Core Outcome Measures in Effectiveness Trials

Engager 2: Developing and evaluating a collaborative care intervention for offenders with common mental health problems, near to and after release.

General Information

Summary:
The development of a set of outcome measures is part of a larger project to develop and evaluate a complex intervention for prisoners with common mental health problems who are coming to the end of their sentence.

Offenders, while in prison and after release, suffer from a range of health problems. More than half have a mental health problem of some kind, with many having two or more. While prison healthcare has improved in the last decade, mental health care is minimal except for those with the severest problems; care after leaving prison is particularly lacking for those with short sentences. We suggest addressing offenders’ mental health problems would lead to considerable gains: to offenders’ own health; to the wellbeing of their families and communities; along with wider economic and social benefits due to reductions in reoffending.

This project will develop and evaluate a complex clinical and organisational intervention for offenders with mental health problems who are near to release. It will ensure a collaborative approach between health and criminal justice services. The project will be based at two sites, one in the North West and one in the South West and will be divided into two phases. The first phase has been divided into work streams:

Work stream 1 – Developing a theoretical model of intervention:
Work stream 2 – Methodological development:
Work stream 4 – Economic modelling

The researchers will work closely with people who have previously been in prison or subject to the criminal justice system (CJS), along with prison and community healthcare providers, to develop the model for the intervention. We will also be developing an appropriate set of outcome measures in order to evaluate the intervention. As with the intervention, we will engage people from a range of backgrounds and undertake field testing to generate an acceptable and informative set of outcome measures.

The study has two phases. Phase I will develop the intervention to be used in the trial (work stream 1), create an outcome set and develop the process measures (work stream 2) and incorporate economic modelling of potential costs and benefits (work stream 4). Phase II will include the exploratory trial to evaluate the intervention.

Contributors:
Prof Richard Byng – Plymouth University (Chief Investigator)
Prof Jenny Shaw – University of Manchester (PI for NW site)
Dr Alex Stirzaker –
Amy Stewart – Plymouth University
Dr Cath Quinn – Plymouth University
Dr Charlotte Lennox - University of Manchester
Mr Charlie Taylor – Plymouth University
Dr Christabel Owens – University of Exeter
Dr Deborah Shenton – Plymouth University
Dr Gill McGauley – St George’s, University of London
Dr Graham Durcan – Centre for Mental Health
Isabel Adeyemi – University of Manchester
Dr Mark Haddad – City University London
Dr Mark Pearson – University of Exeter
Prof Mike Maguire –
Dr Nat Wright – Leeds Community Healthcare NHS Trust
Rachael Hunter – UCL
Dr Rob Anderson – University of Exeter
Prof Rod Taylor – University of Exeter
Dr Sarah Brand – Plymouth University
Sean Duggan – Centre for Mental Health
Prof Susan Michie – UCL
Dr Tim Kirkpatrick – Plymouth University
Dr Tirril Harris – Institute of Psychiatry, KCL
Prof William Henley – University of Exeter

Further Study Information

Current Stage:
Ongoing
Date:
August 2013 - July 2018
Funding source(s):
National Institute for Health Research – Programme Grant for Applied Research NIHR (PGfAR) - RP-PG-1210-12011

Health Area

Disease Category
Mental health

Disease Name
Anxiety
Common mental health problems
Depression

Target Population

Age Range
18 - 100

Sex
Male


Nature / type of Intervention
Complex intervention

Method(s)

Literature review
Other

Development of outcome measures:
The research team will register the work with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (http://www.comet-initiative.org/) and use consensus procedures for selecting outcome measures of relevance to future studies of prisoners with common mental health problems, and which are generalisable to other samples.

We will build on work of Fitzpatrick et al. in their review of outcome measures suitable for the prison population. Their findings suggest the need for further specificity regarding domains, such as quality of life and social inclusion measures, and further evaluation of properties of mental health outcomes for prisoners.

1 Consensus Panel
Consensus group methodology will be used with a panel of up to 30 which will include representation from ex-prisoners, practitioners and researchers. This panel will:
• Agree outcome domains to be used.
• Compare instruments and measures identified as potentially suitable to represent these domains (focusing on relevance and appropriateness, feasibility of use and adequacy of measurement properties).
• Select measures to be tested in the field.

The research team will also (with involvement of the panel, time and resource permitting) select measures to be used for personality disorder and cognitive function.

2 Focused review
Given the low level of use of measures in prison populations a focused review of use of measures in quality of life, social inclusion and recovery used in vulnerable populations will be carried out.

3 Field testing
Outcome measures will be field tested with offenders recruited from two prisons sites. The measures will be assessed on up to 60 prisoners. This work will be co-ordinated with work testing process of care measures and trial procedures.

This piloting will assess and compare acceptability; and compare psychometric properties with those in other populations. Exact studies will be determined by extent of previous testing and validation in offender populations and reported to the consensus panel for decisions.

4 Consensus Panel
Additional consensus procedures will be used to review performance of measures after testing to select those for use in the trial. This will be a two-stage process. The first stage will involve members of a Peer Research Group comprising men with experience of the criminal justice system. This will be to review feedback obtained from the field testing. The second stage will involve practitioners and researchers to review the psychometric properties of the measures tested and decide on the primary and secondary outcome measures to take forward to the trial, taking into account results of field testing and consensus meeting with the Peer Research Group.


Stakeholders Involved

Clinical experts
Researchers
Service users

Study Type

COS for clinical trials or clinical research

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