Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000153516
Ethics application status
Approved
Date submitted
11/01/2024
Date registered
16/02/2024
Date last updated
9/02/2025
Date data sharing statement initially provided
16/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
An exploration of variations in community treatment orders across Australia: A retrospective cohort study of prevalence
Scientific title
An exploration of variations in community treatment orders across Australia: A retrospective cohort study of prevalence
Secondary ID [1] 311308 0
DP230100967
Universal Trial Number (UTN)
Trial acronym
FACTORS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 332558 0
Severe mental illness 332560 0
Condition category
Condition code
Mental Health 329248 329248 0 0
Depression
Mental Health 329249 329249 0 0
Other mental health disorders
Mental Health 329250 329250 0 0
Psychosis and personality disorders
Mental Health 329251 329251 0 0
Schizophrenia
Public Health 329252 329252 0 0
Epidemiology
Public Health 329253 329253 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Community Treatment Orders (CTOs) enforce mental health treatment and have been signalled by some as a serious violation of human rights while others consider them as necessary protection. Australia has high rates by world standards, and variations in rates of use occur within jurisdictions that remain unexplained. This project aims to explain the drivers underpinning variations in the use of CTOs.

This is a retrospective cohort study of prevalence using aggregated administrative health data from the Australian Institute of Health and Welfare (AIHW). We examined the prevalence of CTO use amongst people with contact with community mental health services in Queensland, New South Wales, Victoria and South Australia during 2018. The data were further stratified by age, sex, First Nations status, region of birth, and marital status. Health districts within the state jurisdictions were ranked relative to CTO prevalence (i.e., high CTO users vs low CTO users).
Intervention code [1] 327757 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator/ control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337079 0
Differences between health districts with high and low use of CTOs in terms of the number of people on CTOs.
Timepoint [1] 337079 0
Between 01/01/2018 - 31/12/2018.
Secondary outcome [1] 431471 0
Differences between health districts with high and low use of CTOs in terms of the duration of CTOs.
Timepoint [1] 431471 0
Between 01/01/2018 - 31/12/2018.
Secondary outcome [2] 431473 0
Differences between health districts with high and low use of CTOs in terms of the sociodemographic profiles of people on CTOs.
Timepoint [2] 431473 0
Between 01/01/2018 - 31/12/2018.

Eligibility
Key inclusion criteria
All patients aged 18 years or older (as of 01/01/2018) who had a new or existing CTO between 01/01/2018 - 31/12/2018, based on aggregated AIHW data.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
We will use descriptive statistics to measure the percentage of people in contact with community mental health services, across health districts, within each state jurisdiction, who were on a CTO at any time in 2018. The unit of analysis will be the individual health district. Health districts will be excluded if they are specific to subspecialties such as forensic or child and adolescent psychiatry. Health districts will be ranked by frequency of CTO use in each state jurisdiction, and standard error bars will be plotted.

We will the assess the unadjusted significance of associations between CTO use and the following dichotomised sociodemographic variables in each state jurisdiction using odds ratios and 95% confidence intervals: age (25-44 years old vs all other ages), sex, single status (never married vs all other categories), identified as First Nations or not, and born in Oceania vs elsewhere.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
Actual
29/12/2023
Date of last data collection
Anticipated
27/12/2024
Actual
Sample size
Target
276000
Accrual to date
Final
276000
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 315562 0
Government body
Name [1] 315562 0
NHMRC
Country [1] 315562 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
414 La Trobe St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 317653 0
None
Name [1] 317653 0
Address [1] 317653 0
Country [1] 317653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314460 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 314460 0
Ethics committee country [1] 314460 0
Australia
Date submitted for ethics approval [1] 314460 0
02/02/2023
Approval date [1] 314460 0
14/03/2023
Ethics approval number [1] 314460 0
HREC/2023/QMS/94340

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

Contacts
Principal investigator
Name 131662 0
Prof Lisa Brophy
Address 131662 0
La Trobe University Melbourne Victoria 3086
Country 131662 0
Australia
Phone 131662 0
+61 438544097
Fax 131662 0
Email 131662 0
[email protected]
Contact person for public queries
Name 131663 0
Tessa-May Zirnsak
Address 131663 0
La Trobe University Melbourne Victoria 3086
Country 131663 0
Australia
Phone 131663 0
+61 404994722
Fax 131663 0
Email 131663 0
[email protected]
Contact person for scientific queries
Name 131664 0
Steve Kisely
Address 131664 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 131664 0
Australia
Phone 131664 0
+61 7 3176 9568
Fax 131664 0
Email 131664 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data used in this study was aggregate-level data supplied by the AIHW. The research team are not able to share this data.



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
No additional documents have been identified.