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

IntroductionThe ‘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 analys...

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Veröffentlicht in:BMJ open 2018-02, Vol.8 (2), p.e017931-e017931
Hauptverfasser: Kirkpatrick, Tim, Lennox, Charlotte, Taylor, Rod, Anderson, Rob, Maguire, Michael, Haddad, Mark, Michie, Susan, Owens, Christabel, Durcan, Graham, Stirzaker, Alex, Henley, William, Stevenson, Caroline, Carroll, Lauren, Quinn, Cath, Brand, Sarah Louise, Harris, Tirril, Stewart, Amy, Todd, Roxanne, Rybczynska-Bunt, Sarah, Greer, Rebecca, Pearson, Mark, Shaw, Jenny, Byng, Richard
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container_end_page e017931
container_issue 2
container_start_page e017931
container_title BMJ open
container_volume 8
creator Kirkpatrick, Tim
Lennox, Charlotte
Taylor, Rod
Anderson, Rob
Maguire, Michael
Haddad, Mark
Michie, Susan
Owens, Christabel
Durcan, Graham
Stirzaker, Alex
Henley, William
Stevenson, Caroline
Carroll, Lauren
Quinn, Cath
Brand, Sarah Louise
Harris, Tirril
Stewart, Amy
Todd, Roxanne
Rybczynska-Bunt, Sarah
Greer, Rebecca
Pearson, Mark
Shaw, Jenny
Byng, Richard
description IntroductionThe ‘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 analysisThe study is a parallel two-group randomised controlled trial 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 postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. 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 disseminationThis study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015–283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations.Trial registration number ISRCTN11707331; Pre-results.
doi_str_mv 10.1136/bmjopen-2017-017931
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The trial will evaluate the clinical and cost-effectiveness of the Engager intervention.Methods and analysisThe study is a parallel two-group randomised controlled trial 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 postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. 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 disseminationThis study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015–283). 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All rights reserved. No commercial use is permitted unless otherwise expressly granted.</rights><rights>2018 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-841a679407758ada102c8c917248955782b04d0b4e8ba82d6cb10592e771b4723</citedby><cites>FETCH-LOGICAL-b472t-841a679407758ada102c8c917248955782b04d0b4e8ba82d6cb10592e771b4723</cites><orcidid>0000-0002-1693-0742</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/8/2/e017931.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/8/2/e017931.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77344,77375</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29463586$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kirkpatrick, Tim</creatorcontrib><creatorcontrib>Lennox, Charlotte</creatorcontrib><creatorcontrib>Taylor, Rod</creatorcontrib><creatorcontrib>Anderson, Rob</creatorcontrib><creatorcontrib>Maguire, Michael</creatorcontrib><creatorcontrib>Haddad, Mark</creatorcontrib><creatorcontrib>Michie, Susan</creatorcontrib><creatorcontrib>Owens, Christabel</creatorcontrib><creatorcontrib>Durcan, Graham</creatorcontrib><creatorcontrib>Stirzaker, Alex</creatorcontrib><creatorcontrib>Henley, William</creatorcontrib><creatorcontrib>Stevenson, Caroline</creatorcontrib><creatorcontrib>Carroll, Lauren</creatorcontrib><creatorcontrib>Quinn, Cath</creatorcontrib><creatorcontrib>Brand, Sarah Louise</creatorcontrib><creatorcontrib>Harris, Tirril</creatorcontrib><creatorcontrib>Stewart, Amy</creatorcontrib><creatorcontrib>Todd, Roxanne</creatorcontrib><creatorcontrib>Rybczynska-Bunt, Sarah</creatorcontrib><creatorcontrib>Greer, Rebecca</creatorcontrib><creatorcontrib>Pearson, Mark</creatorcontrib><creatorcontrib>Shaw, Jenny</creatorcontrib><creatorcontrib>Byng, Richard</creatorcontrib><title>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</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionThe ‘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. 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Lennox, Charlotte ; Taylor, Rod ; Anderson, Rob ; Maguire, Michael ; Haddad, Mark ; Michie, Susan ; Owens, Christabel ; Durcan, Graham ; Stirzaker, Alex ; Henley, William ; Stevenson, Caroline ; Carroll, Lauren ; Quinn, Cath ; Brand, Sarah Louise ; Harris, Tirril ; Stewart, Amy ; Todd, Roxanne ; Rybczynska-Bunt, Sarah ; Greer, Rebecca ; Pearson, Mark ; Shaw, Jenny ; Byng, Richard</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-841a679407758ada102c8c917248955782b04d0b4e8ba82d6cb10592e771b4723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Alcohol</topic><topic>Anxiety</topic><topic>Cognition &amp; reasoning</topic><topic>Cost analysis</topic><topic>Cost control</topic><topic>Cost-Benefit Analysis</topic><topic>England</topic><topic>Evidence-based medicine</topic><topic>Health services</topic><topic>Humans</topic><topic>Intervention</topic><topic>Male</topic><topic>Medical research</topic><topic>Mental disorders</topic><topic>Mental Disorders - economics</topic><topic>Mental Disorders - rehabilitation</topic><topic>Mental Disorders - therapy</topic><topic>Mental Health</topic><topic>Mental health care</topic><topic>Narcotics</topic><topic>Patient-centered care</topic><topic>Population</topic><topic>Post traumatic stress disorder</topic><topic>Primary care</topic><topic>Prisoners</topic><topic>Prisons</topic><topic>Psychiatry</topic><topic>Psychotherapy - economics</topic><topic>Psychotherapy - methods</topic><topic>Quality of Life</topic><topic>Questionnaires</topic><topic>Stress, Psychological - prevention &amp; 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The trial will evaluate the clinical and cost-effectiveness of the Engager intervention.Methods and analysisThe study is a parallel two-group randomised controlled trial 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 postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. 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 disseminationThis study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015–283). 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source BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access
subjects Adult
Alcohol
Anxiety
Cognition & reasoning
Cost analysis
Cost control
Cost-Benefit Analysis
England
Evidence-based medicine
Health services
Humans
Intervention
Male
Medical research
Mental disorders
Mental Disorders - economics
Mental Disorders - rehabilitation
Mental Disorders - therapy
Mental Health
Mental health care
Narcotics
Patient-centered care
Population
Post traumatic stress disorder
Primary care
Prisoners
Prisons
Psychiatry
Psychotherapy - economics
Psychotherapy - methods
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title 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
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