TaILOR: a randomised trial to compare the clinical and cost-effectiveness of a patient-initiated follow-up (PIFU) strategy compared to standard care pathways in people with inflammatory arthritis: a study protocol.

BACKGROUND: Inflammatory arthritis comprises lifelong conditions, such as rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis that require long-term treatment and regular monitoring. People with inflammatory arthritis usually require long-term treatment with immune-suppressing medications and are typically reviewed in outpatient clinics every 6-12 months, accounting for 1.3 million appointments/year in the UK. The National Health Service (NHS) is implementing a move to patient-initiated follow-up (PIFU) where patients request appointments as required. To date, there are small studies of PIFU in rheumatoid arthritis and none in other arthritis. Research is required to configure services to optimise outcomes, inform patients and clinicians of the effectiveness and safety of PIFU and ensure that suitable patients are selected for this pathway.

METHODS: TaILOR is a two-arm, pragmatic, parallel group, superiority, randomised controlled clinical study, with an embedded qualitative study conducted across 32 secondary care NHS sites in the UK. Eligible participants must be 18 years or older, with stable inflammatory arthritis, and diagnosed for at least 2 years. In addition, they need to be suitable for PIFU based on NHS England guidance and in the opinion of their usual care team; 438 participants will be randomised in a 1:1 ratio to either PIFU, with a fixed 24-month safety net appointment, or standard care, with 6-12 monthly follow-up visits. The trial includes an internal recruitment feasibility pilot, as well as health economics and qualitative analyses. The primary outcome will assess the effectiveness of PIFU compared to standard care on musculoskeletal quality of life at 24 months. Secondary outcomes include quality of life, incremental costs, cost-effectiveness, treatment escalation, disease activity, flares, patient confidence in interactions with their clinical team (patient perceived efficacy in patient-physician interactions), depression and acceptability of PIFU (via qualitative interviews).

DISCUSSION: As a national multi-centre study, this will provide the definitive evaluation of PIFU for inflammatory arthritis. Qualitative analysis will generate insights into individual and contextual factors affecting the acceptability of PIFU, identify variation across sites or between patients and provide information on how this can be addressed.

TRIAL REGISTRATION: ISRCTN ISRCN10480648. Registered on 17 January 2025. Protocol version {2}: Version 3.0 date 04 Dec 2025.