Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000162415
Ethics application status
Approved
Date submitted
15/01/2016
Date registered
10/02/2016
Date last updated
22/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
JOURNEY TO SOCIAL INCLUSION MARK II: A randomised control trial to assess a modified homelessness intervention (J2SI Mark II) for chronically homeless adults in Melbourne
Scientific title
JOURNEY TO SOCIAL INCLUSION MARK II: A randomised control trial to assess a modified homelessness intervention (J2SI Mark II) on mental health & wellbeing, social & economic participation and housing stability in chronically homeless adults in Melbourne
Secondary ID [1] 288329 0
nil known
Universal Trial Number (UTN)
Trial acronym
J2SI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic homelessness 297303 0
Condition category
Condition code
Other 297499 297499 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
Deliver intensive individualised support for up to 3 years to 60 people experiencing long-term homelessness in areas of high prevalence in metropolitan Melbourne. Enhanced J2SI service model will operate across 5 key service elements:
1.Intensive case management & service coordination
2.Tenancy support and capacity building to maintain housing
3.Trauma informed practice
4.Skills for inclusion
5.Fostering independence

Year 1 has a focus on accessing housing and staying housed using a sustaining tenancies approach with the assistance of a Key Worker (6:1 client ratio). Year 2 shifts the engagement to a team approach to coach and empower clients to progress goals (6:1 client ratio). Year 3 will focus on supporting clients to strengthen their connection with their local community and broader system, and increase a sense of social inclusion through enhanced social and economic activity (12:1 client ratio).

1. How each component will be administered.
- Each component is administered by the Intensive Case Manager (ICM) through approximately 5 hours per week of client work.
- This includes direct and indirect contact with the client using a case management approach that is tailored to the individual.
- Because support plans are individualised each component and its delivery are in response to the clients identified goals, the time allocation varies for each component to ensure tailored and responsive interventions.
- Each component is administered through the process of case management and service co-ordination- some provided directly by ICMs and some by other services coordinated by J2SI ICM, these may be individual, group activities, in an office, in the home, or community. It is all tailored to provide the best response to achieving goals as negotiated by the client.

2. Frequency and duration
- Frequency is tailored, but overall between 3-5 hours per week (6-10 per fortnight), is attributed to each client (includes admin/ travel time).
- Allocation of time (duration) is tailored to meet the agreed support plans, if it takes 5 short visits or 1 extended visit with the client, then this is provided each week.
- But clients need to be offered same amount of support over a monthly period so all clients receive the same allocation of intervention.

3. Brief description of any strategies used to monitor adherence to the intervention
- Fortnightly supervision reviews by supervisors- to confirm intervention is provided as per model
- 6 monthly case file audits
- 6 weekly clinical supervision of staff
- Case reviews
- Practice reflections
- Support plans are used to set goals, identify service interventions, and monitor progress
- Outcomes survey completed by client as part of case management are also used every 6 months (for those consenting) to track outcomes
- Monthly reports by ICMs and Coordinator, and Manager
- SHIP reports that provide breakdown of time, and identify that all 5 outcome areas of J2SI are being translated into support plan during the three years
- Partnership agreements with specialist and mainstream agencies have regular reviews to ensure compliance.
Intervention code [1] 293626 0
Lifestyle
Comparator / control treatment
Treatment as usual (comparison group) will not be prevented from accessing services and will not be impacted on their current level of support. However, they will not receive intensive individualised support under the J2SI intervention.
Control group
Active

Outcomes
Primary outcome [1] 297059 0
Changes in mental health & wellbeing, assessed by DASS21, S-WEMWBS, K10, SISES and linked administrative data from mental health operational data store (ODS), Victorian Admitted Episodes Dataset (VAED) and Victorian Emergency Minimum Dataset (VEMD).
Timepoint [1] 297059 0
At baseline, then 6, 12, 18, 24, 30, 36 and 48 months after baseline (8 time points in total).
Primary outcome [2] 297060 0
Change in social participation assessed by ESSI, 3-item loneliness scale, and self-report data on friends, family and community connections and participation.
Timepoint [2] 297060 0
At baseline, then 6, 12, 18, 24, 30, 36 and 48 months after baseline (8 time points in total).
Primary outcome [3] 297061 0
Change in capacity for independence assessed by 'independent living skills-homelessness' which is an assessment tool designed specifically for this study
Timepoint [3] 297061 0
At baseline, then 6, 12, 18, 24, 30, 36 and 48 months after baseline (8 time points in total).
Secondary outcome [1] 319941 0
Change in economic participation assessed by self-report and linked administrative data on employment status and income earned.
Timepoint [1] 319941 0
At baseline, then 6, 12, 18, 24, 30, 36 and 48 months after baseline (8 time points in total).
Secondary outcome [2] 319942 0
Sustained permanent housing (ability to obtain and maintain a housing tenancy) by linked administrative data from the housing/public housing tenants database (the HiiP database)
Timepoint [2] 319942 0
At baseline, then 6, 12, 18, 24, 30, 36 and 48 months after baseline (8 time points in total).
Secondary outcome [3] 319999 0
Change in health outcomes measured by self report data and linked administrative data from the Victorian Admitted Episodes Dataset (VAED) and Victorian Emergency Minimum Dataset (VEMD)
Timepoint [3] 319999 0
Annual analysis of linked data (but also retrospectively looking at data prior to program entry)
Secondary outcome [4] 320000 0
Compare the cost effectiveness of the program against treatment as usual in relation to service usage, emergency admissions, and contact with justice services by linked administrative data from the Victorian Admitted Episodes Dataset (VAED) and Victorian Emergency Minimum Dataset (VEMD)
Timepoint [4] 320000 0
Annual analysis of linked data (but also retrospectively looking at data prior to program entry)
Secondary outcome [5] 320661 0
Change in health service usage measured by self report data and linked administrative data from the Victorian Admitted Episodes Dataset (VAED) and Victorian Emergency Minimum Dataset (VEMD)
Timepoint [5] 320661 0
Annual analysis of linked data (but also retrospectively looking at data prior to program entry)

Eligibility
Key inclusion criteria
1) Have been sleeping rough continuously for more than a year OR who are homeless and have experienced several episodes of homelessness over the past three years OR who are currently permanently housed, are at risk of homelessness and have been homeless at some point in the last six months; AND
2) Have received some level of case management response from Sacred Heart Misson, VincentCare, St Marys House of Welcome OR are well engaged with an on-site Program but have been unable to secure a case management response; AND
3) Are aged between 25 – 50 years; AND
4) Are a permanent resident; AND
5) Are eligible to access public and/or community housing; AND
6) Agree to participate in the program.
Minimum age
25 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) People who are currently receiving other long term intensive support (e.g., Street2Home); OR
2) People experiencing language barriers that require an interpreter service but budget constraints limit the ability to provide interpreter service support; OR
3) People experiencing an unmanaged mental illness of a severe nature affecting an ability to provide consent and complete a survey even with a guardian present; OR
4) People who for any reason are unable to a) give informed consent or b) participate fully in the intervention or study even with guardian present; OR
5) People deemed by agency staff to pose an identifiable safety risk to agency staff, researchers, other people or the participant themselves.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque sealed envelopes method (SNOSE) will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are three allocation sites for this study (Sacred Heart Mission, VincentCare and St Mary's House of Welcome). Each of these sites will have equal chance of allocation into treatment group, therefore 3 sets of envelopes will be prepared.
A specified number of Group A and Group B envelopes will be placed in each of the three piles. Each of the three piles will be shuffled and numbered separately. Piles to be shuffled by independent person to the study and once shuffled numbered in numerical order (written on front of envelope, a carbon paper inside envelope to copy onto allocation slip to prevent tampering of order).
Participants will then select the next envelope in the container.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have calculated the power of our sample based on the Depression, Anxiety, Stress Scale (DASS) which is a well-known scale we are using in the study. Evidence from studies with similar population groups indicate that in relation to the Depression component of the scale, the difference in the response of matched pairs is normally distributed with standard deviation 8. If the true difference in the mean response of matched pairs is 5, we will need to study a minimum of 22 pairs of subjects to be able to reject the null hypothesis that this response difference is zero with probability (power) 80%. The Type I error probability associated with this test of this null hypothesis is alpha=0.05. If the project study attrition rate is 30% then a minimum recruitment sample of 32 pairs needed. In terms of Anxiety and Stress see below:

DASS Anxiety delta=3.7, sd=6 n=23 in each group
DASS stress delta=4.8, sd=9 n=30 in each group
The sample sizes in the study are around twice n numbers listed above.

While the minimum sample size required for this study is 64 participants, Sacred Heart Mission has funding to provide this program to 60 participants and thus 120 participants in total (60 treatment, 60 treatment as usual), due to the likely attrition in the treatment as usual group we have allowed for sampling of 70 participants.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/01/2016
Actual
8/01/2016
Date of last participant enrolment
Anticipated
29/02/2016
Actual
30/09/2016
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
130
Accrual to date
Final
186
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292697 0
Charities/Societies/Foundations
Name [1] 292697 0
Sacred Heart Mission
Country [1] 292697 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 291423 0
University
Name [1] 291423 0
Swinburne University of Technology
Address [1] 291423 0
John St
Hawthorn VIC 3122
Country [1] 291423 0
Australia
Other collaborator category [1] 278774 0
Charities/Societies/Foundations
Name [1] 278774 0
Sacred Heart Mission
Address [1] 278774 0
87 Grey Street
St Kilda VIC 3182
Country [1] 278774 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294176 0
HREC Univeristy of Western Australia
Ethics committee address [1] 294176 0
Ethics committee country [1] 294176 0
Australia
Date submitted for ethics approval [1] 294176 0
21/10/2015
Approval date [1] 294176 0
08/12/2015
Ethics approval number [1] 294176 0
RA/4/1/7904

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 707 707 0 0
/AnzctrAttachments/369929-J2SI Study protocol Final.pdf
Attachments [2] 708 708 0 0
/AnzctrAttachments/369929-Ethics Approval.pdf

Contacts
Principal investigator
Name 62774 0
Prof Paul Flatau
Address 62774 0
Centre for Social Impact, University of Western Australia (M098) 35 Stirling Hwy, Crawley, WA 6009
Country 62774 0
Australia
Phone 62774 0
+61 8 6488 1366
Fax 62774 0
Email 62774 0
[email protected]
Contact person for public queries
Name 62775 0
Paul Flatau
Address 62775 0
Centre for Social Impact, University of Western Australia (M098) 35 Stirling Hwy, Crawley, WA 6009
Country 62775 0
Australia
Phone 62775 0
+61 8 6488 1366
Fax 62775 0
Email 62775 0
[email protected]
Contact person for scientific queries
Name 62776 0
Paul Flatau
Address 62776 0
Centre for Social Impact, University of Western Australia (M098) 35 Stirling Hwy, Crawley, WA 6009
Country 62776 0
Australia
Phone 62776 0
+61 8 6488 1366
Fax 62776 0
Email 62776 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
No additional documents have been identified.