Condition category
Not Applicable
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
19/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.perceive.iop.kcl.ac.uk

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 measures

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

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

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

Trial participating centre

Oxleas NHS Foundation Trust
DA2 7WG

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

http://www.slam.nhs.uk/

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes