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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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)
Address [1] 3339 0
Office of the NHMRC
Level 2, Fishburn House
Furzer Street
WODEN ACT 2606
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 Officer
Office of Research and Postgraduate Studies
Cumbrae - Stewart Building
Research Road
University of Queensland QLD 4072
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
Prisoners as a group are characterised by chronic social disadvantage, high rates of risky drug use, and poor physical and mental health. Many prisoners enter custody with these problems, and despite the existence of intervention programs in prison, many leave prison with the same problems. This is particularly true of women and Indigenous prisoners.
Little is known about what happens to prisoners once they return to the community – what we do know is that the majority will re-offend at some point in their life, and that almost a third will return to prison within two years of release. In the weeks following release, ex-prisoners also face a massively increased risk of premature death due to drug overdose, accidents, suicide and other causes. Despite this, the few post-release programs that do exist for ex-prisoners in Australia are fragmented, under-funded and based on limited evidence. This project will conduct a randomised, controlled trial of a post-release intervention for adult prisoners in Queensland. Participants will undergo a comprehensive health assessment prior to release, and before release will receive a ‘health passport’ which will encourage and empower them to seek out appropriate health and psychosocial support in their local community. Participants will also receive telephone support from trained support staff, in the first 4 weeks following release. These 4 weeks are known to be a critical time for the reintegration of ex-prisoners. The impact of the Passport to Advantage intervention will be assessed through telephone interviews 4, 12 and 26 week post-release, and by accessing correctional and health (Medicare Australia) records for participants two years post-release. The findings of the study will inform the development of an evidence-based post-release intervention for prisoners in Australia and elsewhere, as well as providing an unprecedented insight into the post-release experiences of prisoners in Queensland.
Trial website
Trial related presentations / publications
Kinner, Lennox, Jamrozik, Haswell-Elkins, Williams & Alati: Passports to advantage: Health and capacity building of prisoners after release: International Association for the Scientific Study of Intellectual Disability (IASSID) 13th World Congress, Capetown, South Africa, 25-30 August 2008. Kinner: Passports to Advantage: Health and capacity building as a basis for reintegration of female ex-prisoners. What Works with Women Offenders: Challenging Stereotypes and Achieving Change, 2nd International Conference, Prato, Italy, 10-12 September 2007. Kinner: Passports to Advantage: Improving health and reducing drug-related harm among recently released prisoners. Alcohol and Drug Foundation, Queensland: Winter School in the Sun Conference, Brisbane, 2 July 2007. Kinner: Passports to Advantage: Health and capacity building as a basis for social integration (keynote paper). The Reintegration Puzzle: Collaborating in Support Conference, Sydney, Australia, 7-8 May 2007. Kinner, S.A., Dietze, P.M., Gouilloiu, M. & Alati, R. (in press). Prevalence and correlates of alcohol dependence in adult prisoners vary according to Indigenous status. Australian and New Zealand Journal of Public Health. Kinner, S. A. (2008). Passports to advantage: Health and capacity building as a basis for social integration. Flinders Journal of Law Reform, 10(3), 581-589. Kinner, S. A., Lennox, N. G., & Taylor, M. (2009). Randomised controlled trial of a post-release intervention for prisoners with and without an intellectual disability. Journal on Developmental Disabilities, 15(2), 72-76. Kinner, S. A., Jenkinson, R., Gouilou, M. & Milloy, M-J. (2012). High-risk drug-use practices among a large sample of Australian prisoners. Drug and Alcohol Dependence, doi 10.1016/j.drugalcdep.2012.05.008. van Dooren K, Claudio F, Kinner SA & Williams M. (2012). Beyond reintegration: a framework for understanding ex-prisoner health, International Journal of Prisoner Health, 7(4), 26-36. Kinner SA, Moore E, Spittal MJ & Indig D. (2013). Opiate substitution treatment to reduce in-prison drug injection: A natural experiment, Int J Drug Policy, 24, 460-463. David M, Alati R, Ware RS & Kinner SA. (2013). Attrition in a longitudinal study with hard-to-reach participants was reduced by ongoing contact, J Clin Epidemiol, 66(5), 575-581. Dias S, Ware RS, Lennox NG & Kinner SA. (2013). Co-occurring mental disorder and intellectual disability in a large sample of Australian prisoners, ANZ J Psychiatry, 47(1), 938-944. Moore R, Winter R, Indig D, Greenberg D & Kinner SA. (2013). Non-fatal overdose among adult prisoners with a history of injecting drug use in two Australian states, Drug and Alcohol Dependence, 133, 45-51. Kinner SA, Lennox N, Williams G, Carroll M, Quinn B, Boyle F & Alati R (2013). Randomised controlled trial of a service brokerage intervention for ex-prisoners in Australia, Contemporary Clinical Trials, 36, 198-206. van Dooren K, Kinner SA & Richards A. (2013). Complex health needs among young, soon-to-be-released prisoners, Health and Justice, 1:1.
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
s.kinner@unimelb.edu.au
Contact person for public queries
Name 11709 0
A/Prof 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
s.kinner@unimelb.edu.au
Contact person for scientific queries
Name 2637 0
A/Prof 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
s.kinner@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary