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

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT07278609
Status
Recruiting
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Conditions

  • Inflammatory Arthritis
  • Muskuloskeletal Diseases
  • Rheumatic Diseases
  • Systemic Autoimmune Diseases
  • Systemic Lupus Erthematosus (SLE)
  • Vasculitis

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MedSafer deprescribing opportunity reports, EMPOWER brochures — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: All participants
    Each participant will serve as their own control and will be followed during control and intervention periods of the study

Primary Outcome Measure

PIM deprescribing [ Time Frame: Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits ]

Central Contacts

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