iFraP-D: Improving consultations about fracture prevention.
Research type
Research Study
Full title
iFraP-D: Improving uptake of Fracture Prevention drug Treatments: Development of a consultation intervention (iFraP)
IRAS ID
264584
Contact name
Zoe Paskins
Contact email
Sponsor organisation
Keele University
Clinicaltrials.gov Identifier
430, Royal Osteoporosis Society (Funder); researchregistry5041, Research Registry
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Summary of Research
Background
Fragility fractures occur from events that would not normally result in a broken bone. For people who experience them, these fractures can result in significant disability, pain and increased risk of loss of independence and even death. Many people who experience a fragility fracture do not take recommended treatment to prevent future fractures. This may be because they are unsure what treatment is for, are confused about fracture ‘risk’ and/or are worried about side-effects. ‘Decision-support tools’ can support health professionals to communicate risks in a more understandable way.
Aim: to develop and design the ‘iFraP’ intervention which consists of
1. A Computerised, web-based decision-support tool which can be used in consultations and will include pictures to better describe a patient’s personal fracture risk, how this risk would improve with treatment, and explain the possible harms of treatment
2. training for clinicians to ensure the information they are giving is understandable and that they address patient concernsMethods
We will review guidelines for clinicians and hold discussion groups with relevant experts and patients. Then we will:
• conduct a survey of clinicians and patients to finalise the content of the tool and training.
• conduct focus groups to understand patients’, GPs’ and fracture prevention nurses’ experiences, and views of the potential iFraP intervention
• use the results to design the intervention
• test the prototype intervention to make sure it works, and makes sense to HCPs and patients.Outputs
After this study we will conduct a trial to find out if the iFraP intervention is 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.Summary of Results
Why was this research needed?
For people with osteoporosis, broken bones can result in disability, pain, increased risk of loss of independence and death. Medicines are available to lower the chance of broken bones for people with osteoporosis. However, many people who experience a broken bone do not start the recommended medicine. Of those who start osteoporosis medicines, fewer than half continue taking the medicine for more than one year. Evidence suggests that people with osteoporosis are often unsure what medicines are for, are confused about their chance of future broken bones (called ‘fracture risk’) and/or are worried about side-effects. This means that patients may find it challenging to make decisions about osteoporosis medicines that are right for them.
What happened during the study?
We have completed 4 linked studies:
1. A survey with patients, carers, and healthcare professionals to reach agreement on what should be included in appointments about bone health
2. Focus groups with patients and healthcare professionals to find out their current experiences of bone health appointments and to get their thoughts about using a decision aid
3. A survey with healthcare professionals to find out about bone health services across the UK, including how they are set-up, what happens in these appointments, and how COVID19 has affected the service
We used the findings from studies 1 – 3 to develop a computer-based decision aid. The decision aid includes pictures to support discussions about bone health and osteoporosis, the chance of the patient breaking a bone in the future, how the chances could be lowered by taking osteoporosis medicine, and to explain the benefits and risks of medicines. We also developed a training package to help healthcare professionals use the decision aid and to ensure that the information they give is understandable and addresses the patient's needs and concerns.
4. We then tested this in 10 face-to-face and telephone bone health appointments at one hospital. Appointments were observed by a researcher. The healthcare professional and patient completed interviews after the appointment.
We regularly met with our dedicated patient advisory group and stakeholder group (including healthcare professionals such as bone health nurses, GPs, and physiotherapists as well as patients, representatives from the Royal Osteoporosis Society, and others). Both groups provided their expert opinion to help us to design the studies, understand the findings, and develop the decision aid.
Who participated in the study?
The patients in our study were people over 50 years old who had osteoporosis and/or a high chance of breaking a bone or had been identified by the hospital as needing an appointment to check their bone health. We also included carers of people with osteoporosis.
Healthcare professionals also took part in the study, including nurses and allied health professionals that conduct bone health assessments and general practitioners (GPs).
What were the results of the study?
The findings from the 4 linked studies:
1. The survey of patients, carers and healthcare professionals identified 18 key tasks that we recommend healthcare professionals complete in bone health appointments, (e.g. the clinician should explain the aim of the appointment).
2. In focus groups, although patients and healthcare professionals reported good experiences of bone health appointments, patients discussed being unsure whether or not to take the osteoporosis medications recommended to them. Similarly, healthcare professionals spoke about many reasons that contributed to their uncertainty when deciding if to recommend osteoporosis medicine, or not.
3. The survey of healthcare professionals found lots of differences between services delivering bone health appointments across the UK. During COVID19, many services faced challenges and increased their use of telephone appointments.
4. When the decision aid was tested in bone health appointments at one hospital, patients and healthcare professionals were positive about its use. Patients and healthcare professionals also recommended parts of the decision aid that could be improved.
How has this study helped patients and researchers?
Findings from this study have helped to develop an osteoporosis decision aid and training package for use in bone health appointments. Following further testing, we hope that the decision aid and training package will support patients and healthcare professionals to talk together about bone health and to support patients to make decisions about osteoporosis medicines that are right for them.
Details of any further research planned
We are currently planning a randomised controlled trial to start in 2022. This trial will test the decision aid and training package in bone health appointments on a larger scale.
Where can I learn more about this study?
You can learn more about this study on our Keele University website:REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0559
Date of REC Opinion
17 Sep 2019
REC opinion
Favourable Opinion