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

NCT07278609 | Recruiting

• 1 other identifier: 2026-11257
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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); Muskuloskeletal Diseases; Systemic Autoimmune Diseases; Vasculitis

Keywords

Deprescribing; Potentially inappropriate medications; Rheumatic Diseases; Polypharmacy

Outcome Measures

Primary Outcomes (1)

• PIM deprescribing

  The proportion with ≥1 PIM deprescribed (stopped, switched to a safer class, significantly dose-reduced) during the control period compared with the intervention period.

  Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits

Secondary Outcomes (4)

• Total number of regular medications

  Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits

• EQ-5D-5L (quality of life)

  Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits

• Serious adverse events (SAE)

  Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits

• Serious adverse drug withdrawal events (ADWE)

  Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits

Other Outcomes (1)

• Medication re-prescribing

  Measured at 4 months (+/-4 weeks) after the index control and index intervention visits

Study Arms (1)

All participants

Each participant will serve as their own control and will be followed during control and intervention periods of the study

Behavioral: MedSafer deprescribing opportunity reports, EMPOWER brochures

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

All participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from patients attending usual follow-up care for chronic rheumatic diseases at the McGill University Health Centre

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent
• Acute life-threatening illness or life expectancy \<12 months

Sponsors & Collaborators

• The Arthritis Society, Canada: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital, McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases; Arthritis; Vasculitis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arielle Mendel, MD MSc

  RI-MUHC/MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arielle Mendel, MD MSc

CONTACT

5149341934; arielle.mendel@mcgill.ca

Jeannette Bere, BSc, LPN

CONTACT

jeannette.bere@rimuhc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)