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

NCT05952193 | Unknown

• 1 other identifier: PI2023_843_0070
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iatrogenesis; Clinical Vignettes; Diagnostic Performance Study; Medical Information Search; Artificial Intelligence

Keywords

Iatrogenesis; Clinical vignettes; Diagnostic performance study; Medical Information Search; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• the proportion of overall correct responses in each groups

  5 minutes

Study Arms (4)

seniority ≥3 years + POSOS

seniority ≥3 years without POSOS

seniority <3 years with POSOS

seniority <3 years without POSOS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Central Study Contacts

Aurélien MARY, Dr

CONTACT

03 22 08 71 40; Mary.aurelien@chu-amiens.fr

Study Design

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

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: June 21, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)