Evaluating Antibiotic Stewardship Assisted by Computer in the University Hospital of Nancy (MACABAO)

Study Overview
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Brief Summary
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Antibiotic resistance is one of the most pressing health threats that mankind faces now and in the coming decades. Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. In order to tackle antibiotic resistance, a computerized-decision support system (CDSS) facilitating antibiotic stewardship and an electronic surveillance software (ESS) facilitating infection prevention and control activities will implement in our tertiary care university hospital. The investigators conduct a pragmatic, prospective, single-centre, before-after uncontrolled study with an interrupted time-series analysis 12 months before and 12 months after the introduction of the CDSS for antibiotic stewardship (APSS) and ESS for infection surveillance (ZINC). APSS and ZINC will assist respectively the antibiotic stewardship and the infection prevention and control teams of Nancy University Hospital (France). The investigators will evaluate the impact of the CDSS/ESS on the antibiotic use in adult (≥ 18 years) inpatients (hospitalised ≥ 48h). The primary outcome is the prescription rate by all healthcare professionals from the hospital of all systemic antibiotics expressed in defined daily doses/1 000 patients/month. Concurrently, the investigators will assess the safety of the intervention, its impact on the appropriateness of antibiotic prescriptions and on additional precautions (isolation precautions) as recommended in guidelines, and on bacterial epidemiology (multidrug-resistant bacteria and Clostridioides difficile infections) in the hospital. Finally, the investigators will evaluate the users' satisfaction and the cost of this intervention from the hospital perspective.

Official Title
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Evaluating Antibiotic Stewardship and Healthcare-associated Infections Surveillance Assisted by Computer in the University Hospital of Nancy

Conditions
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Antibiotic, Healthcare Associated Infection

Intervention / Treatment
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* Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All inpatients ≥ 18 years and hospitalised ≥ 48h in Nancy University Hospital Exclusion Criteria: The paediatric and gynaeco-obstetric departments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adult (≥ 18 years) inpatients (hospitalised ≥ 48h)<br> | Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer<br>* Implementation - in our tertiary care university hospital - of a computerized-decision support system (CDSS) facilitating antibiotic stewardship and of an electronic surveillance software (ESS) facilitating infection prevention and control activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription rate of all systemic antibiotics | The prescription rate by all healthcare professionals from the Nancy University Hospital of all systemic antibiotics (J01 code according to the Anatomical Therapeutic Chemical - ATC - 2017 classification) expressed in DDDs/1 000 patients/month. | Calculated monthly during a 12-month before and 12-month after period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause intra-hospital mortality rate | All causes of death/1 000 inpatients/month | Calculated monthly during a 12-month before and 12-month after period | 
| Average length of stay | Total length of stay for each inpatient/number of stays/month | Calculated monthly during a 12-month before and 12-month after period | 
| Incidence of healthcare associated infections | New cases of HCAI/ number of inpatients/month | Calculated monthly during a 12-month before and 12-month after period | 
| Use of overall antibiotics and by therapeutic classes | DDDs/1 000 patients/month | Calculated monthly during a 12-month before and 12-month after period | 
| Proportion of the antibiotic prescriptions compliant with guidelines | Number of antibiotic prescriptions compliant with guidelines/number of antibiotic prescriptions evaluated | Calculated monthly during a 12-month before and 12-month after period | 
| Proportion of the additional precaution prescriptions compliant with hospital recommendations | Number of additional precaution prescriptions compliant with hospital recommendations/number of additional precaution prescriptions evaluated | Calculated monthly during a 12-month before and 12-month after period | 
| Proportion of C. difficile infections | Number of stays with C. difficile infections/number of stays with antibiotic treatment/month | Calculated monthly during a 12-month before and 12-month after period | 
| Proportion of multidrug resistant bacteria identification | Number of stays with MDRB identification by bacterial sample done after 48h of hospitalization/number of stays with identification of bacterial isolates/month | Calculated monthly during a 12-month before and 12-month after period | 
| Hospital costs | Costs of antibiotics (costs (in €) of all oral and intravenous antibiotics delivered by hospital pharmacy/month) Average cost of hospital stays (costs (in €) of hospital stays for each inpatient/number of stays/month) Costs of the implementation of the CDSS/ESS and of the purchased equipment (costs (in €) of installation and maintenance of the CDSS/ESS after 12 months of implementation) | During the 12-month after period | 
| Users' satisfaction and acceptability | Satisfaction (qualitative study after 6 months of use) Proportion of APSS' alerts accepted by the AMS team (number of APSS' alerts accepted by the AMS team/number of alerts generated by APSS/month) Proportion of AMS team's recommendations accepted by prescribers (number of AMS team's recommendations accepted by prescribers/number of recommendations given by the AMS team to prescribers/month) | During the 12-month after period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection prevention and control, Antibiotic stewardship, Healthcare associated infection, Clinical decision support, Interrupted time series, Antibiotic resistance