Title: Transforming outpatient consultations by integrating regular symptom tracking into clinical care: the Remote Monitoring of Rheumatoid Arthritis (REMORA2) study
Funder: Department of Health and Social Care

Abstract: Background Rheumatoid arthritis (RA) is managed by specialists at infrequent outpatient consultations. Treatment decisions are informed by asking &ldquo;how have you been in the last six months?&rdquo;. However, patients find it difficult to give accurate information, which can negatively affect treatment decisions and outcomes. We have shown that patients with RA and their clinicians can use a daily smartphone symptom tracker integrated into their electronic health record. Patients used the app regularly, and patients and clinicians thought graphical summaries at consultations improved care. There is, however, currently no evidence that integrated symptom tracking improves health outcomes. Aims Improve care and outcomes of people living with long-term conditions, using RA as an exemplar, by integrating regular patient-reported symptom tracking into clinical workflows; Generate and disseminate knowledge on how to successfully implement patient-generated data into the NHS, including necessary behaviour and process change. Objectives Develop and refine implementation resources to encourage uptake of integrated symptom tracking; Evaluate the effect of integrated symptom tracking compared with usual care on disease activity in RA, as well as on quality of life, disability, shared decision making, self-management, and satisfaction; Evaluate the incremental cost-effectiveness of integrated symptom tracking in RA; Explore the impact of integrated symptom tracking on shared decision making, and address barriers to behaviour change and wider implementation; Explore barriers to digital inclusion, and develop and refine supporting materials to address these; Develop governance principles for using patient-generated data to support care and research, and co-design a prototype eConsent module accordingly. Research plan The programme comprises four work streams (WS), conducted at 12 rheumatology departments in Greater Manchester and North West London. WS1 (Month 1-18): two site feasibility study to (i) confirm feasibility of recruitment, retention and outcome assessment with 60 participants, and to (ii) qualitatively explore patients and rheumatologists perspectives on optimising intervention uptake, with refinement of supporting resources. WS2 (Month 19-51): stepped wedge cluster randomised trial of integrated symptom tracking informing consultations, compared to usual care. Research nurses will recruit ~500 adult patients with active RA, blinded to the cluster allocation. Outcomes will be assessed for 12 months post-recruitment including disease activity score (DAS28) (primary outcome) and other secondary patient-reported outcomes. An economic analysis will evaluate incremental cost-effectiveness. A process evaluation will qualitatively assess the effect of integrated symptom tracking on shared decision-making, and explore behaviour change and other factors that may influence its uptake by patients and professionals. WS3 (Months 4-39): qualitatively investigate barriers to inclusion for people from diverse contexts and address them by co-designing and evaluating support for digital inclusion. WS4 (Months 25-48): establish, with key stakeholders, governance requirements for self-administered eConsent for care and research. Subsequent workshops will deliver an iteratively co-designed smartphone eConsent prototype. Impact and dissemination The research will deliver (1) knowledge on whether integrated symptom tracking is clinically and cost-effective in RA, and (2) co-produced, experientially-informed guidance and resources for how integrated symptom tracking can be implemented successfully into the NHS.

Lay abstract: What is the problem? Rheumatoid arthritis (RA) is a common long-term condition that causes painful, swollen joints and disability. To plan treatment, hospital specialists ask people with RA how their symptoms have been since their last appointment. But this last appointment often happened months ago, so people may not remember the details. Good treatment planning is hard without this information, increasing people s chances of continued pain, inability to work, needing surgery and dying earlier. To solve this, we have developed a symptom tracking system . It enables patients to track their symptoms daily using a smartphone app, which sends the results to their electronic patient record for discussion at their next hospital appointment. We know patients and specialists like the system, but we don t know if it improves treatment planning and health outcomes. What are the aims? Support all patients to access and use the system, irrespective of age, background, familiarity with technology or health; Explore what it would take to use the system across the NHS; Test the system s effects on the care and health of people with RA; Test if the system s benefits outweigh its costs; Make it easier for people to share symptom data for research and understand issues around this. What will we do? We will switch on our symptom-tracking system in 12 RA outpatient clinics, one at a time. Chance will determine which clinic goes first. Patients joining the study after the switch-on will use our system; those joining before will receive usual care. We will support patients from across the community to take part. We will use medical records and questionnaires to learn about the system s effects, costs and benefits. We will interview patients and specialists to understand why it is or is not working and to improve the system. How will we involve patients? We have worked closely with patients and specialists to design the system and plan the research. Going forward, a diverse group of ten people with RA will collaborate closely with us to design and deliver the research, co-develop patient materials, understand what we find and help communicate this to other researchers, patients and national RA organisations. The group will co-organise and participate in workshops with specialists, which reflects the need to improve RA care together. How will this benefit patients and the NHS? If our system improves the severity of people s RA and their quality of life, we aim to make the system available across the NHS. Together with existing NHS networks, we will develop materials to make this happen across the country and for other related diseases. This could improve the care and lives of thousands of people with RA and other long-term conditions.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;7.1 INDIVIDUAL CARE NEEDS
Health categories: INFLAMMATORY AND IMMUNE SYSTEM