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Trial registered on ANZCTR


Registration number
ACTRN12623000819628
Ethics application status
Approved
Date submitted
29/06/2023
Date registered
31/07/2023
Date last updated
31/07/2023
Date data sharing statement initially provided
31/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact on Care in Rural and URgent care centres for patients with possible Acute coronary syndrome using the Latest Point-of-Care technology
Scientific title
Investigating the impact on Care in Rural and URgent care centres for patients with possible Acute coronary syndrome using the Latest Point-of-Care technology: A quality improvement project
Secondary ID [1] 310008 0
None
Universal Trial Number (UTN)
Trial acronym
ICare-RURAL POC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest pain 330508 0
Condition category
Condition code
Cardiovascular 327356 327356 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention replaces the existing point-of-care (POC) troponin test with a high-sensitivity POC troponin test. Patients that present to health care facilities will be assessed by their usual health care professionals (usually doctors and nurses) who will perform the assessment and blood tests. The length of time the clinical assessment will take will vary depending on the clinical workload of the facility, time elapsed since the onset of chest pain but will generally take less than 2-hours per participant.

The higher sensitivity and precision of this test allows a modification of the Emergency department assessment of chest pain score (EDACS) threshold to 21 and the opportunity to stratify patients as having low-probability of acute myocardial infarction (AMI) after a single test, if their chest pain onset was at least 3-hours prior to the presentation.

Patients will be classified as having a low-probability of AMI and suitable for community management if all the below are true:
• EDACS less than 21
• There is no new ischaemia on ECG
• and either:
a. Chest-pain onset was 3hrs or greater prior to blood draw and the first (baseline) POC hs-cTn result was below a pre-defined rule-out threshold, or
b. Serial POC hs-cTn results at least 2hrs apart are negative (below the upper-reference limit of the assay).

These patients who have low probability of AMI can be discharged home and follow-up arrangements can be made by the treating health professional as clinically indicated using local guidelines.

Patients that do not fulfil these criteria are at risk of AMI and should be transferred (if not at a hospital site) and admitted to hospital for further assessment. If there is a rise or fall in cTn of at least 20% then treatment for AMI should commence.

This pathway is designed to assess the probability of AMI and not the underlying risk of coronary artery disease. Once AMI has been excluded, the opportunity should be used to assess and reduce this risk using evidence based assessment and treatment.

The intervention will be introduced to clusters of facilities (facilities are randomised into clusters) in one-month intervals starting 6 months after the start of the project. There will be a run-in period of 1 month for health care facilities to embed the new troponin test and pathway in their clinical practice. Data collected from this period will not be analysed in the primary analysis. The intervention will remain in place at all sites for at least 6 months with a maximum of 12 months.

The fidelity of the intervention will monitored using the data collection tool.
Intervention code [1] 326428 0
Diagnosis / Prognosis
Comparator / control treatment
Each site will have a minimum 6-month control period prior to the intervention phase where usual care is practiced. Usual care is defined as implementing the rural accelerated chest pain pathway (RACPP), which has been proven to be safe and effective in a prospective study with over 1000 patients enrolled. The pathway was endorsed by the NZ Cardiac Network in 2020.

Each site will have a minimum 6-month control period prior to the intervention phase where usual care is practiced. Usual care is defined as implementing the rural accelerated chest pain pathway (RACPP), which has been proven to be safe and effective in a prospective study with over 1000 patients enrolled. The pathway was endorsed by the NZ Cardiac Network in 2020.

The RACPP uses the presence of red flags (new ischaemic ECG changes, history strongly suggestive of crescendo angina, haemodynamic instability, ongoing chest pain), EDACS, the presence of ECG changes and two troponin concentrations at 0 and 2 hours to identify patients at low probability for AMI.

Patients are considered low probability for AMI if the satisfy all the following criteria:

- No red flags
- EDACS less than 16
- 0 and 2 hour troponin below threshold
- Clinically stable with no new ischaemic ECG changes.

The low probability pathway is implemented in all facilities and allows the identification of patients who can be discharged home in rural hospital and community settings. Patients who do not have low probability of AMI should be transferred from general practice and urgent care settings to their local referral hospital. These patients will then be assessed using the “Not low-risk” pathway, which aids the identification of those that are at high-risk of AMI.

As with the intervention arm, patients will be assessed by their usual health care professionals (usually doctors and nurses) who will perform the assessment and blood tests. The length of time the clinical assessment will take will vary depending on the clinical workload of the facility, time elapsed since the onset of chest pain but will generally take approximately 2-hours per participant.

The fidelity of the intervention will monitored using the data collection tool.
Control group
Active

Outcomes
Primary outcome [1] 335225 0
Length of stay at health facilities. This will be collected prospectively using the data collection tool. Missing data will be obtained from audit of medical records.
Timepoint [1] 335225 0
This outcome will be assessed at the end of the index presentation to the health facility (i.e. when the patient left the facility)..
Secondary outcome [1] 424262 0
Length of stay of all patients not admitted to hospital. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [1] 424262 0
At discharge from the health care facility at the conclusion of the index presentation.
Secondary outcome [2] 424263 0
Proportion of patients able to have AMI excluded with a single cTn result. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record.
Timepoint [2] 424263 0
At conclusion of the project.
Secondary outcome [3] 424264 0
Length of health facility stay for patients discharged after a single cTn result. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [3] 424264 0
At discharge from the health care facility at the conclusion of the index presentation.
Secondary outcome [4] 424265 0
Rate of AMI or cardiac death within 3 months for patients identified as having low probability for AMI and not admitted to hospital. This will be determined by sending a secure request to the New Zealand Ministry of Health to obtain mortality collection (death) records.
Timepoint [4] 424265 0
3months after discharge from the index event.
Secondary outcome [5] 424266 0
Rate of myocardial infarction or cardiac death within 3 months for all patients. This will be determined by sending a secure request to the New Zealand Ministry of Health to obtain mortality collection (death) records.
Timepoint [5] 424266 0
3months after discharge from the index event.
Secondary outcome [6] 424267 0
The proportion of patients not admitted after 1 hours for those presenting to rural hospitals. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [6] 424267 0
At the conclusion of the project.
Secondary outcome [7] 424268 0
The time between general practice or urgent care assessment and hospital assessment. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record. This will be assessed as a composite outcome.
Timepoint [7] 424268 0
At discharge from the health care facility at the conclusion of the index presentation.
Secondary outcome [8] 424269 0
The proportion of patients admitted to hospital. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [8] 424269 0
At the conclusion of the study.
Secondary outcome [9] 424270 0
The rate of index MI to troponin use. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [9] 424270 0
At the conclusion of the study.
Secondary outcome [10] 424271 0
The rate of troponin use (per month). This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [10] 424271 0
At the conclusion of each month of the project.
Secondary outcome [11] 424272 0
Rate of troponin use per patient presentation (rural hospitals only). The troponin use will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record. The number of patient presentations will be obtained from the New Zealand Ministry of Health's National Minimum Dataset (hospitalisation events).
Timepoint [11] 424272 0
Conclusion of the project.
Secondary outcome [12] 424273 0
The diagnostic performance of the emergency department of chest pain score (EDACS) in community settings. Myocardial infarction or cardiac death will be considered the gold-standard to compare the diagnostic ability.

This will be determined prospectively using the data collection tool and the NZ Ministry of Health national minimum dataset and mortality collections. Missing data will be obtained from the clinical record
Timepoint [12] 424273 0
At discharge from the health care facility at the conclusion of the index presentation.
Secondary outcome [13] 424533 0
Rate of AMI or cardiac death within 6 months for patients identified as having low probability for AMI and not admitted to hospital. This will be determined by sending a secure request to the New Zealand Ministry of Health to obtain mortality collection (death) records.
Timepoint [13] 424533 0
6 months after index admission
Secondary outcome [14] 424534 0
Rate of myocardial infarction or cardiac death within 6 months for all patients. This will be determined by sending a secure request to the New Zealand Ministry of Health to obtain mortality collection (death) records.
Timepoint [14] 424534 0
6 months after index admission
Secondary outcome [15] 424535 0
The proportion of patients not admitted after 2 hours for those presenting to rural hospitals. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [15] 424535 0
At the conclusion of the project.
Secondary outcome [16] 424537 0
The proportion of patients not admitted after 3 hours for those presenting to rural hospitals. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [16] 424537 0
At the conclusion of the study.
Secondary outcome [17] 424541 0
The proportion of patients not admitted after 4 hours for those presenting to rural hospitals. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [17] 424541 0
At the conclusion of the study.
Secondary outcome [18] 424543 0
The proportion of patients not admitted after 5 hours for those presenting to rural hospitals. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [18] 424543 0
At the conclusion of the project.
Secondary outcome [19] 424544 0
The proportion of patients not admitted after 6 hours for those presenting to rural hospitals. This will be determined prospectively using the data collection tool. Missing data will be obtained from the clinical record
Timepoint [19] 424544 0
At the conclusion of the study

Eligibility
Key inclusion criteria
Adults at least 18 years old and having an assessment for possible acute myocardial infarction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

• ST-Segment elevation myocardial infarction (STEMI)
• Patients died in the health facility due to a non-cardiac cause

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)
Sites will be randomised to clusters.
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
Sample size determination:
An average reduced LOS of at least 20-minute in the patients with low probability of AMI would be clinically meaningful, as this is more than the length of one consultation in general practice.

The RACPP study LOS for all low-risk patients was 3.9h and standard deviation 2.8h. At an alpha = 0.05 with a power of 90% and assuming 6 clusters, an intra-cluster correlation coefficient rho = 0.01 (small; based on the ICare-ACS study), and 50% of patients being low-risk (from the RACPP study) then a sample size of 1,036 patients is required (excluding those in the run-in phase). Based on the RACPP study (3.0 patients per site, per month), with 30 sites and expecting a drop- out of sites and patients of approximately 10%, we estimate that a minimum of 13 months are required (excluding run-in period). We propose a time period of 18 months including the run-in month to roll-out and assess this initiative. The total numbers are estimated at 1,458 (or 1,377 excluding the run-in month). With an estimated 20% Maori in the trial there is adequate power (80%) to identify a 31 minute reduction in length of stay amongst Maori.

In the RACPP study, there were 0.0% (95%CI 0% to 0.3%) MACE within 30-days in the low-risk group. Therefore, the largest acceptable difference between the control arm and intervention arm will be 1% (non- inferiority margin). We estimate there will be 364 patients with low-probability of AMI or cardiac death in the intervention arm, which has >95% power with one-sided alpha of 0.05 to test the hypothesis that the experimental arm is non-inferior to the control arm.

Statistical analysis

The analysis for the primary outcome length of stay (LOS) will be analysed with a generalised linear mixed model with cluster and site as fixed effects, and month of presentation of the patient and arm of the study as random effects. The beta-coefficient for Quality Improvement Arm will be presented with 95% Confidence interval. This represents the adjusted difference in LOS between arms.

The primary analysis will be based on the actual date of change of practice for each site.

Data and outcome metrics will be presented using 95% compatibility (confidence) intervals, and with p-values, s-values, and p-value and s-value graphs for the primary analysis.

Additional analysis will include calculation of the probability of AMI for those stratified to each of the low-probability and at risk of AMI groups. An updated risk stratification tool will be created using the troponin measurements and routine data collected for the ECG and EDACS. This will be created using standard regression and machine learning techniques. This will not be tested in this project and maybe used to inform future studies.

Since this is an implementation quality improvement initiative it will adhere to the Standards for Reporting Implementation studies (StaRI) when reporting results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2023
Actual
Date of last participant enrolment
Anticipated
5/05/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1458
Accrual to date
Final
Recruitment outside Australia
Country [1] 25617 0
New Zealand
State/province [1] 25617 0

Funding & Sponsors
Funding source category [1] 314186 0
Government body
Name [1] 314186 0
Health Research Council
Country [1] 314186 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of General Practice and Rural Health
University of Otago
55 Hanover Street,
Central Dunedin,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 316102 0
None
Name [1] 316102 0
Address [1] 316102 0
Country [1] 316102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313312 0
NZ Health and Disability Ethics Committee - Southern
Ethics committee address [1] 313312 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 313312 0
New Zealand
Date submitted for ethics approval [1] 313312 0
28/04/2023
Approval date [1] 313312 0
30/06/2023
Ethics approval number [1] 313312 0
2023 FULL 13807

Summary
Brief summary
This quality improvement initiative plans to measure the effect of implementing a chest pain assessment pathway using a point-of-care (near to patient) highly precise blood test to exclude heart attacks, compared with the existing chest pain assessment pathway (the rural accelerated chest pain pathway (RACPP). The context for the study will be people who experience chest pain and attend a community health setting in rural hospitals and general practice and urban urgent care clinics in Aotearoa New Zealand.

The RACPP includes a clinical assessment (the emergency department assessment of chest pain score (EDACS) of less than 16), an ECG (an electrode recording of the heart) and two troponin blood tests two hours apart that are below threshold. This pathway has been shown to be safe and effective at reducing the number of transfers to hospital or hospital admissions.

The new pathway (ICare-RURAL POC) that includes the new blood test (Siemens Atellica VLTi) allows the following changes to the pathway. The threshold for EDACS is able to be raised to 21 and if the episode of chest pain began at least 3-hours ago, a single blood test only will be required. This brings chest pain assessment in-line with urban emergency departments and may enable patients to receive high quality care near to the patient’s home, whanau, community and work. The main outcome measure is the length of time in a health facility. The hypothesis is that the new intervention will reduce the time that patients will spend in health care facilities.

Health facilities will all have at least 6 months on each arm (RACPP or ICare-RURAL POC) and the project will run for 18 months.
Trial website
https://blogs.otago.ac.nz/icarerural/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127698 0
Dr Rory Miller
Address 127698 0
Department of General Practice and Rural Health
University of Otago
55 Hanover Street,
Central Dunedin,
Dunedin 9016
Country 127698 0
New Zealand
Phone 127698 0
+64 3 479 7430
Fax 127698 0
Email 127698 0
rory.miller@otago.ac.nz
Contact person for public queries
Name 127699 0
Dr Rory Miller
Address 127699 0
Department of General Practice and Rural Health
University of Otago
55 Hanover Street,
Central Dunedin,
Dunedin 9016
Country 127699 0
New Zealand
Phone 127699 0
+64 3 479 7430
Fax 127699 0
Email 127699 0
rory.miller@otago.ac.nz
Contact person for scientific queries
Name 127700 0
Dr Rory Miller
Address 127700 0
Department of General Practice and Rural Health
University of Otago
55 Hanover Street,
Central Dunedin,
Dunedin 9016
Country 127700 0
New Zealand
Phone 127700 0
+64 3 479 7430
Fax 127700 0
Email 127700 0
rory.miller@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a quality improvement project and we have obtained a waiver that states that individual patient consent is not required, we are unable to share individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19567Study protocol    386160-(Uploaded-29-06-2023-08-44-06)-Study-related document.pdf



Results publications and other study-related documents

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