Title: Development and evaluation of a framework for managing liver disease in primary care
Funder: Department of Health and Social Care

Abstract: Background Liver disease is the only chronic condition in the UK where mortality rates are increasing, and the majority of people affected are of working age. Most chronic liver disease in the UK is due to alcohol or metabolic risk factors - alcohol related liver disease (ARLD) or non-alcoholic fatty liver disease (NAFLD). Evidence based, non-invasive methods for detecting liver disease in these high risk groups are available, and early lifestyle intervention has been shown to be effective in reducing risk of progressive disease. Despite this, the majority of liver disease is diagnosed in secondary care, at the stage of irreversibe cirrhosis, when intervention is less effective. There is no widely implemented, consistent pro-active approach for early detection of chronic liver disease in primary care, despite emerging evidence that this is clinically and cost effective. Can an early detection framework for liver disease be routinely used in general practice to improve patient care? Aims and objectives: Develop an evidence-based framework for managing chronic liver disease in primary care, with a focus on widespread uptake, by using implementation science research techniques. Objectives: Develop and refine a complex intervention framework for liver disease management in primary care Pilot implementation of the framework in primary care with ongoing evaluation to guide a wider implementation strategy Methods Work package(WP) 1: Develop a provisional intervention framework for managing chronic liver disease in primary care using published research, my own recent evidence synthesis and example regional pathways. WP2: Formative evaluation to guide intervention refinement - Use qualitative research methods to explore the barriers and facilitators to implementation with GPs, nurses, patients and other key stakeholders using the provisional intervention framework developed in WP1 as a guide. I will use an implementation science theory (Normalization Process Theory - NPT) to guide this qualitative work. Co-production workshops will follow interviews to finalise the intervention framework, and develop training resources needed for pilot implementation. WP3: Process evaluation - Pilot the developed framework for liver disease management in GP practices in Newcastle and Gateshead over a 1 year period. Evaluate the implementation using qualitative and quantitative methods for process analysis to inform wider implementation. NPT will also guide the techniques for evaluating this work package. Timelines for delivery Yr1: WP1. Obtain permissions for WP2 and WP3. Begin formative evaluation. Yr2: Complete and disseminate formative evaluation. Start Process evaluation. Yr3: Finish WP3 and dissemination of results. Write up thesis. Anticipated impact and dissemination Despite a growing evidence base for early detection of chronic liver disease in the community, implementation of this evidence into primary care practice is limited. This fellowship will develop and inform implementation of evidence based strategies for chronic liver disease management into everyday primary care. This will promote earlier detection of liver disease, with reduction of morbidity, mortality and health costs in the long term. This will be of direct benefit to patients and the public. Dissemination will target primary care professionals, policy makers, patient support groups and liver charities, as well as publications in high impact journals.

Lay abstract: My aim is to work out how to introduce improved care for people with liver disease into general practice. BackgroundLiver disease is one of the commonest causes of death amongst working age people in the UK. Death rates for liver disease have been going up over the last 50 years. This is the opposite of what has happened with other common diseases, such as heart disease, where deaths have been falling. We know what causes liver disease. Alcohol related liver disease (ARLD) and non-alcoholic fatty liver disease (NAFLD) are the cause of most liver disease in the UK. NAFLD is linked with certain risk factors - diabetes, obesity, high fat levels in the blood and high blood pressure. If we tackle these, we can stop liver disease progressing. We already know how to test for serious liver disease in people with ARLD and NAFLD. GPs have no agreed way of looking after people with liver disease. People with early liver disease may not know that they have a problem, and most people (around three-quarters) with liver disease will go to their doctors when they already have advanced liver damage (cirrhosis), when little can be done to help. To reduce the impact of liver disease on patients and the NHS, we need to find disease earlier in general practice, and do something about it. This approach needs to be backed by research evidence and introduced in a way that is acceptable and useful for NHS staff and patients. Design and methods Develop and test a way of managing liver disease in the General Practice setting: I will use evidence from research and practice, to set out the key things that general practices need to do, to find and look after patients with liver disease I will produce a framework that is flexible, and it will be developed through the research outlined below. I will interview GPs, nurses and others, to explore the reasons why we don't already have a structured approach to liver disease in primary care. I will use interviews to find out what would make it easier to introduce changes, and what those changes should look like, using the framework developed in WP1 as a guide. The interviews will be followed by workshops, to get people together to develop a way to manage liver disease in primary care, that will work in practice. Finally, I will produce a framework for finding and treating people with liver disease that is ready to be tested in general practice. Doctors, nurses, patients and others involved in the workshops will help me to develop training materials for staff who will use the framework. I will then test this way of finding liver disease in GP practices in Newcastle and Gateshead. I will look at how this works in a real-life setting, how user-friendly it is for people involved in using the framework, and what happens to patients, using different research methods. Patient and public involvement As a GP, I have seen patients with advanced liver disease, who have asked why their disease was not picked up earlier. This is why I want to do this research. I have worked with members of Liver North (the largest liver patient support group in the UK) to develop my ideas. They have agreed to provide me with advice from a patient and family perspective throughout this work. Dissemination GPs and policy makers are my target audience. I will work with my contacts at the British Liver Trust and the Royal College of General Practitioners to make sure that my research improves patient care.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;7.3 MANAGEMENT AND DECISION MAKING
Health categories: ORAL AND GASTROINTESTINAL