Effectiveness of a Observational Unit at St. Olavs Hospital

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01092234
First received: February 23, 2010
Last updated: July 25, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: A Open Randomized Trial of the Effectiveness of a 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 ] [ Designated as safety issue: No ]
    Length of hospital stay in hours


Secondary Outcome Measures:
  • Readmission within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Readmission to hospital for any reason within 30 calender days


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
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 careThere 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092234

Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7006
StOlavs 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

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01092234     History of Changes
Other Study ID Numbers: 2010/105-02, St.Olavs Hospital, NO883974832
Study First Received: February 23, 2010
Last Updated: July 25, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on September 16, 2014