Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 10:16 PM
Study NCT ID:
NCT00880932
Status:
COMPLETED
Last Update Posted:
2009-04-14
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Warfarin and Non-Steroidal Anti-Inflammatory Drugs (NSAID) Customized Alert
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1865}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-13', 'studyFirstSubmitDate': '2009-04-13', 'studyFirstSubmitQcDate': '2009-04-13', 'lastUpdatePostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased rate of prescription of the combination of warfarin and NSAID', 'timeFrame': '17 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['warfarin', 'NSAID', 'The condition is the concomitant prescription of'], 'conditions': ['Warfarin and NSAID']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific "reason for override" on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All resident physicians (RP) and nurse practitioners (NP) involved in inpatient care at two hospitals of the University of Pennsylvania\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00880932', 'briefTitle': 'Warfarin and Non-Steroidal Anti-Inflammatory Drugs (NSAID) Customized Alert', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'The Effect of Customized Alerts Versus Generic Alerts for the Prescription of Warfarin and NSAID', 'orgStudyIdInfo': {'id': '803787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'customized electronic alert', 'description': 'This intervention was not targeted to patients with a disease but to the providers. The intervention was not a drug but a customized electronic alert, requesting the prescriber to specify a "reason for override" whenever the combination drugs of warfarin and NSAID were ordered together.', 'interventionNames': ['Behavioral: Electronic Alert']}, {'type': 'NO_INTERVENTION', 'label': 'Standard practice', 'description': 'The control group was not patients but the providers. Providers in the control group continued with the standard practice of receiving passive alerts in the form of message boxes warning the provider not to prescribe the combination drugs warfarin and NSAID.'}], 'interventions': [{'name': 'Electronic Alert', 'type': 'BEHAVIORAL', 'armGroupLabels': ['customized electronic alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'UPenn School of Medicine'}}}}