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临床试验/NCT05609981
NCT05609981已完成不适用

Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug

SIR Institute for Pharmacy Practice and Policy2 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2022年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
318
试验地点
2
主要终点
number of ceased or dose lowered drugs per patient

研究概览

简要总结

Overuse is common in frail older people with polypharmacy, especially in frail older users of multidose drug dispensing (MDD) systems. In this study, we will investigate the effect of a clinical medication review (CMR) with integration of deprescribing (toolbox) on the number of ceased and dose lowered medications (persistent after 6 months) compared to usual care in older users of MDD systems with hyperpolypharmacy.

We will perform a controlled cluster-randomized trial in 38 community pharmacies. Per pharmacy, 10 older patients (>= 75) with hyperpolyfpharmacy (>10 medicines in use) with a MDD will be included. Pharmacists will receive training to perform the intervention, a 5-step CMR with a deprescribing toolbox (including deprescribing protocols): 1) patient interview; 2) pharmacotherapeutic analysis; 3) pharmacist and GP discuss actions; 4) actions are discussed with patient; 5) (two)weekly follow-up.

详细描述

AIM: is to investigate the effect of a clinical medication review in combination with a toolbox about deprescribing.

STUDY DESIGN: a controlled cluster-randomized trial will be performed, in which participating pharmacists in the Netherlands will be randomized to conduct clinical medication reviews with 10 eligible patients (intervention) or to provide usual care (control).

STUDY POPULATION: hyperpolypharmacy (≥ 10 chronic drugs) older patients (≥75 years) using a multidose drug dispensing (MDD) system

INTERVENTION: the intervention at t=0 consists of a 5-step patient-centred CMR focuses on deprescribing supported by the toolbox developed in WP1. The CMR starts with a patient interview (step 1) by a community pharmacist focussing on patient's preferences with input from the questionnaires on healthproblems, frailty and patient wishes. After the pharmacotherapeutic analysis (step 2), the pharmacist and the GP discuss the identified patient preferences and possible actions, including deprescribing (step 3). When patients are treated for one of more disease by a hospital specialist, pharmacist or GP consults this physician when appropriate. The health care providers decide together with the patient which actions will be conducted and their priority. This will result in a pharmaceutical care plan taking into account the tapering schemes from the deprescribing protocols (step 4). All actions and deprescribing steps will be evaluated with the patient during at least two follow-up moments (or more according to the patient's needs) to monitor the results of the actions. The follow-up moments can be performed by nurse practitioners or GPs with consultation of the community pharmacist when needed, e.g. to adapt tapering schemes based on the patient's health problems or withdrawal symptoms (step 5).

CONTROL: usual care.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • using a multidose drug dispensing system
  • hyperpolypharmacy patient (using 10 drugs or more)
  • age: 75 years or older

排除标准

  • received a CMR in the previous 12 months
  • incapacitated
  • patients for whom the general practitioner is not the primary practionar
  • expected lifespan of less than six motnhs
  • patients who live in a nursing home

结局指标

主要结局

number of ceased or dose lowered drugs per patient

时间窗: 6 months after the start of the medication review (t = 6 months)

number of ceased or dose lowered drugs per patient based on dispensing data

次要结局

未报告次要终点

研究者

发起方
SIR Institute for Pharmacy Practice and Policy
申办方类型
Other
责任方
Sponsor

研究点 (2)

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