Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 697
- 试验地点
- 2
- 主要终点
- Number of patients hospitalised
研究概览
简要总结
In patients aged 65 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy may be a source of iatrogeny due to pharmacokinetic interactions, enhanced sensitivity of older people to medication, or failure to adhere to the therapy. Since January 2018, French community pharmacists have been allowed by the Health ministry to perform medication reviews for people aged 65 years and over, who are being treated with more than 5 medications a day. the present hypothesis is that medication therapy management performed in collaboration with patients, general practitioners, and community pharmacists will lead to a reduction in medical events and inappropriate prescriptions.
详细描述
This is a stepped-wedge cluster randomised controlled trial conducted in 9 regions of France. Each region represents one cluster with 7 community pharmacies located around the University Hospital associated with that cluster. In total, 63 community pharmacies will be enrolled, with each pharmacy including 20 patients over a 10 month-period. Over the life-time of the project, a total of 1260 patients will benefit from either the intervention or from a controlled pharmaceutical care according to the period of time they will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 65 or older suffering from long-term illness
- •Patient aged 75 or older
- •Living at home
- •Having 5 medications or more per day for more than 6 months
- •Being a regular patient of the community pharmacy involved in the study
- •General practitioner of the patient agrees to participate to the study
- •Patient being mentally and physically able to decide on his own to participate in the study
- •Patient available by phone throughout the study
排除标准
- •Patient refuses to participate
- •Patient without a family doctor
- •Patient whose family doctor refuses to participate in the study
- •Patient who does not understand French, or dependant on someone else to manage his medication
- •Resident of a nursing home
- •Patient placed under guardianship
- •Uncertainty of the pharmacist about patient reliability
- •Patient having benefited from a medication review in the previous 12 months
- •Patient already included in another study
结局指标
主要结局
Number of patients hospitalised
时间窗: Month 12
Number of patients hospitalised for more or less than 24 hours, including emergency department transfers during a 12 month-period follow-up.
次要结局
- Girerd compliance test score(Month 12)
- Number of patients hospitalised (only non-scheduled hospitalisations)(Month 12)
- Mean number of medications per patient(Month 12)
- Medication regimen complexity index(Month 12)
- Quality of life measured with the EuroQol Group 5-level EQ-5D version(Month 12)
- Existence of at least one potentially inappropriate drug per patient(Month 12)
- Differential cost ratio(Month 12)
- Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention(Month 2)