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Clinical Trials in Canada / NCT07278609
Recruiting Observational

The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions

NCT07278609 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2025-10-29
Last updated
2026-05-01

Condition(s) studied

Rheumatic DiseasesInflammatory ArthritisSystemic Lupus Erthematosus (SLE)VasculitisMuskuloskeletal DiseasesSystemic Autoimmune Diseases

Investigational drug(s) / intervention(s)

MedSafer deprescribing opportunity reports, EMPOWER brochures

MedSafer deprescribing opportunity reports, EMPOWER brochures: 1. Deprescribing opportunity reports: The MedSafer software generates reports by applying embedded "rules" to medication lists, reflecting best practice recommendations. Deprescribing "opportunities" are classified into high risk (for adverse drug events), intermediate risk (harms must be weighed against benefits), and low risk for harm (but with no added value to continue). Reports include the rationale for deprescribing, tapering instructions, or safer drug alternatives (if relevant), and are provided to clinicians at the point-of-care. 2. Patient-oriented educational material: 1. Deprescribing fact sheet (all participants) 2. Consumer-facing bilingual 'EMPOWER' educational brochures for specific PIMs (e.g., gabapentinoids, proton pump inhibitors, benzodiazepines) if applicable

Study summary

The goal of this prospective observational quality improvement study is to determine if a physician tool, MedSafer, combined with educational brochures for patients, can help to reduce the use of 'potentially inappropriate medications' (PIMs) in adults aged 60 and over with rheumatic conditions and polypharmacy (taking 5 or more regular medications).

Researchers will follow participants during usual rheumatic disease care. They will compare the rate of PIM deprescribing (stopping medications or reducing the dose) before and after the introduction of the following interventions:

* MedSafer reports provided to treating physicians
* EMPOWER consumer brochures provided to participants

Participants will complete 4 study visits over 18-20 months during which researchers will collect information on medication changes, serious adverse events (emergency visits or hospitalizations), and quality of life.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged ≥60 * Followed by a rheumatologist at MUHC for an inflammatory arthritis (such as rheumatoid arthritis, psoriatic arthritis, spondyloarthritis), a systemic autoimmune rheumatic disease (such as systemic lupus erythematosus, inflammatory myositis, systemic sclerosis, antiphospholipid antibody syndrome, Sjogren syndrome, systemic vasculitis), or another chronic musculoskeletal or rheumatic condition (such as crystal arthritis and osteoarthritis) * Currently taking ≥5 regular medications and ≥1 PIM * Anticipated ongoing clinical follow-up in rheumatology at an interval of every 3-9 months Exclusion Criteria: * Unable to provide informed consent * Acute life-threatening illness or life expectancy \<12 months

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Montreal General Hospital, McGill University Health Centre Montreal Quebec Recruiting

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07278609 on ClinicalTrials.gov ↗ ← All trials in Canada