Moore Chris, Bulger Jenna, Morgan Matt, Driscoll Timothy, Porter Alison, Islam Saiful, Smyth Mike, Perkins Gavin, Sewell Bernadette, Rainer Timothy, Nanayakkara Prabath, Okolie Chukwudi, Allen Susan, Fegan Greg, Davies Jan, Foster Theresa, Francis Nick, Smith Fang Gao, Ellis Gemma, Shanahan Tracy, Howe Robin, Snooks Helen
1Welsh Ambulance Services NHS Trust, Wales, UK.
2ILS2, Swansea University Medical School, Swansea University, Singleton Campus, Wales, SA2 8PP UK.
Pilot Feasibility Stud. 2018 Mar 12;4:64. doi: 10.1186/s40814-018-0258-8. eCollection 2018.
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.
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.
ISRCTN, ISRCTN36856873.
脓毒症是一种常见病症，在英国每年导致36,000至64,000人死亡。脓毒症的早期识别与管理已被证明可降低死亡率，并改善脓毒症患者的健康状况和生活质量。护理人员经常接触脓毒症患者，具备提供早期诊断和治疗的良好条件。我们旨在确定开展一项充分有力的随机对照试验（RCT）的可行性，以测试护理人员为脓毒症患者采集血培养样本并给予静脉抗生素治疗的临床效果和成本效益，从而决定是否进行一项充分有力的随机对照试验，该试验将回答有关患者安全性和有效性以及对国民医疗服务体系（NHS）益处的问题。
方法/设计：这是一项个体随机、双臂可行性研究，用于一项比例为1:1的随机对照试验。60名护理人员将接受培训，以帮助他们使用筛查工具识别脓毒症、采集血培养样本并提供静脉抗生素治疗。如果怀疑患有脓毒症，护理人员将使用他们下一张按顺序单独发放的刮刮卡，将患者随机分配至干预组或常规护理组。使用关联的匿名数据对患者进行90天的随访，以记录住院时间和死亡率。我们还将在此时收集自我报告的健康相关生活质量（使用SF - 12量表）。我们将通过电话采访10名患者，并与护理人员举行焦点小组讨论，以了解他们对该干预措施的看法。
在本研究结束时，我们将就是否有必要对护理人员为脓毒症患者采集血培养样本并给予静脉抗生素治疗进行全面随机对照试验提出建议，如果有必要，我们将制定研究资金申请提案，以便推进这项工作。
ISRCTN，ISRCTN36856873
