Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000232437
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
31/03/2025
Date last updated
31/03/2025
Date data sharing statement initially provided
31/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Residential In-Reach Program in Regional and Rural Health Services
Scientific title
Evaluation of a Region-wide Residential In-Reach (RIR) Program in Regional and Rural Health Services: A Stepped-wedge Trial
Secondary ID [1] 313915 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any acute geriatric condition 336607 0
Condition category
Condition code
Public Health 333113 333113 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will be a residential-in-reach program that provides telehealth triaging and care for residents in aged care facilities who experience an acute deterioration in their health status. Aged care staff will make a telehealth referral to central hub, where a nurse practitioner will triage the patient and make recommendations (for example, continue to monitor resident condition, conduct comprehensive assessment, liaise with general practitioner) or further referrals (for example, refer to geriatrician or call an ambulance). A follow-up visit to the patient may be conducted the following day on recommendation by the triaging nurse practitioner.

The program will be rolled-out in the region in a staged manner, with 2 residential aged care facilities beginning to access the program with each calendar month. This pragmatic implementation of the program aligns with a stepped-wedge design, therefore this will be a stepped-wedge evaluation. The effect of the project is on the order in which the aged cate facilities are randomised to start accessing the program.

Residential aged care home staff will receive training prior to roll-out of the program. Training includes 2-3 hours of face-to-face education by Residential-in-Reach program nurse consultants and program lead, 1-2 hours of Telehealth training by Western Victoria Primary Health Network, and regular online check-ins with the residential aged care home manager to identify additional training needs or support

The use of the resi-in-reach program will be assessed at the end of the evaluation based on the number of occasions of use from each enrolled aged care facility.
Intervention code [1] 330507 0
Diagnosis / Prognosis
Comparator / control treatment
Control will be any care that is available and accessible to the residential aged care facility for an older resident who experiences acute deteriorations to their health status, including but not exclusive of calling the emergency line for an ambulance, calling the general practitioner, calling any telehealth-based service (for example, the Virtual Emergency Department in Victoria, Australia).
Control group
Active

Outcomes
Primary outcome [1] 340654 0
Rate of presentations from residential aged care facilities to the emergency department
Timepoint [1] 340654 0
Monthly for monitoring, once at the end of the intervention period for final results
Primary outcome [2] 340655 0
Rate of presentations from residential aged care facilities to the urgent care centre
Timepoint [2] 340655 0
Monthly for monitoring, once at the end of the intervention period for final results
Secondary outcome [1] 444705 0
Days spent in hospital by residential aged care facility residents
Timepoint [1] 444705 0
Monthly for monitoring, once at the end of the intervention period for final results
Secondary outcome [2] 444706 0
Location of mortality in hospital
Timepoint [2] 444706 0
Monthly for monitoring, once at the end of the intervention period for final results
Secondary outcome [3] 444707 0
Barriers and enablers, and feasibility to residential-in-reach program implementation
Timepoint [3] 444707 0
Once at the end of the intervention
Secondary outcome [4] 444708 0
Acceptability, Appropriateness of RIR program
Timepoint [4] 444708 0
• Once to twice at each aged care facility after an occasion of usage of the program for up to two residents • Once at the end of the evaluation with GPs
Secondary outcome [5] 444709 0
Uptake of Education
Timepoint [5] 444709 0
Once at the end of the intervention
Secondary outcome [6] 444710 0
Program Adaptations
Timepoint [6] 444710 0
During monthly project updates, and as they arise and are reported
Secondary outcome [7] 444711 0
Residential-in-reach program occasions of service (in-person and via telehealth)
Timepoint [7] 444711 0
Monthly for monitoring, once at the end of the intervention period for final results
Secondary outcome [8] 444712 0
Victorian Virtual Emergency Department rate of use
Timepoint [8] 444712 0
Monthly for monitoring, once at the end of the intervention period for final results
Secondary outcome [9] 444713 0
Out-of/in-hours general practitioner calls/visits
Timepoint [9] 444713 0
Monthly for monitoring, once at the end of the intervention period for final results
Secondary outcome [10] 444714 0
Ambulance Victoria call-outs and transfers
Timepoint [10] 444714 0
Monthly for monitoring, once at the end of the intervention period for final results

Eligibility
Key inclusion criteria
1. Health services that have emergency departments and/or emergency care centres that admit residents from residential aged care facilities
2. Residential Aged Care Homes that do not currently have access to RIR programs
3. Individual Participants
3.1. health service staff who have been involved with the set-up and delivery of the RIR program,
3.2 Aged care staff who have experience of or accessing the RIR service for residents at least once,
3.3 residents living at a residential aged care facility who has experienced receiving medical care from the RIR program and can provide informed consent, or a family member of the resident,
3.4 general practitioners whose case load includes residents from residential aged care facilities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residential Aged Care facilities that already have access to a residential-in-reach program will be excluded,

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)
Eligibility of aged care facility is not concealed as this is determined by whether the facility has current access to a residential-in-reach program. The stepped-wedge design of this trial means that all eligible facilities will eventually receive the intervention, but the timing (sequence) will be randomised. This randomisation of timing will be concealed until the start of the intervention period, at which time all enrolled facilities will be notified of their expected start time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence at which aged care facilities starts to receive the intervention will be randomised with a computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Over a period of 14 months, with month 1 being a transition month, 3 residential aged care facilities per month will begin to access the resi-in-reach program. By the end of the 14 months, all residential aged care facilities will be accessing the resi-in-reach program.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318388 0
Government body
Name [1] 318388 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 318388 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320789 0
University
Name [1] 320789 0
Deakin University
Address [1] 320789 0
Country [1] 320789 0
Australia
Other collaborator category [1] 283416 0
Other Collaborative groups
Name [1] 283416 0
Western Alliance
Address [1] 283416 0
Country [1] 283416 0
Australia
Other collaborator category [2] 283417 0
Other Collaborative groups
Name [2] 283417 0
Grampians Region Health Service Partnership
Address [2] 283417 0
Country [2] 283417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317021 0
Grampians Health & St John of God Hospital Ballarat Human Research Ethics Committee
Ethics committee address [1] 317021 0
Ethics committee country [1] 317021 0
Australia
Date submitted for ethics approval [1] 317021 0
14/11/2024
Approval date [1] 317021 0
08/01/2025
Ethics approval number [1] 317021 0
HREC/112397/GHSJOG-2025-462490(v4)

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

Contacts
Principal investigator
Name 139762 0
Prof Terry Haines
Address 139762 0
Moorooduc Highway, Monash University Peninsula Campus, Frankston, Victoria 3199
Country 139762 0
Australia
Phone 139762 0
+61399029409
Fax 139762 0
Email 139762 0
[email protected]
Contact person for public queries
Name 139763 0
Kate Huggins
Address 139763 0
Deakin University Burwood Campus, Locked Bag 20000, Geelong, VIC 3220
Country 139763 0
Australia
Phone 139763 0
+61392468259
Fax 139763 0
Email 139763 0
[email protected]
Contact person for scientific queries
Name 139764 0
Terry Haines
Address 139764 0
Moorooduc Highway, Monash University Peninsula Campus, Frankston, Victoria 3199
Country 139764 0
Australia
Phone 139764 0
+61399029409
Fax 139764 0
Email 139764 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24521Ethical approval    Approval Letter.pdf
24522Study protocol    GH protocol RIR trial 31Dec2024_clean.docx



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.