Inselgruppe
Bern, 3007, Switzerland
NCT Number: NCT07115966
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.
This study is active but is not currently recruiting participants.
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Interventional
Not applicable
Bern, 3007, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ward level:
Indvidual patient data for analysis
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".
Time frame: 12 months
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
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
Overall days of treatment (DOT) per 100 patient days (PD) and per patient admission (PA) on ward level
Time frame: 12 months
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
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
All cause in hospital mortality
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Number and proportion of patient admissions to IMC/ICU from studied wards
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Insel Gruppe AG, University Hospital Bern
Other
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
Acronym: TARGET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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