Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000232336
Ethics application status
Approved
Date submitted
23/04/2008
Date registered
7/05/2008
Date last updated
11/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Passports to Advantage: Health and capacity building as a basis for social integration
Scientific title
Passports to Advantage: Evaluation of the impact of a health and psychosocial intervention package on health and offending outcomes for 1,500 adult prisoners released from custody in Queensland in 2008 and 2009
Secondary ID [1] 557 0
409966: National Health and Medical Research Council (NHMRC)
Universal Trial Number (UTN)
Trial acronym
Passports
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-release physical and mental health and health risk behaviours of ex-prisoners 3088 0
Access to and use of health services by ex-prisoners 3089 0
The incidence and timing of recidivism by ex-prisoners 3090 0
Condition category
Condition code
Mental Health 3245 3245 0 0
Addiction
Public Health 3246 3246 0 0
Epidemiology
Other 3247 3247 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detailed, tailored feedback on health and psychosocial assessment and targeted referrals for support following release from prison: provision of a ‘Positives Stories’ booklet upon release; weekly telephone calls during the first 4 weeks post-release and access to a 1800 number to assist with referrals and support during the first 6 months post-release
Intervention code [1] 2828 0
Prevention
Intervention code [2] 2829 0
Lifestyle
Intervention code [3] 2830 0
Behaviour
Comparator / control treatment
Usual care (Participants in the control group may receive treatment and support from government and non-government agencies in the community), plus basic feedback from pre-release health and psychosocial assessment
Control group
Active

Outcomes
Primary outcome [1] 4128 0
Physical health (Pre-release Short Form (SF36), a generic outcome measure of 36 items designed to examine a person's perceived health status; post-release Short Form (SF8), a generic outcome measure of 8 items designed to examine a person's perceived health status )
Timepoint [1] 4128 0
at baseline and 4,12, 26 weeks post-release
Primary outcome [2] 4129 0
Mental health (Kessler 10 to measure Psychological Distress)
Timepoint [2] 4129 0
at baseline and 4,12, 26 weeks post-release
Primary outcome [3] 288302 0
Access to and use of health services (self-report at 1, 3 and 6 months; linkage with Medicare Australia data 2 years post-release)
Timepoint [3] 288302 0
1 month, 3 months, 6 months and 2 years post release
Secondary outcome [1] 6959 0
Alcohol and drug use (Alcohol Use Disorders Identification Test, AUDIT; Self-report questions on drug use and substitution treatment; Alcohol, Smoking and Substance Involvement Screening Test, ASSIST)
Timepoint [1] 6959 0
at baseline and 4,12, 26 weeks post-release
Secondary outcome [2] 6960 0
Percieved social support (Enriched Social Support Inventory)
Timepoint [2] 6960 0
at baseline and 4,12, 26 weeks post-release
Secondary outcome [3] 6961 0
Self-report accommodation status
Timepoint [3] 6961 0
at baseline and 4,12, 26 weeks post-release
Secondary outcome [4] 6962 0
Vocational and Educational Training (Self-report educational level, employment status and income)
Timepoint [4] 6962 0
at baseline and 4,12, 26 weeks post-release
Secondary outcome [5] 299791 0
Reoffending (linkage with correctional data)
Timepoint [5] 299791 0
2 years post-release

Eligibility
Key inclusion criteria
Currently incarcerated within a participating correctional centre in Queensland.
Expected date of release from custody is between 3 and 6 weeks from date of interview.
Currently sentenced on all charges.
Aged 17 years or over.
Provides written, informed consent to participate.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently suffering from a significant psychiatric and/or intellectual disability, such that the individual is unable to provide fully informed consent.
Previously participated in this project (given the high proportion of short sentences and recidivism).
Participants who are under a Dangerous Prisoner Sex Offender Act (DPSOA) order.
Participants who are on remand or facing further charges.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In designated recruitment centres, each week Queensland Corrective Services staff will provide the investigators with a list of all prisoners expecting to be released from custody within the succeeding six weeks. Potential participants will be escorted to the prison medical centre, where they will meet with one of the study team in a private setting. The nature and purpose of the study will be explained in language appropriate to the individual. Those who choose to participate will be asked to sign a consent form, written in plain language and requesting consent for:
Participation by the prisoner in a confidential pre-release health assessment;
Access by the study team, for research purposes, to the individual’s prison health records; health records from Medicare Australia;
Permission to contact individuals at specific intervals post-release, for research purposes.
Consent can only be partially informed because of the need to maintain blindness with regard to the ‘Passports’ intervention.

Before the results of the health assessment are entered into the study database, a member of the study team who is unaware of the individual’s pre-release health assessment will allocate each participant to the intervention or control group, using a coded list of random permutation in blocks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer generated list of random permutation (one for each stratum) will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
18/08/2008
Date of last participant enrolment
Anticipated
Actual
1/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 826 0
QLD 4000 - 4895
Recruitment postcode(s) [2] 827 0
QLD 9726

Funding & Sponsors
Funding source category [1] 3339 0
Government body
Name [1] 3339 0
National Health and Medical Research Council (NHMRC)
Country [1] 3339 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Population Health, University of Queensland, Level 1, Public Health Building, Herston Road, Herston, QLD 4006
Country
Australia
Secondary sponsor category [1] 2984 0
None
Name [1] 2984 0
Address [1] 2984 0
Country [1] 2984 0
Other collaborator category [1] 274 0
Government body
Name [1] 274 0
Queensland Corrective Services
Address [1] 274 0
PO Box 1054, Brisbane QLD 4001
Country [1] 274 0
Australia
Other collaborator category [2] 276947 0
University
Name [2] 276947 0
The University of Melbourne
Address [2] 276947 0
School of Population Health, The University of Melbourne
Level 4, 207 Bouverie St, Carlton, VIC 3010
Country [2] 276947 0
Australia
Other collaborator category [3] 276948 0
Government body
Name [3] 276948 0
Queensland Health
Address [3] 276948 0
Queensland Health Building, 147-163 Charlotte Street, Brisbane, Qld 4000
Country [3] 276948 0
Australia
Other collaborator category [4] 276949 0
Other Collaborative groups
Name [4] 276949 0
Burnet Institute
Address [4] 276949 0
Centre for Population Health, 85 Commercial Road, Prahran, Vic 3004
Country [4] 276949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5363 0
University of Queensland's Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 5363 0
Ethics committee country [1] 5363 0
Australia
Date submitted for ethics approval [1] 5363 0
Approval date [1] 5363 0
11/07/2007
Ethics approval number [1] 5363 0
2007000607

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

Contacts
Principal investigator
Name 28552 0
A/Prof Stuart A. Kinner
Address 28552 0
School of Population Health, The University of Melbourne. Level 4, 207 Bouverie St, Carlton, VIC 3010
Country 28552 0
Australia
Phone 28552 0
+61 3 9035 7598
Fax 28552 0
Email 28552 0
[email protected]
Contact person for public queries
Name 11709 0
Stuart A. Kinner
Address 11709 0
School of Population Health, The University of Melbourne. Level 4, 207 Bouverie St, Carlton, VIC 3010
Country 11709 0
Australia
Phone 11709 0
+61 3 9035 7598
Fax 11709 0
+61 9348 1174
Email 11709 0
[email protected]
Contact person for scientific queries
Name 2637 0
Stuart A. Kinner
Address 2637 0
School of Population Health, The University of Melbourne. Level 4, 207 Bouverie St, Carlton, VIC 3010
Country 2637 0
Australia
Phone 2637 0
+61 3 9035 7598
Fax 2637 0
+61 9348 1174
Email 2637 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseEarly primary care physician contact and health service utilisation in a large sample of recently released ex-prisoners in Australia: Prospective cohort study.2015https://dx.doi.org/10.1136/bmjopen-2015-008021
N.B. These documents automatically identified may not have been verified by the study sponsor.