Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001148864
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
26/08/2021
Date last updated
26/08/2021
Date data sharing statement initially provided
26/08/2021
Date results provided
26/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Hunter Way Back Support Service- a non-clinical care coordination service for people who have deliberately self-poisoned
Scientific title
The Way Back Support Service Evaluation Project: Recurrence of deliberate self-poisoning admissions following provision of nonclinical and practical support after deliberate self-poisoning
Secondary ID [1] 304878 0
None
Universal Trial Number (UTN)
Trial acronym
Hunter WBSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
self-harm 323003 0
deliberate self-poisoning 323198 0
Condition category
Condition code
Mental Health 320569 320569 0 0
Suicide
Injuries and Accidents 320930 320930 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Way Back Support Service (brief name- WBSS) is a suicide prevention aftercare service developed by Beyond Blue. It was developed to prevent repeat suicidal behaviour among people presenting to hospital following a suicide attempt by delivering person-centred, non-clinical and practical support for three months after discharge from hospital. The service provides community-based aftercare by linking people into existing health, clinical and community-based services to address their needs and support their safety.

The WBSS is delivered in the Hunter region (Australia) by Hunter Primary Care (a large mental health non-government organisation). Support coordinators hold a minimum Certificate IV Tafe Diploma in mental health and are supported by a clinical advisor (clinical psychologist). An integrated referral pathway with Calvary Mater Newcastle hospital was established, which allowed WBSS support coordinators to connect with eligible participants during hospital admissions.

As part of contact with the WBSS, participants complete a needs assessment, a safety plan, are provided with information about relevant supports and services and supported to engage with the services. This contact takes up to 1 hour. At the end of service provision, support coordinators develop a wellness plan with the client that includes steps to take in the event of a subsequent suicidal crisis. This contact takes up to 1 hour. A treatment summary is provided via letter to the nominated general practitioner and/or other clinical services.

WBSS contact can be face-to-face, phone, text or email and occurred in the place preferred by the participants (e.g. home, WBSS, café, etc). The exact number of contacts and focus of those contacts is dependent on participant preference and needs. Support can be provided for up to three months post-hospital discharge.

Adherence is measured by completion of needs assessment and safety plan.

The study period for the intervention cohort was 26 April 2016 (when the service commenced) to 30 September 2017. That is, an 18 month cohort of participants who were admitted to the Calvary Mater Newcastle after deliberate self-poisoning during the time the Way Back Support Service was available.
Intervention code [1] 321272 0
Treatment: Other
Intervention code [2] 321273 0
Rehabilitation
Intervention code [3] 321274 0
Behaviour
Comparator / control treatment
The control groups were offered ‘treatment as usual’ aftercare.

Treatment as usual aftercare could include support delivered by a range of health and mental health providers including general practitioners, private psychologists and psychiatrists, non-government organisations and through the public mental health service.

The historical control study periods were: 26 April 2011 to 30 September 2012 and 26 April 2013 to September 2014. Identification of historical controls and data relevant to hospital admissions in the follow-up period was extracted from hospital medical records, as per the process for the intervention cohort..
Control group
Historical

Outcomes
Primary outcome [1] 328388 0
Proportion of participants with any (one or more) Calvary Mater Newcastle deliberate self-poisoning readmissions as drawn from hospital medical records
Timepoint [1] 328388 0
12 months following participant's index admission in the study period.
Primary outcome [2] 328389 0
Number of Calvary Mater Newcastle deliberate self-poisoning readmissions as drawn from hospital medical records
Timepoint [2] 328389 0
12 months following participant's index admission in the study period.
Secondary outcome [1] 398872 0
Length of stay of Calvary Mater Newcastle deliberate self-poisoning readmissions as drawn from hospital medical records
Timepoint [1] 398872 0
12 months following participant's index admission in the study period.
Secondary outcome [2] 398873 0
Proportion of participants with any (one or more) psychiatric admissions within Hunter New England Local Health District as drawn from hospital medical records
Timepoint [2] 398873 0
12 months following participant's index admission in the study period.
Secondary outcome [3] 398874 0
Number of psychiatric admissions within Hunter New England Local Health District as drawn from hospital medical records.
Timepoint [3] 398874 0
12 months following participant's index admission in the study period.
Secondary outcome [4] 398875 0
Length of stay of Hunter New England Local Health District psychiatric inpatient admissions as drawn from hospital medical records
Timepoint [4] 398875 0
12 months following participant's index admission in the study period.

Eligibility
Key inclusion criteria
• Admitted to Calvary Mater Newcastle (Australia) hospital under Hunter Area Toxicology Service during study period.
• Deliberate self-poisoning as ingestion reason.
• 16+ years of age at time of index admission.
• Resided within Hunter region (Newcastle, Lake Macquarie, Port Stephens, Maitland, Cessnock, Singleton) before and after index admission.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Ingestion reason: unintentional, recreational, occupational, adverse effect, iatrogenic, bite/sting

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A non-randomised, three-armed, historical controlled trial design. The intervention period includes the first eighteen months of WBSS delivery (April 2016–September 2017) and outcomes for this cohort will be compared to outcomes to two historical control periods drawn from two 18-month epochs prior to the introduction of the WBSS (April 2011–September 2012; April 2013–September 2014). All participants were admitted to Calvary Mater Newcastle for deliberate self-poisoning during one of the cohort periods.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The power calculation was based on the following assumptions: a binary 12 month repetition rate of 15% was estimated from previous studies for hospital-treated deliberate self-harm populations (Carroll, Metcalfe & Gunnell, 2014), and a clinically meaningful absolute risk reduction of 5% for an expected repetition rate of 10% in the intervention cohort, with Alpha of 0.05 and 80% power. This calculation indicated that a minimum of 686 participants were required per arm of the trial.

Analyses for primary and secondary outcomes will be intention-to-treat using chi-square tests for differences in proportions for any event (binary), Poisson regressions for differences in number of events (count data) reported as Incidence Risk Ratios (IRR) with 95% Confidence Intervals, and Kruskal-Wallis median rank tests for differences in medians for non-normally distributed length of stay (days). For each analysis, the intervention cohort will be used as the referent category. Per-protocol analyses will be conducted comparing WBSS-exposed participants (low, medium and high WBSS exposure) with the historical control cohorts using the same analyses above.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/04/2016
Date of last participant enrolment
Anticipated
Actual
30/09/2017
Date of last data collection
Anticipated
Actual
30/04/2019
Sample size
Target
2058
Accrual to date
Final
2270
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20079 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 34787 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 309252 0
Charities/Societies/Foundations
Name [1] 309252 0
Beyond Blue
Country [1] 309252 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Locked Bag #7
Hunter Region Mail Centre
Warabrook, NSW 2310
Country
Australia
Secondary sponsor category [1] 310225 0
None
Name [1] 310225 0
Address [1] 310225 0
Country [1] 310225 0
Other collaborator category [1] 281924 0
Other
Name [1] 281924 0
Hunter Primary Care
Address [1] 281924 0
7 Warabrook Boulevard
Warabrook
NSW 2304
Country [1] 281924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309097 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309097 0
Ethics committee country [1] 309097 0
Australia
Date submitted for ethics approval [1] 309097 0
29/01/2016
Approval date [1] 309097 0
14/03/2016
Ethics approval number [1] 309097 0
16/02/17/5.05

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

Contacts
Principal investigator
Name 112962 0
Prof Greg Carter
Address 112962 0
Department of Consultation-Liaison Psychiatry, Calvary Mater Newcastle
School of Medicine and Public Health, University of Newcastle

Locked Bag #7 Hunter Region Mail Centre,
Warabrook, NSW 2310
Country 112962 0
Australia
Phone 112962 0
+61 2 4014 4926
Fax 112962 0
+61 2 4014 4933
Email 112962 0
[email protected]
Contact person for public queries
Name 112963 0
Greg Carter
Address 112963 0
Department of Consultation-Liaison Psychiatry, Calvary Mater Newcastle
School of Medicine and Public Health, University of Newcastle

Locked Bag #7 Hunter Region Mail Centre,
Warabrook, NSW 2310
Country 112963 0
Australia
Phone 112963 0
+61 2 4014 4926
Fax 112963 0
+61 2 4014 4933
Email 112963 0
[email protected]
Contact person for scientific queries
Name 112964 0
Greg Carter
Address 112964 0
Department of Consultation-Liaison Psychiatry, Calvary Mater Newcastle
School of Medicine and Public Health, University of Newcastle

Locked Bag #7 Hunter Region Mail Centre,
Warabrook, NSW 2310
Country 112964 0
Australia
Phone 112964 0
+61 2 4014 4926
Fax 112964 0
+61 2 4014 4933
Email 112964 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case by case basis at the discretion of the principal investigator, based on a methodologically sound proposal and relevant ethics approval being received.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access will be subject to approvals by principal investigator. Email address: [email protected].


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.