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

ISRCTN	ISRCTN84014053
DOI	https://doi.org/10.1186/ISRCTN84014053
Protocol serial number	N/A
Sponsor	Institute of Psychiatry, King's College London (UK)
Funder	Programme Grants for Applied Research (ref: RP-PG-0606-1050)

Submission date: 10/06/2008
Registration date: 24/07/2008
Last edited: 19/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Til Wykes
Scientific

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

Study information

Primary study design	Interventional
Study design	Waiting list cluster randomised controlled trial, with several comparison points (so called 'interrupted time series')
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Patient involvement in improving the evidence base on inpatient care: improving inpatient therapeutic environments
Study objectives	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(s)	Bexley and Greenwich NHS Research Ethics Committee, 27/11/2007, ref: 07/HO809/49
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	420
Key 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.
Key exclusion criteria	Patients will only be excluded if they have already been entered into the study at an earlier admission.
Date of first enrolment	01/11/2008
Date of final enrolment	31/10/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Psychiatry, King's College London

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/06/2017: Publication reference added.