Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events

NCT05502107 | Completed

• 3 other identifiers: STUDY00004512U54CK000601-01-01U54CK000601-01
• Study Type: interventional
• Target: 984
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of this study is to evaluate the impact of an Emergency Medical Services (EMS) based sepsis screening and early warning protocol on the timing of early sepsis care in the Emergency Department (ED).

Conditions

Sepsis

Keywords

Sepsis screening; EMS-based screening

Outcome Measures

Primary Outcomes (1)

• Time to First Antibiotic Administration in the ED

  Among eligible EMS patients with sepsis, the time from ED arrival to first antibiotic administration (parenteral only) in the ED will be examined. Time will be censored at the time of hospital admission or ED discharge.

  During ED stay on Day 1

Secondary Outcomes (9)

• EMS Documentation of Sepsis

  During ED stay on Day 1

• EMS Documentation of a Prehospital Sepsis Alert

  During ED stay on Day 1

• Time to Sepsis Bundle from ED Arrival

  During ED stay on Day 1

• Time to First Care Provider Documentation

  During ED stay on Day 1

• Proportion of Patients Without Sepsis Receiving Antibiotics in the ED

  During ED stay on Day 1

Study Arms (2)

PRESS Intervention

EXPERIMENTAL

Study sites will participate in the intervention phase for 6 to 18 months, depending on the order of cluster randomization. Sites will switch from the baseline phase in approximately 6 month blocks, with all sites delivering the intervention for the final 6 months of the study.

Behavioral: PRESS Intervention

Standard of Care

NO INTERVENTION

Study sites will participate in the standard of care phase to collect baseline data for 6 to 18 months, depending on the order of cluster randomization. All sites are in the baseline phase for the first 6 months then sites will switch one at a time, every 6 months, to the intervention phase of the study.

Interventions

PRESS Intervention BEHAVIORAL

The study intervention is PRESS protocol training and educational delivered to EMS providers, followed by protocol implementation. EMS providers will be trained to screen all EMS patients for protocol eligibility and will start using the protocol at the beginning of the intervention phase. The PRESS EMS protocol includes 2 major components: 1) an evidence-based sepsis screening tool, and 2) a prehospital sepsis alert call to the receiving hospital for participants who screen positive. Upon arrival to the ED, ED providers will provide immediate medical assessment to the patient to determine whether there is concern for sepsis. If the treating provider determines there is concern for sepsis, the provider will deliver usual sepsis care per local hospital protocols, workflows, or care pathways. Sepsis treatment interventions will not be specified by this study protocol.

PRESS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lowest EMS systolic blood pressure \<110 mmHg
• Highest EMS pulse rate \>90 beats per minute
• Highest EMS respiratory rate \>20 breaths per minute
• EMS transport to a participating study ED/hospital
• At least one of the following present:
• Lowest systolic blood pressure \<90 mmHg
• Age 40 years or greater
• Hot temperature assessment or temp \>38 degrees Celsius
• Oxygen saturation \<90%
• Nursing home patient
• Emergency Medical Dispatch classification = 'sick person'

You may not qualify if:

• Any of the following EMS conditions present:
• Trauma injury
• Cardiac arrest
• Psychiatric emergency
• Toxic ingestion
• Pregnant patient
• Inability to administratively link EMS and ED/hospital records
• Patient left emergency department prior to being evaluated by a medical provider (inability to classify sepsis status)

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Related Publications (1)

• Das S, Ahmed A, Capurro O, Carr MJ, Castedo FB, Fridkin SK, Hall A, House S, Kellogg J, Kroll M, Kurtzman N, Manjunath R, Mehta CC, Mohr NM, Prakash-Asrani R, Rudolph CC, Spainhour C, Trehan T, Sevransky JE, Polito CC. Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol. Trials. 2025 Nov 11;26(1):491. doi: 10.1186/s13063-025-09172-3.

  PMID: 41220003 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen C Polito, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

• Jonathan E Sevransky, MD, MHS

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a multicenter, cluster-randomized, stepped-wedge implementation study of an EMS sepsis screening and early communication protocol. Each study cluster represents one EMS organization and one partnered acute care hospital. Each cluster pair will participate in both a baseline and intervention phase of study varying between 6-18 months each (baseline and intervention), in approximately 6 month blocks, depending on the order of cluster randomization.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: June 27, 2023
• Primary Completion: May 28, 2025
• Study Completion: July 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available starting after publication of the primary study manuscript (anticipated start date July 2025) and will be available through the Emory Dataverse indefinitely.
• Access Criteria: A limited data set will be available to the general public for the purposes of conducting analyses such as a secondary analysis or meta analysis. Data can be accessed through the Emory Dataverse after requesting access from the primary study investigator.

Locations

US (3)