Effects of a Psychiatric Intensive Care Unit

November 13, 2023 updated by: Norwegian University of Science and Technology

Effects of a Psychiatric Intensive Care Unit in an Acute Psychiatric Department.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7441
        • Østmarka Psychiatric Department, St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychiatric Intensive Care Unit
Procedure: Psychiatric Intensive Care Unit
Active Comparator: Whole acute unit
Procedure: Care in whole acute unit
psychiatric acute care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in Psychiatric Intensive Care Unit (PICU)
Time Frame: 3 days
3 days
Symptoms of psychopathology
Time Frame: 3 days
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
Time Frame: 3 days
recorded with the Staff Observation Aggression Scale-Revised (SOAS-R),
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic steps and nurses' interventions
Time Frame: 3 days
coded daily on a 23-item checklist
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Chair: Olav M Linaker, Professor, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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