OP2026 Poster Presentations Original Research (32 abstracts)
Clinical effectiveness of a complex intervention (iFraP) designed to improve person-centred care and medicine uptake in Fracture Liaison Services: a randomised controlled trial
Laurna Bullock 1 , Elaine Nicholls 1,2 , Andrea Cherrington 2 , Stephanie Butler-Walley 3 , Emma M Clark 4 , Jane Fleming 5 , Ida Bentley 6 , Simon Thomas 7 , David Webb 2 , Jo Smith 2 , Sarah Lewis 2 , Angela Clifford 8 , Joanne Protheroe 1 , Sarah Ryan 8,9 , Janet Lefroy 1 , Nicky Dale 9 , Ashley Hawarden 1,9 , Sarah Connacher 10 , Robert Horne 11 , Terence W O’Neill 12 , Christian D Mallen 1 , Clare Jinks 1 & Zoe Paskins 1,9
1Centre for Musculoskeletal Health Research, School of Medicine, Keele University, Newcastle under Lyme, United Kingdom;2Keele Clinical Trials Unit, Keele University, Newcastle under Lyme, United Kingdom;3Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom;4Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, United Kingdom;5Cambridge Public Health, University of Cambridge, Cambridge, United Kingdom;6School of Medicine People and Communities Group, Keele University, Newcastle under Lyme, United Kingdom;7Prescribing Decision Support, Cheshire, United Kingdom;8School of Nursing Midwifery, Keele University, Newcastle under Lyme, United Kingdom;9Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust, Stoke on Trent, United Kingdom;10Oxford Fracture Prevention Osteoporosis Service, Oxford University Hospitals NHS Foundations Trust, Oxford, United Kingdom;11Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, United Kingdom;12Centre for Epidemiology vs Arthritis, University of Manchester, Manchester, United Kingdom
Background: The improving Fracture Prevention (iFraP) trial compared the clinical effectiveness of the iFraP intervention (advanced consultation skills clinician training; patient and clinician decision support tool; written information resources) with usual Fracture Liaison Service (FLS) care.
Methods: iFraP was a pragmatic, parallel-group, individual randomised controlled trial conducted in four FLS in England. Participants, eligible for FLS care, were randomised equally to receive the iFraP intervention (iFraP-i) or usual care (UC). Outcomes were collected postally/electronically at 2 weeks and 3 months, and by medical records at 3 months. The primary outcome was self-reported ease in medicine decision-making (2 weeks), measured using the decisional conflict scale (DCS, 0-100). Secondary outcomes included patient reported experience measures, beliefs about illness and medicines, and medicine use. 200 participants receiving a medicine recommendation were required to detect an effect size of 0.4 in the DCS between arms, with 80% power (5% two-tailed significance level). Primary analysis was by analysis of covariance (treatment policy approach). The statistician was blind to treatment allocation.
Results: 347 participants were recruited and attended their FLS consultation (85% female, mean age 67 years, 100% white ethnicity), 168 to iFraP-i and 179 to UC, 213 of whom received a medicine recommendation. Follow-up completion rates were 88% at 2 weeks, 80% at 3 months. Less decisional conflict about medicines was seen in iFraP-i compared with UC (adjusted mean difference -8.62, 95% CI (-14.17,-3.07), P 0.002). A statistically significant difference was seen in favour of iFraP-i compared to UC in perceived person-centred care, satisfaction with verbal and written information, and satisfaction with information about medicines. A greater proportion of iFraP-i participants had perceptions of their fracture risk that aligned with their FRAX score. After iFraP-i consultations, participants reported greater increased worry about future falls and fractures. There was no statistically significant difference in medicine use between iFraP-i and UC. iFraP-i participants had higher ratings of medicine necessity relative to concerns after the iFraP consultation.
Conclusion: The iFraP intervention improves ease in decision-making about medicines, person-centred care, and patient experience in FLS. Longer-term data, and in more diverse groups are needed.
Trial Registration: ISRCTN10606407
Volume 8
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