Drug InteractionPROSITNCT04463576
Drug Interactions in Hospital Information System. The PRoSIT System..
An observational study of Drug Interaction, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The French Public Health strategy 2018-2022 aims to reduce inappropriate prescriptions, as potentially dangerous for individuals and collectively. The reduction of co-prescriptions at Risk of Drug Interactions (RoDI) could decrease the prevalence of iatrogenic diseases, and increase the persistence of treatments with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Discharge Prescription
- How many people
- 5,769 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2024to 25 Nov 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: Patients aged 65 years or older AND in the cardiology, internal medicine and neurology departments of University Hospital of Bordeaux, University Hospital of Rennes, and Georges Pompidou European Hospital recorded between June 1, 2018 and June 1, 2019.
Who may be able to join
- A total of 5 676 hospital discharge prescriptions, defined as the list of medications prescribed at discharge from hospital or after a hospital visit, whether new or renewed, will be selected if they concern: patients aged 65 years or older AND in the cardiology, internal medicine and neurology departments of University Hospital of Bordeaux, University Hospital of Rennes, and Georges Pompidou European Hospital recorded between June 1, 2018 and June 1, 2019.
- For the evaluation of the determinants of acceptability and effectiveness of the intervention: a group of 18 hospital practitioners and three hospital pharmacists from the concerned departments of Bordeaux University Hospital will be included.
- For phase 3, all hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions only of the Bordeaux University Hospital will be used to analyse the impact of the feedback.
Who cannot join
- Hospital discharge prescriptions not corresponding to inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Validation and Impact of an Automatic Identification of Co-Prescription at Risk of Interactions in the Hospital Information System. The PRoSIT System.
The French Public Health strategy 2018-2022 aims to reduce inappropriate prescriptions, as potentially dangerous for individuals and collectively. The reduction of co-prescriptions at Risk of Drug Interactions (RoDI) could decrease the prevalence of iatrogenic diseases, and increase the persistence of treatments with a growing efficacy of treatments, in particular in elderly populations. A recent study conducted by our team showed that, in out-patient setting, 2.7% of co-prescriptions contains medications at RoDI of high degree of severity (object of a contra-indication or non-recommended). Up today, there is no French experience concerning the identification of RoDI among the prescriptions performed at the end of a hospitalisation. In France, the recent development of hospital data warehouses is a huge opportunity to develop a system that can identify efficiently co-prescriptions at RoDI and provide feedback directly to prescribers in order to reduce their frequency in hospital context. The primary objective of this study is to evaluate the capacity of a system, called PRoSIT system, to automatically identify the RoDI of high level of severity at hospital discharge.
Read the detailed description
This is a national multicentre study structured in three phases.
- Phase 1. Development of the PRoSIT tool and interface. The PRoSIT tool will identify all the drugs listed in the hospital discharge prescriptions and will automatically search for IMPs, through the thesaurus of interaction of the French Agency of Drug Safety. The PRoSIT interface will allow navigation from aggregated information to source documents. This module will include a never event alert system, will be updated daily, and will be available on demand for the prescribers and referent pharmacists.
- Phase 2. Evaluation of the PRoSIT system performance. This phase will validate the ability of the PRoSIT tool to identify severe IMPs among the drugs listed in the hospital discharge prescriptions. The performance of the PRoSIT system will be evaluated in comparison to a gold standard based of experts opinion of a representative sample of hospital discharge prescriptions in patients aged 65 years or over, hospitalized or seen in consultations in the centres of cardiology, internal medicine or neurology of three University Hospitals (Bordeaux, Rennes and HEGP).
- Phase 3. Impact of PRoSIT on the care organization. Once validated, the PRoSIT tool will be used and evaluated at Bordeaux University Hospital. Its use will be accompanied by a presentation to users (clinicians and hospital pharmacists) as well as though regular feedbacks. A qualitative analysis will allow evaluation of the appropriation of the PRoSIT system and its impact on the organization of care. Semi-structured interviews with practitioners and pharmacists, and a series of observations of the PRoSIT feedback will be conducted, in order to measure the collective dimension of the observed changes in practices.
- Conditions
- Drug Interaction
- Being tested
- Discharge Prescription
- Keywords
- drug-drug interactions, hospital data warehouse, pharmaco-informatics, feedbacks, language processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge PrescriptionOther
All hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions of the Bordeaux and Rennes University Hospital and Georges Pompidou European Hospital will be recorded between June 1, 2018 and June 1, 2019.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | A total of 5 676 hospital discharge prescriptions, defined as the list of medications prescribed at discharge from hospital or after a hospital visit, whether new or renewed, will be selected. Receives: Other: Discharge Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of automatic identification of co-prescription at Risk of Drug Interactions (RoDI)
Thanks to PRoSIT tool and interface development. The PRoSIT tool will identify all the drugs listed in the hospital discharge prescriptions and will automatically search for IMPs, through the thesaurus of interaction of the French Agency of Drug Safety.
Measured: 36 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start13 May 2024
- Primary completion31 Dec 2024
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 5,769 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Synapse bv
- Responsible party
- Sponsor
- Investigators
- Francesco SALVO, Pr, Principal investigator, University Hospital, BordeauxFlorence FRANCIS, Dr, Study chair, USMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463576
- Sponsor's protocol ID
- CHUBX 2019/62
- Acronym
- PROSIT
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2020
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validation and Impact of an Automatic Identification of Co-Prescription at Risk of Interactions in the Hospital Information System. The PRoSIT System.
- ClinicalTrials.gov ID
- NCT04463576
- Acronym / sponsor ID
- PROSIT / CHUBX 2019/62
- Conditions
- Drug Interaction
- Keywords
- drug-drug interactions, hospital data warehouse, pharmaco-informatics, feedbacks, language processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,769 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Synapse bv
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 9 Jul 2020 (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.
The French Public Health strategy 2018-2022 aims to reduce inappropriate prescriptions, as potentially dangerous for individuals and collectively. The reduction of co-prescriptions at Risk of Drug Interactions (RoDI) could decrease the prevalence of iatrogenic diseases, and increase the persistence of treatments with a growing efficacy of treatments, in particular in elderly populations. A recent study conducted by our team showed that, in out-patient setting, 2.7% of co-prescriptions contains medications at RoDI of high degree of severity (object of a contra-indication or non-recommended). Up today, there is no French experience concerning the identification of RoDI among the prescriptions performed at the end of a hospitalisation. In France, the recent development of hospital data warehouses is a huge opportunity to develop a system that can identify efficiently co-prescriptions at RoDI and provide feedback directly to prescribers in order to reduce their frequency in hospital context. The primary objective of this study is to evaluate the capacity of a system, called PRoSIT system, to automatically identify the RoDI of high level of severity at hospital discharge.
Detailed description
This is a national multicentre study structured in three phases.
- Phase 1. Development of the PRoSIT tool and interface. The PRoSIT tool will identify all the drugs listed in the hospital discharge prescriptions and will automatically search for IMPs, through the thesaurus of interaction of the French Agency of Drug Safety. The PRoSIT interface will allow navigation from aggregated information to source documents. This module will include a never event alert system, will be updated daily, and will be available on demand for the prescribers and referent pharmacists.
- Phase 2. Evaluation of the PRoSIT system performance. This phase will validate the ability of the PRoSIT tool to identify severe IMPs among the drugs listed in the hospital discharge prescriptions. The performance of the PRoSIT system will be evaluated in comparison to a gold standard based of experts opinion of a representative sample of hospital discharge prescriptions in patients aged 65 years or over, hospitalized or seen in consultations in the centres of cardiology, internal medicine or neurology of three University Hospitals (Bordeaux, Rennes and HEGP).
- Phase 3. Impact of PRoSIT on the care organization. Once validated, the PRoSIT tool will be used and evaluated at Bordeaux University Hospital. Its use will be accompanied by a presentation to users (clinicians and hospital pharmacists) as well as though regular feedbacks. A qualitative analysis will allow evaluation of the appropriation of the PRoSIT system and its impact on the organization of care. Semi-structured interviews with practitioners and pharmacists, and a series of observations of the PRoSIT feedback will be conducted, in order to measure the collective dimension of the observed changes in practices.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Discharge PrescriptionA total of 5 676 hospital discharge prescriptions, defined as the list of medications prescribed at discharge from hospital or after a hospital visit, whether new or renewed, will be selected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 65 years or older AND in the cardiology, internal medicine and neurology departments of University Hospital of Bordeaux, University Hospital of Rennes, and Georges Pompidou European Hospital recorded between June 1, 2018 and June 1, 2019.
Key inclusion criteria (3 listed)
- A total of 5 676 hospital discharge prescriptions, defined as the list of medications prescribed at discharge from hospital or after a hospital visit, whether new or renewed, will be selected if they concern: patients aged 65 years or older AND in the cardiology, internal medicine and neurology departments of University Hospital of Bordeaux, University Hospital of Rennes, and Georges Pompidou European Hospital recorded between June 1, 2018 and June 1, 2019.
- For the evaluation of the determinants of acceptability and effectiveness of the intervention: a group of 18 hospital practitioners and three hospital pharmacists from the concerned departments of Bordeaux University Hospital will be included.
- For phase 3, all hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions only of the Bordeaux University Hospital will be used to analyse the impact of the feedback.
Key exclusion criteria (1 listed)
- Hospital discharge prescriptions not corresponding to inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge PrescriptionAll hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions of the Bordeaux and Rennes University Hospital and Georges Pompidou European Hospital will be recorded between June 1, 2018 and June 1, 2019. | Other | Experimental |
Primary outcome
Sensitivity of automatic identification of co-prescription at Risk of Drug Interactions (RoDI)
Time frame: 36 months after inclusion
Thanks to PRoSIT tool and interface development. The PRoSIT tool will identify all the drugs listed in the hospital discharge prescriptions and will automatically search for IMPs, through the thesaurus of interaction of the French Agency of Drug Safety.
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 15 Jan 2026.
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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.
Francesco SALVO, Pr principal investigator
University Hospital, Bordeaux
Florence FRANCIS, Dr study chair
USMR
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 Drug Interaction, run by University Hospital, Bordeaux 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 3 inclusion and 1 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 15 Jan 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?
Sensitivity of automatic identification of co-prescription at Risk of Drug Interactions (RoDI) (time frame: 36 months after inclusion). 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 15 Jan 2026.