Journal Article

Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services

Välimäki, Maritta, Normand, Sharon-Lise, Lorig, Kate R., Yang, Min, Lantta, Tella, Pekurinen, Virve, Adams, Clive E., Anttila, Minna

2017

Overview

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 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. 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. Trial registration ClinicalTrials.gov NCT02724748 . Registered on 25 th of April 2016.

• Publisher: BioMed Central,Springer Nature B.V,BMC
• Subject: Adult / Aggression / Aggression - psychology / Behavior disorders / Climate / Clinical Protocols / Clinical trials / Cluster randomised / Cognition & reasoning / Collaboration / Ethics / Evidence-based medicine / Feasibility studies / Female / Finland - epidemiology / Health Personnel - education / Hospitals, Psychiatric / Human subjects / Humans / International organizations / Intervention / Male / Medicine / Medicine & Public Health / Mental disorders / Mental health / Mental health care / Nursing / Patient Isolation - statistics & numerical data / Patient-centered care / Patient-centred / Patients / Prevention / Psychiatry / Psychotherapy / Qualitative research / Quality of life / Registries / Restraint, Physical - statistics & numerical data / Schizophrenia / Schizophrenic Psychology / Single-Blind Method / Social psychiatry / Study Protocol / therapy and provision of mental health care / Treatment culture / User-driven intervention / Violence / Well being / Young Adult