Abstract
BackgroundThe management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting.MethodsThis is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels.The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas.The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80 years with deficient glycaemic control (HbA1c > 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d’Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces.DiscussionThis study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care.Trial registrationClinicaltrials.gov. registration number. NCT02663245; January 25, 2016.
Highlights
The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications
Aims of the study Following this line of thought, the aim of this study is to assess whether glycaemic control improves in very poorly controlled type 2 diabetic patients as a result of interventions based on treatment intensification and on an increase in the patients’ adherence to treatment with a diabetes-targeted clinic held for those patients
In parallel to Intervention group 2, we decided to include an additional comparison group consisting of type 2 diabetic subjects attending primary care centres managed by our institution in our region, with subjects selected according to the same study criteria. To select this latter group, we describe the use of the Sistema dInformació per al Desenvolupament de la investigació en Atenció Primària (SIDIAP) database, which contains anonymised electronic health records of patients attended at primary care centers of the same health care districts not participating in the study
Summary
The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. A meta-analysis performed by Tricco et al regarding the evaluation of strategies used in clinical trials for the improvement of quality procedures used in the management of diabetes shows evidence that the most notable improvements are observed when baseline levels of glycated haemoglobin (HbA1c) are high, especially over 8%, in diabetic patients [5]. This suggests that interventions should focus on patients with poorer control. With regard to strategies aimed at professionals and organizations that demonstrated efficacy, the most efficient were feedback from the information obtained in audits, training of professionals, and organizational changes (such as electronic records, clinical reminders, and case management, in addition to financial incentives)
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