Back to resultsEffects of a Psychiatric Intensive Care Unit
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychiatric Intensive Care Unit
Care in whole acute unit
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring Emergency services, psychiatric, Intensive care units, Hospitals, psychiatric, Aggression, Violence
Eligibility Criteria
Inclusion Criteria: All patients admitted to Østmarka psychiatric department, St. Olavs Hospital in need of a PICU. Exclusion Criteria: Patients with dementia or mental retardation to an extensive degree. Patients not speaking Norwegian or English.
Sites / Locations
- Østmarka Psychiatric Department, St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Psychiatric Intensive Care Unit
Whole acute unit
Arm Description
Outcomes
Primary Outcome Measures
Length of stay in Psychiatric Intensive Care Unit (PICU)
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
Violent or threatening incidents
recorded with the Staff Observation Aggression Scale-Revised (SOAS-R),
Secondary Outcome Measures
Therapeutic steps and nurses' interventions
coded daily on a 23-item checklist
Full Information
NCT ID
NCT00184119
First Posted
September 9, 2005
Last Updated
March 10, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00184119
Brief Title
Effects of a Psychiatric Intensive Care Unit
Official Title
Effects of a Psychiatric Intensive Care Unit in an Acute Psychiatric Department.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The main aim of the study is to compare the effects of using or not using a Psychiatric Intensive Care Unit (PICU) in an acute psychiatric department.The acute ward of Østmarka psychiatric department, St. Olavs Hospital has a PICU separated from the rest of the ward. The PICU is separated with a locked door. Under two different conditions at different times all patients evaluated to be in need of PICU were admitted to the PICU. In the first condition the doors inside the PICU and between the rest of the acute ward and PICU were closed or locked. In the second condition the doors inside the PICU and the door between the PICU and the rest of the acute ward were either removed or held permanently open. In the second condition the patients thus were admitted to a PICU unit not using PICU principles.
The patients were evaluated with different rating scales at admittance, day three and at discharge from PICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Emergency services, psychiatric, Intensive care units, Hospitals, psychiatric, Aggression, Violence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychiatric Intensive Care Unit
Arm Type
Experimental
Arm Title
Whole acute unit
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Psychiatric Intensive Care Unit
Intervention Type
Procedure
Intervention Name(s)
Care in whole acute unit
Intervention Description
psychiatric acute care as usual
Primary Outcome Measure Information:
Title
Length of stay in Psychiatric Intensive Care Unit (PICU)
Time Frame
3 days
Title
Symptoms of psychopathology
Description
assessed by Broset Violence Checklist (BVC), a six-item observer-rated scale scoring behaviours. Higher scores predict imminent violence in psychiatric inpatients
Time Frame
3 days
Title
Violent or threatening incidents
Description
recorded with the Staff Observation Aggression Scale-Revised (SOAS-R),
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Therapeutic steps and nurses' interventions
Description
coded daily on a 23-item checklist
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients admitted to Østmarka psychiatric department, St. Olavs Hospital in need of a PICU.
Exclusion Criteria:
Patients with dementia or mental retardation to an extensive degree.
Patients not speaking Norwegian or English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav M Linaker, Professor
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Østmarka Psychiatric Department, St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7441
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16635934
Citation
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.
Results Reference
result
PubMed Identifier
21418581
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of a Psychiatric Intensive Care Unit
We'll reach out to this number within 24 hrs