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Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial

Ceri Battle, Zoe Abbott, Hayley Hutchings Orcid Logo, Claire O’Neill, Sam Groves, Alan Watkins Orcid Logo, Fiona E Lecky, Sally Jones, James Gagg, Richard Body, Philip A Evans, Adrian Evans Orcid Logo, Samantha Groves

BMJ Open, Volume: 7, Issue: 7, Start page: e015972

Swansea University Authors: Hayley Hutchings Orcid Logo, Alan Watkins Orcid Logo, Adrian Evans Orcid Logo, Samantha Groves

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Abstract

Introduction A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cos...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: 2017
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URI: https://cronfa.swan.ac.uk/Record/cronfa35944
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A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. Methods/analysis This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Ethics and dissemination Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. 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spelling 2020-06-02T16:54:04.5307002 v2 35944 2017-10-05 Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial bdf5d5f154d339dd92bb25884b7c3652 0000-0003-4155-1741 Hayley Hutchings Hayley Hutchings true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false 21761f6eb805546a561c9f036e85405b 0000-0002-0814-5162 Adrian Evans Adrian Evans true false eb642e3823a000ee7550db9c062c2cdb Samantha Groves Samantha Groves true false 2017-10-05 HDAT Introduction A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. Methods/analysis This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Ethics and dissemination Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. Trial registration number ISRCTN95571506; Pre-results. Journal Article BMJ Open 7 7 e015972 2044-6055 2044-6055 BLunt chest wall trauma; prognostic model 1 7 2017 2017-07-01 10.1136/bmjopen-2017-015972 http://bmjopen.bmj.com/content/7/7/e015972 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University Health & Care Research Wales 2020-06-02T16:54:04.5307002 2017-10-05T14:59:48.9006359 College of Human and Health Sciences Swansea Centre for Health Economics Ceri Battle 1 Zoe Abbott 2 Hayley Hutchings 0000-0003-4155-1741 3 Claire O’Neill 4 Sam Groves 5 Alan Watkins 0000-0003-3804-1943 6 Fiona E Lecky 7 Sally Jones 8 James Gagg 9 Richard Body 10 Philip A Evans 11 Adrian Evans 0000-0002-0814-5162 12 Samantha Groves 13 0035944-09112017114638.pdf 35944.pdf 2017-11-09T11:46:38.1030000 Output 618709 application/pdf Version of Record true 2017-11-09T00:00:00.0000000 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license. true eng
title Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
spellingShingle Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
Hayley Hutchings
Alan Watkins
Adrian Evans
Samantha Groves
title_short Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
title_full Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
title_fullStr Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
title_full_unstemmed Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
title_sort Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
author_id_str_mv bdf5d5f154d339dd92bb25884b7c3652
81fc05c9333d9df41b041157437bcc2f
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author_id_fullname_str_mv bdf5d5f154d339dd92bb25884b7c3652_***_Hayley Hutchings
81fc05c9333d9df41b041157437bcc2f_***_Alan Watkins
21761f6eb805546a561c9f036e85405b_***_Adrian Evans
eb642e3823a000ee7550db9c062c2cdb_***_Samantha Groves
author Hayley Hutchings
Alan Watkins
Adrian Evans
Samantha Groves
author2 Ceri Battle
Zoe Abbott
Hayley Hutchings
Claire O’Neill
Sam Groves
Alan Watkins
Fiona E Lecky
Sally Jones
James Gagg
Richard Body
Philip A Evans
Adrian Evans
Samantha Groves
format Journal article
container_title BMJ Open
container_volume 7
container_issue 7
container_start_page e015972
publishDate 2017
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2017-015972
college_str College of Human and Health Sciences
hierarchytype
hierarchy_top_id collegeofhumanandhealthsciences
hierarchy_top_title College of Human and Health Sciences
hierarchy_parent_id collegeofhumanandhealthsciences
hierarchy_parent_title College of Human and Health Sciences
department_str Swansea Centre for Health Economics{{{_:::_}}}College of Human and Health Sciences{{{_:::_}}}Swansea Centre for Health Economics
url http://bmjopen.bmj.com/content/7/7/e015972
document_store_str 1
active_str 0
description Introduction A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. Methods/analysis This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Ethics and dissemination Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. Trial registration number ISRCTN95571506; Pre-results.
published_date 2017-07-01T03:48:56Z
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