Condition category
Mental and Behavioural Disorders
Date applied
25/04/2018
Date assigned
26/04/2018
Last edited
26/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Rates of self-harm in prisoners are high and have been increasing for some years. Nearly a decade ago, the Ministry of Justice (MoJ) implemented Assessment, Care in Custody and Teamwork (ACCT), a risk management plan, to collect all important information for prisoners considered at risk of self-harm and suicide, to assist in reducing self-harm and suicide in prisons. In 2015-16, there were 34,586 reported incidents of self-harm in prisons, 7,271 more than the previous year (a 27% increase). Reducing self-harm and deaths by suicide in custody has been in the forefront of policy and strategy implementation from the MoJ. Self-harm in prisoners has considerable detrimental impacts on an individual’s health, social wellbeing, and may disrupt reintegration on release. It also affects other prisoners and staff as self-harm can be traumatic to witness. Additionally, it carries major resource and cost implications for healthcare in prison and external hospitals. Reduction of such risk is therefore important for the MoJ, the NHS, and public health more generally. The aim of this study is to create a risk assessment tool that can be used in prisons to predict risk of self-harm for prisoners that have just been discharged from ACCT, who are at higher risk of further self-harm.

Who can participate?
Prisoners who have been on ACCT for an episode of self-harm (including threats of self-harm)

What does the study involve?
The study has three parts. The first part involves the development of a risk assessment tool using existing data collected as part of another project. The tool aims to identify the risk of repeat self-harm within 3 months after closure of any ACCT. The second part of the study focuses on assessing the acceptability of this new tool to relevant stakeholders, including prisoners, clinicians and prison staff, and examines barriers to implementation. The researchers work with staff and prisoners over 12 months to develop an implementation and operational pathway to embed the new tool within existing ACCT and post-ACCT procedures and other relevant processes. Participants (staff and prisoners) meet monthly for one year for that purpose. The third part involves testing the instrument’s ability to predict risk of further self-harm (and suicide) in a cohort of prisoners at the end of their ACCTs. A sample of prisoners in London, Buckinghamshire, Lancashire and Yorkshire prisons are approached for permission to access their records. Prisoners are not interviewed but the tool is used to score their self-harm risk according to their records and also "follow up" their prison records for 3 months to identify new episodes of self-harm (and also suicide) in custody.

What are the possible benefits and risks of participating?
Prisoners are not interviewed so there are no direct risks or benefits for individuals. All data collected is anonymised at source. If the research succeeds in developing an effective risk assessment tool that accurately predicts who remains at risk of further self-harming behaviour following the closure of their ACCT, there is the potential for individualised interventions for prisoners at risk to prevent further self-harm or suicide. It therefore could enable the development of effective care pathways to adequately support those at the highest risk of further self-harming behaviour, by intervening before recurrence occurs. Such pathways could be beneficial not only for prisoners at risk but also their families, prisoners potentially affected by witnessing self-harm, and professionals. Furthermore, it could lead to resource savings for the criminal justice system and subsequently free up resources for the wider prison population to access association, activities, and other services, such as treatment programmes available in prison.

Where is the study run from?
1. University of Oxford (UK)
2. Barnet Enfield and Haringey Mental Health Trust (UK)
3. University of Manchester (UK)
4. University of York (UK)

When is the study starting and how long is it expected to run for?
June 2018 to May 2021

Who is funding the study?
NIHR Health Technology Assessment Programme (UK)

Who is the main contact?
1. Prof. Seena Fazel
2. Dr Artemis Igoumenou

Trial website

https://www.journalslibrary.nihr.ac.uk/programmes/hta/1615909/#/

Contact information

Type

Scientific

Primary contact

Prof Seena Fazel

ORCID ID

Contact details

Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Type

Scientific

Additional contact

Dr Artemis Igoumenou

ORCID ID

Contact details

Camlet One
Specialist Services
Chase Farm Hospital
The Ridgeway
Enfield
London
EN2 8JL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 16/159/09

Study information

Scientific title

Development and validation of a risk assessment tool for self-harm in prisoners

Acronym

RAPS

Study hypothesis

Self-harm in prisons is an important cause of morbidity, and led to 2,455 hospital attendances over one year from English and Welsh prisons. Additionally, research investigating patterns of self-harm in English and Welsh prisons have found that it is a risk factor for suicide in custody, which has also been identified as a key challenge for prisons. The effects of self-harm on maintaining and exacerbating underlying mental health problems have been described, and add to the heavy burden of psychiatric morbidity in prisons. Managing self-harm is known to cause stress to prison and medical staff working in prisons.

From an NHS perspective, beyond the immediate consequences of external hospital attendances of individuals that self-harm in prison, most individuals in prison return to the community, and health problems will need addressing, including any physical injuries arising from severe self-harm and ongoing mental health problems. The immediate period after being released from prison has been reported to have one of high risk of accidental death and suicide.

This NIHR themed call is opportune as a valid instrument to predict risk of self-harm/suicide is much needed due to increasing prison self-harm and suicide rates. Placing at risk prisoners on Assessment, Care in Custody and Teamwork process (ACCT) has proven effective in managing risk during the period of observation. However, evidence suggests that risk increases again following ACCT closure. An effective risk tool aimed at the period following closure will enable the implementation of care-pathways to limit further episodes of self-harm and suicide.

Ethics approval

Not provided at time of registration

Study design

This is an observational study and has three parts:
1. Development of a risk assessment tool
2. Qualitative part to assess the acceptability of the new tool to relevant stakeholders
3. Prospective study to assess predictive ability of the study in a cohort of prisoners

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Risk of self-harm in prison settings

Intervention

This study has three parts:
1. Development of a risk assessment tool. In the first year of this project, the trialists will develop the tool using routinely collected data from prison healthcare records and ACCT documents.
2. Qualitative study. The qualitative part of the project will assess the acceptability of this new tool to relevant stakeholders including prisoners, clinicians and prison staff, and examine barriers to implementation. The trialists will use action learning processes.
3. Prospective study. The third part will involve testing the instrument’s ability to predict risk of further self-harm (and suicide) in a cohort of prisoners at the end of their ACCTs. The sample will be from prisons in London, Buckinghamshire, Lancashire and Yorkshire and will be followed up for 3 months to identify new episodes of self-harm (and also suicide) in custody. The new tool will be administered and scored by three researchers (two based in London and Oxford and one in Manchester) working independently from prison ACCT teams so that the tool's performance will not be affected by changes to the management of prisoners based on the tool’s score.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Risk of self-harm is measured using the new risk assessment tool (RAPS) developed at the time of ACCT closure. Outcome is the number of self-harm episodes (and suicide) as well as the number of days between completion of the tool and the end of follow-up period (3 months post ACCT closure)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2018

Overall trial end date

31/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male prisoners who have been on ACCT for an episode of self harm (incl. threats of self harm)
2. Female prisoners who have been on ACCT for an episode of self harm (incl. threats of self harm)
3. Remand and sentenced prisons in UK (London, Buckinghamshire, Lancashire, Yorkshire)

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

Number of participants will be calculated based on results of Part 1 of the project (development of the risk assessment tool).

Participant exclusion criteria

Male and female adult prisoners who have been on ACCT for reasons other than episodes of self harm (incl. threats of self harm)

Recruitment start date

01/06/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
OX3 7JX

Trial participating centre

Barnet Enfield and Haringey Mental Health Trust
EN2 8JL

Trial participating centre

University of Manchester
M13 9PL

Trial participating centre

University of York
YO10 5DD

Sponsor information

Organisation

University of Oxford

Sponsor details

Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol will be available online via the NIHR website. The trialists are planning to publish two journal articles – one on the qualitative study, and one based on the development and validation of the tool. They intend to make conference presentations and to present our findings to prison charities, internal events at the Ministry of Justice and Safer Custody, and the Royal College of Psychiatrists Quality Network for Prison Mental Health Services.

IPD sharing statement
The data sharing plans for the current study are not finalised and will be made available at a later date.

Intention to publish date

31/05/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes