Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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5 September 2022 |
Main ID: |
ISRCTN17993261 |
Date of registration:
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07/03/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Reduction of coercion and aggression in psychiatry - the aggression, coercion reduction study
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Scientific title:
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A project to deal with and reduce coercion and aggression on acute psychiatric wards |
Date of first enrolment:
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01/11/2016 |
Target sample size:
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6 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN17993261 |
Study type:
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Interventional |
Study design:
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Single-centre three-armed cluster-controlled intervention study (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Sebastian
Walther |
Address:
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UPD Bern
Murtenstrasse 21
CH-3000
Berne 60
Switzerland |
Telephone:
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Email:
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Affiliation:
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Name:
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Christian
Burr |
Address:
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UPD Bern
Bolligenstrasse 111
3000
Berne 60
Switzerland |
Telephone:
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+41 (0)31 930 97 12 |
Email:
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christian.burr@upd.ch |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Acute psychiatric ward with admission obligation 2. The positions of the senior physician and the nursing ward manager are filled 3. Adequate data quality from the outcome parameters to be collected during the last 6 months
Exclusion criteria: 1. Wards with specialized therapeutic regimen where patients are admitted only with special indication 2. Day clinics
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coercion and aggression on acute psychiatric wards Not Applicable
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Intervention(s)
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Stratified cluster randomisation was used. The six recruited wards were divided up in two as equal as possible groups regarding the length of average stay, frequency of involuntary admissions and number of seclusion rooms. Then from each group there was a concealed allocation to the following three groups:
1st Intervention: Training and supporting the staff to implement the 10 Safewards interventions. These include simple behavioural tips and training for staff on the topic of de-escalation and conflict management, activities to improve the relationship between patients and staff in everyday life and in problem situations like: weekly support conferences, systematic supportive conversations before or after negative events, as well as hopeful actions regarding the current, but also future situation of the patients, for example with the hopeful discharge messages from patients leaving the ward. All interventions are comprehensively described on the website www.safewards.com.
2nd Intervention: Training and supporting of staff implementing of the communication strategies based and focused on the domains of the Bern Psychopathology Scale (BPS). The BPS is a clinical rating scale developed to group psychotic symptoms in the domains of language, affectivity and motor behavior. These domains are of particular interest for understanding the fundamental communication breakdown during psychotic disorders, since they can be linked to known, higher order brain systems, i.e. the language, the limbic and the motor system. The intervention gives a training to recognize the well-functioning domain and to focus the communications skills on this domain.
Control: Short verbal and written information on the topic of coercio
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Primary Outcome(s)
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Freedom restrictive interventions, measured using the electronic patient record at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)
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Secondary Outcome(s)
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1. Aggressive events, measured using the EVA Form (part of the electronic patient record) at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019) 2. The percentage of hours/days during which the doors of the wards were open, at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019) 3. Perspectives of staff and patients related to the experience on the intervention wards, evaluated in focus group interviews at the end of the intervention phase (01/06/2018-01/08/2018)
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Secondary ID(s)
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Quantitative Part of the Study: Reg-2016-00513; Qualitative Part of the Study: Reg-2017-00846
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Source(s) of Monetary Support
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University Berne Psychiatric Services Inc. University Hospital of Psychiatry and Psychotherapy
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Ethics review
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Status:
Approval date:
Contact:
Ethics Board of the canton of Berne (Switzerland, swissethics), 16/09/2016, Quantitative Part of the Study: Reg-2016-00513; Qualitative Part of the Study: Reg-2017-00846
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/01/2019 |
URL:
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