iFraP

Improving uptake of Fracture Prevention drug Treatments (iFraP)

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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.

 

Cheif Investigator: Dr Zoe Paskins
Associate Investigator: Dr Laurna Bullock
Trial Manager: Stephanie Butler-Walley
Sponsor / Reference Number: Keele University / TBC
Funder / Reference Number:

National Institute for Health Research (NIHR) / 

Clinician Scientist Award CS-2018-18-ST2-010

UKCRN Study Portfolio Reference Number: TBC
Registration Reference Number: TBC
Start Date: 01 Mar 2019
End Date:  28 Feb 2024

Individual randomised controlled trial with parallel mixed methods process evaluation and health economic evaluation.

The overall aim is to examine the experience of care, effectiveness, within-trial cost-effectiveness and value of information of the iFraP intervention compared with standard FLS practice.

Primary objective: 

  1. To determine the effect of the iFraP intervention on person-centred care.
  2. To determine whether use of the iFraP intervention is cost-effective compared to standard Fracture Liaison Services and the value of acquiring additional information using value of information (VOI) analysis

Secondary objectives:

  1. To determine the effect of the iFraP intervention on a range of patient reported outcomes and experience measures including satisfaction with information, confidence in decision making and illness and treatment beliefs
  2. To determine the clinical effectiveness of the iFraP Intervention on treatment initiation rates and adherence to clinical guidelines
  3. To determine the effect of the iFraP intervention on clinicians’ satisfaction
  4. To determine iFraP acceptability, fidelity and adherence, and explore the mechanisms and processes underlying observed effects.
  5. To determine barriers and enablers to implementation of iFraP
  6. To identify changes to the iFraP intervention ahead of implementation
  • Paskins Z, Torres Roldan VD, Hawarden AW, Bullock L, Meritxell Urtecho S, Torres GF, Morera L, Espinoza Suarez NR, Worrall A, Blackburn S, Chapman S, Jinks C, Brito JP. 2020. Quality and effectiveness of osteoporosis treatment decision aids: a systematic review and environmental scan. Osteoporos Int, vol. 31(10), 1837-1851.
  • Paskins Z, Crawford-Manning F, Bullock L, Jinks C. 2020. Identifying and managing osteoporosis before and after COVID-19: rise of the remote consultation?. Osteoporos Int, vol. 31(9), 1629-1632.
  • Hawarden A, Jinks C, Mahmood W, Bullock L, Blackburn S, Gwilym S, Paskins Z. 2020. Public priorities for osteoporosis and fracture research: results from a focus group study. Arch Osteoporos, vol. 15(1), 89.