ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Public Health

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]

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]

Admission to hospital for a psychiatric condition

Timepoint [1]

At least 12 months and up to no more than 10 years from entry into the study.

Primary outcome [2]

Bed-days spent in hospital for psychiatric illness

Timepoint [2]

At least 12 months and up to no more than 10 years from entry into the study

Primary outcome [3]

The number of clinical encounters with mental health clinicians as an outpatient or in a community setting

Timepoint [3]

At least 12 months and up to no more than 10 years from entry into the study

Secondary outcome [1]

Psychiatric symptoms as measured by a standardised psychiatric instrument such as the Health of the Nation Outcome Scales

Timepoint [1]

At least 12 months and up to no more than 10 years from entry into the study

Secondary outcome [2]

Compliance with psychiatric treatment in terms of taking psychotropic medication as directed.

Timepoint [2]

At least 12 months and up to no more than 10 years from entry into the study.

Secondary outcome [3]

Employment as defined by full or part-time work or study

Timepoint [3]

At least 12 months and up to no more than 10 years from entry into the study.

Secondary outcome [4]

Contacts with the criminal justice system as defined by any arrest, conviction or imprisonment

Timepoint [4]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland Summer Scholarship Programme

Address [1]

Research Strategy and Support Office, Faculty of Medicine
Level 6, UQ Oral Health Centre (Bldg. 883)
288 Herston Road, Herston
The University of Queensland
Brisbane Qld 4072 Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

There is conflicting and equivocal evidence for the efficacy of compulsory community treatment (CCT) within Australia and overseas. In addition, although people from Indigenous or culturally and linguistically diverse backgrounds are over-represented in terms of incarceration and compulsory admissions to hospital, little is known about whether this also applies to compulsory community treatment. A previous review of compulsory community treatment worldwide did include some studies from Australia but had several limitations. Firstly it did not include several more recent studies and secondly, it only presented analyses of unadjusted data. In non-randomised studies such as cohort, case control and cross-sectional studies it is important to adjust for potential confounders to adjust for the possibility that people on compulsory community treatment may differ in important ways from voluntary controls. In addition, the review only considered admissions, bed-dsay and community contacts and did not consider other outcomes such as clinical features. Finally, it did not consider predictors of compulsory community treatment placement. 

This systematic review and meta-analysis therefore aims to assess predictors of CCT placement and whether people from Indigenous or culturally and linguistically diverse backgrounds are more likely to be on compulsory community treatment in Australia and New Zealand, as well as assess the subsequent effect on a range of health service, clinical and psychosocial outcomes.

Trial website

Trial related presentations / publications

Public notes

Ethical approval is not required for this systematic review & meta-analysis as all included intervention data has been previously published with ethical approval and is in the public domain.
We estimate there will be 29 papers from 16 papers that will be eligible for inclusion

Contacts

Principal investigator

Name

Prof Steve Kisely

Address

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

Australia

Phone

+61731769568

Fax

s.kisely@uq.edu.au

Contact person for public queries

Name

Steve Kisely

Address

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

Australia

Phone

+61731769568

Fax

s.kisely@uq.edu.au

Contact person for scientific queries

Name

Steve Kisely

Address

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

Australia

Phone

+61731769568

Fax

s.kisely@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	A systematic review and meta-analysis of predictors and outcomes of community treatment orders in Australia and New Zealand.	2021	https://dx.doi.org/10.1177/0004867420954286

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically