A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol.

Bullock, Laurna; Nicholls, Elaine; Cherrington, Andrea; Butler-Walley, Stephanie; Clark, Emma M; Fleming, Jane; Leyland, Sarah; Bentley, Ida; Thomas, Simon; Iglesias-Urrutia, Cynthia P; Webb, David; Smith, Jo; Bathers, Sarah; Lewis, Sarah; Clifford, Angela; Siciliano, Michele; Protheroe, Joanne; Ryan, Sarah; Lefroy, Janet; Dale, Nicky; Hawarden, Ashley; Connacher, Sarah; Horne, Robert; O'Neill, Terence W; Mallen, Christian D; Jinks, Clare; Paskins, Zoe

Abstract

BackgroundGood quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person's life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations.Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation.MethodsThe iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics.DiscussionThe iFraP trial will answer important questions about the effectiveness of the new 'iFraP' osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines.Trial registration isrctn10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.

Citation

Bullock, L., Nicholls, E., Cherrington, A., Butler-Walley, S., Clark, E. M., Fleming, J., …Paskins, Z. (2024). A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol. NIHR Open Research, 4(14), 14. https://doi.org/10.3310/nihropenres.13571.1

• Journal Article Type: Article
• Acceptance Date: Apr 2, 2024
• Online Publication Date: Apr 2, 2024
• Publication Date: Jan 1, 2024
• Deposit Date: Jun 4, 2024
• Publicly Available Date: Jun 4, 2024
• Journal: NIHR open research
• Print ISSN: 2633-4402
• Electronic ISSN: 2633-4402
• Publisher: Taylor and Francis
• Peer Reviewed: Peer Reviewed
• Volume: 4
• Issue: 14
• Pages: 14
• DOI: https://doi.org/10.3310/nihropenres.13571.1
• Keywords: Osteoporosis, Shared Decision-making, Randomised Controlled Trial, Decision Aid, Fracture Liaison Service, Ifrap
• Public URL: https://keele-repository.worktribe.com/output/845892
• PMID: 39145101
• Additional Information: Referee status: Indexed; Referee Report: 10.3310/nihropenres.14731.r31771, Kathlene Camp, University of North Texas Health Science Center, Fort Worth, 18 May 2024, version 1, indexed; Referee Report: 10.3310/nihropenres.14731.r31549, Li Shean Toh, University of Nottingham, Nottingham, England, 24 May 2024, version 1, indexed; Grant Information: This work was supported by National Institute for Health and Care Research Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.; Copyright: This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.