NCT05952193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2025

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

14 days

First QC Date

July 11, 2023

Last Update Submit

June 11, 2026

Conditions

IatrogenesisClinical VignettesMedical Information SearchArtificial IntelligenceDiagnostic Performance Study

Keywords

IatrogenesisClinical vignettesDiagnostic performance studyMedical Information SearchArtificial 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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

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

September 11, 2023

Primary Completion

September 25, 2023

Study Completion

July 18, 2025

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)