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

Allbwn ymchwil: Cyfraniad at gyfnodolynErthygladolygiad gan gymheiriaid

27 Wedi eu Llwytho i Lawr (Pure)

Crynodeb

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
Iaith wreiddiolSaesneg
Rhif yr erthygle017931
Nifer y tudalennau13
CyfnodolynBMJ Open
Cyfrol8
Rhif cyhoeddi2
Dyddiad ar-lein cynnar20 Chwef 2018
Dynodwyr Gwrthrych Digidol (DOIs)
StatwsE-gyhoeddi cyn argraffu - 20 Chwef 2018

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