Empowered Together (coordinated social care in prison)
| ISRCTN | ISRCTN15064570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15064570 |
| IRAS number | 361615 |
| Secondary identifying numbers | LSCFT-RD24002, CPMS 57609 |
- Submission date
- 01/09/2025
- Registration date
- 03/10/2025
- Last edited
- 03/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
Social care helps people who struggle with everyday tasks because of physical or mental health problems. This includes help with cleaning, washing, dressing, using special equipment, and staying connected with others. There hasn’t been much research into how social care works in prisons, but what we do know suggests it’s not as good as it is outside prison. To help improve this, researchers have created a new approach called Empowered Together. The study will test whether this approach works well in prisons.
Who can participate?
Men in selected prisons can take part if they are aged 18 years or older, have at least 7 months left on their sentence, are thought to have high social care needs, and can give their consent to take part.
What does the study involve?
The study has three parts.
In part one, researchers will work with people who have lived in prison to create training for staff, tools to measure how well Empowered Together works, and a short film, event, and website.
In part two, Empowered Together will be tested in two men’s prisons. Seventy-six men with social care needs will take part. Half will receive Empowered Together and half will get usual care. Researchers will test different questionnaires, interview 20 men and 26 staff, and explore the costs of Empowered Together.
In part three, a larger group of 426 men will take part. Half will get Empowered Together and half will get usual care. Researchers will compare the two groups using questionnaires, interview 32 men and 56 staff, observe 16 men, and collect information about costs and how well the approach was delivered.
What are the possible benefits and risks of participating?
The study could help improve social care for future prisoners who need support.
Some people might feel upset during interviews when talking about their daily challenges. If this happens, they can speak to the researcher, prison staff, healthcare staff, or a trained listener. Support and advice will be offered if needed.
Where is the study run from?
Part two will take place in HMP Liverpool and HMP Risley (UK). Part three will be in six to eight prisons, which haven’t been chosen yet.
When is the study starting and how long is it expected to run for?
February 2025 to January 2030.
Who is funding the study?
Lancashire and South Cumbria NHS Foundation Trust (UK)
Who is the main contact?
Dr Katrina Forsyth, katrina.forsyth@manchester.ac.uk
Contact information
Dr Katrina Forsyth
Scientific, Principal investigator
Scientific, Principal investigator
Oxford Rd
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0001-9980-9464 |
|---|---|
| katrina.forsyth@manchester.ac.uk |
Miss Emily Egan
Public
Public
176 Oxford Rd
Manchester
M13 9PY
United Kingdom
| Phone | +353 834824527 |
|---|---|
| emily.egan@manchester.ac.uk |
Study information
| Study design | Two-site parallel individually randomized controlled trial feasibility and definitive study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Prison/detention |
| Study type | Screening, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Empowered Together (coordinated social care in prison): A feasibility and definitive randomised controlled trial, with embedded realist informed process evaluation |
| Study acronym | ET |
| Study objectives | Empowered Together is more effective in reducing the number of unmet social care needs of men in prison than care as usual. |
| Ethics approval(s) |
Submitted 01/09/2025, Wales REC 3 (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922941107; Wales.REC3@wales.nhs.uk), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Social care needs of adult men in prison who are at risk of having unmet needs |
| Intervention | ET Screening: All individuals living in the prison(s) are screened using the ET tool. This was adapted for prison use from one used in the community. It is aligned with the Care Act and briefly asks whether individuals: 1. consider themselves to have any physical or mental health condition/impairment or to be neurodiverse 2. experience difficulties in any of the following social care domains in prison: food, hygiene, toileting, clothing, safety, family relationships. A series of probing questions relevant to these social care in prison domains will be used. If individuals report they may have difficulties in two or more social care domains they will go on to receive an ET assessment. ET Assessment: A strengths-based assessment of social care need, conducted by an ET worker. Strengths and assets-based approaches to assessment and care-planning focus on people’s capabilities, explore help available from wider support networks, and take account of issues of importance to the individual. Care needs change over time, therefore follow-up assessments should occur at least twice yearly with clear review dates identified in response to changing needs follow-up assessments should be conducted, with changes to care-plans being jointly agreed. ET Care Coordination: ET worker coordinates care for those meeting criteria for of social care provision under the Care Act 2014. The ET Worker will coproduce a care plan with the individual/family member/peer carer. This will consider placement in the prison (e.g. vulnerable prisoner wing, healthcare wing, adapted cell) and the support required. All domains of the Care Act 2014 will be considered including adaptations to cells and other parts of the prison (e.g. handrails; hygiene equipment, meal trays); support with maintaining personal relationships; coordination of peer support; necessary changes to the regime; and details of any personalised care. ET is delivered by an ET coordinator, qualified to a minimum of Health and Social Care level 4. The ET workers will receive social care management and clinical supervision monthly. Their role as a prison social care specialist will include conducting screening, assessments, and care co-ordination. They will liaise with prison, health and external social care staff, making referrals where appropriate, improving communication and aiming to ensure that individuals’ needs are met. The role of the ET worker will involve acting as an advocate for the person in prison, and this will include referring for, feeding into and attending the Care Act Assessment conducted by the local authority. They will also liaise with prison authorities, whose responsibilities include adaptation of the environment for social care. The control will be care as usual in the prison. As part of a previous programme delivery grant (PDG) we conducted: 1. A realist synthesis to develop the initial programme theory, logic model and intervention delivery platform for Empowered Together 2. A systematic review of suitable outcome measures 3. Development of patient, public involvement and engagement (PPIE) The proposed study builds on the work conducted in the PDG. It contains three work packages: WP1: Development of: 1. Training manual 2. Bespoke outcome measure 3. Fidelity scale 4. Immersive film, audio, blog, event and webpage WP2: Feasibility study/embedded formative process evaluation 1. Feasibility RCT 2. Cost-effectiveness feasibility 3. Realist-informed formative process evaluation (including implementation fidelity) 4. Review of progression criteria WP3: Definitive RCT and embedded summative process evaluation 1. Definitive RCT 2. Cost-effectiveness analysis 3. Realist-informed summative process evaluation (including implementation fidelity) 4. Development of future funding application to adapt Empowered Together for women Timelines for Delivery Months 0 – 12: Set up 0 – 6: WP 1 6 – 20: WP2 20 – 54: WP3 54 – 60: Impact and Dissemination For the feasibility RCT, this will last nine months in total. Recruitment will occur during the first six months to allow the final participants time to complete the three-month intervention. The feasibility RCT will include follow-ups at 42-days (six weeks) and 90-days (three months) (±7 days) post-baseline. For the definitive trial, the duration of the intervention will also be 9 months, and the follow ups will be at six weeks and six months. Randomisation: Following consent and the completion of the brief ET screening tool and baseline assessments, participants will be individually randomised 1:1 to intervention versus social care as usual, stratified by prison (prison 1, prison 2) and age group (<50, ≥50). Randomisation should occur as soon as possible after baseline, but within one week. The randomisation sequence, using variable blocks sizes, will be generated by a statistician independent to the trial team and implemented through a secure web-based system on REDCap, which will ensure concealment of allocation to blinded members of the research team. Only site staff who have been delegated the role of randomisation on the delegation log will be able to access the randomisation system. An automated confirmation email will be generated when a participant is randomised and sent to the CIs and other delegated members of the study team. Prisoners allocated to the intervention arm will then complete the ET assessment. This strengths-based assessment of social care need will be conducted by an ET worker. Strengths and assets-based approaches to assessment and care planning focus on capabilities, explore help available from wider support networks, and take into account issues important to the individual (56). Those with higher-level social care needs based on the ET assessment will receive the ET intervention, whilst those with lower-level social care needs will be given tailored advice and information about appropriate resources or services. We will clarify the definitions of higher and lower level social care needs as part of our preliminary training development workshops. This definition will also be dependent on the individual processes established at the prison. Again, for the definitive trial, following screening for eligibility, participants will be randomised 1:1 to receive ET or CAU. This will be achieved using block randomisation stratified by prison and age group. |
| Intervention type | Other |
| Primary outcome measure | Feasibility study: Unmet needs of men in prison will be measured using Camberwell Assessments of Needs-Forensic Research CANFOR-R at baseline, 6 weeks, and 3 months Definitive study: Unmet needs of men in prison will be measured using Camberwell Assessments of Needs-Forensic Research CANFOR-R at baseline, 6 weeks, and 6 months |
| Secondary outcome measures | At baseline, 6 weeks, and 3 months in the feasibility trial: 1. Social care related quality of life measured using the Adults Social Care Outcomes Toolkit (ASCOT SCT4) 2. Health related quality of life measured using EQ-5D-5L 3. Wellbeing measured using ICEpop CAPability measure for Adults (ICECAP-A) 4. Recovery outcomes measured using ReQol-10 At baseline, 6 weeks, and 6 months in the definitive trial: 1. Social care related quality of life measured using the Adults Social Care Outcomes Toolkit (ASCOT SCT4) 2. Health related quality of life measured using EQ-5D-5L 3. Wellbeing measured using ICEpop CAPability measure for Adults (ICECAP-A) 4. Recovery outcomes measured using ReQol-10 |
| Overall study start date | 01/02/2025 |
| Completion date | 31/01/2030 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Male |
| Target number of participants | Feasibility trial: 76, Definitive trial: 426 |
| Total final enrolment | 426 |
| Key inclusion criteria | 1. Resident in one of the study prisons 2. Serving a sentence with at least 7 months until release date 3. Over 18 years of age 4. Has mental capacity to consent or appropriate personal or independent consultee who can provide assent (as assessed by researchers in consultation with prison staff) 5. Scores positively on the ET screen |
| Key exclusion criteria | 1. Unsafe for researchers to interview alone 2. In current receipt of a social care package under the Care Act 3. Insufficient knowledge of English to complete assessment and outcome measures |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 01/04/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hmp Liverpool
68 Hornby Road
Liverpool
L9 3DF
United Kingdom
Liverpool
L9 3DF
United Kingdom
Hmp Risley
Warrington Rd, Risley, Croft, Warrington
Preston
WA3 6BP
United Kingdom
Preston
WA3 6BP
United Kingdom
Sponsor information
Lancashire and South Cumbria NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Sceptre Point Sceptre Way, Walton Summit Rd, Walton Summit Centre
Preston
PR56AW
United Kingdom
| Phone | +44 7814659509/ +44 1772 773498 |
|---|---|
| farah.lunat@lscft.nhs.uk | |
| Website | https://www.lscft.nhs.uk/ |
Funders
Funder type
Government
National Institute for Health and Care Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | A comprehensive dissemination and impact strategy will be employed to ensure that our findings are shared with all relevant stakeholders including men in prison, social care and prison staff, social care and prison managers, policy makers, and the public. This will include co-produced outputs for and engagement with professional and lay audiences, namely: ∙ An immersive short film, event and training webpage ∙ An ‘easy read’ article in prison newspaper ‘Inside Times’ ∙ A podcast with ‘Secret Life of Prison’ accessible to those currently living in prison. ∙ A piece for prison radio ∙ A twitter account ∙ At least four academic papers ∙ Presentations at two international conferences and key policy meetings ∙ A dissemination event to embed our findings into policy and practice in conjunction with the Ministry of Justice, and Health and Social Care HMPPs Partnership board. Patients/ service users, carers, NHS, social care organisations and the wider population will be informed of this work through the medium of an immersive short film: The ‘participatory arts’ involve and engage individuals in the creative process of producing film, music, photography, and theatre. Within health and social care, participatory arts allow individuals to express their experiences of their physical and mental health conditions and/or neurodiversity and support received as a therapeutic process as well as a means of describing their unique experiences with those providing care and support. Made by Mortals are a Community Interest Company managed for and by people with lived experience of services and underserved populations including the NHS and/or social care. Paul Hine is Director of Made by Mortals (MbM). MbM will coproduce an immersive short film in collaboration with world-class professional artists, prison, health and social care staff and experts by experience to raise awareness of the issues around the provision of social care in prison and disseminate our findings. A similar video they have produced as generated 250k views. A diverse group of eight individuals, with experience of living in prison with social care needs (or supporting a peer in prison with social care needs), will be recruited to join the production team. We will promote this opportunity via our links with the Prison Reform Network, ADASS Care and Justice Network; the Health and Justice Research Network and Twitter. The experts by experience will work alongside a professional scriptwriter and a drama facilitator, with some input from the research team, to work on the immersive film. The group will meet for eight online workshops. In the first session, the group will agree the theme. The group will then work on the character, script, recording, and soundtrack. We will disseminate the immersive short film, with embedded links to research findings across our comprehensive networks (HJRN, ASASS, BASW, MoJ, NHS) . We will hold a dissemination event to promote this work which can then be used as a training activity for prison, health and social care staff. Easy read article in Inside Times: We will coproduce an article for Inside Times (prison newspaper, accessible to all serving prisoners in paper format and electronically). We have successfully published a similar coproduced article disseminating findings relating to the forthcoming national strategy for older adults. Prison radio: We will coproduce a piece for prison radio. Our OPPIE group highlighted the importance of this due to the tow levels of literacy amongst individuals living in prison. Podcast for ‘Secret life of Prison’: The Secret Life of Prisons tells the hidden stories from behind bar and is co presented by our co-applicant Paula Harriott. It is accessible to those living inside prison and in the community. During this episode our experts by experts will take a lead role in discussing their involvement in the research and our key findings. Twitter account: We will establish an ‘Empowered Together’ twitter account which will be co-managed by our two expert by experience co-applicants and RA. We will work closely with all our partners to ensure maximum exposure. Website: Our website will describe our findings and host links to presentations and documents. Lay summary: we will share a summary of our findings with all participants who agreed to receive this and provided contact details Academic papers: We will aim to publish papers on the following 1) Feasibility RCT; 2) Formative Process evaluation; 3) Definitive RCT 4) Summary process evaluation 5) Evaluation of PPIE involvement. We will aim to reach social care and criminal justice audiences by publishing in journals such as the British Medical Journal; British Journal of Social Work; Health and Justice; Journal of Forensic Psychology and Psychiatry, Health and Social Care in the Community. Presentations: We will present our findings at conferences such as Health and Justice Summit and BASW Conferences and at invites meetings such as ADASS Care and Justice; and the HMPPS Health and Social Care Partnership Board which includes MoJ, NHS, and ADASS partners. The research team already have strong positive relationship with these groups. We have previously presented our findings to this groups who are aware of the preliminary work leading to the proposed programme grant. Dissemination event: A dissemination event to embed our findings into policy and practice in conjunction with the Ministry of Justice, and Health and Social Care HMPPs Partnership board. The specific findings from this study will be disseminated to policy makers, prison and social care practitioners and men in prison through our dissemination strategy outlined above. It will directly raise broad awareness of social care in prisons among the public, professionals and people in prisons, and their families. It will demonstrate that high quality research can be conducted on social care interventions, and that there is now an evidence base for social care interventions in prisons. Study findings will inform the decisions of policy-makers responsible for social care in prison. Our engagement with them through our existing relationships and targeted presentations and publications will ensure awareness. They will have the opportunity to implement an evidence-based intervention across the prison service, and we anticipate that ET will be introduced across the prison estate should it be shown to be effective and cost-effective. ET could be used across prisons in the UK, allowing thousands of people with social care needs to have their needs met improving wellbeing and ensuring best use of public finance. The uptake of study findings will be promoted through the Study Advisory Group, which will include representatives of organisations such as ADASS Care and Justice Group, British Association of Social Work (BASW), HMPPS, the MoJ, the Prison Reform Trust, Restore, Recoop, the Howard League, creating a core network of people who can champion the research and cascade its results. The workshops and study findings will also be promoted via the CHAIN prison and social care research special interest group and HJRN members (approx.. 2000). These activities will build a network of interested parties who will follow the work and be critical friends and advocates for the out puts of the project. We maintain positive working relationships with the MoJ, the Health and Social Care Partnership Board and National Social Work Board, ADASS and health and social care colleagues to ensure the work remains high on the agenda. We will establish NHS Task and finish groups (including prison healthcare providers) to explore commissioning. We will continue to work closely with Policy@Manchester to engage policy makers and commissioners. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 30/06/2025 | 10/09/2025 | No | No |
Additional files
Editorial Notes
03/10/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
