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

BACKGROUND Inflammatory arthritis is a group of different types of arthritis, such as rheumatoid arthritis, that cause joints to become swollen and painful. People with arthritis usually require long term treatment with immune-suppressing medications and are typically reviewed in outpatient clinics every 6-12 months. This accounts for 1.3 million appointments in England every year. Many of these are unnecessary as patients are well at the time of follow up, thus wasting NHS resources and the patients' own time. They also reduce capacity to see people at times of need e.g. during flare-ups.

AIM It has been proposed by NHS England that many people with inflammatory arthritis should no longer have routine follow up appointments, but be seen if and when they flare using an approach called patient-initiated follow up or PIFU. This may offer treatment more quickly to those in need, be more convenient and save money. However some patients and clinicians are concerned that inflammation in their joints may be missed resulting in poor quality care. There are very few studies on PIFU to date. Our aim is to test whether PIFU is better than standard routine follow up for patients. Research is also required to help design PIFU services and to reassure patients and clinicians that the most suitable patients are offered this type of care.

DESIGN/METHODS We will monitor quality of life and how NHS services are used by all patients switched to a PIFU pathway using information recorded routinely by hospitals and GPs across the UK. Alongside this, we will recruit 438 patients with stable inflammatory arthritis to a specific PIFU trial. They will be randomly allocated to receive PIFU (patient initiated appointments as required and an appointment in 2 years) or standard care (appointments every 6-12 months). We will measure their quality of life over the following 2 years. We will also assess how well their disease is controlled, their use of medications and NHS health services and patients' satisfaction with their care. We will also conduct detailed interviews with patients and clinicians to understand their experience of PIFU. We will use the information to assess which patients have the best outcomes with PIFU to help clinicians advise future patients about PIFU options. PPI Three people with inflammatory arthritis (two with rheumatoid arthritis, one with psoriatic arthritis) who support the unmet need have been involved in study design from inception. Representation includes key patient organisations who will help to share information about the study. People with lived experience of inflammatory arthritis will continue to advise throughout the project, including reviewing study information for patients, recruitment methods and questionnaires used, interpreting the results alongside the study team and helping us to share results with patient organisations and the public.

DISSEMINATION Our results will be presented at international research meetings and published in medical and scientific journals so that they can then be used in future treatment recommendations. Our co-applicants include representatives from NHS England and the British Society for Rheumatology who will support with education of doctors and nurses. We will share information with patients and the public with the support of patient organisations. We will also share useful information about how to design and identify patients for PIFU with doctors caring for other conditions.

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.