Samantha L Hider1,2, Milica Bucknall3,4, Clare Jinks3,5, Kelly Cooke6, Kendra Cooke4, Erandie Ediriweera Desilva3,7, Andrew G Finney3,8, Emma L Healey3, Daniel Herron3, Annabelle R Machin3, Christian D Mallen3,5,9, Simon Wathall3, Carolyn A Chew-Graham3,5,9. 1. School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK. s.hider@keele.ac.uk. 2. Haywood Academic Rheumatology Centre, Midlands Partnership Foundation Trust, Stoke on Trent, Staffordshire, ST6 7AG, UK. s.hider@keele.ac.uk. 3. School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK. 4. Keele Clinical Trials Unit, Keele University, Stoke on Trent, UK. 5. National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, Keele, Stoke on Trent, Staffordshire, UK. 6. Haywood Academic Rheumatology Centre, Midlands Partnership Foundation Trust, Stoke on Trent, Staffordshire, ST6 7AG, UK. 7. Family Medicine Unit, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. 8. School of Nursing and Midwifery, Keele University, Clinical Education Centre, University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital, Stoke-on-Trent, ST4 6QG, UK. 9. Midlands Partnership Foundation Trust, Stafford, Staffordshire, ST16 3SR, UK.
Abstract
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.
RCT Entities:
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.
Authors: Kerry N L Avery; Paula R Williamson; Carrol Gamble; Elaine O'Connell Francischetto; Chris Metcalfe; Peter Davidson; Hywel Williams; Jane M Blazeby Journal: BMJ Open Date: 2017-02-17 Impact factor: 2.692
Authors: Richard Partington; Toby Helliwell; Sara Muller; Alyshah Abdul Sultan; Christian Mallen Journal: Arthritis Res Ther Date: 2018-11-20 Impact factor: 5.156