This trial is active, not recruiting.

Conditions aggression, mental disorders
Treatment educational intervention
Sponsor University of Turku
Collaborator The Academy of Finland, Finland
Start date March 2016
End date January 2018
Trial size 28 participants
Trial identifier NCT02724748, 294298


The aim of this study is to generate and investigate the clinical effectiveness of an educational intervention for staff to prevent and manage patient challenging behaviour.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Beside usual care the intervention will encourage collaborative practices between staff, patients and family members to adopt more human patient-centred approach on the unit. The intervention is designed to impact on treatment culture and thereby treatment practices on the study wards.
educational intervention
Educational intervention for staff members will encourage collaboration between patients, relatives and staff members. Skills, intellectual resources, motivation and encouragement among staff members to make changes on the unit will be supported. More detailed content of the intervention to be used in each unit will be tailored based on preparatory phase of the study and individual needs of the unit. The educational intervention will be carried out beside usual care.
(No Intervention)
Wards allocated to comparison wards continue with their usual care. Any restrictions are not identified how nursing staff are working in these wards.

Primary Outcomes

Number of coercive incidences
time frame: three years
Coercive incidences towards patients
time frame: three years
Length of coercive incidences
time frame: three years

Secondary Outcomes

Type of psychiatric hospital admission
time frame: three years
Length of psychiatric hospital admission
time frame: three years
Number of involuntary treatment periods
time frame: three years
Length of involuntary psychiatric treatment (days)
time frame: three years
Place to stay after psychiatric hospital discharge
time frame: three years
Patients' adverse events
time frame: three years
Patients' death
time frame: three years
Patients' mental status
time frame: during the intervention period (8 months)
Patients' satisfaction
time frame: during the intervention period (8 months)
Patients' quality of life
time frame: during the intervention period (8 months)
Team climate among nursing staff
time frame: baseline, after the intervention
Staff turnover
time frame: three years

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Finnish speaking psychiatric inpatient units - Units with seclusion room and/or possibility to use limb restraints - Open 24/7 Exclusion Criteria: - Specialization in forensic, psychogeriatric, or child and adolescent care alone - Similar type of project is already ongoing or planned to start on the specific study unit

Additional Information

Official title The Effectiveness of User-driven Intervention to Manage Patient Aggression in Mental Health Services
Description This is a single-blind, two-arm cluster randomised controlled trial involving 15 hospitals with psychiatric hospital beds across Finland. Units are randomised on an equal basis to receive either staff educational programme (designed together with staff members, patients and relatives on the study units) or standard care. Inpatient psychiatric hospital organisations are the unit of randomisation. The cluster design will be used to avoid contamination between individual staff members in each study ward. We will use centralized randomisation at the University of Turku (Department of Mathematics and Statistics). Randomisation will be fully concealed and computer-generated by an independent statistician, who is not involved in the study. Investigators enrolling wards cannot foresee assignment. Outcome assessors and statisticians will be kept blinded to allocation. However, due to the type of intervention, allocation will be unmasked to patients and their relatives, contact persons in each ward, and health care staff delivering patient care on the wards after randomisation; this would reflect real-world care. While the Data Monitoring Committee undertook ongoing safety surveillance, investigators running the preliminary analysis for the Data Monitoring Committee will be masked to data until investigators released the database. Further, the statisticians and the National Register holder who are responsible in Finnish routine data used in this study, will be masked to ward allocation and patient data in each group. Randomisation will be done after collecting the baseline data from each unit. Baseline data on coercive practices used on the units will be collected by the members of the research team with a help of staff members within the eight weeks, while observational and interview data related to the quality of the services will be collected by the research team (only in the intervention units). On the individual level, all staff members working in the study units, patients, and their relatives are eligible to participate in the study. Staff survey and interviews with staff members, patient groups and relatives will be done on the basis of free will. The staff of the unit/research team members will approach patients and their relatives to explain the purpose of the study and its arrangements orally and in written format. The opportunity to ask questions about the study will be given to them. Those that will be assessed having a lack of capacity to give informed consent and declined to participate will not be interviewed. Staff surveys will be repeated for baseline and follow-up. On the organisational level, the outcomes related to patient service use will be assessed 12 months after baseline data collection. Assessing quality components: The strengths, weaknesses, opportunities, and threats related to the new practices will also be discussed and categorised based on SWOT analysis (Strength, Weakness, Opportunity, Threat). Possible barriers and facilitating factors for change on the on each unit will be identified. The quality of the service facilities will be assessed by observations on the units, based on World Health Organization's (2012) QualityRight Tool Kit focusing on five central quality criteria. Power and sample size: We have systematically searched for, but found no directly relevant past work. We may assume that about 8 % of all adult patients admitted in psychiatric hospitals will be coerced during their stay. We may consider 50% reduction for the use of coercion methods. In order to do this with 80% power at a 5% two-sided significance level (alpha = 0.05 and 80 % power), about 20 wards with total of 1,764 patients would be randomised in two arms. The patient related data will be collected in during the intervention period.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Turku.