Title: CIP-LINC Community pharmacy alcohol-related liver disease risk identification and linkage to care through development of a complex intervention
Funder: Department of Health and Social Care

Abstract: Research Question Can community pharmacy identify people at risk of Alcohol-related Liver Disease (ArLD) and connect them with existing ArLD pathways of care? Background Liver disease is now the 3rd largest cause of premature mortality in the United Kingdom. ArLD causes the majority of these deaths. Mortality from ArLD can be reduced if it is diagnosed earlier.Testing for ArLD in people who drink harmful amounts of alcohol is recommended in national guidance and ArLD pathways exist to facilitate this in primary care. Alcohol identification and brief advice services are already provided by some community pharmacies. There is some evidence that such services can identify harmful alcohol use in people attending the pharmacies but there is no research examining whether these people can be connected to existing ArLD pathways. Methods I will answer the research question through development of the CIP-LINC intervention, a complex intervention that enables community pharmacy to identify people at risk of ArLD and connect them with existing care pathways for ArLD. I will use Medical Research Council guidance on developing complex interventions and Normalisation Process Theory (NPT) to develop and test the intervention in four work packages (WPs) over three years. WP1 - What are the barriers and facilitators to pharmacist-led alcohol identification and brief advice (IBA) in community pharmacy? I will undertake a qualitative evidence synthesis of studies examining barriers and facilitators to implementing IBA in community pharmacy. I will do this according to Cochrane guidance. I will use framework synthesis based on NPT to synthesise the data. WP2 -h; Perspectives of service providers and service users on a role for community pharmacy in ArLD pathways I will undertake a qualitative study of patients with ArLD, pharmacists, pharmacy users and health professionals involved in ArLD pathways to explore their perspectives on a role for community pharmacy in ArLD pathways. I will purposively sample these participants for semi-structured interviews. WP3 -h; Intervention Design I will use the results of WP1 and WP2 to design the complex intervention and training materials. This will be done with key stakeholders in a series of meetings over two months. WP4 -h; Feasibility Study I will undertake a mixed-methods feasibility study of implementing the intervention in community pharmacy. Six pharmacies across Southampton and Portsmouth will be recruited to provide the intervention. I will undertake qualitative interviews with stakeholders to explore the acceptability of the intervention and the feasibility of delivering it. I will collect data that quantifies intervention use and clinical data that could be used to assess effectiveness in a future trial. Impact on NHS/Patients: The intervention has the potential to increase earlier detection of ArLD and thereby decrease morbidity and mortality. The study will develop novel collaborations between community and hospital care, which is in keeping with objectives of the NHS long-term plan. Dissemination strategy: I will publish four journal articles describing my findings and will present my research at academic conferences. I will support a patient with ArLD to write a blog about their involvement in the research.

Lay abstract: Aim I aim to create a toolkit that enables local pharmacists to identify people who are at risk of getting liver disease from drinking too much alcohol and link these people with testing and care for liver disease. BackgroundLiver scarring (known as cirrhosis) is a frequent and ever more common reason for dying in the United Kingdom (UK). The most common cause of liver scarring in the UK is alcohol. Death from liver scarring can be prevented if liver disease is found at an early stage. This can be hard because many people with liver scarring do not look or feel unwell until they develop liver failure. At this stage it is too late to prevent complications. Alcohol-related liver disease can be found earlier by assessing for it in people who drink too much alcohol. This is advised in national guidelines. Local pharmacists are one of the most accessible health professionals. There are over 12000 local pharmacies in England. Lots of these pharmacies are in areas where more people have alcohol problems. Local pharmacists are able to identify people who drink too much alcohol and provide them support to drink less. However, it is not known if local pharmacists can get these people assessed for alcohol-related liver disease. I want to research how this could be done to then create a toolkit to do it. How it will be done? Firstly, I will search for previous research about how pharmacies can identify and help people who drink too much alcohol. I will combine the results of this research to give me the best understanding of what can make it work and what makes it difficult. Secondly, I will find out how people think the toolkit could work. I will do this by talking to patients with alcohol-related liver disease, people who use pharmacies, pharmacists, and health professionals involved in alcohol-related liver disease care. Using my findings from these two pieces of work I will design and create the toolkit with a team of people. The team will include pharmacists, liver and alcohol specialists, members of the public and patients who have liver disease. I will then test the toolkit in local pharmacies. I will collect data to see how it is working. At the same time I will talk to people who use the toolkit to find out what they thought about using it. The results of this testing will guide me on how to adapt the toolkit and how to design a future trial to see if the toolkit is more effective than what is currently done. In the long-term I hope this will reduce deaths from liver disease. Patient and Public Involvement To help design this project I have had meetings with patients who have liver disease and people who regularly use local pharmacies. A group of people who use local pharmacies and two patients with alcohol-related liver disease will be involved in this project. They will help write information that explains the research to people taking part. Two of them will be in the team that design the tool. I will also help one patient share their experience of being involved in the project by writing a blog and social media posts.Dissemination My main outcome will be a toolkit that enables local pharmacies to identify people at risk of liver disease due to alcohol and get them assessed for liver disease. I will publish academic articles about my work and I will present my findings at national and international conferences. This will mean I share my work with pharmacists and liver and alcohol specialists.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;4.3 INFLUENCES AND IMPACT
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL;STROKE