Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000382572
Ethics application status
Approved
Date submitted
1/02/2024
Date registered
2/04/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Bridging Study: Evaluating the Navicare service on mental health service access in regional Australia
Scientific title
Evaluating the access, uptake and outcomes of a co-designed care navigation model targeting mental health service access in regional Australia: The Bridging Study
Secondary ID [1] 310685 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 331599 0
Condition category
Condition code
Public Health 328335 328335 0 0
Health service research
Mental Health 329803 329803 0 0
Depression
Mental Health 329804 329804 0 0
Anxiety
Mental Health 329805 329805 0 0
Addiction
Mental Health 329806 329806 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will evaluate the access, uptake and outcomes of the implementation of the Navicare service in the Greater Whitsundays Region of Queensland Australia.

In the Navicare service, a Care Navigator links help seekers with supports they may need to improve their mental wellbeing. The Care Navigator assists with referrals, makes appointments with mental health care professionals, and provides a private space in which to access online mental health support from online psychology and other service providers. Help seekers can receive Navicare services regardless of their involvement in this study.

The Navicare service is currently being delivered in Moranbah, Queensland. Additional sites will be added in regional towns across the Greater Whitsunday Region. New sites will be determined through community consultation and context mapping. The current site and additional sites will be evaluated through pre-implementation, implementation and post-implementation phases until the end of the study (December 2026).

With informed consent, participants in this study will participate in interviews with research staff and/or complete a questionnaire on service user satisfaction using the Navigation Satisfaction Tool (NAVSAT). Interviews will last for approximately 30-60 minutes, and the NAVSAT survey will take approximately 10 minutes to complete. Interviews and the NAVSAT will be completed up to 6 months after Navicare intake or 3-months after last contact with Navicare. Interviews and focus groups will also be completed with community stakeholders, service providers and Navicare staff.

Aggregated Navicare service level data will be analysed, including referral type, occasions of service, care pathways and sociodemographic details. Aggregated hospital level data will be obtained including length of stay, care type, readmission status, and diagnosis code. No identifiable service user information will be shared with the research team.

For the pre-post implementation comparison component of the study, quantitative data including hospital admissions data and emergency department data will be collected 24-months pre-implementation and up to 12 months after the implementation period. Navicare service level data will commence from each site's first client intake for the implementation period of up to 18 months, and up to 12-months for post-implementation.
Intervention code [1] 327092 0
Not applicable
Comparator / control treatment
A control period will be used for some outcomes. Aggregated hospital level data including Queensland Hospital Admitted Patient Data Collection (QHAPDC) and Emergency Department Data Collection (QHEDC) will be collected for the 24-months prior to Navicare service implementation. There will be no direct involvement with participants.
Control group
Active

Outcomes
Primary outcome [1] 337273 0
Access to the Navicare Service
Timepoint [1] 337273 0
Monthly across the study, comparing the implementation (up to 18-months) and post-implementation (up to 12-months) periods, which will vary across the sites dependent on when each sites commences. All data collection will be completed by the end of 2026.
Secondary outcome [1] 427241 0
Implementation of the Navicare service
Timepoint [1] 427241 0
Monthly across the study, comparing the implementation (up to 18-months) and post-implementation (up to 12-months) periods, which will vary across the sites dependent on when each sites commences. Data collection will be completed by the end of 2026.
Secondary outcome [2] 427242 0
Acceptability of the Navicare service
Timepoint [2] 427242 0
Up to 6-months after Navicare intake or 3-months after last contact with Navicare for service user data including NAVSAT and interviews. Provider interview, workshop and focus group data will be collected at varying intervals dependent on the phase of each study site, with data collection completed by the end of 2026.
Secondary outcome [3] 427243 0
Adoption of the Navicare service
Timepoint [3] 427243 0
Monthly across the implementation (up to 18-months) and post-implementation (up to 12-months) phases, with data collection ceasing by the end of 2026.
Secondary outcome [4] 427244 0
Sustainability of the Navicare service (including sustainment)
Timepoint [4] 427244 0
Up to monthly across the implementation (up to 18-months) and post-implementation (up to 12-months) phases, with frequency dependent on pragmatic factors that are not known in advance (i.e., sites/ stakeholder ability to provide data when available), but at least once during the implementation and post-implementation period (e.g., PSAT, interviews in both periods). Data collection ceasing at the end of 2026.
Secondary outcome [5] 427245 0
Mental health crisis-related Emergency Department attendances
Timepoint [5] 427245 0
Monthly across pre-post study period, For the new sites, data will be collected across the pre-implementation period of 24-months, during the implementation period of up to 18-months, and for the post-implementation period of up to 12-months. For the existing hub site QHEDC data will be collected from up to 12-months before the study start,
18-months implementation and 12-months post-implementation period.
Secondary outcome [6] 427246 0
Fidelity of the Navicare service
Timepoint [6] 427246 0
Up to monthly across the implementation (up to 18-months) and post-implementation (up to 12-months) phases, with frequency dependent on pragmatic factors that are not known in advance (i.e., sites/ stakeholder ability to provide data when available), but at least once during the implementation and post-implementation period (e.g., diaries, interviews in both periods). Data collection ceasing at the end of 2026.
Secondary outcome [7] 431290 0
Feasibility of the Navicare implementation at new sites
Timepoint [7] 431290 0
Up to monthly across the implementation (up to 18-months) and post-implementation (up to 12-months) phases, with frequency dependent on pragmatic factors that are not known in advance (i.e., sites/ stakeholder ability to provide data when available), but at least once during the implementation and post-implementation period (e.g., diaries, interviews in both periods). Data collection ceasing at the end of 2026.
Secondary outcome [8] 431291 0
Health service resource use and costs (related to Navicare service and implementation)
Timepoint [8] 431291 0
Monthly across pre-post study period. 24-months prior to the commencement of the new sites, during the implementation period (up to 18-months), and for up to 12-months post-implementation. For the existing hub site routinely collected QHEDC and QHAPDC data will be collected from 12-months pre-implementation, up to 18-months implementation and 12-months post-implementation period. Navicare service data will be collected monthly from implementation, with data collection ceasing 12 months post-implementation. All data collection will completed by end 2026.
Secondary outcome [9] 431295 0
Admitted hospitalisations for mental ill-health
Timepoint [9] 431295 0
Monthly across the pre-post study period. 24-months prior to the commencement of the new sites, during the implementation period of up to 18-months, and for up to 12-months post-implementation period. For the existing hub site, QHAPDC data will be collected from up to 12-months pre-implementation, 18-months implementation and 12 months post-implementation period. All data collection will be completed by the end of 2026.
Secondary outcome [10] 431296 0
Time in Emergency Department for mental ill-health
Timepoint [10] 431296 0
Monthly across the pre-post study period. 24-months prior to the commencement of the new sites, during the implementation period (up to 18-months), and for up to 12-months post-implementation period. For the existing hub site, QHEDC data will be collected from 12-months pre-implementation, 18-months implementation and 12-months postimplementation period. Data collection will be completed by the end of 2026.
Secondary outcome [11] 431306 0
Appropriateness of the Navicare service implementation
Timepoint [11] 431306 0
Up to monthly across the implementation (up to 18-months) and post-implementation (up to 12-months) phases, with frequency dependent on pragmatic factors that are not known in advance (i.e., sites/ stakeholder ability to provide data when available), but at least once during the implementation and post-implementation period (e.g., diaries, interviews in both periods). Data collection ceasing at the end of 2026.

Eligibility
Key inclusion criteria
Service users of Navicare:
- Current or past user of the Navicare service in any of the Navicare site locations
AND/OR
- Current or past user of mental health services in the Greater Whitsundays Communities region of Queensland, Australia (not Navicare)

Navicare service providers and policy makers
Community members in any of the Navicare site locations
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Both
Statistical methods / analysis
Data will be analysed using qualitative and mixed methods evaluations of processes and outcomes associated with Navicare. The mixed methods evaluation will be combined at the final analysis stage.

A pre-post comparison analyses will be used to examine if Navicare has a greater effect than any underlying secular trend. This will likely be achieved by fitting a generalised linear mixed model with a Poisson distribution (or alternate model if appropriate), to model the rate of mental health Emergency Department presentations, time in the Emergency Department and overnight hospitalisations. Residuals of the model will be checked for assumptions, autocorrelation between timepoints assessed, and adjustments for underlying trends and seasonality made when necessary. Random intercepts will account for clustering of facilities where appropriate. For service access (primary outcome) and adoption the trend before and after formal support for Navicare ends will be modelled (implementation to sustainment periods (primary hypothesis)).

Cost-consequence analyses will be used to estimate the health service resource use and costs associated with Navicare.

Spatial visualisation techniques will be used to analyse and report on data where appropriate.

Qualitative thematic analyses will be completed that capture contextual factors influencing implementation, mechanisms of action, processes, actions, and the perceived success or otherwise based on the implementation outcomes. This will include both rapid and traditional qualitative thematic analyses. Qualitative data sources include interviews, Community Consultations, Workshops, implementation diaries and checklists, meeting minutes, field notes of observations from site visits and study events, memos, and reflective journaling related to these data sources.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
15/07/2024
Date of last participant enrolment
Anticipated
14/09/2026
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
1000
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314905 0
Government body
Name [1] 314905 0
National Heatlh and Medical Research Council
Country [1] 314905 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
20 George St, Brisbane, Queensland, 4001
Country
Australia
Secondary sponsor category [1] 317514 0
None
Name [1] 317514 0
Address [1] 317514 0
Country [1] 317514 0
Other collaborator category [1] 282891 0
Charities/Societies/Foundations
Name [1] 282891 0
Wesley Research Institute
Address [1] 282891 0
Level 8, East Wing, The Wesley Hospital, 451 Coronation Drive, Auchenflower QLD 4066
Country [1] 282891 0
Australia
Other collaborator category [2] 282892 0
Charities/Societies/Foundations
Name [2] 282892 0
Beyond Blue
Address [2] 282892 0
GPO Box 1883, Melbourne VIC 3001
Country [2] 282892 0
Australia
Other collaborator category [3] 282893 0
Government body
Name [3] 282893 0
Isaac Regional Council
Address [3] 282893 0
PO Box 97, Moranbah QLD 4744
Country [3] 282893 0
Australia
Other collaborator category [4] 282894 0
Other Collaborative groups
Name [4] 282894 0
Greater Whitsunday Communities
Address [4] 282894 0
Old Town Hall, 63 Sydney St, Mackay QLD 4740
Country [4] 282894 0
Australia
Other collaborator category [5] 282897 0
University
Name [5] 282897 0
James Cook University
Address [5] 282897 0
1 James Cook Drive, James Cook University QLD 4811
Country [5] 282897 0
Australia
Other collaborator category [6] 282898 0
University
Name [6] 282898 0
University of California, San Diego
Address [6] 282898 0
9500 Gilman Drive, La Jolla California USA 92093
Country [6] 282898 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313898 0
Townsville Hospital and Health Service HREC
Ethics committee address [1] 313898 0
Ethics committee country [1] 313898 0
Australia
Date submitted for ethics approval [1] 313898 0
27/03/2023
Approval date [1] 313898 0
19/07/2023
Ethics approval number [1] 313898 0
HREC/2023/QTHS/95457
Ethics committee name [2] 313899 0
Uniting Care Queensland HREC
Ethics committee address [2] 313899 0
Ethics committee country [2] 313899 0
Australia
Date submitted for ethics approval [2] 313899 0
11/05/2023
Approval date [2] 313899 0
06/10/2023
Ethics approval number [2] 313899 0
Tyack_20230406
Ethics committee name [3] 314346 0
Queensland University of Technology UHREC
Ethics committee address [3] 314346 0
Ethics committee country [3] 314346 0
Australia
Date submitted for ethics approval [3] 314346 0
07/08/2023
Approval date [3] 314346 0
11/12/2023
Ethics approval number [3] 314346 0
7602

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

Contacts
Principal investigator
Name 129718 0
A/Prof Zephanie Tyack
Address 129718 0
Queensland University of Technology, Level 6, 60 Musk Ave, Kelvin Grove QLD 4059
Country 129718 0
Australia
Phone 129718 0
+61 7 3138 6203
Fax 129718 0
Email 129718 0
z.tyack@qut.edu.au
Contact person for public queries
Name 129719 0
Ruth Tulleners
Address 129719 0
Queensland University of Technology, Level 6, 60 Musk Ave, Kelvin Grove QLD 4059
Country 129719 0
Australia
Phone 129719 0
+61 7 3138 0770
Fax 129719 0
Email 129719 0
ruth.tulleners@qut.edu.au
Contact person for scientific queries
Name 129720 0
Zephanie Tyack
Address 129720 0
Queensland University of Technology, Level 6, 60 Musk Ave, Kelvin Grove QLD 4059
Country 129720 0
Australia
Phone 129720 0
+61 7 3138 6203
Fax 129720 0
Email 129720 0
z.tyack@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Qualitative data may only be shared if ethical and governance conditions are met, including those that reduce the likelihood of personal details being revealed.
A synthetic version of the quantitative data set will be made openly available, which will allow the safe sharing of patient data.


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    The study protocol will be made available as a pre... [More Details]
Ethical approval    386665-(Uploaded-14-12-2023-13-24-08)-Study-related document.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.