Strategies for the introduction and implementation of a guideline for the treatment of type 2 diabetics by general practitioners (GPs) of the Lazio region of Italy (IMPLEMEG study): Protocol for a cluster randomised controlled trial [ISRCTN80116232]

Three-arm cluster-randomised trial (C-RCT). 252 GPs were randomised either to arm 1 (comprising a training module and administration of the guideline), or to arm 2 (administration of guideline without training), or to arm 3 (control arm), continuing current practice. Arm 1 participants attended a two-day course with CME credits. Data collection will be performed using current information systems. Patients' health data was also collected to describe diabetic populations cared for by GP participants. Process outcomes will be measured at the patient level and at the cluster level one year after the intervention. We will assess GPs' adherence to guideline recommendations for diabetes management relative to: 1) pharmacological management of diabetes; 2) pharmacological management of cardiovascular risk factors (hypertension and dislypidaemia); 3) measurement of glycosilated haemoglobin as the principal indicator of glycaemic control; 4) micro- and macrovascular complications assessment tests. Outcomes will be expressed as proportions of patients cared for by GPs who will have prescriptions of drugs, requests for tests and for outpatient appointment visits. To estimate the efficiency of resource use associated with the intervention a cost-effectiveness analysis will be carried out. The design of the study is based on three Cochrane and one Health Technology Assessment systematic reviews of guideline dissemination and implementation strategies.In Italy diabetes mellitus (DM) is a major health problem with a prevalence of 3–4% [1,2]. Considerable resources are committed to addressing important clinical problems connected with the treatment of micro- and macrovascular complications [3].In Italy, patients with type 2 non-complicated DM are mainly treated in generale practice, whereas patients with type 1 DM usually receive care from specialists.Although clinical guidelines are available from traditional means, data from an unpublished survey, conducted in a local health distr