Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001680853
Ethics application status
Approved
Date submitted
16/08/2021
Date registered
9/12/2021
Date last updated
13/04/2023
Date data sharing statement initially provided
9/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised and contingency-based interventions for suicide risk.
Scientific title
Personalised and contingency-based interventions for suicide risk: A cluster randomised controlled trial in an Australian veteran community sample.
Secondary ID [1] 305053 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide risk 323255 0
Condition category
Condition code
Mental Health 320827 320827 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open Arms - Veterans & Families Counselling (Open Arms) is Australia’s leading provider of high quality, nationally accredited, mental health care for veterans and their families. A key service delivery arm of the Department of Veterans’ Affairs, Open Arms provides free and confidential 24-hour counselling and support.

Any current and former Australian Defence Force (ADF) member with one day continuous full-time service can receive support through Open Arms, as can their partners and children.

There is no limit on the number of counselling sessions a person receives through Open Arms, support is provided based on clinical need.

Open Arms services include: counselling for individuals, couples and families; care coordination for clients with more complex needs; group programs to develop skills and enhance support; lived experience mental health peer support; after-hours telephone counselling and telehealth; mental health literacy and suicide awareness training; information, education and self-help resources; and referrals to other services or specialist treatment programs, as needed.

Clients receiving care from an Open Arms clinician (psychologist or accredited mental health social worker), in the intervention condition, will be assessed for suicide risk utilising the Open Arms Risk Assessment (OARA) template. The OARA is a tool developed by Open Arms to deliver a personalised and contingency-based response to suicide risk. The template contains the Columbia Suicide Severity Rating Scale (C-SSRS) and standardised assessment questions related to risk of harm to self. The OARA tool supports clinicians in the development of a risk formulation and safety plan.

For this research, the personalised and contingency-based approach being utilised is the SafeSide Framework for Recovery-Oriented Suicide Prevention (SafeSide).

SafeSide is a formulation-based approach to suicide risk assessment with a focus on planning rather than prediction. It is widely accepted that suicide cannot be predicted, therefore this model aims to assess the vulnerability and strengths of individual clients; and develop plans to mitigate risk and extend supports. The Framework unites mental health professionals through a shared framework that focusses on four core goals of person-centred suicide care: Connect – Assess – Respond – Extend.

Risk formulation is an approach to suicide risk assessment, which comprises a concise synthesis of empirically based suicide risk information regarding a client’s immediate distress and resources at a specific time and place. The goal of this synthesis is not to predict behaviour but to promote communication and collaboration among professionals, client, and families to reduce risk in the short and long term.

This study is a cluster randomised controlled trial (CRCT) whereby clinicians are randomly allocated to two conditions, a) standard care, without training (control group), and b) standard care, with training and implementation support (intervention group). Clinician and client outcomes between groups, and within groups, will be compared.

InPlace Learning is SafeSide’s approach to sustainable, engaging work-force training by combining video-based instruction with live group interaction. Video instruction is delivered by Dr Pisani and co-led by lived experience consultant and patient advocate, Kristina Mossgraber. Open Arms will provide the core training online to clinicians across two half day sessions.

Upon completion of the training:
• Clinicians will be able to name three foundational goals for forming productive collaborations with clients and their families to address suicide risk.
• Given a scenario, clinicians will be able to communicate a prevention-oriented risk formulation, orally and in writing.
• Clinicians will be able to name four key domains to document in a short-term response to suicide risk to facilitate care and minimize liability.
• Clinicians will be able to state at least two steps their own organization or program can take to strengthen care transitions.

Following training, clinicians join the SafeSide community of practice which provides them access to expert supervision during monthly Office Hours, as well as regular updates, new modules and refreshers throughout the year.
Intervention code [1] 321449 0
Prevention
Comparator / control treatment
Clients receiving care from an Open Arms clinician in the control condition will be assessed for suicide risk utilising the Risk Assessment and Management Plan template. The RAMP is a tool developed by Open Arms to assess risk and protective behaviours. The template contains 4 screening questions and 18 standardised assessment questions related to risk of harm to self. The tool is based on the Commonwealth of Australia Living is For Everyone (LIFE) Framework (2007) and has not been validated. The RAMP tool results in a categorical determination of risk level expressed as either high, medium or low.
Control group
Active

Outcomes
Primary outcome [1] 328627 0
Safety plan quality measured by a standardised chart extraction tool. The assessment will include Safety Plan completeness (e.g., whether each step of the plan is completely documented) and Safety Plan quality (e.g., the degree to which the safety plan items reflect multiple, detailed, and personalised responses).
Timepoint [1] 328627 0
Assessment of Safety Plan quality will occur at the following time points in line with standard care: at the commencement of care (baseline), by completion of the third session (care plan), and monthly thereafter until case closure. Clinical records that are posted within three months after the index safety plan will also be reviewed to determine whether clients a) attended additional sessions after the episode of care in which they were identified as at-risk, b) had a subsequent hospital admission, and c) attempted suicide post-safety plan intervention.
Secondary outcome [1] 399752 0
Distress measured by the Kessler Psychological Distress Scale (K10).
Timepoint [1] 399752 0
By completion of the third session (care plan), and monthly thereafter until case closure.
Secondary outcome [2] 403256 0
Suicidal ideation and behaviours measured by the Columbia Suicide Severity Rating Scale (C-SSRS).
Timepoint [2] 403256 0
By completion of the third session (care plan), and monthly thereafter until case closure.
Secondary outcome [3] 403994 0
Treatment engagement measured by session attendance and the Working Alliance Inventory – Short Revised (WAI-SR).
Timepoint [3] 403994 0
By completion of the third session (care plan), and monthly thereafter until case closure.
Secondary outcome [4] 403995 0
Connection to supports will be assessed by the chart extraction. This will include, but not limited to, involvement of family and/or friends, involvement of peer workers, referral and collaboration with external supports and services.
Timepoint [4] 403995 0
By completion of the third session (care plan), and monthly thereafter until case closure.
Secondary outcome [5] 403996 0
Implementation effectiveness measured by the NoMAD instrument based on Normalisation Process Theory; clinician confidence in risk assessment skills (pre/post) and the Perception of Training Transfer Scale (post-only) (Pisani et al 2012; Pisani et al, in press; Pisani et al 2012; Cross et al 2019; Holton et al 2000; Holton et al 2007); and social network analysis (Bunger et al, 2018).
Timepoint [5] 403996 0
Pre/post-training and at 3 month and 6 month follow-up.

Eligibility
Key inclusion criteria
Data for the following groups will be collected as part of standard care:
• Clients aged over 18 years with a positive screen for suicide risk.
• Clinicians and mental health peer workers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Data will be excluded for clients who have not provided informed consent.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To ensure balance when allocating to the two conditions, on the basis of location and size, a minimisation approach will be adopted. Sites will be de-identified before allocation so that the person conducting the allocation (independent of the researchers) will be blinded to the sites.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The proposed study will use a cluster randomised controlled trial (CRCT) design to evaluate the implementation of a personalised and contingency-based approach to suicide risk. The approach will be compared to treatment as usual on a range of client outcome measures. Clinicians will be grouped according to location and randomised to commence training at two time points, six months apart. A comparison of intervention effect and control condition between groups will occur during this period, as well as an assessment of implementation effectiveness.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This study intends to utilise the records of clients who receive care between February 2022 and September 2022. The sample will include those who have screened positively for suicide risk at point of intake. Based on the previous 12 months of service utilisation data, the estimated number of client records will be between 1,500 and 2,000.

To detect a small effect (d=0.2) between the two groups with 90% power will require a sample of N=704. Conservatively accounting for missing data from up to 20% of participants, and clustering of participants within clinicians (up to a design effect of 1.1), we will aim to recruit a sample of N=1,000 at intake, which is highly feasible based on the estimated client population of 1,500 to 2,000, and a large clinician population over 1,000 in total.

Data-file preparation and preliminary analyses will be conducted using SPSS version 24, while substantive analyses will then be conducted using SPSS or STATA.

First, a series of descriptive analyses will be conducted to summarise the characteristics of clients and clinicians, as well as:

• The number of clients being identified with a positive risk screen;
• The number of risk assessments being completed;
• The rate of involvement of others;
• The proportion of safety plans to risk assessments; and
• The rate of session attendance.

Further analyses will comprise regression analyses which will identify factors that may explain variance in clinical practice (e.g., frequency of assessments) and implementation of the SafeSide Framework.

Between group differences will be examined using two-way ANOVAs or linear mixed models.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
As above, the clinician training is no longer being implemented.
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
30/12/2022
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309450 0
Government body
Name [1] 309450 0
Department of Veterans' Affairs
Country [1] 309450 0
Australia
Primary sponsor type
Government body
Name
Open Arms - Veterans & Families Counselling
Address
GPO Box 9998, Brisbane, QLD, 4001.
Country
Australia
Secondary sponsor category [1] 311462 0
Individual
Name [1] 311462 0
Jennifer Veitch
Address [1] 311462 0
Open Arms - Veterans & Families Counselling
GPO Box 9998, Brisbane, QLD, 4001.
Country [1] 311462 0
Australia
Other collaborator category [1] 282084 0
Individual
Name [1] 282084 0
Jennifer Veitch, Co-Principal Investigator
Address [1] 282084 0
Open Arms - Veterans & Families Counselling.
21 Genge Street, Canberra, 2601.
Country [1] 282084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309243 0
Departments of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [1] 309243 0
Ethics committee country [1] 309243 0
Australia
Date submitted for ethics approval [1] 309243 0
08/04/2021
Approval date [1] 309243 0
16/08/2021
Ethics approval number [1] 309243 0
355-21

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

Contacts
Principal investigator
Name 113466 0
Prof Philip Batterham
Address 113466 0
The Australian National University, 63 Eggleston Road, Canberra, ACT, 2600.
Country 113466 0
Australia
Phone 113466 0
+61 02 61251031
Fax 113466 0
Email 113466 0
Philip.batterham@anu.edu.au
Contact person for public queries
Name 113467 0
Jennifer Veitch
Address 113467 0
Open Arms - Veterans & Families Counselling
GPO Box 9998, Brisbane, QLD, 4001.
Country 113467 0
Australia
Phone 113467 0
+61 02 62896474
Fax 113467 0
Email 113467 0
jennifer.veitch@dva.gov.au
Contact person for scientific queries
Name 113468 0
Jennifer Veitch
Address 113468 0
Open Arms - Veterans & Families Counselling
GPO Box 9998, Brisbane, QLD, 4001.
Country 113468 0
Australia
Phone 113468 0
+61 02 62896474
Fax 113468 0
Email 113468 0
jennifer.veitch@dva.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is linked to client care.


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.