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

Abstract

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.

Effectiveness of chronic care models for the management of type 2 diabetes mellitus in Europe: a systematic review and meta-analysis

“…The objective of each trial was the structured multifaceted management of diabetes, and the interventions were aimed at improving the patients’ cardiovascular risk profile44 45 and metabolic control,33 35 39 40 43 44 and assessing the effect of multifaceted care on the occurrence of cardiovascular events,35 39 40 43 overall mortality41 and risk factors for clinical complications 41. Interventions focused on all aspects of the CCM including more regular and frequent consultations, annual screening for diabetes complications, patient education/advice, guideline-based clinical treatment and physician education, regular/annual feedback reports to physicians, referrals, record keeping, formation of multidisciplinary (primary care provider) teams, delegation of routine diabetes tasks to a trained practice nurse, patient and physician reminders and patient–physician communication and decision-making.…”

“…The interventions were largely delivered by general practitioners and physicians, yet specialised nurses or practice nurses were also involved in the intervention-programme as part of the practice team and to (partly) replace the physician in providing diabetes care 3335 39 40 43 44…”

“…Three trials33 44 45 had included patients with prevalent diabetes and intervened for 1-year. The average diabetes duration in these studies ranged from 5.8 to 9.5 years.…”

“…Table 1 presents an overview of interventions and findings of the included publications. Tables 2 and 3 present the baseline patient characteristics for the trials that recruited patients with prevalent diabetes33 44 45 and for the trials that recruited patients with screen-detected39 43 46 and newly diagnosed diabetes,41 respectively.…”

A Conceptual Model of the Role of Complexity in the Care of Patients With Multiple Chronic Conditions

“…[18][19][20] It incorporates impact at multiple levels of a socioecologically focused approach: community, health system, patient, and care team. The model describes the components of chronic care as contextual factors such as community resources and policies; healthcare system domains including decision support tools, clinical information systems, and delivery system design that promotes effective, efficient, evidence-based, and culturally appropriate care by health teams; and self-management for patients.…”