Transforming outpatient consultations by integrating regular symptom tracking into clinical care: the Remote Monitoring of Rheumatoid Arthritis (REMORA2) study

Background Rheumatoid arthritis (RA) is managed by specialists at infrequent outpatient consultations. Treatment decisions are informed by asking "how have you been in the last six months?". 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.