Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000322437
Ethics application status
Approved
Date submitted
22/03/2024
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of increasing the capacity of Community Managed Organisations to provide preventive care to people with a mental health condition
Scientific title
The impact of increasing the capacity of Community Managed Organisations on access to preventive care for people with a mental health condition: a cluster randomised controlled trial
Secondary ID [1] 311004 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Harmful alcohol consumption 332111 0
Poor nutrition 332110 0
Tobacco smoking 332109 0
Inadequate physical activity 332112 0
Condition category
Condition code
Mental Health 328839 328839 0 0
Schizophrenia
Public Health 328834 328834 0 0
Health promotion/education
Mental Health 328835 328835 0 0
Other mental health disorders
Mental Health 328838 328838 0 0
Psychosis and personality disorders
Public Health 328833 328833 0 0
Health service research
Mental Health 328836 328836 0 0
Anxiety
Mental Health 328837 328837 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sites allocated to the intervention condition will implement a new model of providing preventive care for key chronic disease risk behaviours (smoking, poor nutrition, harmful alcohol consumption, and physical inactivity). Practice change strategies will be delivered over 6 months to build the capacity of sites and their staff in implementing the new model of preventive care with the people they support.
Both the model of care and practice change strategies have been co-developed with the participating mental health community managed organisation (CMO) through a series of co-development workshops with people accessing the service, support workers, managers and the research team.

Model of Care:

The Model of Care uses language that has been informed by people with lived experience of a mental health issue. Chronic disease risk behaviours are hereafter referred to as living well activities.
By living well activities, we mean:
- reducing or stopping smoking or vaping
- healthy eating
- limiting alcohol
- being physically active

CMO support workers will provide support for living well activities, using a co-developed framework: the “Live Well and Flourish Framework.” This support will be provided during usual sessions between the worker and person they support. The amount of time and number of sessions will vary for each person supported dependent on their preferences, needs and what changes to the Live Well Activities they may or may not like to make.
The 5 key ‘moments’ are:
(1) Co-create the context: agree to have a conversation about Living Well Activities and organise a time and place to do so,
(2) Start the conversation: to understand what the person’s living well activities look like currently and if they have unmet needs they would like support with. Any unmet needs will be recorded using an existing tool in the electronic records.
(3) Cultivate change: explore reasons for changing living well activities, using strategies based on motivational interviewing and healthy conversation skills to build motivation. Goals the person sets will be recorded in the person’s individual recovery plan,
(4) Connect with supports and resources: The worker and person supported decide together what support would be helpful for Living Well Activities, and then the worker assists in providing connections to resources, support and referrals/behaviour change services (based on what is locally available),
(5) Continue the support commitment: check-back in at previously agreed times (depending on the preference of the person supported) to discuss progress and new actions, and celebrate achievements together.
See implementation strategy ‘audit and provide feedback’ for information on how implementation of the framework will be monitored.

Implementation Strategies:

To support the CMO sites to implement the new model of care, implementation strategies (aligned with ERIC strategies and supported by Cochrane Systematic Review evidence as well as findings of pilot work undertaken with the participating CMO) will be delivered. These include:
1. Leadership support/Mandate change: to reinforce and communicate support for the new approach and the importance of routine preventive care provision (e.g., communication in regular staff meeting). Leaders will join a project steering group to guide and review implementation. A guideline outlining the project components for staff will be disseminated.
2. Educational materials for staff: materials have been developed specifically for this study and will include a guide in how to provide physical wellbeing support according to the Live Well and Flourish Framework. Topics covered will include information about what the framework is, how to provide support according to this framework, and where to record support in the CMOs electronic systems.
3. Resources to guide support (prepare and involve consumers to be active participants; used by staff and people accessing the CMO): these resources have been developed specifically for this study and will include: conversation starter cards to prompt conversations about living well activities. Cards will be used as a suggested but optional resource in support sessions, depending on the preference of the person being supported. Additionally, a connections guide for each site will list local services/resources available to support live well activities (developed by the research team and site champions), with a separate sub-section for services relevant to each live well activity. The guide will be available as an option to help inform discussions between the worker and person they support about relevant services and resources based on any live well activity needs or goals identified.
4. Staff training (educational outreach visits): including one face-to-face session of ‘healthy conversation skills lite’ facilitated by an experienced trainer and by Flourish staff who have been trained in healthy conversation skills train-the-trainer sessions (https://www.healthyconversationskills.co.uk/). This is an existing training session for how to have conversations about physical health, including identification of issues and barriers, solution generation, as well as development of staff skills (asking open discovery questions, listening, reflection around practice, goal setting). Additionally, 5 online modules (one to guide staff through each of the 5 key moments/components in the framework/model of care) will be embedded within the existing learning management system of the CMO. These will be developed specifically for the study and will include information on: why each component is important, what the component includes, and how to implement it. Online training will use interactive elements such as scenarios and role-plays to guide staff through the content. Process data will be collected on the completion of face-to-face and online training.
5. Audit and provide feedback: feedback will be sought from staff and people accessing the CMO about project progress via champions and regular reporting from electronic records will monitor implementation of the Framework by assessing completion of relevant physical health tools; a summary of this data will be regularly communicated to participating sites (e.g., via email, flyers)
6. Identify and prepare physical health champions: A support worker at each site will be identified by CMO managers as the site champion. Champions will attend regular project meetings (with the research team) to discuss and provide feedback on how the project is being implemented and received on the ground. They will also be available to answer any questions from staff (or escalate questions to the project team where needed). They will promote project activities (e.g., provide reminders about training during regular staff meetings); and collate and provide feedback to the project team.

The new approach will be implemented at the service level within sites allocated to the intervention condition. Implementation strategies will be offered to sites allocated to the intervention condition. All people accessing support (consumers) from eligible services at the participating intervention sites will be subject to the intervention regardless of whether or not they are eligible for and/or take part in the data collection. Data collection will comprise two cross-sectional surveys (at baseline and follow-up) for consumers at intervention and control sites, each with independent samples to assess intervention outcomes. For participants who complete both baseline and follow-up surveys, responses will be linked.

Additionally, two surveys will take place (baseline and follow-up) for staff (who provide direct support to people supported by the CMO), each with independent samples. All eligible staff at control and intervention sites will be encouraged to complete the surveys.
Intervention code [1] 327468 0
Prevention
Intervention code [2] 327469 0
Behaviour
Intervention code [3] 327467 0
Lifestyle
Comparator / control treatment
Services randomised to the control condition will continue to provide preventive care in accordance with usual practices at the participating CMO organisation. Usual practices may include use of pre-existing tools within the CMO to guide support and identify needs around physical health (these are tools developed specifically by the CMO e.g., a ‘preventative health check-in’ to prompt conversation about physical health and support needs). This also includes the recording of support needs and goals for the person supported in an individual recovery plan.
Control group
Active

Outcomes
Primary outcome [1] 336670 0
Proportion of participants who reported being offered help to facilitate access to a service or resource for at least one 'living well activity' (reducing or stopping smoking or vaping, healthy eating, limiting alcohol, being physically active).
Timepoint [1] 336670 0
Baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [1] 430722 0
Proportion of people who used at least one support or resource offered for a ‘living well activity’ need by Flourish.
Timepoint [1] 430722 0
Consumer baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [2] 430719 0
Proportion of people who had a conversation with a support worker that led to identifying at least one 'living well activity' need.
Timepoint [2] 430719 0
Consumer baseline survey and follow-up survey 6 months post completion of baseline data collection
Secondary outcome [3] 430723 0
Satisfaction with care. Proportion of people who were satisfied with care provided around each 'living well activity' need
Timepoint [3] 430723 0
Consumer baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [4] 445612 0
Staff-report of the proportion of people they support for whom they had a conversation to identify support needs for at least one 'living well activity'
Timepoint [4] 445612 0
Staff baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [5] 445615 0
Provision of support for 'living well activities’ - proportion of people supported that staff checked back in with about their progress & support needs after an initial conversation
Timepoint [5] 445615 0
Staff baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [6] 445613 0
Staff-report of the proportion of people they support who they assisted to develop plans or actions for at least one 'living well activity' need
Timepoint [6] 445613 0
Staff baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [7] 445616 0
Staff-reported confidence (1-10 scale) to routinely suggest the people they support visit or access services or resources for 'living well activities'
Timepoint [7] 445616 0
Staff baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [8] 430720 0
Proportion of people who received support to develop actions or a plan to help with at least one ‘living well activity’ need.
Timepoint [8] 430720 0
Consumer baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [9] 430721 0
Proportion of people who made progress about actions/plans with at least one ‘living well activity’ need.
Timepoint [9] 430721 0
Consumer baseline survey and follow-up survey 6 months post completion of baseline data collection.
Secondary outcome [10] 445614 0
Provision of support for 'living well activities’ - proportion of people supported that staff suggested resources/services people can connect with
Timepoint [10] 445614 0
Staff baseline survey and follow-up survey 6 months post completion of baseline data collection.

Eligibility
Key inclusion criteria
Baseline and follow-up cross-sectional surveys of mental health service consumers i.e. a person who is currently accessing supports from the CMO at a participating site (independent samples, with ability to identify participants who complete both surveys; approximately 370 at each time-point (total 732) across all participating sites; eligibility assessed at each timepoint):
-18 years or over;
-English speaking; and
-mentally and physically capable of responding to survey items.


For staff, baseline and follow-up surveys (independent samples; approximately 100 staff at each time-point (total 200) across all participating sites; eligibility assessed at each timepoint):
- Provide direct support to people accessing services at the CMO



Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by a computer with assistance by a statistician uninvolved in any other aspect of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to commencement of the trial, a statistician independent of the study will randomly allocate 12 services in a 1:1 ratio to either the intervention or control condition. Following randomisation, researchers, CMO staff, and services will not be blind to allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
932
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 315267 0
Government body
Name [1] 315267 0
National Health and Medical Research Council (NHMRC): MRFF Cardiovascular health Mission – 2022 Cardiovascular Health Grant Proposal
Country [1] 315267 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 317301 0
None
Name [1] 317301 0
Address [1] 317301 0
Country [1] 317301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314187 0
University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 314187 0
Ethics committee country [1] 314187 0
Australia
Date submitted for ethics approval [1] 314187 0
18/08/2023
Approval date [1] 314187 0
10/10/2023
Ethics approval number [1] 314187 0
H-2023-0321

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

Contacts
Principal investigator
Name 130718 0
Prof Jenny Bowman
Address 130718 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 130718 0
Australia
Phone 130718 0
+61 0249215958
Fax 130718 0
Email 130718 0
[email protected]
Contact person for public queries
Name 130719 0
Caitlin Fehily
Address 130719 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 130719 0
Australia
Phone 130719 0
+61 0249217181
Fax 130719 0
Email 130719 0
[email protected]
Contact person for scientific queries
Name 130720 0
Caitlin Fehily
Address 130720 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 130720 0
Australia
Phone 130720 0
+61 0249217181
Fax 130720 0
Email 130720 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data published as a result of this study will only contain aggregate results, and no identifiable or potentially identifiable information regarding individual participants will be included. Aggregate data only will be presented internally through reports and presentations and externally in peer reviewed journal articles, reports, presentations and potentially students' theses.



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.