Improving uptake of Fracture Prevention Treatments (iFRAP): Development and evaluation of a consultation intervention

Background One in two women and one in five men aged 50 and over will experience one or more fragility fractures in their lifetime. These fractures, which include fractures of the hip, spine and wrist, result in significant disability, increased risk of mortality, many unplanned admissions, and cost the UK economy £4.4 billion per annum. Prevention of fractures is therefore a Public Health England priority area; effective treatments exist for patients deemed at high risk of fracture, but many patients do not start or continue these treatments, even when bespoke fracture prevention services (FLS) exist. Qualitative research demonstrates that poor medication compliance is often driven by misconceptions about the purpose of fracture prevention treatment and bone fragility (osteoporosis), and that patients do not understand their personal fracture risk assessments, all indicating suboptimal communication in the consultation. Furthermore, patients with fractures and osteoporosis have rated 'access to information from health professionals' as the number one priority for research in a national study. Decision-support tools (DSTs) are a well-recognised mechanism by which to enhance communication - particularly of risks (of prognosis, treatment benefits and harms) - and are known to improve patient knowledge, satisfaction and uptake of preventative treatments. However existing fracture prevention DSTs are not being used in practice and do not meet patient needs. Aims This study aims to develop and evaluate the iFRAP intervention: a theoretically-informed complex intervention, including a computerised (C)DST, enhanced consultation and clinician training, to enhance the communication of individualised fracture risk and, benefits and harms of fracture prevention medication in the consultation. Methods Three workpackages (WPs) are planned and adhere to the Medical Research Council guidance for development and evaluation of complex interventions. WP1: months 1-12 We will use a review of evidence (guidelines and existing systematic reviews), knowledge of stakeholders and a Delphi exercise to derive content for the intervention and use qualitative research to understand the context, and barriers and facilitators to implementation. WP2: months 13-24 The intervention components will be developed based on findings from WP1. The CDST will be web-based, and informed by evidence and fracture risk as calculated in existing algorithms. A training programme will be developed and the integrated intervention will be refined using in-practice testing and qualitative methods. WP3: months 25-60 An exploratory pilot and feasibility cluster randomised controlled trial with eight fracture prevention services will investigate the feasibility, acceptability and fidelity of the intervention. A parallel process evaluation will examine quantity and quality of what is delivered in practice and a health economic study, including value of information analysis, will establish if information derived from the pilot is sufficient for decision-making or whether a further full trial is justified. Anticipated impact and dissemination The hypothesis is that the iFRAP intervention will lead to increased patient knowledge, self-efficacy, participation and improved rates of treatment initiation and long-term treatment persistence, ultimately leading to fewer fragility fractures. Patient partners, Keele's Impact Accelerator Unit, the National Osteoporosis Society and other stakeholders will be actively engaged in widespread dissemination of the findings.