Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001002471
Ethics application status
Approved
Date submitted
24/08/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Date data sharing statement initially provided
10/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The OPERATE Research Program (Older Persons Early Recognition, Access and Treatment in Emergencies) (Phase 1)
Scientific title
The OPERATE Research Program (Older Persons Early Recognition, Access and Treatment in Emergencies) (Phase 1) to evaluate effects of interventions for acute care of older patients in addressing emergency department presentations and hospital admissions.
Secondary ID [1] 315181 0
Nil
Universal Trial Number (UTN)
Trial acronym
OPERATE Phase 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aged care 338625 0
emergency care 338661 0
Condition category
Condition code
Emergency medicine 334920 334920 0 0
Other emergency care
Public Health 335040 335040 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 initial part of OPERATE Phase I is an environmental scan of existing interventions specifically designed to decrease pressure on emergency departments from acute presentations by older persons (aged 65 and older). This exploratory process will identify such interventions across the three adult tertiary health services emergency departments in Perth, Western Australia. The interventions will be screened and selected for appropriate scope matching the goals of the project; quality and granularity of any clinical or evaluation data; engagement with the research project; and the resources required to perform the evaluation. The screening and selection process will be undertaken by the investigator team which consists of 25 persons and includes emergency physicians, geriatricians, allied health professionals, nurses, consumers, academic clinicians and health system scientists.
Once consensus is reached of the participating interventions, data from individual patients having had an intervention will be identified and accessed from pre-existing evaluation data and pre-existing routinely collected clinical and systems information in the respective health services. These data will be merged and analysed to describe the clinical service outcomes for each patient such as ED attendance and hospital admission. Since these data are retrospectively obtained and routinely collected, human research ethics approvals will be sought for waiver of consent for obtaining patient clinical data. No prospective data will be collected.
The dates and duration of the data collected will be individualised for each intervention in terms of commencement of service, and numbers of patients undergoing the intervention. It is expected that the duration of data collection for each invention will be six to twelve months and the individual patient data captured will form the exposure cohort, It is expected the data collection will occur within the period of 2020 to 2024 but the exact dates of data collection will vary according to each intervention.
Once the detailed evaluation is completed by the investigator team, a blueprinting process will occur to prioritise the interventions in terms of the ability to be integrated into a coordinated process (across pre-, in- and post-emergency department interventions) and potential for safely and effectively decreasing the pressure on emergency departments. The blueprinting process will involve the investigator team using a Delphi approach. This will require coordination from a steering group, several iterative rounds of surveys, anonymity of members submissions, controlled feedback, a priori excluding/closing criteria for each round, and stability and consensus of results. The results of the blueprinting will form the basis for implementation of a proof-of-concept model of acute aged care.
Intervention code [1] 331949 0
Not applicable
Comparator / control treatment
Where possible, case-comparative data similar to the exposure cohort will also be derived from the health datasets based on age, sex, primary acute diagnosis, and comorbidities to act as historical control groups. These data will be used to derive the historical comparator participants (before and after data). It is expected the data collection will occur within the period of 2018 to 2024 but the exact dates of data collection will vary according to the timeframe of data collection for each intervention. It is expected that the historical comparative (before-intervention) data will be collected across a similar time period and time of year to decrease effects of seasonality.
The comparator participants will not have had the relevant intervention, but will have attended emergency departments or called for an emergency ambulance and been provided with routine care.
Control group
Active

Outcomes
Primary outcome [1] 342552 0
Number and rate of episodes of emergency department care during, or in the 7 days following the completion of, the intervention.
Timepoint [1] 342552 0
Data will be collected during the period of the evaluation of each individual intervention. The duration is likely to be between six and twelve months and this duration will vary according to the intervention being evaluated. Within each study period, data will identify occasions of service of the intervention for each participant and the date of the final intervention service, Data collection for each participant will continue for a further 7 days following the cessation of any intervention to obtain information for this outcome.
Primary outcome [2] 342553 0
Number and rate of hospital admissions during, or in the 28 days following completion of, the intervention.
Timepoint [2] 342553 0
Data will be collected during the period of the evaluation of each individual intervention. The duration is likely to be between six and twelve months and this duration will vary according to the intervention being evaluated. Within this study period, data will identify occasions of service of the intervention for each participant and the date of the final intervention service, Data collection for each participant will continue for a further 28 days following the cessation of any intervention to obtain information for this outcome.
Secondary outcome [1] 451740 0
Frequency of emergency department avoidance (composite outcome) during, or in the 28 days following the completion, of the intervention.
Timepoint [1] 451740 0
Data will be collected during the period of the evaluation of each individual intervention. The duration is likely to be between six and twelve months and this duration will vary according to the intervention being evaluated. Within this study period, data will identify occasions of service of the intervention for each participant and the date of the final intervention service, Data collection for each participant will continue for a further 28 days following the cessation of any intervention to obtain information for this outcome.

Eligibility
Key inclusion criteria
The study sample will be patients aged 65 years or over presenting to EDs, at risk of presenting, or requiring an emergency ambulance, in participating WA health service areas.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/07/2024
Date of last participant enrolment
Anticipated
30/05/2026
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
35000
Accrual to date
6000
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319752 0
Government body
Name [1] 319752 0
MRFF - Australian Government Department of Health, Disability, and Ageing
Country [1] 319752 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 322259 0
None
Name [1] 322259 0
Address [1] 322259 0
Country [1] 322259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318304 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 318304 0
Ethics committee country [1] 318304 0
Australia
Date submitted for ethics approval [1] 318304 0
Approval date [1] 318304 0
13/03/2024
Ethics approval number [1] 318304 0
Ethics committee name [2] 318305 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [2] 318305 0
Ethics committee country [2] 318305 0
Australia
Date submitted for ethics approval [2] 318305 0
Approval date [2] 318305 0
30/04/2024
Ethics approval number [2] 318305 0
Ethics committee name [3] 318306 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [3] 318306 0
Ethics committee country [3] 318306 0
Australia
Date submitted for ethics approval [3] 318306 0
Approval date [3] 318306 0
17/04/2024
Ethics approval number [3] 318306 0
Ethics committee name [4] 318307 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [4] 318307 0
Ethics committee country [4] 318307 0
Australia
Date submitted for ethics approval [4] 318307 0
Approval date [4] 318307 0
Ethics approval number [4] 318307 0

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

Contacts
Principal investigator
Name 143766 0
Prof Antonio (Tony) Celenza
Address 143766 0
QEII Medical Centre, Hospital Avenue, Nedlands, 6009, WA
Country 143766 0
Australia
Phone 143766 0
+61 08 61510955
Fax 143766 0
Email 143766 0
[email protected]
Contact person for public queries
Name 143767 0
Antonio (Tony) Celenza
Address 143767 0
QEII Medical Centre, Hospital Avenue, Nedlands, 6009, WA
Country 143767 0
Australia
Phone 143767 0
+61 08 61510955
Fax 143767 0
Email 143767 0
[email protected]
Contact person for scientific queries
Name 143768 0
Antonio (Tony) Celenza
Address 143768 0
QEII Medical Centre, Hospital Avenue, Nedlands, 6009, WA
Country 143768 0
Australia
Phone 143768 0
+61 08 61510955
Fax 143768 0
Email 143768 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.