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Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol

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journal contribution
posted on 01.12.2016, 11:45 by N. Khalifa, E. Talbot, J. Schneider, D. M. Walker, P. Bates, Y. Bird, D. Davies, C. Brookes, J. Hall, B . Völlm
Introduction People with involvement in forensic psychiatric services face many obstacles to employment, arising from their offending, as well as their mental health problems. This study aims to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of individual placement and support (IPS), in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations. IPS has been found consistently to achieve employment rates above 50% in psychiatric patients without a history of involvement in criminal justice services. Methods/design This is a single-centre feasibility cluster RCT. Clusters will be defined according to clinical services in the community forensic services of Nottinghamshire Healthcare NHS Foundation Trust (NHCT). IPS will be implemented into 2 of the randomly assigned intervention clusters in the community forensic services of NHCT. A feasibility cluster RCT will estimate the parameters required to design a full RCT. The primary outcome is the proportion of people in open employment at 12-month follow-up. Secondary outcome measures will include employment, educational activities, psychosocial and economic outcomes, as well as reoffending rates. Outcome measures will be recorded at baseline, 6 months and 12 months. In accordance with the UK Medical Research Council guidelines on the evaluation of complex interventions, a process evaluation will be carried out; qualitative interviews with patients and staff will explore general views of IPS as well as barriers and facilitators to implementation. Fidelity reviews will assess the extent to which the services follow the principles of IPS prior, during and at the end of the trial. Ethics and dissemination Ethical approval was obtained from the East Midlands Research Ethics Committee-Nottingham 1 (REC reference number 15/EM/0253). Final and interim reports will be prepared for project funders, the study sponsor and clinical research network. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. Trial registration number NCT02442193; Pre-results.

Funding

This article presents independent research funded by the National Institute for Health Research under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1013-32093).

History

Citation

BMJ Open, 2016;6:e012710

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Clinical Trials Unit

Version

VoR (Version of Record)

Published in

BMJ Open

Publisher

BMJ Publishing Group

issn

2044-6055

eissn

2044-6055

Acceptance date

23/05/2016

Available date

01/12/2016

Publisher version

http://bmjopen.bmj.com/content/6/7/e012710

Notes

Prepublication history and additional material is available. To view please visit the journal (http://dx.doi.org/10.1136/bmjopen-2016-012710).

Language

en

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