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

NCT ID: NCT07115966

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-31

Brief Summary

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.

Conditions

Antibiotic Prescriptions; In-Patient Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Best practice alert (BPA)

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.

Group Type: EXPERIMENTAL

Computerized decision support by best practice alert (BPA)

Intervention Type: BEHAVIORAL

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".

Controls - No 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computerized decision support by best practice alert (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".

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

Ward level:

• Emergency departments
• Outpatient clinics
• Haemato-oncologic stem cell transplant wards, where daily ID visits are performed
• ICU wards, where daily ID visits are performed

Indvidual patient data for analysis

• Refusal of institutional general consent for further use of patient data

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Jent, PD

Role: STUDY_CHAIR

Inselgruppe Bern

Nasstasja Wassilew, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Inselgruppe Bern

Locations

Inselgruppe

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2025-00735

Identifier Type: -

Identifier Source: org_study_id