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Trial registered on ANZCTR


Registration number
ACTRN12624000152527
Ethics application status
Approved
Date submitted
7/02/2024
Date registered
16/02/2024
Date last updated
16/02/2024
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 case-control study of incidence
Scientific title
An exploration of variations in community treatment orders across Australia: A retrospective case-control study of incidence
Secondary ID [1] 311491 0
DP230100967
Universal Trial Number (UTN)
Trial acronym
FACTORS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 332819 0
Severe mental illness 332820 0
Condition category
Condition code
Mental Health 329536 329536 0 0
Depression
Mental Health 329537 329537 0 0
Other mental health disorders
Mental Health 329538 329538 0 0
Psychosis and personality disorders
Mental Health 329539 329539 0 0
Schizophrenia
Public Health 329540 329540 0 0
Epidemiology
Public Health 329541 329541 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 case-control study of incidence 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 case-control cohort design, we will compare the incidence of admitted patient discharges onto CTOs (exposure group) between 01/01/2018 - 31/12/2022 compared to admitted patient discharges onto voluntary community treatment (comparator group) around the same time (plus or minus 6-months). The exposure group will be matched to comparator group 1:1 on sex and age (as far as possible). Patterns of mental health service use (community and admitted) will be examined in the two years prior to their first discharge onto CTO or voluntary community treatment (herein referred to as the "index date"), as well as 12-months after the index date. Patient deaths after the index date will also be counted.
Intervention code [1] 327941 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator group will comprise individuals who were discharged from an inpatient stay onto voluntary community treatment around the same time (plus or minus 6-months) as the exposure group. They will be matched to exposure group members 1:1 on sex and age (as far as possible).
Control group
Active

Outcomes
Primary outcome [1] 337334 0
Differences between exposure group and comparator groups in the 12-months post index date based on the number of hospital admissions.
Timepoint [1] 337334 0
Between 01/01/2018 - 31/12/2022.
Secondary outcome [1] 431480 0
Differences between exposure group and comparator groups in the 12-months post index date based on the average number of bed-days (i.e., length of stay).
Timepoint [1] 431480 0
Between 01/01/2018 - 31/12/2022.
Secondary outcome [2] 431481 0
Differences between exposure group and comparator groups in the 12-months post index date based on the number of contacts with community mental health services.
Timepoint [2] 431481 0
Between 01/01/2018 - 31/12/2022.

Eligibility
Key inclusion criteria
Exposure group: all patients aged 18 years or older (as of 01/01/2018) who were (i) discharged from inpatient psychiatric hospital stays (based on ICD-10-AM codes F00-F99) between 01/01/2018 – 31/12/2022; (ii) placed on a CTO at discharge (specifically, we are only interested in their first placement on CTO at discharge during this period i.e., the index date); and (iii) who continued their treatment in a community mental health service within 30 days of their hospital discharge.

Comparator group: all patients aged 18 years or older (as of 01/01/2018) who were (i) discharged from inpatient psychiatric hospital stays (based on ICD-10-AM codes F00-F99) between 01/01/2018 - 31/12/2022; and (ii) who voluntarily continued their treatment in a community mental health service within 30 days of their hospital discharge.
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
Case control
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 compare the sociodemographic, clinical and health service use patterns of exposure and comparator groups as appropriate. We will use logistic, multiple or Poisson regression as appropriate, depending on the type of comparisons being conducted between exposure and comparator groups. 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.

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] 315778 0
Government body
Name [1] 315778 0
NHMRC
Country [1] 315778 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 317903 0
None
Name [1] 317903 0
Address [1] 317903 0
Country [1] 317903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314638 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 314638 0
https://metrosouth.health.qld.gov.au/research/about-us/hrec
Ethics committee country [1] 314638 0
Australia
Date submitted for ethics approval [1] 314638 0
02/02/2023
Approval date [1] 314638 0
14/03/2023
Ethics approval number [1] 314638 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 understand differences in sociodemographic, clinical and health service use patterns (hospital and community) between individuals discharged onto CTOs compared to voluntary treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132242 0
Prof Lisa Brophy
Address 132242 0
La Trobe University Melbourne Victoria 3086
Country 132242 0
Australia
Phone 132242 0
+61 438544097
Fax 132242 0
Email 132242 0
[email protected]
Contact person for public queries
Name 132243 0
Tessa-May Zirnsak
Address 132243 0
La Trobe University Melbourne Victoria 3086
Country 132243 0
Australia
Phone 132243 0
+61 404994722
Fax 132243 0
Email 132243 0
[email protected]
Contact person for scientific queries
Name 132244 0
Steve Kisely
Address 132244 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 132244 0
Australia
Phone 132244 0
+61 7 3176 9568
Fax 132244 0
Email 132244 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
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.