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

NCT07278609 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-12-12

No results posted yet for this study

Summary

People with rheumatic conditions often take many medications, but more pills can increase the risk of side effects, especially in older adults. Some drugs (such as those intended to help pain or sleep) may cause more harm than good in the long term, and others may simply be no longer needed. These are known as 'potentially inappropriate medications' (PIMs).

This quality improvement study focuses on people with rheumatic conditions aged 60 and over who take 5 or more daily medications. The goal of the study is to learn if a publicly available physician tool, MedSafer, combined with educational brochures (for patients), can help to reduce PIMs in this group.

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 'bundle':

* MedSafer reports provided to treating physicians
* EMPOWER consumer brochures provided to patients

Participants will be followed over 4 study visits (for 14-18 months) during which researchers will collect information on medication changes and serious adverse events (emergency visits or hospitalizations) and will complete questionnaires measuring quality of life.

Conditions

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

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

Sponsors & Collaborators

  • The Arthritis Society, Canada

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Arielle Mendel, MD MSc · RI-MUHC/MUHC

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278609 on ClinicalTrials.gov