Clinical trial NCT05420168: Antibiotic Prescription Relevance Indicators: Calculation From Electronic Health Records
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Antibiotic
Keywords: Antibiotic
Relevance
Indicators
Antibioprophylaxis
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
First posted: 2022-06-15
Enrollment: 2115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients whose medical and administrative data are available in an electronic format in the hospital information system, Adult patients aged over 18.

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.

Eligibility criteria: 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
  * Patients having received 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

Primary outcomes:
measure: Sensitivity of the automatic tool to identify inappropriate antibiotic prescriptions compared to classical practices audits (gold standard).
timeFrame: Between January 2021 and December 2024
Secondary outcomes:
measure: Metrological performances of each indicator
timeFrame: Between January 2021 and December 2023
measure: Number of responses done by the system
timeFrame: Between December 2022 and December 2024
measure: Number of response with justification of the prescription
timeFrame: Between December 2022 and December 2024
measure: Number of alerts without responses from the prescriber
timeFrame: Between December 2022 and December 2024
measure: Evaluate the score with scale MAUQ_E
timeFrame: Between June 2023 and December 2024
measure: Evaluate the score with scale MAUQ_I
timeFrame: Between June 2023 and December 2024
measure: Evaluate the score with scale MAUQ_U
timeFrame: Between June 2023 and December 2024
measure: Number of inappropriate antibiotic prescriptions
timeFrame: Between April 2023 and December 2024
Other outcomes:
Locations:
city: Arcachon
country: France
facility: Arcachon Hospital
city: Blaye
country: France
facility: Blaye Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Bordeaux
country: France
facility: Charles Perrens Hospital
city: Cadillac
country: France
facility: Cadillac Hospital
city: Langon
country: France
facility: Sud-Gironde Hospital
city: Libourne
country: France
facility: Libourne Hospital
city: Sainte Foy la Grande
country: France
facility: Sainte Foy la Grande Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Frantz THIESSARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: