Title: Monitoring Long Term Conditions in Primary Care
Funder: Department of Health and Social Care

Abstract: Aims and Objectives To improve the management of chronic conditions in Primary Care by optimising the utility and frequency of tests used for monitoring on two specific areas arranged as two work streams: chronic kidney disease (CKD) and chronic heart failure (CHF). Background and rationale Focus for the management of chronic conditions has gradually changed from hospital based (secondary care) to GPs (primary care), as conditions are recognized earlier in their disease process. Once diagnosed, a major aspect of management is monitoring. However, for many conditions there is no or poor evidence on how, what, and when to monitor. Our group has produce evidence for better monitoring in several areas. This proposal aims to extend our work into two clinical areas that represent two ends in the spectrum of the monitoring carried out in Primary Care; renal monitoring in Chronic Kidney disease (CKD) and monitoring people with Chronic Heart Failure (CHF). In CKD, the majority of monitoring occurs in mild/moderate disease with the final stages of disease (renal failure necessitating dialysis or transplantation), rarely occurring or occurring after many years. Conversely, in CHF, the prognosis is poor and therefore the majority of monitoring is conducted in the latter stages of disease. Research environment This work will be carried out by three world leading centres in their respective fields, the Oxford Centre for Monitoring and Diagnosis in Primary Care (MaDOx), the Health Experiences Research Group (HERG) and the Health Economics Research Centre (HERC). Two of which are based at the Department of Primary Care Health Sciences, ranked highest in its field (primary care research) in the Research Assessment Exercise 2008. Research plan The proposed programme will allow us to develop and populate a clinical and economic model of renal function decline, to then estimate the effectiveness and cost-effectiveness of different models used for monitoring CKD in Primary Care &ndash; Workstream 1. For CHF we will explore the use of B-type Natriuretic Peptide (BNP) and weight as monitoring tests as well as evaluating the costs of different monitoring strategies &ndash; Workstream 2. Workstream 1: Monitoring Chronic Kidney Disease in Primary Care WS 1.1 Current practice in monitoring CKD WS 1.2 Systematic reviews of CKD management WS 1.3 Estimation of variability of eGFR and related measures WS 1.4 Prospective cohort study of eGFR for monitoring CKD in primary care WS 1.5 Qualitative evaluation of monitoring CKD WS 1.6 Cost-effectiveness model of monitoring strategies for CKD Workstream 2: Monitoring Chronic Heart Failure WS 2.1 Evaluation of Intervention Components of managing CHF WS 2.2 Systematic reviews of CHF management WS 2.3 Estimation of variability of BNP and weight for monitoring CHF WS 2.4 Feasibility study of the use of POC-BNP in Primary Care WS 2.5 Qualitative evaluation of monitoring CHF WS 2.6 Economic issues of monitoring CHF patients Projected Outputs and Dissemination plans This programme will provide new evidence that will inform adequate management in Chronic Kidney disease and Chronic Heart Failure in Primary care. An important part of the focus will go into understanding the impact our findings will have on patients and health professionals. We will use links with NICE and GP commissioners in Oxfordshire to disseminate these findings. Relevant expertise and experience of the research team The team includes research groups with complementary expertise in diagnosis and monitoring from Primary Health Care, evaluation and analysis of Patients Health Experiences, and Health Economics at Oxford University; along with clinical experts on Renal Function and Cardiovascular Disease specifically focused in Primary Care. Programme Management Perera Programme Lead, Bankhead and Stevens Deputy Leads Six monthly Steering group 1-3 monthly Senior Management group (teleconference) with PPI input Monthly investigator meetings (MaDOx, HERG, and HERC) Justification of costs &pound;2 million over five years will fund 6 systematic reviews, development and piloting of Point of Care testing of BNP for CHF, at least 30 new depth interviews plus re-analysis of existing interviews, focus groups for each condition, at least four statistical and one economic modelling study, and a large cohort to evaluate the impact of replacing creatinine with cystatin C for the management of CKD. Management and Governance, including Programme Management and any ethical implications Key issues are confidentiality, informed consent, and the flow of relevant information on test results to health professionals and patients. We will use the structure of the Primary Care Clinical trials Unit (lead by Professor Farmer) to guarantee careful consenting process and best practice is used. Public and Patient Involvement This application has been reviewed by individuals with long term conditions that require frequent monitoring. We will invite lay representatives for both conditions CKD and CHF to the Steering and Senior Management groups. In addition, PPI members will advise and help develop participant information and data collection tools.

Lay abstract: We are living longer and healthier lives due to health promotion, better medical care and improved disease prevention. However, this means that most of us will live, and live longer, with a chronic condition, such as diabetes, kidney disease, or coronary heart disease. The management of chronic conditions has gradually shifted from hospital (secondary care) to GPs (primary care), as conditions are recognized earlier in their disease process. A major aspect of good management is long-term monitoring. Despite the considerable economic costs, for many conditions there is no or poor evidence on how, what, and when to monitor. More frequent monitoring is not necessarily better. Besides the financial costs, there are considerable downsides to over-frequent measurement. There are personal costs such as the time spent, the need for invasive tests, the extra levels of anxiety, and sometimes unnecessary hospital visits. Perhaps more important is the potential for inadequate management based on incorrect test results showing deterioration when it is not really present and vice versa. Our overall aim is to improve understanding, methods, evidence-base, and practice of clinical monitoring within UK Primary Care. The Oxford Monitoring Group has developed evidence in the areas of cardiovascular disease monitoring (cholesterol and blood pressure), warfarin monitoring and diabetes monitoring. In particular we have developed new methods for defining the optimal monitoring strategy in chronic conditions. This proposal aims to extend this work to other important clinical areas in Primary Care that we have not yet addressed and that represent two extremes in the way monitoring is carried out in Primary care; renal monitoring in Chronic Kidney disease (CKD) and monitoring people with Chronic Heart Failure (CHF). In CKD, the majority of monitoring occurs in mild/moderate disease with the final stages of disease (renal failure needing dialysis or transplantation) rarely occurring or occurring after many years. Conversely, in CHF, the outlook is poor and therefore the majority of monitoring is conducted in the latter stages of disease. However, treatment of heart failure can improve patient quality of life, both in terms of physical and emotional well-being. The questions we are aiming to answer in these areas are: Does the choice of test impact on better care while being affordable to the NHS? Can the number of tests that are used to manage individuals at early stages of kidney disease be reduced and hence the associated costs? Is it possible to monitor heart failure using a simple blood test (b-type natriuretic peptide)? Can this be done using a rapid test within a GP consultation? Would changes in the management of these conditions be acceptable to individuals living with these conditions?

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: RENAL AND UROGENITAL;CARDIOVASCULAR