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CLUES 研究:一项针对初级保健中心心血管指南实施情况评估的整群随机临床试验。

The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care.

机构信息

Hernani Health Center, Gipuzkoa Health District, Basque Health Service, c/Aristizabal 1, 20120 Hernani, Spain.

出版信息

BMC Health Serv Res. 2013 Oct 24;13:438. doi: 10.1186/1472-6963-13-438.

DOI:10.1186/1472-6963-13-438
PMID:24156549
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4015502/
Abstract

BACKGROUND

The appropriate care for people with cardiovascular risk factors can reduce morbidity and mortality. One strategy for improving the care for these patients involves the implementation of evidence-based guidelines. To date, little research concerning the impact of such implementation strategies in our setting has been published. Aims. To evaluate the effectiveness of a multifaceted tailored intervention in the implementation of three cardiovascular risk-related guidelines (hypertension, type 2 diabetes and dyslipidemia) in primary care in the Basque Health Service compared with usual implementation.

METHODS/DESIGN: A two-year cluster randomized clinical trial in primary care in two districts in the Basque Health Service. All primary care units are randomized. Data from all patients with diabetes, hypertension and those susceptible to coronary risk screening will be analyzed.Interventions. The control group will receive standard implementation. The experimental group will receive a multifaceted tailored implementation strategy, including a specific web page and workshops for family physicians and nurses.Endpoints. Primary endpoints: annual request for glycosylated hemoglobin, basic laboratory tests for hypertension, cardiovascular risk screening (women between 45-74 and men between 40-74 years old). Secondary endpoints: other process and clinical guideline indicators.

ANALYSIS

Data will be extracted from centralized computerized medical records. ANALYSIS will be performed at a primary care unit level weighted by cluster size.

DISCUSSION

The main contribution of our study is that it seeks to identify an effective strategy for cardiovascular guideline implementation in primary care in our setting.

TRIAL REGISTRATION

Current Controlled Trials, ISRCTN88876909.

摘要

背景

针对心血管风险因素患者的适当护理可以降低发病率和死亡率。改善此类患者护理的一种策略是实施基于证据的指南。迄今为止,在我们的环境中,很少有关于此类实施策略影响的研究。目的:评估在巴斯克卫生服务的初级保健中,针对三种心血管风险相关指南(高血压、2 型糖尿病和血脂异常)实施多方面量身定制干预的有效性,与常规实施相比。

方法/设计:在巴斯克卫生服务的两个地区的初级保健中进行为期两年的集群随机临床试验。所有初级保健单位均随机化。将分析所有患有糖尿病、高血压和有冠心病风险筛查的患者的数据。干预措施。对照组将接受标准实施。实验组将接受多方面量身定制的实施策略,包括针对家庭医生和护士的特定网页和研讨会。

主要终点

每年糖化血红蛋白的请求,高血压的基本实验室检查,心血管风险筛查(45-74 岁女性和 40-74 岁男性)。次要终点:其他过程和临床指南指标。

分析

数据将从集中化的计算机化病历中提取。分析将在初级保健单位一级进行,按集群大小加权。

讨论

我们研究的主要贡献在于,它旨在确定在我们的环境中实施心血管指南的有效策略。

试验注册

当前对照试验,ISRCTN88876909。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2d3/4015502/7e6c35dbf85a/1472-6963-13-438-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2d3/4015502/7e6c35dbf85a/1472-6963-13-438-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2d3/4015502/7e6c35dbf85a/1472-6963-13-438-1.jpg

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