ANZCTR - Registration

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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]

IMP012

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tobacco smoking

Harmful alcohol consumption

Inadequate fruit and/or vegetable consumption

Inadequate physical activity

Chronic disease

Sleep quality

Condition category

Condition code

Public Health

Health service research

Mental Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Baseline and 4-month follow-up.

Primary outcome [2]

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]

Baseline and 4-month follow-up.

Primary outcome [3]

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]

Baseline and 4-month follow-up.

Secondary outcome [1]

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]

Baseline and 4 month follow-up.

Secondary outcome [2]

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]

Baseline and 4 month follow-up.

Secondary outcome [3]

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]

Cost outcomes collected throughout intervention development and implementation, and during the 3 months post intervention.

Secondary outcome [4]

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]

Baseline and 4 month follow-up.

Secondary outcome [5]

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]

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]

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]

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]

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]

baseline and 4 month followup

Secondary outcome [8]

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]

baseline and 4 month followup

Secondary outcome [9]

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]

baseline and 4 month followup

Secondary outcome [10]

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]

baseline and 4 month followup

Secondary outcome [11]

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]

baseline and 4 month followup

Secondary outcome [12]

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]

Baseline and 4 month followup

Secondary outcome [13]

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]

baseline and 4 month followup

Secondary outcome [14]

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]

Baseline and 4 month followup

Secondary outcome [15]

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]

Baseline and 4 months followup

Secondary outcome [16]

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]

baseline and 4 month followup

Secondary outcome [17]

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]

baseline and 4 month followup

Secondary outcome [18]

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]

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?

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]

Government body

Name [1]

Cancer Institue NSW

Address [1]

PO Box 41, Alexandria NSW 1435
Level 9, 8 Central Ave,
Australian Technology Park,
Eveleigh NSW 2015

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Hunter New England Population Health

Address [1]

Longworth Ave Wallsend NSW 2287

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag No 1
HRMC NSW 2310

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2018

Approval date [1]

24/01/2019

Ethics approval number [1]

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

Prof Jenny Bowman

Address

The University of Newcastle
Behavioural Science Building (room W212)
Callaghan, University Drive,
NSW 2308, Australia

Country

Australia

Phone

+61 0249215958

Fax

[email protected]

Contact person for public queries

Name

Jenny Bowman

Address

The University of Newcastle
Behavioural Science Building (room W212)
Callaghan, University Drive,
NSW 2308, Australia

Country

Australia

Phone

+61 0249215958

Fax

[email protected]

Contact person for scientific queries

Name

Jenny Bowman

Address

The University of Newcastle
Behavioural Science Building (room W212)
Callaghan, University Drive,
NSW 2308, Australia

Country

Australia

Phone

+61 0249215958

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
5093	Study protocol				Study protocol will be provided when published.

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Clustering of chronic disease risks among people accessing community mental health services.	2022	https://dx.doi.org/10.1016/j.pmedr.2022.101870

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically