Drug Interactions in Hospital Information System. The PRoSIT System..

NCT04463576 | Completed

• 1 other identifier: CHUBX 2019/62
• Study Type: observational
• Target: 5,769
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Drug Interaction

Keywords

drug-drug interactions; hospital data warehouse; pharmaco-informatics; feedbacks; language processing

Outcome Measures

Primary Outcomes (1)

• 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.

  36 months after inclusion

Study Arms (1)

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.

Other: Discharge Prescription

Interventions

Discharge Prescription OTHER

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Synapse bv: collaborator

Study Sites (1)

Hopital Pellegrin

Bordeaux, 33000, France

Location

Study Officials

• Francesco SALVO, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Florence FRANCIS, Dr

  USMR

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: May 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: November 25, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)