Improving uptake of Fracture Prevention drug treatments: a protocol for Development of a consultation intervention (iFraP-D).

Introduction: Prevention of fragility fractures, a source of significant economic and personal burden, is hindered by poor uptake of fracture prevention medicines. Enhancing communication of scientific evidence and elicitation of patient medication-related beliefs has the potential to increase patient commitment to treatment. The I mproving uptake of Fra cture P revention drug treatments (iFraP) programme aims to develop and evaluate a theoretically informed, complex intervention consisting of a computerised web-based decision support tool, training package and information resources, to facilitate informed decision-making about fracture prevention treatment, with a long-term aim of improving informed treatment adherence. This protocol focuses on the iFraP D evelopment (iFraP-D) work.
Methods and Analysis: The approach to iFraP-D is informed by the Medical Research Council complex intervention development and evaluation framework and the three-step implementation of change model. The context for the study is UK fracture liaison services (FLS), which enact secondary fracture prevention. An evidence synthesis of clinical guidelines and Delphi exercise will be conducted to identify content for the intervention. Focus groups with patients, FLS clinicians and general practitioners and a usual care survey will facilitate understanding of current practice, and investigate barriers and facilitators to change. Design of the iFraP intervention will be informed by decision aid development standards and theories of implementation, behaviour change, acceptability and medicines adherence. The principles of co-design will underpin all elements of the study through a dedicated iFraP community of practice including key stakeholders and patient advisory groups. In-practice testing of the prototype intervention will inform revisions ready for further testing in a subsequent pilot and feasibility randomised trial.
Ethics and Dissemination: Ethical approval was obtained from North West-Greater Manchester West Research Ethics Committee (19/NW/0559). Dissemination and knowledge mobilisation will be facilitated through national bodies and networks, publications and presentations.
Trial Registration Number: researchregistry5041.
Competing Interests: Competing interests: ZP reports grants from the NIHR Clinician Scientist Award (CS-2018-18-ST2-010), Royal Osteoporosis Society and the Haywood Rheumatology Research and Development Foundation to conduct this study. CJ reports funding from the NIHR Applied Research Collaboration (ARC) West Midlands; CM reports grants from the NIHR Research Professorship in General Practice (NIHR-RP-2014-04-026), the NIHR School for Primary Care Research and NIHR Applied Research Collaborations (West Midlands), Wellcome, Medical Research Council, Dunhill, Versus Arthritis and Bristol Myer-Squibb, outside the submitted work; FC-M reports grants from NIHR Clinical Research Network Scholar Programme; ST and SRC report receiving funds from National Institute for Health Research (NIHR) (Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy) and the Royal Osteoporosis Society via Prescribing Decision Support Ltd to support the development of the iFraP decision support tool; TWO’N reports grants and non-financial support from AMGEN and the NIHR Manchester Biomedical Research Centre outside the submitted work; CI reports grants from NIHR during the conduct of the study and disclosed being a member of NICE’s Medical Technologies Advisory Committee outside the submitted work; JJE reports grants as a NIHR Academic Clinical Lecturer in Primary Care (CL-2016-10-003). ECo reports grants from Versus Arthritis, NIHR RfPB, HQIP and the Royal Osteoporosis Society.
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