Prehospital recognition and antibiotics for 999 patients with sepsis: protocol for a feasibility study

Chris Moore, Jenna Bulger, Matt Morgan, Timothy Driscoll, Alison Porter, Saiful Islam, Mike Smyth, Gavin Perkins, Bernadette Sewell, Timothy Rainer, Prabath Nanayakkara, Chukwudi Okolie, Susan Allen, Greg Fegan, Jan Davies, Theresa Foster, Nick Francis, Fang Gao Smith, Gemma Ellis, Tracy Shanahan, Robin Howe, Helen Snooks, Chris Moore, Jenna Bulger, Matt Morgan, Timothy Driscoll, Alison Porter, Saiful Islam, Mike Smyth, Gavin Perkins, Bernadette Sewell, Timothy Rainer, Prabath Nanayakkara, Chukwudi Okolie, Susan Allen, Greg Fegan, Jan Davies, Theresa Foster, Nick Francis, Fang Gao Smith, Gemma Ellis, Tracy Shanahan, Robin Howe, Helen Snooks

Abstract

Background: Sepsis is a common condition which kills between 36,000 and 64,000 people every year in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve the health and well-being of people with sepsis. Paramedics frequently come into contact with patients with sepsis and are well placed to provide early diagnosis and treatment.We aim to determine the feasibility of undertaking a fully powered randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics obtaining blood cultures from and administering IV antibiotics to patients with sepsis, so we can make a decision about whether to proceed to a fully powered randomised controlled trial, which will answer questions regarding safety and effectiveness for patients and benefit to the National Health Service (NHS).

Methods/design: This is an individually randomised, two-arm feasibility study for a randomised controlled trial with a 1:1 ratio. Sixty paramedics will receive training to assist them to recognise sepsis using a screening tool, obtain blood cultures, and provide IV antibiotics. If sepsis is suspected, paramedics will randomly allocate patients to intervention or usual care using their next sequential individually issued scratch card. Patients will be followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We will also collect self-reported health-related quality of life (using SF-12) at this time. We will interview ten patients by telephone and hold a focus group with paramedics, to find out what they think about the intervention.

Discussion: At the end of this study, we will make a recommendation about whether a full randomised controlled trial of paramedics obtaining blood cultures and administering IV antibiotics for sepsis is warranted, and if so, we will develop a proposal for research funding in order to take the work forward.

Trial registration: ISRCTN, ISRCTN36856873.

Keywords: Antibiotics; Paramedic; Prehospital; Sepsis.

Conflict of interest statement

CM is the chief investigator for PhRASe. JKB is the trial manager for PhRASe. GF is the director of Swansea Trials Unit. HAS is a professor of Health Services Research and methodologist for the PhRASe. SI is the statistician for PhRASe. BS is the health economist for PhRASe. AP is the qualitative lead for PhRASe. TD is the data manager for PhRASe. GE is the lead nurse for Sepsis at University Hospital Wales. SA, PN, and TR are consultants of emergency medicine; MS is a research fellow; and MM is a consultant of Intensive Care Medicine; GP is a professor of Critical Care Medicine—all sit on the PhRASe Trial Management Group. CO is a research officer.The Wales Research Ethics Committee 4 granted ethical approval (reference 17-WA-0186).The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Screening tool

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