Intensification to injectable therapy in type 2 diabetes: mixed methods study (protocol)

Simon De Lusignan,Julie Mount,Neil Munro,Michael Feher,Martin Whyte,Emmanouela Konstantara,William Hinton

doi:10.1186/s12913-019-4112-3

Abstract

BackgroundIn the UK, type 2 diabetes mellitus (T2D) is largely managed in primary care. Delay in the intensification to injectable therapy, a form of clinical inertia, is associated with worse glycaemic control. UK general practice is highly computerised, with care being recorded on computerised medical record systems; this allows for quantitative analysis of clinical care but not of the underpinning decision-making process. The aim of this study is to investigate perceptions of patients and clinicians in primary care on the initiation of injectable therapies in T2D, and the context within which those decisions are made.MethodsThis is a mixed methods study, taking a “realist evaluation” approach. The qualitative components comprise focus groups, interviews, and video recordings of simulated surgeries; the quantitative analysis: an overview of participating practices, elements of the video recording, and an online survey. We will recruit primary care clinicians (general practitioners and nurses) and patients from a representative sample of practices within the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. Participants will be patients with T2D, and primary care clinicians. Focus groups and semi-structured interviews will be recorded, transcribed verbatim and analysed using Framework Analysis. The simulated surgeries will include cases that might be escalated to injectable therapy. The consultation will be reviewed using the Calgary-Cambridge model to assess communication and determination of adherence to national prescribing guidelines. We will conduct multi-channel video recording including screen capture, clinician and patient facial expressions, wide angle view of the consultation, and the computerised medical record screen. This allows annotation and qualitative analysis of the video recordings, and statistical analyses for the quantitative data. We will also conduct an online survey of primary care clinicians’ attitudes to, and perceptions of, initiation of injectable therapies, which will be analysed using summary statistics.DiscussionResults aim to provide a detailed insight into the dynamic two-way decision-making process underpinning use of injectable therapy for T2D. The study will provide insights into clinical practice and enable the development of training, interventions and guidelines that may facilitate, where appropriate, the intensification to injectable therapy.

Highlights

In the UK, type 2 diabetes mellitus (T2D) is largely managed in primary care
Following analyses of the Framingham study in the 1970s it became clear that T2D is a major risk factor for macrovascular disease, and studies since have demonstrated that macrovascular risk increases with worsening glycaemic control [9, 10]
In a large-scale European study, real-world diabetes care was compared against the glycaemic targets produced by the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD), and found that only 53.6% of people with T2D achieved adequate glycaemic control, with considerable variation between countries [23]

Summary

Methods

Study design and setting This study combines qualitative and quantitative methods, and should be regarded as a mixed methods study [45,46,47]. We will carry out a video study to provide quantitative data on key prompts/triggers for the initiation of injectable therapy raised during a consultation with a simulated T2D patient. We will present the GPs with consensus statements to explore where there is a consensus or disagreement about the facilitators and barriers to intensification of treatment to injectable therapy [66] These statements will be generated using the findings of the focus groups in phase 1. The use of video recorded simulated surgeries to explore themes that were derived from focus groups is a novel approach, but we feel necessary to capture information about context and mechanise that may not emerge from the narrative.

Discussion

Background

Findings