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Effectiveness of an Observational Unit at St. Olavs Hospital

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092234
First Posted: March 24, 2010
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Olavs Hospital
  Purpose
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.

Condition Intervention
Emergency Patients Other: Traditional ward Other: Organizational change

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: An Open Randomized Trial of the Effectiveness of an Observational Unit at St. Olavs Hospital

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Length of stay (LOS) [ Time Frame: 1 year ]
    Length of hospital stay in hours


Secondary Outcome Measures:
  • Readmission within 30 days [ Time Frame: 30 days ]
    Readmission to hospital for any reason within 30 calender days


Enrollment: 105
Actual Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional ward Other: Traditional ward
provision of care in a traditional unit/ward.
Experimental: Observational unit
Organizational change. Innovative organization of in-hospital care
Other: Organizational change
Observational unit (new organizational unit) for organizing in-hospital care
Other Name: Healthcare innovation

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092234


Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Principal Investigator: Erik Rødevand, MD St. Olavs Hospital
Study Chair: Siv Mørkved, Professor St. Olavs Hospital
  More Information

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01092234     History of Changes
Other Study ID Numbers: 2010/105-02
NO883974832 ( Other Identifier: St.Olavs Hospital )
First Submitted: February 23, 2010
First Posted: March 24, 2010
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Observational units
Length of stay (LOS)
Readmission

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes