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Clinical Trials/NCT05420168
NCT05420168
Recruiting
Not Applicable

Automatisation du Recueil d'Indicateurs de Pertinence de Prescription d'Antibiotiques : Développement, Validation et efficacité d'un Outil Utilisant Les systèmes d'Information d'un Groupement Hospitalier de Territoire

University Hospital, Bordeaux8 sites in 1 country2,115 target enrollmentStarted: January 2, 2021Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University Hospital, Bordeaux
Enrollment
2,115
Locations
8
Primary Endpoint
Sensitivity of the automatic tool to identify inappropriate antibiotic prescriptions compared to classical practices audits (gold standard).

Overview

Brief Summary

This research focuses on the development and validation of indicators on the relevance of antibiotic prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of quality indicators as part of a structured approach to improve future practices. The main objective of the study is to develop indicators on the appropriateness of antibiotic prescriptions and on surgical prophylaxis automated from the hospital information system and to assess their criterion validity.

Detailed Description

According to the national program to control Antimicrobial resistance, hospitals are required to report two indicators on antibiotic prescriptions appropriateness: 1/the percentage of inappropriate treatment among treatments lasting more than 7 days; 2/the percentage of surgical antibiotic prophylaxis lasting more than 24 hours.

These indicators are collected via practice audits that are time-consuming and cover a limited number of patient records.

The main objective of ARIPPA project is to assess the ability of an automatic tool to detect inappropriate antibiotic prescriptions directly from the electronic health records (sensitivity). Secondary objectives are 1) to assess the specificity, positive predictive value and negative predictive value of the tool for automatically calculating indicators of the relevance of antibiotic prescriptions from information systems, 2) to assess the impact of individual and collective feedbacks on antibiotic prescription appropriateness 3) to explore acceptability of this automated tool by prescribers.

This observational study consists in 4 steps: 1/ development of the automatic tool to detect inappropriate antibiotic prescriptions directly from the electronic health records - for treatments lasting more than 7 days, the study will focus on respiratory infections and urinary tract infections which are the most common infections in hospitals; 2/ assessment of metrologic performance of the tool by comparison to practice audits as the gold standard; 3/ feedback of the indicators to the prescribers and 4/ evaluation of the impact of this feedback on appropriateness of antibiotic prescriptions.

This project will be piloted at Bordeaux University hospital and then implemented in other public hospitals belonging to a same territorial organization. As each hospital information system is different, the investigators will propose transposable tools to other healthcare institutions to allow an automated construction of these indicators.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients whose medical and administrative data are available in an electronic format in the hospital information system
  • Adult patients aged over 18;
  • Patients hospitalized at the Bordeaux University Hospital or one of the hospital of the territorial organization ;
  • Patients hospitalized between 01/01/2022 and 31/12/2024 ;
  • Indicator 1: "antibiotic treatments of more than 7 days without justifications"
  • Patients with of a hospitalization of more than 24 hours;
  • Patients with urinary or respiratory infections on admission or during the hospitalization (including sepsis related to urinary or respiratory infection);
  • Patients with a prescription for at least one antibiotic, initiated on admission or during the hospitalization, for more than 7 days including the hospital prescription AND the discharge prescription
  • Indicator 2: "surgical antibiotic prophylaxis lasting more than 24 hours"
  • Patients with surgery requiring an antibiotic prophylaxis

Exclusion Criteria

  • Patients not hospitalized at the Bordeaux University Hospital or one of the hospital of the territorial organization.
  • Patients whose medical and administrative data are not available in an electronic format in the hospital information system;
  • Patients who have refused the secondary use of their data for research purpose
  • Indicator 1: "Indicator of antibiotic treatments of more than 7 days without justifications"
  • Patients with another concomitant infectious pathology
  • Patient with pulmonary or urinary tuberculosis
  • Indicator 2: "surgical antibiotic prophylaxis lasting more than 24 hours"
  • Patients without any surgery or with surgery for which antibiotic prophylaxis is not required
  • Patients without antibiotic prophylaxis

Outcomes

Primary Outcomes

Sensitivity of the automatic tool to identify inappropriate antibiotic prescriptions compared to classical practices audits (gold standard).

Time Frame: Between January 2021 and December 2024

Indicator "inappropriate treatment lasting more than 7 days": antibiotic treatment initiated or continued more than 7 days in clinical situations (urinary and respiratory infections) where a shorter treatment is recommended Indicator "surgical antibiotic prophylaxis lasting more than 24 hours": antibiotic given for a more than 24 hours for a surgical procedure requiring antibiotic prophylaxis The gold standard is the judgement of prescription appropriateness by infectious diseases experts. The gold standard will be measured independently from the automatic tool. Data will be manually extracted from patient electronic health record and assessed, independently, by two infectious diseases specialists to identify inappropriate prescriptions. In case of disagreement, an expert committee will be convened.

Secondary Outcomes

  • Number of response with justification of the prescription(Between December 2022 and December 2024)
  • Number of alerts without responses from the prescriber(Between December 2022 and December 2024)
  • Evaluate the score with scale MAUQ_E(Between June 2023 and December 2024)
  • Evaluate the score with scale MAUQ_U(Between June 2023 and December 2024)
  • Number of inappropriate antibiotic prescriptions(Between April 2023 and December 2024)
  • Metrological performances of each indicator(Between January 2021 and December 2023)
  • Number of responses done by the system(Between December 2022 and December 2024)
  • Evaluate the score with scale MAUQ_I(Between June 2023 and December 2024)

Investigators

Sponsor
University Hospital, Bordeaux
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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