Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001379101
Ethics application status
Approved
Date submitted
24/05/2019
Date registered
9/10/2019
Date last updated
9/10/2019
Date data sharing statement initially provided
9/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving adoption of preventive care policy and care provision in community mental health services
Scientific title
The impact of an implementation support intervention on preventive care practices in community mental health clinics: A non-randomised trial.
Secondary ID [1] 297611 0
IMP012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 311874 0
Harmful alcohol consumption 311875 0
Inadequate fruit and/or vegetable consumption 311876 0
Inadequate physical activity 311877 0
Chronic disease 311899 0
Sleep quality 312776 0
Condition category
Condition code
Public Health 310468 310468 0 0
Health service research
Mental Health 310483 310483 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supporting community mental health services to provide preventive care
Model of preventive care to be implemented: In line with policy within the local health district (within which the trial is being conducted), community mental health clinicians are to use practices consistent with the AAR ‘Assess, Advise, Refer’ (AAR) model for the addressing preventable risk factors. The focus of this model is the routine assessment of preventable risk factors for chronic disease (tobacco smoking, harmful alcohol consumption, inadequate fruit and/or vegetable consumption, inadequate physical activity), provision of very brief advice around the value in addressing these risk behaviours, and connection of clients to existing specialist evidence-based services to enable ongoing behaviour change support (referral). The provision of preventive care following the ‘AAR’ model allows health risks to be addressed, but not necessarily directly by mental health service clinicians, and has demonstrated effectiveness for reducing health risk behaviours.

Implementation support intervention. One community mental health service will receive practice support strategies to support the implementation of preventive care practices (AAR) into routine practice. The strategies will be tailored to overcome the impediments to preventive care provision that are specific to the community mental health service context and developed collaboratively with clinicians in the practice support service. The final mode of training, and the specifics of the final intervention components will arise during the co-development process with the community mental health service representatives. It is likely that they will include evidence-based strategies such as:
• education and training (interactive activities and face to face group training)
• feedback reports,
• aids to enable care provision (hardcopy and electronic materials and handouts designed specifically for the study) and
• a designated support person (will be recruited from within the service to assist clinicians in putting the policy into practice)

Community mental health clinicians: All clinicians within the selected service will receive the implementation support strategies. The training will be delivered over a minimum of 4 weeks. The frequency of the training delivered will be specified during the co-development planning stage with the community mental health service representatives.


Intervention code [1] 313844 0
Prevention
Intervention code [2] 313845 0
Behaviour
Intervention code [3] 313863 0
Lifestyle
Comparator / control treatment
The control community mental health service will not receive the implementation support intervention and will deliver usual care to their clients.
Control group
Active

Outcomes
Primary outcome [1] 319331 0
Composite outcome: Client receipt of assessment of risk status for all four health risk behaviours (tobacco smoking, harmful alcohol consumption, inadequate fruit and/or vegetable consumption, inadequate physical activity)
Cross-sectional telephone interviews will be undertaken with (n=300) clients of the practice support service and (n=300) clients of the control service at baseline and follow-up. This represents the minimum sample size required for sufficient power (80%) to detect a 10%-15% differential change in care between groups from baseline to follow-up at the 95% alpha level. 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] 319331 0
Baseline and 4-month follow-up.
Primary outcome [2] 320388 0
Composite outcome: Client receipt of advice for all relevant risks (amongst clients determined to be at risk for at least one health behaviour).
Outcome will be assessed via the cross-sectional telephone interviews with clients at baseline and 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 [2] 320388 0
Baseline and 4-month follow-up.
Primary outcome [3] 320389 0
Composite outcome: Client receipt of referral offer for at least one behaviour (amongst clients determined to be at risk for at least one health behaviour).
Outcome will be assessed via the cross-sectional telephone interviews with clients at baseline and 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 [3] 320389 0
Baseline and 4-month follow-up.
Secondary outcome [1] 367809 0
PRIMARY OUTCOME 4:
Composite outcome: Client receipt of ‘best practice’ (assessment of all behaviours, advice for all relevant behaviours, and referral offer for at least one behaviour) (amongst clients determined to be at risk for at least one health behaviour).
Outcome will be assessed via the cross-sectional telephone interviews with clients at baseline and 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 [1] 367809 0
Baseline and 4 month follow-up.
Secondary outcome [2] 367810 0
Appropriateness of implementation support intervention.
Assessment will be via the online clinician survey to be conducted during baseline, and the follow-up period with intervention service clinicians. Items were developed specifically for this study.
Timepoint [2] 367810 0
Baseline and 4 month follow-up.
Secondary outcome [3] 367811 0
Costs (economic evaluation). Costs associated with the practice support e.g. resources and labour costs such as training time and personnel) will be recorded in project logs.
A cost consequence evaluation will examine costs associated with the development and implementation of practice support and compare this to outcomes achieved.
Timepoint [3] 367811 0
Cost outcomes collected throughout intervention development and implementation, and during the 3 months post intervention.
Secondary outcome [4] 370764 0
Client satisfaction with preventive care received. This will be assessed during the computer assisted telephone interviews by items previously developed and used by the investigators.
Timepoint [4] 370764 0
Baseline and 4 month follow-up.
Secondary outcome [5] 373141 0
Feasibility, acceptability and appropriateness of preventive care delivery.
Assessment will be via the online clinician survey to be conducted during baseline, and the follow-up period with intervention and control service clinicians. Items were developed specifically for this study.
Timepoint [5] 373141 0
Assessment will be via the clinician survey to be conducted during baseline, and the follow up period with the intervention service clinicians.
Secondary outcome [6] 374583 0
Acceptability of implementation support intervention.
Assessment will be via the online clinician survey to be conducted during baseline, and the follow-up period with intervention service clinicians. Items were developed specifically for this study.
Timepoint [6] 374583 0
Assessment will be via the clinician survey to be conducted during baseline, and the follow up period with the intervention service clinicians.
Secondary outcome [7] 374584 0
Client receipt of assessment of risk status for tobacco smoking. Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [7] 374584 0
baseline and 4 month followup
Secondary outcome [8] 374585 0
Client receipt of assessment of risk status for harmful alcohol consumption.
assessed via the cross-sectional telephone interviews with clients at baseline and 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 [8] 374585 0
baseline and 4 month followup
Secondary outcome [9] 374586 0
Client receipt of assessment of risk status for inadequate fruit and/or vegetable consumption.
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [9] 374586 0
baseline and 4 month followup
Secondary outcome [10] 374587 0
Client receipt of assessment of risk status for inadequate physical activity.
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [10] 374587 0
baseline and 4 month followup
Secondary outcome [11] 374588 0
Client receipt of advice for tobacco smoking (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [11] 374588 0
baseline and 4 month followup
Secondary outcome [12] 374589 0
Client receipt of advice for harmful alcohol consumption (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [12] 374589 0
Baseline and 4 month followup
Secondary outcome [13] 374590 0
Client receipt of advice for inadequate fruit and/or vegetable consumption (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [13] 374590 0
baseline and 4 month followup
Secondary outcome [14] 374591 0
Client receipt of advice for inadequate physical activity (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [14] 374591 0
Baseline and 4 month followup
Secondary outcome [15] 374592 0
Client receipt of an offer of referral for tobacco smoking (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [15] 374592 0
Baseline and 4 months followup
Secondary outcome [16] 374593 0
Client receipt of an offer of referral for harmful alcohol consumption (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [16] 374593 0
baseline and 4 month followup
Secondary outcome [17] 374594 0
Client receipt of an offer of referral for inadequate fruit and/or vegetable consumption (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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 [17] 374594 0
baseline and 4 month followup
Secondary outcome [18] 374595 0
Client receipt of an offer of referral for inadequate physical activity (among clients at risk)
Assessed via the cross-sectional telephone interviews with clients at baseline and 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] 374595 0
Baseline and 4 month followup

Eligibility
Key inclusion criteria
CLIENTS: Clients eligible for participation in the computer-assisted telephone interviews (CATI) at baseline and follow-up will be those who: are 18 years or older; have attended at least one appointment in the last 4-months in the community mental health service. Additional client eligibility criteria will be assessed upon phone contact and will include: English speaking; not currently inpatient, not living in aged care facilities or jail, and being physically and mentally capable of responding to the survey items.

CLINICIANS: All clinicians within the practice support service will receive the relevant implementation support intervention strategies. This includes psychiatrists, psychologists, social workers, dieticians, nurses and occupational therapists.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who are under the age of 18 or identified as too unwell or clinically inappropriate to contact, have not attended at least one appointment in the last 4-months in the community mental health service, not English speaking, currently inpatient, living in aged care facilities or jail.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
The interviewers doing the client data collection will not be aware of the service allocation.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to describe the characteristics of the clinical and health risk behaviour characteristics. Logistic regression analysis will be undertaken for each unit to determine if the prevalence of each element of preventive care delivery provided to patients has changed over time. A cost consequence evaluation using regression analyses will examine costs associated with the intervention and implementation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
350
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302154 0
Government body
Name [1] 302154 0
Cancer Institue NSW
Country [1] 302154 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 301993 0
Government body
Name [1] 301993 0
Hunter New England Population Health
Address [1] 301993 0
Longworth Ave Wallsend NSW 2287
Country [1] 301993 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302836 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302836 0
Locked Bag No 1
HRMC NSW 2310
Ethics committee country [1] 302836 0
Australia
Date submitted for ethics approval [1] 302836 0
21/11/2018
Approval date [1] 302836 0
24/01/2019
Ethics approval number [1] 302836 0
2018/ETH00521

Summary
Brief summary
The aim of this quality improvement project is to implement and examine the effectiveness of strategies to support clinical staff in the provision of the preventive care policy within community mental health services in the Hunter New England LHD. An implementation intervention will be co-developed with the service to support clinicians to provide preventive care for tobacco smoking, harmful alcohol consumption, inadequate fruit and/or vegetable consumption, and inadequate physical activity. Evidence based strategies such as education and training, feedback reports, aids to enable care provision, and a designated support person will be tailored, specifically to overcome the impediments to preventive care provision in community mental health. It is hypothesised that clients from the intervention service will receive higher levels of preventive care compared to a control service who will receive no implementation intervention.
Trial website
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 91558 0
Prof Jenny Bowman
Address 91558 0
The University of Newcastle
Behavioural Science Building (room W212)
Callaghan, University Drive,
NSW 2308, Australia
Country 91558 0
Australia
Phone 91558 0
+61 0249215958
Fax 91558 0
Email 91558 0
jenny.bowman@newcastle.edu.au
Contact person for public queries
Name 91559 0
Prof Jenny Bowman
Address 91559 0
The University of Newcastle
Behavioural Science Building (room W212)
Callaghan, University Drive,
NSW 2308, Australia
Country 91559 0
Australia
Phone 91559 0
+61 0249215958
Fax 91559 0
Email 91559 0
jenny.bowman@newcastle.edu.au
Contact person for scientific queries
Name 91560 0
Prof Jenny Bowman
Address 91560 0
The University of Newcastle
Behavioural Science Building (room W212)
Callaghan, University Drive,
NSW 2308, Australia
Country 91560 0
Australia
Phone 91560 0
+61 0249215958
Fax 91560 0
Email 91560 0
jenny.bowman@newcastle.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
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?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5093Study protocol    Study protocol will be provided when published.


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5093[Marked for deletion] [Marked for deletion][Marked for deletion][Marked for deletion][Marked for deletion] [Marked for deletion] [Marked for deletion]

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClustering of chronic disease risks among people accessing community mental health services.2022https://dx.doi.org/10.1016/j.pmedr.2022.101870
N.B. These documents automatically identified may not have been verified by the study sponsor.