Realist Evaluation Of A Digital Care Intervention To Improve The Long-Term Management And Outcomes Of People Affected By Coeliac Disease

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.