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

Cardiovascular Diabetology

Study Protocol

Johann Steurer¹  Ulrike Held¹  Thomas Rosemann²  Corinne Chmiel³  Anja Frei⁴  Beatrice Birnbaum⁵  Hansueli Schläpfer⁶ 

[1] Horten Centre for Patient-oriented Research, University of Zurich, Zurich, Switzerland;Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland;Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland;Division of Internal Medicine, University Hospital of Zurich, Switzerland;Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland;Horten Centre for Patient-oriented Research, University of Zurich, Zurich, Switzerland;Schweizerischer Verband Medizinischer PraxisAssistentinnen, Bern, Switzerland;Ärztenetz säntiMed, Herisau, Switzerland;

关键词: Diabetes Type;    Primary Care Setting;    Diabetes Care;    Practice Nurse;    Chronic Care Model;   

DOI  :  10.1186/1475-2840-9-23

 received in 2010-04-01, accepted in 2010-06-15,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundDiabetes 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/DesignCARAT 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 (<130/80), HbA1c (=<6.5%) and low-density lipoprotein-cholesterol (<2.6 mmol/l), increases patients' quality of life (SF-36) and several evidence-based quality indicators for diabetes care. These improvements in care will be experienced by the patients (PACIC-5A) as well as by the practice team (ACIC). According to the power calculation, 28 general practitioners will be randomized either to the intervention group or to the control group. Each general practitioner will include 12 patients suffering from diabetes type II. In the intervention group the general practitioner as well as the practice nurse will be trained to perform care for diabetes patients according to the Chronic Care Model in teamwork. In the control group no intervention will be applied at all and patients will be treated as usual. Measurements (pre-data-collection) will take place in months II-IV, starting in February 2010. Follow-up data will be collected after 1 year.DiscussionThis study challenges the hypothesis that the Chronic Care Model can be easily implemented by a practice nurse focused approach. If our results will confirm this hypothesis the suggestion arises whether this approach should be implemented in other chronic diseases and multimorbid patients and how to redesign care in Switzerland.

【 授权许可】

CC BY   
© Frei et al; licensee BioMed Central Ltd. 2010