IatrogenesisYGenHiViNCT05952193
Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study
An observational study of Iatrogenesis and Clinical Vignettes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iatrogenesis, Clinical Vignettes, Diagnostic Performance Study
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2023to 18 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| seniority ≥3 years + POSOS | Not described | |
| seniority ≥3 years without POSOS | Not described | |
| seniority <3 years with POSOS | Not described | |
| seniority <3 years without POSOS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of overall correct responses in each groups
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start11 Sep 2023
- Primary completion25 Sep 2023
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IatrogenesisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Bourg en Bresse, Saint Antoine University Hospital, CHU de Rouen - Accueil, CHU de Créteil, Médipôle Lyon-Villeurbanne, Centre Hospitalier Universitaire de Nice, University Hospital, Montpellier, University Hospital, Lille, Centre Hospitalier de Niort, Centre Hospitalier Régional Metz-Thionville, University Hospital, Grenoble, CHU de Reims
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952193
- Sponsor's protocol ID
- PI2023_843_0070
- Acronym
- YGenHiVi
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study
- ClinicalTrials.gov ID
- NCT05952193
- Acronym / sponsor ID
- YGenHiVi / PI2023_843_0070
- Conditions
- Iatrogenesis, Clinical Vignettes, Diagnostic Performance Study, Medical Information Search, Artificial Intelligence
- Keywords
- Iatrogenesis, Clinical vignettes, Diagnostic performance study, Medical Information Search, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Bourg en Bresse, Saint Antoine University Hospital, CHU de Rouen - Accueil, CHU de Créteil, Médipôle Lyon-Villeurbanne, Centre Hospitalier Universitaire de Nice, University Hospital, Montpellier, University Hospital, Lille, Centre Hospitalier de Niort, Centre Hospitalier Régional Metz-Thionville, University Hospital, Grenoble, CHU de Reims
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| seniority ≥3 years + POSOS | – | – |
| seniority ≥3 years without POSOS | – | – |
| seniority <3 years with POSOS | – | – |
| seniority <3 years without POSOS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the proportion of overall correct responses in each groups
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Iatrogenesis
RecruitingObservational study
Identification of Iatrogenic Drug Events Upon Admission to the Adult Emergency Departments
Iatrogenic Drug Events
Not yet recruiting
Optimization of Medical Time in the Emergency Department: Impact of an AI-Based System on Prescription Entry
Drug-related Iatrogenesis, Emergency Department
RecruitingObservational study
Evaluation of the Impact of a Paramedical Training Program for Nurses and Nursing Assistants on the Length of Stay and Prevention of Hospital Iatrogenic Complications in Elderly Patients
Iatrogenesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenesis and Clinical Vignettes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of overall correct responses in each groups (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.