Relapsing - Remitting Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, CDSS
Brief 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.
Interventions
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
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study uses a cluster-randomized design with hospital (where the patient receives MS care) as cluster. Each center will be randomly allocated in a 1:1 ratio to experimental group (using CDSS/ use of the CDSS during the consultation), control group (receive usual care).The study is conducted in an open-label manner, with both patients and treating physicians aware of CDSS use.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged \>18 and ≤50 years. * Patients with relapsing-remitting multiple sclerosis (RRMS) according to the McDonald 2024 criteria. * Patients for whom a change in therapeutic management is being considered due to: * intolerance to treatment or personal preference in the absence of inflammatory activity, whether patients are: * on a moderately effective disease-modifying therapy \[Interferon beta; Glatiramer acetate; Teriflunomide; Dimethyl fumarate; Diroximel fumarate\] for at least 12 months without interruption * on anti-S1P therapy \[Fingolimod; Ponesimod\] for at least 12 months without interruption or * recent inflammatory activity (relapse or at least one T1 Gd+ lesion or one new T2 lesion) reported or observed at inclusion, whether patients are: * treatment-naïve * on a moderately effective disease-modifying therapy for at least 6 months or on anti-S1P therapy for at least 6 months * untreated for at least one year * Patients with MRI follow-up including at least one 3D brain FLAIR sequence and a T1 Gd+ sequence in the case of a re-baseline brain MRI within the past 6 months. * Patients whose MRI scans are available for download on the day of consultation. * Patients affiliated with or beneficiaries of a social security system. * Patients able to provide written informed consent. For women of childbearing potential, use of an effective method of contraception throughout the study in accordance with the recommendations of the Clinical Trials Coordination Group
Exclusion criteria
* Patients with a progressive form of multiple sclerosis (primary or secondary). * Patients with current or past history of other autoimmune diseases. * Patients with uncontrolled disease, other than active MS. * Patients exposed to Mitoxantrone, Alemtuzumab, or Cladribine within the 3 years prior to inclusion. * Patients exposed to Ocrelizumab or Rituximab within the 18 months prior to inclusion. * Patients exposed to Ofatumumab within the 12 months prior to inclusion. * Patients receiving high-efficacy disease-modifying therapy \[Natalizumab; Ofatumumab; Alemtuzumab; Cladribine; Mitoxantrone; Ocrelizumab\], or Rituximab, with the exception of S1P receptor modulators. * Patients receiving Mycophenolate mofetil, azathioprine, cyclophosphamide (Endoxan), or having undergone stem cell transplantation. * Patients participating in another clinical trial, whether therapeutic or not, that could interfere with the objectives of the study. * Patients who have participated in a therapeutic trial within the 24 months prior to inclusion. * Pregnant or breastfeeding women, or those planning pregnancy during the study. * Patients under legal protection (guardianship, curatorship, or other protective measures).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment choice | once at Month 1 | Treatment decision at the end of the consultation with or without CDSS use. Patients will be classified into groups: high-efficacy disease-modifying therapies (anti-CD20 therapies, natalizumab, cladribine, S1P receptor modulators), moderate-efficacy therapies (interferon beta, dimethyl fumarate, teriflunomide), or no treatment. Results will be expressed as the percentage of patients in each category/ The distribution of treatment strategies will be expressed as the percentage of patients in each category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment decision concordance with expert recommendation | Month 1 | Assessment of concordance defined as agreement (Yes/no) between the treatment decision made by the neurologist at the end of the consultation (Month 1, with or without CDSS use) and the treatment decision recommended by an independent expert panel of experts. |
| Patient Adherence: Concordance Between Prescribed and Actual Treatment | Month 10, last visit | Assessment of concordance (yes/no) between the treatment decision made by the neurologist at the end of the consultation (Month 1, with or without CDSS use) and the treatment actually taken by the patient at Month 10. |
| Treatment Decision Concordance with Dynamic Score Recommendation | Month 1 | Assessment of concordance defined as agreement (yes/no) between the treatment decision made by the neurologist at the end of the consultation (M1, with or without CDSS use) and recommendations derived from a dynamic scoring system designed to guide early switching from first-line to second-line disease-modifying therapy in patients with relapsing-remitting MS.For this outcome measure, results will be reported as the proportion of participants whose treatment decision is concordant with the recommendation generated by the dynamic score (Yes/No).The dynamic score is based on predefined clinical and radiological criteria and identifies patients who may benefit from early treatment escalation to reduce the risk of relapse.The recommendation generated by the score (maintain first-line therapy or escalate to second-line therapy) will be compared to the neurologist's treatment decision.Concordance will be considered achieved if the neurologist's treatment decision matches the recommendations |
| Evolution of treatment decision | Month 1 | Assessment of concordance defined as agreement (yes/no) between the treatment decision initially considered by the neurologist at inclusion (Month 0) and the treatment decision made at the end of the consultation (Month 1, with or without CDSS use). This outcome evaluates whether the initial treatment strategy is maintained or modified between Month 0 and Month 1, including potential influence of CDSS use during the consultation |
| Cost-utility analysis of CDSS use | Month 0 to Month 10 | A cost-utility analysis will be conducted from a societal perspective over a 10-month period : at baseline (Month 0), Month 1, and Month 10 to evaluate the impact of CDSS use. Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five response levels. Utility index values range from values below 0 (health states worse than death) to 1 (perfect health), with higher scores indicating better health status. Costs related to multiple sclerosis care will be collected over the study period (M0-M10) using patient diaries. Quality-adjusted life years (QALYs) will be estimated from EQ-5D-5L utility values and combined with cost data to perform the cost-utility analysis. |
| Patient-Reported Outcomes: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score | Month 0 and Month 10 | Health-related quality of life will be assessed using validated patient-reported outcome (PRO) instrument : the Multiple Sclerosis-specific quality of life questionnaire (MusiQoL) at baseline (Month 0) and Month 10. The MusiQoL provides a disease-specific assessment of quality of life in multiple sclerosis. The MusiQoL global index score ranges from 0 to 100. Higher scores indicate better health-related quality of life. |
| Patient-Reported Outcomes: Health-Related Quality of life : 12-Item Short Form Health Survey (SF-12) Score | Month 0 and Month 10 | General health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12) at baseline (Month 0) and Month 10. It evaluates general health-related quality of life. The SF-12 generates Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores generally range from 0 to 100. Higher scores indicate better health-related quality of life. |
| Clinician-Reported Usability of the Clinical Decision Support System (CDSS) | Month 1 | In the CDSS arm only, patient experience will be assessed using a dedicated 10-item questionnaire administered after a consultation supported by the Clinical Decision Support System (CDSS) at Month 1. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating a better patient experience with the CDSS-supported consultation. |
| Patient experience with CDSS use Patient Experience with Clinical Decision Support System (CDSS) Use | Month 1 | In the CDSS arm only, patient experience will be assessed using a dedicated 10-item questionnaire administered after a consultation supported by the Clinical Decision Support System (CDSS) at Month 1. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating a better patient experience with the CDSS-supported consultation. |
| Neurologist Experience with MRI Viewer Use During Consultation | Month 1 | Neurologists' experience with MRI viewer use during consultation will be assessed in both study arms (with or without CDSS use). Experience will be assessed using a dedicated 10-item questionnaire rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating greater satisfaction and perceived usability of MRI visualization. All participating neurologists will complete the questionnaire. |
| Patient Experience with MRI Viewer Use During Consultation | Month 1 | Patient experience regarding MRI visualization using the viewer during neurological consultation will be assessed in both study arms. Experience will be assessed using a dedicated 10-item questionnaire rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating greater satisfaction and improved understanding of MRI information. All included patients will complete the questionnaire. |
| Consultation duration | Month 1 | Impact of the (CDSS) on the duration of the neurological consultation. Consultation duration will be defined as the time (in minutes) elapsed between the start and end of the consultation (in minutes) at Month 1, conducted either with or without CDSS support |
| Device reliability | Month 1 | Reliability of the Clinical Decision Support System (CDSS) will be assessed by recording the number of device-related issues occurring during the study period. These issues include system failures, software bugs, interface malfunctions, security issues, interpretation errors, performance degradation, and connectivity problems. All CDSS-related malfunctions or operational issues will be recorded |
Countries
France
Contacts
CONTACTDavid M LAPLAUD, Professor
CONTACTSelma Mrs EL ANDALOUSSI, Project Manager
Outcome results
None listed