Article Text

Protocol
Improving uptake of Fracture Prevention drug treatments: a protocol for Development of a consultation intervention (iFraP-D)
  1. Zoe Paskins1,2,
  2. Laurna Bullock1,
  3. Fay Crawford-Manning1,2,
  4. Elizabeth Cottrell1,
  5. Jane Fleming3,4,
  6. Sarah Leyland5,
  7. John James Edwards1,
  8. Emma Clark6,
  9. Simon Thomas7,
  10. Stephen Robert Chapman7,
  11. Sarah Ryan2,8,
  12. J E Lefroy1,
  13. Christopher J Gidlow9,
  14. C Iglesias10,11,
  15. Joanne Protheroe1,
  16. Robert Horne12,
  17. Terence W O'Neill13,14,
  18. Christian Mallen1,
  19. Clare Jinks1
  1. 1School of Medicine, Keele University, Keele, UK
  2. 2Haywood Academic Rheumatology Centre, Haywood Hospital, Stoke-on-Trent, UK
  3. 3Cambridge Public Health, University of Cambridge, Cambridge, UK
  4. 4Cambridge University Hospitals NHS Trust, Addenbrooke’s Hospital, Cambridge, UK
  5. 5Royal Osteoporosis Society, Bath, UK
  6. 6Bristol Medical School, University of Bristol, Bristol, UK
  7. 7School of Pharmacy and Bioengineering, Keele University, Stoke-on-Trent, UK
  8. 8School of Medicine & School of Nursing and Midwifery, Keele University, Stoke-on-Trent, UK
  9. 9Centre for Health and Development, Staffordshire University, Stoke-on-Trent, UK
  10. 10Department of Health Sciences, University of York, York, UK
  11. 11Danish Centre for Healthcare Improvements, Aalborg Universitet, Aalborg, Denmark
  12. 12Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK
  13. 13Centre for Epidemiology Versus Arthritis, University of Manchester, Manchester, UK
  14. 14NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK
  1. Correspondence to Dr Zoe Paskins; z.paskins{at}keele.ac.uk

Abstract

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 Improving uptake of Fracture Prevention 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 Development (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.

  • rheumatology
  • musculoskeletal disorders
  • qualitative research
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Footnotes

  • Twitter @iFraP_Study, zpaskins, @f_m_manning, @cottrell_lizzie

  • Contributors ZP conceived the study. ZP, LB, ECo, JF, SL, JJE, ECl, ST, SRC, CJG, CI, TWO'N, CM and CJ reviewed the study design and contributed to study implementation as part of the iFraP Study Management Group. JP and RH contributed to study design as expert study advisors. FC-M will support study set up and data collection. JEL, SL and SR will form the iFraP training development group. ST and SRC will inform design and development of the prototype iFraP CDST. CI will provide health economic expertise. All authors contributed to refinement of the study protocol and approved the final manuscript.

  • Funding This study was funded by the National Institute for Health Research (NIHR) (Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy), the Royal Osteoporosis Society (REF: 430) and the Haywood Rheumatology Research and Development Foundation (not applicable).

  • 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.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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