Clinical Trial: Managing Patient Aggression in Mental Health Services

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Effectiveness of User-driven Intervention to Manage Patient Aggression in Mental Health Services

Brief Summary: 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.

Detailed Summary:

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
Sponsor: University of Turku

Current Primary Outcome:

  • Number of coercive incidences [ Time Frame: three years ]
    Coercive incidence includes seclusion, limb restraints, forced injection and physical restraint
  • Coercive incidences towards patients [ Time Frame: three years ]
    Percentage of all patients on the wards / relative amount of patients. Coercive incidence includes seclusion, limb restraints, forced injection and physical restraint
  • Length of coercive incidences [ Time Frame: three years ]
    Coercive incidence includes seclusion, limb restraints, forced injection and physical restraint


Original Primary Outcome:

  • Number of coercive incidences [ Time Frame: three years ]
    Coercive incidence includes seclusion, limb restraints, forced injection and physical restraint
  • Coercive incidences towards patients [ Time Frame: three years ]
    Percentige of all patients on the wards / relative amount of patients. Coercive incidence includes seclusion, limb restraints, forced injection and physical restraint
  • Length of coercive incidences [ Time Frame: three years ]
    Coercive incidence includes seclusion, limb restraints, forced injection and physical restraint


Current Secondary Outcome:

  • 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) ]
    The Global Assessment Scale (GAS)
  • Patients' satisfaction [ Time Frame: during the intervention period (8 months) ]
    Client Satisfaction Questionnaire (CSQ-8)
  • Patients' quality of life [ Time Frame: during the intervention period (8 months) ]
    Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
  • Team climate among nursing staff [ Time Frame: baseline, after the intervention ]
    Team Climate Inventory (TCI)
  • Staff turnover [ Time Frame: three years ]


Original Secondary Outcome: Same as current

Information By: University of Turku

Dates:
Date Received: March 18, 2016
Date Started: March 2016
Date Completion: December 2018
Last Updated: December 30, 2016
Last Verified: December 2016