Title: Realist Evaluation Of A Digital Care Intervention To Improve The Long-Term Management And Outcomes Of People Affected By Coeliac Disease
Funder: Health Education England

Abstract: Background Coeliac disease (CD) is an autoimmune condition estimated to affect 680,000 people in the UK. Current guidelines recommend regular follow-up in either primary or secondary care. This uses significant NHS time and resources (this could be more than 48.9M per annum). Patients and providers have concern with current practice, namely: that it is not evidence-based; the prescribed regularity is unnecessary for most and inhibits those who need more follow-up from receiving it and; follow-up often revolves around reassurance and patient's wanting to 'stay in the system'. Importantly, patients and providers want and need flexibility, not a 'one-size fits all' approach. Digital follow-up can provide this and is already being piloted across the NHS. However, it is not known how this should be implemented so that it delivers desired outcomes and addresses health inequalities. My study will address these knowledge gaps by evaluating whether the digital software works, who it works for and how it can be refined to improve outcomes and address inequalities. Furthermore, this study will produce transferable knowledge for other similar conditions, thus providing value for patients and to the NHS. Research Question How, why, for whom, in what contexts and to what extent does a digital follow-up intervention for CD patients work? Aim To understand the delivery and implementation of a digital follow-up intervention for CD patients in primary and secondary care, with a focus on inequalities. Objectives 1: To understand the challenges of accessing and using the digital intervention. 2: To understand in which contexts the intervention causes desired or unintended outcomes. 3: To understand the mechanisms which cause these outcomes. 4: To understand how the whole follow-up process and the digital technology can be improved and implemented to reduce health inequalities. 5: To develop recommendations for guidance for physicians and policy-makers with stakeholder input. Methods A PPI Group and Steering Group (including patients, NHS and charities) will guide this study. Two realist approaches (realist review and realist evaluation) will be used to make sense of this complex intervention (i.e. digital follow-up for CD patients). This study will address the question of what works for whom, in what respects, to what extent, in what contexts and how? The realist review in Phase One will develop an initial programme theory (IPT) which will be enhanced by feedback and advice from stakeholders and PPI. The IPT will inform Phase Two, a realist evaluation which collects qualitative data from 30-40 semi-structured interviews with patients who have used the software. The IPT will be further refined iteratively using this primary data and with stakeholder and PPI input. The refined IPT will provide the in-depth understanding needed to develop the study's outputs. Anticipated impact and dissemination I will produce guides for decision-makers, software companies and practitioners. Following this, I will apply for a fellowship to enable implementation of the improved software as a Randomised Controlled Trial. Work will be disseminated through presentation at conferences, to Coeliac UK members and the study's own PPI and Steering Groups, publications and a website.

Lay abstract: Why is this study needed? Coeliac disease is a chronic gut disease. It affects one in 100 people. The only treatment is never eating foods that contain gluten, which are proteins found in wheat, barley, and rye. Following a gluten-free diet (GFD) can help relieve symptoms, improve quality of life and reduce complications. National guidelines recommend coeliac disease patients have yearly follow-up appointments. Currently, some patients receive lots of follow-up, while others don't receive any follow-up. A new technology has been developed to support follow-up. This involves monitoring patients through software on computers or mobile phones. This could allow patients to get the right amount of care at the right time. It could also save the NHS money. This is being used by patients taking part in a research study at six UK hospitals. Aim: This study will explore whether this technology works and if it works equally for all patients. How will the research be carried out? This study has three phases: Phase One I will review the literature on the use of technology for coeliac disease patients, using an approach called a realist review. I will look at existing research and talk to relevant professionals, organisations and patients. I will then create a model explaining how this technology is likely to work, for whom and in which circumstances. I will check this with professionals and patients and change the model if needed. Phase Two I will interview patients who used the technology (in the research study) at 4 hospital sites. This will help me to understand their opinions and experience of the technology. I will use this information to check whether the model from Phase One is correct. If it isn't, I will adjust the model. Phase Three I will run workshops to discuss the model with coeliac disease patients and appropriate professionals. I will change the model to reflect their views. I will use this model to produce three guidance documents. These will be for policy-makers, practitioners and the software company. These will help use of the technology be the best it can be, for the most patients. How will the public be involved? This research plan has been developed with help from patients and members of Coeliac UK. Coeliac disease patients have agreed to join a Patient and Public Involvement Group which will meet every 3-6 months throughout the study and will: Shape how the study looks Point out any issues they see with the study, in particular with recruiting and interviewing patients Tell me whether the documents for patients are easy to understand; and Help share key messages and findingsPatients helping to steer the study will be repaid for their time and commitments (following national recommendations) and will be offered training to support their roles, fully. Patients will comment throughout the study and will guide me on the best ways to share findings and will play an active role in sharing the findings through helping with publications and giving patient focused talks with me. What will happen to the research findings? Findings will be shared with the software company, decision-makers, practitioners, healthcare professionals, patients and members of the public through: Journal publications and conference presentations Presentations and talks to relevant organisations through meetings, blog posts, websites, newsletters and journal articles.I will then apply for more funding to allow me to use these findings to run a large research study. This study will allow more patients to use the technology. Findings from this will mean the technology can be used in the NHS in the best way possible for all coeliac disease patients.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: ORAL AND GASTROINTESTINAL;INFLAMMATORY AND IMMUNE SYSTEM