TaILOR - trial of patient-initiated care leading to improved outcomes in rheumatology

Research Question: What is the clinical and cost-effectiveness of patient-initiated follow-up (PIFU) compared with standard booked appointments for people with inflammatory arthritis?

Background: Inflammatory arthritis comprises lifelong conditions, such as rheumatoid arthritis (RA), axial spondyloarthritis and psoriatic arthritis that require long-term treatment and regular monitoring of disease and treatment. NHS rheumatology services are dominated by routine follow-up hospital appointments every 6-12 months accounting for 1.3 million appointments/year.

The NHS Long term plan aims to redesign outpatient services including implementation of patient-initiated follow-up (PIFU) where patients request appointments as required. To date, there are small studies of PIFU in RA and none in other arthritis. Research is required to configure services to optimise outcomes, reassure patients and clinicians of its safety and ensure that suitable patients are selected for this pathway.

Aims and objectives: Our primary objective is to establish whether PIFU is superior to standard care for people with inflammatory arthritis. We will assess effects on musculoskeletal health-related quality of life, disease activity, patient acceptability, satisfaction, experience and overall cost-effectiveness. We will investigate for factors associated with better PIFU outcomes to guide patient selection.

Methods: Working with UK rheumatology departments, NHS England and the British Society for Rheumatology, we will monitor patients with inflammatory arthritis within the NHS rollout using routine data to identify NHS resource use as patients switch from standard follow up to PIFU. In parallel, we will recruit 438 patients with inflammatory arthritis who will be randomised 1:1 to PIFU or standard care.

Standard care will consist of 6-12 monthly booked appointments depending on local preference. PIFU will consist of PIFU appointments as required and a 24-month safety-net appointment. The primary outcome will be musculoskeletal health-related quality of life measured by the MSK-HQ over 24 months in each group.

A nested qualitative work stream will ensure that the views and experiences of patients, clinicians and service providers inform our understanding of PIFU in clinical practice.

Timelines for delivery: The grant starts in Apr 2024. Confidential advisory group approval will be obtained by September allowing work on OpenSAFELY to begin with the first analysis output expected in Nov 2025 and later analysis in Nov 2027. Recruitment to the RCT will start by January 2025 with patient recruitment over 9 months and 24 months follow up. This allows 5 months for analysis including statistical modelling and a final 2 months for publication and dissemination.

Anticipated impact and dissemination: As a national multi-centre study, this will provide the definitive study of PIFU in inflammatory arthritis to impact on practice globally. Analysis will investigate factors associated with positive outcomes allowing optimal selection of patients in future practice. 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.

Collaborations with NHS England, NHS Improvement and the British Society for Rheumatology will ensure rapid dissemination and implementation in practice.