Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study

Artificial Intelligence Clinical Trial

— YGenHiVi  

Official title:

Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952193
• Other study ID #: PI2023_843_0070
• Status: Recruiting
• Start date: June 21, 2023
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Aurélien MARY, Dr
• Phone: 03 22 08 71 40
• Email: Mary.aurelien[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a multicenter evaluation of diagnostic performance using simulated clinical vignettes. It aims to test the effectiveness of the POSOS app in detecting drug-induced iatrogenesis in urgent medical situations, an issue of public health importance. Participating physicians, who are randomly assigned to either use or not use POSOS, are categorized based on their years of experience. Vignettes, including a mixture of complex, simple, and non-iatrogenesis cases, are assigned to these doctors. During the simulation, physicians respond to their respective vignettes on the YgheniVi platform, with responses recorded at two intervals (5 min and 15 min). The supervising physicians subsequently fill out an e-CRF, providing further data on the time spent, the number of medical research applications used, and the overall user experience of POSOS. A doctor/pharmacist pair then corrects the answers to the vignettes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Not applicable as the study population is made up of clinical vignettes, there is no inclusion of patients.

• The physicians included are emergency physicians, selected by convenience so as to have as many physicians (seniority of practice 3 years after thesis) as (seniority of practice less).

Exclusion Criteria:

• Not applicable.

• Simulations with technical faults will be excluded: (absence of the test doctor, internet access not working, PC malfunction, serious disruptions during the simulation).

Related Conditions & MeSH terms

• Artificial Intelligence

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (13)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Bourg en Bresse, Centre Hospitalier de Niort, Centre Hospitalier Régional Metz-Thionville, Centre Hospitalier Universitaire de Nice, CHU de Créteil, CHU de Reims, CHU de Rouen - Accueil, Médipôle Lyon-Villeurbanne, Saint Antoine University Hospital, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of overall correct responses in each groups		5 minutes