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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05952193

PI2023_843_0070

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

128 participants in 4 patient groups

seniority ≥3 years + POSOS

seniority ≥3 years without POSOS

seniority <3 years with POSOS

seniority <3 years without POSOS