Antibiotic Prescription Relevance Indicators: Calculation From Electronic Health Records

NCT05420168 | Unknown

• 1 other identifier: CHUBX 2018/69
• Study Type: observational
• Target: 2,115
• Locations: 1 country
• Sites: 8

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.

Conditions

Surgery; Antibiotic

Keywords

Antibiotic; Relevance; Indicators; Antibioprophylaxis

Outcome Measures

Primary Outcomes (1)

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

  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.

  Between January 2021 and December 2024

Secondary Outcomes (8)

• Metrological performances of each indicator

  Between January 2021 and December 2023

• Number of responses done by the system

  Between December 2022 and December 2024

• 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

Study Arms (1)

Patient who received antibiotic prophylaxis

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

Other: Automatic tool to identify inappropriate antibiotic prescriptions

Interventions

Automatic tool to identify inappropriate antibiotic prescriptions OTHER

The system will identify inappropriate antibiotic prescriptions.

Patient who received antibiotic prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (8)

Arcachon Hospital

Arcachon, 33120, France

NOT YET RECRUITING

Blaye Hospital

Blaye, 33390, France

NOT YET RECRUITING

Bordeaux University Hospital

Bordeaux, 33000, France

RECRUITING

Charles Perrens Hospital

Bordeaux, 33000, France

NOT YET RECRUITING

Cadillac Hospital

Cadillac, 33410, France

NOT YET RECRUITING

Sud-Gironde Hospital

Langon, 33210, France

NOT YET RECRUITING

Libourne Hospital

Libourne, France

NOT YET RECRUITING

Sainte Foy la Grande Hospital

Sainte-Foy-la-Grande, 33220, France

NOT YET RECRUITING

Study Officials

• Frantz THIESSARD, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frantz THIESSARD, MD, PhD

CONTACT

+ 33 557 574 522; frantz.thiessard@u-bordeaux.fr ; frantz.thiessard@chu-bordeaux.fr

Catherine DUMARTIN, PharmD; PhD

CONTACT

+ 33 556 796 058; catherine.dumartin@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 15, 2022
• Study Start: January 2, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)