Emergency PatientsNCT01092234
Effectiveness of an Observational Unit at St. Olavs Hospital
A study testing Traditional ward and Organizational change in people with Emergency Patients, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The trial is designed to evaluate the effectiveness of a newly established Observational unit at St. Olavs Hospital in terms of readmission rates, compared to the provision of care in normal/traditional units for defined diagnosis and medical problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Patients
- What is being tested?
- Traditional ward and Organizational change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency admitted patients only
- All patients on the list (appendix 1) with a tentative length of stay < 24 hours
- Predicted stay of less than 24 hours
- Willingness and able to sign a informed consent
Who cannot join
- Emergency admitted patients with life threatening illnesses
- Patients with a tentative length of stay > 24 hours based on the summary of medical and logistical considerations e.g. need of major - surgery, infections with prolonged infusions of antibiotics.
- Unwillingness to sign a informed consent
- By discretion of the physician/surgeon
- Readmission of any reason in the study period (within 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Randomized Trial of the Effectiveness of an Observational Unit at St. Olavs Hospital
The trial is designed to evaluate the effectiveness of a newly established Observational unit at St. Olavs Hospital in terms of readmission rates, compared to the provision of care in normal/traditional units for defined diagnosis and medical problems.
Read the detailed description
Observational units are thought to be more efficient than traditional ward units, but the evidence is scarce. The trial will in a randomized fashion evaluate the study hypothesis at an organizational level and not confined to specific diagnosis. The hypothesis to be tested is to confirm or reject the equal effectiveness of an Observational unit compared to a traditional ward for organizing in-hospital care.There are established eligibility and exclusion criteria based on clinical experience. Endpoint is length of stay and readmission within 30 days. In addition the study will give information on the use of diagnostic and treatment resources used and collect some basic demographic variables.
- Conditions
- Emergency Patients
- Being tested
- Traditional ward, Organizational change
- Keywords
- Observational units, Length of stay (LOS), Readmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional wardOther
provision of care in a traditional unit/ward.
Organizational changeOther
Also called Healthcare innovation
Observational unit (new organizational unit) for organizing in-hospital care
| Study group | Role | What they receive |
|---|---|---|
| Traditional ward | Active comparator | Not described Receives: Other: Traditional ward |
| Observational unit | Experimental | Organizational change. Innovative organization of in-hospital care Receives: Other: Organizational change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS)
Length of hospital stay in hours
Measured: 1 year
Secondary outcomes (1)
Readmission within 30 days
Readmission to hospital for any reason within 30 calender days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency PatientsStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Rødevand, MD, Principal investigator, St. Olavs HospitalSiv Mørkved, Professor, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092234
- Sponsor's protocol ID
- 2010/105-02
- Other IDs
- NO883974832
- Status last verified
- Sep 2017
- First submitted
- 23 Feb 2010
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Trial of the Effectiveness of an Observational Unit at St. Olavs Hospital
- ClinicalTrials.gov ID
- NCT01092234
- Acronym / sponsor ID
- 2010/105-02
- Conditions
- Emergency Patients
- Keywords
- Observational units, Length of stay (LOS), Readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Mar 2010 (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 trial is designed to evaluate the effectiveness of a newly established Observational unit at St. Olavs Hospital in terms of readmission rates, compared to the provision of care in normal/traditional units for defined diagnosis and medical problems.
Detailed description
Observational units are thought to be more efficient than traditional ward units, but the evidence is scarce. The trial will in a randomized fashion evaluate the study hypothesis at an organizational level and not confined to specific diagnosis. The hypothesis to be tested is to confirm or reject the equal effectiveness of an Observational unit compared to a traditional ward for organizing in-hospital care.There are established eligibility and exclusion criteria based on clinical experience. Endpoint is length of stay and readmission within 30 days. In addition the study will give information on the use of diagnostic and treatment resources used and collect some basic demographic variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional ward | Active comparator | Other: Traditional ward |
| Observational unit | Experimental | Other: Organizational changeOrganizational change. Innovative organization of in-hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Emergency admitted patients only
- All patients on the list (appendix 1) with a tentative length of stay < 24 hours
- Predicted stay of less than 24 hours
- Willingness and able to sign a informed consent
Key exclusion criteria (5 listed)
- Emergency admitted patients with life threatening illnesses
- Patients with a tentative length of stay > 24 hours based on the summary of medical and logistical considerations e.g. need of major - surgery, infections with prolonged infusions of antibiotics.
- Unwillingness to sign a informed consent
- By discretion of the physician/surgeon
- Readmission of any reason in the study period (within 30 days)
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 |
|---|---|---|
| Traditional wardprovision of care in a traditional unit/ward. | Other | Traditional ward |
| Organizational changeAlso: Healthcare innovationObservational unit (new organizational unit) for organizing in-hospital care | Other | Observational unit |
Primary outcome
Length of stay (LOS)
Time frame: 1 year
Length of hospital stay in hours
1 secondary outcome
Readmission within 30 days
Time frame: 30 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 2 Oct 2017.
- 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.
Erik Rødevand, MD principal investigator
St. Olavs Hospital
Siv Mørkved, Professor study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional ward and Organizational change in people with Emergency Patients, run by St. Olavs Hospital 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 4 inclusion and 5 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 2 Oct 2017. 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 (LOS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2017.