Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001892202
Ethics application status
Approved
Date submitted
16/11/2018
Date registered
21/11/2018
Date last updated
9/01/2023
Date data sharing statement initially provided
21/11/2018
Date results provided
9/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting Aboriginal Community Controlled Health Services to deliver alcohol care: A cluster randomised controlled trial
Scientific title
Increasing uptake of evidence-based management of unhealthy alcohol use in Aboriginal
primary health care services: a cluster randomised controlled trial
Secondary ID [1] 296620 0
APP1105339
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hazardous alcohol use 310430 0
alcohol use disorders 310443 0
Condition category
Condition code
Public Health 309158 309158 0 0
Health service research
Mental Health 309159 309159 0 0
Addiction
Public Health 309160 309160 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Support is provided to staff of Aboriginal Community Controlled Health Services. This support focuses on building staff capacity and systems to improve AUDIT-C screening rates, and to respond with appropriate clinical care if unhealthy drinking (hazardous use or alcohol use disorders) is detected. Support is composed of the following :
1. Services asked to nominate two project champions
2. Project champions attend a two-day national workshop provided by the research team and selected invited speakers.. The workshop briefs participants on the nature of the study, and participants take part in small group discussions on the strengths and needs of their services in responding to alcohol issues. Brief interactive training sessions cover screening, brief intervention, home detox (withdrawal management), relapse prevention medicines, supporting families and supporting communities in responding to alcohol.
3. Onsite training is provided at one site for each health service, and all service staff are invited to attend. Training is provided by Prof Kate Conigrave (Addiction Medicine specialist) and by an Aboriginal staff member with clinical experience (Ms Kristie Harrison, a Wiradjuri woman with a background in alcohol and other drugs work, and youth work for the early support phase). The training includes core elements: screening, brief intervention, home detox, relapse prevention medicines, working with family and working with communities. Training is interactive. ITs duration and delivery is tailored to local needs and staff availability. Up to two days training is offered per service.
4. Support with refining practice software to facilitate screening, if needed
5. Provision of one-off funding ($9000 for 'early support' ['intervention'] services) for resources to support their work with alcohol. Services are provided with a list of potential resources (e.g. visual aids to brief intervention, breathalysers), but are also able to suggest their own resources. Resources must have prior approval from the Principal Investigator (KC)
6. Feedback of routinely collected clinical data every two months - AUDIT-C screening rates and results, rate of provision of brief intervention, counselling, and relapse prevention medicines for alcohol. The feedback is provided as a visual and easy-to-read pdf document, so that is accessible to community boards as well as to staff. This is emailed to service champions during their support phase
7. Phone conferences for champions every two months - to support sharing of expertise between services. The teleconferences last about 45 minutes and are chaired by the research staff (KC and Krisitie Harrison). These occur for two years during the support phase. The teleconferences focus on the service champions reporting back on what is working well in their service with regard to improving screening and response to alcohol, and what are the challenges. Services are split into two groups according to remoteness for the teleconferences, to increase the opportunity for interaction.
8. Password-protected website and online forum to share resources and ideas with other services in the 'support' phase. Resources are posted by the researchers; in addition service staff have the option for online 'chat' with each other or with the researchers on a discussion board. There is no required use of this discussion board.
Support is provided over one year actively, and one year in maintenance mode
Adherence to the protocol is monitored by a spreadsheet: on this, research staff record the date that each element of support is provided to each study site. In addition, attendance is recorded for second monthly teleconferences, and for all training sessions.
Intervention code [1] 312924 0
Other interventions
Comparator / control treatment
Wait-list control. The control group will receive the intervention 2-3 years after the 'intervention' (or 'early support') group. All elements are the same, except that wait-list control services receive a smaller amount of funds ($3500) for resources during their support phase,. This is because resources and training are expected to be more fully developed by the time their support phase starts.
Control group
Active

Outcomes
Primary outcome [1] 308128 0
AUDIT-C screening rate -- The number of clients attending a given service who are screened using AUDIT-C will be assessed using routinely collected clinical data, extracted from the practice software ('Communicare').
Timepoint [1] 308128 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date for assessing 'intervention' effectiveness is one year after the start of the intervention.
Secondary outcome [1] 354016 0
Provision of brief interventions for unhealthy alcohol use (hazardous consumption or alcohol use disorders) as recorded using the variable 'advice/education' will be assessed using routinely collected clinical data, extracted from the practice software ('Communicare').
Timepoint [1] 354016 0
Data will be extracted on the 28th day of every second month from the practice software. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention.
Secondary outcome [2] 354017 0
Provision of counselling as routinely recorded on the practice software
Timepoint [2] 354017 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date s is one year after the start of the intervention.
Secondary outcome [3] 354018 0
Prescriptions for acamprosate as routinely recorded on practice software
Timepoint [3] 354018 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..
Secondary outcome [4] 354135 0
Prescriptions for naltrexone as routinely recorded in the practice software
Timepoint [4] 354135 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..
Secondary outcome [5] 354136 0
Prescriptions for disulfiram as routinely recorded in the practice software
Timepoint [5] 354136 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..
Secondary outcome [6] 354137 0
AUDIT-C score, and results of its three individual items as routinely recorded in the practice software
Timepoint [6] 354137 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..
Secondary outcome [7] 354138 0
Systolice blood pressure as routinely recorded in the practice software
Timepoint [7] 354138 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..
Secondary outcome [8] 354139 0
Gamma glutamyltransferase (GGT; the liver enzyme) as routinely recorded in the practice software (note: not all patients will have a GGT recorded).
Timepoint [8] 354139 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..
Secondary outcome [9] 354140 0
HbA1c as routinely recorded in the practice software (note: not all patients will have a HbA1c level)
Timepoint [9] 354140 0
Data will be extracted on the 28th day of every second month. Data will also be retrospectively extracted for the 12-month period before the start of the intervention.
The census date is one year after the start of the intervention..

Eligibility
Key inclusion criteria
Health services are the recruitment target. Health Services were eligible to participate if:
1. They are an Aboriginal Community Controlled Health Service.
2. They serve at least 1,000 unique clients annually
3. If they use 'Communicare' as their practice software
4. Only data from clients age 15+ were used.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Health services which were not controlled by Aboriginal communities
2. Health services which served under 1000 clients annually
3. Health services which did not use 'Communicare' as their practice software

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The services were divided into three tiers according to remoteness, and each service was allocated a code. A statistician based at a separate site (A/Prof Tim Dobbins), and who had not been involved in recruitment or determining eligibility, conducted the randomisation by computer. The randomised codes were then returned to the principal investigator (KC), who matched the matched the codes to service names to discover the allocation of services..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was achieved using a randomisation table created by computer software (i.e. computerised sequence generation)
Randomisation was conducted within three tiers of service remoteness.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study design is intervention compared to wait-control. The wait control services receive no intervention initially. Then, at the end of the 'early support' phase (two years after the early support services start receiving the intervention), the wait-control services receive a nearly identical set of supports. The only difference is that they receive a smaller sum of money for resources ($3500). This is in acknowledgement of the fact that early support services will have needed to spend more time developing resources or approaches which can then be adopted by the late support services.
The early support services continue receiving data feedback during the late support phase, but no other supports.
During the testing of the interventions, staff of services in the 'intervention' arm are not told which services are participating in the wait-control arm, and vice-versa.
During the wait-control phase, all services become aware of other services involved in the study, to maximise sharing of experiences and skills.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This dataset is hierarchically clustered. Observations are nested under client IDs which are nested under services. To account for the non-independence of observations, the results will be analysed with multi-level modelling.
As further power was required to detect an increase in treatment provision, than was required for increase in screening rate, power analysis considered treatment provision. The power analysis concluded that we would need to recruit at least 10 services per arm in order to detect an increase in treatment provision of 13% (80% power and 2-sided significance of 0.05).
The power analysis was performed with the following assumptions:
1. Eligible services see at least 1000 clients per year.
2. Approximately 60% of clients are likely to be over 16 years or older
3. Approximately 57% of clients are likely to have been screened for alcohol use within 12 months
4. the Intracluster Correlation Coefficient (ICC) for services will be approximately 0.04

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/10/2016
Date of last participant enrolment
Anticipated
Actual
12/06/2017
Date of last data collection
Anticipated
28/04/2021
Actual
28/02/2021
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 301197 0
Government body
Name [1] 301197 0
National Health and Medical Research Council
Country [1] 301197 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
C39, The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 300822 0
Hospital
Name [1] 300822 0
Royal Prince Alfred Hospital
Address [1] 300822 0
Missenden Rd
Camperdown
NSW 2050
Country [1] 300822 0
Australia
Secondary sponsor category [2] 300830 0
Other
Name [2] 300830 0
Inala Indigenous Health Service
Address [2] 300830 0
PO Box 52
Inala
QLD 4077
Country [2] 300830 0
Australia
Secondary sponsor category [3] 300832 0
Other
Name [3] 300832 0
Illawarra Aboriginal Medical Service
Address [3] 300832 0
150 Church St, Wollongong NSW 2500
Country [3] 300832 0
Australia
Secondary sponsor category [4] 300833 0
University
Name [4] 300833 0
University of New South Wales
Address [4] 300833 0
University of New South Wales
Sydney NSW 2052
Country [4] 300833 0
Australia
Secondary sponsor category [5] 300834 0
University
Name [5] 300834 0
Curtin University
Address [5] 300834 0
GPO Box U1987
Perth WA 6845
Country [5] 300834 0
Australia
Secondary sponsor category [6] 300835 0
Other
Name [6] 300835 0
Aboriginal Health Council, SA
Address [6] 300835 0
220 Franklin St, Adelaide SA 5000
Country [6] 300835 0
Australia
Secondary sponsor category [7] 300836 0
Other
Name [7] 300836 0
Aboriginal Drug and Alcohol Council, SA
Address [7] 300836 0
155 Holbrooks Rd, Underdale SA 5032
Country [7] 300836 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301938 0
Aboriginal Health & Medical Research Council, NSW
Ethics committee address [1] 301938 0
Ethics committee country [1] 301938 0
Australia
Date submitted for ethics approval [1] 301938 0
23/09/2016
Approval date [1] 301938 0
21/11/2016
Ethics approval number [1] 301938 0
1217/16
Ethics committee name [2] 301944 0
Central Australian Human Research Ethics Committee Centre for Remote Health
Ethics committee address [2] 301944 0
Ethics committee country [2] 301944 0
Australia
Date submitted for ethics approval [2] 301944 0
24/04/2017
Approval date [2] 301944 0
01/06/2017
Ethics approval number [2] 301944 0
CA-17-2842
Ethics committee name [3] 301945 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [3] 301945 0
Ethics committee country [3] 301945 0
Australia
Date submitted for ethics approval [3] 301945 0
19/01/2017
Approval date [3] 301945 0
10/04/2017
Ethics approval number [3] 301945 0
2017-2737
Ethics committee name [4] 301946 0
Central Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [4] 301946 0
Ethics committee country [4] 301946 0
Australia
Date submitted for ethics approval [4] 301946 0
17/03/2017
Approval date [4] 301946 0
17/05/2017
Ethics approval number [4] 301946 0
HREC17/QCQ/9
Ethics committee name [5] 301947 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [5] 301947 0
Ethics committee country [5] 301947 0
Australia
Date submitted for ethics approval [5] 301947 0
24/03/2017
Approval date [5] 301947 0
01/06/2017
Ethics approval number [5] 301947 0
17/QCH/45-1143
Ethics committee name [6] 301948 0
Aboriginal Health Research Ethics Committee
Ethics committee address [6] 301948 0
Ethics committee country [6] 301948 0
Australia
Date submitted for ethics approval [6] 301948 0
18/09/2016
Approval date [6] 301948 0
20/10/2016
Ethics approval number [6] 301948 0
04-16-694
Ethics committee name [7] 301949 0
St. Vincent's Hospital (Melbourne) Human Research Ethics Committee
Ethics committee address [7] 301949 0
Ethics committee country [7] 301949 0
Australia
Date submitted for ethics approval [7] 301949 0
14/02/2017
Approval date [7] 301949 0
01/03/2017
Ethics approval number [7] 301949 0
LRR 036/17
Ethics committee name [8] 301950 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [8] 301950 0
Ethics committee country [8] 301950 0
Australia
Date submitted for ethics approval [8] 301950 0
06/04/2017
Approval date [8] 301950 0
22/09/2017
Ethics approval number [8] 301950 0
779

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

Contacts
Principal investigator
Name 88626 0
Prof Katherine Conigrave
Address 88626 0
Addiction Medicine,
C39, The University of Sydney
NSW 2006
Country 88626 0
Australia
Phone 88626 0
+61 02 9515 8650
Fax 88626 0
Email 88626 0
[email protected]
Contact person for public queries
Name 88627 0
Katherine Conigrave
Address 88627 0
Addiction Medicine,
C39, The University of Sydney
NSW 2006
Country 88627 0
Australia
Phone 88627 0
+61 02 9515 8650
Fax 88627 0
Email 88627 0
[email protected]
Contact person for scientific queries
Name 88628 0
Katherine Conigrave
Address 88628 0
Addiction Medicine,
C39, The University of Sydney
NSW 2006
Country 88628 0
Australia
Phone 88628 0
+61 02 9515 8650
Fax 88628 0
Email 88628 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
Ethical clearance has not been sought to broadly distribute potentially sensitive clinical data.


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSupporting Aboriginal Community Controlled Health Services to deliver alcohol care: Protocol for a cluster randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2019-030909
EmbaseEffects of service-wide support on regularity of alcohol screening of clients in Australian Aboriginal and Torres Strait Islander Community Controlled Health Services: a cluster randomised trial.2022https://dx.doi.org/10.1186/s13722-022-00294-6
EmbaseSupport for Aboriginal health services in reducing harms from alcohol: 2-year service provision outcomes in a cluster randomized trial.2022https://dx.doi.org/10.1111/add.15712
Dimensions AILow rates of prescribing alcohol relapse prevention medicines in Australian Aboriginal Community Controlled Health Services2023https://doi.org/10.1111/dar.13708
N.B. These documents automatically identified may not have been verified by the study sponsor.