Managing Patient Aggression in Mental Health Services
Condition: Aggression; Mental Disorders
MeSH terms: Mental Disorders; Aggression
Study type: Interventional

Summary: 
      To compare the effects of an educational intervention to usual practice (no specified staff
      education) on improving treatment culture and supporting team climate in staff members, which
      further could reduce the need for the use of coercive methods in psychiatric care.
    

Detailed description: 
      This is a single-blind, two-arm, cluster randomised controlled trial involving 28 psychiatric
      hospital wards 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 and 24 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.

      We have systematically searched for, but found no directly relevant past work. We assume that
      if the data will be obtained from local hospital registers by sampling 7 clusters (hospitals)
      with 265 subjects each in intervention group and 7 clusters with 265 subjects each in control
      group, we will have 80% power to detect a difference between the group proportions of
      -0.0400. The control group proportion is 0.1100. The intervention group proportion is assumed
      to be 0.1100 under the null hypothesis and 0.0700 under the alternative hypothesis. The test
      statistic used is the two-sided Z test (unpooled) with an overall significance level at 0.05.
      We may assume based on the hospital registers that sample size for the total population
      admitted in the study wards in one year will be 3710. However, if we consider a loss of 20%
      patients in the local care registers, the total number of patients on the randomised wards
      should be about 4454 patients. Further, if we assume 50% response rate for patient survey out
      of possible 3710 participants, we will assume that we will obtain 928 filled questionnaires
      during 6 month survey data collection period. The sample size calculation was adjusted for
      intra-cluster correlation at 0.005.
    

Intervention name(s): Educational intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Aggression; Mental Health; Education, Continuing