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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

Authors

Andrea Cherrington

Stephanie Butler-Walley

Emma M Clark

Jane Fleming

Sarah Leyland

Ida Bentley

Simon Thomas

Cynthia P Iglesias-Urrutia

David Webb

Jo Smith

Sarah Bathers

Sarah Lewis

Michele Siciliano

Sarah Ryan

Nicky Dale

Sarah Connacher

Robert Horne

Terence W O'Neill

Christian D Mallen



Abstract

Background
Good 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.

Methods
The 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.

Discussion
The 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.

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, https://doi.org/10.3310/nihropenres.13571.2

Journal Article Type Article
Acceptance Date Oct 2, 2024
Publication Date 2024
Deposit Date Jan 7, 2025
Journal NIHR Open Research
Print ISSN 2633-4402
Publisher Taylor and Francis
Peer Reviewed Peer Reviewed
DOI https://doi.org/10.3310/nihropenres.13571.2
Public URL https://keele-repository.worktribe.com/output/1021807