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

Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol
Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol
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.
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Khalifa, N.
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Talbot, E.
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Schneider, J.
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Walker, D.-M.
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Bates, P.
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Bird, Y.
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Davies, D.
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Brookes, C.
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Hall, J.
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Völlm, B.
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Khalifa, N.
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Talbot, E.
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Schneider, J.
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Walker, D.-M.
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Bates, P.
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Bird, Y.
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Davies, D.
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Brookes, C.
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Hall, J.
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Völlm, B.
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Khalifa, N., Talbot, E., Schneider, J., Walker, D.-M., Bates, P., Bird, Y., Davies, D., Brookes, C., Hall, J. and Völlm, B. (2016) Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol. BMJ Open, 6 (7), 1-7. (doi:10.1136/bmjopen-2016-012710).

Record type: Article

Abstract

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.

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Accepted/In Press date: 23 May 2016
e-pub ahead of print date: 22 July 2016
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 399099
URI: http://eprints.soton.ac.uk/id/eprint/399099
PURE UUID: 92efdd99-e64f-407f-b730-8d0e12ba4a00
ORCID for D.-M. Walker: ORCID iD orcid.org/0000-0003-2135-1363

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Date deposited: 05 Aug 2016 09:15
Last modified: 15 Mar 2024 03:51

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Contributors

Author: N. Khalifa
Author: E. Talbot
Author: J. Schneider
Author: D.-M. Walker ORCID iD
Author: P. Bates
Author: Y. Bird
Author: D. Davies
Author: C. Brookes
Author: J. Hall
Author: B. Völlm

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