The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PIM deprescribing
研究概览
简要总结
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.
详细描述
OBJECTIVES AND PURPOSE The primary objective is to evaluate the effectiveness of provider-facing MedSafer reports, combined with patient-facing educational brochures, for deprescribing PIMs in adults aged ≥60 with rheumatic diseases who have polypharmacy (taking 5 or more regular medications).
HYPOTHESIS MedSafer reports combined with consumer-facing brochures could safely increase PIM deprescription above usual care, improving medication appropriateness.
STUDY DESIGN AND SETTING Prospective before-and-after quality improvement quasi-experimental study within the outpatient rheumatology clinic at the Montreal General Hospital, McGill University Health Centre (MUHC), Montreal, Canada. All participants will be followed during 'control' and 'intervention' periods, and all participants will receive the intervention, acting as their own control.
DESCRIPTION OF INTERVENTION
- Physician-oriented individualized deprescribing opportunity reports are created for each patient within MedSafer by cross referencing a patients' medical conditions and medications (https://www.medsafer.org/public). Deprescribing opportunities are categorized as "high risk" for adverse drug events if the drug is continued, "intermediate risk" (harms must be weighted against the benefits) and "low risk" for harm (but with little to no added value to continue). Specific tapering instructions, including for sedative hypnotic medications, are provided to complement deprescribing reports. Deprescribing decisions remain at the treating physicians' discretion, and no physician will be obligated to act on a deprescribing suggestion.
- Patient-oriented educational material, available to the public for routine use (https://www.deprescribingnetwork.ca/patient-handouts).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to provide informed consent
- •Acute life-threatening illness or life expectancy <12 months
研究组 & 干预措施
All participants
Each participant will serve as their own control and will be followed during control and intervention periods of the study
干预措施: MedSafer deprescribing opportunity reports, EMPOWER brochures (Behavioral)
结局指标
主要结局
PIM deprescribing
时间窗: Measured at 4 months (+/- 4 weeks) after the index control and index intervention visits
The proportion with ≥1 PIM deprescribed (stopped, switched to a safer class, significantly dose-reduced) during the control period compared with the intervention period.
次要结局
- 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)
研究者
Arielle Mendel
Assistant Professor/Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre