Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 503
- 主要终点
- Number of patients with medications discontinued, reduced dose or changed.
研究概览
简要总结
Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized.
Design: randomized, open, multicenter and two branches of parallel intervention clinical trial.
Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Control intervention: usual procedure.
Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP consultations, hospital emergency department and hospital admissions for acute illness, c) pharmaceutical expenditure, d) restart medication e) complications underlying diseases. Follow-up control at 1 month (security) and at 3, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years or more
- •Currently receiving eight or more drugs, except ointments and administered via topical nonprescription
- •Give their informed written consent to participate in the study.
排除标准
- •Estimated life expectancy less than 6 months.
- •Active cancer
- •Participation in any other clinical trial or program for evaluation of medication in the elderly.
- •Institutionalized in nursing homes.
- •Surgical intervention scheduled for the next 6 months
结局指标
主要结局
Number of patients with medications discontinued, reduced dose or changed.
时间窗: baseline, 3, 6 and 12 months
Number of discontinued medications, changed or changing doses.
时间窗: baseline, 3, 6 and 12 months
次要结局
- Pharmaceutical recommendations acceptance rate(baseline)
- Quality of life(baseline, 3 and 6 months)
- Resumption of medication(3, 6 and 12 months)
- Medication adherence(baseline, 3 and 6 months)
- Healthcare resource consumption(3, 6 and 12 months)
- Mortality(3, 6 and 12 months)