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临床试验/NCT05616689
NCT05616689已完成不适用

Bundled Hyperpolypharmacy Deprescribing: Implementation and Evaluation of a System-wide Quality Improvement Intervention

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 2,471 人开始时间: 2020年10月19日最近更新:
适应症
干预措施

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

No Intervention

Eligible participants with physician authorization who are randomly assigned to usual care

Bundled hyperpolypharmacy intervention

Experimental

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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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