Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Managing Patient Aggression in Mental Health Services (Violin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724748
Recruitment Status : Enrolling by invitation
First Posted : March 31, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
Academy of Finland
Turku University Hospital
Harvard Medical School
Harvard School of Public Health
Stanford University
Sichuan University of China, China
University of Nottingham
World Health Organisation, Philippines
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Maritta Välimäki, University of Turku

Brief 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.

Condition or disease Intervention/treatment Phase
Aggression Mental Disorders Behavioral: Educational intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of User-driven Intervention to Manage Patient Aggression in Mental Health Services
Actual Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Educational intervention
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.
Behavioral: 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: Treatment as usual
Wards allocated to comparison wards continue with their usual care. No restrictions on how nursing staff works in these wards, although participation in corresponding projects is not supported.



Primary Outcome Measures :
  1. The incidence of seclusion room use. [ Time Frame: Three years ]
    The incidence of seclusion room use by patients in each unit.


Secondary Outcome Measures :
  1. Other types of coercive measures [ Time Frame: Three years ]
    Organisational outcomes. Incidence of other types of coercive measures used on patients (limb restraint, forced injection, physical restraint).

  2. Service use [ Time Frame: Three years ]
    Organisational outcomes. Type of admission, length of stay, deaths.

  3. Team climate [ Time Frame: 18-20 months after beginning of the intervention ]
    Staff outcomes. Team Climate Inventory, TCI.

  4. Turnover [ Time Frame: Three years ]
    Staff outcomes.

  5. The functional capacity of patients [ Time Frame: Nine months after beginning of the intervention ]
    Patient outcomes. Gobal Assessment Scale, GAS.

  6. Patient treatment satisfaction [ Time Frame: Nine months after beginning of the intervention ]
    Patient outcomes. Client Satisfaction Questionnaire, CSQ-8.

  7. Quality of Life [ Time Frame: Nine months after beginning of the intervention ]
    Patient outcomes. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Q-LES-Q-SF



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Finnish speaking hospital organisations
  • at least 1 psychiatric ward
  • open 24/7
  • are able to use coersive measures (seclusion room, limb restraint, forced medication, physical restraint)

Exclusion Criteria:

  • wards specialised in forensic, psychogeriatric, or child and adolescent care alone
  • similar type of project is underway or is planned to start

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724748


Sponsors and Collaborators
University of Turku
Academy of Finland
Turku University Hospital
Harvard Medical School
Harvard School of Public Health
Stanford University
Sichuan University of China, China
University of Nottingham
World Health Organisation, Philippines
The Hong Kong Polytechnic University
Investigators
Layout table for investigator information
Study Director: Maritta Välimäki, Professor University of Turku, Hong Kong Polytechnic University

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Maritta Välimäki, Professor, University of Turku
ClinicalTrials.gov Identifier: NCT02724748     History of Changes
Other Study ID Numbers: 294298
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maritta Välimäki, University of Turku:
Aggression
Mental Health
Education, Continuing
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Aggression
Behavioral Symptoms