Recruiting

MedSafer & EMPOWER

Sponsor:

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

Code:

NCT07278609

Conditions

Rheumatic Diseases

Inflammatory Arthritis

Systemic Lupus Erthematosus (SLE)

Vasculitis

Muskuloskeletal Diseases

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

MedSafer deprescribing opportunity reports, EMPOWER brochures

Study Details

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)

Vasculitis

Muskuloskeletal Diseases

Study ID

NCT07278609

Start date

Oct 29, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

All participants

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Arielle Mendel, MD MSc

5149341934arielle.mendel@mcgill.ca

Jeannette Bere, BSc, LPN

jeannette.bere@rimuhc.ca

Locations

Montreal General Hospital, McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G1A4

Contacts

Arielle Mendel, MD MSc

514-934-1934arielle.mendel@mcgill.ca

Jeannette Bere, BSc

jeannette.bere@rimuhc.ca

Principal Investigator:

Arielle Mendel, MD MSc

More Information

Sponsor

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

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Deprescribing
  • Potentially inappropriate medications
  • Rheumatic Diseases
  • Polypharmacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-05-01.