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Title: Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services
Authors: Valimaki, M 
Yang, M
Normand, SL
Lorig, KR
Anttila, M
Lantta, T
Pekurinen, V
Adams, CE
Issue Date: 2017
Source: BMC psychiatry, 2017, v. 17, 123, p. 1-13
Abstract: Background: People admitted to psychiatric hospitals with a diagnosis of schizophrenia may display behavioural problems. These may require management approaches such as use of coercive practices, which impact the wellbeing of staff members, visiting families and friends, peers, as well as patients themselves. Studies have proposed that not only patients' conditions, but also treatment environment and ward culture may affect patients' behaviour. Seclusion and restraint could possibly be prevented with staff education about user-centred, more humane approaches. Staff education could also increase collaboration between patients, family members and staff, which may further positively affect treatment culture and lower the need for using coercive treatment methods. Methods: This is a single-blind, two-arm cluster randomised controlled trial involving 28 psychiatric hospital wards across Finland. Units will be randomised to receive either a staff educational programme delivered by the team of researchers, or standard care. The primary outcome is the incidence of use of patient seclusion rooms, assessed from the local/national health registers. Secondary outcomes include use of other coercive methods (limb restraint, forced injection, and physical restraint), service use, treatment satisfaction, general functioning among patients, and team climate and employee turn-over (nursing staff). Discussion: The study, designed in close collaboration with staff members, patients and their relatives, will provide evidence for a co-operative and user-centred educational intervention aiming to decrease the prevalence of coercive methods and service use in the units, increase the functional status of patients and improve team climate in the units. We have identified no similar trials.
Keywords: User-driven intervention
Patient-centred
Psychiatry
Aggression
Treatment culture
Cluster randomised
Controlled trial
Effectiveness
Publisher: BioMed Central
Journal: BMC psychiatry 
ISSN: 1471-244X
DOI: 10.1186/s12888-017-1266-6
Rights: © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
The following publication Valimaki, M., Yang, M., Normand, S. L., Lorig, K. R., Anttila, M., Lantta, T., … Adams, C. E. (2017). Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services. BMC Psychiatry, 17, 123, 1-13 is available at https://dx.doi.org/10.1186/s12888-017-1266-6
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