INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control

Abstract

Background: The 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.

Methods: This 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.

Discussion: This 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 registration: Clinicaltrials.gov . registration number. NCT02663245; January 25, 2016.

Keywords: Clinical inertia; Glycated haemoglobin; Intervention; Primary care; Treatment intensification; Type 2 diabetes.

Conflict of interest statement

Ethics approval and consent to participate

The study will be conducted according to the Helsinki Declaration and Good Clinical Practice guidelines. The study protocol was approved by the Ethics Committee of IDIAP Jordi Gol, Institute of Research in Primary Health Care. Trial Registration Number: P14/129.

The study was registered in the Reporting of this trial will adhere to the most relevant and up-to-date CONSORT statement [29] and its relevant extensions [30]. The results from this study will be published regardless of the outcomes.

Confidentiality and anonymity of the data will be ensured according to Law 15/1999 of data confidentiality, both in the implementation phase of the project and in the resulting presentations and/or publications. Individual data will be codified to ensure anonymity. Only researchers and monitors will have access to the data.

Summary of the informed consent procedure

We used the final study protocol to prepare the patient information sheet (PIS) and the written informed consent form (ICF) in accordance with the current Spanish applicable legislation. The PIS included all the procedures, visits, risks and inconveniences for the participant in the study. A properly qualified site investigator provided the information to the potential study participants during a personal interview prior to the subject’s inclusion and before performing any procedures of the study. During the interview, all subjects had an adequate period of time to reflect before making the decision to participate in the study, and had the opportunity to ask any questions or concerns about the study procedures. Once they agreed to participate, each study subject signed and dated the ICF, and included information regarding the complete name of the investigator and the date of the interview. All the procedures of informed consent acquirement were adequately reflected in the patient’s clinical history.

Consent for publication

Not applicable.

Competing interests

The authors declare that do not have any conflict of interest.

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Figures

Fig. 1

Study flow chart. *Control group: usual clinical care with the usual control by the family doctor and nurse according to the current CPG protocol. +Intervention 1: Usual clinical care with the usual control + Monographic consultation + Basic training in clinical practice guidelines + Training in coaching + 2-h training program to update the coaching strategy + Intervention based on patients SMS phone messages. ++Intervention 2: Usual clinical care with the usual control + Basic training in clinical practice guidelines + Training in coaching + 2-h training program to update the coaching strategy + Intervention based on patients SMS phone messages. m: months