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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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). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations.Trial registration number ISRCTN11707331; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2017-017931</identifier><identifier>PMID: 29463586</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>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 ; Quality of Life ; Questionnaires ; Stress, Psychological - prevention & control ; Suicides & suicide attempts ; Well being</subject><ispartof>BMJ open, 2018-02, Vol.8 (2), p.e017931-e017931</ispartof><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.</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. 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.</description><subject>Adult</subject><subject>Alcohol</subject><subject>Anxiety</subject><subject>Cognition & reasoning</subject><subject>Cost analysis</subject><subject>Cost control</subject><subject>Cost-Benefit Analysis</subject><subject>England</subject><subject>Evidence-based medicine</subject><subject>Health services</subject><subject>Humans</subject><subject>Intervention</subject><subject>Male</subject><subject>Medical research</subject><subject>Mental disorders</subject><subject>Mental Disorders - economics</subject><subject>Mental Disorders - rehabilitation</subject><subject>Mental Disorders - therapy</subject><subject>Mental Health</subject><subject>Mental health care</subject><subject>Narcotics</subject><subject>Patient-centered care</subject><subject>Population</subject><subject>Post traumatic stress disorder</subject><subject>Primary care</subject><subject>Prisoners</subject><subject>Prisons</subject><subject>Psychiatry</subject><subject>Psychotherapy - 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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 & control</topic><topic>Suicides & suicide attempts</topic><topic>Well being</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kirkpatrick, Tim</au><au>Lennox, Charlotte</au><au>Taylor, Rod</au><au>Anderson, Rob</au><au>Maguire, Michael</au><au>Haddad, Mark</au><au>Michie, Susan</au><au>Owens, Christabel</au><au>Durcan, Graham</au><au>Stirzaker, Alex</au><au>Henley, William</au><au>Stevenson, Caroline</au><au>Carroll, Lauren</au><au>Quinn, Cath</au><au>Brand, Sarah Louise</au><au>Harris, Tirril</au><au>Stewart, Amy</au><au>Todd, Roxanne</au><au>Rybczynska-Bunt, Sarah</au><au>Greer, Rebecca</au><au>Pearson, Mark</au><au>Shaw, Jenny</au><au>Byng, Richard</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2018-02-20</date><risdate>2018</risdate><volume>8</volume><issue>2</issue><spage>e017931</spage><epage>e017931</epage><pages>e017931-e017931</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>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.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>29463586</pmid><doi>10.1136/bmjopen-2017-017931</doi><orcidid>https://orcid.org/0000-0002-1693-0742</orcidid><oa>free_for_read</oa></addata></record> |
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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 Quality of Life Questionnaires Stress, Psychological - prevention & control Suicides & suicide attempts Well being |
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 |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-30T06%3A03%3A25IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Evaluation%20of%20a%20complex%20intervention%20(Engager)%20for%20prisoners%20with%20common%20mental%20health%20problems,%20near%20to%20and%20after%20release:%20study%20protocol%20for%20a%20randomised%20controlled%20trial&rft.jtitle=BMJ%20open&rft.au=Kirkpatrick,%20Tim&rft.date=2018-02-20&rft.volume=8&rft.issue=2&rft.spage=e017931&rft.epage=e017931&rft.pages=e017931-e017931&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2017-017931&rft_dat=%3Cproquest_pubme%3E2007121739%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2288017290&rft_id=info:pmid/29463586&rfr_iscdi=true |