Parafricta bootees compared to UK standard care to reduce heel pressure ulcers: a multicentre pragmatic randomised controlled trial with blinded assessment at three days

Severe sepsis is a common condition responsible for up to 64,000 deaths in the UK per year.

Administration of intravenous (IV) antibiotics within the first hour of diagnosis has been shown to reduce morbidity and mortality.

Emergency medical services (EMS) personnel frequently encounter patients with severe sepsis and are well placed to make a diagnosis and begin treatment. There is currently no well-defined pre-hospital protocol for sepsis, and the ambulance service does not routinely deliver key critical interventions.

Aim: To assess the feasibility of conducting a randomised trial of a protocol for paramedics to assess and administer IV antibiotics to patients with suspected severe sepsis, and to prepare for a full trial if indicated.

Objectives:

1- Developing the intervention:

1a To work with clinicians, paramedics, and service users to develop a pre-hospital sepsis intervention, comprising:
1b Training for paramedics to accurately identify sepsis, carry out key investigations, and administer a first dose of IV antibiotics
1c Protocol for assessment and administration of antibiotics
1d Handover protocol

2- Intervention feasibility:

2a To assess paramedic uptake and satisfaction with the training package
2b To assess paramedic compliance with assessment/treatment protocol
2c To determine acceptability of the intervention by paramedics

3- RCT feasibility:
3a To develop and test trial recruitment, randomisation, and data collection processes
3b To assess sample size requirements and attrition rates
3c To determine availability of outcome data
3d To clarify primary and secondary outcome measures

4- Full trial planning:
4a To determine feasibility to carry out a fully powered, multi-centre trial, as indicated by findings matched to our progression criteria
4b If so, draft a full trial application to the HTA Research Programme

Design: This feasibility study will use a randomised design in a single NHS (Wales) Ambulance Trust. Randomisation will be determined by bespoke designed scratchcards issued to participating paramedics in the study area.

All study paramedics will receive training in sepsis recognition and delivery of an enhanced sepsis management protocol (to include blood culture collection, IV fluids, high flow oxygen, first dose of IV antibiotics, pre-alert to Emergency Department [ED]) or usual care (rapid transport to ED and pre-alert).

Plan of investigation: We will recruit 60 paramedics from the study area who will be provided additional training as described above. If acute sepsis is suspected, paramedics will select a study scratchcard to determine whether the patient receives enhanced care (intervention), or standard care (control), prior to arrival at the ED.

We will conduct post trial interviews with patients and hold a focus group with paramedics to find out whether the intervention is acceptable, and to assess barriers and facilitators to intervention and trial implementation.

We will decide whether to progress to a full trial using preset criteria related to:
- Acceptability of the intervention to paramedics and patients
- Completeness of outcome data retrieval
- Safety of the intervention in practice.

If indicated, we will make preparations for a full trial, including: refinements to intervention; selection of outcome measures; measurement of timepoints; sample size calculation; agreements with partner sites; and development and submission of a HTA funding proposal.