TY - JOUR
T1 - A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP)
T2 - a pragmatic, parallel-group, individual randomised controlled trial protocol
AU - Bullock, Laurna
AU - Nicholls, Elaine
AU - Cherrington, Andrea
AU - Butler-Walley, Stephanie
AU - Clark, Emma M
AU - Fleming, Jane
AU - Leyland, Sarah
AU - Bentley, Ida
AU - Thomas, Simon
AU - Iglesias-Urrutia, Cynthia P
AU - Webb, David
AU - Smith, Jo
AU - Bathers, Sarah
AU - Lewis, Sarah
AU - Clifford, Angela
AU - Siciliano, Michele
AU - Protheroe, Joanne
AU - Ryan, Sarah
AU - Lefroy, Janet
AU - Dale, Nicky
AU - Hawarden, Ashley
AU - Connacher, Sarah
AU - Horne, Robert
AU - O'Neill, Terence W
AU - Mallen, Christian D
AU - Jinks, Clare
AU - Paskins, Zoe
N1 - Copyright: © 2024 Bullock L et al.
PY - 2024
Y1 - 2024
N2 - 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.TRIAL REGISTRATION: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.
AB - 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.TRIAL REGISTRATION: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.
U2 - 10.3310/nihropenres.13571.1
DO - 10.3310/nihropenres.13571.1
M3 - Article
C2 - 39145101
SN - 2633-4402
VL - 4
SP - 14
JO - NIHR Open Research
JF - NIHR Open Research
ER -