iFraP
Improving uptake of Fracture Prevention drug Treatments (iFraP)
Summary
What is iFraP?
iFraP is a study to develop and test a computerised decision-support tool, healthcare professional training package, and other resources to support communication about osteoporosis medicines, in the clinical consultation.
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 about risk and to make decisions, for instance about starting a new medication. We want to develop and test a web-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.
Methods
We will review guidelines for healthcare professionals and hold discussion groups with relevant experts and patients. Then we will:
- conduct a survey of healthcare professionals and patients to discuss the content of the tool and training.
- conduct focus groups to understand patients’, GPs’ and fracture prevention nurses’ experiences, and views of current FLS practice and the potential iFraP intervention
- use the results to design the iFraP intervention
- test the prototype iFraP intervention to make sure it works, and makes sense to healthcare professionals and patients.
Outputs
After this study we will conduct a trial to find out if the iFraP intervention is effective, acceptable and practical to deliver.
If successful, the iFraP intervention will benefit patients and the NHS by:
- improving patient knowledge and satisfaction
- increasing the numbers of people with fragility fractures who start and continue fracture prevention medication
- reducing fragility fractures, and associated personal and financial costs.
Chief Investigator: | Dr Zoe Paskins |
Associate Investigator: | Dr Laurna Bullock |
Trial Manager: | Dr Andrea Cherrington |
Sponsor / Reference Number: | Keele University / RG-0345-22 |
Funder / Reference Number: | National Institute for Health Research (NIHR) / Clinician Scientist Award CS-2018-18-ST2-010 |
UKCRN Study Portfolio Reference Number: | 53843 |
Registration Reference Number: | ISRCTN10606407 |
Start Date: | 01 Mar 2019 |
End Date: | 28 Feb 2024 |
Study design
Individual randomised controlled trial with parallel mixed methods process evaluation and health economic evaluation.