Background
Type 2 diabetes (T2D) is a major problem for many health care systems [
1‐
8]. The World Health Organisation (WHO) has estimated that there are approximately 422 million people in the world with T2D [
1]. Following analyses of the Framingham study in the 1970s it became clear that T2D is a major risk factor for macrovascular disease (including myocardial infarction and stroke), and studies since have demonstrated that macrovascular risk increases with worsening glycaemic control [
9,
10]. Diabetes is also associated with an increased risk of microvascular complications which includes diabetic retinopathy, neuropathy, and renal disease [
11]. Several landmark trials have demonstrated that risk for both microvascular and macrovascular complications of diabetes can be reduced by improving blood glucose control [
12‐
15].
National and international guidelines have provided targets for optimum glycaemic control, which have been established through observational evidence and clinical trials [
16‐
22]. However, adequate glycaemic control is difficult to achieve for a significant proportion of people with T2D. 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].
In the UK, T2D is largely managed in primary care, reinforced by pay-for-performance (P4P) in general practitioners’ contracts [
2,
3,
24] - a scheme called the Quality and Outcomes Framework (QOF). UK general practice consultations are recorded into computerised medical record (CMR) systems which actively flag whether a patient with T2D is at target. Rewards paid through the P4P system, QOF, are solely based on information recorded in CMR systems. These computerised systems record the diagnosis of T2D and link to pathology services allowing transfer of glycated haemoglobin (HbA1c) data to the individual’s medical records. CMR systems also record all the prescriptions issued in primary care. Additionally, most brands of CMR systems prompt the primary care clinician at every consultation if a person with T2D is not at their glycaemic target. Therefore, every time a person with T2D presents to their general practitioner (GP) or other primary care clinician, the clinician can readily tell if they are at target, and generally with one mouse click, whether they are receiving maximal oral therapy [
25].
QOF remuneration targets for T2D include optimising the number of people below set glycaemic thresholds. CMR based interventions are known to generally improve care [
25] and the introduction of these P4P targets appear to have improved glycaemic control and reduced inequalities in T2D management [
26,
27]. However, it is difficult to disentangle these effects from other quality improvement initiatives.
One component of suboptimal management is delay in intensification of therapy. Delays in intensification occur at each stage of treatment: from diagnosis to first oral medication, to second and third oral medications, to the initiation of injectable therapies and escalation of injectable therapies once initiated [
28]. These delays termed “therapeutic inertia” or, more commonly “clinical inertia” [
29], are associated with impaired glycaemic control and concomitant complications including microvascular (e.g. retinopathy, chronic kidney disease) and macrovascular diseases (e.g. heart failure, stroke) [
30]. Despite improved glycaemic control following the use of injectable therapy, drawbacks of insulin include weight gain, and severe hypoglycaemia and increased risk of death [
31,
32], whilst glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been linked to gastrointestinal symptoms such as nausea, vomiting, and diarrhoea [
33], which may deter people from using them. Other barriers to starting injectable therapy include the individual struggling to acknowledge that their diabetes has progressed, anxiety and fear of pain from injecting, the need to regularly test blood glucose levels, and the difficulty incorporating injecting during working hours [
34‐
36].
Clinician, patient, and health service factors have been identified as contributing to clinical inertia [
37‐
44]. However, an improved understanding of the specific patient, clinician, and health service factors that influence clinical inertia is urgently needed to facilitate improved glycaemic control and health outcomes in people with T2D.
Discussion: strengths and weaknesses
One of the strengths of the study is its representativeness. The RCGP RSC sentinel network provides access to a nationally representative sample of real world evidence (RWE) data. This can facilitate the development of interventions that have real-world effectiveness [
87].
What this study adds is a robust exploration from a realist evaluative stance. The study aims to capture the details of context and mechanism and how these combine to affect outcome (in this case commencing injectable therapy for diabetes).
Our context is one where T2D is largely managed by GPs and nurses in primary care. A registration based system where one patient is seen in a single practice, often by the same doctor or nurse for their diabetes care. These general practices are highly computerised, and the consultations will be recorded on the practice CMR system. The CMR also allows all previous blood tests including glycated haemoglobin to be readily visualised.
The mechanism for achieving change includes prompts and guidance pointing out poor glycaemic control. These reminders may nudge the clinician towards escalation of treatment. There is also the P4P/QOF incentive to intensify treatment and achieve glycaemic control and other indicator standards. These factors are in addition to those already described in the literature.
A weakness of the study is that as language is an important aspect of qualitative research, only English-speaking individuals can participate. This means that perceptions of people with different language may not be explored. Whilst video is much used for training and assessment in primary care, there are always concerns it may interfere with the clinician-patient relationship. However, research suggest that consultation behaviour is little affected by awareness of video recording [
64].
In summary, we will explore the topic of intensification to injectable therapy using a triangulation of qualitative and quantitative research methods. 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. This study will gain insight into the different dimensions of highly context-dependent settings, in our case general practice.
Acknowledgements
The practices and patients of the RCGP RSC network who participated in this study; Dr. Filipa Ferreira, senior project manager, for ongoing support through this project and involvement in research collaboration.