Condition category
Mental and Behavioural Disorders
Date applied
17/10/2018
Date assigned
28/08/2019
Last edited
29/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aim
Service users in acute mental health inpatient wards are encouraged to participate in all aspects of their treatment and care, including planned daily activities. Some research in these settings has found that planned activities are not often or not adequately provided and that this may have a negative effect on service users.

The environment including the design of the hospital building and how staff and service users relate to each other may be linked and may also have an effect on planned activities. This study aims to explore the environment of one acute mental health unit to identify factors that can potentially or hinder service user engagement in planned activities.

Who can participate?
The study will be carried out in an inner-London mental health inpatient unit, which has 3 wards and one therapy unit providing care for adults aged 18-65. Anyone who has been admitted to that ward for 7 days or more and has the ability to make an informed decision about taking part in the study will be eligible to be included. All staff involved in providing clinical care to service users within the unit, from all professional groups, will be eligible to be included.

What does the study involve?
The study is made up of three distinct parts, which may overlap in terms of time and participants.
1. We will ask some service users (around 30 in total) and all staff (around 40) on the wards in the unit to complete similar questionnaires which ask some questions about themselves, how satisfied they are with the hospital building and design, how the environment can be improved and their impression of the wards in ten areas.
2. We will ask clinical staff only (between 6 and 10) to volunteer to take part in a series of five group meetings over an eight-month period to discuss issues related to the hospital environment and suggest recommendations they feel will improve the environment. We hope to include as many professional groups as possible. The chief investigator will facilitate the meeting, which will be tape-recorded.
3. Individual in-depth interviews with key staff members who may be unable to attend the group meetings or are from professions which may be under-represented within the group.

What are the possible benefits and risks of participating?
Service user participant will be offered £10.00 in lieu of their time spent in completing the questionnaire. Staff participants in the group discussions will be offered £100.00 per session in lieu of their time and travel expenses. They will participate in the meetings in their own time, either on days off or when on annual leave.

Whilst there are no direct benefits to taking part in the study for either service users or staff, we hope that there will be a longer-term an indirect benefit through the research findings having a positive influence on mental health hospital environments for service users and staff experiences elsewhere.

We do not anticipate any risks to participants. However, there is a low, but still present, risk that both staff and service users may become distressed by the questions in the stage one interview, or through the group settings. The chief investigator is a registered occupational therapist with experience of working in mental health settings, and the study team members (PhD supervisors) have considerable experience between them of managing and working in acute care in busy urban environments. We believe that this will help lower the risk of participants becoming distressed, and if they do, the study team should be able to provide or seek appropriate help.

Participants won’t be identified in any way when the study results are reported, and all of their contributions will be anonymous.

Where is the study run from?
This is a joint study between University of Essex, Colchester and a single mental health inpatient site within Central and North-West London (CNWL) NHS Foundation Trust

When is the study starting and how long is it expected to run for?
The data collection for the study is expected to start in May 2018 and to be completed at the end of 2019. The analysis of data and report writing will take another 6 months and the study will be completed by September 2020.

Who is funding the study?
This study has received a grant of £6,000 from CNWL NHS Foundation Trust to cover participant payments and catering for group meetings and any additional small cost which may incur. The chief investigator is conducting the work in the context of her PhD at the University of Essex. She was awarded a university scholarship through open competition which pays tuition fees and provides a stipend of £12,000 per annum for 3 years.

Who is the main contact?
Chief Investigator, Ellen S. Adomako
ea16632@essex.ac.u

Trial website

Contact information

Type

Public

Primary contact

Ms Ellen Adomako

ORCID ID

http://orcid.org/0000-0002-2871-7308

Contact details

School of Health and Social care
University of Essex
Colchester
CO4 3SQ
United Kingdom
07722930943
ea16632@essex.ac.uk

Type

Scientific

Additional contact

Prof Fiona Nolan

ORCID ID

Contact details

Florence Nightingale Foundation Clinical Professor of Mental Health Nursing
School of Health & Social Care
University of Essex
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
01206872943
f.nolan@essex.ac.uk

Type

Scientific

Additional contact

Dr Simone Coetzee

ORCID ID

Contact details

Health and Human Sciences
University of Essex
Room 2S2.3.26
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
+441206 872278
scoetzee@essex.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Ref 17036

Study information

Scientific title

The impact of the environment on engagement in therapeutic activities of service users in an acute mental health unit

Acronym

Study hypothesis

How does the physical, social and cultural environment of the acute mental health unit impact on service users' engagement in therapeutic activities during their stay on the wards?

Ethics approval

1. Approved 27/04/2018, NHS HRA and Health and Care Research Wales (HCRW) (hra.approval@nhs.net), ref: 18/LO/0331.
2. Approved 27/04/2018, NHS Health Research Authority (London - Camden & Kings Cross Research Ethics Committee, NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; 02071048018; nrescommittee.london-camdenandkingscross@nhs.net), ref: 18/LO/0331.
3. Approved 13/08/2018, University of Essex (School of health and social care, Kimmy Eldridge building, Colchester; lcmckee@essex.ac.uk), ref: 17036.

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Mental health

Intervention

This study has two modules.
Module one involves a survey, where questionnaires will be given to clinical staff and service users to gather their views on the physical, social and cultural environment of the acute mental health unit.
Module two involves formation of the Participatory Action Research (PAR) group, with a maximum of ten clinical staff. This group will collaboratively work with the researcher and a service user researcher to identify overall social issues of the environment that impact on service user engagement in therapeutic activities, and to develop recommendations. The group will meet five times over an 8 month period, the first of which will be an induction and the other four of which will engage participants in the cycle of action and reflection. During the meetings, participants will be involved in discussing issues and making contributions from their professional perspectives.
Additional interviews will be conducted with clinical staff, whose veiws may not be represented in the data gathered in the PAR group meetings.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Perceptions of the ward atmosphere of staff and service users are measured using the Ward Atmosphere Scale (Moss 1974) at one time-point only which occurs between May to September 2018.

Secondary outcome measures

Staff and service user satisfaction with the physical features of the hospital environment is measured using a 16 item measure developed for the purposes of the study by the Chief investigator and her supervisors at the same time as the Ward Atmosphere Scale at one time-point only which occurs between May to September 2018.

Overall trial start date

20/01/2017

Overall trial end date

01/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Module one
Clinical staff
1. Working at the Gordon Hospital

Service users
1. Capacity to consent
2. Admitted to the ward for at least 7 days
3. Able to read and understand English

Module two - criteria for selecting clinical staff to join the PAR group:
1. Clinical staff of the Gordon Hospital, registered or non-registered (including doctors, mental health nurses, occupational therapists, psychologists, associate practitioners, art therapists, peer support workers (ex-service users) and support workers)
2. Active responsibility for delivering care and treatment to service users at the hospital
3. Facilitate, support or provide therapeutic activities and group sessions to service users
4. Worked at the Gordon Hospital for a minimum of 3 months

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

Module two:
1. Agency or bank staff
2. Trainees (including nurses, doctors, occupational therapists, psychologists)
3. Social workers
4. Pharmacists

Recruitment start date

10/05/2018

Recruitment end date

11/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Gordon Hospital
Bloomburg Street
London
SW1V 2RH
United Kingdom

Sponsor information

Organisation

University of Essex

Sponsor details

Trust Headquarters
350 Euston Road
Wivenhoe Park
Colchester
Essex
CO4 3SQ
United Kingdom

Sponsor type

University/education

Website

www.essex.ac.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Acute services, Central and North West NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan includes conference presentations, publications in peer reviewed journals and professionall journals, and reports to stakeholder groups.

IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from School of Health Sciences, University of Essex. The custodian of the data will be the chief investigator (ea16632@essex.ac.uk) and in her absence the PhD supervisor, Prof Fiona Nolan (f.nolan@essex.ac.uk). Data will be retained for 10 years, in accordance with university regulations.
Data will be available to access once full analysis has been completed. Access will be provided to secondary, anonymised data only, and will be granted by the custodians. The participant consent form, sections: 5 for service user questionnaire and staff interviews, 4 for staff questionnaire and 6 for Staff participatory action research indicate that consent was obtained from participants to sharing their data in this form. We do not anticipate any ethical or legal restrictions on use of these anonymised data.

Intention to publish date

30/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

29/08/2019: The participant information sheets and study protocol were uploaded as additional files.