Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Quality networks are designed to help clinicians and managers assess and improve the quality of the care they provide. Quality networks involve setting standards, organising independent peer reviews during which quality of care is assessed against these standards, and providing feedback to services about changes that may need to be made to improve the quality of care that they provide.
Follow-up studies have shown that quality of care provided by services that take part in quality networks generally improves. However, services that do not take part in these networks do other things to improve the quality of care they provide and the extent of any additional benefit resulting from participation in quality networks is not known.
This study aims to evaluate the effectiveness of a quality network for Forensic Low Secure Units run by the College Centre for Quality Improvement (CCQI) at the Royal College of Psychiatrists. Forensic Low Secure Services provide a service for people who have a learning disability who offend. People are detained under the Mental Health Act, they are offered rehabilitation programmes and are followed-up by health professionals. The study will investigate whether taking part in this new network improves service quality and patient outcomes beyond changes that are seen in units that do not take part in the network.

Who can participate?
All stand-alone Forensic Low Secure Units across England and Wales that express an interest in joining the quality network for low secure services will be recruited to take part in this study.

What does the study involve?
The Forensic Low Secure Units that agree to take part in the study will be randomly allocated to either an “early intervention group” or a “late intervention group” (control group). The services in the early intervention group will enter the quality network immediately whist those in the late intervention group will join the network one year later. Researchers from the CCQI (who do not know whether the units are in the intervention or control group) will assess the quality of the service and patient outcomes at the beginning of the study and 12 months later to find out what impact, if any, participation in the network has on these measures. We will also ask staff working in these units to complete a survey questionnaire to find out if participation in the quality network affects how they feel about their work (e.g. high or low burnout). The outcomes of the study will contribute to generate data that could help improving the quality of care that the service members and other units provide in the coming years.

What are the possible benefits and risks to participants?
The aim of the study is to gather evidence about the real impact of participation in a quality network. The outcomes of the study will therefore be beneficial to the participants who will be able to receive (users) and provide (staff) a better quality of care in the coming years.
By taking part in the study we believe the risk that individual participants will be exposed to is very small. Service users and staff who participate will be asked to allocate some of their time to complete a survey questionnaire. We estimate that this survey will take participants approximately 10 minutes to complete. We acknowledge that there can be risks in administering questionnaires to vulnerable adults such as psychiatric patients and to professional groups who are under considerable pressure as front line staff. The participant information sheets make it clear that if completion of the questionnaires does cause any difficulty or upset, participants can stop at any time, skip questions they do not want to answer, or withdraw from the study at any time. The information sheets also make it clear that if participants would like help or support due to any distress felt through taking part in the study, they can contact the main researcher whose contact details are shown on the information sheet. The main researcher will then be able to direct them to the most appropriate type of support.

Where is the study run from?
Forensic Low Secure Units across England and Wales. The data collection is carried out before and after the peer-review cycle of the quality network for Forensic Low Secure Units which takes place annually. Participating services will be recruited only for the first, second and third peer-review cycle of the network. A researcher of the CCQI will arrange to visit all participating services to carry out two identical assessments of their quality of care at the start of the study and at follow-up

When is the study starting and how long is it expected to run for?
The study started in July 2012 and is expected to be completed in December 2015.

Who is funding the study?
Funding has been provided by the Royal College of Psychiatrists, College Centre for Quality Improvement until the end of the study in December 2015.

Who is the main contact?
Dr Lina Aimola

Trial website

Contact information



Primary contact

Prof Mike Crawford


Contact details

Royal College of Psychiatrists
21 Prescott Street
E1 8BB
United Kingdom
+44 (0)20 3701 2647

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Evaluation of a peer-led quality improvement network: a cluster randomised control trial


eLSU (evaluated network for Low Secure Units)

Study hypothesis

It is hypothesised that in wards participating in the evaluated network the compliance with a selection of key standards of care will be higher 12 months after entry into the study than in wards that do not participate. The null hypothesis is that there will be no difference between the participating and non-participating wards.

Ethics approval

College Centre for Quality Improvement (CCQI) Ethics Committee, 31/10/2012, CCQI REC ref: 2012-3

Study design

Three-year two-armed parallel-group researcher-masked cluster randomised control trial (single site)

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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




Services randomised to the intervention group will go through an annual peer-review cycle set up by the managers of the forensic quality network. During this review cycle the services are asked to complete a review of the care they provide according to nationally agreed standards. They will then receive a visit from a peer-review team who will check the self-review document and prepare a report highlighting areas of achievement and areas that need to be improvement if the service is to meet agreed standards of care. The final stage of the cycle involves action planning for the services, dissemination of a National Report amongst members and attendance at the Annual Forum. The National Report provides a helpful list of good practice and people to contact for advice on specific issues, while in the Annual Forum services will be able to share the lesson learnt.

The services in the control group instead will continue to use other methods to review and improve the quality of care they provide as normal including local audits, internal reviews and inspections from statutory authorities.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The services’ compliance with a selection of key standards of care measured with an environmental checklist. The checklist covers the following standards:
1. Whether the service has an external perimeter that meets the standards for security
2. Whether there are separate, accessible and appropriately furnished facilities for visitors
3. Whether all visitors, staff and patients access the unit via airlock
4. Whether there are any ligature points on the ward(s)
5. Whether the service has a multi-faith room accessible and appropriate for use by all patients
6. Whether the service has a seclusion room
7. Whether the service has a de-escalation room
8. Whether patients’ bedrooms are designed to maintain safety
9. Whether there is a variety of recreational facilities accessible to patients
10. Whether there is a variety of occupational facilities accessible to patients
The maximum total score for the environmental checklist is 100. The higher the score on this checklist the higher the compliance of the services with the key standard of care assessed

All outcomes are measured at baseline and at 12 months.

Secondary outcome measures

1. Safety of the service measured by number of violent incidents and people absconding
2. Levels of patient satisfaction measured with a shorter 4-items version of the Quality of Care Questionnaire (QOCQ). The items are scored with a Likert scale ranging from '4' (very satisfied) to '0' (very unsatisfied). The higher the total score the higher the level of patient’s satisfaction
3. Patients’ mental well-being measured with the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Each question is scored with a Likert scale ranging from '1' (none of the time) to '5' (all the time). The higher the total score the higher the level of mental well-being of the patients
4. Levels of staff burnout measured with the Maslach Burnout Inventory (MBI). The 22 items of this survey create three general subscales assessing: emotional exhaustion, depersonalization and personal accomplishment. The items are scored on a 7-points Likert scale which ranges from 0 = 'Never' to 6 = 'every day'. High scores of emotional exhaustion and depersonalization together with low scores of personal accomplishment indicate high levels of burnout
5. Costs of service provision (e.g. cost per bed)

All outcomes are measured at baseline and at 12 months.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. All stand alone low secure services in England and Wales
2. Participating patients are both male and female individuals above 18 years old detained under the Mental Health Act (1983) in a stand alone low secure service

Participant type


Age group




Target number of participants

86 wards

Participant exclusion criteria

Low secure services are not eligible for the study if they are based on the same site of medium secure services. This is because staff who work across both sets of services may already have implemented quality improvement measures resulting from their experience of taking part in this other network, which has the potential to 'contaminate' the results.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Royal College of Psychiatrists
E1 8BB
United Kingdom

Sponsor information


Royal College of Psychiatrists (UK)

Sponsor details

21 Prescott Street
E1 8BB
United Kingdom
+44 (0)20 7235 2531

Sponsor type




Funder type


Funder name

Royal College of Psychiatrists

Alternative name(s)

RCPsych, The Royal College Of Psychiatrists, RC PSYCH

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)


United Kingdom

Results and Publications

Publication and dissemination plan

Publication of the results in a high-impact peer reviewed journal is planned for August 2018.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

2016 protocol in:
2018 results in: [added 12/02/2019]

Publication citations

Additional files

Editorial Notes

12/02/2019: Publication reference added. 15/12/2016: The publication and dissemination plan and availability of participant level data have been updated. 08/12/2016: The overall trial end date has been updated from 31/12/2015 to 31/08/2017. 23/09/2016: Publication reference added.