How does patient-initiated follow-up compare to standard care follow-up for people living with inflammatory arthritis?

ISRCTN ISRCTN10480648
DOI https://doi.org/10.1186/ISRCTN10480648
IRAS number 329838
Secondary identifying numbers CPMS 56645, NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) Grant Codes: NIHR156922
Submission date
14/01/2025
Registration date
17/01/2025
Last edited
16/05/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
People with inflammatory arthritis usually require long-term treatment with arthritis drugs (medications) (though some manage without specific medication) and typically have routine follow-up appointments every 6-12 months. Some of these appointments may be unnecessary as people can be well at the time of the appointment, and people with inflammatory arthritis have told us they feel they are wasting their time and also NHS resources. NHS England has recently proposed that many people with inflammatory arthritis should no longer have routine follow-up appointments but instead be seen if and when they have a flare or need advice on managing their condition, using an approach called Patient Initiated Follow-Up or PIFU. Researchers working with the British Society for Rheumatology have produced a short video about PIFU which can be accessed via this link (https://bit.ly/3WcFDmf). They have also created a list of frequently asked questions and answers which may be helpful to read to find out more about PIFU. This can be found here: https://bit.ly/3PvfMCl. There is very little information about whether PIFU is better than routine follow-up appointments. This study aims to find out whether PIFU is better than standard routine follow-up for those with inflammatory arthritis in terms of the impact on patient’s quality of life, disease activity and what this might potentially save the NHS.

Who can participate?
Adults who have been diagnosed with inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, undifferentiated arthritis) for at least 2 years and whose health care team consider their disease to be generally well-controlled. Patients that have ever been on PIFU for their inflammatory arthritis, would not be eligible to take part.

What does the study involve?
Of those who agree to take part in the study, half will remain to have what is called standard care – this would mean that they would continue to come into the hospital approximately every 6-12 months to see their rheumatology care team, the other half will move to PIFU where they will not have any follow-up appointments made but instead be given a guide to PIFU and how to contact their care team if you need some advice or an appointment. Regardless of what treatment group they are assigned to, participants would come to the clinic for an appointment at the start of the study and again at 24 months. These visits would include a routine disease assessment and several questionnaires for completion. Participants will also be sent questionnaires at 1 week and 6, 12 and 18 months to complete at home. If participants agree, they may be invited to take part in 1-2 interviews during the study to help us understand their experience of PIFU.

What are the possible benefits and risks of participating?
Participants may not directly benefit from taking part in this study but they will be making a significant contribution to research to help us to understand whether PIFU or standard care is better and which patients would benefit from PIFU. It is also hoped that study results will help to understand what PIFU costs the NHS compared to regular follow-up.

Where is the study run from?
The University of Oxford and 30 NHS secondary sites in the UK.

When is the study starting and how long is it expected to run for?
April 2024 to October 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Gretchen Brewer, tailor@ndorms.ox.ac.uk

Study website

Contact information

Prof Laura Coates
Public, Scientific, Principal Investigator

Botnar Research Centre
University of Oxford
Windmill Road
Headington
Oxford
OX3 7LF
United Kingdom

ORCiD logoORCID ID 0000-0002-4756-663X
Phone +44 (0)1865 613739
Email tailor@ndorms.ox.ac.uk

Study information

Study designRandomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home, Hospital, Medical and other records
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleWhat is the clinical and cost-effectiveness of a patient-initiated follow-up (PIFU) strategy compared to traditional care pathways in people with inflammatory arthritis treated with long-term immune-suppressing therapies?
Study acronymTaILOR
Study objectivesThe study aims to assess whether patient-initiated follow-up (PIFU) care is superior to standard care in terms of musculoskeletal quality of life (QoL) outcomes for patients with inflammatory arthritis.
Ethics approval(s)

Approved 22/01/2025, South East Scotland Research Ethics Committee 1 (2nd Floor, Waverley Gate, Edinburgh, EH1 3EG, United Kingdom; +44 (0)7814 764 241; Sandra.Wyllie@nhs.scot), ref: 25/SS/0004

Health condition(s) or problem(s) studiedInflammatory arthritis
InterventionThe study aims to recruit 438 patients with stable inflammatory arthritis from approximately 30 centres from varied demographic areas in the UK.

Patients will primarily be approached during their routine clinic visits or invited via letter ahead of their appointment. If a patient is assessed to be suitable for PIFU and is eligible and happy to join the study, informed consent will be requested ahead of study procedures.

Demographic, disease and treatment history information will be collected and recorded for the purposes of the study. Clinical data from patients' routine care will also be recorded from their medical notes (disease activity score including a physical exam and CRP measurement from blood draw) as well as hospital-reported resource use. Participants will complete questionnaires to collect patient-reported outcomes. Patient-reported outcomes include questionnaires about quality of life (musculoskeletal and overall), mental health, participation in health care decisions, and management of health care. Hospital-reported resource use will be collected for the 12 months prior to baseline. No additional procedures for the purpose of the study will take place at the baseline visit.

Patients will then be randomised 1:1 into either PIFU or standard care with routine remote or face-to-face follow-up appointments at 6-12 months in accordance with local practice. Patients randomised into the PIFU arm will be provided with information about PIFU and how to access rheumatology follow-up care if they become unwell due to their arthritis. The study team will not be blinded to intervention but the protocol requests, but does not insist on, a blinded assessor for participants' disease activity score which is assessed at the beginning of the start and month 24 of the study.

At week 1, all patients will be asked to complete remote, self-reported questionnaires about the decision-making process relating to taking part in the study as well as questions about time spent accessing patient education materials about managing their care.

At 6-8 weeks and 11 months, a member of the study team will confirm that patients have been assigned to the correct pathway (PIFU or standard care).

At months 6, 12 and 18 all patients will be asked to complete remote, self-reported questionnaires to assess quality of life, costs relating to medical care for their arthritis and flare information for the previous 6 months.

At 24 months, all patients will be seen in their rheumatology outpatient clinic as part of routine care for both PIFU and standard care. Patients will have been sent questionnaires to be completed remotely ahead of their visit. Clinical data from their visit will be recorded. Clinical data from patients' routine care will also be collected from their medical notes (disease activity score including a physical exam and CRP measurement from blood draw). At 24 months, hospital-reported flare information and resource use will be collected for the duration of the study.

The recruitment target of 438 participants allows for a 20% crossover/dropout rate. No interim analysis is planned but an independent data monitoring committee will review data every 6-12 months. Additionally, PROMS completion rates will be reported monthly to the TMG by the trial management group.

The grant includes a qualitative sub-study led by Prof Emma Dures from The University of the West of England, Bristol. She is a co-applicant on the main NIHR grant (also sponsored by Oxford University). She will lead both the anonymous survey to understand why potential participants choose not to take part in the TaILOR randomised clinical study (described in the following paragraph) and the qualitative interviews.

Patients who decline the study will be offered the opportunity to complete an anonymous electronic or paper survey. The survey aims to help us understand the reasons for not wanting to take part in the study as well as understand the demographics of these patients. As this is an anonymous survey that will not be collecting identifiable information, respondents will not be consented for this activity. Sites will provide the survey to patients who decline to take part (either via e-survey or paper survey to be posted back to CTU). No personal data will be collected.

The qualitative sub-study (interviews) aims to further understand the acceptability of PIFU by patients, healthcare professionals and administrators. Participants in the main study will be given the option to consent to be contacted by the qualitative team about taking part in interviews. Of those that consent to be contacted, 30-45 participants will be selected for interviews to take place at 2-12 weeks and/or 16-24 months post-randomisation. Additionally, 25 healthcare and service professionals from TaiLOR research sites will also be invited to tell us about their experiences with PIFU. These interviews will take place once the associated sites have been open to recruitment for 12 months through the last patient, and last visit. All qualitative interviews will take place over TEAMS or by telephone.

Three patient partners were extensively involved in the design of the study along with a project supported by the British Society for Rheumatology to develop a PIFU manual for hospital sites as well as educational materials for patients. Patient partners were involved in the selection of primary and secondary outcomes, the main metric they wanted was 'good care' where patients were satisfied with their care and disease management.

Four patient partners were involved with the development of the PIS, infographic, patient-facing letters and questionnaires. Specifically, patients provided critical feedback in the phrasing of instructions and questions of PROMS related to specific secondary outcomes. They will provide ongoing support with decisions relating to the execution of the study in relation to recruitment, site support and study burden. They will also assist in the interpretation of overall grant findings and dissemination.
Intervention typeOther
Primary outcome measureMusculoskeletal quality of life is measured using MSK-HQ score over 24 months (measured at baseline, months 6, 12, 18 and 24)
Secondary outcome measures1. Musculoskeletal quality of life is measured using MSK-HQ score at baseline, months 6, 12, 18 and 24
2. Overall health-related quality of life is measured using EQ-5D-5L and EQ-VAS scores at baseline, months 12 and 24
3. Incremental cost measured using patient health resource use and costs at baseline, months 6, 12, 18 and 24
4. Incremental cost measured using hospital-reported health resource use and costs at 12 months prior to baseline through month 24
5. Cost-effectiveness measured using Cost per quality-adjusted life year (QALY) gained over the 24-month time horizon
6. Progression from no treatment to first-line DMARD measured using the proportion of patients starting a first-line DMARD during the study
7. Progression from conventional drugs to biologic therapies measured using the proportion of patients starting a first biologic during the study
8. Disease activity is measured using disease-specific activity score (CDAI, DAS28-CRP, ASDAS, DAPSA) at baseline and 24 months
9. Disease activity is measured using the number of patient-reported flares from baseline to 24 months
10. Disease activity is measured using the number of hospital-reported flares from baseline to 24 months
11. Patient efficacy is measured using perceived efficacy in patient-physician interactions (PEPPI) score at baseline and 24 months
12. Depression is measured using PHQ-4 score at baseline and 24 months
13. Acceptability of PIFU to patients is measured using qualitative methods at Weeks 2-12 and Months 16-24
14. Acceptability of PIFU health professionals/service providers is measured using qualitative methods once the site has been open to recruitment for at least 12 months
Overall study start date01/04/2024
Completion date01/10/2027

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 438; UK Sample Size: 438
Key inclusion criteria1. Age 18 years or over
2. Diagnosis of inflammatory arthritis (RA, PsA, axSpA, undifferentiated arthritis) for at least 2 years
3. Stable disease: defined as a level of disease control that the physician feels is suitable for PIFU; on the same conventional, targeted synthetic or biologic DMARD(s), or no treatment, for at least the previous 3 months; and with no escalation in therapy planned
4. Able to contact the Rheumatology team when required
5. Suitable for PIFU in the opinion of their consultant
6. Willing and able to give consent and comply with study procedures
Key exclusion criteria1. Currently or previously on PIFU for inflammatory arthritis
2. Safeguarding/consent/capacity concerns (using General Medical Council guidance)
3. Health literacy concerns from the treating clinician related to inflammatory arthritis
4. Women who are pregnant or planning to start a family
5. Currently undergoing radiotherapy, immunotherapy or chemotherapy for malignancy
6. Patients on end-of-life care pathways
Date of first enrolment21/03/2025
Date of final enrolment30/09/2025

Locations

Countries of recruitment

  • England
  • Northern Ireland
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Lancashire & South Cumbria NHS Foundation Trust
Sceptre Point
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Belfast City Hospital
51 Lisburn Rd
Belfast
BT9 7AB
United Kingdom
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Gobowen
Oswestry
SY10 7AG
United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Royal Devon University NHS Ft
Barrack Road
Exeter
EX2 5DW
United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
NHS Lothian
Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom
Medway Maritime Hospital
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom
Betsi Cadwaladr University Lhb
Executive Offices, Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Northern General Hospital
Northern General Hospital NHS Trust
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Northampton General Hospital
Northampton General Hospital NHS Trust
Cliftonville
Northampton
NN1 5BD
United Kingdom
NHS Lanarkshire
Kirklands
Fallside Road
Bothwell
Glasgow
G71 8BB
United Kingdom
Westmorland General Hospital
Burton Rd
Kendal
LA9 7RG
United Kingdom
Peterborough City Hospital
Edith Cavell Campus
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Torbay Hospital
Newton Road
Torquay
TQ2 7AA
United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Western Isles
37 South Beach
Stornoway
HS1 2BB
United Kingdom
Royal Cornwall Hospital (treliske)
Treliske
Truro
TR1 3LJ
United Kingdom
Harrogate & District NHS Foundation Trust
Strayside Wing
Harrogate District Hospital
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom
Bedfordshire Hospitals NHS Foundation Trust
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Sponsor information

University of Oxford
Hospital/treatment centre

University Offices
Oxford
OX1 2JD
England
United Kingdom

Email not@available.com
Website https://www.ox.ac.uk
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/10/2028
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe study results will be published in an open-access journal, in accordance with the NIHR’s policy on open-access research. The study will be reported following the Consolidated Standards of Reporting Trials guideline (CONSORT) including any applicable extensions to this. The Template for Intervention Description and Replication (TIDieR) statement will be used for reporting the intervention. Study results will be submitted for publication within 1 year of the end-of-trial date.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Editorial Notes

16/05/2025: The study participating centres Harrogate & District NHS Foundation Trust, Bedfordshire Hospitals NHS Foundation Trust were added.
21/03/2025: The recruitment start date was changed from 03/02/2025 to 21/03/2025.
18/03/2025: Ethics approval date added.
14/01/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).