Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study [version 3; peer review: 2 approved, 1 approved with reservations]

Background High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. The improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes. Methods We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation. Discussion The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407