Condition category
Mental and Behavioural Disorders
Date applied
10/06/2008
Date assigned
24/07/2008
Last edited
15/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Til Wykes

ORCID ID

Contact details

Department of Psychology
PO Box 77
Institute of Psychiatry
King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Patient involvement in improving the evidence base on inpatient care: improving inpatient therapeutic environments

Acronym

Study hypothesis

1. To investigate in detail the difference that increasing therapeutic activities makes on the environmental milieu and how this is perceived by the patients and staff
2. To explore the sustainability of positive effects (particularly on staff morale and the level of increased activities) and the appearance of side effects

Ethics approval

Bexley and Greenwich NHS Research Ethics Committee, 27/11/2007, ref: 07/HO809/49

Study design

Waiting list cluster randomised controlled trial, with several comparison points (so called 'interrupted time series')

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please email emese.csipke@iop.kcl.ac.uk to request a patient information sheet

Condition

Acutely mentally ill patients

Intervention

Ward based non-pharmaceutical therapies (e.g, groups for voice hearers, medication information, communication training): specifics to be decided by Autumn 2008. Assessment will take place on four occasions, at six-monthly intervals.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. User perceptions of inpatient services: the final measure will include domains of outcomes that are judged by service users as important in the inpatient context. The design of the measure will allow an overall score relating to satisfaction but may also allow negative aspects to be assessed separately as well as factors scores.
2. Staff perceptions of inpatient services: the final measure will include domains of outcomes that are judged by service users as important in the inpatient context. The design of the measure will allow an overall score relating to satisfaction but may also allow negative aspects to be assessed separately as well as factors scores.

To be collected at baseline, then at 6 months, 12 months and 18 months.

Secondary outcome measures

1. Patient assessments:
1.1. Use of therapeutic activities available: through records of weekly activity planning reviews
1.2. Symptoms: Positive and Negative Symptoms Scale (PANSS) scores
1.3. The Nurses' Observation Scale for Inpatient Evaluation (NOSIE): behaviour scale measuring social and disruptive behaviours over a short time frame
1.4. Satisfaction measure (chosen from assessment in WP1)
2. Staff assessments:
2.1. Maslach Burnout Inventory to measure burn out and positive attributes of the work place
2.2. Satisfaction measure (chosen from assessments in WP1)
3. General ward assessments:
3.1. Length of stay on inpatient wards during the study period
3.2. Ward Atmosphere Scale
3.3. Routine incident reporting from electronic records
3.4. Therapeutic programme guide based on activities available
3.5. Movement of ward staff measured as length of stay, number of new staff and their ward origin
4. Economic measure: Client Service Receipt Inventory for Inpatient Care (CSRI-I)

To be collected at baseline, then at 6 months, 12 months and 18 months.

Overall trial start date

01/11/2008

Overall trial end date

31/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All patients (both genders, aged 18 - 65 years) present on the ward during a two week interval during each of the four assessment periods.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

420

Participant exclusion criteria

Patients will only be excluded if they have already been entered into the study at an earlier admission.

Recruitment start date

01/11/2008

Recruitment end date

31/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry, King's College London
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, King's College London (UK)

Sponsor details

De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1050)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes