Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000533190
Ethics application status
Approved
Date submitted
13/03/2019
Date registered
3/04/2019
Date last updated
10/03/2020
Date data sharing statement initially provided
3/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of Rural Acute Coronary Syndrome (MORACS)- implementing a hub and spoke system to improve identification and management of patients with ACS in Rural hospitals.
Scientific title
Management of Rural Acute Coronary Syndrome (MORACS)- implementing a hub and spoke system to improve identification and management of patients with ACS in Rural hospitals within a Local Health District.
Secondary ID [1] 297709 0
Nil known
Universal Trial Number (UTN)
U1111-1230-0156
Trial acronym
MORACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 312018 0
ST elevation myocardial infarction 312019 0
NON ST elevation infarction 312020 0
Atrial Fibrillation 312021 0
Condition category
Condition code
Cardiovascular 310582 310582 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All Rural Emergency Departments within a Local Health District are randomised to either usual care or a mandated transmission of ECG and troponin from spoke (Rural) hospitals to a central hub service. Protocol directed advice from the NSW Health Chest Pain Pathway will be given to the randomised Rural Hospital clinicians by telephone, and will channel patients into the existing ACS management structures: The State Cardiac Reperfusion Strategy (SCRS) for STEMI patients, and the NSW Chest Pain Pathway for non-STEMI patients.
Phone calls to interventional sites will be made within the first 30 minutes of the patients initial arrival to Hospital and as required thereafter during the patients initial presentation to Hospital until the patient is discharged from the Emergency Department or transferred to a Referral centre. Thirty-day and 12-month readmission rates (and reasons) will be identified through the patient information management system, and Centre for Health Record Linkage (CHeReL). Deaths will be identified through the National Death Index. Advice provided will be based on the ECG, Patients troponin, and presentation once established, ensuring consistency with chest pain pathway. Advice will include one of the following dependent on this clinical information; Return to routine care, Conference call to a Cardiologist for advice and potential pt transfer, Advice for admission and transfer to referral Hospital. Clinical data and Advice provided is documented on the research database for analysis at the end of the trial. ECGs will be independently reported and compared with the MORACS service interpretation at the end of the trial.
Clinicians providing protocol directed advice and referral will comprise of Senior Cardiology Nursing staff, with extensive experience in ECG interpretation, and management of patients with suspected Acute Coronary Syndrome.
Intervention code [1] 313944 0
Treatment: Other
Comparator / control treatment
The control arm of this study will continue with current practice and treatment processes which will consist of management of patients without supportive expert advice, except where this is requested as part of normal process. Outcome measures will compared against the interventional group.
Control group
Active

Outcomes
Primary outcome [1] 319434 0
Proportion of correctly identified STEMI (indicator 3b ACSQHC). ECGs will be adjudicated by a senior clinician. ECGs performed on all patients presenting with possible ACS will be analysed.
Timepoint [1] 319434 0
Analysis of the primary outcome will occur at 2 years following 15 months of patient recruitment.
Secondary outcome [1] 368181 0
In Hospital Mortality
Timepoint [1] 368181 0
Assessed at end of Hospitalisation
Secondary outcome [2] 368182 0
Time to coronary reperfusion from presentation in patients with myocardial infarction. This will be measured from presentation to Hospital to resolution of ST segment elevation in patients with STEMI that receive thrombolysis, or for those that undergo percutaneous intervention, from time of presentation to TIMI III flow (which ever occurs first). This will be assessed by presentation time stamp automatically generated from the patient administration system, the Electronic ECG database and the patients digital medical record.
Timepoint [2] 368182 0
Time of Coronary reperfusion from presentation documented
Secondary outcome [3] 368183 0
Length of Hospital stay
Timepoint [3] 368183 0
At end of Hospitalisation, reviewed at 30 day intervals until discharge.
Secondary outcome [4] 368185 0
Major Adverse Cardiac Events (Death, Repeat Myocardial Infarction, or all cause readmission) at 30 days and 12 months. This data will be obtained from the electronic patient administration system and Births, Deaths and Marriages.
Timepoint [4] 368185 0
At 30 days and 12 month interval post primary event/hospitalisation
Secondary outcome [5] 368685 0
30 day mortality
Timepoint [5] 368685 0
At 30 days from presentation to Hospital
Secondary outcome [6] 368686 0
12 month Mortality
Timepoint [6] 368686 0
Assessed at 12 months post Hospital presentation
Secondary outcome [7] 368787 0
Economic evaluation - Health provider perspective.
A cost-effectiveness analysis to report the resources required per unit improvement in the identification of STEMI. Costs will include the cost of the intervention as well as related costs such as hospital stay, treatments and readmissions. The measure of effect will be based on the primary outcome, and will be measured at the end of the study.
Timepoint [7] 368787 0
This will be evaluated at 30 days post the conclusion of the study.
Secondary outcome [8] 368788 0
Economic evaluation; Cost-consequence analysis.
The cost of the intervention and its range of consequences such as the change in STEMI identification, reperfusion times, hospital admissions, readmissions and MIs.
Timepoint [8] 368788 0
This will be evaluated at 30 days post the conclusion of the study.

Eligibility
Key inclusion criteria
All patients presenting with chest pain for investigation to hospitals from rural and remote communities throughout the HNELHD.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with prehospital ECGs performed by ambulance paramedics showing STEMI will NOT go through this process, they will go via existing SCRS pathway.

Patients presenting with cardiac arrest who decease prior to ROSC and ECG being performed.

Patients receiving active palliation.

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 concealed - central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Hospitals are randomised to receive the intervention (MORACS) or control (usual care). Randomisation is undertaken independently by personnel from the HMRI statistical support unit via simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
1) Power calculation: Based on local data, anticipated number of presentations to hospital with suspected ACS over a 12-month period are approximately 6,300, which includes HNELD and SWSLHD. Of these an estimated 50% will require admission and investigation for ACS. Around 15% of the total patient group will have non-STEMI and a further 5% have STEMI, i.e. ~315 STEMI per year across all centres. An estimated 36% of the patients with STEMI will be missed and we wish to detect an absolute reduction in missed STEMI of 16%, i.e. 36% down to 20%, which will require 280 participants (140 per arm), at 80% power and p=0.05. We also include a design effect of 1.24 (assuming cluster sizes of 13 and ICC=0.015) for a total of 338 patients across 26 clusters total. Therefore, it will take approximately 15 months to recruit. In the two-year timeframe, we will be able to analyse the rate of STEMI detection (primary endpoint) and will have a median 12-month follow-up for the secondary endpoints.
2) Evaluation of Results: Analysis of the primary outcome (the proportion of correctly identified STEMI) will be via logistic regression with adjustment for stratifying variables (size and staffing of hospital), and analysis of the secondary outcomes will be via linear and logistic regression.
3) Economic evaluation: Assuming an improvement in STEMI identification, three economic evaluations will be conducted. 1) From a health provider perspective, a cost-effectiveness analysis to report the resources required per unit improvement in the identification of STEMI. Costs will include the cost of the intervention as well as related costs such as hospital stay, treatments and readmissions. The measure of effect will be based on the primary outcome (identification of STEMI). 2) A cost-consequence analysis will report the cost of the intervention and its range of consequences such as the change in STEMI identification, reperfusion times, hospital admissions, readmissions and MIs. 3) A modelling exercise to estimate costs and potential downstream impacts from the intervention over a ten-year time frame, these will include avoided healthcare costs as a consequence of improved STEMI detection and treatment, as well as adherence to secondary prevention therapies. This will be informed by data linkage with MBS and PBS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/12/2018
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
7500
Accrual to date
6800
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13380 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [2] 13381 0
Barraba Multi Purpose Service - Barraba
Recruitment hospital [3] 13382 0
Bingara Multipurpose Service - Bingara
Recruitment hospital [4] 13383 0
Cessnock District Hospital - Cessnock
Recruitment hospital [5] 13384 0
Denman Multi Purpose Service - Denman
Recruitment hospital [6] 13385 0
Dungog Community Hospital - Dungog
Recruitment hospital [7] 13386 0
Glen Innes District Hospital - Glen Innes
Recruitment hospital [8] 13387 0
Gloucester Soldiers Memorial Hospital - Gloucester
Recruitment hospital [9] 13388 0
Gunnedah District Hospital - Gunnedah
Recruitment hospital [10] 13389 0
Guyra Multi Purpose Service - Guyra
Recruitment hospital [11] 13390 0
Kurri Kurri District Hospital - Kurri Kurri
Recruitment hospital [12] 13391 0
Merriwa Multi Purpose Service - Merriwa
Recruitment hospital [13] 13392 0
Moree District Hospital - Moree
Recruitment hospital [14] 13393 0
Wilson Memorial Community Hospital - Murrurundi
Recruitment hospital [15] 13394 0
Muswellbrook Hospital - Muswellbrook
Recruitment hospital [16] 13395 0
Narrabri District Hospital - Narrabri
Recruitment hospital [17] 13396 0
Tomaree Community Hospital - Nelson Bay
Recruitment hospital [18] 13397 0
Singleton District Hospital - Singleton
Recruitment hospital [19] 13398 0
Scott Memorial Hospital, Scone - Scone
Recruitment hospital [20] 13399 0
Prince Albert Tenterfield - Tenterfield
Recruitment hospital [21] 13400 0
Walcha Multipurpose Service - Walcha
Recruitment hospital [22] 13401 0
Warialda Multipurpose Service - Warialda
Recruitment postcode(s) [1] 25983 0
2350 - Armidale
Recruitment postcode(s) [2] 25984 0
2347 - Barraba
Recruitment postcode(s) [3] 25985 0
2404 - Bingara
Recruitment postcode(s) [4] 25986 0
2325 - Cessnock
Recruitment postcode(s) [5] 25987 0
2328 - Denman
Recruitment postcode(s) [6] 25988 0
2420 - Dungog
Recruitment postcode(s) [7] 25989 0
2370 - Glen Innes
Recruitment postcode(s) [8] 25990 0
2422 - Gloucester
Recruitment postcode(s) [9] 25991 0
2380 - Gunnedah
Recruitment postcode(s) [10] 25992 0
2365 - Guyra
Recruitment postcode(s) [11] 25993 0
2327 - Kurri Kurri
Recruitment postcode(s) [12] 25994 0
2329 - Merriwa
Recruitment postcode(s) [13] 25995 0
2400 - Moree
Recruitment postcode(s) [14] 25996 0
2338 - Murrurundi
Recruitment postcode(s) [15] 25997 0
2333 - Muswellbrook
Recruitment postcode(s) [16] 25998 0
2390 - Narrabri
Recruitment postcode(s) [17] 25999 0
2315 - Nelson Bay
Recruitment postcode(s) [18] 26000 0
2330 - Singleton
Recruitment postcode(s) [19] 26001 0
2337 - Scone
Recruitment postcode(s) [20] 26002 0
2372 - Tenterfield
Recruitment postcode(s) [21] 26003 0
2354 - Walcha
Recruitment postcode(s) [22] 26004 0
2402 - Warialda

Funding & Sponsors
Funding source category [1] 302232 0
Government body
Name [1] 302232 0
NSW Ministry of Health
Country [1] 302232 0
Australia
Primary sponsor type
Individual
Name
Professor Andrew Boyle
Address
Cardiovascular Department John Hunter Hospital
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 302088 0
None
Name [1] 302088 0
Address [1] 302088 0
Country [1] 302088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302912 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302912 0
Ethics committee country [1] 302912 0
Australia
Date submitted for ethics approval [1] 302912 0
17/09/2018
Approval date [1] 302912 0
17/10/2018
Ethics approval number [1] 302912 0
18/10/17/4.08

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

Contacts
Principal investigator
Name 91822 0
Prof Andrew Boyle
Address 91822 0
Cardiovascular Department John Hunter Hospital
Lookout Road New Lambton Heights
NSW 2305
Country 91822 0
Australia
Phone 91822 0
+61 249214200
Fax 91822 0
+61 249214210
Email 91822 0
[email protected]
Contact person for public queries
Name 91823 0
Fiona Dee
Address 91823 0
Cardiovascular Department John Hunter Hospital
Lookout Road New Lambton Heights
NSW 2305
Country 91823 0
Australia
Phone 91823 0
+61 2 49214200
Fax 91823 0
+61 2 49214210
Email 91823 0
[email protected]
Contact person for scientific queries
Name 91824 0
Andrew Boyle
Address 91824 0
Cardiovascular Department John Hunter Hospital
Lookout Road New Lambton Heights
NSW 2305
Country 91824 0
Australia
Phone 91824 0
+61 2 49214200
Fax 91824 0
+61 2 49214210
Email 91824 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
Not individually consented


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
SourceTitleYear of PublicationDOI
EmbaseManagement of Acute Coronary Syndromes in Patients in Rural Australia: The MORACS Randomized Clinical Trial.2022https://dx.doi.org/10.1001/jamacardio.2022.1188
N.B. These documents automatically identified may not have been verified by the study sponsor.