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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05952193

Collaborator

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

128

Enrollment

Location

12.4

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iatrogenesis Clinical Vignettes Diagnostic Performance Study Medical Information Search Artificial Intelligence

Study Design

Study Type:

Observational

Anticipated Enrollment :

128 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 21, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
seniority ≥3 years + POSOS
seniority ≥3 years without POSOS
seniority <3 years with POSOS
seniority <3 years without POSOS

Outcome Measures

Primary Outcome Measures

the proportion of overall correct responses in each groups [5 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05952193

Other Study ID Numbers:

PI2023_843_0070

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Iatrogenesis

Clinical vignettes

Diagnostic performance study

Medical Information Search

Artificial Intelligence

Study Results

No Results Posted as of Jul 19, 2023