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药物评估促进医疗衔接(MedBridge):一项实用型整群随机交叉试验的研究方案

Medication Reviews Bridging Healthcare (MedBridge): Study protocol for a pragmatic cluster-randomised crossover trial.

作者信息

Kempen Thomas G H, Bertilsson Maria, Lindner Karl-Johan, Sulku Johanna, Nielsen Elisabet I, Högberg Angelica, Vikerfors Tomas, Melhus Håkan, Gillespie Ulrika

机构信息

Pharmacy Department, Uppsala University Hospital, Ing.13 2 tr, 751 85 Uppsala, Sweden.

Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

出版信息

Contemp Clin Trials. 2017 Oct;61:126-132. doi: 10.1016/j.cct.2017.07.019. Epub 2017 Jul 21.

Abstract

BACKGROUND

Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.

AIM

To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.

DESIGN

Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.

SETTING

8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.

PARTICIPANTS

Patients aged 65years or older, admitted to one of the study wards.

EXCLUSION CRITERIA

Palliative stage; residing in other than the hospital's county; medication review within the last 30days; one-day admission.

INTERVENTIONS

1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care.

PRIMARY OUTCOME MEASURE

Incidence of unplanned hospital visits during a 12-month follow-up period.

DATA COLLECTION AND ANALYSES

Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using hierarchical models.

RELEVANCE

This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.

摘要

背景

老年人用药处方管理不善及用药不当给当前医疗体系带来了巨大压力。在住院期间进行药物评估,即对患者用药情况进行结构化的严格审查,并积极跟进至初级保健阶段,可优化治疗效果并将危害降至最低。然而,缺乏高质量证据阻碍了其广泛应用。本手稿描述了一项实用的整群随机交叉试验的基本原理和设计,以满足对证据的这一需求。

目的

研究与1)常规护理和2)仅基于医院的评估相比,由医院发起的包括积极跟进的全面药物评估对老年患者医疗保健利用的影响。

设计

多中心、三治疗组、重复、整群随机交叉试验。

设置

瑞典3个县4家医院内的8个配备多学科团队的病房。

参与者

年龄在65岁及以上、入住其中一个研究病房的患者。

排除标准

姑息治疗阶段;不住在医院所在县;在过去30天内进行过药物评估;住院一天。

干预措施

1,住院期间进行全面药物评估;2,与1相同,但增加对初级保健的积极跟进;3,常规护理。

主要结局指标

12个月随访期内计划外住院就诊的发生率。

数据收集与分析

从各县的病历系统提取并收集到符合GCP的电子数据采集系统中。使用分层模型进行意向性分析。

意义

本研究很有可能显示老年患者发病率降低,从长远来看有助于实现更可持续的医疗保健。

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