Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/11/2008
Overall study end date
31/10/2012
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Programme Grants for Applied Research (ref: RP-PG-0606-1050)
Alternative name(s)
NIHR Programme Grants for Applied Research, PGfAR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | Yes | No |