NCT00184119

Brief Summary

The purpose of the study is to compare the effects of using or not using a Psychiatric Intensive Care Unit (PICU) in an acute psychiatric department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

8.7 years

First QC Date

September 9, 2005

Last Update Submit

November 18, 2024

Conditions

Keywords

Emergency services, psychiatricIntensive care unitsHospitals, psychiatricAggressionViolence

Outcome Measures

Primary Outcomes (3)

  • Length of stay in Psychiatric Intensive Care Unit (PICU)

    3 days

  • Symptoms of psychopathology

    assessed by Broset Violence Checklist (BVC), a six-item observer-rated scale scoring behaviours. Higher scores predict imminent violence in psychiatric inpatients

    3 days

  • Violent or threatening incidents

    recorded with the Staff Observation Aggression Scale-Revised (SOAS-R),

    3 days

Secondary Outcomes (1)

  • Therapeutic steps and nurses' interventions

    3 days

Study Arms (2)

Psychiatric Intensive Care Unit

EXPERIMENTAL
Procedure: Psychiatric Intensive Care Unit

Whole acute unit

ACTIVE COMPARATOR
Procedure: Care in whole acute unit

Interventions

Psychiatric Intensive Care Unit

psychiatric acute care as usual

Whole acute unit

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to Østmarka psychiatric department, St. Olavs Hospital in need of a PICU.

You may not qualify if:

  • Patients with dementia or mental retardation to an extensive degree.
  • Patients not speaking Norwegian or English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østmarka Psychiatric Department, St. Olavs Hospital

Trondheim, 7441, Norway

Location

Related Publications (2)

  • Vaaler AE, Morken G, Flovig JC, Iversen VC, Linaker OM. Effects of a psychiatric intensive care unit in an acute psychiatric department. Nord J Psychiatry. 2006;60(2):144-9. doi: 10.1080/08039480600583472.

  • Vaaler AE, Iversen VC, Morken G, Flovig JC, Palmstierna T, Linaker OM. Short-term prediction of threatening and violent behaviour in an Acute Psychiatric Intensive Care Unit based on patient and environment characteristics. BMC Psychiatry. 2011 Mar 18;11:44. doi: 10.1186/1471-244X-11-44.

MeSH Terms

Conditions

Mental DisordersAggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Olav M Linaker, Professor

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

October 1, 2001

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations