The INCLUDE study
Research type
Research Study
Full title
INCLUDE: INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community: A pilot randomised controlled trial.
IRAS ID
229592
Contact name
Tracy Nevatte
Contact email
ISRCTN Number
ISRCTN12765345
Duration of Study in the UK
1 years, 10 months, 27 days
Research summary
The impact of inflammatory rheumatic conditions, including rheumatoid arthritis (RA) psoriatic arthritis (PsA), ankylosing spondylitis (AS), polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), for patients extends beyond the musculoskeletal system. Patients with these conditions are at an increased risk of common comorbidities such as cardiovascular disease (CVD), osteoporosis and depression.
At present, NICE guidance advocates people with RA should have an “annual review” with a holistic assessment of their condition plus assessment for linked comorbidities (e.g. CVD and osteoporosis). Such an annual review would seem to be one way to improve care for these patients. Even for patients with RA, care is fragmented between primary and secondary care, meaning some tests are done twice, whilst others are missed.
Nurse-led care is increasingly advocated for management of chronic inflammatory arthritis. To date much of this has been delivered in specialist secondary care rheumatology services, but given the multi-morbidity expertise in primary care, developing innovative nurse-led models of care in primary care may improve outcomes for these patients.
The INCLUDE trial is two arm cluster pilot randomised controlled trial to examine the feasibility and acceptability of a nurse-led integrated care review in primary care for patients with inflammatory rheumatological conditions. Approximately 200 participants (100/arm) will be recruited from up to 10 GP practices. Data will be collected from participants on three occasions over six months via postal questionnaires and via a review of GP medical records after 12 months. In addition, participants from intervention practices will be offered an ‘INCLUDE review’ appointment at their practice to screen for associated comorbidities. A sub-sample of these appointments (approximately 20) will be audio-recorded to assess how the intervention was delivered. Intervention participants and practitioners will also be invited to an interview to share their perceptions and experiences of the INCLUDE review.
REC name
Wales REC 5
REC reference
17/WA/0427
Date of REC Opinion
22 Dec 2017
REC opinion
Favourable Opinion