Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000922875
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
15/07/2021
Date last updated
2/05/2022
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the implementation of a new approach to preventive care provided by community mental health services to people with a mental health condition
Scientific title
Evaluating the implementation of a new approach to preventive care provided by community mental health services to people with a mental health condition: a cluster randomised controlled trial
Secondary ID [1] 304048 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 321683 0
Poor nutrition 321684 0
Harmful alcohol consumption 321685 0
Inadequate physical activity 321686 0
Overweight 321760 0
Obesity 322244 0
Condition category
Condition code
Public Health 319427 319427 0 0
Health service research
Public Health 319428 319428 0 0
Health promotion/education
Mental Health 319429 319429 0 0
Other mental health disorders
Diet and Nutrition 319866 319866 0 0
Obesity
Mental Health 319867 319867 0 0
Anxiety
Mental Health 319868 319868 0 0
Depression
Mental Health 319869 319869 0 0
Schizophrenia
Mental Health 319870 319870 0 0
Psychosis and personality disorders
Mental Health 319871 319871 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Services allocated to the intervention condition will implement a new approach to providing preventive care for key chronic disease risk behaviours (tobacco smoking, poor nutrition, harmful alcohol consumption, and physical inactivity) and weight. Practice change strategies, tailored to each service, will be delivered over 9-months to support the implementation of the new approach to preventive care.

New approach to preventive care:
A dedicated consultation will be scheduled for adult clients with a ‘healthy choices coach’ (HCC) dedicated to addressing risk behaviours. The HCC will be an experienced mental health clinician and will complete approximately a week of training in delivery of the intervention. This training will be delivered via mixed modes (online and face-to-face) by the research team. Training content and length will be developed in consultation with the participating services and be responsive to service preferences and feasibility.
Intervention content will be framed around providing AAR: Assessment (asking about engagement in each of the risk behaviours), Advice (provision of brief advice to change risk behaviours) and Referral (to local available services) for risk factors; and setting relevant behaviour change goals. The consultation will incorporate behaviour change techniques, such as motivational interviewing and will be delivered in line with a manualised protocol developed collaboratively by the research team and participating services. The consultation we be approximately 40-minutes in length and we be delivered face-to-face (however, if required to respond to service demands, this mode may be adapted to be delivered via teleconference). To monitor adherence, a checklist will be used by the coach to record the aspects of the intervention that were delivered.

An individualised care management plan will be initiated during the consultation; summarising the client’s current health behaviours, priority goal(s) for change, and referrals to behaviour change supports (offered and accepted). This plan will serve as a basis for ongoing behaviour change support in routine consultations (with the client's mental health clinician), to discuss client progress in achieving goals and taking up referrals. The care plan will be integrated in the electronic system (see practice change strategy 2 below), and a copy will also be provided to clients (the mode of doing so will be co-developed and tailored to participating services, and may include, for example, a printed hard copy at the time of the consultation and/or an electronic copy sent via email).

Practice change strategies:
Evidence based practice change strategies will be implemented by intervention services. These strategies will be co-developed with participating services to tailor them to the particular context of each service; aiming to implement the approach to preventive care as a component of standard practice. Implementation of the practice change strategies will not be sequential, and will occur simultaneously throughout the course of the intervention commencing at the beginning of the intervention period. These strategies will include:
1. Clinical leadership and consensus to reinforce and communicate the strong support for the new care initiative from service managers and clinical directors to staff.
2. Enabling systems: a template for the care management plan integrated into electronic records (available at the commencement of the intervention period).
3. Education and training for staff in the importance of preventive care, information regarding risk guidelines, strategies/skills for providing ongoing support for behaviour change and goal setting, and information about referral services. We anticipate utilising a variety of modes including online, face-to-face and written materials; with education provided throughout the intervention period. The exact content, mode of delivery, duration, frequency, and training provider will be co-developed with participating services to be tailored based on their differing needs, preferences and feasibility.
4. Audit and feedback: a working group within each service will create a brief summary of preventive care provision each month to provide to team leaders and clinicians, including recommendations for action where appropriate. Data to be included in the summary will be co-developed with participating services, and may include information regarding, for example, consultation attendance and care plans initiated. The mechanisms for how these feedback summaries will be provided to staff will also be co-developed and tailored to each service (for example, via email, in regular clinical review meetings, online presentation, etc.).
5. Client activation strategies: posters and leaflets will be placed in waiting rooms to inform clients about the extra consultation.
6. Healthy choices coach: a healthy choices coach will be embedded in the intervention services for a period of 9-months, with a dual role: (1) to provide the additional consultation to clients and (2) support all clinicians within the service to continue to provide preventive care in their routine consultations. Research staff will be in regular contact with the healthy choices coach to support them in that role.

The new approach and practice change strategies will be implemented at the service level. Therefore, all clients of the intervention services will be subject to the intervention regardless of whether or not they are eligible for and/or take part in the data collection procedures. That is, participation in data collection will be independent of care provided by the mental health service. Data collection will comprise two cross-sectional surveys at baseline and 9-months of independent samples to assess practice change outcomes. Additionally, to enable assessment of client behaviour change outcomes, a random sub-sample of eligible participants who completed the baseline survey will be followed-up in a 9-month cohort follow-up (i.e. same sample).
Intervention code [1] 320367 0
Lifestyle
Intervention code [2] 320368 0
Prevention
Intervention code [3] 320369 0
Behaviour
Comparator / control treatment
Services randomised to the control condition will continue to provide preventive care in accordance with their usual practices (including any support from their LHD that would ordinarily be provided to do so). In accordance with NSW Health guidelines this may include: assessment of chronic disease risk behaviours (smoking, nutrition, alcohol, physical activity), advice to change risk behaviours, and referrals to support changes in risk behaviours. Such care may be provided by clients' usual mental health clinician during their routine mental health appointment. Previous research indicates such care provision is sub-optimal.
Control group
Active

Outcomes
Primary outcome [1] 327289 0
Composite outcome: proportion of clients who received assessment for all four health risk behaviours (tobacco smoking, poor nutrition, harmful alcohol consumption, and physical inactivity). Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients (n=1440 clients invited to take part; average of 120 per service) at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [1] 327289 0
Baseline and 9-month post-baseline cross-sectional surveys.
Primary outcome [2] 327290 0
Composite outcome: proportion of clients who received advice for all relevant behavioural risks (i.e. receipt of advice for all behavioural risks a clients is determined to be at risk for, of: tobacco smoking, poor nutrition, harmful alcohol consumption, and physical inactivity).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [2] 327290 0
Baseline and 9-month post-baseline cross-sectional surveys.
Primary outcome [3] 327291 0
Composite outcome: proportion of clients who received a referral offer for at least one relevant behavioural risks (i.e. receipt of a referral for at least one of the risk behaviours a client is determine to be at risk for, of: tobacco smoking, poor nutrition, harmful alcohol consumption, and physical inactivity).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [3] 327291 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [1] 394483 0
Proportion of clients who received assessment of risk status for tobacco smoking.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [1] 394483 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [2] 394484 0
Proportion of clients who received assessment of risk status for alcohol consumption.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [2] 394484 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [3] 394485 0
Proportion of clients who received assessment of risk status for fruit and/or vegetable consumption (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [3] 394485 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [4] 394486 0
Proportion of clients who received assessment of risk status for physical activity.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [4] 394486 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [5] 394487 0
Proportion of clients who received assessment of risk status for weight.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [5] 394487 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [6] 394488 0
Proportion of clients who received advice for tobacco smoking (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [6] 394488 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [7] 394489 0
Proportion of clients who received advice for harmful alcohol consumption (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [7] 394489 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [8] 394490 0
Proportion of clients who received advice for inadequate fruit and/or vegetable consumption (among clients at risk) (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [8] 394490 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [9] 394491 0
Proportion of clients who received advice for inadequate physical activity (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [9] 394491 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [10] 394492 0
Proportion of clients who received advice for inadequate weight (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [10] 394492 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [11] 394493 0
Proportion of clients who were offered a referral for tobacco smoking (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [11] 394493 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [12] 394494 0
Proportion of clients who were offered a referral for harmful alcohol consumption (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [12] 394494 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [13] 394495 0
Proportion of clients who were offered a referral for inadequate fruit and/or vegetable consumption (among clients at risk) (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [13] 394495 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [14] 394496 0
Proportion of clients who were offered a referral for inadequate physical activity (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [14] 394496 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [15] 394497 0
Proportion of clients who were offered a referral for weight (among clients at risk).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [15] 394497 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [16] 394498 0
Proportion of clients who contacted a behaviour change support service (following a referral) for at least one relevant risk factor (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [16] 394498 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [17] 394499 0
Proportion of participants who had a conversation with their mental health clinician about their goals for changing at least one relevant risk factor (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at each time point (independent samples). Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [17] 394499 0
Baseline and 9-month post-baseline cross-sectional surveys.
Secondary outcome [18] 394500 0
Proportion of clients currently smoking. Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients (n=200 invited to take part) at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [18] 394500 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [19] 394501 0
Number of cigarettes consumed per day.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [19] 394501 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [20] 394502 0
Number of standard drinks consumed in a typical week.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [20] 394502 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [21] 394503 0
Serves of fruit consumed per day.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [21] 394503 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [22] 394649 0
Serves of vegetables consumed per day.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [22] 394649 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [23] 394650 0
Total minutes of moderate (defined as: activities that require some effort but you can also hold a conversation, such as fast walking, baseball, tennis, easy bicycling, volleyball and easy swimming) and vigorous (defined as: activities that make you breath harder or puff such as running, jogging, gym classes, boxing, soccer or squash; during these activities it is hard to have a conversation) physical activity per week (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [23] 394650 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [24] 394651 0
Self-reported weight (kg).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [24] 394651 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [25] 394652 0
Proportion of clients who attempted to change at least one relevant risk factor in the previous 9 months (composite outcome).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview item and response options are based on the readiness ruler for alcohol use (Heather, 2008).
Timepoint [25] 394652 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [26] 394653 0
Readiness to change smoking.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview item and response options are based on the readiness ruler for alcohol use (Heather, 2008).
Timepoint [26] 394653 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [27] 394654 0
Readiness to change nutrition (defined as fruit and vegetable intake; one item).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview item and response options are based on the readiness ruler for alcohol use (Heather, 2008).
Timepoint [27] 394654 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [28] 394655 0
Readiness to change alcohol consumption.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Item is the readiness ruler for alcohol use (Heather, 2008).
Timepoint [28] 394655 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [29] 394656 0
Readiness to change physical activity levels.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview item and response options are based on the readiness ruler for alcohol use (Heather, 2008).
Timepoint [29] 394656 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [30] 394657 0
Readiness to change weight.

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview item and response options are based on the readiness ruler for alcohol use (Heather, 2008).
Timepoint [30] 394657 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [31] 394658 0
Confidence to change smoking (1-10 scale).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [31] 394658 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [32] 394777 0
Confidence to change nutrition (defined fruit and vegetable intake: one item) (1-10 scale).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [32] 394777 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [33] 394778 0
Confidence to change alcohol consumption (1-10 scale).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [33] 394778 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [34] 394779 0
Confidence to change physical activity levels (1-10 scale).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [34] 394779 0
Baseline and 9-months post-baseline cohort follow-up
Secondary outcome [35] 395063 0
Confidence to change weight (1-10 scale).

Assessed via client self-report in telephone interviews undertaken with a random sample of eligible clients at baseline and a cohort follow-up. Interview items are based on those previously used by the research team in community health, community mental health and community drug and alcohol services.
Timepoint [35] 395063 0
Baseline and 9-months post-baseline cohort follow-up

Eligibility
Key inclusion criteria
Baseline and 9-month post-baseline cross-sectional surveys (independent samples; eligibility assessed at each timepoint):
-18 years or over;
-Attended at least two consultations within the previous 9 months at a participating community mental health service (control or intervention);
-English speaking; and
-mentally and physically capable of responding to survey items.

9-month post-baseline cohort follow-up:
-Completed the baseline cross-sectional survey; and:
-If in a control service: attended at least one mental health appointment in the preceding 9 months (at the time of the cohort follow-up); or
-If in an intervention service: attended the healthy choices consultation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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; stratified by LHD and service size. Following randomisation, researchers, clinicians, and services will not be blind to allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed effects logistic regression models will compare primary and secondary practice change outcomes between the intervention and control groups at the 9-month post-baseline cross-sectional survey, adjusting for clustering by service with a service level random intercept. Models will also adjust for potential confounders including baseline prevalence of preventive care, age, gender, psychiatric diagnosis, and length of time in treatment, as well as LHD as fixed effects.

Mixed effects logistic regression models will be used to determine, in the participant cohort, the change over time (baseline to 9-months post-baseline cohort follow-up) in the intervention compared to control participants in the secondary client health outcomes. Models will similarly adjust for potential confounders as well as LHD.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2021
Actual
20/09/2021
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
720
Accrual to date
483
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308431 0
Government body
Name [1] 308431 0
The National Health and Medical Research Council (NHMRC), Medical Research Future Fund (MRFF)
Country [1] 308431 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309263 0
Government body
Name [1] 309263 0
Hunter New England Population Health
Address [1] 309263 0
Longworth Ave, Wallsend, NSW 2287
Country [1] 309263 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308389 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 308389 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 308389 0
Australia
Date submitted for ethics approval [1] 308389 0
29/01/2021
Approval date [1] 308389 0
23/04/2021
Ethics approval number [1] 308389 0
2020/ETH03234

Summary
Brief summary
People with mental health conditions die up to 20 years earlier than the general population, largely due to a higher prevalence of risk factors: nutrition, physical inactivity, alcohol overconsumption, tobacco smoking and weight. ‘Preventive care’ to address risk factors is infrequently provided in community mental health services.

A new approach to providing preventive care will be co-developed with mental health clinicians; incorporating a ‘dedicated provider’ within community mental health services and strategies to facilitate the integration of preventive care into usual practice. The research team will evaluate this new approach in a cluster randomised controlled trial across three local health districts (Hunter New England, Mid North Coast, and Central Coast). Community mental health services will be randomly allocated to an intervention or control group. Primary outcomes will be client-reported receipt of assessment, advice and referral for relevant risk behaviours (nutrition, smoking, alcohol, physical activity) from their mental health service.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110546 0
Prof Jenny Bowman
Address 110546 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 110546 0
Australia
Phone 110546 0
+61 0249215958
Fax 110546 0
Email 110546 0
[email protected]
Contact person for public queries
Name 110547 0
Dr Caitlin Fehily
Address 110547 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 110547 0
Australia
Phone 110547 0
+61 0249217181
Fax 110547 0
Email 110547 0
[email protected]
Contact person for scientific queries
Name 110548 0
Dr Caitlin Fehily
Address 110548 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 110548 0
Australia
Phone 110548 0
+61 0249217181
Fax 110548 0
Email 110548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11456Study protocolFehily, C., McKeon, E., Stettaford, T., Campbell, E., Lodge, S., Dray, J., ... & Bowman, J. (2022). The Effectiveness and Cost of an Intervention to Increase the Provision of Preventive Care in Community Mental Health Services: Protocol for a Cluster-Randomized Controlled Trial. International journal of environmental research and public health, 19(5), 3119.https://www.mdpi.com/1660-4601/19/5/3119/htm 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effectiveness and Cost of an Intervention to Increase the Provision of Preventive Care in Community Mental Health Services: Protocol for a Cluster-Randomized Controlled Trial.2022https://dx.doi.org/10.3390/ijerph19053119
N.B. These documents automatically identified may not have been verified by the study sponsor.