Mental DisordersNCT00184119
Effects of a Psychiatric Intensive Care Unit
A study testing Psychiatric Intensive Care Unit and Care in whole acute unit in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Psychiatric Intensive Care Unit and Care in whole acute unit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2001to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to Østmarka psychiatric department, St. Olavs Hospital in need of a PICU.
Who cannot join
- Patients with dementia or mental retardation to an extensive degree.
- Patients not speaking Norwegian or English.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St. Olavs Hospital
Trondheim, 7441
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- Psychiatric Intensive Care Unit, Care in whole acute unit
- Keywords
- Emergency services, psychiatric, Intensive care units, Hospitals, psychiatric, Aggression, Violence
- Medical subject headings
- Mental Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric Intensive Care UnitProcedure or surgery
Care in whole acute unitProcedure or surgery
psychiatric acute care as usual
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric Intensive Care Unit | Experimental | Not described Receives: Procedure: Psychiatric Intensive Care Unit |
| Whole acute unit | Active comparator | Not described Receives: Procedure: Care in whole acute unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in Psychiatric Intensive Care Unit (PICU)
Measured: 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
Measured: 3 days
Violent or threatening incidents
recorded with the Staff Observation Aggression Scale-Revised (SOAS-R),
Measured: 3 days
Secondary outcomes (1)
Therapeutic steps and nurses' interventions
coded daily on a 23-item checklist
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Olav M Linaker, Professor, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184119
- Sponsor's protocol ID
- AEV-01
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2005
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16635934Vaaler 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.
PubMed 21418581
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Psychiatric Intensive Care Unit in an Acute Psychiatric Department.
- ClinicalTrials.gov ID
- NCT00184119
- Acronym / sponsor ID
- AEV-01
- Conditions
- Mental Disorders
- Keywords
- Emergency services, psychiatric, Intensive care units, Hospitals, psychiatric, Aggression, Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Oct 2001
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychiatric Intensive Care Unit | Experimental | Procedure: Psychiatric Intensive Care Unit |
| Whole acute unit | Active comparator | Procedure: Care in whole acute unit |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to Østmarka psychiatric department, St. Olavs Hospital in need of a PICU.
Key exclusion criteria (2 listed)
- Patients with dementia or mental retardation to an extensive degree.
- Patients not speaking Norwegian or English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric Intensive Care Unit | Procedure or surgery | Psychiatric Intensive Care Unit |
| Care in whole acute unitpsychiatric acute care as usual | Procedure or surgery | Whole acute unit |
Primary outcome
Length of stay in Psychiatric Intensive Care Unit (PICU)
Time frame: 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
Violent or threatening incidents
Time frame: 3 days
recorded with the Staff Observation Aggression Scale-Revised (SOAS-R),
1 secondary outcome
Therapeutic steps and nurses' interventions
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Results publication: PubMed 16635934Vaaler 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.
- Derived from this study: PubMed 21418581Vaaler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav M Linaker, Professor study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric Intensive Care Unit and Care in whole acute unit in people with Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in Psychiatric Intensive Care Unit (PICU) (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.