The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions
NCT07278609 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-05-01
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.
Conditions
- Rheumatic Diseases
- Inflammatory Arthritis
- Systemic Lupus Erthematosus (SLE)
- Vasculitis
- Muskuloskeletal Diseases
- Systemic Autoimmune Diseases
Interventions
- BEHAVIORAL
-
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
Sponsors & Collaborators
-
The Arthritis Society, Canada
collaborator OTHER -
McGill University Health Centre/Research Institute of the McGill University Health Centre
lead OTHER
Principal Investigators
-
Arielle Mendel, MD MSc · RI-MUHC/MUHC
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-29
- Primary Completion
- 2028-03-31
- Completion
- 2028-06-30
Countries
- Canada
Study Locations
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