An interventional study of Computerized decision support by best practice alert (BPA) in Antibiotic Prescriptions and In-Patient Treatment, sponsored by Insel Gruppe AG, University Hospital Bern. Active, not recruiting at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Prevention
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.
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ward level:
Indvidual patient data for analysis
Intervention: The BPA will appear to the prescribing physician for every patient on the respective ward. Activation of the BPA is ward-based. A 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. The 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. By the end of the trial, after 12 months, all wards will be using the automated BPA.
Behavioral: Computerized decision support by best practice alert (BPA)
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.
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. An 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. If 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".
Days of antibiotic spectrum coverage (DASC) per patient admission (PA)
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
Time frame: 12 months
Days of antibiotic spectrum coverage (DASC) per patient antibiotic day (PAD)
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.
Time frame: 12 months
Days of treatment (DOT) per 100 patient days (PD) and per patient admission on ward level
Overall days of treatment (DOT) per 100 patient days (PD) and per patient admission (PA) on ward level
Time frame: 12 months
Defined daily doses (DDD) per 100 patient days (PD) and per patient admission (PA)
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.
Time frame: 12 months
Antibiotic (AB) days per patient admission (PA)
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
Time frame: 12 months
In hospital mortality
All cause in hospital mortality
Time frame: 12 months
Hospital length of stay (LOS)
Time frame: 12 months
Unplanned readmission within first 30 days after discharge
Time frame: 12 months
Patient admission to IMC/ICU from studied wards
Number and proportion of patient admissions to IMC/ICU from studied wards
Time frame: 12 months
Number of Infectious diseases (ID) consultation per patient admission (PA)
Time frame: 12 months
In hospital C. difficile infection incidence within hospital stay per patient admission (PA) and per 100 patient days (PD)
Time frame: 12 months
Inhospital incidence of multi-drug-resistant-organisms (MDRO) detection per100 patient days (PD) or per patient admission (PA)
Time frame: 12 months
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern