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The impact of increasing the capacity of Community Managed Organisations to provide preventive care to people with a mental health condition

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000322437
Enrollment
932
Registered
2025-04-17
Start date
2025-05-01
Completion date
2026-06-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with a mental health condition experience increased morbidity and mortality, with the majority of this burden attributable to chronic disease. This is largely due to a high incidence of key modifiable risk behaviours (smoking, poor nutrition, excessive alcohol consumption, physical inactivity). Mental health community managed organisations are well positioned to provide preventive care for these behaviours, however currently care is not comprehensive or routine in the sector. A new model of providing preventive care for key chronic disease risk behaviours will be implemented. Practice change strategies will be delivered over 6 months to build the capacity of services and their staff in implementing the new model of preventive care. The model of care and implementation strategies have been co-developed in workshops with the participating CMO. The research team will evaluate this new approach in a cluster randomised controlled trial across 12 sites in New South Wales, Queensland and South Australia. Primary outcome will be the proportion of consumers that received an offer from their support worker to facilitate access to services or resources.

Interventions

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 parti

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.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026