Title: A multiple methods investigation of the role of patient-practitioner interactions, health behaviours and cardiovascular risk among patients with type 2 diabetes in primary care
Funder: Department of Health and Social Care

Abstract: Background Diabetes is a common chronic condition managed in primary care, and accounts for significant UK cardiovascular disease (CVD) morbidity and mortality. Interventions to modify CVD risk factors have been shown to be effective in reducing morbidity and mortality, but diabetes related complications and the health burden remains high. With an increasing prevalence of the disease, additional long-term effective and cost-effective strategies to manage CVD risk are needed. There is strong evidence from observational data that improved patient-practitioner interactions during consultations are associated with lower CVD risk factor levels in type 2 diabetes. (Griffin et al., 2004) (Kelley et al., 2014) However, translation of evidence into effective interventions for patient benefit, has not been universally successful. More research is needed to understand the direction of causality, and mechanisms linking patient-practitioner interaction to CVD risk factor levels. Recent evidence also suggests that the nature of patient-practitioner interactions in relation to CVD risk is particularly important in patients with type 2 diabetes who have poor glycaemic control (HbA1c >8.5% (69 mmol/mol). (Slingerland et al., 2013) Patients with poor glycaemic control have high rates of CVD morbidity, mortality and associated health care costs. While most secondary prevention strategies focus on the average diabetes patient, it is individual characteristics that relate to the risk of developing complications. Therefore, effective secondary prevention strategies should focus on diabetes patients with specific risk profiles. There is a relative paucity of published data on this, especially in primary care. Consequently, we will examine patient-practitioner interaction, health behaviours and CVD risk in diabetes patients with varying glycaemic control in primary care. Aim To contribute to evidence on the extent to which patient-practitioner interactions are associated with lower CVD risk factor levels in type 2 diabetes stratified by defined risk profile, and to examine the extent to which these associations are mediated through changes in health behaviours. We will also examine the potential cost benefit of better experiences of patient-practitioner interactions in diabetes care. Methods A multiple methods study is proposed as a parallel independent analysis to the ADDITION-Cambridge trial; a randomised controlled trial among 49 East Anglia general practices and 867 type 2 diabetes patients. Ten year trial data is currently being collected and provides an opportunity to input an additional data collection stream. Patient-practitioner interactions are measured with the consultation and relational empathy questionnaire (CARE measure), a patient-rated experience measure that has undergone validation and reliability testing in general practice. (Mercer et al., 2005) The CARE measure assesses empathy in the context of a therapeutic relationship within the consultation and is a holistic, patient-centred measure. Cohort analyses and mediation analyses will be combined with qualitative analyses of new purpose developed interviews with practitioners and patients, to examine the association and potential mechanisms linking the quality and nature of patient-practitioner interaction to long-term health behaviours, and CVD risk factor levels. We will also include economic analysis by estimating cost per patient and QALYs to examine how cost varies with better patient-practitioner interactions in diabetes. Outcome To improve diabetes care, health outcomes and associated costs by informing consultations that can efficiently and effectively influence health behaviours, and therefore CVD risk. It is envisaged that this research will inform the development of a complex behavioural intervention to improve patient-practitioner interactions in specific diabetes groups. This research will also feed in to the training of practitioners through case vignettes generated from the interviews. Additionally, the proposed research will also inform commissioners and policy makers in terms of how diabetes care should be structured and delivered in primary-care.

Lay abstract: Background Type 2 diabetes is a common condition that is associated with an increased risk of heart disease, stroke, amputations, blindness and kidney damage. Despite current educational, lifestyle and medication interventions, patients with diabetes still have poor health outcomes, associated loss of capacity and quality of life. Diabetes related complications also account for significant health care costs. There is therefore a need to refocus efforts on trying to prevent these complications, improve health outcomes and reduce health costs. We know from previous studies that careful attention to risk factors including raised blood glucose, blood pressure and cholesterol can lower the risk of diabetes complications and death. There is evidence that the interaction between practitioner and patient during consultations may be important in lowering these risk factor levels. Patient-practitioner interaction refers to the content of consultations, and how doctors/nurses and patients relate to each other. When these interactions are personalised by taking into account the patient concerns or experiences, and encouraging patient participation in the consultation process, diabetes health outcomes are better. (Kelley et al., 2014) Greater trust and understanding leads to more meaningful and optimised treatment plans. Greater patient satisfaction will also translate to greater uptake of practitioners' advice on physical activity, diet or adherence to medications. Although it seems logical that these kinds of patient-centred interactions could lead to lower risk factors levels, the mechanisms of this have not been clearly established. More evidence is needed to enable translation of this research into clinical practice, and it is unclear how cost effective such an approach could be in diabetes care. Aim To contribute to evidence on the extent to which patient-practitioner interactions are associated with lower risk factor levels in type 2 diabetes and if so, among which group of diabetes patients? We will also aim to discover if the mechanism for this may be mediated through patient health behaviours such as physical activity and diet. Additionally, we will investigate the potential cost-benefits of improved patient-practitioner interactions in diabetes care. Method The study will be conducted alongside a large diabetes trial (ADDITION-Cambridge). The trial includes 867 patients with newly diagnosed type 2 diabetes that have been followed up over ten years in general practice. The trial investigates the effect of early detection of diabetes on long term outcomes. The availability of data related to patient-practitioner interaction provides a unique opportunity to extend existing trial work to include the examination of patient-practitioner interactions, health behaviours and risk factor levels over ten years. Data will be collected on patients' interactions with their practitioners through the consultation and relational empathy measure (CARE) measure. The CARE measure is a patient-centred questionnaire with particular focus on measuring empathy during a one-on-one consultation. It includes ten patient-completed questions and has been shown to be a quick, acceptable and a valid measure of patient-practitioner interactions. Data is also collected on patients' risk factor levels, quality of life, medication use and health behaviours. No previous study has collected such data over ten years at multiple time points in a group of recently diagnosed type 2 diabetes patients in primary care. This is important as risk factor levels improve following a new diagnosis of diabetes, but these improvements are often short-lived and difficult to maintain long term. This highlights the importance of research into long-term health behaviours and risk factor levels in diabetes, so that we can try to improve outcomes. We will use data collected to examine the link between the patient-practitioner interactions and health outcomes, and conduct analysis to determine if health behaviours explain this link. This will be alongside interviews with doctors, nurses and diabetes patients to understand their views on patient-practitioner interactions and health behaviours. This will further help us to elucidate mechanisms linking patient-practitioner interaction and risk factor levels.Outcome The results of this research could help improve care of patients with diabetes by informing practitioners on how to conduct effective consultations that may influence risk factor levels via changes in health behaviours. This could improve quality of life and reduce complications associated with the disease. Also, by including cost benefit analysis, this will be helpful in informing policy makers and commissioners about how the health care system should be delivered and organised in terms of the consultation in primary care. This research also has implications for how current and future doctors and nurses are trained, and we will use our research findings to feedback to practitioners on how to improve and tailor their interactions in type 2 diabetes.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: METABOLIC AND ENDOCRINE