title: Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services.
abstract: 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 well-being 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  ClinicalTrials.gov NCT02724748 . Registered on 25thof April 2016.
authors.affiliation: Department of Nursing Science, Faculty of Medicine, University of Turku , Turku, Finland. mava@utu.fi.|School of Nursing, Hong Kong Polytechnic University, Hong Kong, China. mava@utu.fi.|Turku University Hospital, Turku, Finland. mava@utu.fi.
authors.forename: Maritta
authors.initials: M
authors.lastname: Välimäki
authors.affiliation: West China Research Center for Rural Health Development, Sichuan University Huaxi Medical Center, Sichuan University of China, Administration Building, No 17,Section 3,Ren Ming Nan Lu, Chengdu, Sichuan, China.|Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA, 02115-5899, USA.
authors.forename: Min
authors.initials: M
authors.lastname: Yang
authors.affiliation: Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA, 02115-5899, USA.|Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard Medical School, 180 Longwood Avenue, Boston, MA, 02115-5899, USA.
authors.forename: Sharon-Lise
authors.initials: SL
authors.lastname: Normand
authors.affiliation: Department of Medicine - Med/Immunology & Rheumatology, Stanford University, 1000 WELCH RD. #204, Stanford, CA, 94305-5755, USA.
authors.forename: Kate R
authors.initials: KR
authors.lastname: Lorig
authors.affiliation: Department of Nursing Science, Faculty of Medicine, University of Turku , Turku, Finland.
authors.forename: Minna
authors.initials: M
authors.lastname: Anttila
authors.affiliation: Department of Nursing Science, Faculty of Medicine, University of Turku , Turku, Finland.
authors.forename: Tella
authors.initials: T
authors.lastname: Lantta
authors.affiliation: Department of Nursing Science, Faculty of Medicine, University of Turku , Turku, Finland.
authors.forename: Virve
authors.initials: V
authors.lastname: Pekurinen
authors.affiliation: Institute of Mental Health, Division of Psychiatry, University of Nottingham, Jubilee Campus, Wollaton Road, Nottingham, NG8 1BB, UK.
authors.forename: Clive E
authors.initials: CE
authors.lastname: Adams
mesh_terms: D000328:Adult; D000374:Aggression / Q000523:psychology*; D002985:Clinical Protocols; D005260:Female; D005387:Finland / Q000453:epidemiology; D006282:Health Personnel / Q000193:education*; D006778:Hospitals, Psychiatric; D006801:Humans; D008297:Male; D010356:Patient Isolation / Q000706:statistics & numerical data; D012042:Registries; D012149:Restraint, Physical / Q000706:statistics & numerical data; D012565:Schizophrenic Psychology; D016037:Single-Blind Method; D055815:Young Adult
keywords: Aggression; Cluster randomised; Controlled trial; Effectiveness; Patient-centred; Psychiatry; Treatment culture; User-driven intervention