Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT07115966
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use in a Tertiary and Three Secondary Hospitals
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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Cluster allocation will also be blinded to the wards and prescribers; however, prescribers may become aware of their cluster assignment when working across different wards in both intervention and control clusters, based on whether or not they receive the BPA.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Wards will be cluster-randomized according to specialty and antibiotic use (DASC/PA), based on retrospective data. The BPA will be activated in a stepwise manner for each cluster every two months over a 12-month period. By the end of the study, the BPA will be active in all participating wards.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of antibiotic spectrum coverage (DASC) per patient admission (PA)', 'timeFrame': '12 months', 'description': 'Overall score of days of antibiotic spectrum coverage per patient admission. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values'}], 'secondaryOutcomes': [{'measure': 'Days of antibiotic spectrum coverage (DASC) per patient antibiotic day (PAD)', 'timeFrame': '12 months', 'description': 'Overall score of antibiotic spectrum coverage per patient antibiotic day. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values.'}, {'measure': 'Days of treatment (DOT) per 100 patient days (PD) and per patient admission on ward level', 'timeFrame': '12 months', 'description': 'Overall days of treatment (DOT) per 100 patient days (PD) and per patient admission (PA) on ward level'}, {'measure': 'Defined daily doses (DDD) per 100 patient days (PD) and per patient admission (PA)', 'timeFrame': '12 months', 'description': 'Overall defined daily doses) per 100 patient days (PD) and per patient admission (PA) on ward level. Standard metrics recommended by WHO for international benchmarking.'}, {'measure': 'Antibiotic (AB) days per patient admission (PA)', 'timeFrame': '12 months', 'description': 'No of days an AB per PA gives the proportion of days antibiotics have been applicated, irrespective of single, double, triple combinations, in relation to total PA'}, {'measure': 'In hospital mortality', 'timeFrame': '12 months', 'description': 'All cause in hospital mortality'}, {'measure': 'Hospital length of stay (LOS)', 'timeFrame': '12 months'}, {'measure': 'Unplanned readmission within first 30 days after discharge', 'timeFrame': '12 months'}, {'measure': 'Patient admission to IMC/ICU from studied wards', 'timeFrame': '12 months', 'description': 'Number and proportion of patient admissions to IMC/ICU from studied wards'}, {'measure': 'Number of Infectious diseases (ID) consultation per patient admission (PA)', 'timeFrame': '12 months'}, {'measure': 'In hospital C. difficile infection incidence within hospital stay per patient admission (PA) and per 100 patient days (PD)', 'timeFrame': '12 months'}, {'measure': 'Inhospital incidence of multi-drug-resistant-organisms (MDRO) detection per100 patient days (PD) or per patient admission (PA)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['best practice alert', 'quanlity and quantity of antibiotic use', 'in-patients'], 'conditions': ['Antibiotic Prescriptions', 'In-Patient Treatment']}, 'descriptionModule': {'briefSummary': 'The goal of the stepped-wedge cluster-randomized trial is to assess the impact of an antimicrobial stewardship intervention: a simple, automated Best Practice Alert (BPA) that reminds prescribers to reevaluate antibiotic therapy after 72 hours (or 24 hours for prophylaxis), in accordance with guideline recommendations. The primary hypothesis is that this simple BPA reduces antibiotic use in terms of quantity (amount and duration) and quality (spectrum breadth), measured by days of antibiotic spectrum coverage at the patient level (primary outcome), as well as at both patient and cluster levels using various metrics of antibiotic use. The trial will introduce the BPA in a stepwise manner, with all wards implementing it by the end. It will compare the intervention period to the baseline (pre-intervention) and control periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• All inpatient wards with at least 50 PA/year, except those listed in the exclusion criteria\n\nExclusion Criteria:\n\nWard level:\n\n* Emergency departments\n* Outpatient clinics\n* Haemato-oncologic stem cell transplant wards, where daily ID visits are performed\n* ICU wards, where daily ID visits are performed\n\nIndvidual patient data for analysis\n\n• Refusal of institutional general consent for further use of patient data'}, 'identificationModule': {'nctId': 'NCT07115966', 'acronym': 'TARGET', 'briefTitle': 'Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use in a Tertiary and Three Secondary Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use - a Stepped-wedge, Cluster Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '2025-00735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Best practice alert (BPA)', 'description': 'Intervention:\n\nThe BPA will appear to the prescribing physician for every patient on the respective ward.\n\nActivation of the BPA is ward-based.\n\nA total of 58 wards will be stratified according to their focus-surgical, medical, intermediate care, rehabilitation, or pediatric-and grouped based on their baseline antibiotic consumption, measured in days of antibiotic spectrum coverage per patient admission (DASC/PA). This stratification will result in 9 to 10 clusters across 6 groups.\n\nThe clusters will then be randomized to the timing of BPA activation, and all wards will sequentially switch to the BPA arm every 2 months over a 12-month period.\n\nBy the end of the trial, after 12 months, all wards will be using the automated BPA.', 'interventionNames': ['Behavioral: Computerized decision support by best practice alert (BPA)']}, {'type': 'NO_INTERVENTION', 'label': 'Controls - No BPA', 'description': 'Control: standard patient care with no BPA activated. By the end of the trial, after 12 months, all wards will be using the automated BPA.'}], 'interventions': [{'name': 'Computerized decision support by best practice alert (BPA)', 'type': 'BEHAVIORAL', 'description': 'The antimicrobial stewardship intervention encourages prescribers by a simple alert to follow guidelines for reviewing antimicrobial prescriptions after a set timeframe for potential de-escalation to targeted therapy or discontinuation of the antibiotics, as recommended by national and international guidelines.\n\nAn automated simple BPA will trigger after an antibiotic prescription with therapeutic indication (72 hours) or surgical prophylaxis (24 hours, reminding prescribers to reassess treatment for possible de-escalation, adaption to targeted therapy, or cessation.\n\nIf ignored, the prescription remains unchanged, but the alert will continue until addressed. Prescribers must select reasons for not changing the prescription, such as pending microbiology results. The control group corresponds to the inpatient wards not yet receiving the BPA, where antibiotics are managed according to "standard-of-care".', 'armGroupLabels': ['Best practice alert (BPA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3007', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselgruppe', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Philipp Jent, PD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inselgruppe Bern'}, {'name': 'Nasstasja Wassilew, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselgruppe Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}