Back to resultsEffectiveness of an Observational Unit at St. Olavs Hospital
Primary Purpose
Emergency Patients
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Traditional ward
Organizational change
Sponsored by
About this trial
This is an interventional health services research trial for Emergency Patients focused on measuring Observational units, Length of stay (LOS), Readmission
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional ward
Observational unit
Arm Description
Organizational change. Innovative organization of in-hospital care
Outcomes
Primary Outcome Measures
Length of stay (LOS)
Length of hospital stay in hours
Secondary Outcome Measures
Readmission within 30 days
Readmission to hospital for any reason within 30 calender days
Full Information
NCT ID
NCT01092234
First Posted
February 23, 2010
Last Updated
September 28, 2017
Sponsor
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01092234
Brief Title
Effectiveness of an Observational Unit at St. Olavs Hospital
Official Title
An Open Randomized Trial of the Effectiveness of an Observational Unit at St. Olavs Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Patients
Keywords
Observational units, Length of stay (LOS), Readmission
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional ward
Arm Type
Active Comparator
Arm Title
Observational unit
Arm Type
Experimental
Arm Description
Organizational change. Innovative organization of in-hospital care
Intervention Type
Other
Intervention Name(s)
Traditional ward
Intervention Description
provision of care in a traditional unit/ward.
Intervention Type
Other
Intervention Name(s)
Organizational change
Other Intervention Name(s)
Healthcare innovation
Intervention Description
Observational unit (new organizational unit) for organizing in-hospital care
Primary Outcome Measure Information:
Title
Length of stay (LOS)
Description
Length of hospital stay in hours
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Readmission within 30 days
Description
Readmission to hospital for any reason within 30 calender days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Rødevand, MD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Siv Mørkved, Professor
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of an Observational Unit at St. Olavs Hospital
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