The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions
McGill University Health Centre/Research Institute of the McGill University Health Centre
100 participants
Oct 29, 2025
OBSERVATIONAL
Conditions
Summary
People with rheumatic conditions often take many medications, but more pills can increase the risk of side effects, especially in older adults. Some drugs (such as those intended to help pain or sleep) may cause more harm than good in the long term, and others may simply be no longer needed. These are known as 'potentially inappropriate medications' (PIMs). This quality improvement study focuses on people with rheumatic conditions aged 60 and over who take 5 or more daily medications. The goal of the study is to learn if a publicly available physician tool, MedSafer, combined with educational brochures (for patients), can help to reduce PIMs in this group. 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 'bundle': * MedSafer reports provided to treating physicians * EMPOWER consumer brochures provided to patients Participants will be followed over 4 study visits (for 14-18 months) during which researchers will collect information on medication changes and serious adverse events (emergency visits or hospitalizations) and will complete questionnaires measuring quality of life.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- Unable to provide informed consent
- Acute life-threatening illness or life expectancy \<12 months
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07278609