Dynamic Electronic Tracking and Escalation to reduce Critical care Transfers (DETECT): the protocol for a stepped wedge mixed method study to explore the clinical effectiveness, clinical utility and cost-effectiveness of an electronic physiological surveillance system for use in children

Background: Active monitoring of hospitalised adults, using handheld electronic physiological surveillance systems, is associated with reduced in-patient mortality in the UK. Potential also exists to improve the recognition and response to deterioration in hospitalised children. However, the clinical effectiveness, the clinical utility, and the cost-effectiveness of this technology to reduce paediatric critical deterioration, have not been evaluated in an NHS environment.

Method: This is a non-randomised stepped-wedge prospective mixed methods study. Participants will be in-patients under the age of 18 years, at a tertiary children's hospital. Day-case, neonatal surgery and Paediatric Intensive Care Unit (PICU) patients will be excluded. The intervention is the implementation of Careflow Vitals and Connect (System C) to document vital signs and sepsis screening. The underpinning age-specific Paediatric Early Warning Score (PEWS) risk model calculates PEWS and provides associated clinical decision support. Real-time data of deterioration risk are immediately visible to the entire clinical team to optimise situation awareness, the chronology of the escalation and response are captured with automated reporting of the organisational safety profile. Baseline data will be collected prospectively for 1 year preceding the intervention. Following a 3 month implementation period, 1 year of post-intervention data will be collected. The primary outcome is unplanned transfers to critical care (HDU and/or PICU). The secondary outcomes are critical deterioration events (CDE), the timeliness of critical care transfer, the critical care interventions required, critical care length of stay and outcome. The clinical effectiveness will be measured by prevalence of CDE per 1000 hospital admissions and per 1000 non-PICU bed days. Observation, field notes, e-surveys and focused interviews will be used to establish the clinical utility of the technology to healthcare professionals and the acceptability to in-patient families. The cost-effectiveness will be analysed using Health Related Group costs per day for the critical care and hospital stay for up to 90 days post CDE.

Discussion: If the technology is effective at reducing CDE in hospitalised children it could be deployed widely, to reduce morbidity and mortality, and associated costs.

Trial registration: Current Controlled Trials ISRCTN61279068 , date of registration 03.06.19, retrospectively registered.