Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 10:41 AM
Study NCT ID:
NCT07368660
Status:
COMPLETED
Last Update Posted:
2026-01-26
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
InPART RX - Epicenters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stepped wedge cluster randomized approach of a quality improvement effort of peer comparative inpatient prescribing reports sent to hospitalists in 5 hospitals. The intervention will be rolled out sequentially to all 5 hospitals in 3-month intervals. The intervention will last 18 months at all 5 sites.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed provider-specific antibiotic prescribing rate', 'timeFrame': 'Baseline and bimonthly for 2 years', 'description': 'The observed provider-specific antibiotic prescribing rate is defined as the billed days of therapy (DOT) of Broad-Spectrum, Hospital-Onset (BS-HO) antibiotics per 1000 billed patient-days.'}], 'secondaryOutcomes': [{'measure': 'C. difficile infection', 'timeFrame': 'Up to 8 weeks post discharge (9 weeks from admission on average)', 'description': 'C. difficile infection occurring during inpatient stay (average 7 days) or within 8 weeks after discharge among patients managed by hospital medicine and discharged with an ICD-10 diagnosis code for community-acquired pneumonia, urinary tract infection (UTI), or urosepsis.'}, {'measure': 'Number of participants with a prolonged length of initial hospital stay', 'timeFrame': 'Hospital stay, an average of 10 days', 'description': 'Prolonged initial hospital stays, defined as a length of stay exceeding 7 days from arrival at the emergency department (ED) to hospital discharge, among patients managed by hospital medicine and discharged with an International Classification of Diseases (ICD)-10 diagnosis code for community-acquired pneumonia, urinary tract infection (UTI), or urosepsis.'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Hospital admission, an average of 7 days', 'description': 'Rate of in-hospital mortality among patients managed by hospital medicine and discharged with an ICD-10 diagnosis code for community-acquired pneumonia, urinary tract infection (UTI), or urosepsis.'}, {'measure': 'Hospital readmissions', 'timeFrame': '30 days after hospital discharge', 'description': 'Hospital readmissions up to 30 days after index hospital discharge among patients managed by hospital medicine and discharged with an ICD-10 diagnosis code for community-acquired pneumonia, urinary tract infection (UTI), or urosepsis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stepped wedge', 'Stewardship', 'Hospitalists', 'Quality Metrics', 'Antibiotics Prescription', 'C. Difficile Infection (CDI)'], 'conditions': ['Hospital Infection', 'Standardized Antibiotic Prescribing Ratio (SAR)']}, 'descriptionModule': {'briefSummary': "InPART Rx is a collaborative research study to measure the impact of a planned quality improvement initiative to reduce unnecessary antibiotic prescribing by the Hospital Medicine Service through a process of receiving peer-comparison summary prescribing data bimonthly. The initiative is a collaboration between EHC Pharmacy, the School of Medicine (SOM) Division of Infectious Diseases, and the SOM Hospital Medicine Service.\n\nRoughly one-third of antibiotics prescribed in the hospital setting are for the wrong dose, wrong drug, or wrong duration, resulting in considerable unnecessary antibiotic exposure among the inpatient population. Such use increases patient risk for adverse events such as infectious diarrhea or antibiotic-resistant infections. Inpatients cared for by Hospital Medicine providers are a growing proportion of all patients, and developing efficient techniques to reduce unnecessary antibiotic prescribing by these providers would benefit this growing population of patients.\n\nThe research team aims to measure the impact of implementing a process to provide peer comparisons of antibiotic prescribing among Hospitalists at four Emory Healthcare (EHC) hospitals back to these providers in an effort to minimize unnecessary antibiotic prescribing. All 147 current Hospital Medicine Service providers will participate as part of the Division's quality improvement effort, receiving no compensation. Only summary patient encounter information without private health insurance (PHI) will be presented back to the providers; investigators will track changes in summary prescribing metrics and summary patient outcomes every month. If such an automated peer-comparison feedback process is effective in safely reducing unnecessary antibiotic prescriptions in EHC, similar processes may be adapted to other inpatient provider groups or serve as a model for other healthcare systems.\n\nThe goal of this quality improvement (QI) work is to use traditional QI methods of peer-comparison through data feedback to improve antibiotic prescribing among EHC HMS by reducing unnecessary antibiotic use and improving patient safety on the EHC HMS.", 'detailedDescription': 'The intervention is messaging to hospitalists via email every 2 months (bi-monthly) that contains peer comparison data of the previous 2 months and antibiotic prescribing educational content.\n\nThe details of the content may include a relative rank in prescribing metrics, with blinding to specific peers\' identities, and department-wide and facility-specific goals highlighted. Those in the lowest prescribing quartile will earn the designation of "Top Performer". The usual care arm will be an educational email about simple steps to improve antibiotic prescribing sent bimonthly to all hospitalists.\n\nData Sources: The primary source of data will be the Emory Hospital (EH) Clinical Data Warehouse (CDW), a repository that integrates data from multiple clinical applications within EHC and has the flexibility to create customized, research-specific metrics for all adults (≥18 years old) admitted to the HMS at either Emory University Hospital (EUH), Emory University Hospital Midtown (EUHM), Emory Johns Creek Hospital (EJCH), or Emory St. Joseph\'s Hospital (ESJH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All Hospital Medicine Service (HMS) Providers at either Emory University Hospital (EUH), Emory University Hospital Midtown (EUHM), Emory Johns Creek Hospital (EJCH), or Emory St. Joseph's Hospital (ESJH)\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT07368660', 'acronym': 'InPART RX', 'briefTitle': 'InPART RX - Epicenters', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'InPART Rx - Inpatient Provider Antibiotic Rate Benchmarking to Reduce Unnecessary Prescribing', 'orgStudyIdInfo': {'id': '2025P009466'}, 'secondaryIdInfos': [{'id': 'U54CK000601-01', 'link': 'https://reporter.nih.gov/quickSearch/U54CK000601-01', 'type': 'NIH'}, {'id': 'STUDY00003936', 'type': 'OTHER', 'domain': 'Emory IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HMS Providers', 'description': 'Hospitalists will receive messages via email every 2 months with comparison data of the previous 2 months and antibiotic prescribing educational content.\n\nHMS providers will be receiving data on prescribing as part of the intervention.', 'interventionNames': ['Other: Messaging Hospitalists']}, {'type': 'OTHER', 'label': 'Usual Care Arm (Control)', 'description': 'Hospitalists will receive bimonthly educational emails about simple steps to improve antibiotic prescribing.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Messaging Hospitalists', 'type': 'OTHER', 'description': "The intervention has two parts: (1) a one-time educational session on antibiotic de-escalation, and (2) bimonthly email feedback reports. Educational sessions, led by facility stewardship leads, focused on evidence-based recommendations for presumed pneumonia and urosepsis, specifically indications for empiric anti-pseudomonal coverage and use of Emory Healthcare's antibiotic prescribing assistance tool. Feedback reports reinforced these indications and provided a link to the tool.", 'armGroupLabels': ['HMS Providers']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'The usual care arm will be an educational email about simple steps to improve antibiotic prescribing sent bimonthly to all hospitalists.', 'armGroupLabels': ['Usual Care Arm (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Saint Joseph's Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown (EUHM)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital (EUH)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30097', 'city': 'Johns Creek', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Johns Creek Hospital', 'geoPoint': {'lat': 34.02893, 'lon': -84.19858}}], 'overallOfficials': [{'name': 'Scott K. Fridkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Epidemiology', 'investigatorFullName': 'Scott K. Fridkin', 'investigatorAffiliation': 'Emory University'}}}}