Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000542897
Ethics application status
Approved
Date submitted
10/03/2021
Date registered
7/05/2021
Date last updated
5/05/2022
Date data sharing statement initially provided
7/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-harm and suicidality in vulnerable prisoners: Evaluating a new service intervention involving a structured approach to risk assessment and management
Scientific title
Self-harm and suicidality in vulnerable prisoners: Evaluating a new service intervention involving a structured approach to risk assessment and management
Secondary ID [1] 303648 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicidality 321040 0
self-harm 321041 0
Condition category
Condition code
Mental Health 318843 318843 0 0
Suicide
Mental Health 319245 319245 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The focus of the study is an evaluation of the implementation of new documentation guidelines based on the structured professional judgment approach to suicide risk assessment and management, in a prison mental health unit. Suicide risk assessments on the unit are currently completed routinely as part of mental health assessments/reviews conducted by custodial mental health staff (mental health nurses and psychiatrists) however assessments vary between clinicians according to clinical skill and experience, and are often primarily focussed on current thoughts of suicide or self-harm. The ‘SLIPS’ documentation guidelines allow for both clinical judgement and the identification of empirically-derived risk factors specific to an offending population or within a custodial environment. It is intended as an additional resource to aid clinical decision making around prisoners at risk of suicide or self-harm. SLIPS is an acronym of Suicide, Legal, Individual, Psychiatric, Safety plan and represents evidence-based risk factors that should be considered during a prison suicide risk assessment and a guide to safety planning with at-risk prisoners.
- SUICIDE factors include: History of suicide attempts/self harm behaviours, seriousness, frequency, recency of attempts; experience of suicide (eg suicide of loved one); current suicidal cognitions (ideation & intent)
- LEGAL factors include: Legal status (remand/sentenced), stress around court, long sentence or likelihood of long sentence; nature of offence; victim factors – family/domestic violence/child related; and shame/guilt around offence; experience of custody – first time in custody, bullying/victimisation, poor coping with custodial environment, placement: protection/segregation
- INDIVIDUAL factors include: Case specific factors (idiosyncratic factors that may be related to this person’s risk); cultural considerations; stressors causing concern outside of prison eg family/relationship/financial/health; history of trauma and/or adverse childhood experiences; social supports/visits/family contact
- PSYCHIATRIC factors include: Mental Health History, diagnoses and treatment; current mental state: active symptoms, feelings of hopelessness, poor self esteem; future focus; coping; intoxication or withdrawal; compliance/response to biopsychosocial treatments
- SAFETY PLAN component is a structured safety and support plan to be completed or updated with the prisoner at each assessment and includes consideration of warning signs, internal coping strategies, supports, creating a safe environment, reasons for living.
The Safety Plan component of the guidelines involves a safety plan document being completed collaboratively between the staff member and patient at the first assessment to occur post-implementation. In subsequent sessions, a new safety plan will not be required but rather the clinician and patient will review and update it as necessary.

The guidelines will be used during all staff/patient interactions where a suicide risk assessment would usually occur and will be documented in the clinical notes as per the SLIPS acronym. In this unit, a suicide risk assessment would occur during all mental health reviews. The frequency of review varies from patient to patient but an initial assessment of approximately 60 minutes occurs upon admission to the unit which would include a suicide risk assessment (up to 30 mins), and subsequent mental health reviews including suicide risk assessments will occur as per the formal management plan for prisoners who are in camera cells (ie, daily, weekly reviews, etc as determined by treating team); and “as clinically required” for those in less restrictive placements on the unit. The guidelines will be used as an adjunct to the existing process of risk assessment rather than an additional intervention, it is therefore difficult to determine how often a patient will be subject to this intervention as patients' requirements, clinical presentation and length of stay in the unit vary. The SLIPS guidelines are intended to guide the clinician around the types of risk factors to consider or questions to ask during a risk assessment. Some of the information recorded in the clinical notes as per the SLIPS acronym will be gleaned from the patient interview (as part of the mental health review) and other information will be available to the clinician through other means (eg prior knowledge of this patient, available documentation, electronic patient information). As SLIPS is a guideline and not an assessment tool, strict fidelity is not required. It is anticipated that any use of the guidelines will improve on the existing process of clinical judgment alone. The researchers will monitor the clinical notes in the mental health unit on a monthly basis to determine whether the SLIPS acronym is being utilised.

A training package for suicide and self harm and SLIPS has been developed by the project lead for the Justice Health Towards Zero Suicides in Custody initiative, assisted by the research team (forensic psychiatrists and psychologists with experience in suicide risk management with offending populations). Health staff (nursing and medical) are in the process of being trained in the use of the guidelines with implementation to occur shortly. Training is conducted in small groups of staff, in person, with use of power-point presentation, practice scenarios and group discussion, facilitated by the project lead, Zero Suicides in Custody and the Mental Health Screening Unit Clinical Nurse Educator. Sessions take around one hour. The facilitators are responsible for ensuring that all health staff are trained prior to implementation and that any new staff to the unit post implementation receive training. Copies of the guidelines & manual will be accessible on the unit. A (psychiatrist) member of the project team and the clinical nurse educator, who work clinically on the mental health unit where the trial is taking place will provide assistance to staff on the use of the guidelines throughout implementation as required. The researchers will monitor the clinical notes in the mental health unit on a monthly basis to determine whether the SLIPS acronym is being utilised.
Intervention code [1] 319947 0
Prevention
Comparator / control treatment
We will be comparing unit level data (ie monthly rate and proportion of self-harm incidents) on the Mental Health Screening Unit, Metropolitan Reception and Remand Centre, extracted from electronic incident management systems for two years prior to intervention: Sept 2019 - Sept 2021 and one year post: Sept 2021 - Sept 2022)
Control group
Historical

Outcomes
Primary outcome [1] 326790 0
Number of self-harm incidents on unit per month, with self harm incidents defined as causing intentional harm to self, intentionally attempting to end one's life, or expressing thoughts to harm or kill oneself. Monthly incident reports for the unit will be extracted from electronic incident management systems and each incident cross-checked with clinical notes by the researchers.
Timepoint [1] 326790 0
for 12-months after the intervention is implemented (ie 12 months after the start date)
Secondary outcome [1] 392689 0
Proportion of patients on the on unit engaging in self-harm per month, with self harm incidents defined as causing intentional harm to self, intentionally attempting to end one's life, or expressing thoughts to harm or kill oneself. Monthly incident reports for the unit will be extracted from electronic incident management systems and each incident cross-checked with clinical notes by the researchers. The researchers will determine the proportion by calculating Number of Patients who self-harm in a month divided by the number of beds and express this as a percentage.
Timepoint [1] 392689 0
for 12-months after the intervention is implemented (ie 12 months after the start date)

Eligibility
Key inclusion criteria
Admitted to the Mental Health Screening Unit at Metropolitan Reception and Remand Centre for the 2 years prior to intervention being implemented and 1 year post.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We will be evaluating data on incidents on the unit for 24 months pre implementation (using retrospective data) and for 12 months post implementation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will utilise a quasi-experimental design: an Interrupted Time Series (ITS) analysis will be employed to test the effects of the implementation of the SLIPS guidelines in the unit. Routinely collected data on self-harm incidents is available through the Justice Health and Corrective Services electronic incident reporting systems. As a long pre-intervention phase is recommended to increase power to detect secular trends, monthly baseline data will be obtained retrospectively for a period of 24 months pre-implementation. 12 months of post-implementation data will be collected, resulting in a total of 36 data points for analysis. Outcome measures will be the rate of self-harm (number of self-harm incidents in the unit per month) and the proportion of self-harm (number of patients on the unit engaging in self-harm per month). Data will be subject to a segmented regression analysis to examine if any trends are observed in rates and proportion of self-harm over the data collection period and whether there has been any significant effect of the intervention

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308069 0
Charities/Societies/Foundations
Name [1] 308069 0
Suicide Prevention Australia
Country [1] 308069 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 308803 0
Government body
Name [1] 308803 0
Justice Health and Forensic Mental Health Network
Address [1] 308803 0
1300 Anzac Parade, Malabar NSW 2036
Country [1] 308803 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308059 0
Justice Health and Forensic Mental Health Network HREC
Ethics committee address [1] 308059 0
Ethics committee country [1] 308059 0
Australia
Date submitted for ethics approval [1] 308059 0
05/04/2021
Approval date [1] 308059 0
08/02/2022
Ethics approval number [1] 308059 0
2021/ETH00391
Ethics committee name [2] 308271 0
Corrective Services Ethics Committee
Ethics committee address [2] 308271 0
Ethics committee country [2] 308271 0
Australia
Date submitted for ethics approval [2] 308271 0
28/04/2021
Approval date [2] 308271 0
13/01/2022
Ethics approval number [2] 308271 0
Ethics committee name [3] 308272 0
Aboriginal Health and Medical Research Council Ethics Committee
Ethics committee address [3] 308272 0
Ethics committee country [3] 308272 0
Australia
Date submitted for ethics approval [3] 308272 0
25/05/2021
Approval date [3] 308272 0
Ethics approval number [3] 308272 0

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

Contacts
Principal investigator
Name 109378 0
Prof Kimberlie Dean
Address 109378 0
School of Psychiatry
Level 1, AGSM Building
UNSW
Sydney NSW 2052
Country 109378 0
Australia
Phone 109378 0
+61 2 9700 3830
Fax 109378 0
Email 109378 0
[email protected]
Contact person for public queries
Name 109379 0
Christie Browne
Address 109379 0
School of Psychiatry
Level 1, AGSM Building
UNSW
Sydney NSW 2052
Country 109379 0
Australia
Phone 109379 0
+61 2 9700 3858
Fax 109379 0
Email 109379 0
[email protected]
Contact person for scientific queries
Name 109380 0
Kimberlie Dean
Address 109380 0
School of Psychiatry
Level 1, AGSM Building
(Gate 11 Botany Street)
UNSW
Sydney NSW 2052
Country 109380 0
Australia
Phone 109380 0
+61 2 9700 3830
Fax 109380 0
Email 109380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Highly sensitive data involving incidents of self-harm in vulnerable sample (incarcerated, mental health issues).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10948Study protocol    381580-(Uploaded-08-04-2022-11-38-32)-Study-related document.pdf



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.