Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT00996320
Status:
COMPLETED
Last Update Posted:
2009-10-16
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-15', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple Sleep Latency Test', 'timeFrame': 'Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle'}], 'secondaryOutcomes': [{'measure': 'Hours slept per night measured by actigraphy', 'timeFrame': 'Daily'}, {'measure': 'Pharmaceutical order error rate', 'timeFrame': 'Daily'}, {'measure': 'Burnout measured by Maslach Burnout Inventory', 'timeFrame': 'Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation'}, {'measure': 'Beck Depression Inventory, Second Edition (BDI-II)', 'timeFrame': 'Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation'}, {'measure': 'Hours worked per shift on the traditional and intervention schedules', 'timeFrame': 'Daily'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Internship and Residency', 'Medical Errors', 'Burnout, Professional', 'Burnout', 'Depression', 'Actigraphy', 'Personnel Staffing and Scheduling', 'Sleep Deprivation', 'Workload', 'Humans', 'Adult', 'Male', 'Female', 'Intensive Care Units', 'Prospective Studies', 'Crossover Studies', 'Work Schedule Tolerance', 'Disorders of Excessive Somnolence', 'Guideline Adherence', 'Internal Medicine Education'], 'conditions': ['Sleep Deprivation', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.', 'detailedDescription': 'Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Interns rotating at Providence St. Vincent Medical Center ICU\n\nExclusion Criteria:\n\n* Diagnosis of narcolepsy'}, 'identificationModule': {'nctId': 'NCT00996320', 'briefTitle': 'Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Providence Health & Services'}, 'officialTitle': "Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors", 'orgStudyIdInfo': {'id': 'IRB 08-74B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Schedule', 'description': 'Interns on the intervention schedule work the a modified ICU schedule averaging about 60 hours per week over 4 weeks, with maximum scheduled shift length 16 hours.', 'interventionNames': ['Other: Reduced work hour schedule']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional Schedule', 'description': 'Interns on the traditional schedule work the usual ICU schedule averaging about 80 hours per week over 4 weeks, with maximum shift length 30 hours.'}], 'interventions': [{'name': 'Reduced work hour schedule', 'type': 'OTHER', 'description': 'Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.', 'armGroupLabels': ['Intervention Schedule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center Intensive Care Unit', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Michelle L Schoepflin Sanders, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence St. Vincent Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Health & Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Providence St. Vincent Department of Medicine', 'class': 'UNKNOWN'}, {'name': 'Providence Center for Outcomes Research and Education', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Michelle Schoepflin Sanders MD', 'oldOrganization': 'Providence St. Vincent Department of Medicine'}}}}