Condition category
Mental and Behavioural Disorders
Date applied
23/11/2016
Date assigned
28/11/2016
Last edited
28/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The few weeks after discharge from a psychiatric ward can be very difficult. Rates of readmission to hospital, and levels of suicide and self-harm are high. Inpatient care is very expensive and Mental Health Trusts are exploring ways to reduce readmissions. Recent research suggests ‘peer worker’ roles can be beneficial. Peer Workers are employed in mental health services to support service users by using their own experiences of mental health problems. There is some evidence that Peer Workers help people stay out of hospital after discharge by supporting individual mental health recovery. Nationally lots of different approaches to employing Peer Workers are being tried, but research about what works well, and whether money is saved as a result, is still not clear. A program has been developed in which Peer Workers are trained and supported to meet service users on the ward before discharge, and continue to work with them in the community in the crucial post-discharge period. The aim of this study is to find out whether this Peer Worker program is an effective way of helping to reduce readmission rates when adults are discharge from psychiatric wards.

Who can participate?
Inpatients of adult acute psychiatric wards with at least one previous psychiatric admission in the preceding two years

What does the study involve?
Participants who agree to take part in the study are interviewed by a member of the research team who asks them to complete some questionnaires about their mental health and other experiences. After the questionnaires are completed, participants are randomly selected by online computer software to either receive support for discharge from a peer worker (someone with their own experiences of using mental health services who has been trained to provide peer support) or to receive an information pack about support in the community prior to discharge. All participants also receive all the support they would usually expect from community mental health services. Participants offered a peer worker have at least one meeting with them while on the ward and then weekly face-to-face meetings with the peer worker for the first ten weeks after discharge followed by three fortnightly meetings, plus additional phone contact as arranged. Peer support involves a range of approaches to support, delivered by the peer worker, based on the specialised peer support training they have received. Four months after participants have left hospital – once the peer support has finished – participants are interviewed again by a researcher using a similar set of questionnaires. People who received support from a peer worker may also be contacted to take part in an in-depth interview which focuses on their personal experiences of the peer support they have received. As part of the research information about the mental health services participants have received from their mental health Trust is also collected directly from Electronic Patient Record (the notes that the Trust keeps) about the 12 months before the participant was admitted to hospital, and then about the 12 months after they were discharged.

What are the possible benefits and risks of participating?
Half of people who consent to take part in the research will receive peer support for discharge from inpatient to community mental health care. There are no additional personal benefits of taking part in this study. It is unlikely that there are any risks in taking part in the research. 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 they find difficult to talk about. However, 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. If they decide to do so this will have no effect on the services they receive. If difficult issues come up in any interview the researcher can help the participant to make arrangements to receive support from an appropriate person involved in their care.

Where is the study run from?
1. South West London & St George's Mental Health NHS Trust (UK)
2. East London NHS Foundation Trust (UK)
3. Sussex Partnership NHS Foundation Trust (UK)
4. South West Yorkshire Partnership NHS Foundation Trust (UK)
5. Central & North West London NHS Foundation Trust (UK)
6. Dorset Healthcare University NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2014 to August 2019

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

Who is the main contact?
1. Dr Steve Gillard (scientific)
sgillard@sgul.ac.uk
2. Ms Jacqueline Marks (public)
jmarks@sgul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steve Gillard

ORCID ID

Contact details

Population Health Research Institute
St George's
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 20 8725 3614
sgillard@sgul.ac.uk

Type

Public

Additional contact

Ms Jacqueline Marks

ORCID ID

Contact details

Population Health Research Institute
St George's
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 20 8725 4942
jmarks@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V3.0 22/SEP/2016

Study information

Scientific title

Enhanced discharge from inpatient to community health care (ENRICH): a programme of applied research to manualise, pilot and trial a Peer Worker intervention

Acronym

ENRICH

Study hypothesis

Readmission rate will be lower, in the year post-discharge, for people receiving a Peer Worker intervention to enhance discharge from inpatient to community mental health care than for people discharged to community mental health care as usual plus Discharge Information Pack.

Ethics approval

London Bridge NHS Research Ethics Committee, 10/05/2016, ref: 16/LO/0470

Study design

Multi-centre two-arm pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Mental health

Intervention

Participants will be randomised to the treatment arms in a 1:1.03 ratio (reflecting nested clustering of participants within the two trial arms). Randomisation will be stratified by site and diagnostic group using randomly permuted blocks of randomly varying length to conceal the allocation sequence and achieve the allocation ratio. Diagnostic group has three strata: Psychotic Disorders – ICD-10 diagnoses F20-29; Personality Disorders – ICD-10 diagnoses F60; other eligible disorders. Randomisation will be performed using a centralised internet service, created and hosted by the Pragmatic Clinical Trials Unit, Queen Mary, University of London.

Intervention group: Participants allocated to the intervention arm of the trial will receive manualised peer support for discharge (in addition to treatment as usual; follow up from community mental health services within 7 days of discharge). The intervention will comprise at least one face to face meeting with a peer worker while the participants is still an inpatient, followed by 10 weekly face to face meetings and then three fortnightly face to face meetings in the community, following discharge, plus telephone contact between meetings (i.e. the intervention lasts a total of four months post-discharge). Peer workers will have received a manualised training as part of the intervention – providing them with a set of strengths-based tools, including a Discharge Information Pack, to support the discharge transition – and will receiving ongoing supervision and support from a named Peer Worker Coordinator. Participants allocated to the control arm of the trial will receive the Discharge Information Pack from a member of the clinical staff team prior to discharge plus treatment as usual.

Control group: Participants in the control arm of the study will receive a Discharge Information Pack from a member of the ward clinical team immediately prior to discharge. This pack will contain information and contact details of the range of statutory and voluntary sector services locally that would be available to provide post-discharge support. The pack will be developed as part of the resources available to peer workers as detailed in the intervention manual and will be the same pack that peer workers will use with participants in the intervention arm of the study.

Participants in both intervention and control arms of the study will receive treatment as usual. Treatment as usual will comprise statutory follow-up by community mental health services within 7 days of discharge. All participants will receive care from community mental health services post-discharge as individually indicated in formal discharge plans and any subsequent care plans.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Readmission rate to psychiatric inpatient care is assessed by review of patient notes at 12 months post-discharge.

Secondary outcome measures

1. Number of readmissions in the 12 months post-discharge are measured by review of patient notes at baseline and 12 months post-discharge
2. Time to (first) readmission is measured in days post-discharge from index admission by review of patient notes at baseline and 12 months post-discharge
3. Type of admission (compulsory or voluntarily) is measured by review of patient notes at baseline and 12 months post-discharge
4. Length of stay of any readmission (days in hospital) is measured by review of patient notes at baseline and 12 months post-discharge
5. Use of A&E for psychiatric emergency is measured as the number of separate episodes of liaison psychiatry contact in hospital A&E and self-reported visits to A&E for psychiatric emergency at baseline and 12 months post-discharge
6. Quality Adjusted Life Years are calculated using the EQ5D-5L at baseline and 4 months
7. Strength of Social Network is measured using the Social Contacts Assessment (SCA) at baseline and 4 months
8. Subjective quality of life is measured by Manchester Short Assessment of Quality of Life at baseline and 4 months
9. Social inclusion is measured using the Objective Social Outcomes Index (SIX) at baseline and 4 months
10. Hope is measured using the Herth Hope Index at baseline and 4 months
11. Social Functioning is measured using the Life Skills Profile (LSP-16) at baseline and 4 months
12. Psychiatric Symptoms are measured using the Brief Psychiatric Rating Scale at baseline and 4 months

Overall trial start date

01/03/2014

Overall trial end date

31/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Inpatients of adult acute psychiatric wards (acute admission wards and their equivalents as termed locally) with at least one previous psychiatric admission in the preceding two years
2. Aged 18+
3. Assessed by an appropriate member of the ward clinical team as having sufficient capacity to give informed consent to participate in the study
4. Assessed by ward clinical team as likely to be discharged within the next month
5. Given written, witnessed informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

590

Participant exclusion criteria

1. Diagnosis of organic mental health conditions
2. Primary diagnosis of eating disorders, learning disability, or drug or alcohol dependency
3. Assessed by ward clinical team as lacking sufficient capacity to give informed consent to participate in the study
4. Assessed by ward clinical team as unlikely to be discharged within the next month
5. Assessed by ward clinical team as presenting a current, substantial risk to peer worker
6. Already participants in either arm of the study (having been readmitted during follow-up)
7. Not having given written, witnessed informed consent to participate in the study

Recruitment start date

01/12/2016

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

East London NHS Foundation Trust
9 Alie Street
London
E1 8DE
United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Swandean Arundel Road
Worthing
BN13 3EP
United Kingdom

Trial participating centre

South West Yorkshire Partnership NHS Foundation Trust
Fieldhead Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom

Trial participating centre

Central & North West London NHS Foundation Trust
Stephenson House 75 Hampstead Road Kings Cross
London
NW1 2PL
United Kingdom

Trial participating centre

Dorset Healthcare University NHS Foundation Trust
Sentinel House 4-6 Nuffield Road
Poole
BH17 0RB
United Kingdom

Sponsor information

Organisation

St George's, University of London

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 20 8725 5013
dmccartn@sgul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication of the main trial paper from this research in a high impact medical journal, with further peer reviewed outputs in social psychiatry and health services research journals
2. Planned presentation at national and international professional and academic conferences - e.g. Clinical Research Network and NHS Confederation/Health Services Research Network national conferences, European Network for Mental Health Service Evaluation (ENMESH) and Evidence Based Healthcare (EBHS) international conferences, and international congresses of the World Psychiatric Association and International Health Economics Association
3. Planned presentation of clinical and applied findings to academic meetings of professional bodies, including RCP faculty meetings, RCN national and international conferences, and faculty meetings of the BPS Division of Clinical Psychology

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes