Bundled Hyperpolypharmacy Deprescribing: Implementation and Evaluation of a System-wide Quality Improvement Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,471
- 试验地点
- 1
- 主要终点
- Change in prevalence of geriatric syndrome
研究概览
简要总结
Older patients using many prescription drugs (hyperpolypharmacy) may be at increased risk of adverse drug effects. This randomized controlled trial tested the effectiveness and safety of a quality intervention intended to reduce hyperpolypharmacy. The study was set at Kaiser Permanente Northern California, an integrated health system with multiple pre-existing deprescribing workflows. Eligible patients were aged ≥76 years using ≥10 prescription medications. The intervention included physician-pharmacist collaborative drug therapy management, standard-of-care practice recommendations, shared decision-making, and deprescribing protocols administered by telephone over multiple cycles for a maximum of 180 days after allocation. A priori primary effectiveness endpoints included change in the number of medications and in the prevalence of geriatric syndrome from 181-365 days after allocation. Second endpoints included utilization and adverse drug withdrawal effects. Information was obtained from the electronic health record.
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
- 76 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kaiser Permanente patients
- •Age ≥76 years
- •≥10 drugs (excluding topicals) where
- •drug filled ≥2 times in the past year and
- •drug last filled < 180 days ago
排除标准
- •less than 12 months preceding enrollment at Kaiser Permanente
- •no primary care practitioner assigned
- •on dialysis
- •history of heart, liver, lung, breast, or bone marrow transplant
- •in hospice
- •under active treatment for cancer during the past 12 months
- •has received an intervention through the Pharmacy Targeted Deprescribing Program in the preceding year.
研究组 & 干预措施
Control
Eligible participants with physician authorization who are randomly assigned to usual care
Bundled hyperpolypharmacy intervention
Eligible participants with physician authorization who are randomly assigned to intervention
干预措施: Bundled hyperpolypharmacy (Other)
结局指标
主要结局
Change in prevalence of geriatric syndrome
时间窗: Difference between (days 181-365 after randomization) and (180 days before randomization)
Change in prevalence for any of the following: Falls (hip fracture, lower leg fracture, osteoporosis with fracture, pathologic fracture, osteonecrosis; gait; repeated falls; syncope; tripping; reduced mobility), Cognition (Somnolence; awareness; dizziness; malaise; Urinary incontinence (Unspecified urinary incontinence; retention of urine, unspecified; functional urinary incontinence; stress incontinence ; other specified urinary incontinence) and Pain (Drug induced headache; joint pain; muscle weakness, rhabdomyolysis, spas; myalgia)
Change in number of medications
时间窗: Difference between (days 181-365 after randomization) and (180 days before randomization)
Change in number of dispensed medications recorded in the comprehensive, integrated pharmacy information system
次要结局
- Utilization(Difference between (days 181-365 after randomization) and (180 days before randomization))
