跳至主要内容
临床试验/NCT05929417
NCT05929417招募中不适用

Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Pharmacists' adherence to the intervention

研究概览

简要总结

The goal of this feasibility study is to evaluate the feasibility of an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. The main questions it aims to answer are:

  • To what extent will Belgian community pharmacists adhere to the intervention?
  • To what extent will patients and general practitioners take up the intervention to deprescribe benzodiazepines and z-drugs?
  • To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants?

Participants will receive an educational brochure from their pharmacist. Their pharmacist will also propose to send a new standardized form to their general practitioner to enhance collaboration about a potential benzodiazepine deprescribing.

Researchers will compare this intervention to usual care to see if the intervention is feasible and to gather first data on intervention effectiveness in benzodiazepine deprescribing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • being aged ≥65 years,
  • taking a benzodiazepine receptor agonist for ≥4 weeks (Anatomical Therapeutic Chemical codes: N05BA, N05CD, N05CF and N03AE01)
  • being a regular patient of the community pharmacy (defined as ≥ 4 visits/12 previous months).

排除标准

  • Severe mental illness (assessed through having an active prescription of any antipsychotic medication).
  • Dementia or significant cognitive impairment (assessed through an active prescription or any past prescription during the last 12 months of anticholinesterase inhibitors or memantine) and/or pharmacist's judgment).
  • Patients unable to read or communicate in French.
  • Ongoing benzodiazepine receptor agonist withdrawal at the time of recruitment.
  • Known current alcohol withdrawal.

结局指标

主要结局

Pharmacists' adherence to the intervention

时间窗: At 6 months

Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)

Feasibility of the data collection process

时间窗: At 6 months

The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).

Participants' responsiveness

时间窗: At 6 months

How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).

Feasibility of the recruitment process

时间窗: At 6 months

The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).

次要结局

  • Mechanisms of impact potentially influencing the intervention(At 6 months)
  • Contextual factors potentially influencing the intervention effects at the patient-level.(At baseline)
  • Contextual factors potentially influencing the intervention effects at the pharmacist-level.(At baseline)
  • Exploratory benzodiazepine deprescribing rate analysis(At 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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