Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol

Background: Sepsis is a common, life-threatening medical emergency in which early recognition and treatment are cornerstones of management. Best practice guidelines recommend standardized sepsis screening in hospitals to facilitate early recognition. In contrast, very little is known about the efficacy and safety of standardized sepsis screening in the prehospital Emergency Medical Services (EMS) environment. To help address this knowledge gap, this study protocol will evaluate the impact of implementing an evidence-based sepsis protocol in ambulances. Methods: We plan to conduct a multicenter, stepped-wedge, cluster-randomized trial at 3 sites and enroll 984 participants over 24 months. EMS personnel will be trained to screen all eligible EMS patients using a sepsis screening and early notification protocol. Study inclusion criteria include all the following: (1) EMS systolic blood pressure < 110 mmHg, (2) EMS pulse > 90 beats/min, (3) EMS respiratory rate > 20 breaths/min, and (4) a positive sepsis screen based on the EMS sepsis protocol. To evaluate the clinical impact of the EMS sepsis protocol on patient care, the primary outcome is time to first antibiotic administration in the ED (emergency department) among patients with sepsis (a key treatment intervention in patients with sepsis). To evaluate the potential risk of the EMS sepsis protocol, the surrogate primary safety outcome is the total number of antibiotic DOT (days of therapy) during the first 7 days of hospitalization among patients without sepsis (i.e., false positive sepsis screens). Discussion: Successful completion of this trial will expand our understanding of prehospital sepsis screening as a standardized approach to prehospital sepsis care. Trial registration: ClinicalTrials.gov Identifier: NCT 05502107. Date of first posting: 08–16-2022. https://clinicaltrials.gov/ct2/show/NCT05502107.