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Background: People with inflammatory rheumatological conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica and giant cell arteritis are at an increased risk of common comorbidities including cardiovascular disease, osteoporosis and mood problems, leading to increased morbidity and mortality. Identifying and treating these problems could lead to improved patient quality of life and outcomes. Despite these risks being well-established, patients currently are not systematically targeted for management interventions for these morbidities. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) of a nurse-led integrated care review in primary care to identify and manage these morbidities. Methods: A pilot cluster RCT was delivered across four UK general practices. Patients with a diagnostic Read code for one of the inflammatory rheumatological conditions of interest were recruited by post. In intervention practices (n = 2), eligible patients were invited to attend the INCLUDE review. Outcome measures included health-related quality of life (EQ-5D-5L), patient activation, self-efficacy and treatment burden. A sample (n = 24) of INCLUDE review consultations were audio-recorded and assessed against a fidelity checklist. Results: 453/789 (57%) patients responded to the invitation, although 114/453 (25%) were excluded as they either did not fulfil eligibility criteria or failed to provide full written consent. In the intervention practices, uptake of the INCLUDE review was high at 72%. Retention at 3 and 6 months both reached pre-specified success criteria. Participants in intervention practices had more primary care contacts than controls (mean 29 vs 22) over the 12 months, with higher prescribing of all relevant medication classes in participants in intervention practices, particularly so for osteoporosis medication (baseline 29% vs 12 month 46%). The intervention was delivered with fidelity, although potential areas for improvement were identified. Conclusions: The findings of this pilot study suggest it is feasible to deliver an RCT of the nurse-led integrated care (INCLUDE) review in primary care. A significant morbidity burden was identified. Early results suggest the INCLUDE review was associated with changes in practice. Lessons have been learnt around Read codes for patient identification and refining the nurse training. Trial registration: ISRCTN, ISRCTN12765345 [ABSTRACT FROM AUTHOR]

Background: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack)., Methods: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486., Findings: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care., Interpretation: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice., Funding: National Institute for Health and Care Research Health Technology Assessment (16/111/78)., Competing Interests: Declaration of interests LCR reports an educational grant from Pfizer held by their institute; consulting fees from the Musculoskeletal Association of Chartered Physiotherapists; and meeting support from Eurospine. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)