Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall?: Protocol for a randomised controlled feasibility study

Shane Clarke; Rachel Bradley; Bethany Simmonds; Chris Salisbury; Jonathan Benger; Elsa Marques; Rosemary Greenwood; Lee Shepstone; Maria Robinson; John Appleby-Fleming; Rachael Gooberman-Hill

doi:10.1136/bmjopen-2014-005744

Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall? Protocol for a randomised controlled feasibility study

Shane Clarke^*, Rachel Bradley, Bethany Simmonds, Chris Salisbury, Jonathan Benger, Elsa Marques, Rosemary Greenwood, Lee Shepstone, Maria Robinson, John Appleby-Fleming, Rachael Gooberman-Hill

^*Corresponding author for this work

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Abstract

Introduction - Currently identification, and therefore, management of patients at risk of osteoporotic fracture in the UK is suboptimal. As the majority of patients who fracture have fallen, it follows that people who fall can usefully be targeted in any programme that aims to reduce osteoporotic fracture. Targeting vulnerable patients who are likely to benefit from intervention may help shift the management of fracture prevention into primary care, away from emergency departments. Paramedics who attend to patients who have fallen may be well placed to assess future fracture risk, using the Fracture Risk Assessment Tool (FRAX) and communicate that information directly to general practitioners (GPs).

Methods and analysis - This feasibility study takes the form of a pragmatic, randomised controlled trial aimed at exploring and refining issues of study design, recruitment, retention, sample size and acceptability preceding a large-scale study with fracture as the end point. Patients (aged >50) who fall, call an ambulance, are attended by a study paramedic and give verbal consent will be asked FRAX and fall questions. Patients who subsequently formally consent to participation will be randomised to control (usual care) or intervention groups. Intervention will constitute transmission of calculated future fracture risk to the patients’ GP with suitable, evidence-based recommendations for investigation or treatment. 3 months after the index fall, data (proportion of patients in each group undergoing investigation or starting new treatment, quality of life and health economic) will be collected and analysed using descriptive statistics. A nested qualitative study will explore issues of acceptability and study design with patients, paramedics and GPs.

Ethics and dissemination - This protocol was approved by NRES Committee South Central Oxford C in October 2012. Research Ethics Committee ref.12/SC/0604. The study findings will be disseminated through peer-reviewed journals, conference presentations and local public events. A publication plan and authorship criteria have been preagreed.

Trial registration number - ISRCTN: 36245726

Original language	English
Article number	e005744
Number of pages	9
Journal	BMJ Open
Volume	4
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2014-005744
Publication status	Published - 03 Sept 2014
Externally published	Yes

Keywords

Accidental Falls/prevention & control
Allied Health Personnel
Feasibility Studies
General Practice
Humans
Osteoporotic Fractures/epidemiology
Risk Assessment
World Health Organization

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Clarke, S., Bradley, R., Simmonds, B., Salisbury, C., Benger, J., Marques, E., Greenwood, R., Shepstone, L., Robinson, M., Appleby-Fleming, J., & Gooberman-Hill, R. (2014). Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall? Protocol for a randomised controlled feasibility study. BMJ Open, 4(9), Article e005744. https://doi.org/10.1136/bmjopen-2014-005744

@article{5045d0d7873f426dae25d1ad0caf8c69,

title = "Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall?: Protocol for a randomised controlled feasibility study",

abstract = "Introduction - Currently identification, and therefore, management of patients at risk of osteoporotic fracture in the UK is suboptimal. As the majority of patients who fracture have fallen, it follows that people who fall can usefully be targeted in any programme that aims to reduce osteoporotic fracture. Targeting vulnerable patients who are likely to benefit from intervention may help shift the management of fracture prevention into primary care, away from emergency departments. Paramedics who attend to patients who have fallen may be well placed to assess future fracture risk, using the Fracture Risk Assessment Tool (FRAX) and communicate that information directly to general practitioners (GPs).Methods and analysis - This feasibility study takes the form of a pragmatic, randomised controlled trial aimed at exploring and refining issues of study design, recruitment, retention, sample size and acceptability preceding a large-scale study with fracture as the end point. Patients (aged >50) who fall, call an ambulance, are attended by a study paramedic and give verbal consent will be asked FRAX and fall questions. Patients who subsequently formally consent to participation will be randomised to control (usual care) or intervention groups. Intervention will constitute transmission of calculated future fracture risk to the patients{\textquoteright} GP with suitable, evidence-based recommendations for investigation or treatment. 3 months after the index fall, data (proportion of patients in each group undergoing investigation or starting new treatment, quality of life and health economic) will be collected and analysed using descriptive statistics. A nested qualitative study will explore issues of acceptability and study design with patients, paramedics and GPs.Ethics and dissemination - This protocol was approved by NRES Committee South Central Oxford C in October 2012. Research Ethics Committee ref.12/SC/0604. The study findings will be disseminated through peer-reviewed journals, conference presentations and local public events. A publication plan and authorship criteria have been preagreed.Trial registration number - ISRCTN: 36245726",

keywords = "Accidental Falls/prevention & control, Allied Health Personnel, Feasibility Studies, General Practice, Humans, Osteoporotic Fractures/epidemiology, Risk Assessment, World Health Organization",

author = "Shane Clarke and Rachel Bradley and Bethany Simmonds and Chris Salisbury and Jonathan Benger and Elsa Marques and Rosemary Greenwood and Lee Shepstone and Maria Robinson and John Appleby-Fleming and Rachael Gooberman-Hill",

note = "Funding Information: 1University Hospitals NHS Foundation Trust, Bristol, UK 2Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK 3Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK 4School of Social and Community Medicine, University of Bristol, Bristol, UK 5Norwich Medical School University of East Anglia, Norwich, UK 6South Western Ambulance Service NHS Foundation Trust, Exeter, UK 7School of Clinical Sciences, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, UK Acknowledgements All the authors acknowledge and are grateful for the support of South West Ambulance Service NHS Foundation Trust (and the former Great Western Ambulance Service), the Research Design Service and University Hospitals Bristol NHS Foundation Trust for support in designing and carrying out this study. The authors, and the study design, have benefitted from the help and advice of their patient partners (the Oak Leaves) to whom they are indebted. They acknowledge also the support of the National Institute for Health Research, through the Comprehensive Clinical Research Network. Finally, they would like to acknowledge the help of all those patients who participate in this research. Funding Information: Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0711-25070). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Funding Information: All the authors acknowledge and are grateful for the support of South West Ambulance Service NHS Foundation Trust (and the former Great Western Ambulance Service), the Research Design Service and University Hospitals Bristol NHS Foundation Trust for support in designing and carrying out this study. The authors, and the study design, have benefitted from the help and advice of their patient partners (the Oak Leaves) to whom they are indebted. They acknowledge also the support of the National Institute for Health Research, through the Comprehensive Clinical Research Network. Finally, they would like to acknowledge the help of all those patients who participate in this research. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0711-25070). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Publisher Copyright: {\textcopyright} 2014, BMJ Publishing Group. All rights reserved.",

year = "2014",

month = sep,

day = "3",

doi = "10.1136/bmjopen-2014-005744",

language = "English",

volume = "4",

journal = "BMJ Open",

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Clarke, S, Bradley, R, Simmonds, B, Salisbury, C, Benger, J, Marques, E, Greenwood, R, Shepstone, L, Robinson, M, Appleby-Fleming, J & Gooberman-Hill, R 2014, 'Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall? Protocol for a randomised controlled feasibility study', BMJ Open, vol. 4, no. 9, e005744. https://doi.org/10.1136/bmjopen-2014-005744

TY - JOUR

T1 - Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall?

T2 - Protocol for a randomised controlled feasibility study

AU - Clarke, Shane

AU - Bradley, Rachel

AU - Simmonds, Bethany

AU - Salisbury, Chris

AU - Benger, Jonathan

AU - Marques, Elsa

AU - Greenwood, Rosemary

AU - Shepstone, Lee

AU - Robinson, Maria

AU - Appleby-Fleming, John

AU - Gooberman-Hill, Rachael

N1 - Funding Information: 1University Hospitals NHS Foundation Trust, Bristol, UK 2Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK 3Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK 4School of Social and Community Medicine, University of Bristol, Bristol, UK 5Norwich Medical School University of East Anglia, Norwich, UK 6South Western Ambulance Service NHS Foundation Trust, Exeter, UK 7School of Clinical Sciences, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, UK Acknowledgements All the authors acknowledge and are grateful for the support of South West Ambulance Service NHS Foundation Trust (and the former Great Western Ambulance Service), the Research Design Service and University Hospitals Bristol NHS Foundation Trust for support in designing and carrying out this study. The authors, and the study design, have benefitted from the help and advice of their patient partners (the Oak Leaves) to whom they are indebted. They acknowledge also the support of the National Institute for Health Research, through the Comprehensive Clinical Research Network. Finally, they would like to acknowledge the help of all those patients who participate in this research. Funding Information: Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0711-25070). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Funding Information: All the authors acknowledge and are grateful for the support of South West Ambulance Service NHS Foundation Trust (and the former Great Western Ambulance Service), the Research Design Service and University Hospitals Bristol NHS Foundation Trust for support in designing and carrying out this study. The authors, and the study design, have benefitted from the help and advice of their patient partners (the Oak Leaves) to whom they are indebted. They acknowledge also the support of the National Institute for Health Research, through the Comprehensive Clinical Research Network. Finally, they would like to acknowledge the help of all those patients who participate in this research. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0711-25070). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Publisher Copyright: © 2014, BMJ Publishing Group. All rights reserved.

PY - 2014/9/3

Y1 - 2014/9/3

N2 - Introduction - Currently identification, and therefore, management of patients at risk of osteoporotic fracture in the UK is suboptimal. As the majority of patients who fracture have fallen, it follows that people who fall can usefully be targeted in any programme that aims to reduce osteoporotic fracture. Targeting vulnerable patients who are likely to benefit from intervention may help shift the management of fracture prevention into primary care, away from emergency departments. Paramedics who attend to patients who have fallen may be well placed to assess future fracture risk, using the Fracture Risk Assessment Tool (FRAX) and communicate that information directly to general practitioners (GPs).Methods and analysis - This feasibility study takes the form of a pragmatic, randomised controlled trial aimed at exploring and refining issues of study design, recruitment, retention, sample size and acceptability preceding a large-scale study with fracture as the end point. Patients (aged >50) who fall, call an ambulance, are attended by a study paramedic and give verbal consent will be asked FRAX and fall questions. Patients who subsequently formally consent to participation will be randomised to control (usual care) or intervention groups. Intervention will constitute transmission of calculated future fracture risk to the patients’ GP with suitable, evidence-based recommendations for investigation or treatment. 3 months after the index fall, data (proportion of patients in each group undergoing investigation or starting new treatment, quality of life and health economic) will be collected and analysed using descriptive statistics. A nested qualitative study will explore issues of acceptability and study design with patients, paramedics and GPs.Ethics and dissemination - This protocol was approved by NRES Committee South Central Oxford C in October 2012. Research Ethics Committee ref.12/SC/0604. The study findings will be disseminated through peer-reviewed journals, conference presentations and local public events. A publication plan and authorship criteria have been preagreed.Trial registration number - ISRCTN: 36245726

AB - Introduction - Currently identification, and therefore, management of patients at risk of osteoporotic fracture in the UK is suboptimal. As the majority of patients who fracture have fallen, it follows that people who fall can usefully be targeted in any programme that aims to reduce osteoporotic fracture. Targeting vulnerable patients who are likely to benefit from intervention may help shift the management of fracture prevention into primary care, away from emergency departments. Paramedics who attend to patients who have fallen may be well placed to assess future fracture risk, using the Fracture Risk Assessment Tool (FRAX) and communicate that information directly to general practitioners (GPs).Methods and analysis - This feasibility study takes the form of a pragmatic, randomised controlled trial aimed at exploring and refining issues of study design, recruitment, retention, sample size and acceptability preceding a large-scale study with fracture as the end point. Patients (aged >50) who fall, call an ambulance, are attended by a study paramedic and give verbal consent will be asked FRAX and fall questions. Patients who subsequently formally consent to participation will be randomised to control (usual care) or intervention groups. Intervention will constitute transmission of calculated future fracture risk to the patients’ GP with suitable, evidence-based recommendations for investigation or treatment. 3 months after the index fall, data (proportion of patients in each group undergoing investigation or starting new treatment, quality of life and health economic) will be collected and analysed using descriptive statistics. A nested qualitative study will explore issues of acceptability and study design with patients, paramedics and GPs.Ethics and dissemination - This protocol was approved by NRES Committee South Central Oxford C in October 2012. Research Ethics Committee ref.12/SC/0604. The study findings will be disseminated through peer-reviewed journals, conference presentations and local public events. A publication plan and authorship criteria have been preagreed.Trial registration number - ISRCTN: 36245726

KW - Accidental Falls/prevention & control

KW - Allied Health Personnel

KW - Feasibility Studies

KW - General Practice

KW - Humans

KW - Osteoporotic Fractures/epidemiology

KW - Risk Assessment

KW - World Health Organization

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U2 - 10.1136/bmjopen-2014-005744

DO - 10.1136/bmjopen-2014-005744

M3 - Article

C2 - 25186156

VL - 4

JO - BMJ Open

JF - BMJ Open

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M1 - e005744

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