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

Bullock, Laurna; Cherrington, Andrea; Clark, Emma M; Fleming, Jane; Bentley, Ida; Nicholls, Elaine; Webb, David; Smith, Jo; Bathers, Sarah; Lewis, Sarah; Horne, Robert; O'Neill, Terence W; Mallen, Christian D; Jinks, Clare; Paskins, Zoe

Abstract

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.

Citation

Bullock, L., Cherrington, A., Clark, E. M., Fleming, J., Bentley, I., Nicholls, E., …Paskins, Z. (in press). 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. NIHR Open Research, 4, 70. https://doi.org/10.3310/nihropenres.13751.1

• Journal Article Type: Article
• Acceptance Date: Nov 13, 2024
• Online Publication Date: Nov 13, 2024
• Deposit Date: Nov 20, 2024
• Journal: NIHR Open Research
• Print ISSN: 2633-4402
• Publisher: Taylor and Francis
• Peer Reviewed: Peer Reviewed
• Volume: 4
• Pages: 70
• DOI: https://doi.org/10.3310/nihropenres.13751.1
• Keywords: Shared decision-making, decision aid, osteoporosis, randomised controlled trial, Fracture Liaison Service, iFraP, process evaluation, implementation
• Public URL: https://keele-repository.worktribe.com/output/979633
• Publisher URL: https://openresearch.nihr.ac.uk/articles/4-70/v1
• Additional Information: Referee status: Awaiting Peer Review; Grant Information: This project is funded by the National Institute for Health and Care Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy]. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the Department of Health and Social Care.; This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. 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.