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ISRCTN
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ISRCTN84014053
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ClinicalTrials.gov identifier
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Public title
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Patient involvement in improving the evidence base on inpatient care: improving inpatient therapeutic environments
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Ethics approval
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Ethics approval received from the Bexley and Greenwich NHS Research Ethics Committee on the 27th November 2007 (ref: 07/HO809/49).
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Study design
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A waiting list cluster randomised controlled trial, with several comparison points (so called ‘interrupted time series’).
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acutely mentally ill patients
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Participants - inclusion criteria
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All patients (both genders, aged 18 - 65 years) present on the ward during a two week interval during each of the four assessment periods.
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Participants - exclusion criteria
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Patients will only be excluded if they have already been entered into the study at an earlier admission.
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Anticipated start date
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01/11/2008
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Anticipated end date
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31/10/2012
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please email emese.csipke@iop.kcl.ac.uk to request a patient information sheet
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Target number of participants
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420
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1050)
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Trial website
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Publications
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Contact name
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Prof
Til
Wykes
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Address
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Department of Psychology
PO Box 77
Institute of Psychiatry
King's College London
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor
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Institute of Psychiatry, King's College London (UK)
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Address
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De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor website:
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http://www.iop.kcl.ac.uk/
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Date applied
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10/06/2008
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Last edited
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24/07/2008
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Date ISRCTN assigned
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24/07/2008
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