Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study

Keywords Shared decision-making, decision aid, osteoporosis, randomised controlled trial, Fracture Liaison Service, iFraP, process evaluation, implementation ALL Metrics - Views Downloads How to cite this article Bullock L, Cherrington A, Clark EM et al. Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study [version 1; peer review: 1 approved]. NIHR Open Res 2024, 4:70 (https://doi.org/10.3310/nihropenres.13751.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol [version 1; peer review: 1 approved] Laurna Bullock https://orcid.org/0000-0002-4193-1835 1, Andrea Cherrington2, Emma M Clark https://orcid.org/0000-0001-8332-9052 3, [...] Jane Fleming https://orcid.org/0000-0002-8127-2061 4,5, Ida Bentley6, Elaine Nicholls1,2, David Webb https://orcid.org/0009-0009-9313-385X 2, Jo Smith https://orcid.org/0009-0007-9030-4110 2, Sarah Bathers2, Sarah Lewis https://orcid.org/0000-0003-3992-6938 2, Robert Horne7, Terence W O'Neill8,9, Christian D Mallen https://orcid.org/0000-0002-2677-1028 1, Clare Jinks1, Zoe Paskins https://orcid.org/0000-0002-7783-2986 1,10Laurna Bullock https://orcid.org/0000-0002-4193-1835 1, Andrea Cherrington2, [...] Emma M Clark https://orcid.org/0000-0001-8332-9052 3, Jane Fleming https://orcid.org/0000-0002-8127-2061 4,5, Ida Bentley6, Elaine Nicholls1,2, David Webb https://orcid.org/0009-0009-9313-385X 2, Jo Smith https://orcid.org/0009-0007-9030-4110 2, Sarah Bathers2, Sarah Lewis https://orcid.org/0000-0003-3992-6938 2, Robert Horne7, Terence W O'Neill8,9, Christian D Mallen https://orcid.org/0000-0002-2677-1028 1, Clare Jinks1, Zoe Paskins https://orcid.org/0000-0002-7783-2986 1,10 PUBLISHED 13 Nov 2024 Author details Author details 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University, Newcastle under Lyme, England, UK 2 Keele Clinical Trials Unit, Keele University, Newcastle under Lyme, England, UK 3 Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK 4 Cambridge Public Health, University of Cambridge, Cambridge, UK 5 Addenbrooke’s Hospital Fracture Liaison Service, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK 6 School of Medicine Research User Group, Keele University, Newcastle under Lyme, England, UK 7 Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, England, UK 8 Centre for Epidemiology Versus Arthritis, The University of Manchester, Manchester, England, UK 9 NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK 10 Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust, Stoke-on-Trent, UK 2 Keele Clinical Trials Unit, Keele University, Newcastle under Lyme, England, UK 3 Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK 4 Cambridge Public Health, University of Cambridge, Cambridge, UK 5 Addenbrooke’s Hospital Fracture Liaison Service, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK 6 School of Medicine Research User Group, Keele University, Newcastle under Lyme, England, UK 7 Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, England, UK 8 Centre for Epidemiology Versus Arthritis, The University of Manchester, Manchester, England, UK 9 NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK 10 Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust, Stoke-on-Trent, UK Laurna Bullock Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Andrea Cherrington Roles: Methodology, Project Administration, Software, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Project Administration, Software, Writing – Original Draft Preparation, Writing – Review & Editing Emma M Clark Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Jane Fleming Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Ida Bentley Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Elaine Nicholls Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing David Webb Roles: Investigation, Project Administration, Software, Writing – Review & Editing Roles: Investigation, Project Administration, Software, Writing – Review & Editing Jo Smith Roles: Project Administration, Resources, Software, Writing – Review & Editing Roles: Project Administration, Resources, Software, Writing – Review & Editing Sarah Bathers Roles: Methodology, Project Administration, Resources, Software, Writing – Review & Editing Roles: Methodology, Project Administration, Resources, Software, Writing – Review & Editing Sarah Lewis Roles: Project Administration, Resources, Software, Writing – Review & Editing Roles: Project Administration, Resources, Software, Writing – Review & Editing Robert Horne Roles: Resources, Writing – Review & Editing Roles: Resources, Writing – Review & Editing Terence W O'Neill Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Christian D Mallen Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Clare Jinks Roles: Methodology, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Zoe Paskins Roles: Conceptualization, Funding Acquisition, Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. The improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes. We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation. The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice. ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407 Fragility fractures (or broken bones) can result in significant disability and loss of independence and confidence. Many people who have osteoporosis are not offered, do not start, or do not continue to take medicine to reduce the chance of fractures. Sometimes this is because people with osteoporosis are concerned about the medicine side effects or are unsure about what the benefits are. To address this, we developed the ‘iFraP intervention’: 1. The iFraP ‘decision support tool’: to support patients and healthcare professionals talk together to make decisions about osteoporosis medicines 2. iFraP training for healthcare professionals to: a.use the tool in appointments with patients b.give understandable, clear and consistent information c.listen to and address patient concerns The iFraP intervention is being tested in a randomised controlled trial to see if it improves decision-making about osteoporosis medicines. Alongside the trial, this process evaluation will answer questions, such as: How do healthcare professionals use the tool and training? What factors influence this? What do patients and healthcare professionals think of the tool? What do healthcare professionals think of the training? What parts of the tool and training work (or do not work)? What factors influence this? Does the tool help patients and healthcare professionals to make decisions about osteoporosis medicines, and how? We will use the range of approaches: Video/audio-recorded appointments Interviews with patients and healthcare professionals Questionnaires completed by patients Information about if, and how, the tool is used in consultations Findings from each approach will be combined to learn about the iFraP intervention. This process evaluation will help to understand how the iFraP intervention was used and why, how the intervention works (or not), and factors that influence this. Findings will help to learn about how decision support tools can be used in practice. Shared decision-making, decision aid, osteoporosis, randomised controlled trial, Fracture Liaison Service, iFraP, process evaluation, implementation Corresponding Author(s) Zoe Paskins ([email protected]) Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy]. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the Department of Health and Social Care. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2024 Bullock L et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Bullock L, Cherrington A, Clark EM et al. Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study [version 1; peer review: 1 approved]. NIHR Open Res 2024, 4:70 (https://doi.org/10.3310/nihropenres.13751.1) First published: 13 Nov 2024, 4:70 (https://doi.org/10.3310/nihropenres.13751.1) Latest published: 02 Apr 2026, 4:70 (https://doi.org/10.3310/nihropenres.13751.3) This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. There is a newer version of this article available. of this article available. Shared decision-making involves the patient and clinician working together to make decisions based on evidence (including risks, benefits, and possible treatment options) and the patient’s life, preferences, beliefs, and values1. For people with osteoporosis and/or high fracture risk, evidence-based medicines, such as bisphosphonates, are recommended by the National Institute for Health and Care Excellence (NICE)2. Despite being inexpensive, cost-effective, readily available and effective at reducing fracture risk, 25% of people who are offered medication decline it (non-initiation)3. Among those who are recommended osteoporosis medicines at specialist Fracture Liaison Services (FLSs; sometimes referred to as Fracture ‘Prevention’ Services), few persist for long enough for it to be effective, with persistence estimated at 28% at one-year post-fracture4. Low levels of osteoporosis medicine initiation and persistence, collectively described as ‘adherence’5, are optimised if a person believes that a medicine is necessary, relevant, safe, and practicable6. This demonstrates how shared decision-making has the potential to support osteoporosis medicine adherence7,8, by ensuring that the medicine is a good ‘fit’ for the patient9. NICE’s shared decision-making guidelines recommend that, where available, clinicians should use ‘tools’ to implement shared decision-making – often called decision aids (DAs), conversation aids, or decision support tools (DSTs) - as one part of a ‘toolkit’ alongside other clinician skills1. DSTs are a well-recognised mechanism to support shared decision-making7, however, several unanswered questions remain regarding the effectiveness and implementation of DSTs. Further research has been called for to explore if and how DSTs promote meaningful patient involvement in healthcare decisions10, highlighting the need to further investigate the mechanisms of impact that underpin the effectiveness of DSTs. Furthermore, despite availability of many DSTs7 (including osteoporosis DSTs11), the existence of high-quality evidence supporting the use of DSTs to facilitate shared decision-making7, and shared decision-making being an NHS public health priority12, implementation of DSTs in clinical practice is poor13. A recent survey found that 79% of patient DSTs were not implemented into clinical practice following published randomised controlled trials13, with limited research providing an in-depth investigation of DST implementation14. Barriers to implementation that require further exploration include: low perception of quality and maintenance of DSTs; limited awareness, knowledge, and skills to use DSTs; perception that ‘we do shared decision-making already,’ or that ‘patients don’t want shared decision-making’; usability of DSTs with diverse patients; and failing to fit DSTs into the clinical structure or ‘workflow’ alongside competing demands and priorities15,16. Many of these barriers may be linked to the minimal or complete lack of training provided to clinicians to implement DSTs in clinical practice17, with DSTs often described as ‘requiring minimal training for use’. However, to promote successful implementation of shared decision-making in routine clinical practice, it is important those delivering the DST ‘buy in’ to shared decision-making and are provided with adequate shared decision-making skills training18. Remote consultations became more commonplace in the context of COVID1919, accelerating what was already an NHS England priority20. However, there is concern that remote consultations, without proactive efforts to ensure equity, are associated with lower shared decision-making21. Importantly, this would be particularly detrimental to people with existing health disparities, with qualitative research during the pandemic identifying that some patients lack confidence consulting by telephone, likely detrimental to shared decision-making22,23. This is despite evidence suggesting that shared decision-making interventions, such as DSTs, are of more benefit to disadvantaged groups and are therefore a potential mechanism by which to reduce health inequalities24. Limited research to date has evaluated the quality of shared decision-making or the use of DSTs in remote consultations25. The iFraP randomised controlled trial examines the effectiveness of the iFraP intervention compared with usual FLS practice and is the subject of this process evaluation. Protocols outlining the iFraP intervention development and randomised controlled trial are published elsewhere26,27. This paper will therefore only briefly describe the iFraP intervention and trial to give context to the process evaluation design. The context for the iFraP intervention and trial are FLSs in England, UK. FLSs enact secondary fracture prevention by systematically identifying adults aged ≥50 years with fragility fractures and conducting bone health assessments. Services are usually nurse or allied health professional-led and address bone health by assessing the patient's risk of falls and future fracture and providing treatment recommendations to the patient and primary care, at one or more consultations, typically 2 months after the fracture. The iFraP intervention aims to improve patient ease in decision-making about osteoporosis medicines (by increasing the extent that the patient was informed and involved in the consultation), to facilitate shared decision-making. It consists of three core components: 1. The iFraP DST, used on the computer during a face-to-face or telephone FLS consultation. The DST includes clinician decision-support and a patient-facing DA. It is dynamic, interactive, and tailored to the risks and needs of the patient. 2. iFraP Enhanced Consultation Skills Training Course, completed by FLS clinicians. The course includes (1) an interactive eLearning package including modules introducing the intervention and guidance on using the iFraP DST in-practice, risk communication techniques, shared decision-making skills, universal precautions for health literacy and communicating about osteoporosis; and (2) one 3-hour role play session, facilitated by experts in osteoporosis, shared decision-making and consultation communication skills. 3. Information resources (paper and online) for the patient and primary care clinician e.g. General Practitioner (GP) to refer to after the FLS consultation. This includes an individualised A4 PDF output (described as the ‘personal Bone Health Record’) from the iFraP DST. The Bone Health Record is accompanied by a dentist card that the patient can show to their dentist to support conversations about osteoporosis medicine and dental care. The iFraP intervention is being tested in 4 FLSs in England in Stoke-on-Trent, Portsmouth, Wolverhampton and Oxford that decide, recommend, and communicate osteoporosis medicine recommendations to patients. FLS models of care and service provision varies across the UK and consultations are enacted using different communication modalities (remote or face-to-face)28, demonstrating important contextual factors that may influence the implementation of shared decision-making and a DST. Randomised controlled trials often test the effectiveness of multicomponent complex interventions in multisite, pragmatic trials, where there is likely to be variation in how the ‘same’ intervention is implemented. A mixed methods process evaluation collects and combines quantitative and qualitative data to deepen and broaden understanding about the inherent complexity of a complex intervention delivered in complex systems. Mixed methods process evaluations, alongside randomised controlled trials, expand the question from “is the intervention effective?” to “effective for whom, under what circumstances, and why?”29, to address the evidence gap about shared decision-making implementation in different clinical contexts25. This mixed method process evaluation, in line with the Medical Research Council (MRC) guidance30, aims to understand what is implemented and how, how the delivered iFraP intervention produces change (or not), and how context affects implementation of iFraP and outcomes. Specific objectives are to: 1. Investigate (quantitative) and explore (qualitative) how the iFraP intervention is delivered and received, including quantity and quality of implementation (fidelity, dose and adaptation) and explore factors influencing implementation variation, including barriers to, and facilitators of, implementation, such as perceived acceptability (qualitative) 2. Integrate the quantitative results and qualitative findings to draw inferences about the implementation of the iFraP intervention (mixed methods) 3. Investigate (quantitative) and explore (qualitative) the iFraP intervention’s hypothesised mechanisms of impact and outcomes, including contextual factors associated with variability, to test the proposed intervention theory 4. Integrate the quantitative results and qualitative findings to draw inferences about how the iFraP intervention works, including factors associated with variation (mixed methods) The intervention programme theory (or ‘logic model’) details the iFraP intervention resources, hypothesised mechanisms and outcomes, and contextual factors. The iFraP programme theory was developed at the start of the iFraP study based on existing evidence and theories, and further refined iteratively throughout the intervention development work (see Figure 1). The iFraP DST and Enhanced Consultation Skills Training Course targets FLS clinician behaviour change by increasing clinicians’ skills in shared decision-making and clinical decision-making, specifically, increasing their own confidence in communicating risks, health literacy approaches and in eliciting and addressing patient beliefs, preferences and values. By targeting clinician behaviour change, hypothesised mechanisms of action include greater patient involvement in decision-making, satisfaction with information about osteoporosis and bone health, realistic expectations of own fracture risk, and modified illness and treatment perceptions (see Figure 1). These mechanisms of action are, in part, underpinned by the Extended Self-Regulatory Model31, which incorporates both Leventhal’s Common-Sense Model of Illness32 and the Necessity Concerns Framework33, acknowledging the link between illness perceptions, beliefs about medicines and medicine adherence31. Leventhal’s Common-Sense Model of Illness outlines cognitive illness representations that, together, help people to ‘make sense’ of their illness. In osteoporosis research, it’s common for people to not understand their bone health (illness coherence)34 and have low perceptions about how controllable osteoporosis is (illness controllability)34 e.g. thinking that osteoporosis is an inevitable part of ageing. The Necessity Concerns Framework informs the UK’s National Institute for Health and Care Excellence (NICE) guidance on medicines adherence6, postulating that when patients make decisions about taking a prescribed medicine, they weigh up their perceived need for the medicine (necessity beliefs) against concerns that they have about their medicine (concern beliefs). Evidence suggests that eliciting and addressing patient illness perceptions and beliefs about medicines as part of a shared decision-making conversation can promote medicine commitment, by ensuring that the medicine is a good ‘fit’ for the patient. In response to intervention development work findings about the importance of having better integration between specialist (FLS) and primary and other healthcare35, the iFraP intervention resources also include an individualised patient information leaflet (known as the ‘personalised Bone Health Record’) to be given/sent to the patient and their GP after the FLS consultation, and a card which patients can show their dentist, if they are recommended osteoporosis medicines. These resources are hypothesised to improve the consistency of messages across primary care, dentistry, FLS and other social networks. The iFraP intervention together is hypothesised to produce outcomes, including patient lifestyle changes for improved bone health and osteoporosis medicine uptake, ultimately reducing fractures. The intervention programme theory also lists candidate contextual factors that may be associated with expected outcomes, identified in the intervention development work, including variation in FLS models of care28, adherence as key performance indicators of services35, and the influence of media and wider societal perceptions of osteoporosis on health behaviours. To help with the development and delivery of the intervention, a group of public contributors with osteoporosis and their carers was convened. Public contributors met throughout the iFraP intervention development work and continue to meet throughout the randomised controlled trial. Involvement of public contributors throughout the iFraP study has been described elsewhere26,27. Dedicated public involvement meetings helped to design the process evaluation and will continue to guide data collection, interpretation and dissemination. Communities of Practice (CoPs) bring together expertise with a common concern or interest, with the aim of improving and learning to do better through regular group interaction36. iFraP CoP members include FLS clinicians, GPs, osteoporosis specialists, patients with experience of using osteoporosis medicines (supported by a public involvement worker), representatives from the Royal Osteoporosis Society (ROS) and Health Literacy UK and a behaviour change expert. The iFraP CoP met regularly throughout intervention development and will continue to meet during the iFraP trial and process evaluation (e.g. to discuss findings, knowledge mobilisation and dissemination). The MRC process evaluation guidelines outline the need to be transparent about the degree of separation or integration between process and outcome evaluation teams30. In this study, the process evaluation team will work separately to prevent biasing interpretations. This means that the quantitative and qualitative data collection and analysis presented below will be conducted concurrently by the appropriate evaluation team and only brought together during mixed methods data integration. An overview of process evaluation data collection methods alongside trial procedures is presented in Figure 2. Table 1 outlines how the data collection methods described below map onto each research objective. All FLS clinicians (regardless of their allocation to deliver the intervention or usual care) across all four sites will have the opportunity to provide optional consent to audio/video record their consultations with consenting patients. Recordings of iFraP intervention consultations allows intervention implementation to be assessed using a pre-defined fidelity checklist (objective 1). Recording of FLS usual care consultations will examine how risk was discussed and the extent of any contamination. The observer OPTION 5 scale37 will assess the extent to which clinicians involve patients in the decision-making process about osteoporosis medicines in both trial arms (objective 3). Two raters will independently score a proportion of recordings, guided by the OPTION 5 training manual37. Ratings will be compared and discussed to assess interrater reliability, followed by further dual scoring, if required38,39. All FLS clinicians allocated to deliver the iFraP intervention completed the iFraP Enhanced Consultation Skills Training Course. To understand the impact of the training course on expected mechanisms of action (objective 3), FLS clinicians were asked to anonymously complete evaluation forms and multiple-choice quizzes at various time points. FLS clinicians were asked to share their views on what was good, what could be improved, any outstanding training needs, and how the course had potential to change their clinical practice, as well as questions to gauge their knowledge. Responses to Likert scales will be summarised using frequencies and proportions and free-text responses will be summarised narratively. The iFraP DST will collect analytical data, providing insight into how clinicians use the DST in iFraP intervention consultations (objective 1). Collected analytics include: the length of ‘session’ using the DST, and printing and/or saving of the patient’s personal Bone Health Record. Clinician adherence to treatment recommendations produced by the DST will also be captured (objective 3). Analytical data will be aggregated by FLS site and summarised as frequencies and proportions. FLS clinicians will complete Case Report Forms (CRFs) hosted on REDCap (a secure web platform for building and managing online databases and surveys) after each iFraP consultation. FLS clinicians allocated to deliver the iFraP intervention will be asked, as part of the CRF, to self-report whether they used the iFraP DST (in full, partially, or not used), if they completed and provided patients with their personal Bone Health Record (yes, printed and handed to the patient; yes, admin to send to the patient at a later date; or not provided) and whether the patient was provided with a dentist card. Clinician responses will be summarised using frequencies and percentages to capture clinician’s self-reported intervention fidelity (objective 1). FLS clinicians delivering the intervention are asked to upload a PDF copy of the patient’s personal Bone Health Record to REDCap. The Bone Health Record includes answers to questions the patient and clinician complete together that aim to capture the patient’s views about medicine benefit and concerns (objective 3). Three participant groups will be invited to take part in a semi-structured interview to explore intervention implementation (objective 1), intervention acceptability (objective 1) and hypothesised mechanisms and outcomes (objective 3, and the influence of contextual factors on this (objectives 1 and 3). 1. Patient participants in the iFraP intervention arm (n=20) 2. All FLS clinicians delivering the iFraP intervention across all four FLS sites (n=5–10) 3. Primary care clinicians who consult with a patient following an iFraP intervention consultation (n=5–10). Patients that are (1) randomised to receive the iFraP intervention, (2) complete and return their 2-week electronic or paper follow-up questionnaire, and (3) provide consent to be contacted about an interview in the initial trial consent form will be invited to interview. Patients will be purposively sampled to capture variation in characteristics, such as age, sex, FLS site, and decision to take medicine (yes/no/unsure). FLS clinicians delivering the iFraP intervention (iFraP-i), who provide optional consent to take part in an interview, will be invited to take part. Primary care clinicians will be invited to take part in an interview, identified from patients indicating that they visited their general practice post FLS consultation in their 2 week and/or 3-month trial questionnaires or during their semi-structured interview. Primary care clinicians will be aware about the possibility of being contacted for interview in the letter sent to notify them of their patient’s participation in the trial. All interviews will be completed in-person, by telephone, or using Microsoft Teams. Interview topic guides are developed informed by findings of the iFraP in-practice feasibility testing40 and hypothesised programme theory. The topic guides will also be sensitised using the Normalisation Process Theory (NPT) to focus on the ‘work’ that individuals and groups do to enable intervention implementation41. The four key NPT components are: coherence (or sense-making); cognitive participation (or engagement); collective action (work done to enable the intervention to happen); and reflexive monitoring (formal and informal appraisal of the benefits and costs of the intervention). Topic guides will be iteratively updated, based on consultation recordings, ongoing interview findings, and discussions with expert CoP stakeholders and public contributors. Interviews will be recorded and transcribed verbatim. Data will be analysed using the framework method to develop an analytical framework to systematically apply to the dataset42. Use of a ‘matrix’ will help to reduce the data in order to analyse it ‘by case’ and ‘by code’, supporting interdisciplinary and collaborative discussions with team members, CoP and public contributors. The NPT will facilitate data interpretation to unpick factors that promoted and inhibited implementation of the iFraP intervention during the randomised controlled trial, and help to think through intervention implementation post-trial. Patients participating in the trial are asked to complete questionnaires at baseline (before their FLS appointment) and 2 weeks and 3 months after their FLS appointment. Questionnaires will be completed online or by paper, depending on the patient’s preference. The hypothesised mechanisms and outcomes of the iFraP intervention, as detailed in the iFraP programme theory, informed the choice of outcome measures included in patient questionnaires (objective 3). Shared decision-making was a key hypothesised mechanism underpinning the iFraP intervention, including concepts such as: patient self-reported ease in decision-making (Decisional Conflict Scale43), patient centred care (Patient-Professional Interaction Questionnaire [PPIQ]44), illness and treatment perceptions (modified Brief Illness Perceptions Questionnaire [BIPQ]45 and Beliefs about Medicines Questionnaire [BMQ]46), and satisfaction with information about bone health (modified satisfaction with cancer information profile [SCIP]47). Additional hypothesised outcomes, such as medicine initiation and persistence will also be captured in patient self-reported questionnaires. A complete list of outcome measures included in the patient questionnaires are provided in the trial protocol27. Patient questionnaires will also ask the patient participant to report: whether the FLS clinician implemented ‘essential’ tasks in the FLS consultation (objective 1). ‘Essential’ consultation tasks (e.g. ‘to what extent did the healthcare professional explain the aim and purpose of the appointment?’) were determined by the iFraP intervention development consensus survey48 and integrated into the Enhanced Consultation Skills Training Course and underpinned the iFraP DST structure. if they received the intervention in their FLS appointment (2 week questionnaire) or personalised written information during/after the FLS appointment (3 month questionnaire) to investigate intervention implementation (objective 1). Data will be summarised and reported as frequencies and percentages, means and standard deviations, or medians and inter-quartile ranges, as appropriate. Statistics (such as t-tests, correlations, chi-square tests), will be used to examine relationships in the data (e.g. to compare between trial arms). We will consider contextual factors that may play a role in implementation variation, for example by stratifying results by FLS sites that deliver face-to-face vs telephone consultations. It is common for qualitative research to be conducted alongside randomised controlled trials to evaluate complex interventions. However, quantitative and qualitative findings are rarely integrated49. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation50. Key finding statements from each dataset will be displayed in a convergence coding matrix49,51 to assess agreement, partial agreement, silence, or dissonance between findings. Team members from the process and outcome evaluation teams, wider study team members, CoP stakeholders, and public contributors will facilitate interpretation of ‘meta-themes’ (themes that cut across the findings from different methods), thereby enhancing rigour and credibility52. Ethical approval for the process evaluation is incorporated into the ethics application for the iFraP randomised controlled trial obtained from East of Scotland Research Ethics Service (EoSRES) (22/ES/0038). Participants give full informed written consent to data collection from interviews, consultation recordings, CRFs, and trial questionnaires. Training evaluation data was provided under implied consent. Following initial approval from the Research Ethics Committee (REC), the REC will be continually informed of all substantial changes to the management of the study. Routine reporting will take place in line with REC requirements. This paper describes the design of a mixed methods process evaluation, running in parallel with the iFraP pragmatic randomised controlled trial, to understand what elements of the iFraP intervention are implemented and how, how the delivered iFraP intervention produces change (or not), and how context affects implementation of iFraP and outcomes. The process evaluation findings will add to the existing evidence base examining DST implementation16,18, with novel contributions about the role of complementary enhanced clinician training to facilitate shared decision-making and the delivery of shared decision-making and DSTs in consultations delivered using varied modalities, including remote consultations25. Ethical approval for this process evaluation is incorporated into the ethics application for the iFraP randomised controlled trial. Ethical approval was obtained from East of Scotland Research Ethics Service (EoSRES) (22/ES/0038) on 21st October 2022. Participants will give full informed written consent to data collection from interviews, consultation recordings, CRFs, and trial questionnaires. Clinician anonymous training evaluation data was provided under implied consent. The approach to consent was approved by the ethics committee. Following initial approval from the Research Ethics Committee (REC), the REC will be continually informed of all substantial changes to the management of the study. Routine reporting will take place in line with REC requirements. Trial Sponsor: Keele University Sponsor’s Reference: RG-0345-22 The authors would like to thank all those that funded the iFraP intervention development (iFraP-D) work, including the National Institute for Health and Care Research (CS-2018-18-ST2-010)/NIHR Academy], the Royal Osteoporosis Society, and Haywood Foundation. We would also like to thank those that supported development of the iFraP intervention, including participants, Study Management Group members, stakeholders, and expert advisors and members of the iFraP Trial Management Group. We would also like to thank the public contributors that helped to design the trial, iFraP TSC members Professor Neil Gittoes (chair), Professor Alicia O’Cathain, and Dr Sara Muller and iFraP DMC members Professor Lee Shepstone (chair), Professor Gretl McHugh, and Dr Kenneth Poole. Thank you to Keele Clinical Trials Unit for their role in trial delivery and REDCap development. Faculty Opinions recommendedReferences - 1. National Institute for Health and Care Excellence: Shared decision making. (accessed 21 January 2020). Reference Source - 2. NICE: Bisphosphonates for treating osteoporosis. 2019; (accessed 5 August 2024). Reference Source - 3. 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PubMed Abstract | Publisher Full Text | Free Full Text Author details Author details 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University, Newcastle under Lyme, England, UK 2 Keele Clinical Trials Unit, Keele University, Newcastle under Lyme, England, UK 3 Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK 4 Cambridge Public Health, University of Cambridge, Cambridge, UK 5 Addenbrooke’s Hospital Fracture Liaison Service, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK 6 School of Medicine Research User Group, Keele University, Newcastle under Lyme, England, UK 7 Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, England, UK 8 Centre for Epidemiology Versus Arthritis, The University of Manchester, Manchester, England, UK 9 NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK 10 Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust, Stoke-on-Trent, UK 2 Keele Clinical Trials Unit, Keele University, Newcastle under Lyme, England, UK 3 Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK 4 Cambridge Public Health, University of Cambridge, Cambridge, UK 5 Addenbrooke’s Hospital Fracture Liaison Service, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK 6 School of Medicine Research User Group, Keele University, Newcastle under Lyme, England, UK 7 Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, England, UK 8 Centre for Epidemiology Versus Arthritis, The University of Manchester, Manchester, England, UK 9 NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK 10 Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust, Stoke-on-Trent, UK Laurna Bullock Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Andrea Cherrington Roles: Methodology, Project Administration, Software, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Project Administration, Software, Writing – Original Draft Preparation, Writing – Review & Editing Emma M Clark Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Jane Fleming Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Ida Bentley Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Elaine Nicholls Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing David Webb Roles: Investigation, Project Administration, Software, Writing – Review & Editing Roles: Investigation, Project Administration, Software, Writing – Review & Editing Jo Smith Roles: Project Administration, Resources, Software, Writing – Review & Editing Roles: Project Administration, Resources, Software, Writing – Review & Editing Sarah Bathers Roles: Methodology, Project Administration, Resources, Software, Writing – Review & Editing Roles: Methodology, Project Administration, Resources, Software, Writing – Review & Editing Sarah Lewis Roles: Project Administration, Resources, Software, Writing – Review & Editing Roles: Project Administration, Resources, Software, Writing – Review & Editing Robert Horne Roles: Resources, Writing – Review & Editing Roles: Resources, Writing – Review & Editing Terence W O'Neill Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Christian D Mallen Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Clare Jinks Roles: Methodology, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Zoe Paskins Roles: Conceptualization, Funding Acquisition, Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests ZP is funded by the NIHR [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy] and has received consultancy fees from UCB Pharma. Keele University has received sponsorship from UCB Pharma. TON is supported by the NIHR Manchester Biomedical Research Centre. CM is funded by the NIHR Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research. CJ is part funded by NIHR Applied Research Collaboration West Midlands. Other authors declare no other competing interests. Grant information This project is funded by the National Institute for Health and Care Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy]. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the Department of Health and Social Care. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (3) Copyright © 2024 Bullock L et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Bullock L, Cherrington A, Clark EM et al. Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study [version 1; peer review: 1 approved]. NIHR Open Res 2024, 4:70 (https://doi.org/10.3310/nihropenres.13751.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 13 Nov 2024 Views 0 How to cite this report: Ebeling PR. Reviewer Report For: Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study [version 1; peer review: 1 approved]. NIHR Open Res 2024, 4:70 (https://doi.org/10.3310/nihropenres.14938.r33785) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-70/v1#referee-response-33785 https://openresearch.nihr.ac.uk/articles/4-70/v1#referee-response-33785 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 23 Jan 2025 Peter R. Ebeling, Monash University, Clayton, Victoria, Australia Approved VIEWS 0 "Bullock L et al. Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study”. This is a well-constructed and detailed protocol for a mixed ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close This is a well-constructed and detailed protocol for a mixed ... Continue reading "Bullock L et al. Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study”. This is a well-constructed and detailed protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines (iFRAP). This is an important area as although osteoporosis medications are both effective and cheap, both treatment initiation and persistence at 12 months are low, even when patients are seen in a fracture liaison service, the best standard of care. Quantitative data will be collected using case report forms; self-reported questionnaires completed by patients; and decision support tool analytic data. Qualitative data will be collected using semi-structured interviews with patients receiving the iFraP intervention, FLS clinicians delivering iFraP appointments, and primary care clinicians consulting with a patient after their iFraP FLS appointment; and FLS consultation recordings. The quantitative and qualitative findings will be integrated to generate novel insights about the intervention. The process evaluation, alongside the trial, will help to understand the effectiveness and acceptability of the iFraP intervention. Other insights about the implementation of shared decision making and the use of decision support tool in practice will be gained. The study design is well conceived and robust without any areas of concern on reducing feasibility. If effective it could lead to changes in clinical practice in osteoporosis management, particularly pertaining to fracture liaison services. This reviewer has no comments for further enhancements or changes to the protocol. This is a well-constructed and detailed protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines (iFRAP). This is an important area as although osteoporosis medications are both effective and cheap, both treatment initiation and persistence at 12 months are low, even when patients are seen in a fracture liaison service, the best standard of care. Quantitative data will be collected using case report forms; self-reported questionnaires completed by patients; and decision support tool analytic data. Qualitative data will be collected using semi-structured interviews with patients receiving the iFraP intervention, FLS clinicians delivering iFraP appointments, and primary care clinicians consulting with a patient after their iFraP FLS appointment; and FLS consultation recordings. The quantitative and qualitative findings will be integrated to generate novel insights about the intervention. The process evaluation, alongside the trial, will help to understand the effectiveness and acceptability of the iFraP intervention. Other insights about the implementation of shared decision making and the use of decision support tool in practice will be gained. The study design is well conceived and robust without any areas of concern on reducing feasibility. If effective it could lead to changes in clinical practice in osteoporosis management, particularly pertaining to fracture liaison services. This reviewer has no comments for further enhancements or changes to the protocol. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Endocrine disorders CITE HOW TO CITE THIS REPORT Ebeling PR. Reviewer Report For: Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study [version 1; peer review: 1 approved]. NIHR Open Res 2024, 4:70 (https://doi.org/10.3310/nihropenres.14938.r33785) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-70/v1#referee-response-33785 https://openresearch.nihr.ac.uk/articles/4-70/v1#referee-response-33785 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 15 Oct 2025Laurna Bullock, Centre for Musculoskeletal Health Research, School of Medicine, Keele University, Newcastle under Lyme, UK15 Oct 2025Author ResponseThank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.Competing Interests: No competing interests were disclosed.Thank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.Thank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.Competing Interests: No competing interests were disclosed. Close COMMENTS ON THIS REPORT - Author Response 15 Oct 2025Laurna Bullock, Centre for Musculoskeletal Health Research, School of Medicine, Keele University, Newcastle under Lyme, UK15 Oct 2025Author ResponseThank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.Competing Interests: No competing interests were disclosed.Thank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.Thank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.Competing Interests: No competing interests were disclosed. Close Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | ||| |---|---|---|---| | 1 | 2 | 3 | | | Version 3 (revision) 02 Apr 26 | ||| | Version 2 (revision) 13 Oct 25 | read | read | | | Version 1 13 Nov 24 | read | - Peter R. Ebeling, Monash University, Clayton, Australia - Martina Behanova, Ludwig Boltzmann Institute of Osteology At Hanusch Hospital of OEGK and AUVA Trauma Center Meidling 1st Med.Dep. Hanusch Hospital Heinrich Collin Str. 30 1140 Vienna, Austria, Vienna, Austria Sign up for content alerts You are now signed up to receive this alert Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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