Title: Improving uptake of Fracture Prevention Treatments (iFRAP): Development and evaluation of a consultation intervention
Funder: Department of Health and Social Care

Abstract: BackgroundOne 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.AimsThis 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.MethodsThree workpackages (WPs) are planned and adhere to the Medical Research Council guidance for development and evaluation of complex interventions.WP1: months 1-12We 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 13-24The 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 25-60An 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 disseminationThe 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.

Lay abstract: Background Fragility fractures occur from events that would not normally result in a broken bone. They are fractures in people aged 50 years and over, after a fall from standing height or less. 1 in 5 men and 1 in 2 women will experience fragility fracture(s) in their lifetime. For people who experience them, these fractures can result in significant disability, pain and increased risk of loss of independence and death. These fractures costs the NHS 4.4 billion a year. Many people who experience a fragility fracture do not start the recommended treatment to prevent future fractures. Of those who start treatment, less than half continue taking treatment for more than one year. Sometimes this is because they are unsure what they are for, are confused about fracture 'risk' and/or are worried about side-effects. Healthcare professionals (HCPs) need to communicate the risks and benefits clearly. However, patients often feel information from HCPs is lacking and have rated this as the most important area for research. 'Decision-support tools' can support HCPs to know when to suggest medicines and can help HCPs and patients talk together to make decisions. We want to develop and test a web-based tool that can be used in consultations. This tool will include pictures to better describe a patient's personal fracture risk, how this risk would improve with treatment, and explain the possible harms of treatment. We will also develop training for HCPs to ensure the information they are giving is understandable, that they address patient concerns, and that they give clear, consistent information during the consultation. The decision-support tool and training package together are called the iFRAP intervention. The iFRAP intervention will be designed for any HCP, including GPs, to use with patients. However, we will test the intervention in dedicated fracture prevention services first (Fracture Liaison Services). It will be easier to test the intervention in this setting because all consultations are about fracture prevention. Methods The proposal is split into 3 workpackages (WPs). WP1. We will decide what important messages need to be included in the training for HCPs and the decision-support tool. We will do this by reviewing guidelines for HCPs and holding discussion groups with GPs, fracture prevention nurses, hospital specialists, patients and other relevant experts. We will also conduct a survey of HCPs and patients to finalise the content of the tool and training. We will conduct focus groups to understand patients', GPs' and fracture prevention nurses' experiences, and views of the potential iFRAP intervention. WP2. We will use the results from WP1 to develop the decision-support tool and training. The decision-support tool will undergo testing with patients and nurses. This will make sure it works, and makes sense to HCPs and patients. WP3. A trial in eight Fracture Liaison Services with approximately 302 patients will find out how well nurses deliver the iFRAP intervention and whether it is acceptable and practical to deliver. We will measure patient knowledge, satisfaction, whether patients take fracture prevention medication after the consultation, and side effects. We will make improvements based on the results.Outputs If successful, the iFRAP intervention will benefit patients and the NHS by: improving patient knowledge and satisfaction increasing the numbers of people with fragility fractures who start and continue fracture prevention medication reducing fragility fractures reducing costs to the NHS of fragility fractures reducing disability and death associated with fragility fracturesWe will involve patients throughout this research to: advise on developing the iFRAP intervention help design study documents oversee the running and reporting of the studies advise on easily understandable messages to publicise study findings.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS;7.1 INDIVIDUAL CARE NEEDS
Health categories: INJURIES AND ACCIDENTS