A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol

Background and rationale

In the UK, three million people are estimated to have osteoporosis¹, a condition characterised by low bone density, contributing to over 500,000 fragility fractures (fractures resulting from low or no trauma) per year. Evidence-based treatments, such as bisphosphonates, are recommended by the National Institute for Health and Care Excellence (NICE) for people with osteoporosis and/or a high fracture risk². 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 do start bisphosphonates, few persist for long enough for it to be effective, with persistence estimated at 18% to 75% at one year⁴. Low levels of osteoporosis medicine initiation and persistence, collectively described as ‘adherence’⁵, demonstrates an ‘osteoporosis treatment gap’⁶. The ‘treatment gap’ refers to the proportion of people in whom osteoporosis medicine is recommended by clinical guidelines, but do not receive treatment. The treatment gap arises because people at risk are either not identified or offered treatment, or are offered treatment, but decide not to take it. The newly proposed term ‘care gap’⁷) instead represents the gap between care offered to people with, or at risk of, osteoporotic fractures, and best practice, person-centred care, respecting that non-adherence might represent an informed choice and, instead of focussing on patient non-adherence, shifts attention to interventions and improvements that target healthcare services and professional’s actions and behaviours.

A good quality shared decision-making conversation involves the patient and clinician working together to make decisions based on evidence (including risks, benefits, and possible options) and discussions about how the medicine ‘fits’ with the patient’s life, preferences, beliefs and values⁸. Medicine adherence is optimised if a person believes that a medicine is necessary, relevant, safe, and practicable⁹. This demonstrates how shared decision-making has the potential to support osteoporosis medicine adherence^10,11, by ensuring that the medicine is a good ‘fit’ for the patient¹². However, patients often do not feel they have sufficient information to make informed decisions about medicines. A UK population survey of 1188 people with osteoporosis and fragility fractures identified ‘improving access to information from health professionals’, and ‘understanding further the safety and benefit of osteoporosis drug treatments’ as the top two patient priorities for research¹³. Insufficient or inaccessible patient information that does not address health literacy needs limits patient involvement in the consultation and treatment decisions^14–16. Aligning with this, experts suggest that the osteoporosis care gap, in part, represents poor communication of the benefits and risks of osteoporosis medicines.

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 skills⁸. DSTs are evidence-based tools to help people be involved in decision-making about healthcare options; supporting people to make informed, values-based decisions¹⁰. DSTs have been shown to increase patient certainty about decisions (decreased decisional conflict), patient knowledge, and improve the accuracy of risk perception¹⁰. Evidence also suggests that shared decision-making is an important mechanism to improve patient uptake of medicines¹¹. There is, therefore, promise that an osteoporosis DST may be beneficial in reducing the osteoporosis care gap. However, existing osteoporosis DSTs have so far not been evidenced to improve adherence and importantly, fail to comprehensively meet international quality standards and patient needs¹⁷.

To address the need for an osteoporosis DST that meets international standards and patient needs, we developed the iFraP intervention. Intervention development was guided by the Medical Research Council (MRC) complex intervention development and evaluation framework¹⁸ and the three-step implementation of change model¹⁹, drawing on theory, empirical evidence, stakeholder engagement and guidance²⁰. The iFraP intervention is a person-centred consultation intervention, consisting of a computerised individualised DST, clinician training in enhanced shared decision-making, risk communication, health literacy and use of the tool, and additional paper and web-based resources for patients and their primary care provider. We hypothesize that the iFraP intervention will improve patient ease in decision-making about osteoporosis medicines (by increasing the extent that the patient was informed and involved in the consultation), facilitate shared decision-making, increase informed medicine initiation and reduce levels of medicine discontinuation. A protocol outlining the studies that underpinned iFraP intervention development is published²⁰, and the results of the development studies are also reported elsewhere^17,21–23.

The current protocol (version 1.6, 13 December 2023) is described below. Key amendments to the protocol since initial trial registration are highlighted with comments in square brackets.

Objectives

Primary objectives

The primary objectives of this trial are to determine:

Secondary objectives

The secondary objectives of this trial are to determine:

Separate protocols will detail the process evaluation and health economic evaluation.

Trial context

This trial takes place in the context of Fracture Liaison Services (FLSs) in England, UK (sometimes referred to as Fracture ‘Prevention’ Services). 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.

Service provision varies across FLSs, with services ranging from operating a ‘one-stop shop’ model of care, meaning that, if appropriate, patients have a bone density scan (Dual-energy X-ray absorptiometry [DXA]), nurse assessment, drug treatment recommendation, and blood tests as part of one consultation. Other FLS models may not complete all components for all patients (for example, not all patients receive a DXA scan), or may split these components across multiple appointments, supported by different communication modalities (remote, face-to-face, letter)²².

The trial baseline is taken as the FLS consultation where treatment recommendations are given.

Trial design

The trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to UK FLS, with nested process evaluation and health economic evaluation.

The intervention arms are:

Consenting patient participants referred to FLS will be randomised to one of the intervention arms in the trial using a 1:1 ratio. Data is gathered at baseline (before the FLS consultation) and then at 2 weeks, and 3 months after their FLS consultation, via postal or online questionnaires. REDCap, a secure web-based data collection system, will be used to capture and manage all recruitment and data collection.

We considered randomisation at site, clinician, and patient level²⁴. An individual patient level randomised controlled trial was chosen to minimise (a) disruption of clinician turn over (b) complexity of using multiple sites in a cluster design (c) risk of unbalanced recruitment. Contamination between intervention arms was previously hypothesized as a concern. However, contamination is thought to be minimal as only clinicians delivering iFraP will have access to the computerised DST and receive the iFraP clinician training programme. We will attempt to minimise contamination by excluding patients who have a friend or relative in the study. Evidence of contamination will be explored in the process evaluation (separate protocol).

Ethics

Ethical approval was obtained from East of Scotland Research Ethics Service (EoSRES) (22/ES/0038). Following initial approval from the Research Ethics Committee (REC), they will continually be informed of all substantial changes to the management of the study. Routine reporting will take place in line with REC requirements.

Site eligibility and recruitment

To be eligible for this trial, FLSs must:

The Royal Osteoporosis Society (ROS), existing clinical networks and the NIHR Clinical Research Network (CRN) will be used to identify eligible FLSs for the iFraP study. The selection of potential FLS sites will consider capturing variation in the FLS’s service provision (informed by the iFraP national survey of FLSs²²) and characteristics of the local population. Identified FLSs (face-to-face or remotely) meet with study team members who fully explain the study and describe the study requirements. Informed consent for FLSs to participate will be provided by the research lead/authorised person in each service, acting as ‘guardian’ for patients in their care, following agreement with the team clarifying willingness to undertake the iFraP intervention. FLS clinician agreement to take part in the trial will be captured as part of the written agreement completed by the research lead/authorised person in each service. FLS consent to participate in the trial is formalised through a Sponsor-site agreement. The number of FLSs approached, declining, or considered not eligible will be recorded.

The research sites receive local management approval, trial specific training and trial administrative procedures prior to the start of recruitment into the trial. FLS clinicians and other team members (e.g. FLS administrators) will also be provided with study-specific training including training on completion of study documentation, using the REDCap database, good clinical practice as applicable to research and the maintenance of the study site file and study records.

FLS clinicians are allocated by the study team to intervention arm or comparator usual FLS NHS care arm, considering seniority and years of experience, to try and achieve balance of skills and experience in both arms of the trial.

Patient participants

The study population consists of patient participants aged ≥50 years referred to the FLS. The eligibility criteria for patients to take part in the iFraP trial reflects the eligibility criteria for FLS.

Inclusion criteria

Exclusion criteria

Patient identification, recruitment and consent

As part of FLS normal NHS care, adults aged ≥50 years with a recent fragility fracture(s) are systematically identified (primary inclusion criteria). Those that require a face-to-face or remote consultation where medicine may be discussed will be mailed an initial invitation pack, including a flyer explaining that the patient needs a bone health assessment in FLS as part of normal NHS care and a letter introducing the iFraP trial. Age at invite and sex at birth of those mailed will be collected to compare the characteristics of non-responders with responders. See Figure 1 for an overview of recruitment.

Figure 1. Overview of patient identification.

Patients interested in hearing more about the study can either access a website (hosted on REDCap), phone, or post back a reply slip to Keele Clinical Trials Unit (CTU) giving consent to contact for more information. Patients that give verbal (via phone) consent to contact, or provide consent to contact using the REDCap or postal forms will be entered onto the Keele study database and allocated a unique participant study ID. Patients who do not respond to the initial mail-out within a defined time window will be telephoned by NHS site staff to explain the purpose of the FLS, explain and gauge interest in the study, and encourage those who do not wish to participate in the study to continue to engage with their normal NHS care FLS appointment.

If the identified patient declines participation or does not respond within an agreed time window, this will be communicated to site allowing an FLS appointment to be booked as per normal NHS care.

Patients that provide consent to contact will be sent the study recruitment pack by post or email, which includes the participant information sheet, consent form, baseline questionnaire and prepaid return envelope (if posted). The study pack includes contact details for the Keele CTU to discuss consent or provide support with data collection, including the opportunity to access translation services.

Patients will be asked to complete and return the study recruitment pack remotely before being randomised and booked an FLS appointment with an appropriate FLS clinician. Remote consent is proportionate with the low-risk nature of the intervention and appropriate for patients that are identified virtually with their consultation by telephone (rendering face-to-face consent inappropriate).

Consent is requested for:

Optional consent is also requested to:

If the patient completes and returns the study recruitment pack within an agreed time window, they proceed to randomisation. If the patient does not return the pack within a defined period, they will receive a reminder telephone call and/or postcard [Amendment 04, see Table 2]. If the patient does not respond, or declines participation, a non-trial normal NHS FLS appointment will be booked.

At a mid-point in patient recruitment, the Data Monitoring Committee (DMC) will examine the characteristics of the patients recruited to the trial to determine if the sample is representative of the general population. This insight will allow for consideration of approaches to increase diversity [Amendment 08, see Table 2], e.g. whether the NHS site staff could adapt their approach to the introduction telephone calls to focus on underserved groups, who may not be adequately represented.

Randomisation

Sequence generation

The randomisation sequence will be computer-generated (via a computerised random number generator), blocked (random permuted blocks), and stratified by FLS, with an allocation ratio 1:1 and was developed by a database developer with no clinical input to the trial.

Allocation

Participants will be randomised by the NHS site team after consent and baseline data collection using the randomisation module in the REDCap database. Once randomised, the authorised staff member at site will be notified by REDCap of the participant’s intervention arm allocation, allowing site to book the appropriate clinic appointment. Emergency telephone backup randomisation will also be available.

Allocation concealment

Concealment of the allocation process will be ensured through the remote computer-generation of the randomisation sequence and web-based interface including entry of participant details and necessary consent prior to disclosure of trial arm allocation.

Blinding

Participants and clinicians will not be blind to allocation to iFraP intervention (iFraP-i) or comparator usual NHS care (iFraP-u) trial arms. However, any member of the research study team undertaking minimum data collection (MDC) and the statistician will be blind to the trial arm allocation. The qualitative researcher will not be blinded to trial arm allocation.

Interventions

Patient participants will be allocated to an FLS appointment with an appropriate FLS clinician, based on their randomised allocation. The interventions are to be delivered in a face-to-face or remote FLS consultation where treatment recommendations are given.

iFraP intervention (iFraP-i)

The iFraP intervention is a consultation intervention delivered by FLS clinicians to eligible adults aged ≥50 years systematically identified as having a fragility fracture(s), with the aim of facilitating shared decision-making about osteoporosis medicines.

The iFraP intervention consists of three core components:

Participants randomised to iFraP-i will be scheduled their FLS appointment with an FLS clinician that has completed the iFraP Consultation Skills Training Course. iFraP-i is delivered in one consultation which may be conducted face-to-face or remotely by video or telephone, depending on a variety of local factors including service commissioning, staffing, and the impact of COVID-19, usually lasting approximately 30 minutes. During the appointment, the FLS clinician will use the iFraP DST and provide the patient with iFraP information resources, such as an individualised summary of the appointment (the ‘personal Bone Health Record’), printed from the iFraP DST in-person (if consulting face-to-face), or sent by post (if consulting remotely). After the consultation, the Bone Health Record will also be shared with the patient’s GP.

Comparator usual FLS NHS care (iFraP-u)

Participants randomised to this comparator arm will be scheduled their face-to-face or remote FLS appointment with an FLS clinician delivering usual FLS NHS care. At present, usual FLS care does not use Decision Support Tools to support patient-clinician discussion, nor do FLS clinicians have access to the iFraP Consultation Skills Training Course or information resources that would be provided as part of the iFraP intervention. FLS clinicians delivering iFraP-u will be offered the opportunity to partake in the intervention training at the end of the trial.

Crossover and post-trial care

Participants cannot crossover from one arm of the trial to the other. Any protocol deviations that occur during the trial will be recorded and their impact assessed for future trial conduct and the final data analysis plan.

Participants’ clinical care after the FLS appointment returns to normal FLS NHS care.

Clinical champion

One FLS clinician at each site will be a ‘Clinical Champion’ [Amendment 02, see Table 2] to facilitate the implementation of the iFraP intervention. The Clinical Champion’s role will be to promote the iFraP training and use of the iFraP tool locally, mentor iFraP-i clinicians, and act as a link between the FLS team and the Keele University research team. An introduction session with the Keele University research team will outline the Clinical Champion role and responsibilities, with subsequent monthly meetings attended by all Clinical Champions and Keele University research team to share learning, achievements and overcome challenges. To support this role, the Clinical Champion will take part in the iFraP Consultation Skills Training Course and therefore will not deliver FLS NHS usual care (iFraP-u) appointments to avoid contamination. To support implementation of the iFraP training, email reminders and newsletters will also be sent to participating intervention clinicians.

Data collection

All participants will be asked to complete 3 paper or online (via REDCap) questionnaires, depending on their specified preference. Questionnaires collect data at baseline (before randomisation), 2 weeks and 3 months after FLS consultation.

Case Report Forms (CRFs) will all be completed electronically using REDCap.

Baseline data collection

Baseline data collection will be collected before randomisation, as part of the recruitment pack. Data includes demographic characteristics (date of birth, sex at birth), ethnicity, socioeconomic status (Index of Multiple Deprivation), employment status, marital status, fracture site and risk factors, health literacy²⁵, barriers to communication and first language, digital access, experience of osteoporosis medication. Additional measures included are outlined in Table 1.

Primary outcome measure

Patient reported ease in decision-making about osteoporosis medication, collected at 2 weeks, measured using the Decisional Conflict Scale (DCS)²⁶. The DSC will be completed by those recommended an osteoporosis medicine, using 16 items each measured using 5 Likert response categories from ‘strongly disagree’ to ‘strongly agree’.

Secondary outcome measures

The secondary outcome measures collected at 2-weeks and/or 3 months following FLS consultation, completed by all participants, include:

Additional secondary outcome measures will be self-reported at 2 weeks and/or 3 months by participants recommended osteoporosis medication during their FLS consultation. These include:

Table 1 summarises the content of the participant questionnaires at baseline, 2-weeks, and 3-months.

Follow up assessments

Non-responders to the baseline questionnaire will not be enrolled into the trial and will be allocated a non-trial normal NHS care FLS consultation.

Non-responders to the 2-week and/or 3-month questionnaires will receive a reminder by post and/or email, after approximately 10 days [Amendment 08, see Table 2]. Non-responders to the reminder will be telephoned (by a blinded trial administrator) after approximately 10 days for MDC. A brief questionnaire for MDC will be sent by post or email to those who cannot be contacted after 3 telephone attempts, as per participant’s preference. The MDC questionnaires aim to collect the primary outcome (if appropriate), health-related quality of life (EQ-5D-5L) and self-reported medicine use, along with date of birth and sex at birth to ensure the data are provided by the intended participant.

The flow of events as participants proceed through the trial is outlined in (Figure 1) and the timing of key events outlined in Table 1.

Medical record review

Hospital Medical Record Review (MRR) will be completed 3 months after the FLS appointment. Prescription data, including the number initiated (prescribed osteoporosis drug treatment since FLS date: yes/no) and number discontinued (determined by last date of prescription ≥6 weeks prior to MRR or recorded discontinuation in the patient medical record = yes) will be captured [Amendment 04, Table 2]. Medical record review will also capture information about appointments/visits related to bone health.

Adverse events

The clinical management recommendations given to participating FLS clinicians, as part of the iFraP DST, are evidence-based best practice, following national guidelines and in line with normal NHS care. Therefore, adverse events in this trial are expected to be minimal. Side effects of osteoporosis medications will be captured as an outcome but not reported as Adverse Events in this trial.

All serious adverse events (SAEs) either confirmed or suspected will be communicated to Keele CTU within 24 hours. An authorised medic would then conduct a causality assessment. Suspected or confirmed SAEs are to be reviewed by the DMC and reported to the Trial Steering Committee (TSC).

Sample size

To address the objectives of the trial, 380 participants (190 in each intervention arm) need to be recruited to detect a between group effect size of at least 0.4 in the primary outcome at 2-week follow-up, with 2-tailed 5% significance and 80% power [Amendment 09, see Table 2 and progress of the trial]. This sample size target of 380 has been calculated based on estimations that 200 participants will complete the primary outcome at 2 weeks (100 per intervention arm). It is expected that approximately 27% of patients will not receive a medicine recommendation (hence for whom the primary outcome is not relevant), 20% loss to follow-up in the primary outcome at 2-weeks, and 10% loss to follow-up because of ‘Do Not Attends’ (DNAs).

With an estimated standard deviation of 15, this translates to minimum clinically important difference (MCID) of 6 points on the DCS (scale range 0 – 100) – a difference considered to be meaningful and one that produces an effect size in the range of meaningful effect sizes recommended by the authors of the DSC²⁶.

Analysis methods

Separate a priori analysis plans will be written to describe all pre-planned trial analysis, including clinical and cost-effectiveness of the iFraP intervention alongside the process evaluation. The analysis plans will be agreed and signed off by the TSC and DMC prior to lock down of the final dataset and will be the definitive version. Consequently, only a brief outline of the planned analysis is given here.

Statistical analysis

A CONSORT flow diagram will describe the flow of participants through the study and will include reasons for study withdrawal if given. Descriptive statistics will be used to describe the key baseline characteristics of participants at each stage of recruitment and follow-up, and by intervention arm, to assess if there is any evidence of selection bias and to evaluate the success of the randomisation procedure.

Analysis of covariance (ANCOVA) will be used to analyse the primary outcome (the total DCS score) at the 2-week primary endpoint, by comparing the mean outcome in each intervention arm, after adjustment for any pre-specified baseline covariates. A sensitivity analysis of the primary outcome model will be conducted to explore whether study conclusions change when outcome variation between FLS clinicians is accounted for in the model. This will be achieved by adapting the ANCOVA model into a mixed model framework and incorporating a random effect term to represent the clinician who treated the patient. The magnitude of the treatment effect from this model will then be compared to that from the primary analysis in the study. We will consider using multiple imputation to impute the patient-level missing data if the missing data rate is greater than 5% for at least one patient-level outcome or predictor of interest. If multiple imputation is used, this will be regarded as the primary analysis over a complete-case analysis.

Treatment effects for secondary outcomes measured at a single follow-up time-point will be explored using similar methods to the primary outcome analysis, but with ANCOVA, logistic and ordinal regression used as appropriate for continuous, binary, and ordinal outcomes. For outcome measures collected at more than one time-point, linear mixed models will be used to model change in the outcome over time. Results will be presented either as mean or percentage differences/odds ratios alongside their associated 95% confidence intervals.

Descriptive statistics (numbers and percentages) will be used to describe patients experience of their FLS appointment and exploratory analysis conducted to explore whether patients’ perception of their fracture risk changes following the intervention, and whether their post intervention perception of risk is more in line with their predicted fracture risk (as calculated by their Fracture Risk Assessment (FRAX®) score. In addition, we will also explore whether patients’ level of worry about falls and fractures changes following their FLS consultation and whether such changes are similar in both trial arms.

Economic evaluation

The economic evaluation will comprise a within-trial cost-effectiveness and value of information (VoI) analysis to determine whether the iFraP intervention is cost-effective compared with usual care. The health economic evaluation protocol will be published separately.

Process evaluation

A mixed methods process evaluation, in line with the MRC guidance³⁶, will explore perceived acceptability of iFraP amongst patients and clinicians, what components of iFraP were delivered and how (fidelity), how much of iFraP was delivered (dose), whether iFraP results in a change in outcomes (e.g. shared decision-making, medicine initiation rates) and how, context affects implementation of iFraP and outcomes. Various methods, including semi-structured interviews, CRFs, consultation recordings, and DST analytics will capture data for the process evaluation. The process evaluation protocol will be published separately.

Patient and Public Involvement

A group of public contributors with osteoporosis and their carers was convened to support the development of the iFraP research programme and the NIHR funding application. The group met prior to funding, helping to define the research questions, and influencing research design. Members of this group have subsequently been invited to form a Patient Advisory Group (PAG) to support delivery of the iFraP research programme. The PAG met throughout the iFraP intervention development work, as outlined elsewhere²⁰. More recently, the PAG have also supported design of the trial, by discussing appropriate outcome measures, piloting the 2-week follow up questionnaire, and commenting on other patient-facing documents. The PAG continue to work with the research team throughout the trial and one member of the PAG has joined the trial study team, regularly attending monthly Trial Management Group (TMG) meetings. Two independent public contributors attend Trial Steering Committee meetings, to ensure public involvement oversight and monitoring of the trial.

Community of Practice

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 interaction³⁷. 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 ROS and Health Literacy UK and a behaviour change expert. The iFraP CoP met regularly throughout the research programme and will continue to meet during the iFraP trial (e.g. to discuss knowledge mobilisation and dissemination).

Trial organisation and monitoring

The iFraP TMG have overall responsibility for the clinical set-up, promotion, ongoing management and monitoring of the study, and for analysis and interpretation of results. The TMG meet on a regular basis throughout the study. The TMG will monitor protocol compliance of recruitment, treatment, and follow-up procedures during conduct of this study, and this will be discussed at monthly TMG meetings.

The independent TSC provides overall supervision of the research programme according to agreed timelines. The TSC met prior to ethics application to agree the trial protocol, and at agreed time intervals over the course of the trial. An independent DMC approved the protocol and will monitor trial data. Detailed reports focusing on recruitment, retention, protocol compliance, and adverse events are prepared by Keele CTU.

All data collection, database design, data input and cleaning, as well as trial oversight procedures, are in line with the standard operating procedures of Keele CTU and the conditions of the grant. Data will be centrally monitored for quality and completeness by Keele CTU.

Data confidentiality and archiving

All information collected during the trial will be kept strictly confidential. Information will be held securely on paper and managed electronically using REDCap through Keele CTU. Keele CTU achieve the legal obligations set by the Data Protection Act (2018) and the General Data Protection Regulation (GDPR). If a participant withdraws consent from trial intervention and/or further collection of data, their data will remain on file and is included in the final study analysis. At the end of the trial, data will be securely archived in line with the Sponsor’s procedures for a minimum of 10 years. Data held by Keele CTU will be archived in the designated Keele CTU archive facility and site data and documents will be archived at the participating sites. Following authorisation from the Sponsor, arrangements for confidential destruction will then be made.

Any subsequent requests for access to the data from anyone outside of Keele CTU (e.g. collaboration, joint publication, data sharing requests from publishers) will follow Keele University’s standard operating procedure.

Progress of the Trial

Recruitment commenced in May 2023. A review of recruitment and follow up rates with the DMC and TSC in July 2023 and with the TSC in October 2023 identified slower recruitment and lower follow up rates than anticipated. The TSC recommended that an additional FLS site is recruited to participate in the trial. This resulted in three key amendments to the number of sites, target sample size and recruitment duration and rate:

Protocol amendments are described in detail, along with rationale for change, in Table 2.

Dissemination

The iFraP trial results will be submitted to peer-review journals for consideration. The research team will also submit abstracts to national and international conferences. Established clinical and third-sector networks will facilitate dissemination to clinical audiences. Dissemination plans will be discussed with public contributors to ensure that results are understandable and reach lay audiences. Patient participants will be informed about the results of the trial at the end of the study.

The iFraP intervention resources will be made freely available on the Evidenced Resources for Osteoporosis (ERO) website — a partnership between the Royal Osteoporosis Society and Keele’s Impact Accelerator Unit to curate, disseminate and increase the impact of osteoporosis evidence-based resources.