Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT03580603
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2018-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Decision Support Tools for Antibiotic Prescribing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provider knowledge', 'timeFrame': 'To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.', 'description': "Provider knowledge of patients' previous culture sensitivity results as determined by the proportion of correct answers on a questionnaire:\n\nDo you think this patient has had previous resistance to each of these antibiotics at BIDMC (Beth Israel Deaconess Medical Center)?\n\n\\[List of the top 4 antibiotic classes to which resistance is seen at BIDMC that the patient has previously had tested for antibiotic sensitivities\\]\n\nYes (previous organisms resistant or with intermediate resistance)\n\nNo (no previous resistance noted)"}], 'secondaryOutcomes': [{'measure': 'Post-intervention survey', 'timeFrame': 'To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.', 'description': "Providers will be asked survey questions regarding their decision-making and the usability and usefulness of the tool using a 5 point Likert scale:\n\nI understand the previous culture data for this patient (Strongly disagree) 1 2 3 4 5 (Strongly agree)\n\nI feel like I made an informed antibiotic choice (Strongly disagree) 1 2 3 4 5 (Strongly agree)\n\nThe tool provided new information that you were not previously aware of (Strongly disagree) 1 2 3 4 5 (Strongly agree)\n\nThe tool enabled you to more quickly understand this patient's microbiological data (Strongly disagree) 1 2 3 4 5 (Strongly agree)\n\nThe tool was easy to use (Strongly disagree) 1 2 3 4 5 (Strongly agree)"}, {'measure': 'Antibiotic order changes', 'timeFrame': 'To be assessed at the time of patient enrollment + 1 day', 'description': 'Antibiotic orders that are not complete by the time of the intervention will be monitored for any cancellation or change in orders'}, {'measure': 'Final culture results', 'timeFrame': 'To be assessed at the time of patient enrollment + 1 week', 'description': 'Final culture results drawn from that visit will be compared to antibiotic orders for effectiveness'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infectious Disease']}, 'descriptionModule': {'briefSummary': "The goal of this study is to assess the utility of a data visualization tool for providers' understanding patients' past microbiological culture sensitivities. Providers that are ordering antibiotics for patients with previous culture data in the medical record will be asked to answer questions regarding past sensitivity results. They will be randomized to either using the visualization tool before answering the questions or using the standard medical record tools. They will then be surveyed about their decision-making, knowledge, and the usefulness of the tool."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* provider is caring for a patient with a previous positive urine or blood cultures\n* provider is caring for a patient currently in a clinical location being investigated\n* provider is caring for a patient with orders placed for an intravenous, intramuscular, oral antibiotics\n\nExclusion Criteria:\n\n* the patient has already received the antibiotic by the time of the intervention\n* the antibiotic has been cancelled by the time of intervention\n* the research assistant is unable to reach the ordering provider before the visit is completed\n* participation by the clinician in the study would impede clinical care\n* age \\< 18'}, 'identificationModule': {'nctId': 'NCT03580603', 'briefTitle': 'Clinical Decision Support Tools for Antibiotic Prescribing', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results', 'orgStudyIdInfo': {'id': '2017P000432'}, 'secondaryIdInfos': [{'id': '2017P000432', 'type': 'OTHER', 'domain': 'Committee on Clinical Investigations Beth Israel Deaconess Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotic visualization tool', 'description': 'Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool.', 'interventionNames': ['Other: Visualization tool']}, {'type': 'NO_INTERVENTION', 'label': 'Standard practice', 'description': 'Provider will answer microbiological sensitivity questions using standard medical record tools.'}], 'interventions': [{'name': 'Visualization tool', 'type': 'OTHER', 'description': 'Visual representation of past microbiological culture data', 'armGroupLabels': ['Antibiotic visualization tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven Horng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steven Horng, MD', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}