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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
25/06/2013
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
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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
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Secondary ID [1]
282425
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nil
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Universal Trial Number (UTN)
U1111-1142-1023
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking
289022
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Inadequate nutrition
289023
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Harmful alcohol consumption
289024
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Inadequate physical activity
289025
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Chronic disease
289026
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Chronic disease prevention
289027
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Condition category
Condition code
Public Health
289362
289362
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0
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Health service research
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Public Health
289637
289637
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0
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Health promotion/education
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Mental Health
289638
289638
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287065
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Prevention
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Intervention code [2]
287066
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Behaviour
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Intervention code [3]
287067
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Lifestyle
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [1]
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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.
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Assessment method [1]
303109
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Timepoint [1]
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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.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Other
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Other design features
Two group multiple baseline
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
29/10/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
3120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
287391
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Government body
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Name [1]
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National Health and Medical Research Council - Partnership Grant
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Address [1]
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Level 1
16 Marcus Clarke St
Canberra ACT 2601
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Country [1]
287391
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Australia
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Funding source category [2]
287392
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Other Collaborative groups
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Name [2]
287392
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Hunter Medical Research Institute (HMRI)
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Address [2]
287392
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Locked Bag 1
Hunter Regional Mail Centre
NSW 2310
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Country [2]
287392
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Australia
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Funding source category [3]
287393
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Government body
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Name [3]
287393
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Population Health
Hunter New England Local Health District
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Address [3]
287393
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Locked Bag 10,
Wallsend
NSW 2287
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Country [3]
287393
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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Address
University Drive,
Callaghan NSW 2308
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Country
Australia
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Secondary sponsor category [1]
286135
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Government body
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Name [1]
286135
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Hunter New England Population Health
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Address [1]
286135
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Locked Bag 10,
Wallsend NSW 2287
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Country [1]
286135
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289362
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
289362
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Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton
NSW 2305
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Ethics committee country [1]
289362
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Australia
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Date submitted for ethics approval [1]
289362
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Approval date [1]
289362
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20/08/2009
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Ethics approval number [1]
289362
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09/06/17/4.03
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Ethics committee name [2]
289363
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University of Newcastle Human Research Ethics Committee
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Ethics committee address [2]
289363
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University Drive
Callaghan NSW 2308
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Ethics committee country [2]
289363
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Australia
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Date submitted for ethics approval [2]
289363
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Approval date [2]
289363
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30/06/2010
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Ethics approval number [2]
289363
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H-2010-1116
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Summary
Brief summary
The study will be undertaken within community mental health services across one local health district in New South Wales, Australia. A two group multiple baseline design will be utilised to assess the effectiveness of a 12 month intervention.
The 12 month intervention will be implemented sequentially across the two groups, and involve clinical practice change strategies to increase clinician provision of three elements of care for clients (assessment, brief advice, referral) for four health risk behaviours (smoking, inadequate fruit and vegetable consumption, harmful alcohol consumption and inadequate physical activity).
Primary data collection will consist of repeated cross-sectional computer assisted telephone interviews (CATIs) undertaken with clients receiving care from the community mental health services. The interviews will measure client reported receipt of preventive care on a weekly basis for 36 months. Surveys 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. To supplement the client data, CATIs will be undertaken with community mental health clinicians pre and post the intervention periods, to measure clinician self-reported preventive care provision.
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Trial website
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Trial related presentations / publications
-Oral presentation: Kate Bartlem, Jenny Bowman, Megan Freund, Paula Wye, Kate Ross, Jenny Knight, John Wiggers. Community mental health services as a setting for preventive care: Current practice and predictors of care. 10th Annual Meeting of the Australasian Society for Behavioural Health and Medicine (ASBHM), Annual Scientific Conference, Newcastle, Australia, Feb 2013.
-Symposium presentation: Paula Wye, Kate Bartlem, Jenny Bowman, John Wiggers. Physical health issues in mental health services: an audit of need. 10th Annual Meeting of the Australasian Society for Behavioural Health and Medicine (ASBHM), Annual Scientific Conference, Newcastle, Australia, Feb 2013.
-Symposium presentation: Kate Bartlem, Jenny Bowman, Megan Freund, Paula Wye, Jenny Knight, John Wiggers. Is preventive care provided in community mental health settings? 10th Annual Meeting of the Australasian Society for Behavioural Health and Medicine (ASBHM), Annual Scientific Conference, Newcastle, Australia, Feb 2013.
-Symposium presentation: Kate Bartlem, Jenny Bowman, Megan Freund, Paula Wye, John Wiggers, Kathleen McElwaine, Jenny Knight, Patrick McElduff, Karen Gillham. A model of care: preventive care in community mental health. 10th Annual Meeting of the Australasian Society for Behavioural Health and Medicine (ASBHM), Annual Scientific Conference, Newcastle, Australia, Feb 2013.
-Oral presentation: Kate Bartlem*, Jenny Bowman, Megan Freund, Jenny Knight, Kathleen McElwaine, Wiggers John, Wye Paula. Community mental health services as a setting for health promotion: Current practice. NSW Health Promotion Symposium, Sydney, Nov 2012
-Poster presentation: K Bartlem, J Bowman, M Freund, J Knight, K McElwaine, J Wiggers, P Wye. Providing smoking cessation support to Australian community mental health patients: Need & current practice. World Conference on Tobacco or Health (WCTOH), Singapore, Singapore, March, 2012.
-Oral Presentation: Bartlem K , Bowman J, Wiggers J, Freund M, Wye P, Bailey J. Prevalence of Modifiable Health Risk Behaviours in Community Mental Health Clients. Population Health Congress. Adelaide, SA, Australia. 10-12 Sept 2012
-Workshop: Wiggers J, Bowman J, Freund M, Wolfenden L, Wye P, Bartlem K, McElwaine K, Gillham K (Workshop), Translational research in health promotion: increasing the provision of preventive care within clinical health services. Population Health Congress. Adelaide, SA, Australia. 10-12 Sept 2012
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Public notes
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Contacts
Principal investigator
Name
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Prof John Wiggers
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Address
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Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
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Country
39694
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Australia
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Phone
39694
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+61 2 4924 6247
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Fax
39694
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+61 2 4924 6048
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Email
39694
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[email protected]
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Contact person for public queries
Name
39695
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Prof John Wiggers
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Address
39695
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Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
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Country
39695
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Australia
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Phone
39695
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+61 2 4924 6247
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Fax
39695
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+61 2 4924 6048
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Email
39695
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[email protected]
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Contact person for scientific queries
Name
39696
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Prof John Wiggers
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Address
39696
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Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
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Country
39696
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Australia
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Phone
39696
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+61 2 4924 6247
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Fax
39696
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+61 2 4924 6048
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Email
39696
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Effectiveness of an intervention in increasing the provision of preventive care by community mental health services: a non-randomized, multiple baseline implementation trial.
2016
https://dx.doi.org/10.1186/s13012-016-0408-4
Embase
Chronic disease health risk behaviours amongst people with a mental illness.
2015
https://dx.doi.org/10.1177/0004867415569798
Embase
Evaluating 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.
2013
https://dx.doi.org/10.1186/1748-5908-8-85
N.B. These documents automatically identified may not have been verified by the study sponsor.
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