Improving uptake of Fracture Prevention drug Treatments (iFraP)
Research type
Research Study
Full title
A person-centred approach to improving uptake of Fracture Prevention drug Treatments (iFraP): a randomised controlled trial of the iFraP intervention in Fracture Liaison Services [Patient facing title: Being informed and involved: Improving appointments about your bone health]
IRAS ID
315303
Contact name
Zoe Paskins
Contact email
Sponsor organisation
Keele University
ISRCTN Number
ISRCTN10606407
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Summary of Research
The iFraP study team have developed a web based visual tool called a ‘decision-support tool’ to support Fracture Liaison Service healthcare professionals to know when to suggest treatments and aid conversations with patients about risk and to make decisions, for instance about starting osteoporosis medicines. The team have also developed 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’.
The iFraP study will look at whether the iFraP intervention makes decision making about osteoporosis medicines easier, and whether it is cost-effective, acceptable and practical to deliver.
328 participants will be recruited to this study; these will be adults aged 50 years and older who have been referred to a Fracture Liaison Service. Study participants will be allocated to receive one of two options: usual NHS care or the iFraP intervention. Everyone who takes part in the study will receive best current NHS practice in their Fracture Liaison Service appointment.
Participants will be asked to complete 3 questionnaires (one at baseline, one at 2 weeks and one at 3 months after their Fracture Liaison Service appointment) and they will also have the option to have their appointment recorded. A selection of participants will be invited to take part in an interview to find out what they thought of their Fracture Liaison Service appointment. Patients will be involved in the study for a duration of 3 months follow up.Summary of Results
Background For people with osteoporosis, broken bones (called ‘fragility fractures’) can occur from low or no trauma and cause significant disability. Medicines can strengthen bone and lower the chance of fragility fractures. However, many people who experience a fragility fracture do not start or continue taking osteoporosis medicines. People commonly choose not to take osteoporosis medicines because they are unsure what medicines are for, confused about fracture ‘risk’ and/or worried about side-effects.
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 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 This trial investigated whether the iFraP intervention made decision-making about osteoporosis medicines easier, and whether it was acceptable and practical to deliver.Methods:
Patients who were 50 years and older and referred to a fracture prevention service, because they have broken a bone, were invited to take part. Patients who agreed to take part were allocated to receive either a usual NHS appointment or an appointment using the iFraP intervention. Patients completed a questionnaire before their appointment, and 2 weeks and 3 months afterwards.
Some patients who received the intervention and clinicians who delivered the intervention were asked if they consent to have their appointment recorded and/or be interviewed, to understand how the decision-support tool was used, and their views of the iFraP intervention.Results
347 patients agreed to take part and attended their fracture prevention service appointment. Of the 347 patients, 179 were allocated to a usual NHS appointment and 168 to an appointment using the iFraP intervention. 213 of the 347 patients received a recommendation for osteoporosis medicines. 88% of patients completed the 2-week questionnaire and 80% completed the 3-month questionnaire. 21 patients and 10 clinicians completed an interview. 37 appointments were audio recorded.
Patients who received the iFraP intervention reported easier decision-making about medicines, greater person-centred care, and greater satisfaction with verbal and written information compared to patients who received a usual NHS appointment. Patients who received the iFraP intervention reported higher perceived need for medicines relative to concerns about medicines after their appointment compared to before.
Interviews with patients and clinicians found that they perceived the iFraP intervention to be acceptable, helping to increase patient involvement in discussions, understand the patient’s thoughts and feelings, and support understandable information sharing. Recorded appointments showed that the iFraP intervention was often used as intended.Next steps
We will soon be sharing the results of the trial and promoting use the iFraP intervention. If used, we hope the iFraP intervention will benefit patients and the NHS by helping patients make decisions about osteoporosis medicine.
The iFraP intervention is currently being updated to ensure more patients have the opportunity to access and benefit from it. As part of this process, we are rebranding the intervention as ‘Osteoporosis Options’. To learn more about the trial and recent updates to the intervention, visit https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.osteoporosisoptions.co.uk%2F&data=05%7C02%7Capprovals%40hra.nhs.uk%7C1232facd7e9840b8161508de3e55b9ac%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639016735089904749%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2BIQ8e2z3Kd0YMMJgT5Xvmu%2FbHV2GXR%2FNr2hlaaNTP7g%3D&reserved=0REC name
East of Scotland Research Ethics Service REC 1
REC reference
22/ES/0038
Date of REC Opinion
21 Oct 2022
REC opinion
Further Information Favourable Opinion