Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000469617
Ethics application status
Approved
Date submitted
29/04/2014
Date registered
6/05/2014
Date last updated
22/09/2024
Date data sharing statement initially provided
22/09/2024
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 drug and alcohol services.
Scientific title
The effectiveness of a clinical practice change intervention in increasing clinician provision of preventive care across a network of community based drug and alcohol services; a pre-post trial.
Secondary ID [1] 284492 0
Nil
Universal Trial Number (UTN)
U1111-1155-5119
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinician delivery of preventive care 291742 0
Smoking 291786 0
Inadequate nutrition 291787 0
Harmful alcohol consumption 291788 0
Inadequate physical activity 291789 0
Chronic disease prevention 291790 0
Condition category
Condition code
Public Health 292110 292110 0 0
Health promotion/education
Public Health 292111 292111 0 0
Health service research
Diet and Nutrition 292151 292151 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total duration of the trial is 24 months. All participating drug and alcohol community health services will receive a 12 month clinical practice change intervention, implemented simultaneously. Data collection will commence six months prior to the intervention implementation, and continue until six months post the intervention implementation.

The 12 month clinical practice change intervention will consist of:

Leadership and consensus: the intervention will be formalised through district-wide policy guidelines and compliance procedures, made available to all clinicians. Clinical services, teams and management will be consulted prior to and during the implementation of the intervention. Senior management will be consulted regarding their support for the intervention and to reach agreement on key performance indicators. The service managers and clinicians for each individual facility will be regularly consulted throughout the intervention.

Enabling systems & procedures: the existing medical record system used district-wide by all community health services will be modified to include a standardised electronic tool. The tool will be incorporated into medical records to allow the standardized provision and recording of assessment of each health risk behaviour and for clients at risk: provision of brief advice in line with the current Australian national guidelines, referral to best practice referral options, automatic generation of a tailored client information handout detailing advice and referral for health risk behaviour(s), and automatic generation of a letter to the clients’ general practitioner or Aboriginal Medical Service detailing the care provided during the appointment(s).

Clinician training & support: clinicians and managers will be trained using both online and face-to-face training. Training will be made available at the start of the intervention and all existing clinicians will be expected to complete training within the first 2 months. The online training will take approximately 2 hours to complete and will cover the importance of providing preventive care, the policy guidelines and Key Performance Indicators (KPIs), the model of preventive care, and how to use the standardized assessment tool to record preventive care in the existing medical record system. Clinicians will be required to complete a brief competency based multiple choice quiz following the training. Clinicians will be considered trained once they have completed the quiz and scored 100%. Each site will have a designated support officer who will provide the initial face to face training to managers and follow up with a minimum of one face to face visit per month and fortnightly phone or email contact with managers. Further support and resources will be provided through an email helpline and internet information site.

Monitoring and feedback: Each month, feedback reports detailing the provision of preventive care at a service and facility level will be emailed to managers. The reports will include the proportion of eligible clients assessed, the proportion of at risk clients given brief advice and the proportion of at risk clients offered a referral. Effective feedback will include measuring performance and comparing to professional standards through district wide key performance indicators, delivering both verbal and written feedback through printed reports and discussions with support officers, and providing frequent feedback through monthly performance reports. Furthermore, the feedback will be sent to managers to disseminate to clinicians. Support officers will discuss reports with managers each month to highlight the team’s performance against district-wide key performance indicators, review strategies that are working for the team and develop strategies to increase the provision of preventive care where applicable.

Provision of clinical practice change resources: clinicians and managers will be provided with resources to aid the provision of preventive care including, a detailed guide to providing and recording care within the electronic medical records system, copies of a paper tool for assessment away from a computer (e.g. home visits), flip charts to use as visual aids with clients, client handouts to provide further information about risk factors and care, helpline fax referral forms, a detailed flow chart outlining preventive care steps and processes, and posters to be used in waiting and assessment rooms. Additionally clinicians will be provided with monthly newsletters containing helpful tips and tricks and managers will have email and phone access to the support officer a minimum of once a fortnight.
Intervention code [1] 289251 0
Prevention
Intervention code [2] 289252 0
Behaviour
Intervention code [3] 289253 0
Lifestyle
Comparator / control treatment
Prior to the implementation of the intervention usual preventive care will be provided.
Continuous data collection will occur for 6 months prior to the intervention implementation (baseline period) and will act as the control for the intervention period.
Control group
Historical

Outcomes
Primary outcome [1] 291990 0
Client reported receipt of preventive care (assessment, advice, referral) by community drug and alcohol clinicians for four health risk behaviours (smoking, inadequate fruit or vegetable consumption, harmful alcohol consumption, inadequate physical activity). Self-report data will be collected by undertaking computer assisted telephone interviews (CATIs) with clients receiving care from the community drug and alcohol services.
Timepoint [1] 291990 0
Continuous data collection on a weekly basis for 24 months, commencing six months prior to the intervention implementation and continuing until six months post intervention implementation.
Secondary outcome [1] 307967 0
Community drug and alcohol 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 drug and alcohol services.
Timepoint [1] 307967 0
Baseline data collection will occur immediately prior the intervention implementation. Follow-up data collection will occur immediately post the implementation of the intervention.

Eligibility
Key inclusion criteria
Inclusion criteria for community drug and alcohol health services receiving the intervention:
-Community drug and alcohol service within the Local Health District
-Provide care to adults (18 years or older)
Inclusion criteria for clients of community drug and alcohol services to participate in data collection:
-over 18 years of age,
-have attended a face to face appointment with an eligible service within the previous 2 weeks,
-have not previously participated in the survey,
-have not been identified as inappropriate for contact by their clinician,
-are undergoing active treatment and are not attending drug court
-English speaking
-being mentally and physically capable of completing the survey

Inclusion criteria for community drug and alcohol staff to participate in the survey
-have had at least 10 appointments with adult clients (>18 years) within the previous 2 months
-have been employed for at least 3 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 design features
Phase
Not Applicable
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
1350
Accrual to date
Final
1362
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289138 0
Government body
Name [1] 289138 0
National Health and Medical Research Council - Partnership Grant
Country [1] 289138 0
Australia
Funding source category [2] 289139 0
Other Collaborative groups
Name [2] 289139 0
Hunter Medical Research Institute (HMRI)
Country [2] 289139 0
Australia
Funding source category [3] 289140 0
Government body
Name [3] 289140 0
Population Health Hunter New England Local Health District
Country [3] 289140 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 287802 0
Government body
Name [1] 287802 0
Hunter New England Population Health
Address [1] 287802 0
Locked Bag 10,
Wallsend NSW 2287
Country [1] 287802 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290914 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 290914 0
Ethics committee country [1] 290914 0
Australia
Date submitted for ethics approval [1] 290914 0
Approval date [1] 290914 0
20/08/2009
Ethics approval number [1] 290914 0
09/06/17/4.03
Ethics committee name [2] 290915 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 290915 0
Ethics committee country [2] 290915 0
Australia
Date submitted for ethics approval [2] 290915 0
Approval date [2] 290915 0
30/06/2010
Ethics approval number [2] 290915 0
H-2010-1116

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

Contacts
Principal investigator
Name 47950 0
Prof John Wiggers
Address 47950 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 47950 0
Australia
Phone 47950 0
+61 2 4924 6247
Fax 47950 0
+61 2 4924 6048
Email 47950 0
[email protected]
Contact person for public queries
Name 47951 0
John Wiggers
Address 47951 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 47951 0
Australia
Phone 47951 0
+61 2 4924 6247
Fax 47951 0
+61 2 4924 6048
Email 47951 0
[email protected]
Contact person for scientific queries
Name 47952 0
John Wiggers
Address 47952 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 47952 0
Australia
Phone 47952 0
+61 2 4924 6247
Fax 47952 0
+61 2 4924 6048
Email 47952 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


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
Dimensions AIModifiable health risk behaviours and attitudes towards behaviour change of clients attending community-based substance use treatment services2016https://doi.org/10.1111/dar.12439
EmbaseSubstance use treatment clinician attitudes to care for chronic disease health risk behaviours and associations of attitudes with care provision.2020https://dx.doi.org/10.1111/dar.13044
N.B. These documents automatically identified may not have been verified by the study sponsor.