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Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)

Jenna Jones, Susan Allen, Jan Davies, Timothy Driscoll Orcid Logo, Gemma Ellis, Greg Fegan, Theresa Foster, Nick Francis, Saiful Islam Orcid Logo, Matt Morgan, Prabath W. B. Nanayakkara, Gavin D. Perkins, Alison Porter Orcid Logo, Timothy Rainer, Samuel Ricketts, Berni Sewell, Tracy Shanahan, Fang Gao Smith, Michael A. Smyth, Helen Snooks Orcid Logo, Chris Moore

Scientific Reports, Volume: 11, Issue: 1

Swansea University Authors: Jenna Jones, Timothy Driscoll Orcid Logo, Greg Fegan, Saiful Islam Orcid Logo, Alison Porter Orcid Logo, Berni Sewell, Helen Snooks Orcid Logo

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DOI (Published version): 10.1038/s41598-021-97979-w

Abstract

Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity...

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Published in: Scientific Reports
ISSN: 2045-2322
Published: Springer Science and Business Media LLC 2021
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URI: https://cronfa.swan.ac.uk/Record/cronfa58284
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Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). 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spelling 2022-10-27T11:34:31.3321550 v2 58284 2021-10-10 Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe) e662b6c5aba239a9cd0f115d16df0a82 Jenna Jones Jenna Jones true false 2be5c329c44d14550ceac4934fcb409e 0000-0001-9879-2509 Timothy Driscoll Timothy Driscoll true false a9005418b89918776f3d8895ba42e850 Greg Fegan Greg Fegan true false 4157d27b800a8357873bdfc9c71bd596 0000-0003-3182-8487 Saiful Islam Saiful Islam true false fcc861ec479a79f7fb9befb13192238b 0000-0002-3408-7007 Alison Porter Alison Porter true false f6a4af2cfa4275d2a8ebba292fa14421 Berni Sewell Berni Sewell true false ab23c5e0111b88427a155a1f495861d9 0000-0003-0173-8843 Helen Snooks Helen Snooks true false 2021-10-10 MEDS Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). This feasibility study met its pre-determined progression criteria; an application will therefore be prepared and submitted for funding for a fully-powered multi-centre randomised trial. Journal Article Scientific Reports 11 1 Springer Science and Business Media LLC 2045-2322 20 9 2021 2021-09-20 10.1038/s41598-021-97979-w Author Correction available at https://doi.org/10.1038/s41598-022-06469-0 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Health and Care Research Wales, Reference number 1191. 2022-10-27T11:34:31.3321550 2021-10-10T07:38:39.4489298 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Jenna Jones 1 Susan Allen 2 Jan Davies 3 Timothy Driscoll 0000-0001-9879-2509 4 Gemma Ellis 5 Greg Fegan 6 Theresa Foster 7 Nick Francis 8 Saiful Islam 0000-0003-3182-8487 9 Matt Morgan 10 Prabath W. B. Nanayakkara 11 Gavin D. Perkins 12 Alison Porter 0000-0002-3408-7007 13 Timothy Rainer 14 Samuel Ricketts 15 Berni Sewell 16 Tracy Shanahan 17 Fang Gao Smith 18 Michael A. Smyth 19 Helen Snooks 0000-0003-0173-8843 20 Chris Moore 21 58284__21369__7689905aa9734f078a867a54e0af26eb.pdf 58284.pdf 2021-10-29T14:21:23.9370451 Output 1126491 application/pdf Version of Record true © The Author(s) 2021. This article is licensed under a Creative Commons Attribution 4.0 International License true eng http://creativecommons.org/licenses/by/4.0/
title Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
spellingShingle Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
Jenna Jones
Timothy Driscoll
Greg Fegan
Saiful Islam
Alison Porter
Berni Sewell
Helen Snooks
title_short Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
title_full Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
title_fullStr Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
title_full_unstemmed Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
title_sort Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)
author_id_str_mv e662b6c5aba239a9cd0f115d16df0a82
2be5c329c44d14550ceac4934fcb409e
a9005418b89918776f3d8895ba42e850
4157d27b800a8357873bdfc9c71bd596
fcc861ec479a79f7fb9befb13192238b
f6a4af2cfa4275d2a8ebba292fa14421
ab23c5e0111b88427a155a1f495861d9
author_id_fullname_str_mv e662b6c5aba239a9cd0f115d16df0a82_***_Jenna Jones
2be5c329c44d14550ceac4934fcb409e_***_Timothy Driscoll
a9005418b89918776f3d8895ba42e850_***_Greg Fegan
4157d27b800a8357873bdfc9c71bd596_***_Saiful Islam
fcc861ec479a79f7fb9befb13192238b_***_Alison Porter
f6a4af2cfa4275d2a8ebba292fa14421_***_Berni Sewell
ab23c5e0111b88427a155a1f495861d9_***_Helen Snooks
author Jenna Jones
Timothy Driscoll
Greg Fegan
Saiful Islam
Alison Porter
Berni Sewell
Helen Snooks
author2 Jenna Jones
Susan Allen
Jan Davies
Timothy Driscoll
Gemma Ellis
Greg Fegan
Theresa Foster
Nick Francis
Saiful Islam
Matt Morgan
Prabath W. B. Nanayakkara
Gavin D. Perkins
Alison Porter
Timothy Rainer
Samuel Ricketts
Berni Sewell
Tracy Shanahan
Fang Gao Smith
Michael A. Smyth
Helen Snooks
Chris Moore
format Journal article
container_title Scientific Reports
container_volume 11
container_issue 1
publishDate 2021
institution Swansea University
issn 2045-2322
doi_str_mv 10.1038/s41598-021-97979-w
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
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description Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). This feasibility study met its pre-determined progression criteria; an application will therefore be prepared and submitted for funding for a fully-powered multi-centre randomised trial.
published_date 2021-09-20T20:06:18Z
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score 11.04748

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