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PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis
Sponsor: Nantes University Hospital
Summary
This study evaluates a Clinical Decision Support System (CDSS), named PRIMUS, designed to support therapeutic decision-making in MS. The CDSS is based on a validated reference database integrating retrospective data from randomized controlled trials and the French national MS cohort (Observatoire Français de la Sclérose en Plaques, OFSEP). This reference database consists of synthetic data derived from these sources. PRIMUS enables visualization of disease activity at 1 and 2 years under different therapeutic scenarios, based on clinical and MRI characteristics of patients similar to the patient of interest. The CDSS PRIMUS aims to support informed and individualized treatment decisions. Because MRI is a critical marker of disease activity previously acquired MRI scans will be reanalyzed using automated segmentation and validated by a radiologist to standardize lesion assessment across centers. The results will be displayed to the neurologist and, if appropriate shown to the patient using a dedicated viewer, and can be discussed during the consultation. A cluster-randomized controlled trial, with hospitals as the unit, will be conducted to evaluate the impact of the CDSS on treatment decision-making in patients with relapsing-remitting MS. The primary objective is to assess whether the use of the CDSS influences therapeutic choices during clinical consultations. The study hypothesis is that use of the CDSS will increase the proportion of high-efficacy treatments initiated or selected, compared with usual care without CDSS support. In parallel, an optional sub-study using a mixed-methods approach will explore clinicians' and patients' perceptions of, and interactions with, the CDSS.
Official title: PRIMUS a Multi-centre, Controlled, Cluster-randomised, Open Study of Multiple Impacts of CDSS Use in Multiple Sclerosis : Real World Usage for Real World Evidence
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
448
Start Date
2026-06-30
Completion Date
2028-07-31
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
Clinical decision support system
The Clinical Decision Support System (CDSS) PRIMUS is a software (as medical device) designed to support therapeutic decisions in multiple sclerosis (MS) and assist clinicians during consultations in which initiation or modification of MS treatment is considered. The system uses retrospective clinical and MRI data from a reference database to generate visualizations of disease evolution over a 2-year period under different therapeutic scenarios, based on patient-specific characteristics entered by the clinician. PRIMUS does not make treatment recommendations and does not replace clinical judgment. All treatment decisions remain at the discretion of the clinician
Locations (31)
Angers Hospital
Angers, France
Antibes Hospital
Antibes, France
Bordeaux Hospital
Bordeaux, France
CHU Brest
Brest, France
Caen Hospital
Caen, France
Clermont-Ferrand Hospital
Clermont-Ferrand, France
CHU Colmar
Colmar, France
Hôpital Henri Mondor
Créteil, France
Dijon Hospital
Dijon, France
Hôpital Emile Durkheim Epinal
Épinal, France
Grenoble Alpes Hospital
Grenoble, France
CHD Vendee
La Roche-sur-Yon, France
Lille Hospital
Lille, France
Hospices civils de Lyon
Lyon, France
Marseille Hospital / La Timone
Marseille, France
CHR Metz-Thionville / Mercy Hospital
Metz, France
Montpellier Hospital
Montpellier, France
Nancy Hospital
Nancy, France
Nice Hospital
Nice, France
Nimes Hospital
Nîmes, France
Hopital Fondation ROTSCHILD
Paris, France
CHIC Poissy
Poissy, France
Poitiers Hospital
Poitiers, France
Rennes Hospital
Rennes, France
Rouen Hospital
Rouen, France
Saint-Brieuc Hospital
Saint-Brieuc, France
Groupement Hospitalier Rance Emeraude Saint Malo
St-Malo, France
Strasbourg Hospital
Strasbourg, France
Toulouse Hospital
Toulouse, France
tours Hospital
Tours, France
Groupement Hospitalier Brocéliande Atlantique Vannes
Vannes, France