NCT02724748

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

March 18, 2016

Last Update Submit

February 24, 2020

Conditions

Keywords

AggressionMental HealthEducation, Continuing

Outcome Measures

Primary Outcomes (1)

  • The incidence of seclusion room use.

    The incidence of seclusion room use by patients in each unit.

    Three years

Secondary Outcomes (7)

  • Other types of coercive measures

    Three years

  • Service use

    Three years

  • Team climate

    18-20 months after beginning of the intervention

  • Turnover

    Three years

  • The functional capacity of patients

    Nine months after beginning of the intervention

  • +2 more secondary outcomes

Study Arms (2)

Educational intervention

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

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.

Educational intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Valimaki M, Yang M, Normand SL, Lorig KR, Anttila M, Lantta T, Pekurinen V, Adams CE. Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services. BMC Psychiatry. 2017 Apr 4;17(1):123. doi: 10.1186/s12888-017-1266-6.

    PMID: 28372555BACKGROUND
  • Valimaki M, Yang M, Vahlberg T, Lantta T, Pekurinen V, Anttila M, Normand SL. Trends in the use of coercive measures in Finnish psychiatric hospitals: a register analysis of the past two decades. BMC Psychiatry. 2019 Jul 26;19(1):230. doi: 10.1186/s12888-019-2200-x.

  • Valimaki M, Lantta T, Anttila M, Vahlberg T, Normand SL, Yang M. An Evidence-Based Educational Intervention for Reducing Coercive Measures in Psychiatric Hospitals: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2229076. doi: 10.1001/jamanetworkopen.2022.29076.

  • Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.

Related Links

MeSH Terms

Conditions

AggressionMental DisordersPsychological Well-Being

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Maritta Välimäki, Professor

    University of Turku, Hong Kong Polytechnic University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 31, 2016

Study Start

February 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share