Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000333910
Ethics application status
Not required
Date submitted
20/02/2020
Date registered
10/03/2020
Date last updated
13/07/2021
Date data sharing statement initially provided
10/03/2020
Date results provided
13/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A systematic review and meta-analysis of predictors and outcomes of compulsory community treatment for severe mental illness in Australia and New Zealand
Scientific title
A systematic review and meta-analysis of predictors and outcomes of compulsory community treatment for severe mental illness in Australia and New Zealand
Secondary ID [1] 300717 0
PROSPERO acknowledgement of receipt [155996]
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe mental illness 316367 0
Condition category
Condition code
Mental Health 314628 314628 0 0
Schizophrenia
Mental Health 314629 314629 0 0
Psychosis and personality disorders
Public Health 314777 314777 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 for compulsory psychiatric treatment. These require
people with mental disorders to reside at a specified place, and to attend specified treatment
programs that include psychoeducation and rehabilitation. Orders can also enforce medication.
Intervention code [1] 316923 0
Not applicable
Comparator / control treatment
People on voluntary psychiatric treatment in the community. This includes voluntarily taking psychiatric medications, attending sessions with a mental health clinician or participating in psychosocial rehabilitation
Control group
Active

Outcomes
Primary outcome [1] 322956 0
Admission to hospital for a psychiatric condition
Timepoint [1] 322956 0
At least 12 months and up to no more than 10 years from entry into the study.
Primary outcome [2] 322957 0
Bed-days spent in hospital for psychiatric illness
Timepoint [2] 322957 0
At least 12 months and up to no more than 10 years from entry into the study
Primary outcome [3] 322958 0
The number of clinical encounters with mental health clinicians as an outpatient or in a community setting
Timepoint [3] 322958 0
At least 12 months and up to no more than 10 years from entry into the study
Secondary outcome [1] 380361 0
Psychiatric symptoms as measured by a standardised psychiatric instrument such as the Health of the Nation Outcome Scales
Timepoint [1] 380361 0
At least 12 months and up to no more than 10 years from entry into the study
Secondary outcome [2] 380362 0
Compliance with psychiatric treatment in terms of taking psychotropic medication as directed.
Timepoint [2] 380362 0
At least 12 months and up to no more than 10 years from entry into the study.
Secondary outcome [3] 380363 0
Employment as defined by full or part-time work or study
Timepoint [3] 380363 0
At least 12 months and up to no more than 10 years from entry into the study.
Secondary outcome [4] 380364 0
Contacts with the criminal justice system as defined by any arrest, conviction or imprisonment
Timepoint [4] 380364 0
At least 12 months and up to no more than 10 years from entry into the study.

Eligibility
Key inclusion criteria
Inclusion criteria will be any randomised controlled trial or quasi experimental study conducted in Australia or New Zealand that compares people on compulsory community treatment for severe mental illness who are subject to civil commitment. with controls receiving voluntary psychiatric treatment.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude studies of compulsory treatment in the community for drug or alcohol dependence and community treatments for mentally or behaviourally disordered offenders, as well as any design that does not compare people on a community treatment order with with controls receiving voluntary psychiatric treatment.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
We will include the following study designs in the systematic review and meta-analysis: randomised controlled trials, cohort studies, case control and cross-sectional studies. Where data are available for two or more studies, they will be combined in a meta-analysis using programmes such as RevMan, Comprehensive Meta-analysis or Win_Pepi . We will combine data using the mean difference or standardised mean difference, as appropriate, for continuous data, and the relative risk (RR) for any dichotomous outcome, assessing for publication bias where there are at least 10 studies. Where we encounter a situation where data for the same outcome are presented in some studies as dichotomous data and in others as continuous data, we will combine them using statistical approaches as recommended in the Cochrane Reviewer’s Handbook. These techniques re-express standardized mean differences as log odds ratios allowing dichotomous and continuous data to be pooled together using inverse variance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/01/2020
Date of last participant enrolment
Anticipated
15/04/2020
Actual
15/04/2020
Date of last data collection
Anticipated
15/04/2020
Actual
15/04/2020
Sample size
Target
230000
Accrual to date
Final
218034
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22370 0
New Zealand
State/province [1] 22370 0

Funding & Sponsors
Funding source category [1] 305030 0
University
Name [1] 305030 0
University of Queensland Summer Scholarship Programme
Country [1] 305030 0
Australia
Primary sponsor type
Individual
Name
Prof Steve Kisely
Address
PA-Southside Clinical Unit l School of Clinical Medicine
Faculty of Medicine l The University of Queensland
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 305390 0
None
Name [1] 305390 0
Address [1] 305390 0
Country [1] 305390 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 305426 0
Ethics committee address [1] 305426 0
Ethics committee country [1] 305426 0
Date submitted for ethics approval [1] 305426 0
Approval date [1] 305426 0
Ethics approval number [1] 305426 0

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

Contacts
Principal investigator
Name 100338 0
Prof Steve Kisely
Address 100338 0
PA-Southside Clinical Unit,
School of Clinical Medicine
Faculty of Medicine,
The University of Queensland
Level 4, Building 1, Princess Alexandra Hospital,
Ipswich Road, Woolloongabba, QLD 4102
Country 100338 0
Australia
Phone 100338 0
+61731769568
Fax 100338 0
Email 100338 0
[email protected]
Contact person for public queries
Name 100339 0
Steve Kisely
Address 100339 0
PA-Southside Clinical Unit,
School of Clinical Medicine
Faculty of Medicine,
The University of Queensland
Level 4, Building 1, Princess Alexandra Hospital,
Ipswich Road, Woolloongabba, QLD 4102
Country 100339 0
Australia
Phone 100339 0
+61731769568
Fax 100339 0
Email 100339 0
[email protected]
Contact person for scientific queries
Name 100340 0
Steve Kisely
Address 100340 0
PA-Southside Clinical Unit,
School of Clinical Medicine
Faculty of Medicine,
The University of Queensland
Level 4, Building 1, Princess Alexandra Hospital,
Ipswich Road, Woolloongabba, QLD 4102
Country 100340 0
Australia
Phone 100340 0
+61731769568
Fax 100340 0
Email 100340 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
EmbaseA systematic review and meta-analysis of predictors and outcomes of community treatment orders in Australia and New Zealand.2021https://dx.doi.org/10.1177/0004867420954286
N.B. These documents automatically identified may not have been verified by the study sponsor.