Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000278538
Ethics application status
Approved
Date submitted
8/02/2024
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Tasmanian Emergency Care Outcomes Registry
Scientific title
The Tasmanian Emergency Care Outcomes Registry
Secondary ID [1] 311502 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TECOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emergency medicine 332833 0
emergency department 332834 0
Condition category
Condition code
Emergency medicine 329550 329550 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
The purpose and aims of this clinical quality registry are to monitor emergency care processes and outcomes through the provision of timely extraction and analysis of ED clinical data.

Conditions observed and exposures will include intubation, procedural sedation, suspected illicit substance misuse, deterioration whilst in the ED requiring a medical activation team call. Quality will be measured by clinical pathways compliance including fractured neck of femur pathway, stroke pathway, chest pain pathway and sepsis pathway.

Minimum data set for observational assessment will be vital signs on arrival. Additional observations will be collected depending on area of interest, for example, for intubated patients we will be collecting all observations just prior, during and following intubation.

Data from all Tasmanian hospitals from the 1st of January 2016 to the time of recruitment of the first prospective patient, will be collected retrospectively.

Intervention code [1] 327950 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337344 0
Our primary outcome are the rates of mortality (within 30 days of presentation) in our EDs.
Timepoint [1] 337344 0
Rates of mortality of patients presenting to the ED within the last 30 days of life.
Primary outcome [2] 337661 0
Morbidity (defined by the number of safety events reported through mandatory reporting systems) in our EDs.
Timepoint [2] 337661 0
Rates of safety events from the ED (noting that some event notifications can occur up to 1 year after the event has occurred).
Secondary outcome [1] 431520 0
Length of stay in the ED
Timepoint [1] 431520 0
We will use time of discharge from the ED as the 'length of stay' in ED.

Eligibility
Key inclusion criteria
All patients presenting to a public Tasmanian ED.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are linked to the ED but where emergency care is not actually provided by Emergency Staff will be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 26157 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 26158 0
Launceston General Hospital - Launceston
Recruitment hospital [3] 26159 0
Mersey Community Hospital - Latrobe
Recruitment hospital [4] 26160 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 42019 0
7000 - Hobart
Recruitment postcode(s) [2] 42020 0
7250 - Launceston
Recruitment postcode(s) [3] 42021 0
7307 - Latrobe
Recruitment postcode(s) [4] 42022 0
7320 - Burnie

Funding & Sponsors
Funding source category [1] 315792 0
Government body
Name [1] 315792 0
Tasmanian Health Service
Country [1] 315792 0
Australia
Primary sponsor type
Government body
Name
Tasmanian Department of Health
Address
Country
Australia
Secondary sponsor category [1] 317918 0
None
Name [1] 317918 0
Address [1] 317918 0
Country [1] 317918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314650 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 314650 0
http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu
Ethics committee country [1] 314650 0
Australia
Date submitted for ethics approval [1] 314650 0
26/02/2024
Approval date [1] 314650 0
26/02/2024
Ethics approval number [1] 314650 0
30260

Summary
Brief summary
The purpose and aims of this clinical quality registry are to monitor emergency care processes and outcomes through the provision of timely extraction and analysis of ED clinical data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132282 0
A/Prof Viet Tran
Address 132282 0
Royal Hobart Hospital Emergency Department, 48 Liverpool Street, Hobart, TAS 7000
Country 132282 0
Australia
Phone 132282 0
+61 431225509
Fax 132282 0
Email 132282 0
v.tran@utas.edu.au
Contact person for public queries
Name 132283 0
Viet Tran
Address 132283 0
Royal Hobart Hospital Emergency Department, 48 Liverpool Street, Hobart, TAS 7000
Country 132283 0
Australia
Phone 132283 0
+61 431225509
Fax 132283 0
Email 132283 0
v.tran@utas.edu.au
Contact person for scientific queries
Name 132284 0
Viet Tran
Address 132284 0
Royal Hobart Hospital Emergency Department, 48 Liverpool Street, Hobart, TAS 7000
Country 132284 0
Australia
Phone 132284 0
+61 431225509
Fax 132284 0
Email 132284 0
v.tran@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.