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Trial registered on ANZCTR


Registration number
ACTRN12613000693729
Ethics application status
Approved
Date submitted
3/06/2013
Date registered
25/06/2013
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a clinical practice change intervention in increasing clinician provision of preventive care across a network of community based mental health services
Scientific title
The effectiveness of a clinical practice change intervention in increasing clinician provision of preventive care in a network of community based mental health services; a multiple baseline study
Secondary ID [1] 282425 0
nil
Universal Trial Number (UTN)
U1111-1142-1023
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 289022 0
Inadequate nutrition 289023 0
Harmful alcohol consumption 289024 0
Inadequate physical activity 289025 0
Chronic disease 289026 0
Chronic disease prevention 289027 0
Condition category
Condition code
Public Health 289362 289362 0 0
Health service research
Public Health 289637 289637 0 0
Health promotion/education
Mental Health 289638 289638 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total duration of the two group multiple baseline trial is 36 months.
Each intervention group will receive a 12 month clinical practice change intervention, implemented sequentially. Data collection will commence in both groups six months prior to the intervention implementation in the first group, and continue until six months post the intervention implementation in the second. Hence, the first intervention group will have a baseline period of 6 months, and a follow-up period of 18 months. The second intervention group will have a baseline period of 18 months, and a follow-up period of 6 months.

The 12 month clinical practice change intervention will consist of:

Leadership and consensus:
Area wide policy guidelines and policy compliance procedures will be implemented to formalise the intervention and increase adherence. Existing clinical networks, clinical sites and teams will be engaged and consulted prior to and during the implementation of the intervention. Consultation will be undertaken with high level management regarding their advocacy, leadership and support of the intervention, and to gain agreement on Key Performance Indicators. At each clinical site, managers and clinicians will be consulted regularly throughout the intervention.


Enabling systems and procedures:
Modifications will be made to the existing medical record software routinely used by all community mental health clinicians. A standardised electronic assessment tool will be incorporated into the medical record to enable the standardised provision and recording of: risk assessment for each health risk behaviour, brief advice on how to improve behaviours in order to meet the Australian National Guidelines (where a client is at risk), referral to the recommended referral services and/or additional local referral avenues (where a client is at risk), automated production of a tailored client information handout regarding health risk behaviour, advice, and referral, and automated production of a referral letter to clients’ General Practitioner or Aboriginal Medical Service regarding care provided during the appointment(s). The standardised tool will prompt assessment for each health risk behaviour and based on the risk assessment information entered, will prompt advice and referral where a client has a risk.

Clinician and manager training:
Clinicians will be required to complete three online educational competency based training modules covering the importance of providing preventive care, information on the policy guidelines and Key Performance Indicators, the model of preventive care, and the recording of preventive care in the standardised electronic assessment tool. The online training modules will take approximately two hours to complete, and will be followed by a brief competency based multiple choice quiz. Training modules will be made available at the commencement of the intervention period, and remain available for existing and new clinicians to complete throughout the intervention period. Existing clinicians will be expected to complete all training modules and the quiz within the first two months of the intervention. Clinicians will be considered trained upon the completion of the quiz, with a score of 100% attained. Managers of each service will be required to attend a two hour face to face training session within the first three months of the intervention covering the importance of providing leadership in preventive care, and education around the performance monitoring and feedback strategy including interpretation and use of preventive care performance reports.


Monitoring and feedback:
Modifications will be made to the existing electronic medical record software to allow automated production of preventive care performance reports. The reports will include: the proportion of clients assessed, and of those identified at risk, the proportions provided brief advice and offered referral. Reports will be provided to, and discussed with managers on a monthly basis. Report discussions will be linked to the area wide Key Performance Indicator and will focus on developing strategies to improve performance where required. Existing area wide quality assurance systems will also be modified to incorporate preventive care indicators.


Provision of practice change resources:
All clinicians and managers will receive a Preventive Care resource pack to assist with delivery of care. Resources within these packs include: a preventive care process flowchart, a guide for providing and recording care within the electronic medical record software, information on fruit and vegetable serving sizes and standard alcoholic drinks, fax-based referral forms to the Quitline and Get Healthy lines, a preventive care flipchart to use as a visual aid during care provision, and paper based preventive care assessment tools for the delivery and recording of preventive care when away from a computer. All clinicians will be provided with monthly newsletters and tip-sheets, and access to an e-mail helpline and internet resource site. Each service will be provided a clinical practice change support officer to support intervention delivery, and provide a minimum of fortnightly phone calls and/or e-mails to support managers in implementing and maintaining preventive care delivery, and monthly face to face visits to support managers and clinicians.
Intervention code [1] 287065 0
Prevention
Intervention code [2] 287066 0
Behaviour
Intervention code [3] 287067 0
Lifestyle
Comparator / control treatment
Prior to the implementation of the intervention in each group of services, usual preventive care will be provided.

Continuous data collected during the baseline periods (group 1 = 6 months, group 2 = 18 months) for each group of services will act as a control for the intervention periods.
Control group
Historical

Outcomes
Primary outcome [1] 289725 0
Client reported receipt of preventive care (assessment, advice, referral) by community mental health clinicians for four health risk behaviours (smoking, inadequate fruit or vegetable consumption, harmful alcohol consumption, inadequate physical activity).
Self report data will be collected through undertaking computer assisted telephone interviews (CATIs) with clients receiving care from the community mental health services.
Timepoint [1] 289725 0
Continuous data collection on a weekly basis for 36 months. Data collection will commence in both groups six months prior to the intervention implementation in the first group of services, and continue until six months post the intervention implementation in the second group of services.
Secondary outcome [1] 303109 0
Community mental health clinician reported provision of preventive care (assessment, advice, referral) to their adult clients for four health risk behaviours (smoking, inadequate fruit or vegetable consumption, harmful alcohol consumption, inadequate physical activity).
Self report data will be collected through undertaking computer assisted telephone interviews (CATIs) with clinicians from the community mental health services.
Timepoint [1] 303109 0
Baseline data collection will occur immediately prior the intervention implementation in the first group of services. Follow-up data collection for the first group of services will occur immediately post the implementation of the intervention in the first group of services, and will occur for the second group of services immediately post the implementation of the intervention in the second group of services.

Eligibility
Key inclusion criteria
Inclusion criteria for community mental health services receiving the intervention:
-Community mental health service within the Local Health District
-Provide care to adults (18 years or older)

Inclusion criteria for community mental health service clients to partake in data collection:
-18 years or older
-Have attended at least one face to face, individual (not group) appointment with a community mental health clinician from an eligible service, within the previous two weeks
-Not previously been selected to participate
-Not identified by their clinician as inappropriate to contact
-English speaking
-Not participating in any other phone surveys regarding health behaviours or are received at community based health services
-Not living in aged care or gaol
-Physically and mentally capable of responding to the survey items

Inclusion criteria for community mental health service clinicians to partake in data collection:
-Minimum of 10 face to face, individual appointments with adults within the two months prior to the survey
-Have been employed for a minimum of three months
-Not contractors
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following service types are excluded from receiving the intervention:
-Inpatient services
-Intake triage services
-Services providing care solely to clients under the age of 18

Clients and clinicians from these services are excluded from participating in data collection.

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
Other design features
Two group multiple baseline
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/10/2009
Date of last participant enrolment
Anticipated
Actual
27/06/2014
Date of last data collection
Anticipated
Actual
27/06/2014
Sample size
Target
3120
Accrual to date
Final
3552
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287391 0
Government body
Name [1] 287391 0
National Health and Medical Research Council - Partnership Grant
Country [1] 287391 0
Australia
Funding source category [2] 287392 0
Other Collaborative groups
Name [2] 287392 0
Hunter Medical Research Institute (HMRI)
Country [2] 287392 0
Australia
Funding source category [3] 287393 0
Government body
Name [3] 287393 0
Population Health
Hunter New England Local Health District
Country [3] 287393 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 286135 0
Government body
Name [1] 286135 0
Hunter New England Population Health
Address [1] 286135 0
Locked Bag 10,
Wallsend NSW 2287
Country [1] 286135 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289362 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289362 0
Ethics committee country [1] 289362 0
Australia
Date submitted for ethics approval [1] 289362 0
Approval date [1] 289362 0
20/08/2009
Ethics approval number [1] 289362 0
09/06/17/4.03
Ethics committee name [2] 289363 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 289363 0
Ethics committee country [2] 289363 0
Australia
Date submitted for ethics approval [2] 289363 0
Approval date [2] 289363 0
30/06/2010
Ethics approval number [2] 289363 0
H-2010-1116

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

Contacts
Principal investigator
Name 39694 0
Prof John Wiggers
Address 39694 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 39694 0
Australia
Phone 39694 0
+61 2 4924 6247
Fax 39694 0
+61 2 4924 6048
Email 39694 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for public queries
Name 39695 0
John Wiggers
Address 39695 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 39695 0
Australia
Phone 39695 0
+61 2 4924 6247
Fax 39695 0
+61 2 4924 6048
Email 39695 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 39696 0
John Wiggers
Address 39696 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 39696 0
Australia
Phone 39696 0
+61 2 4924 6247
Fax 39696 0
+61 2 4924 6048
Email 39696 0
John.Wiggers@hnehealth.nsw.gov.au

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


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
SourceTitleYear of PublicationDOI
EmbaseEvaluating the effectiveness of a clinical practice change intervention in increasing clinician provision of preventive care in a network of community-based mental health services: a study protocol of a non-randomized, multiple baseline trial.2013https://dx.doi.org/10.1186/1748-5908-8-85
EmbaseChronic disease health risk behaviours amongst people with a mental illness.2015https://dx.doi.org/10.1177/0004867415569798
EmbaseEffectiveness of an intervention in increasing the provision of preventive care by community mental health services: a non-randomized, multiple baseline implementation trial.2016https://dx.doi.org/10.1186/s13012-016-0408-4
N.B. These documents automatically identified may not have been verified by the study sponsor.