Antibiotic Prescription Relevance Indicators: Calculation From Electronic Health Records

Recruiting

• Conditions: Surgery; Antibiotic
• Interventions: Other: Automatic tool to identify inappropriate antibiotic prescriptions

• Registration Number: NCT05420168
• Lead Sponsor: University Hospital, Bordeaux

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 Timeline

• Study Start: 2021-01-02
• Status Verified: 2022-04
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-15
• Last Update Posted: 2022-06-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient who received antibiotic prophylaxis	Automatic tool to identify inappropriate antibiotic prescriptions	Patient who received antibiotic prophylaxis to assess appropriateness and consumption of treatment.

Primary Outcome Measures

Name	Time	Method
Sensitivity of the automatic tool to identify inappropriate antibiotic prescriptions compared to classical practices audits (gold standard).	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 Outcome Measures

Name	Time	Method
Metrological performances of each indicator	Between January 2021 and December 2023	specificity , positive and negative predictive values to identify inappropriate prescriptions will be compared to gold standard (practices audits)
Number of response with justification of the prescription	Between December 2022 and December 2024	The number and the content of responses: acknowledgment of inappropriateness or justification of the prescription The number of alerts without responses from the prescriber.
Number of alerts without responses from the prescriber	Between December 2022 and December 2024	The number and the content of responses: acknowledgment of inappropriateness or justification of the prescription The number of alerts without responses from the prescriber.
Evaluate the score with scale MAUQ_E	Between June 2023 and December 2024	The usability of the tool will be assessed with the mHealth App Usability Questionnaire ( Zhou L, Bao J, Setiawan A, Saptono A, Parmanto B, (2019), "The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study", JMIR mHealth and uHealth, 7(4):e11500. DOI: 10.2196/11500. PMID: 30973342).; This score evaluate the ease of use of Interface Items of Scale are from 1 to 7 : 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither , agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.
Evaluate the score with scale MAUQ_U	Between June 2023 and December 2024	The usability of the tool will be assessed with the mHealth App Usability Questionnaire ( Zhou L, Bao J, Setiawan A, Saptono A, Parmanto B, (2019), "The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study", JMIR mHealth and uHealth, 7(4):e11500. DOI: 10.2196/11500. PMID: 30973342).; This score evaluate the usefulness. Items of Scale are from 1 to 7 : 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither , agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.
Number of inappropriate antibiotic prescriptions	Between April 2023 and December 2024	Changes in the proportion of inappropriate prescriptions will be assessed 4 months after implementation of the automatic tool and compared with the pre-implementation period
Number of responses done by the system	Between December 2022 and December 2024	The number and the content of responses: acknowledgment of inappropriateness or justification of the prescription The number of alerts without responses from the prescriber.
Evaluate the score with scale MAUQ_I	Between June 2023 and December 2024	The usability of the tool will be assessed with the mHealth App Usability Questionnaire ( Zhou L, Bao J, Setiawan A, Saptono A, Parmanto B, (2019), "The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study", JMIR mHealth and uHealth, 7(4):e11500. DOI: 10.2196/11500. PMID: 30973342).; This score evaluate the satisfaction use of Interface Items of Scale are from 1 to 7 : 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither , agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.

Trial Locations

Locations (8)

Arcachon Hospital; 🇫🇷 Arcachon, France

Blaye Hospital; 🇫🇷 Blaye, France

Sainte Foy la Grande Hospital; 🇫🇷 Sainte Foy la Grande, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Charles Perrens Hospital; 🇫🇷 Bordeaux, France

Cadillac Hospital; 🇫🇷 Cadillac, France

Sud-Gironde Hospital; 🇫🇷 Langon, France

Libourne Hospital; 🇫🇷 Libourne, France