a cluster randomized controlled trial - Cardiovascular Diabetology

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Jun 15, 2010 - Methods/Design: CARAT is a cluster randomized controlled trial with general practitioners as the unit of .... P2: Percentage of patients receiving a dilated eye exam- ..... tus and cardiovascular risk factor management in a pri-.
Frei et al. Cardiovascular Diabetology 2010, 9:23 http://www.cardiab.com/content/9/1/23

STUDY PROTOCOL

CARDIO VASCULAR DIABETOLOGY

Open Access

The Chronic CARe for diAbeTes study (CARAT): a cluster randomized controlled trial Study protocol

Anja Frei*1,2, Corinne Chmiel1,3, Hansueli Schläpfer4, Beatrice Birnbaum5, Ulrike Held2, Johann Steurer2 and Thomas Rosemann1

Abstract Background: Diabetes is a major challenge for the health care system and especially for the primary care provider. The Chronic Care Model represents an evidence-based framework for the care for chronically ill. An increasing number of studies showed that implementing elements of the Chronic Care Model improves patient relevant outcomes and process parameters. However, most of these findings have been performed in settings different from the Swiss health care system which is dominated by single handed practices. Methods/Design: CARAT is a cluster randomized controlled trial with general practitioners as the unit of randomization (trial registration: ISRCTN05947538). The study challenges the hypothesis that implementing several elements of the Chronic Care Model via a specially trained practice nurse improves the HbA1c level of diabetes type II patients significantly after one year (primary outcome). Furthermore, we assume that the intervention increases the proportion of patients who achieve the recommended targets regarding blood pressure (