Investigating the effectiveness of inpatient mental health rehabilitation services in the NHS and independent sector
| ISRCTN | ISRCTN17381762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17381762 |
| IRAS number | 311434 |
| Secondary identifying numbers | CPMS 52629, IRAS 311434, award ID: NIHR130693 |
- Submission date
- 08/07/2022
- Registration date
- 01/11/2022
- Last edited
- 28/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Mental health rehabilitation services provide specialist treatment to people with particularly severe and complex problems. These services include inpatient units and supported accommodation in the community. Over half of the 4400 mental health inpatient rehabilitation beds in England are provided by the independent sector, but there have been no studies investigating the effectiveness of inpatient rehabilitation services that have included the independent sector. Our study aims to address this gap.
Who can participate?
Any patient with an adequate understanding of English at one of the mental health inpatient rehabilitation units selected for this study.
What does the study involve?
A research interview which takes about 30 min where participants will be asked a series of questions about how satisfied they are with different aspects of their life, how they spend their time, the freedom they have to make day-to-day decisions, and how they feel about the care you receive from the inpatient rehabilitation service. The research team will also invite participants to a brief 5 min interview at 6, 12, and 18 months after the first interview. These interviews will be done over the telephone or video call (e.g. Zoom or Microsoft Teams).
The research team will also ask participants for their permission to ask a staff member about their abilities, needs, any specific difficulties they may have, their activities in the community, and whether they have been at risk or posed any risk to others. The research team will then contact staff involved in the participant's healthcare at regular intervals over the next 18 months to see if they have been discharged from the inpatient rehabilitation service, and, if they have been discharged, details of where they have been discharged to and whether they have had any readmissions. Participants may ask the researcher to see a copy of these questions.
The research team would also ask participants for their permission to collect some information from their healthcare records about the care they have received from mental health services in the past.
What are the possible benefits and risks of participating?
By participating in this study, participants will help the research team to assess the effectiveness of NHS and independent sector inpatient mental health rehabilitation services. It is hoped that the information collected from this study will help to improve inpatient rehabilitation services in the future. Each participant will be offered £20 in recognition of the time they have given to be involved in the study.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
From December 2019 to June 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Services Delivery Research programme (UK)
Who is the main contact?
Christian Dalton-Locke (Project Manager)
c.dalton-locke@ucl.ac.uk
Contact information
Principal Investigator
University College London
UCL Division of Psychiatry
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
 ORCID ID |
0000-0003-2481-4802 |
|---|---|
| Phone | +44 (0)207 679 9710 |
| h.killaspy@ucl.ac.uk |
Scientific
University College London
UCL Division of Psychiatry
Maple House
149 Tottenham Court Road
London
W1T 7BN
United Kingdom
| Phone | +44 (0)20 7679 9632 |
|---|---|
| c.dalton-locke@ucl.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Assessing the Clinical and cost-Effectiveness of inpatient mental health Rehabilitation services provided by the NHS and independent sector (ACER) |
| Study acronym | ACER V1.0 |
| Study hypothesis | 1. Do sociodemographic and clinical characteristics of patients differ between people receiving inpatient rehabilitation in the NHS and the independent sector? 2. Does service quality differ between inpatient rehabilitation units provided by the NHS and the independent sector? 3. Do the experiences of treatment and care, from the perspectives of patients, informal carers and staff, differ between inpatient rehabilitation services provided by the NHS and the independent sector? 4. Is inpatient rehabilitation clinically more effective at preventing readmission when provided by the independent sector or the NHS, after adjusting for differences between the sectors in terms of patient characteristics and length of stay? 5. Is inpatient rehabilitation more cost-effective when provided by the independent sector or the NHS, after adjusting for differences between the sectors in terms of key predictors of costs such as patient characteristics and length of stay? |
| Ethics approval(s) | Approved 08/06/2022, North East - Newcastle & North Tyneside 2 Research Ethics Committee (NHS BT Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ; +44 (0)2071048086; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 22/NE/0067 |
| Condition | Mental health |
| Intervention | As we cannot compare NHS and independent sector services through a randomised trial, our programme will draw together findings from four components to assess the effectiveness of these services: 1. Survey of 60 inpatient mental health rehabilitation services across England (30 NHS and 30 independent sector) 2. In-depth interviews with users, relatives/carers, staff, and commissioners of these services to explore their experiences and perspectives 3. Cohort study to compare outcomes for 600 patients of the NHS and independent sector rehabilitation services surveyed in Component 1, using statistical methods that take account of any differences between them such as the severity of their mental health problems 4. Health economic evaluation to assess the cost-effectiveness of inpatient rehabilitation services provided by the NHS and the independent sector Survey: We aim to recruit 500 patients from 60 inpatient mental health rehabilitation units across England (30 NHS and 30 independent sector) over a 12-month period to participate in a survey (patients at this stage will be asked to consent to take part in Components 1 and 3). Once selected services have agreed to participate, researchers will visit the unit and describe the project to staff. The staff will be asked to introduce the patients to the researchers who will then provide the patient with a Participant Information Sheet. The study will be fully explained to the patient, including the purpose of the study, what their participation would involve, what data will be collected and how it will be collected, and that they are free to withdraw from the study at any point without it affecting their clinical care. The patient will have at least 24 hours to consider whether they would like to participate and have the opportunity to ask the researcher any questions. Patients who provide their informed consent by completing the consent form will then participate in a research interview where data will be collected using standardised measures regarding their quality of life (DIALOG, Recovering Quality of Life, EQ-5D-5L), autonomy (Resident Choice Scale), engagement in activities (Time Use Diary), satisfaction with care (Client Assessment of Treatment), and healthcare costs (Client Receipt Inventory). In addition, staff will be asked to complete standardised measures on the patient's social functioning (Life Skills Profile), challenging behaviours (Special Problems Rating Scale), alcohol and drug use (Clinical Alcohol and Drug Scale), needs (Camberwell Assessment of Needs, and activities (Time Use Diary). Sociodemographic, healthcare service use, current and previous risk, and engagement in community-based activities will be collected from the patient's healthcare records. Also, researchers will complete the QuIRC with the managers of each service. The QuIRC is a quality assessment tool developed specifically for inpatient mental health rehabilitation units. In-depth interview (qualitative) study: We will select and invite 10 inpatient rehabilitation units (5 NHS and 5 independent sector) participating in Component 1 to participate in Component 2. We will invite all staff from these services to participate in a focus group and ask about their experience and perspective of working in these services. We will also conduct additional staff interviews, including interviews with senior service managers, commissioners, and community care coordinators, to expand on any themes not adequately covered in the focus group, including the decision-making process about where an individual receives their inpatient rehabilitation. From these participating services, we will also aim to interview between three and five patients from each service (between 30 and 50 in total) and ask about their experiences and perspectives on the care they are receiving. We will ask these patient participants for permission to contact and invite their relatives/carers to participate in an in-depth interview. We aim to recruit around 20 relatives/carers in total. Interviews with relatives/carers will take place via telephone or videoconferencing. Cohort study: Participants recruited into Component 1 will comprise the cohort for Component 3. The researchers will contact the services managers of the inpatient rehabilitation units participating in Component 1 once a month for 18 months to ask if any of the participants have been discharged from the unit, and if they have been discharged, information about where they have been discharged to including contact details of relevant staff (i.e. their 'key informant') who we may complete future monthly follow-ups with. We expect on most occasions this will be the participant’s community care coordinator. We will invite all participants to a short research interview via telephone or video call (Teams of Zoom) at six, 12, and 18 months to complete two quality of life measures (Recovering Quality of Life and EQ-5D-5L). In addition, at six, 12, and 18 months we will ask key informants of participants who have been discharged from the inpatient rehabilitation service they were recruited from about any subsequent inpatient service use, and social care costs (use of supported accommodation and any individual ‘care packages’). Health economic evaluation: Using data collected in Components 1 and 3 analyses will be conducted to investigate the cost-effectiveness of NHS and independent inpatient rehabilitation services by calculating quality-adjusted life-years. |
| Intervention type | Other |
| Primary outcome measure | Cohort study: Successful discharge from inpatient rehabilitation, defined as being discharged to the community without readmission, measured using staff reports collected at 6, 12, and 18 months Health economic evaluation: Incremental cost-effectiveness ratio (ICER) comparing rehabilitation in the independent sector and rehabilitation in an NHS service calculated using cost-utility analysis (CUA) where the QALYs are measured using patient responses to the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire collected at baseline, 6, 12, and 18 months |
| Secondary outcome measures | Cohort study: Total inpatient days over the follow-up period measured using staff reports collected at 6, 12, and 18 months |
| Overall study start date | 20/12/2019 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Participant inclusion criteria | Patients: 1. Inpatients at rehabilitation units that are participating in the study 2. Provide informed consent to participate in the study. All efforts will be made to maximise the capacity of each patient to be able to provide informed consent for the study (for example, by explaining the purpose and process of the study in simple terms and over a number of meetings), and any patient with capacity who declines participation will not be included. However, for eligible patients who lack capacity to give informed consent we will seek advice from a consultee on their participation. Further detail on the procedure for seeking informed consent and assessing capacity is provided in section 8. Research data for participants lacking capacity will be collected via staff interview and healthcare records (as described above), but these participants will not be asked to participate in an interview themselves. The researchers expect only a minority of eligible patients to lack capacity (around 8% based on the REAL study) but it is important they are included in the study in order to prevent sample bias. Services: 1. High dependency, community, or longer-term high dependency rehabilitation units 2. Community rehabilitation units will only be included if they are registered with CQC as an inpatient unit (rather than supported housing or residential care) |
| Participant exclusion criteria | Patients: 1. Unavailable during the researcher's visit, because they are on leave from the ward during the visit or are otherwise unavailable 2. Do not have an adequate understanding of English to understand the main purpose of the research and what participating would involve for them Services: 1. Highly specialist units that focus on sub-groups (such as people with a diagnosis on the autism spectrum or those with neurodegenerative disease) 2. Specialist forensic mental health units (i.e. low secure rehabilitation units) as they do not form part of the standard mental health rehabilitation care pathway and are subject to specialist commissioning by NHS England |
| Recruitment start date | 08/06/2022 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
4 St Pancras Way
London
NW1 0PE
United Kingdom
Newbridge Hill
Bath
BA1 3QE
United Kingdom
50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom
350 Euston Road
Regents PLACE
London
NW1 3AX
United Kingdom
Wilsons Lane
Coventry
CV6 6NY
United Kingdom
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Charles Hastings Way
Worcester
WR5 1JR
United Kingdom
Thorpe Park
Leeds
LS15 8ZB
United Kingdom
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
Kings Business Park
Kings Drive
Prescot
L34 1PJ
United Kingdom
Bellringer Road
Trentham
Stoke-on-trent
ST4 8HH
United Kingdom
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Tickhill Road
Doncaster
DN4 8QN
United Kingdom
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
61 Glenburnie Road
London
SW17 7DJ
United Kingdom
Swandean
Arundel Road
Worthing
BN13 3EP
United Kingdom
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Northampton
NN1 5DG
United Kingdom
Hammersmith Road
London
W14 8UD
United Kingdom
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
Pinewood PLACE
Dartford
DA2 7WG
United Kingdom
Sceptre Way
Walton Summit
Preston
PR5 6AW
United Kingdom
Calmore
Southampton
SO40 2RZ
United Kingdom
Sponsor information
Hospital/treatment centre
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom
| Phone | +44 (0)20 7685 5949 |
|---|---|
| sponsor.noclor@nhs.net | |
| Website | http://www.candi.nhs.uk/ |
"ROR" |
https://ror.org/03ekq2173 |
Funders
Funder type
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 | 30/06/2026 |
|---|---|
| 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 | Planned dissemination of findings through peer-reviewed scientific journal publications by the end of 2025, hosting two webinars for participating services at key stages during the study to report on the progress of the study, and also presentation of the main findings at conferences. |
| 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 1.3 | 07/06/2022 | 05/08/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol article | 06/02/2024 | 07/02/2024 | Yes | No |
Additional files
Editorial Notes
28/01/2025: The following changes were made:
1. The recruitment end date was changed from 31/01/2025 to 30/09/2025.
2. The intention to publish date was changed from 31/12/2025 to 30/06/2026.
3. The study participating centres Lancashire and South Cumbria NHS Foundation Trust and Hampshire and Isle of Wight Healthcare NHS Foundation Trust were added.
10/10/2024: The study participating centres were updated to remove East London NHS Foundation Trust and Leicestershire Partnership NHS Trust and add Barnet Enfield and Haringey Mental Health NHS Trust and Oxleas NHS Foundation Trust.
08/10/2024: The recruitment end date was changed from 31/10/2024 to 31/01/2025.
07/02/2024: Publication reference added.
01/11/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 30/05/2022 to 08/06/2022.
2. The overall end date was changed from 08/12/2024 to 30/06/2026.
3. The plain English summary was updated to reflect these changes.
08/07/2022: Trial's existence confirmed by the NIHR.
