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基层医疗中的高血压管理:一项整群随机对照试验的研究方案

Hypertension management in primary care: study protocol for a cluster randomized controlled trial.

作者信息

Weltermann Birgitta, Viehmann Anja, Kersting Christine

机构信息

Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.

出版信息

Trials. 2015 Mar 21;16:105. doi: 10.1186/s13063-015-0627-z.

Abstract

BACKGROUND

Studies worldwide show insufficient blood pressure control rates, and effective management of hypertension remains a challenge in general practice. Although structured forms of care improved blood pressure in randomized controlled trials, little is known about their effects under routine primary care. This cluster randomized trial (CRT) evaluates the effects of a modern interactive medical education series for general practitioners on hypertension management, including practice redesign strategies.

METHODS/DESIGN: For this CRT, 24 primary care academic teaching practices of the University of Duisburg-Essen, Germany, are randomized into two study arms. With the objective of improving hypertension control, general practitioners of the intervention group participate in a three-session medical education program on structured hypertension management. The program aims at changing physician awareness and practice design. Various practice tools are provided: for example, checklists on valid blood pressure readings, medication selection, detection of secondary hypertension, and patient education. General practitioners of both study groups include hypertensive patients with and without hypertension-related diseases such as angiographically proven coronary disease, and peripheral or cerebral vascular disease. Blood pressure is measured by 24-hour readings. Analyses will focus on differences in blood pressure control and changes of practice management between intervention and control group.

DISCUSSION

The study will determine the effectiveness of our practice redesign intervention on hypertension control. The intervention addresses general practitioners and practice assistants, while aiming at benefits on the patient level. Therefore, the cluster design is used to evaluate the effects.

TRIAL REGISTRATION

DRKS00006315 (date of registration: 14 July 2014).

摘要

背景

全球研究表明血压控制率不足,在全科医疗中有效管理高血压仍然是一项挑战。尽管在随机对照试验中结构化护理形式可改善血压,但对于其在常规初级保健中的效果知之甚少。这项整群随机试验(CRT)评估了针对全科医生的现代交互式医学教育系列对高血压管理的影响,包括实践重新设计策略。

方法/设计:对于这项CRT,德国杜伊斯堡 - 埃森大学的24个初级保健学术教学实践被随机分为两个研究组。为了提高高血压控制水平,干预组的全科医生参加一个关于结构化高血压管理的三阶段医学教育项目。该项目旨在改变医生的认知和实践设计。提供了各种实践工具:例如,关于有效血压读数、药物选择、继发性高血压检测和患者教育的检查表。两个研究组的全科医生纳入患有和未患有高血压相关疾病(如血管造影证实的冠心病、外周或脑血管疾病) 的高血压患者。通过24小时读数测量血压。分析将集中于干预组和对照组之间血压控制的差异以及实践管理的变化。

讨论

该研究将确定我们的实践重新设计干预对高血压控制的有效性。该干预针对全科医生和实践助理,同时旨在为患者带来益处。因此,采用整群设计来评估效果。

试验注册

DRKS00006315(注册日期:2014年7月14日)。

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