Antibiotic Prescription Relevance Indicators: Calculation From Electronic Health Records

NCT ID: NCT05420168

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-02

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Surgery Antibiotic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient who received antibiotic prophylaxis

Patient who received antibiotic prophylaxis to assess appropriateness and consumption of treatment.

Automatic tool to identify inappropriate antibiotic prescriptions

Intervention Type OTHER

The system will identify inappropriate antibiotic prescriptions.

Interventions

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Automatic tool to identify inappropriate antibiotic prescriptions

The system will identify inappropriate antibiotic prescriptions.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bordeaux

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frantz THIESSARD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Arcachon Hospital

Arcachon, , France

Site Status NOT_YET_RECRUITING

Blaye Hospital

Blaye, , France

Site Status NOT_YET_RECRUITING

Bordeaux University Hospital

Bordeaux, , France

Site Status RECRUITING

Charles Perrens Hospital

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Cadillac Hospital

Cadillac, , France

Site Status NOT_YET_RECRUITING

Sud-Gironde Hospital

Langon, , France

Site Status NOT_YET_RECRUITING

Libourne Hospital

Libourne, , France

Site Status NOT_YET_RECRUITING

Sainte Foy la Grande Hospital

Sainte-Foy-la-Grande, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Frantz THIESSARD, MD, PhD

Role: CONTACT

Catherine DUMARTIN, PharmD; PhD

Role: CONTACT

+ 33 556 796 058

Facility Contacts

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Stéphanie Bez, MD

Role: primary

Cathy Rakotomalala, MD

Role: primary

Anne-Marie Rogues, MD PhD

Role: primary

Françoise Obeniche, MD

Role: primary

Laurence Parneix-Sediey, PharmD

Role: primary

Philippe Cormier, MD

Role: primary

Caroline Fondrinier, PharmD

Role: primary

Corinne Thé, PharmD

Role: primary

Other Identifiers

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CHUBX 2018/69

Identifier Type: -

Identifier Source: org_study_id

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