RecruitingNCT07278609

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

100 participants

Start Date

Oct 29, 2025

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This quality improvement study aims to reduce the number of potentially inappropriate medications (PIMs) — drugs that may cause more harm than benefit in older adults — taken by people aged 60 and over with rheumatic conditions like rheumatoid arthritis or lupus who are on five or more regular medications. Doctors will receive personalized medication review reports through a tool called MedSafer, and patients will receive educational brochures explaining why certain drugs may no longer be appropriate, with the goal of safely stopping or reducing unnecessary medications. Adults aged 60 or older who are followed by a rheumatologist at the Montreal General Hospital, are on at least 5 medications including at least one potentially inappropriate one, and have regular follow-up every 3–9 months may be eligible. Participation involves four study visits over about 14–18 months, completing quality-of-life questionnaires, and a review of medication changes and any hospital visits. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMedSafer 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