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临床试验/NCT01739816
NCT01739816已完成不适用

Polymedication Check - Evaluation of the Impact of Community Pharmacy Based Medication Review on Medicines Use and Humanistic Outcomes

Kurt Hersberger2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2012年6月1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
发起方
入组人数
450
试验地点
2
主要终点
Medication possession ratio (MPR), gaps and persistence in medicines use

研究概览

简要总结

Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to patients on ≥4 prescribed drugs taken over ≥3 months.

Aims:

To evaluate first experiences shortly after implementation, missed pharmaceutical care issues and barriers to implementation on pharmacist's level as well as patient's acceptance through qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary Care and to evaluate economic, clinical and humanistic outcomes in a subsequent randomized controlled trial.

详细描述

Evaluating the newly implemented Swiss 'Polymedication-Check', a specialised medication review and screening for adherence issues, offers a large field of interesting research questions. Using the current PMC-Protocol as a structured interview guide, pharmacists are able to document their counselling on medication use issues and other drug related problems.

In a randomized-controlled trial we aim at analysing 800 recruited patients from 70 study pharmacies during seven months. Patients were recruited in the regions Basel, Aargau-Solothurn, Waadt in Switzerland and randomised using 1:1 block randomisation.

Primary outcome focuses on the improvement of adherence and persistence after 'Polymedication Check' (using medication possession ratio (MPR), gaps in medicines history records and patient's interviews).

Second outcomes are time to planned or unplanned consulting with a physician or hospitalisation, knowledge, safety of medicines use and patients management of polypharmacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • more than 3 drugs over at least 3 months prior to recruitment
  • german or french language (written and spoken)
  • medicines use in self management

排除标准

  • provision of Polymedication Check in the past
  • living in a nursing home
  • use of prefilled pill organiser or individually blistered medication

研究组 & 干预措施

Control group

No Intervention

Patients get no intervention at study start, but only at study end after seven months.

Intervention group

Active Comparator

At the beginning and at the end of the study, this group receives a pharmacist's led medication review focusing on daily medicines use (= Polymedication Check).

干预措施: Medication review (Behavioral)

Observational arm

Other

If participants after recruitment violate inclusion criteria (e.g. change from autonomous medication management to external home care) or insists on intervention despite being randomised to control group or patient condition forces pharmacist to provide a PMC.

干预措施: Medication review (Behavioral)

结局指标

主要结局

Medication possession ratio (MPR), gaps and persistence in medicines use

时间窗: Seven months after recruitment

Improvement of adherence seven months after 'Polymedication-Check' using medication possession ratio (MPR), gaps and persistence out of history records from community pharmacy.

次要结局

  • Patient knowledge about his medicines(After two weeks, four and seven months after recruitment)
  • Time to planned or unplanned consulting with a physician or hospitalisation(Seven months after recruitment)
  • Self reported adherence(At study start and two weeks, four and seven months after after recruitment)
  • Patients safety(After two weeks, four and seven months after recruitment)

研究者

发起方
Kurt Hersberger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kurt Hersberger

Professor

University Hospital, Basel, Switzerland

研究点 (2)

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