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
Year: 2024
Type: article
Study design: Study Protocol
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 i mproving uptake of Fra cture P revention 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. Trial registration ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407
Source: NIHR Open Research
Authors: Laurna Bullock, Elaine Nicholls, 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, Angela Clifford, Michele Siciliano, Joanne Protheroe, Sarah Ryan, Janet Lefroy, Nicky Dale, Ashley Hawarden, Sarah Connacher, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Zoe Paskins
Institutions: Keele University, Cancer Research UK Clinical Trials Unit, University of Birmingham, University of Bristol, University of Cambridge, Addenbrooke's Hospital, Royal Osteoporosis Society, University of York, Aalborg University, Midlands Partnership NHS Foundation Trust, Oxford University Hospitals NHS Trust, UCL School of Pharmacy, University College London, University of Manchester, Manchester University NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, Centre for Epidemiology Versus Arthritis
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4403067518