Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial

Tim Kirkpatrick, Charlotte Lennox, Rod Taylor, Rob Anderson, Mike Maguire, Mark Haddad, Susan Michie, Christabel Owens, Graham Durcan, Alex Stirzaker, William Henley, Caroline Stevenson, Lauren Carroll, Cath Quinn, Sarah L. Brand, Tirril Harris, Amy Stewart, Roxanne Todd, Sarah Rybczynska-Bunt, Rebecca GreerMark Pearson, Jenny Shaw, Richard Byng

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    Abstract

    Introduction
    The ‘Engager’ programme is a ‘through-the-gate’ intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost effectiveness of the Engager intervention.

    Methods and Analysis
    The study is a parallel two-group randomised controlled trial (RCT) with 1:1 individual allocation to either: a) the Engager intervention plus standard care (intervention group), or b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders’ mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks post-release. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) at six months post-release. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health related quality of life, and wellbeing related quality of life measured at three and six months post-release; change in objective social domains, drug and alcohol dependence, service utilisation, perceived helpfulness and change in trust, hope and motivation at six months post-release; and recidivism at 12 months post release. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness.

    Ethics and Dissemination
    This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (NOMS; ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations.

    Trial registration: ISRCTN11707331. Registration date 04/02/2016
    Original languageEnglish
    Article numbere017931
    Number of pages13
    JournalBMJ Open
    Volume8
    Issue number2
    Early online date20 Feb 2018
    DOIs
    Publication statusE-pub ahead of print - 20 Feb 2018

    Keywords

    • Prison
    • resettlement
    • randomised controlled trial
    • mental health

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