Improving uptake of Fracture Prevention drug Treatments (iFraP): Development and evaluation of a consultation intervention
What is iFraP?
iFraP is a study to develop and test a computerised decision support tool, training package, and other resources to support communication about osteoporosis medicines, in the clinical consultation.
Who is this study relevant for?
This study is relevant for people with osteoporosis and/or high fracture risk and healthcare professionals who consult with patients, where fracture risk is calculated and prevention treatments are recommended.
Those with an interest in osteoporosis and/or fragility fracture prevention will also be interested in this study.
Why is this study important?
For people with osteoporosis, fragility fractures (occurring from events that would not normally result in a broken bone) can result in significant disability, pain, increased risk of loss of independence and death. Medications are available to maintain bone density and reduce the chance of a fragility fractures for people with osteoporosis. However, many people who experience a fragility fracture do not start the recommended medication to prevent future fractures. Of those who start treatment, fewer than half continue taking treatment for more than one year. If we increase the number of people with osteoporosis that start, and continue taking osteoporosis medications we will lower the number of future fractures, and associated negative outcomes (e.g. significant disability).
To potentially increase the number of people with osteoporosis taking medications, it is important to understand why many chose not to take them. Evidence suggests that people with osteoporosis are often unsure what medications are for, are confused about fracture ‘risk’ and/or are worried about side-effects. It is important that we support healthcare professionals to discuss medications with the patient and to explain the risks and benefits of medications. At the moment, this may be challenging to do without visual tools. One option is to develop a visual tool called a ‘decision-support tool’.
What are ‘decision-support tools’?
‘Decision-support tools’ can support healthcare professionals to know when to suggest treatments and can help healthcare professionals and patients talk together to make decisions, for instance about starting a new medication. We want to develop and test an internet-based ‘tool’ that can be used in appointments after someone has had a fragility fracture. This would be a website which healthcare professionals can use with patients when assessing their bone health. It will include, for example, pictures to help describe a patient’s individual likelihood of breaking a bone again, how the chances could be lowered by taking medication to help keep up bone strength, and to explain the possible harms of treatment. We will also develop training for healthcare professionals to help them use the tool and to ensure that the information they are giving is understandable, that they address patient concerns, and that they give clear, consistent information during the appointment. The decision-support tool and training package together are called the iFraP intervention.
Important information about the iFraP treatment discussion aid and personal bone health record
The iFraP tool is intended for use by appropriately trained healthcare providers, for use with patients who are aged 50 years and over and have one or more fragility fractures.
Improving bone health - clinician decision support and patient treatment discussion aid.
Evidence on drug benefits and side effects is derived from relevant NICE guidelines and drug specific Summary of Product Characteristics. Where no data exists,what d assumptions have been made based on data from other similar drugs and other sources of evidence e.g. meta-analyses and verified by external scientific advisors. Uncertainty is expressed by the use of the word 'about'. Fracture risk, (if not manually entered) is estimated from look up tables, derived from FRAX and based on age, gender, steroid use, presence of osteoporosis and prior fracture, assuming a normal BMI.
Active – open to recruitment
The aim of this study is to develop and test the iFraP intervention (decision-support tool and training package), to support clinicians to:
- Enhance the communication of risk
- Facilitate informed decision-making about fracture prevention treatment
- Improve informed long-term treatment adherence
The iFraP intervention will be designed for any healthcare professional, including GPs, to use with patients. However, we will test the intervention in dedicated fracture prevention services first (Fracture Liaison Services).
Since the start of the study in September 2019, we have completed 4 linked studies:
- A survey with patients with osteoporosis and/or high fracture risk, carers, and clinicians to reach agreement on what tasks should be completed as part of a model Fracture Liaison Service consultation.
- Focus groups and interviews to find out patient and clinician current experiences of Fracture Liaison Service consultations and to get their thoughts about using a Treatment Discussion Aid.
- A usual care survey was developed to find out about Fracture Liaison Services across the UK, including how they are set-up, what happens in these appointments (including the extent of discussion about osteoporosis medicines), and how COVID19 has affected each service.
We used the findings from studies 1 – 3 to develop the prototype iFraP intervention, including the iFraP Treatment Discussion Aid and clinician training package focusing on shared decision-making, universal precautions for health literacy, and risk communication.
- We then tested the iFraP intervention in Fracture Liaison Service appointments at one hospital – called ‘in-practice testing’. The Fracture Liaison Service clinician and patient each completed interviews after the appointment to talk about their experience of the iFraP intervention. In-practice testing interviews revealed that patients and Fracture Liaison Service clinicians were positive about use of the iFraP decision aid and reflected upon the potential beneficial outcomes for patients. Patients and clinicians also recommended parts of the decision aid that could be improved.
Findings from the in-practice testing were used to refine the iFraP intervention in-preparation for the iFraP randomised controlled trial which will start to recruit patient participants in March 2023.
What are the possible benefits and risks of taking part in this trial?
Whilst there are not any direct benefits to taking part, there is potential future benefit to other patients. By taking part in this study, participants will help to design and test the iFraP intervention, which we hope will help patients to make informed decisions about osteoporosis treatments. In this way the findings may gave future benefit to patients with osteoporosis and/or high fracture risk. There are no obvious risks to taking part in the study.
When is this study starting and how long is it expected to run for?
The iFraP study started in March 2019 and will end in September 2024. The iFraP intervention trial phase starts September 2021 and will run until September 2024. This study is funded by the National Institute for Health and Care Research (NIHR), the Royal Osteoporosis Society and the Haywood Rheumatology Research and Development Foundation.
How long will the study be recruiting participants for?
We are recruiting patient participants from March 2023 to September 2023 to support the design of the intervention. Unfortunately, it is not possible to take part in the study unless you have been sent an invitation.
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