Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001275358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/10/2026
Date registered
Help: Date registered
23/10/2026
Date last updated
Help: Date last updated
23/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/10/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
A Clinician Navigator for Older Adults Discharge Home Following Injury: a mixed-methods feasibility study
Scientific title
A Clinician Navigator for Older Adults Discharge Home Following Injury: a mixed-methods feasibility study
Additional trial identifiers [1] 318599 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Traumatic injury in older adults 343799 0
Transition from hospital to home after injury 343800 0
Condition category
Condition code
Injuries and Accidents 339936 339936 0 0
Fractures
Injuries and Accidents 339937 339937 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 339938 339938 0 0
Other physical medicine / rehabilitation
Public Health 339939 339939 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants received a telephone-based navigator service for four weeks after discharge home from hospital following traumatic injury.
The service was delivered by clinically trained navigators (physiotherapists), who had access to the participant's hospital and discharge records. Navigators could seek advice from the trauma service nurse coordinator, trauma physicians and a geriatrician.

Participants were offered up to eight scheduled telephone calls over the four weeks, with the first call within 24 to 72 hours of discharge and subsequent calls once or twice weekly (depending on need and participant preference). Each call was allocated up to 30 minutes, including follow-up tasks. Participants were able to decline individual calls.

At each contact, the navigator was available to support the participant with identification of needs, provide information and to support problem-solving. Navigators could advise and signpost but not make referrals on the participants behalf. The service was provided in addition to usual care. GP's were notified at commencement and completion of the service.

Adherence and fidelity were monitored through a structured contact record completed for every contact. It recorded the timing and duration of each call, needs identified and actions taken. Delivery was assessed against the planned number and timing of contacts and call duration.
Intervention code [1] 335505 0
Rehabilitation
Description of the comparator or control
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 347108 0
Intervention delivery (feasibility), that the service was delivered as intended: successful telephone contact with participants.
Timepoint [1] 347108 0
Collected at each scheduled contact during the 4-week intervention, summarised per participant at end of intervention (primary timepoint).
Primary outcome [2] 347109 0
Intervention delivery (feasibility), that the service was delivered within time limits allocated for navigator service delivery (anticipated up to 60 per call, reflecting an anticipated 30 min on call, up to 30 min on follow-up tasks).
Timepoint [2] 347109 0
Collected at each scheduled contact during the 4-week intervention, summarised per participant at end of intervention (primary timepoint).
Primary outcome [3] 347110 0
Acceptability (participants - composite)
Timepoint [3] 347110 0
Following intervention completion (within the week of navigator service discharge or later, according to participant availability and preference).
Secondary outcome [1] 468951 0
Categorise and quantify participant needs identified (across domains)
Timepoint [1] 468951 0
Collected at each scheduled contact during the 4-week intervention, summarised per participant at end of intervention (primary timepoint).

Eligibility
Key inclusion criteria
Adults aged 65 years or over who are admitted to the trauma service after a physical traumatic injury, with an anticipated total length of stay of 28 days or less, and who meet all of the following:
- community dwelling before injury
- English speaking
- able to use a telephone
- able to read well enough to use printed materials
- discharged to their usual residence or to that of an informal support person
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Dementia or cognitive impairment that prevents informed consent
- Discharge with home-based hospital or rehabilitation services, or discharge to residential care
- Receiving palliative care
- Injury related to, or under investigation for, self-harm or elder abuse
- Injury secondary to a medical event requiring direct admission to an acute medical unit

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Efficacy
Statistical methods / analysis
Exploratory associations between baseline characteristics and volume of need (count) across the intervention. The characteristics are age, injury severity, comorbidity (Charlson Comorbidity Index), length of stay (up to 3 days versus 4-28 days), function (Barthel Index), quality of life (AQOL-8D) and transition quality at discharge (Partners at Care Transitions, PACT-1), health literacy (Single Item Literacy Screener), receipt of subacute care and living alone. Need was measured as number of needs across identified domains.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/03/2025
Date of last participant enrolment
Anticipated
Actual
14/11/2025
Date of last data collection
Anticipated
Actual
21/01/2026
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 30331 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 46744 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 323172 0
Government body
Name [1] 323172 0
Lifetime Support Authority
Country [1] 323172 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 326137 0
Hospital
Name [1] 326137 0
Southern Adelaide Local Health Network (Flinders Medical Centre)
Address [1] 326137 0
Country [1] 326137 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321578 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 321578 0
Ethics committee country [1] 321578 0
Australia
Date submitted for ethics approval [1] 321578 0
21/11/2024
Approval date [1] 321578 0
22/01/2025
Ethics approval number [1] 321578 0
226.24

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

Contacts
Principal investigator
Name 154138 0
Prof Kate Laver
Address 154138 0
Flinders University GPO Box 2100 Adelaide SA 5001
Country 154138 0
Australia
Phone 154138 0
+61 8 7221 8335
Fax 154138 0
Email 154138 0
[email protected]
Contact person for public queries
Name 154139 0
Jill Williams
Address 154139 0
Flinders University GPO Box 2100 Adelaide SA 5001
Country 154139 0
Australia
Phone 154139 0
+61402637044
Fax 154139 0
Email 154139 0
[email protected]
Contact person for scientific queries
Name 154140 0
Jill Williams
Address 154140 0
Flinders University GPO Box 2100 Adelaide SA 5001
Country 154140 0
Australia
Phone 154140 0
+61402637044
Fax 154140 0
Email 154140 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not part of ethics/consent



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Study_4_226.24 ERP__approval.pdf


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.