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Completed

NCT Number: NCT05502107

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

Sepsis is life-threatening medical emergency and a common cause of morbidity and mortality among hospitalized patients. Recognizing and treating sepsis immediately is key to achieving optimal patient outcomes after sepsis. The prehospital, EMS setting represents a unique opportunity to implement best practice by operationalizing guideline-recommended, system-wide sepsis screening protocols in an effort to facilitate earlier recognition of sepsis and minimize delays in evaluation and treatment. Unfortunately, evidence-based screening tools to assist EMS providers in recognizing this heterogenous syndrome are lacking, and recognition by EMS providers is generally poor.

The purpose of this study is to evaluate the prehospital sepsis (PRESS) protocol, which is an evidence-based sepsis screening and early communication protocol designed for use in the prehospital, EMS environment. The PRESS protocol pairs a validated sepsis screening tool with a prehospital sepsis alert to the receiving ED for patients who are screen positive. This innovative approach has been used to improve patient care and outcomes in other life-threatening, time-sensitive medical emergencies including heart attack and stroke. Prehospital screening and an early warning call to the ED before patient arrival provides valuable lead time that makes immediate evaluation and treatment by EMS providers possible once a patient arrives in the ED.

This study includes three study sites which are each comprised of cluster pairs of one EMS organization and one partnered acute care hospital. Each cluster pair will participate in both a baseline and intervention phase of study. EMS providers will be trained to screen for sepsis according to the PRESS protocol. 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. The overarching hypothesis is that implementation of an EMS-based sepsis screening and early warning protocol will be associated with a reduction in time first antibiotic administration in the ED among patients with sepsis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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'

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Time to First Antibiotic Administration in the ED

    Time frame: During ED stay on Day 1

    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.

Secondary outcomes

  1. EMS Documentation of Sepsis

    Time frame: During ED stay on Day 1

    Among eligible EMS patients with sepsis, the proportion with EMS documentation of suspected or possible sepsis or positive PRESS screen will be assessed.

  2. EMS Documentation of a Prehospital Sepsis Alert

    Time frame: During ED stay on Day 1

    Among eligible EMS patients with sepsis, the proportion who receive sepsis bundle care within 3 hours of ED arrival (sepsis bundle = blood culture order, lactic acid order, antibiotic administration) will be assessed. Care bundle elements will be analyzed individually and in composite.

  3. Time to Sepsis Bundle from ED Arrival

    Time frame: During ED stay on Day 1

    Among eligible EMS patients with sepsis, the time to sepsis bundle care elements from ED arrival will be assessed. Time will be censored at the time of hospital admission or ED discharge.

  4. Time to First Care Provider Documentation

    Time frame: During ED stay on Day 1

    Among all eligible EMS patients, the time from ED arrival to first care provider documentation in the ED will be assessed.

  5. Proportion of Patients Without Sepsis Receiving Antibiotics in the ED

    Time frame: During ED stay on Day 1

    Among all eligible EMS patients without sepsis, the proportion who receive antibiotic administration (parenteral only) in the ED will be assessed.

  6. Antibiotic Days of Therapy

    Time frame: Up to 10 days (on average)

    The total number of antibiotic days of therapy (DOT) will be assessed. Antibiotic DOT is measured as last calendar day of consecutive antibiotic therapy minus the first calendar day of antibiotic therapy, among patients with and without sepsis.

  7. Proportion of Patients Admitted to the ICU

    Time frame: During hospital stay (up to 20 days, on average)

    Among all eligible EMS patients with and without sepsis, the proportion admitted from the ED directly to ICU level of care will be assessed, stratified by sepsis status.

  8. Hospital Length of Stay

    Time frame: During hospital stay (up to 20 days, on average)

    Among all eligible EMS patients with and without sepsis, total hospital length of stay will be assessed, stratified by sepsis status. Hospital length of stay is defined as days since ED arrival to day of hospital discharge.

  9. In-hospital Death

    Time frame: During hospital stay (up to 20 days, on average)

    In-hospital death among patients with and without sepsis will be assessed, stratified by sepsis status.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

A Multicenter, Stepped Wedge, Cluster Randomized Study of a Prehospital Sepsis Protocol and Its Impact on Timely Antibiotic Administration in the Emergency Department and Subsequent Adverse Events

Acronym: IMPRESS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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