Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Til Wykes
ORCID ID
http://orcid.org/0000-0002-5881-8003
Contact details
Institute of Psychiatry
PO Box 77
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4237
Study information
Scientific title
Patient involvement in improving the evidence base on inpatient care - increasing the therapeutic activities on wards (WP3)
Acronym
Study hypothesis
This is a randomised wait list control study with frequent assessments of the effects and acceptability of increasing activities on inpatient wards.
Ethics approval
Bromley Research Ethics Committee, 27/11/2007, ref: 07/H0809/49
Study design
Randomised interventional process of care and treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/04/2008
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 800; UK sample size: 800
Total final enrolment
120
Participant exclusion criteria
Patients will only be excluded if they have been entered into the study on an earlier admission
Recruitment start date
01/11/2008
Recruitment end date
01/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South London and Maudsley NHS Foundation Trust
SE5 8AZ
United Kingdom
Trial participating centre
Oxleas NHS Foundation Trust
DA2 7WG
United Kingdom
Sponsor information
Organisation
South London and Maudsley NHS Trust (UK)
Sponsor details
Clinical Treatment Centre
1st Floor
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
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
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28726599
2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30566316
3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30762512
4. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31852502 (added 20/12/2019)