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.
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
Unable to provide informed consent
Acute life-threatening illness or life expectancy <12 months
Participants will be recruited from patients attending usual follow-up care for chronic rheumatic diseases at the McGill University Health Centre
Cohort
Prospective
MedSafer deprescribing opportunity reports, EMPOWER brochures
Behavioral1. 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
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.
Total number of regular medications
Change in median total number of regular medications taken during the control and intervention periods
EQ-5D-5L (quality of life)
Proportion with stable or improved EQ-5D-5L and VAS scores during the control and intervention periods
Serious adverse events (SAE)
Any unplanned emergency department visit, hospitalization, or death
Serious adverse drug withdrawal events (ADWE)
Any SAE attributed to deprescribing a PIM, adjudicated by two independent reviewers, blinded to intervention exposure period, using the Leape and Bates Likert scale. In the primary analysis, scores of 5 or 6 (probably or definitely caused by withdrawing a medication) will define ADWEs. A third blinded reviewer will resolve discordant rankings.
Medication re-prescribing
Proportion of medication re-escalation or re-initiation following deprescribing during control and intervention periods
Click on the lead sponsor to view all of their trials.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
The Arthritis Society, Canada
Collaborator
