Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 2:07 PM
Study NCT ID:
NCT01092234
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2010-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an Observational Unit at St. Olavs Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009936', 'term': 'Organizational Innovation'}], 'ancestors': [{'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay (LOS)', 'timeFrame': '1 year', 'description': 'Length of hospital stay in hours'}], 'secondaryOutcomes': [{'measure': 'Readmission within 30 days', 'timeFrame': '30 days', 'description': 'Readmission to hospital for any reason within 30 calender days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Observational units', 'Length of stay (LOS)', 'Readmission'], 'conditions': ['Emergency Patients']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency admitted patients only\n* All patients on the list (appendix 1) with a tentative length of stay \\< 24 hours\n* Predicted stay of less than 24 hours\n* Willingness and able to sign a informed consent\n\nExclusion Criteria:\n\n* Emergency admitted patients with life threatening illnesses\n* 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.\n* Unwillingness to sign a informed consent\n* By discretion of the physician/surgeon\n* Readmission of any reason in the study period (within 30 days)'}, 'identificationModule': {'nctId': 'NCT01092234', 'briefTitle': 'Effectiveness of an Observational Unit at St. Olavs Hospital', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'An Open Randomized Trial of the Effectiveness of an Observational Unit at St. Olavs Hospital', 'orgStudyIdInfo': {'id': '2010/105-02'}, 'secondaryIdInfos': [{'id': 'NO883974832', 'type': 'OTHER', 'domain': 'St.Olavs Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional ward', 'interventionNames': ['Other: Traditional ward']}, {'type': 'EXPERIMENTAL', 'label': 'Observational unit', 'description': 'Organizational change. Innovative organization of in-hospital care', 'interventionNames': ['Other: Organizational change']}], 'interventions': [{'name': 'Traditional ward', 'type': 'OTHER', 'description': 'provision of care in a traditional unit/ward.', 'armGroupLabels': ['Traditional ward']}, {'name': 'Organizational change', 'type': 'OTHER', 'otherNames': ['Healthcare innovation'], 'description': 'Observational unit (new organizational unit) for organizing in-hospital care', 'armGroupLabels': ['Observational unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Erik Rødevand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}, {'name': 'Siv Mørkved, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}