Reducing unnecessary medications in older adults with rheumatic conditions
The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions
This project will test whether giving doctors individualized MedSafer reports plus patient EMPOWER brochures helps people 60+ with rheumatic conditions who take five or more regular medications stop or reduce risky medicines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07278609 on ClinicalTrials.gov |
What this trial studies
This prospective before-and-after quality improvement study will enroll adults aged 60 and older with rheumatic conditions and polypharmacy at the Montreal General Hospital rheumatology clinic. Each participant will act as their own control as researchers compare rates of deprescribing before and after introducing provider-facing MedSafer reports and patient-facing EMPOWER brochures. Participants will attend four visits over 18–20 months while investigators record medication changes, serious adverse events (emergency visits or hospitalizations), and quality of life. The intervention gives clinicians individualized deprescribing opportunities categorized by risk and provides patients with educational materials and tapering guidance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older followed in the MUHC rheumatology clinic for a rheumatic or musculoskeletal condition who take five or more regular medications and have at least one potentially inappropriate medication.
Not a fit: Patients with life expectancy under 12 months, those unable to consent, or those not taking five or more regular medications (or without any PIMs) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce potentially inappropriate medications, lower drug-related harms, and improve medication safety and quality of life for older adults with rheumatic disease.
How similar studies have performed: Prior deprescribing interventions and patient EMPOWER materials have shown benefit in older adults in other clinical settings, but combining MedSafer reports with EMPOWER brochures specifically in rheumatology is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec
- Montreal General Hospital, McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Arielle Mendel, MD MSc — Ri-Muhc/muhc
- Study coordinator: Arielle Mendel, MD MSc
- Email: arielle.mendel@mcgill.ca
- Phone: 5149341934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.