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RECRUITING
NCT07278609

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

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-10-29

Completion Date

2028-06-30

Last Updated

2026-05-01

Healthy Volunteers

No

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

Locations (1)

Montreal General Hospital, McGill University Health Centre

Montreal, Quebec, Canada