Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001053314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
6/08/2026
Date registered
Help: Date registered
26/08/2026
Date last updated
Help: Date last updated
26/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
26/08/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
NSW Statewide Brain Injury Telepsychiatry Service: A consultative telepsychiatry service model for people with brain injury in rural and regional New South Wales
Scientific title
NSW Statewide Brain Injury Telepsychiatry Service: Effect of a consultative telepsychiatry service model on anxiety and post-traumatic symptoms for people with brain injury in rural and regional New South Wales.
Additional trial identifiers [1] 318082 0
Nil
Universal Trial Number (UTN)
Trial acronym
NSW-BITS
Related trial records

Health condition
Health condition(s) studied:
Traumatic brain injury 343103 0
Condition category
Condition code
Injuries and Accidents 339191 339191 0 0
Other injuries and accidents
Mental Health 339192 339192 0 0
Anxiety
Mental Health 339193 339193 0 0
Depression
Mental Health 339194 339194 0 0
Other mental health disorders
Neurological 339365 339365 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is an ongoing consultative telepsychiatry service designed to improve access to specialist neuropsychiatric assessment and management for people with traumatic brain injury (TBI) living in rural and regional New South Wales. The service is implemented as an ongoing model of care rather than a time-limited intervention with a fixed number or frequency of consultations. Participants enrolled in the research study will undergo research assessments at baseline and 12 months; however, the frequency and timing of telepsychiatry consultations will be determined by individual clinical need.

Telepsychiatry consultations are delivered via secure audio and video conferencing using an approved videoconferencing platform. Each consultation is led by a consultant psychiatrist, with participation from psychiatry trainees or registrars where relevant, and local clinicians involved in the participant's care. Consultations involve comprehensive clinical assessment, diagnostic clarification, medication review where appropriate, risk assessment, and collaborative development of management recommendations. Consultation duration will vary according to clinical complexity and individual need.

The model prioritises consultation, shared care and capacity building. Specialist advice and recommendations are provided to support ongoing management by existing local treating teams rather than replacing these teams. Participants may receive one or more consultations during the 12-month study follow-up period, with any further consultations arranged according to clinical need. The overall telepsychiatry service will operate on an ongoing basis throughout the implementation and evaluation period.

Delivery of the intervention will be monitored through routine service records, including referral, appointment and consultation records. These records will be used to document service utilisation, including the number and timing of consultations delivered, attendance at scheduled consultations, and whether consultations were completed or cancelled. As this is a clinically responsive service, adherence is assessed primarily through service engagement and uptake rather than completion of a predetermined number of sessions.

The intervention also incorporates embedded education and workforce development activities for clinicians involved in the care of people with TBI and other forms of acquired brain injury (ABI). These activities are integrated into routine service delivery and are intended to build local knowledge and capacity in recognising, assessing and managing neuropsychiatric and behavioural presentations following brain injury. Education may include case-based discussion, clinical consultation and feedback, discussion of assessment and management approaches, and knowledge sharing regarding relevant neuropsychiatric presentations, risk assessment, diagnostic considerations and treatment strategies.

Education and workforce development are delivered primarily through the telepsychiatry consultation process and associated case-based interactions between the consultant psychiatrist, psychiatry trainees or registrars, and local clinicians involved in participants' care. Additional education activities may be provided where appropriate as part of service implementation. These activities do not constitute a separate fixed training programme with a prescribed number of modules or sessions; instead, they occur on an ongoing and needs-responsive basis throughout implementation of the telepsychiatry service.

The education component is led by the consultant psychiatrist, with involvement from psychiatry trainees or registrars as appropriate. It is directed primarily towards local clinicians and interdisciplinary teams involved in participants' ongoing care, although psychiatry trainees or registrars participating in consultations may also benefit from the embedded learning opportunities. Educational materials or resources may be shared where clinically relevant; no compulsory homework or standardised independent learning activities are required.

Participation in embedded education and workforce development activities will be monitored through routine records of consultation attendance and, where applicable, attendance records for additional education sessions. The education component occurs concurrently with implementation and delivery of the telepsychiatry service and is embedded throughout the ongoing service model.

Approximately 20 clinicians from brain injury medical and interdisciplinary support teams will also be invited to participate in qualitative interviews as part of the evaluation of the service, rather than as a component of the intervention itself. These interviews will explore clinicians' experiences and perspectives regarding implementation of the telepsychiatry model, including perceived accessibility, feasibility, acceptability, clinical utility, barriers and facilitators to implementation, and the impact of the service on local clinical capacity and care. Each clinician will participate in one online survey or semi-structured interview (depending on preference) of approximately 30 minutes. Interviews will be conducted with clinicians involved in, or affected by, implementation of the service and will occur during and/or following the implementation period. Participation and survey/interview completion will be documented for research purposes. These interviews do not provide training or form part of the clinical intervention.

Participants will receive care through the telepsychiatry service as part of the implementation and evaluation of this model. Research outcomes will be assessed at baseline and 12 months and will examine service accessibility, feasibility, clinical impact, user experience and implementation outcomes.
Intervention code [1] 334959 0
Rehabilitation
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346435 0
Psychosocial wellbeing: Specified here to refer to a composite outcome from two subscales (HADS-Anxiety, HADS-Depression) derived from the broader HADS measure.
Timepoint [1] 346435 0
Baseline, 12 month follow up (primary timepoint)
Primary outcome [2] 346436 0
Post-traumatic symptoms: Assessed as a single outcome using the total score from the PTSD Checklist for DSM-5 (PCL-5)
Timepoint [2] 346436 0
Baseline, 12 month follow up (primary timepoint)
Primary outcome [3] 346437 0
Functional outcomes: Assessed as a single outcome using the total score from the Mayo-Portland Adaptability Inventory – 4th Edition (MPAI-4)
Timepoint [3] 346437 0
Baseline, 12 month follow up (primary timepoint)
Secondary outcome [1] 465841 0
Health related quality of life: Assessed as an outcome using an overall score from the PROMIS-29 +2 Profile v2.1
Timepoint [1] 465841 0
Baseline, 12 month follow up
Secondary outcome [2] 465842 0
Depression
Timepoint [2] 465842 0
Baseline, 12 month follow up
Secondary outcome [3] 465843 0
Telepsychiatry service experience
Timepoint [3] 465843 0
12 month follow up

Eligibility
Key inclusion criteria
Patients: Patients referred to the telepsychiatry service must:
Have a diagnosis of mild, moderate, or severe traumatic brain injury
Be aged 18 years or older
Meet eligibility criteria for referral and admission to the Royal Rehab telepsychiatry service
Be able to provide informed consent
Be of any gender
Reside within the state of New South Wales (NSW)

Clinicians / health professionals: Medical staff, nurses, allied health professionals, and other clinical staff involved in the care of patients receiving telepsychiatry services must:
Be employed within a hospital, community health service, or rehabilitation centre
Be aged 18 years or older
Reside within the state of New South Wales (NSW)
Be able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Patients are excluded from participation if:
- They are unable to provide informed consent
- They do not meet eligibility criteria for admission to the Royal Rehab telepsychiatry service

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
Based on service delivery estimates, approximately 30% of patients accessing the service will receive two consultations and 20% will receive three consultations over the study period. Accounting for repeat consultations, it is estimated that approximately 300 unique patients will receive telepsychiatry services throughout the 18-month pilot. By completion of the pilot service, it is anticipated that:
- Approximately 300 patients will be referred to and receive telepsychiatry services;
- Approximately 20 clinicians from brain injury medical and interdisciplinary support teams will participate in interviews;
- Approximately 10 patient “stories of change” will be captured using a qualitative narrative approach.
The total expected number of participants contributing data to the service evaluation is n = 335. A formal power calculation is not applicable, as the study does not aim to test treatment effects or hypotheses. Instead, sample size is determined by service capacity and the objectives of describing service uptake, implementation processes, and stakeholder experiences within a pilot framework.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2023
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
335
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29946 0
Royal Rehab - Ryde - Ryde
Recruitment postcode(s) [1] 46309 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 322641 0
Government body
Name [1] 322641 0
NSW Ministry of Health Grant
Country [1] 322641 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 325565 0
Hospital
Name [1] 325565 0
Royal Rehab
Address [1] 325565 0
Country [1] 325565 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321099 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 321099 0
Ethics committee country [1] 321099 0
Australia
Date submitted for ethics approval [1] 321099 0
Approval date [1] 321099 0
09/06/2022
Ethics approval number [1] 321099 0
PID00188

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

Contacts
Principal investigator
Name 152662 0
Prof Leanne Togher
Address 152662 0
ABI Communication Lab, Level 7, D18 Susan Wakil Health Building, University of Sydney, Western Ave, Camperdown NSW 2050
Country 152662 0
Australia
Phone 152662 0
+61 2 9351 9639
Fax 152662 0
Email 152662 0
[email protected]
Contact person for public queries
Name 152663 0
Leanne Togher
Address 152663 0
ABI Communication Lab, Level 7, D18 Susan Wakil Health Building, University of Sydney, Western Ave, Camperdown NSW 2050
Country 152663 0
Australia
Phone 152663 0
+61 2 9351 9639
Fax 152663 0
Email 152663 0
[email protected]
Contact person for scientific queries
Name 152664 0
Leanne Togher
Address 152664 0
ABI Communication Lab, Level 7, D18 Susan Wakil Health Building, University of Sydney, Western Ave, Camperdown NSW 2050
Country 152664 0
Australia
Phone 152664 0
+61 2 9351 9639
Fax 152664 0
Email 152664 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.