Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000684325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/05/2026
Date registered
Help: Date registered
5/06/2026
Date last updated
Help: Date last updated
5/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
5/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Consumers and carers as Health Care Navigators to increase physical health care screening checks and preventive care for people who access mental health services in rural Australia: A randomised implementation and effectiveness trial
Scientific title
Consumers and carers as Health Care Navigators to increase physical health care screening checks and preventive care for people who access mental health services in rural Australia: A randomised implementation and effectiveness trial
Additional trial identifiers [1] 315868 0
NHMRC 2023/GNT2025179
Universal Trial Number (UTN)
Trial acronym
PHCN
Related trial records

Health condition
Health condition(s) studied:
Mental health 339631 0
Cancer 341566 0
Vaccine Preventable conditions 341758 0
Diabetes 341759 0
Respiratory disease 341760 0
Cardiovascular disease 341761 0
Oral health 341762 0
Condition category
Condition code
Mental Health 335876 335876 0 0
Other mental health disorders
Cardiovascular 335877 335877 0 0
Normal development and function of the cardiovascular system
Cancer 337641 337641 0 0
Any cancer
Infection 337834 337834 0 0
Other infectious diseases
Blood 337835 337835 0 0
Normal development and function of platelets and erythrocytes
Respiratory 337836 337836 0 0
Normal development and function of the respiratory system
Public Health 337837 337837 0 0
Health promotion/education
Skin 337838 337838 0 0
Normal skin development and function
Oral and Gastrointestinal 337839 337839 0 0
Normal oral and gastrointestinal development and function
Public Health 337962 337962 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a healthcare navigator intervention designed to facilitate access to health screening and health protective services for people with mental illness by addressing barriers such as low health literacy, psychosocial barriers or other health service access challenges. This is a non-drug trial focusing on behaviour, education, and healthcare navigation/utilisation/linkage.

Duration of sessions is anticipated to be between 30 and 45 minutes.
The default frequency of sessions will be weekly,

The navigation intervention involves a minimum of four (4) sessions with someone acting in a navigator role. There are three navigator types: (1) peer/lived experience worker, (2) carer lived experience worker, (3) mental health professional. The sessions can be delivered in-person, online or over the phone as preferred by participants. They conduct an initial 'health needs' assessment using the Neami Health Prompt (equallywell.org.au/neami-health-prompt/), then support participants to access services designed to prevent, screen, diagnose, treat and manage chronic health conditions as appropriate. The navigators work as part of a multi-disciplinary community mental health team. Their role is to help identify health screening needs, and support navigation to access the health screening and health protective services the participants wish to access. Their expertise is in service navigation. All health or mental health related clinical decisions are made by the mental health team or the physical health professional accessed (eg GP).

Training and support
Navigator training is provided by the research project Research Assistant. It is mixed mode online training, for 2 and a half days a week for a 4-week period prior to the recruitment of the first participants. Each week is a self-contained learning module. Each module/component is designed to take 2 and a half days (18.75 hours). This equates to a total of 75 hours of training equally spread across 4 weeks (18.75 hours each week). The learning environment combines live videoconference sessions, interspersed with a set syllabus of learning activities in an online environment. The learning outcomes are shared with the Research Assistant at weekly (60-90 minute) follow-up sessions.
In addition, there are fortnightly supervision sessions, in the form a project Community of Practice Meeting, These sessions will take between 60 and 90 minutes. These Community of Practice Meetings are scheduled throughout the duration of the trial, where ongoing supervision is provided and if necessary additional training and support provided, This is supplemented by 1 to 1 support and supervision with the research assistant as may be required.
Program fidelity is monitored through inspection of the navigation logs, and through practice reflection in the Community of Practice Sessions
Intervention code [1] 332474 0
Early detection / Screening
Intervention code [2] 334049 0
Behaviour
Intervention code [3] 334050 0
Prevention
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343585 0
Feasibility of the trial/model as reflected in - Retention rate
Timepoint [1] 343585 0
All data collected throughout trial period and analysed at end of trial.
Primary outcome [2] 343586 0
Intervention acceptability of the participants (mental health consumers)
Timepoint [2] 343586 0
End of intervention period for consumers (post engagement survey)
Primary outcome [3] 345395 0
Acceptability of the Model of Care from the perspective of the multidisciplinary staff in the host community mental health team.
Timepoint [3] 345395 0
The survey will be administered at the end of the trial.
Secondary outcome [1] 454830 0
Changes in engagement with physical health care prevention, early detection and treatment services.
Timepoint [1] 454830 0
At baseline and post-intervention
Secondary outcome [2] 460549 0
Psychological distress
Timepoint [2] 460549 0
Baseline and post-intervention
Secondary outcome [3] 461522 0
Acceptability of the Model of Care from the perspective of the Physical Health Care Navigators and the
Timepoint [3] 461522 0
The navigator semi-structured, qualitative interviews will be conducted at the end of the trial.

Eligibility
Key inclusion criteria
• Adults (18+ years)
• people already accessing community-based mental health services from participating organisations
• Willing and able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Unable to provide informed consent
• People admitted to a mental health inpatient ward
- People admitted to emergency department
- People currently not under care of community mental health team.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed by utilising random allocation procedure automated in REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Quantitative data will be analysed using descriptive statistics to report characteristics of the participant sample (health and demographic characteristics) recruitment, retention and workload counts, percentages, and averages, derived from navigator logs. Health service engagement will be analysed using paired comparisons to identify pre–post changes (baseline to post-navigation). Pre and post trends overall and will be analysed across the baseline and post engagement measures. Effectiveness of the intervention will be evaluated across navigator role types (peer, carer, clinician), psychological distress and global physical/mental health severity scores, and service locations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2026
Actual
Date of last participant enrolment
Anticipated
30/10/2026
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 29403 0
Western NSW Mental Health & Drug and Alcohol Service - Dubbo
Recruitment hospital [2] 29404 0
Bundaberg Hospital - Bundaberg
Recruitment postcode(s) [1] 45724 0
2830 - Dubbo
Recruitment postcode(s) [2] 45725 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 320462 0
Government body
Name [1] 320462 0
NHMRC
Country [1] 320462 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 323081 0
None
Name [1] 323081 0
Address [1] 323081 0
Country [1] 323081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319013 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 319013 0
Ethics committee country [1] 319013 0
Australia
Date submitted for ethics approval [1] 319013 0
12/12/2025
Approval date [1] 319013 0
10/03/2026
Ethics approval number [1] 319013 0
2025/ETH02395

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

Contacts
Principal investigator
Name 145982 0
Prof Russell Roberts
Address 145982 0
Charles Sturt University, Orange Campus, PO Box 883 ORANGE NSW 2800 Australia
Country 145982 0
Australia
Phone 145982 0
+61 418 852 748
Fax 145982 0
Email 145982 0
[email protected]
Contact person for public queries
Name 145983 0
Professor Russell Roberts
Address 145983 0
Charles Sturt University, Orange Campus, PO Box 883 ORANGE NSW 2800 Australia
Country 145983 0
Australia
Phone 145983 0
+61 418 852 748
Fax 145983 0
Email 145983 0
[email protected]
Contact person for scientific queries
Name 145984 0
Professor Russell Roberts
Address 145984 0
Charles Sturt University, Orange Campus, PO Box 883 ORANGE NSW 2800 Australia
Country 145984 0
Australia
Phone 145984 0
+61 418 852 748
Fax 145984 0
Email 145984 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.