Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000153516
Ethics application status
Approved
Date submitted
11/01/2024
Date registered
16/02/2024
Date last updated
16/02/2024
Date data sharing statement initially provided
16/02/2024
Date results information 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 anonymous population-based linked administrative health data from Queensland, New South Wales, Victoria and South Australia. The cohort for linkage will include all individuals aged 18 years and older as of 01/01/2018 with any community mental health service use record between 01/01/2018 - 31/12/2022. These data will be linked to admitted patient data collection and community mental health service use records between 01/01/2016 - latest available, as well as death registration records from 01/01/2018 - latest available. Using a retrospective cohort design, we will examine the prevalence of CTOs (new and existing) among adults aged 18 years and older from 01/01/2018 – 31/12/2018. We will also examine the mental health service use (community and admitted) patterns of these individuals in the 2-years prior to their new or existing CTO.
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 and clinical 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, as identified in each states’ community mental health dataset (QLD = CIMHA, NSW = NSW Mental Health Ambulatory Data Collection, VIC = CMI/ODS, SA = CBIS) who were on a CTO.
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
The Student’s t, Mann-Whitney U-test, Kruskal-Wallis H-test, Wilcoxon signed-ranks test and Pearson’s chi-squared test will initially be used to examine differences between health districts with high and low use of CTOs in terms of the number of people on CTOs, and the sociodemographic and clinical profiles of people on CTOs. CTO duration and time to readmission will be assessed using Kaplan–Meier survival analyses. These will be followed by multivariate analyses to control for confounding variables at either the health service or individual level. We will use logistic, multiple or Poisson regression as appropriate, to compare CTO use between health services. Predictor variables for each regression model will include jurisdiction/relevant legislation, health service and patient characteristics, including age, gender, Indigenous status, ethnicity, marital status, occupation and diagnosis. Predictors of the duration of CTOs and time to readmission will be addressed using Cox regression.

Adjusting for confounders: The models will be adjusted for age, area-level socio-economic status, rurality and state as above.

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
199 Ipswich Rd, Woolloongabba, QLD, 4102
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
People with mental illness often have to accept medication and other treatments in the community through the use of community treatment orders (CTOs). Yet forced treatment remains one of the most contentious issues in mental health service delivery; its efficacy is unresolved, its usage is irregular and unequal, and it raises serious ethical and human rights concerns. Responses to these debates must be informed by valid and reliable data. This study will be the first to investigate the justifications for CTOs across Australia to allow greater understanding of the variance in rates of CTOs and enable appropriate action by stakeholders. The primary aim of this study is to analyse data on the sociodemographic and clinical features of people on CTOs across Australia comparing similar services across Australia to understand the wide variation in their use nationwide.
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
L.Brophy@latrobe.edu.au
Contact person for public queries
Name 131663 0
Ms 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
t.zirnsak@latrobe.edu.au
Contact person for scientific queries
Name 131664 0
Prof 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
s.kisely@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a data linkage study using large datasets with de-identified data under the jurisdiction of data custodians.


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.