Patient involvement - inpatient care (WP3)

ISRCTN	ISRCTN06545047
DOI	https://doi.org/10.1186/ISRCTN06545047
Secondary identifying numbers	4237

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 20/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The Francis report focussed attention on the quality of inpatient care. Staff report that they feel under-skilled and have too little time to provide therapeutic activities, and service users report that wards were boring places and provided little therapy. The aim of this study is to find out whether the quality of inpatient care can be improved by providing staff training.

Who can participate?
Adult inpatients from relevant boroughs (Southwark, Lambeth, Croydon, Lewisham) during a fixed time period

What does the study involve?
Participating wards are randomly allocated to either receive increased skills training to increase group activities, or to be put on a waiting list. Staff and inpatients' perceptions of the ward are measured using questionnaires.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. South London and Maudsley NHS Foundation Trust NHS Foundation Trust (UK)
2. Oxleas NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2008 to March 2012

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

Who is the main contact?
Prof. Til Wykes

Study website

Contact information

Prof Til Wykes
Scientific

Institute of Psychiatry
PO Box 77
16 De Crespigny Park
London
SE5 8AF
United Kingdom

ORCID ID	0000-0002-5881-8003

Study information

Study design	Randomised interventional process of care and treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
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	Patient involvement in improving the evidence base on inpatient care - increasing the therapeutic activities on wards (WP3)
Study objectives	This is a randomised wait list control study with frequent assessments of the effects and acceptability of increasing activities on inpatient wards.
Ethics approval(s)	Bromley Research Ethics Committee, 27/11/2007, ref: 07/H0809/49
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network, Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics), Service Delivery; Disease: Not Applicable
Intervention	Wards will be randomly assigned to receive increased psychologically based group activities or wait list control and will be followed every 6 months. Individual patients will enter the study once. This work package will also test the feasibility of new measures generated in linked work packages 1 and 2. WP3 includes increased skills training for in-patient staff so as to directly increase the availability of therapeutic interventions. The participatory theme continues from the initial work packages through to the interventions by including service user researchers to lead research as well as collecting data. Follow-up length: 0 months Study entry: single randomisation only
Intervention type	Other
Primary outcome measure	Staff and service user perceptions of the ward, measured every 6 months, at four time points (at times, 0, 1, 2 and 3)
Secondary outcome measures	Measured every 6 months, at four time points (at times, 0, 1, 2 and 3): 1. Length of hospital stay 2. Readmissions
Overall study start date	01/04/2008
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 800; UK sample size: 800
Total final enrolment	120
Key inclusion criteria	Current inclusion criteria as of 07/04/2017: 1. All in-patient admissions from South London and Maudsley NHS Foundation Trust and Oxleas NHS Foundation Trust during a fixed time period 2. Adults of either sex Previous inclusion criteria: 1. All in-patient admissions from relevant boroughs (Southwark, Lambeth, Croydon, Lewisham) during a fixed time period 2. Adults of either sex
Key exclusion criteria	Patients will only be excluded if they have been entered into the study on an earlier admission
Date of first enrolment	01/11/2008
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

South London and Maudsley NHS Foundation Trust

SE5 8AZ
United Kingdom

Oxleas NHS Foundation Trust

DA2 7WG
United Kingdom

Sponsor information

South London and Maudsley NHS Trust (UK)
Hospital/treatment centre

Clinical Treatment Centre
1st Floor, Maudsley Hospital
Denmark Hill
London
SE5 8AZ
England
United Kingdom

Website	http://www.slam.nhs.uk/
"ROR"	https://ror.org/015803449

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
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
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in high impact journals in two papers. One will summarise the service user outcome data as this follows the stepped wedge design. The other paper is more complex as it reports staff data which has some repeated measures in the stepped wedge design.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Til Wykes

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2018		Yes	No
Results article	results	01/12/2018		Yes	No
Results article	results	01/01/2019		Yes	No
Results article	results	18/12/2019	20/12/2019	Yes	No

Editorial Notes

20/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
15/02/2019: Publication reference added.
21/12/2018: Publication reference added.
27/11/2018: Publication reference added.