Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

National Institute for Health and Care Research - Tập 7 Số 20 - Trang 1-136
Lynne Callaghan1, Tom Thompson1, Siobhan Creanor1, Cath Quinn1, Jane Senior2, Colin Green3, Annie Hawton3, Richard Byng1, Gary Wallace4, Julia Sinclair5, Amy Kane1, Emma Hazeldine1, Samantha Walker1, Rebecca Crook2, Verity Wainwright2, Doyo Gragn Enki1, Ben Jones1, Elizabeth Goodwin3, Lucy Cartwright1, Jane Horrell1, Jenny Shaw2, Jill Annison6, Adrian Taylor1
1Faculty of Health: Medicine, Dentistry and Human Sciences, University of Plymouth, Plymouth, UK
2Faculty of Biology and Mental Health, University of Manchester, Manchester, UK
3University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK
4Trading Standards and Health Improvement, Plymouth City Council, Plymouth, UK
5Faculty of Medicine, University of Southampton, Southampton, UK
6Faculty of Business, University of Plymouth, Plymouth, UK

Tóm tắt

Background Little is known about the effectiveness or cost-effectiveness of interventions, such as health trainer support, to improve the health and well-being of people recently released from prison or serving a community sentence, because of the challenges in recruiting participants and following them up. Objectives This pilot trial aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and cost-effectiveness of health trainer support versus usual care. Design This trial involved a pilot multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1 : 1 individual allocation to receive support from a health trainer and usual care or usual care alone, with a mixed-methods process evaluation, in 2017–18. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or the National Probation Service in Plymouth. The intervention was delivered in the community. Participants Those who had been out of prison for at least 2 months (to allow community stabilisation), with at least 7 months of a community sentence remaining, were invited to participate; those who may have posed an unacceptable risk to the researchers and health trainers and those who were not interested in the trial or intervention support were excluded. Interventions The intervention group received, in addition to usual care, our person-centred health trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. Health trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity) and take on the Five Ways to Well-being [Foresight Projects. Mental Capital and Wellbeing: Final Project Report. 2008. URL: www.gov.uk/government/publications/mental-capital-and-wellbeing-making-the-most-of-ourselves-in-the-21st-century (accessed 24 January 2019).], and also signposted to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and well-being. Main outcome measures The main outcomes included the Warwick–Edinburgh Mental Well-being Scale scores, alcohol use, smoking behaviour, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, intervention engagement and feasibility and acceptability of trial methods and the intervention. Results A great deal about recruitment was learned and the target of 120 participants was achieved. The minimum trial retention target at 6 months (60%) was met. Among those offered health trainer support, 62% had at least two sessions. The mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. The proposed primary outcome, the Warwick–Edinburgh Mental Well-being Scale scores, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified, with a sample size of around 900 participants to detect between-group differences in the Warwick-Edinburgh Mental Well-being Scale scores at a 6-month follow-up. Future work A number of recruitment, trial retention, intervention engagement and blinding issues were identified in this pilot and recommendations are made in preparation of and within a full trial. Trial registration Current Controlled Trials ISRCTN80475744. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 20. See the National Institute for Health Research Journals Library website for further project information.

Từ khóa


Tài liệu tham khảo

Thompson, 2018, Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN), BMJ Open, 8, e023123, 10.1136/bmjopen-2018-023123

Sirdifield, 2012, The prevalence of mental health disorders amongst offenders on probation: a literature review, J Ment Health, 21, 485, 10.3109/09638237.2012.664305

Carswell, 2017, Barriers between offenders and primary health care after release from prison: a case study, Practice Nursing, 28, 386, 10.12968/pnur.2017.28.9.386

Hertfordshire Probation Trust. A Health Needs Assessment of the Hertfordshire Probation Trust Caseload. Welwyn Garden City: Hertfordshire Probation Trust; 2011.

Binswanger, 2011, ‘From the prison door right to the sidewalk, everything went downhill,’ a qualitative study of the health experiences of recently released inmates, Int J Law Psychiatry, 34, 249, 10.1016/j.ijlp.2011.07.002

Howerton, 2007, Understanding help seeking behaviour among male offenders: qualitative interview study, BMJ, 334, 303, 10.1136/bmj.39059.594444.AE

Light, 2013, Gender Differences in Substance Misuse and Mental Health amongst Prisoners: Results from the Surveying Prisoner Crime Reduction (SPCR) Longitudinal Cohort Study of Prisoners

Public Health England, 2012, Specification No.29 Section 7A Public Health Services for Children and Adults in Secure and Detained Settings in England. Public Health Services for People in Prison or Other Places of Detention, Including Those Held in the Children & Young People’s Secure Estate

Newbury-Birch, 2016, A rapid systematic review of what we know about alcohol use disorders and brief interventions in the criminal justice system, Int J Prisoner Health, 12, 57, 10.1108/IJPH-08-2015-0024

Willey, 2016, Is treatment for alcohol use disorder associated with reductions in criminal offending? A national data linkage cohort study in England, Drug Alcohol Depend, 161, 67, 10.1016/j.drugalcdep.2016.01.020

Byng, 2012, COCOA: Care for Offenders, Continuity of Access: NIHR Service Delivery and Organisation programme

Department of Health and Social Care, 2004, Choosing Health: Making Healthy Choices Easier

Visram, 2017, Impact and acceptability of lay health trainer-led lifestyle interventions delivered in primary care: a mixed method study, Prim Health Care Res Dev, 18, 333, 10.1017/S146342361700010X

Michie, 2008, Improving Health – Changing Behaviour: NHS Health Trainer Handbook

Attree, 2012, NHS health trainers: a review of emerging evaluation evidence, Crit Public Health, 22, 25, 10.1080/09581596.2010.549207

Visram, 2014, Making and maintaining lifestyle changes with the support of a lay health advisor: longitudinal qualitative study of health trainer services in northern England, PLOS ONE, 9, e94749, 10.1371/journal.pone.0094749

Dooris, 2013, Probation as a setting for building well-being through integrated service provision: evaluating an Offender Health Trainer service, Perspect Public Health, 133, 199, 10.1177/1757913913486036

Newbury-Birch, 2009, Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol, BMC Public Health, 9, 418, 10.1186/1471-2458-9-418

Coulton, 2012, Screening for alcohol use in criminal justice settings: an exploratory study, Alcohol Alcohol, 47, 423, 10.1093/alcalc/ags048

Orr, 2015, Applying an Alcohol Brief Intervention (ABI) model to the community justice setting: learning from a pilot project, Criminol Crim Justice, 15, 83, 10.1177/1748895813509636

Newbury-Birch, 2014, Alcohol screening and brief interventions for offenders in the probation setting (SIPS Trial): a pragmatic multicentre cluster randomized controlled trial, Alcohol Alcohol, 49, 540, 10.1093/alcalc/agu046

Kouyoumdjian, 2015, A systematic review of randomized controlled trials of interventions to improve the health of persons during imprisonment and in the year after release, Am J Public Health, 105, e13, 10.2105/AJPH.2014.302498

Lang, 2014, Linking probation clients with mainstream health services: experience in an outer London borough, Probat J, 61, 278, 10.1177/0264550514536757

Foresight Projects, 2008, Mental Capital and Wellbeing: Final Project Report

Malcolm, 2013, The impact of exercise projects to promote mental wellbeing, J Ment Health, 22, 519, 10.3109/09638237.2013.841874

Taylor, 2014, Change in mental health after smoking cessation: systematic review and meta-analysis, BMJ, 348, g1151, 10.1136/bmj.g1151

Tennant, 2007, The Warwick–Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation, Health Qual Life Outcomes, 5, 63, 10.1186/1477-7525-5-63

Ryan, 2000, Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being, Am Psychol, 55, 68, 10.1037/0003-066X.55.1.68

Bartram, 2011, Validation of the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) as an overall indicator of population mental health and well-being in the UK veterinary profession, Vet J, 187, 397, 10.1016/j.tvjl.2010.02.010

Bartram, 2013, Further validation of the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) in the UK veterinary profession: Rasch analysis, Qual Life Res, 22, 379, 10.1007/s11136-012-0144-4

NHS Digital, Health Survey for England 2013

Elsey, 2018, Assessing the impact of care farms on quality of life and offending: a pilot study among probation service users in England, BMJ Open, 8, e019296, 10.1136/bmjopen-2017-019296

Stranges, 2014, Major health-related behaviours and mental well-being in the general population: the Health Survey for England, BMJ Open, 4, e005878, 10.1136/bmjopen-2014-005878

The Scottish Government, Scottish Health Survey 2013

Taylor, 2014, A pilot randomised trial to assess the methods and procedures for evaluating the clinical effectiveness and cost-effectiveness of Exercise Assisted Reduction then Stop (EARS) among disadvantaged smokers, Health Technol Assess, 18, 10.3310/hta18040

Kirkpatrick, 2018, 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, BMJ Open, 8, e017931, 10.1136/bmjopen-2017-017931

Taylor, 2018, Engaging ‘seldom heard’ groups in research and intervention development: Offender mental health, Health Expectations, 21, 1104, 10.1111/hex.12807

Markland, 2005, Motivational Interviewing and Self Determination Theory, J Soc Clin Psychol, 24, 811, 10.1521/jscp.2005.24.6.811

Nutt, 2014, Doing it by numbers: a simple approach to reducing the harms of alcohol, J Psychopharmacol, 28, 3, 10.1177/0269881113512038

Lindson, 2009, Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial, Trials, 10, 69, 10.1186/1745-6215-10-69

Ministry of Justice, Women and the Criminal Justice System Statistics 2015

Teare, 2014, Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study, Trials, 15, 264, 10.1186/1745-6215-15-264

Byng, Developing and Evaluating a Collaborative Care Intervention for Prisoners, with Common Mental Health Problems, near to and after release (ENGAGER 2)

Taggart, 2016, Warwick–Edinburgh Mental Well-being Scale (WEMWBS) user guide – version 2

2015, NVivo qualitative data analysis Software; QSR International Pty Ltd

Eldridge, 2016, CONSORT 2010 statement: extension to randomised pilot and feasibility trials, BMJ, 355, i5239, 10.1136/bmj.i5239

Lee, 2014, The statistical interpretation of pilot trials: should significance thresholds be reconsidered?, BMC Med Res Meth, 14, 41, 10.1186/1471-2288-14-41

Browne, 1995, On the use of a pilot sample for sample size determination, Stat Med, 14, 1933, 10.1002/sim.4780141709

Kidger, 2016, Protocol for a cluster randomised controlled trial of an intervention to improve the mental health support and training available to secondary school teachers – the WISE (Wellbeing in Secondary Education) study, BMC Public Health, 16, 1089, 10.1186/s12889-016-3756-8

Powell, 2012, Effectiveness of a web-based cognitive-behavioral tool to improve mental well-being in the general population: randomized controlled trial, J Med Internet Res, 15, e2, 10.2196/jmir.2240

Borm, 2007, A simple sample size formula for analysis of covariance in randomized clinical trials, J Clin Epidemiol, 60, 1234, 10.1016/j.jclinepi.2007.02.006

Curtis, 2017, Unit Costs of Health and Social Care 2017

Curtis, 2015, Unit Costs of Health and Social Care 2015

NHS Improvement, NHS Reference Costs 2016/17

Department of Health and Social Care, Reference Costs 2011/12

Curtis, 2016, Unit Costs of Health and Social Care 2016

Brazier, 2007, Measuring and Valuing Health Benefits for Economic Evaluation

Glick, 2007, Economic Evaluation in Clinical Trials

National Institute for Health and Care Excellence, Guide to the Methods of Technology Appraisal 2013

van Hout, 2012, Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets, Value Health, 15, 708, 10.1016/j.jval.2012.02.008

Dolan, 1997, Modeling valuations for EuroQol health states, Med Care, 35, 1095, 10.1097/00005650-199711000-00002

National Institute for Health and Care Excellence, NICE Position Statement on the EQ-5D-5L

Brazier, 2002, The estimation of a preference-based measure of health from the SF-36, J Health Econ, 21, 271, 10.1016/S0167-6296(01)00130-8

Goodwin, 2018, Involving members of the public in health economics research: insights from selecting health states for valuation to estimate quality-adjusted life-year (QALY) weights, Appl Health Econ Health Policy, 16, 187, 10.1007/s40258-017-0355-5

Hughes, 2016, Conducting economic evaluations alongside randomised trials: current methodological issues and novel approaches, PharmacoEconomics, 34, 447, 10.1007/s40273-015-0371-y

Noble, 2012, Missing data in trial-based cost-effectiveness analysis: the current state of play, Health Econ, 21, 187, 10.1002/hec.1693

Husereau, 2013, Consolidated Health Economic Evaluation Reporting Standards (CHEERS) – explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force, Value Health, 16, 231, 10.1016/j.jval.2013.02.002

Sanders, 2016, Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine, JAMA, 316, 1093, 10.1001/jama.2016.12195

Fenwick, 2005, A guide to cost-effectiveness acceptability curves, Br J Psychiatry, 187, 106, 10.1192/bjp.187.2.106

Lambert, 2017, Assessment of fidelity in individual level behaviour change interventions promoting physical activity among adults: a systematic review, BMC Public Health, 17, 765, 10.1186/s12889-017-4778-6

Thompson, 2018, Intervention delivery fidelity assessment of a counselling based intervention for multiple behaviours, Health Psychol, 37, 627, 10.1037/hea0000613

Dreyfus, 1998, Competency Based Education and Training

Marshall, 2016, What IAPT services can learn from those who do not attend, J Ment Health, 25, 410, 10.3109/09638237.2015.1101057

Ministry of Justice. Transforming Rehabilitation: A Strategy for Reform. London: The Stationary Office; 2013. URL: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/228744/8619.pdf (accessed 29 August 2019).

Brazier, 2004, A comparison of the EQ-5D and SF-6D across seven patient groups, Health Econ, 13, 873, 10.1002/hec.866

Kind, 1998, Variations in population health status: results from a United Kingdom national questionnaire survey, BMJ, 316, 736, 10.1136/bmj.316.7133.736

Kind, 1999, UK Population Norms for EQ-5D

van den Berg, 2012, SF-6D population norms, Health Econ, 21, 1508, 10.1002/hec.1823

Walters, 2005, Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D, Qual Life Res, 14, 1523, 10.1007/s11136-004-7713-0

Taylor, 2019, A Multicentred Trial of Physical Activity-Assisted Reduction of Smoking (TARS). Health Technol Assess

Joint Formulary Comittee. British National Formulary. 74 ed. London: BMJ Group and Pharmaceutical Press; 2017.

Thông tin
Thông tin xuất bản

National Institute for Health and Care Research

Tập 7 Số 20

1-136

Thông tin tác giả