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中国县级医院药师参与的用药重整评估研究方案:一项多中心、开放标签、评估者盲法、非随机对照研究。

Study protocol for the evaluation of pharmacist-participated medication reconciliation at county hospitals in China: a multicentre, open-label, assessor-blinded, non-randomised, controlled study.

作者信息

Yu Aichen, Wei Guilin, Chen Fanghui, Wang Zining, Fu Mengyuan, Wang Guoying, Wushouer Haishaerjiang, Li Xixi, Guan Xiaodong, Shi Luwen

机构信息

Department of Pharmacy Administration and Clinical Pharmacy, Peking University, Beijing, China.

Department of Pharmacy, The First Affiliated Hospital of Gannan Medical University, Jiangxi, China.

出版信息

BMJ Open. 2022 Mar 11;12(3):e053741. doi: 10.1136/bmjopen-2021-053741.

Abstract

INTRODUCTION

Pharmacist-participated medication reconciliation proved an effective strategy to decrease the risk of medication discrepancy-related errors. However, it is still under pilot in China and its effectiveness in the Chinese healthcare system remains unclear. This study aims to conduct a pharmacist-participated medication reconciliation intervention for elderly patients in county hospitals in China and to evaluate its effect.

METHODS AND ANALYSIS

This is a multicentre, prospective, open-label, assessor-blinded, cluster, non-randomised, controlled study for elderly patients. The study will be conducted in seven county hospitals, and the clusters will be hospital wards. In each hospital, two internal medicine wards will be randomly allocated into either intervention group or control group. Patients in the intervention group will receive pharmacist-participated medication reconciliation, and those in the control group will receive standard care. The primary outcome is the incidence of medication discrepancy, and the secondary outcomes are patients' medication adherence, healthcare utilisation and medical costs within 30 days after discharge.

ETHICS AND DISSEMINATION

Ethics committee approval of this study was obtained from Peking University Institution Review Board (IRB00001052-21016). We have also obtained ethical approvals from all the participating centres. The findings will be published in scientific and conference presentations.

TRAIL REGISTRATION NUMBER

ChiCTR2100045668.

摘要

引言

药师参与的用药核对被证明是一种降低用药差异相关错误风险的有效策略。然而,在中国其仍处于试点阶段,在我国医疗体系中的有效性尚不清楚。本研究旨在对我国县级医院的老年患者实施药师参与的用药核对干预并评估其效果。

方法与分析

这是一项针对老年患者的多中心、前瞻性、开放标签、评估者盲法、整群、非随机对照研究。研究将在7家县级医院开展,整群为医院病房。在每家医院,两个内科病房将被随机分配到干预组或对照组。干预组患者将接受药师参与的用药核对,对照组患者将接受标准护理。主要结局是用药差异的发生率,次要结局是患者出院后30天内的用药依从性、医疗服务利用情况和医疗费用。

伦理与传播

本研究已获得北京大学机构审查委员会(IRB00001052 - 21016)的伦理委员会批准。我们也已获得所有参与中心的伦理批准。研究结果将发表在科学期刊及会议报告中。

试验注册号

ChiCTR2100045668。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d729/8919460/68554922cbe6/bmjopen-2021-053741f01.jpg

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