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Open Access Highly Accessed Study protocol

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

Arritxu Etxeberria1*, Itziar Pérez2, Idoia Alcorta2, Jose Ignacio Emparanza3, Elena Ruiz de Velasco4, Maria Teresa Iglesias3, Domingo Orozco-Beltrán5 and Rafael Rotaeche6

Author Affiliations

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

2 Bidasoa Integrated Healthcare Organization, Basque Health Service, Irun, Spain

3 University Hospital, IIS Biodonostia, San Sebastian, Spain

4 Bilbao Health District, Basque Health Service, Bilbao, Spain

5 Miguel Hernandez University, Alicante, Spain

6 Alza Health Centre, Basque Health Service, San Sebastian, Spain

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BMC Health Services Research 2013, 13:438  doi:10.1186/1472-6963-13-438

Published: 24 October 2013

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

Keywords:
Diabetes; Education; Medical continuing; Guidelines; Health plan implementation; Hyperlipidemias; Hypertension; Primary health care; Risk factors; Cardiovascular