and discharge time.
Timepoint [8] 413857 0
At initial emergency department presentation. The ED presentation time and hospital discharge time (from the ED or from a Ward) are recorded electronically in the patient health record.

Eligibility
Key inclusion criteria
1. Adults aged >= 18 years.
2. Patients being assessed using the local hospital clinical pathway for possible acute coronary syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Died in ED

Study design
Purpose of the study
Diagnosis
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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Stepped Wedge - 1 month intervals between two sites at each interval starting the intervention.
The Christchurch Hospital will act as a sentinel site and so will undergo the intervention first. This is to aid the translation process by using the lessons learned from Christchurch Hospital to inform the translation process in other sites.
Other sites will be randomised to time of start of intervention.
The intervention phase will be preceded by two month “run-in” period which will allow for clinicians to get used to the change of practice and for any teething problems to be addressed. Prior to intervention each hospital will be encouraged to develop a site-specific framework which reflects local practice and which also incorporates lessons learned from other DHBs about optimal implementation strategies (from focus groups, consultations with key stakeholders etc). The study end will be at the end of the 4-month intervention phase of the final study site. Follow-up data will be collected at all sites for 30-days. The duration of the study is 14 months with the final patients being followed for an additional 30 days. It is intended that successful implementation strategies will remain in place at each site.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This a pragmatic study of effectiveness in a real-life change of clinical practice. We will use a generalised linear mixed model.
Length of stay ~Arm + Site + Cluster + time of presentation + Season + Shift + Site*time of presentation
Arm: Usual care or Intervention
Site: Name of hospital
Cluster: Month when hospital crossed over to the intervention
Time of presentation: Month during which a patient presented
Season: Winter (Jun-Aug), Spring (Sept-Nov), Summer (Dec-Feb), Autumn (Mar-May)
Shift: Day (0800-1600), Evening (1600-2400), Night (2400-0800)
Site*time of presentation: Interaction term
Cluster random, site random, time fixed (categorical) arm fixed.

Sensitivity analyses:
(i) By actual times of change of practice at each site
(ii) First presenters only
(iii) Including the run-in period within the intervention
(iv) All sites excluding Christchurch
(v) All sites excluding any who did not have a single-sample rule-out as standard practice for the duration of the control period.
(vi) Period during which there is overlap of Control and Run-in or Intervention (months 8-13).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/01/2024
Actual
Sample size
Target
8400
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 21619 0
New Zealand
State/province [1] 21619 0
Across New Zealand

Funding & Sponsors
Funding source category [1] 303083 0
Government body
Name [1] 303083 0
Health Research Council of New Zealand
Country [1] 303083 0
New Zealand
Funding source category [2] 311289 0
Commercial sector/Industry
Name [2] 311289 0
Siemens Healthcare Limited
Country [2] 311289 0
New Zealand
Funding source category [3] 311290 0
Government body
Name [3] 311290 0
Ministry of Health New Zealand
Country [3] 311290 0
New Zealand
Primary sponsor type
Individual
Name
Dr Martin Than
Address
Canterbury District Health Board and Emergency Care Foundation
c/- 21 Taylors Mistake Road
Sumner
Christchurch 8081
Country
New Zealand
Secondary sponsor category [1] 303066 0
Individual
Name [1] 303066 0
Professor John Pickering
Address [1] 303066 0
c/- Emergency Care Foundation
P O Box 13-149
Christchurch 8141
Country [1] 303066 0
New Zealand
Other collaborator category [1] 280740 0
Hospital
Name [1] 280740 0
Canterbury District Health Board
Address [1] 280740 0
Canterbury District Health Board
32 Oxford Terrace
Christchurch 8011
Country [1] 280740 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303628 0
Health and Disability Ethics Committee
Ethics committee address [1] 303628 0
c/- Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 303628 0
New Zealand
Date submitted for ethics approval [1] 303628 0
10/12/2020
Approval date [1] 303628 0
06/05/2021
Ethics approval number [1] 303628 0
21/STH/9

Summary
Brief summary
About 65,000 patients annually in New Zealand are assessed with dedicated clinical pathways for possible Acute Myocardial Infarction (AMI), usually because of chest pain. These enable up-to 35% of patients to have AMI ruled-out within 6 hours. These pathways require two blood tests for cardiac troponin (cTn) over two to six hours from Emergency Department (ED) presentation. Newer, laboratory-based, high-sensitivity assays can now measure cTn at low concentrations with high enough precision to allow rule-out of AMI in 31 to 49% of patients by applying a low-concentration decision threshold to a single ‘baseline’ blood test (done on arrival at the ED).
Despite the time-efficiencies that this creates, the turnaround-time taken from blood-draw to actioning of the results is an important limitation to rapid decision-making. Time to transport to a central laboratory and prepare a sample for measurement is a significant component of this time. Additionally, since results are not immediately available, there is also delay because the decision-making clinician is busy with other patients when the results become available.
A new high-precision point-of-care cardiac (POC) cTn assays using a near-bedside analyser can provide results in ˜15 minutes. Consequently, rule-out of AMI is now possible using a single ‘baseline’ blood-test with TnI-Nx utilising a low-concentration threshold. We hypothesise that implementation of this assay will result in more patients being released earlier from the ED.
Aims
This is a multi-centre measured implementation project to enable and evaluate a TnI-Nx based strategy across 10 diverse hospital settings. We aim to (a) reduce length of ED and hospital stay and (b) identify optimal knowledge translation strategies needed to support implementation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94318 0
Dr Martin Than
Address 94318 0
Canterbury District Health Board and Emergency Care Foundation
21 Taylors Mistake Road
Sumner
Christchurch 8081
Country 94318 0
New Zealand
Phone 94318 0
+64 21450685
Fax 94318 0
Email 94318 0
[email protected]
Contact person for public queries
Name 94319 0
Dr Martin Than
Address 94319 0
Canterbury District Health Board and Emergency Care Foundation
21 Taylors Mistake Road
Sumner
Christchurch 8081
Country 94319 0
New Zealand
Phone 94319 0
+64 21450685
Fax 94319 0
Email 94319 0
[email protected]
Contact person for scientific queries
Name 94320 0
Prof John Pickering
Address 94320 0
c/- Emergency Care Foundation
P O Box 13-149
Christchurch 8140
Country 94320 0
New Zealand
Phone 94320 0
+64 21 253 7877
Fax 94320 0
Email 94320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an measured implementation study which does not require patient level ethics approval, therefore it is not possible to obtain ethical approval for this level of data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4160Study protocol  [email protected]
4161Statistical analysis plan  [email protected]



Results publications and other study-related documents

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