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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06901167




Registration number
NCT06901167
Ethics application status
Date submitted
4/03/2025
Date registered
28/03/2025

Titles & IDs
Public title
Evaluation of a Residential In-Reach Program in Regional and Rural Australia
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] 0 0
HREC/112397/GHSJOG-2025-462490
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aged 0 0
Acute Disease 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Residential In-Reach Program

Experimental: Residential-in-reach - All enrolled residential aged care homes will be able to access the residential-in-reach (RIR) program intervention. The RIR program provides a consultation service from a central hospital to an aged care facility in the Grampians region in the state of Victoria, Australia. Aged care staff will make a telehealth referral to central hub, where a nurse practitioner will triage the patient and make recommendations (for example, monitor resident condition, more examples: comprehensive assessment for unwell residents, liaison with the General Practitioners for diagnosis and treatment plan, provide education and support to staff) or further referrals (for example, refer to geriatrician or call an ambulance).


Other interventions: Residential In-Reach Program
All enrolled residential aged care homes will be able to access the residential-in-reach (RIR) program intervention. The RIR program provides a consultation service from a central hospital to an aged care facility in the Grampians region in the state of Victoria, Australia. Aged care staff will make a telehealth referral to central hub, where a nurse practitioner will triage the patient and make recommendations (for example, monitor resident condition, more examples: comprehensive assessment for unwell residents, liaison with the General Practitioners for diagnosis and treatment plan, provide education and support to staff) or further referrals (for example, refer to geriatrician or call an ambulance).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of presentations from residential aged care homes to emergency departments and emergency care centres
Timepoint [1] 0 0
From enrolment to the end of the trial for 14 months
Secondary outcome [1] 0 0
Days spent in hospital by aged care home resident
Timepoint [1] 0 0
From enrolment to the end of the trial for 14 months
Secondary outcome [2] 0 0
Location of mortality in hospital
Timepoint [2] 0 0
From enrolment to the end of the trial for 14 months
Secondary outcome [3] 0 0
Number of barriers to residential-in-reach program implementation
Timepoint [3] 0 0
From enrolment to 1 month after the end of the trial, for 15 months
Secondary outcome [4] 0 0
Number of enablers to residential-in-reach program implementation
Timepoint [4] 0 0
From enrolment to 1 month after the end of the trial, for 15 months
Secondary outcome [5] 0 0
Stakeholder reported feasibility of the residential-in-reach program implementation
Timepoint [5] 0 0
From enrolment to 1 month after the end of the trial, for 15 months
Secondary outcome [6] 0 0
Stakeholder reported acceptability of the residential in-reach program
Timepoint [6] 0 0
From enrolment to the end of the trial for 14 months
Secondary outcome [7] 0 0
Stakeholder reported appropriateness of the residential in-reach program
Timepoint [7] 0 0
From enrolment to the end of the trial for 14 months
Secondary outcome [8] 0 0
Number of aged care staff who attend education sessions for the use of the residential in-reach program
Timepoint [8] 0 0
From enrolment to the end of the trial for 14 months
Secondary outcome [9] 0 0
Number of adaptations made to the residential in-reach program
Timepoint [9] 0 0
From enrolment to the end of the trial fo

Eligibility
Key inclusion criteria
* Health services that have emergency departments and/or emergency care centres that admit residents from residential aged care homes (RACH)
* RACHs that do not currently have access to RIR programs
* health service staff who have been involved with the set-up and delivery of the RIR program,
* RACH staff who have experience of or accessing the RIR service for residents at least once,
* residents living at a RACH who has experienced receiving medical care from the RIR program and can provide informed consent, or a family member of the resident,
* general practitioners whose case load includes residents from RACHs.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• RACHs that already have access to a RIR program will be excluded

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
East Grampians Health Service - Ararat
Recruitment hospital [2] 0 0
Grampians Health - Ballarat
Recruitment hospital [3] 0 0
Beaufort and Skipton Health Service - Beaufort
Recruitment hospital [4] 0 0
Central Highlands Rural Health - Daylesford
Recruitment hospital [5] 0 0
Maryborough District Health Service - Maryborough
Recruitment hospital [6] 0 0
West Wimmera Health Service - Nhill
Recruitment hospital [7] 0 0
East Wimmera Health Service - St Arnaud
Recruitment hospital [8] 0 0
Rural Northwest Health - Warracknabeal
Recruitment postcode(s) [1] 0 0
3377 - Ararat
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
3373 - Beaufort
Recruitment postcode(s) [4] 0 0
3460 - Daylesford
Recruitment postcode(s) [5] 0 0
3465 - Maryborough
Recruitment postcode(s) [6] 0 0
3418 - Nhill
Recruitment postcode(s) [7] 0 0
3478 - St Arnaud
Recruitment postcode(s) [8] 0 0
3393 - Warracknabeal

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deakin University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Terry Haines
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dai Pu
Address 0 0
Country 0 0
Phone 0 0
61 03 9904 4004
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06901167