Condition category
Mental and Behavioural Disorders
Date applied
10/02/2020
Date assigned
11/02/2020
Last edited
11/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many people experiencing a mental health crisis go to A&E and wait a long time for assessment. They may be admitted to a psychiatric ward unnecessarily because of a lack of proper assessment. People not signposted to the most appropriate aftercare might repeatedly attend A&E and be admitted to hospital. New Psychiatric Decision Units (PDUs; also called mental health decision units [MDHUs]) are designed to address this. PDUs are short stay units with a high staff: patient ratio delivering in-depth assessment of individual support, aiming to reduce unnecessary hospital admissions and attendance at A&E, and to improve experiences of crisis care.

The researchers will study four new MHDUs in England in detail. The researchers will use a longitudinal cohort study to examine the changes in crisis care service use by comparing service use in the nine month period leading up to a service user’s first stay on a mental health decision unit to the nine months following that stay.
The researchers will also conduct in-depth interviews with service users and with PDU staff and staff who refer to PDUs about experiences of care, assessment and aftercare. Staff will be interviewed once, but service users will be interviewed for a second time, nine months following their stay on the PDU. There are other studies which are connected to this study - these are registered separately and include an interrupted time series and synthetic control study. The DECISION research team includes people who have used mental health services and the research is coproduced.

Who can participate?
There are no eligibility criteria other than capacity to consent and admission to MHDU as this is a naturalistic study and we are interested in understanding who is admitted to MHDUs. Staff participants will be working at an MDHU.

What does the study involve?
For participants taking part in the longitudinal cohort study:
There will be a short questionnaire about your quality of life, and we will ask the local Trusts to let us know how much you have used services, and which services you have used for your mental health in the nine months preceding and following your first admission to the MHDU. We will be in touch after 9 months to ask you to complete the short questionnaire again. Participants are involved in the study for 9 months.
For participants taking part in qualitative interviews for service users:
There will be two in-depth interviews about experiences of crisis care in mental health services. The first interview will be within a fortnight of leaving MHDU and the second will be nine months later. The interview will take about-60-90 minutes to complete. We will audio record the interview.
For staff participants taking part in qualitative interviews:
We will conduct an in-depth interview about your experiences of working in mental health crisis care, your experiences of working in or with the decision unit, and/or your knowledge of the mental health crisis care pathway. The interview will take about 45-60 minutes to complete and will be audio recorded.

What are the possible benefits and risks of participating?
It is unlikely that there are any risks in taking part. It is possible that some people may find some of the issues discussed in the interviews sensitive or uncomfortable to talk about. Participants do not have to discuss anything that you find difficult to talk about, and it is OK to not answer any of the questions. If difficult issues come up during the interview participants are free to stop the interview at any point to take a break, rearrange or end the interview, or withdraw from the study. There are no consequences to doing so for participants.

Where is the study run from?
1. St George's, University of London (UK)
2. St George's Hospital (UK)
3. Springfield Hospital (UK)
4. Lincolnshire Partnership NHS Foundation Trust (UK)
5. Lincoln County Hospital (UK)
6. Birmingham and Solihull Mental Health NHS Foundation Trust (UK)
7. Queen Elizabeth Medical Centre (UK)
8. Sheffield Health & Social Care NHS Foundation Trust (UK)
9. Royal Hallamshire Hospital (UK)
10. Kingston Hospital NHS Foundation Trust (UK)
11. Sandwell General Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2019 to February 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Lucy Goldsmith
lgoldsmi@sgul.ac.uk

Trial website

https://decisionstudy.org/

Contact information

Type

Public

Primary contact

Dr Lucy Goldsmith

ORCID ID

http://orcid.org/0000-0002-6934-1925

Contact details

Population Health Research Institute
St George's
University of London
Cramner Road
Tooting
London
SW17 0RE
United Kingdom
+44 (0)208 7250167
lgoldsmi@sgul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NIHR HS&DR 17/49/70, IRAS 256406

Study information

Scientific title

Evaluating mental health decision units in acute care pathways (DECISION): a quasi-experimental and health economic evaluation

Acronym

DECISION

Study hypothesis

The aims of the study are:
1. To establish the effects of psychiatric decision units (also known as mental health decision units) in England on service use outcomes
2. To examine whether psychiatric decision units benefit all people equally
3. To ascertain the staff and service user experiences of these units in order to inform potential national scale-up

Ethics approval

Approved 12/08/2019, NRES Committee: East Midlands – Leicester South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8310; NRESCommittee.Eastmidlands-LeicesterSouth@nhs.net), Ref: 19/EM/0226

Study design

Observational longitudinal cohort study with additional qualitative data collection

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Psychiatric crisis / Mental health crisis

Intervention

This is an observational study investigating an intervention which is already part of clinical practice. The intervention is ‘mental health decision units’ (also known as ‘psychiatric decision units). The longitudinal cohort study examines changes in crisis care service use following the first stay on a psychiatric decision unit, by comparing changes in the pattern and rate of crisis care service use in the nine months preceding and following the first admission to a decision unit. The qualitative study examines both staff and patient experiences of psychiatric decision units.

The researchers will study four new MHDUs in England in detail. The researchers will use a longitudinal cohort study to examine the changes in crisis care service use by comparing service use in the nine-month period leading up to a service user’s first stay on a mental health decision unit to the nine months following that stay.

The researchers will also conduct in-depth interviews with service users and with PDU staff and staff who refer to PDUs about experiences of care, assessment and aftercare. Staff will be interviewed once, but service users will be interviewed for a second time, nine months following their stay on the PDU. There are other studies which are connected to this study - these are registered separately and include an interrupted time series and synthetic control study. The DECISION research team includes people who have used mental health services and the research is coproduced.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Note: there is a primary outcome for both mental health trusts and acute trusts. For the longitudinal cohort study, these primary outcomes are:
1. Informal admissions (mental health trust) during the study
2. A&E presentations, as measured as liaison psychiatry episodes (acute trust) during the study

Secondary outcome measures

Note: there are a large number of secondary outcomes as mental health decision units (MHDUs) are purported to make a difference to these outcomes; the study will enable these claims to be examined.
Using patient records, during the study period:
1. Inpatient admissions
2. 0-5 day inpatient admissions
3. Average length of inpatient stay (bed days)
4. Compulsory admissions
5. Use of community mental health team (CMHT) and other mental health trust services

Qualitative study:
6. Staff and patient experiences of psychiatric decision units measured using qualitative interviews at the end of the study

Overall trial start date

01/03/2019

Overall trial end date

28/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

For patients:
1. First admission to MHDU
2. Capacity to consent to participate in research.
For staff:
1. MDHU staff

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Longitudinal cohort study: estimate of throughput to and recruitment from PDUs in a 6 month recruitment period: 1,151; qualitative study: 66.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2019

Recruitment end date

29/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University Hospitals NHS Foundation Trust
St George's Hospital Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

South West London and St George's Mental Health NHS Trust
Springfield Hospital 61 Glenburnie Road
London
SW17 7DJ
United Kingdom

Trial participating centre

Lincolnshire Partnership NHS Foundation Trust
Unit's 8 & 9 The Point Lions Way Sleaford
Lincolnshire
NG34 8GG
United Kingdom

Trial participating centre

United Lincolnshire Hospitals NHS Trust
Lincoln County Hospital Greetwell Road
Lincolnshire
LN2 4AX
United Kingdom

Trial participating centre

Birmingham and Solihull Mental Health NHS Foundation Trust
Unit 1 50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Medical Centre Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Sheffield Health & Social Care NHS Foundation Trust,
Fulwood House Old Fulwood Rd
Sheffield
S10 3TH
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital Glossop Rd
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

St George's, University of London

Sponsor details

Cramner Road
Tooting
London
SW17 0RE
United Kingdom
+44 (0)208 266 6866
jmontebe@sgul.ac.uk

Sponsor type

University/education

Website

http://www.sgul.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Longitudinal Cohort Study Results 01/04/2021
Service user experience: qualitative study 01/04/2021
Staff experience: qualitative study 01/04/2021

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository

Intention to publish date

01/04/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/02/2020: Trial’s existence confirmed by East Midlands – Leicester South Research Ethics Committee