Objectives The improving uptake of Fracture Prevention treatments (iFraP) intervention consists of an osteoporosis decision support tool (DST), clinician skills training, and information resources, to improve shared decision-making (SDM) about, and uptake of, osteoporosis medicines in Fracture Liaison Services (FLS). This paper details the development and feasibility of the prototype intervention.

Methods Intervention development was underpinned by (1) theories of SDM, medicines adherence, and behaviour change; (2) integrated findings from six discrete development studies; and (3) extensive public contributor, patient, and clinician contribution to identify key ‘needs’ for the intervention to address and the intervention’s content, functionality and scope.

Feasibility testing was conducted at one FLS. Intervention consultations were observed and audio recorded, and interviews completed with FLS clinicians and patients to explore perceived acceptability and feasibility.

Results Intervention development identified patient and clinician unmet needs for personalised and evidence-based information about osteoporosis, its consequences, and its treatment within and after FLS consultations, to facilitate clinical and SDM about medicines. The prototype intervention was designed to meet identified needs and overcome barriers to use.

Clinicians delivered the prototype iFraP intervention in 10 consultations with consenting patients. Findings demonstrated that the intervention was acceptable and feasible to deliver, with potential to improve patient outcomes. The intervention was refined to support implementation.

Conclusion The multi-facilitated approach to intervention development and testing ensured that the iFraP intervention was acceptable and feasible for use in UK FLS to support SDM about osteoporosis medicines. The iFraP trial will evaluate implementation, and cost and clinical effectiveness.

Key messages

Verbal and written communications concerning osteoporosis are currently confusing, technical and impede decision-making and medicine uptake

Key barriers to implementing shared decision-making and decision aids include clinician goals, professional roles and contextual factors

A decision tool with clinician training and information resources was co-designed, acceptable, and addressed identified needs and barriers

Keele University has received sponsorship from UCB Pharma. ZP has received consultancy for non-promotional activity from UCB Pharma. CDM is funded by grants from the NIHR and is Director of the NIHR School for Primary Care Research. SHR reports research funding to his institution from the Royal Osteoporosis Society, the Kennedy Trust, Kyowa Kirin, and UCB, outside the submitted work and unrestricted educational grants from Pfizer, Abbvie, Kyowa Kirin, Alexion, Amgen, Cellgene, Bristol Myers Squibb, Janssen-Cilag, Novartis, Eli Lilly, Thornton & Ross, Sanofi Genzyme, Sandoz and Roche, outside the submitted work. EMC is a Trustee of the Royal Osteoporosis Society.

The iFraP intervention development and feasibility work was funded by the National Institute for Health and Care Research (CS-2018-18-ST2-010)/NIHR Academy], the Royal Osteoporosis Society, and Haywood Foundation. This study presents independent research funded by the NIHR. The views expressed are those of the author(s) and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health and Social Care.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical permission for the iFraP development and feasibility studies was given by North West-Greater Manchester West Research Ethics Committee (reference number: 19/NW/0559).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

All data produced in the present study are available upon reasonable request to the authors