Development of early warning and rapid response system for patients with novel coronavirus pneumonia (COVID-19): A research protocol

BACKGROUND: Coronavirus disease 2019 (COVID-19) has caused serious damage to public health. COVID-19 has no vaccine or specific therapy; its mortality rate increases significantly once patients deteriorate. Furthermore, intensive monitoring of COVID-19 is limited by insufficient medical resources and increased risks of exposure to medical staff. We therefore aim to build an early warning and rapid response system (EWRRS) to address these problems. METHOD: The research is designed as a prospective cohort study, to verify a dynamic and interactive evaluation system; it includes patient self-reporting, active monitoring, early alarming and treatment recommendations. Adult patients diagnosed with COVID-19 will be recruited from Sept 2020 to Aug 2021 at a tertiary contagious hospital. Patients with life expectancy <48 hours, pregnant or lactating, in immunosuppression states or end-stage diseases will be excluded. The intervention is implementation of EWRRS to detect early signs of clinical deterioration of COVID-19 patients, to provide timely and efficient treatment suggestions by the system. EWRRS can determine the classification and interactive evaluation of patient information; the determination is based on the application of 3 different scenario modules, separately driven by patients, nurses, and physicians. The primary outcome is change in disease severity category after treatment. Secondary outcomes include the proportion of patients with different disease severity types; critical deterioration events; patients who had unplanned transfers to an intensive care unit (ICU) and required critical care interventions; intervals from warning to implementation of clinical interventions; hospital mortality; length of ICU and hospital stay; workload of medical staff and risks of exposure to COVID-19. DISCUSSION: Our hypothesis is that EWRRS provides an example of an early identification, warning, and response system for COVID-19. In addition, EWRRS can potentially be extended to use as a grading metric for general critically ill patients in an ICU setting.