Clinical trial NCT05502107: Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: Sepsis screening
EMS-based screening
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-08-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to First Antibiotic Administration in the ED
timeFrame: During ED stay on Day 1
Secondary outcomes:
measure: EMS Documentation of Sepsis
timeFrame: During ED stay on Day 1
measure: EMS Documentation of a Prehospital Sepsis Alert
timeFrame: During ED stay on Day 1
measure: Time to Sepsis Bundle from ED Arrival
timeFrame: During ED stay on Day 1
measure: Time to First Care Provider Documentation
timeFrame: During ED stay on Day 1
measure: Proportion of Patients Without Sepsis Receiving Antibiotics in the ED
timeFrame: During ED stay on Day 1
measure: Antibiotic Days of Therapy
timeFrame: Up to 10 days (on average)
measure: Proportion of Patients Admitted to the ICU
timeFrame: During hospital stay (up to 20 days, on average)
measure: Hospital Length of Stay
timeFrame: During hospital stay (up to 20 days, on average)
measure: In-hospital Death
timeFrame: During hospital stay (up to 20 days, on average)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Emory University
name: Carmen C Polito, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Jonathan E Sevransky, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: