Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT03173768
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of appropriateness of intravenous antibiotics prescriptions at hospital discharge between groups', 'timeFrame': '16 months', 'description': 'To calculate the number of antibiotic prescriptions at hospital discharge over the total number of prescriptions, comparing between pre-and post-intervention period.'}], 'secondaryOutcomes': [{'measure': 'The costs of antibiotics for the course of treatment', 'timeFrame': '16 months', 'description': 'To compare the cost of antibiotics for the course of treatment between the 2 periods'}, {'measure': 'Clinical improvement at 1 week', 'timeFrame': '1 week', 'description': 'To calculate the number of patients who had clinical improvement at 1 week over the total number of patients in each period, comparing between the 2 periods'}, {'measure': 'Readmission within 30 days, length of hospital stay', 'timeFrame': '30 days', 'description': 'To calculate the number of patients who were readmitted within 30 days over the total number of patients in each period, comparing between the 2 periods'}, {'measure': 'Length of hospital stay', 'timeFrame': '60 days', 'description': 'To calculate the length of hospital stays in days between 2 periods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intravenous antibiotics', 'appropriateness', 'outpatient antimicrobial therapy'], 'conditions': ['Anti-Infectives Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'A quasi-experimental study was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital to determine the appropriateness of intravenous antibiotics at hospital discharge with and without ID consultation.', 'detailedDescription': 'The pre-intervention period was started from November 1, 2015 to April 30, 2016 (6-month period), in which the intravenous antibiotics at hospital discharge were prescribed by the primary care team. The post-intervention period was started from May 1, 2016 to February 28, 2017 (10-month period), in which the intravenous antibiotics at hospital discharge were reviewed and intervened by ID team.\n\nThe appropriateness of intravenous antibiotics was assessed separately by the ID fellow and ID specialist. If disagreement occurred, the feedback to the ID fellow was performed and the decision by ID specialist was used in the final analysis of appropriateness.\n\nIn post-intervention period, ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics\n\nFinally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adult patients who met the following criteria were consecutively enrolled;\n\n1. ageā„ 15 years old and\n2. had infections at any sites and received intravenous antibiotics.\n\nExclusion Criteria:\n\n\\- They were evaluated by infectious diseases specialist for appropriate antibiotics during admission'}, 'identificationModule': {'nctId': 'NCT03173768', 'briefTitle': 'Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Quasi-experimental Study Comparing Intravenous Antibiotics Prescriptions at Hospital Discharge With and Without ID Consultation', 'orgStudyIdInfo': {'id': '3631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'pre-intervention period', 'description': 'The charts of patients who were prescribed intravenous antibiotics at hospital discharge were reviewed. Appropriateness of intravenous antibiotics was assessed by ID specialists.'}, {'type': 'EXPERIMENTAL', 'label': 'post-intervention period', 'description': 'The intervention is the charts of patients who were prescribed intravenous antibiotics at hospital discharge by the primary team were prospectively reviewed and intervened by ID team (ID specialist approval)', 'interventionNames': ['Procedure: ID specialist approval']}], 'interventions': [{'name': 'ID specialist approval', 'type': 'PROCEDURE', 'description': 'Appropriateness of intravenous antibiotics ordered by the primary team was assessed by ID specialist. ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics. Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.', 'armGroupLabels': ['post-intervention period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Medicine', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Romanee Chaiwarith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharaj Nakorn Chiang Mai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Romanee Chaiwarith', 'investigatorAffiliation': 'Chiang Mai University'}}}}