Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01573195
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2011-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Merck IISP Stewardship Grant for Antibiotic Best Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1285}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2011-05-04', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of best practice alerts(BPA) that were completely accepted, partially accepted, or rejected within 72 hours of issuing the BPA', 'timeFrame': 'One Year', 'description': 'after issuing the BPA for deescalation, the responding healthcare provider will respond in one of the manners above'}], 'secondaryOutcomes': [{'measure': 'The number and type of antiinfectives that were administered before and after(11days) the best practice alert is issued.', 'timeFrame': 'One year', 'description': 'The antiinfective use before and after the BPA will be analyzed in detail. The number of antibiotics, percentage decrease(or less likely increase) in antiinfectives in the 3 days before BPA , and 11 days after the BPA will be analyzed. A cost analysis will be performed. Patient outcomes will not be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deescalation', 'best practice alert', 'antimicrobial stewardship'], 'conditions': ['Antibiotic Resistant Infection']}, 'referencesModule': {'references': [{'pmid': '24225610', 'type': 'RESULT', 'citation': 'Schulz L, Osterby K, Fox B. The use of best practice alerts with the development of an antimicrobial stewardship navigator to promote antibiotic de-escalation in the electronic medical record. Infect Control Hosp Epidemiol. 2013 Dec;34(12):1259-65. doi: 10.1086/673977. Epub 2013 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot the use of best practices alerts to enhance an antimicrobial stewardship program using the electronic medical record, EPIC.', 'detailedDescription': 'The purpose of this study is to pilot the use of best practices to enhance an antimicrobial stewardship program using the electronic medical record, EPIC. Screening information technology tools via SETNET/Safety SUrveyor(Premier) and the electronic anti-infective order form would allow for sufficient medical record review to create best practices alerts for the purpose of appropriate de-escalation of anti-invectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1285 consecutive patients issued BPA for de-escalation of antibiotics in EPIC', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physicians with prescribing privileges at the UWHC\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01573195', 'briefTitle': 'Merck IISP Stewardship Grant for Antibiotic Best Practices', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Implementation of Antimicrobial Stewardship and Decision Support Into the EPIC Electronic Medical Record', 'orgStudyIdInfo': {'id': '2012-0168 (MSN141105)'}, 'secondaryIdInfos': [{'id': 'Merk Dr Fox', 'type': 'OTHER_GRANT', 'domain': 'Proposal #38732'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All prescribing MDs at UWHC', 'description': 'Observational for accept, reject, or accept with modification of Best Practice Alers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospitals and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Barry C Fox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}