Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001474741p
Ethics application status
Submitted, not yet approved
Date submitted
8/11/2022
Date registered
23/11/2022
Date last updated
23/11/2022
Date data sharing statement initially provided
23/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Queensland new troponin evaluation for patients presenting to the emergency department with suspected acute coronary syndrome
Scientific title
Queensland introduction of the Siemen's Atellica high sensitivity troponin and its effect on time to emergency department discharge in patients presenting to the emergency department with suspected acute coronary syndrome: A health services evaluation
Secondary ID [1] 308339 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
New-T
Linked study record
This record is a follow up study of ACTRN12621000053820.

Health condition
Health condition(s) or problem(s) studied:
Acute myocardial infarction 328128 0
Suspected acute coronary syndrome 328129 0
Chest pain 328130 0
Condition category
Condition code
Cardiovascular 325186 325186 0 0
Coronary heart disease
Public Health 325267 325267 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The implementation of a new high sensitivity troponin into clinical care and associated clinical pathway utilised for the assessment of patients with suspected acute myocardial infarction (AMI) will be examined.

This will be a retrospective pre-post analysis of adult emergency patients presenting to 20 hospitals across Queensland. Six months of pre- and six months of post-implementation data will be included, with one month block out where no data is included for implementation will be collected for each site. Due to staggered state-wide implementation, data will be collected from April 2021 to February 2023.

Data will be obtained from existing hospital databases including the following: Emergency Data Collection (EDC) minimum data set, Queensland Hospital Admitted Patient Data Collection (QHAPDC) database, and Auslab. Consent will not be sought from patients and no direct patient involvement will be required. De-identified observational patient data will be examined from ED presentation to ED discharge or until hospital discharge if they are admitted. The following data will be collected: time to ED discharge, time to hospital discharge (if admitted) and cardiac investigations during hospitalisation including angiogram.

The pre-implementation period for data collection is April 2021 to February 2022. The post-implementation period for data collection is April 2022 to February 2023.
Intervention code [1] 324791 0
Diagnosis / Prognosis
Comparator / control treatment
This study includes a pre-implementation group who were managed on a previous clinical pathway utilising a different high sensitivity troponin assay. Pre-implementation data including all patients who presented to ED with suspected AMI will be included from April 2021 to February 2022. Historical data will be retrospectively obtained from existing hospital databases including the following: Emergency Data Collection (EDC) minimum data set, Queensland Hospital Admitted Patient Data Collection (QHAPDC) database, and Auslab.
Control group
Historical

Outcomes
Primary outcome [1] 333014 0
The primary outcome is the proportion of patients discharged from the ED within four-hours of presentation for suspected acute coronary syndrome (ACS).

Data from Auslab, EDC and QHAPDC databases will be linked by the Queensland Health statistical services branch.
Timepoint [1] 333014 0
Patients presenting to the ED with suspected ACS between April 2021 and February 2022 (pre-implementation) will be compared with those presenting between April 2022 and February 2023 (post-implementation).
Secondary outcome [1] 415613 0
Emergency department length of stay is a secondary outcome. Data from Auslab, EDC and QHAPDC databases will be linked by the Queensland Health statistical services branch.
Timepoint [1] 415613 0
The ED length of stay is the time from ED arrival to the time of ED discharge.
Secondary outcome [2] 415614 0
Total hospital length of stay is a secondary outcome. Data from Auslab, EDC and QHAPDC databases will be linked by the Queensland Health statistical services branch.
Timepoint [2] 415614 0
Total hospital length of stay is the time from emergency department arrival to hospital discharge.
Secondary outcome [3] 415616 0
The proportion of patients receiving a single troponin test during emergency department presentation for suspected ACS is a secondary outcome. Data from Auslab, EDC and QHAPDC databases will be linked by the Queensland Health statistical services branch.
Timepoint [3] 415616 0
Patients presenting to the ED with suspected ACS between April 2021 and February 2022 (pre-implementation) will be compared with those presenting between April 2022 and February 2023 (post-implementation).
Secondary outcome [4] 415892 0
The proportion of patients admitted to hospital. Data from Auslab, EDC and QHAPDC databases will be linked by the Queensland Health statistical services branch.
Timepoint [4] 415892 0
Patients presenting to the ED with suspected ACS between April 2021 and February 2022 (pre-implementation) will be compared with those presenting between April 2022 and February 2023 (post-implementation).
Secondary outcome [5] 415893 0
The proportion of patients undergoing cardiovascular testing. Data from Auslab, EDC and QHAPDC databases will be linked by the Queensland Health statistical services branch.
Timepoint [5] 415893 0
Patients presenting to the ED with suspected ACS between April 2021 and February 2022 (pre-implementation) will be compared with those presenting between April 2022 and February 2023 (post-implementation).

Eligibility
Key inclusion criteria
Patients will be eligible for enrolment if they are 18 years of age or older and have at least one troponin test ordered within 3 hours of their presentation to the ED. Participants will be included in the pre-implementation group if presenting to a Queensland ED prior to implementation of the Siemen's Atellica assay between April 2021 and February 2022. Participants will be included in the post-implementation group if presenting to a Queensland ED where the Siemen's Atellica assay was implemented between April 2022 and February 2023.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they presented to the ED with troponin testing during the block-out implementation period relevant for each facility occurring between October 2021 and July 2022.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Statistical methods / analysis
For the primary analyses, the proportion of patients admitted will be compared in the pre- and post-implementation groups. Generalized linear models will be fit where admission is regression on time, implementation period and the interaction between the two. This will identify whether there was a difference pre- and post-intervention after adjustment for time-based changes that can confound pre-post studies. Such analyses will use a binomial error distribution and an exchangeable working correlation to account for clustering within hospitals.

For all secondary analyses, the difference in the pre- and post-implementation groups will be reported along with the 95% confidence intervals of the difference. Such confidence intervals will be calculated using an appropriate distribution for the data and will be adjusted for clustering within hospitals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2022
Actual
Date of last participant enrolment
Anticipated
30/01/2023
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
120000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23516 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 38924 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 312583 0
Hospital
Name [1] 312583 0
Pathology Queensland
Country [1] 312583 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street, Herston, Queensland 4029
Country
Australia
Secondary sponsor category [1] 314192 0
Hospital
Name [1] 314192 0
Pathology Queensland
Address [1] 314192 0
Pathology Administration, Ground Floor, E Block, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, Queensland, 4215
Country [1] 314192 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311909 0
Metro North Ethics Committee A
Ethics committee address [1] 311909 0
Ethics committee country [1] 311909 0
Australia
Date submitted for ethics approval [1] 311909 0
03/11/2022
Approval date [1] 311909 0
Ethics approval number [1] 311909 0

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

Contacts
Principal investigator
Name 122806 0
Prof Louise Cullen
Address 122806 0
Emergency Trauma Centre,
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029.
Country 122806 0
Australia
Phone 122806 0
+61 736468153
Fax 122806 0
Email 122806 0
Louise.cullen@health.qld.gov.au
Contact person for public queries
Name 122807 0
Louise Cullen
Address 122807 0
Emergency Trauma Centre,
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland, 4029.
Country 122807 0
Australia
Phone 122807 0
+61 736468153
Fax 122807 0
Email 122807 0
Louise.cullen@health.qld.gov.au
Contact person for scientific queries
Name 122808 0
Louise Cullen
Address 122808 0
Emergency Trauma Centre,
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland, 4029.
Country 122808 0
Australia
Phone 122808 0
+61 736468153
Fax 122808 0
Email 122808 0
Louise.cullen@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Health information subject to ethical and data sharing restrictions


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.