SurgeryARIPPANCT05420168
Antibiotic Prescription Relevance Indicators: Calculation From Electronic Health Records
An observational study of Surgery and Antibiotic, run by University Hospital, Bordeaux at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Antibiotic
- What is being tested?
- Automatic tool to identify inappropriate antibiotic prescriptions
- How many people
- 2,115 participants
- Where
- 8 sitesFrance
- Study dates
- 2 Jan 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whose medical and administrative data are available in an electronic format in the hospital information system, Adult patients aged over 18.
Who may be able to join
- 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;
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
Frantz THIESSARD, MD, PhD contact
frantz.thiessard@u-bordeaux.fr ; frantz.thiessard@chu-bordeaux.fr
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Arcachon Hospital
Arcachon, 33120
Stéphanie Bez, MD, stephanie.bez@ch-arcachon.fr
Stéphanie Bez, MD
- Not yet recruiting
Blaye Hospital
Blaye, 33390
Cathy Rakotomalala, MD, rakotomalala@chblaye.fr
Cathy Rakotomalala, MD
- Recruiting
Bordeaux University Hospital
Bordeaux, 33000
Anne-Marie Rogues, MD PhD, anne-marie.rogues@chu-bordeaux.fr
Anne-Marie Rogues, MD PhD
- Not yet recruiting
Charles Perrens Hospital
Bordeaux, 33000
Françoise Obeniche, MD, fobeniche@ch-perrens.fr
Françoise Obeniche, MD
- Not yet recruiting
Cadillac Hospital
Cadillac, 33410
Laurence Parneix-Sediey, PharmD, laurence.parneix@ch-cadillac.fr
Laurence Parneix-Sediey, PharmD
- Not yet recruiting
Sud-Gironde Hospital
Langon, 33210
Philippe Cormier, MD, Philippe.cormier@ch-sudgironde.fr
Philippe Cormier, MD
- Not yet recruiting
Libourne Hospital
Libourne
Caroline Fondrinier, PharmD, Caroline.fondrinier@ch-libourne.fr
Caroline Fondrinier, PharmD
- Not yet recruiting
Sainte Foy la Grande Hospital
Sainte-Foy-la-Grande, 33220
Corinne Thé, PharmD, Corinne.The@ch-sudgironde.fr
Corinne Thé, PharmD
About this study
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
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.
Read the 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.
- Conditions
- Surgery, Antibiotic
- Being tested
- Automatic tool to identify inappropriate antibiotic prescriptions
- Keywords
- Antibiotic, Relevance, Indicators, Antibioprophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic tool to identify inappropriate antibiotic prescriptionsOther
The system will identify inappropriate antibiotic prescriptions.
| Study group | Role | What they receive |
|---|---|---|
| Patient who received antibiotic prophylaxis | Patient who received antibiotic prophylaxis to assess appropriateness and consumption of treatment. Receives: Other: Automatic tool to identify inappropriate antibiotic prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between January 2021 and December 2024
Secondary outcomes (8)
Metrological performances of each indicator
specificity , positive and negative predictive values to identify inappropriate prescriptions will be compared to gold standard (practices audits)
Measured: Between January 2021 and December 2023
Number of responses done by the system
The number and the content of responses: acknowledgment of inappropriateness or justification of the prescription The number of alerts without responses from the prescriber.
Measured: Between December 2022 and December 2024
Number of response with justification of the prescription
The number and the content of responses: acknowledgment of inappropriateness or justification of the prescription The number of alerts without responses from the prescriber.
Measured: Between December 2022 and December 2024
Number of alerts without responses from the prescriber
The number and the content of responses: acknowledgment of inappropriateness or justification of the prescription The number of alerts without responses from the prescriber.
Measured: Between December 2022 and December 2024
Evaluate the score with scale MAUQ_E
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.
Measured: Between June 2023 and December 2024
Evaluate the score with scale MAUQ_I
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.
Measured: Between June 2023 and December 2024
Evaluate the score with scale MAUQ_U
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.
Measured: Between June 2023 and December 2024
Number of inappropriate antibiotic prescriptions
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
Measured: Between April 2023 and December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start2 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Frantz THIESSARD, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420168
- Sponsor's protocol ID
- CHUBX 2018/69
- Acronym
- ARIPPA
- Status last verified
- Apr 2022
- First submitted
- 24 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05420168
- Acronym / sponsor ID
- ARIPPA / CHUBX 2018/69
- Conditions
- Surgery, Antibiotic
- Keywords
- Antibiotic, Relevance, Indicators, Antibioprophylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,115 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- University of Bordeaux
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who received antibiotic prophylaxis | – | Other: Automatic tool to identify inappropriate antibiotic prescriptionsPatient who received antibiotic prophylaxis to assess appropriateness and consumption of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose medical and administrative data are available in an electronic format in the hospital information system, Adult patients aged over 18.
Key inclusion criteria (11 listed)
- 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"
Key exclusion criteria (9 listed)
- 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"
- Indicator 2: "surgical antibiotic prophylaxis lasting more than 24 hours"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic tool to identify inappropriate antibiotic prescriptionsThe system will identify inappropriate antibiotic prescriptions. | Other | Patient who received antibiotic prophylaxis |
Primary outcome
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.
8 secondary outcomes
Metrological performances of each indicator
Time frame: Between January 2021 and December 2023
Number of responses done by the system
Time frame: Between December 2022 and December 2024
Number of response with justification of the prescription
Time frame: Between December 2022 and December 2024
Number of alerts without responses from the prescriber
Time frame: Between December 2022 and December 2024
Evaluate the score with scale MAUQ_E
Time frame: Between June 2023 and December 2024
Evaluate the score with scale MAUQ_I
Time frame: Between June 2023 and December 2024
Evaluate the score with scale MAUQ_U
Time frame: Between June 2023 and December 2024
Number of inappropriate antibiotic prescriptions
Time frame: Between April 2023 and December 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frantz THIESSARD, MD, PhD contact
frantz.thiessard@u-bordeaux.fr ; frantz.thiessard@chu-bordeaux.fr
Frantz THIESSARD, MD, PhD principal investigator
University Hospital, Bordeaux
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Antibiotic, run by University Hospital, Bordeaux at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frantz THIESSARD, MD, PhD (+ 33 557 574 522, frantz.thiessard@u-bordeaux.fr ; frantz.thiessard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.