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

Sepsis Clinical Trial

— IMPRESS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502107
• Other study ID #: STUDY00004512
• Secondary ID: U54CK000601-01-0
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Emory University
• Contact: Carmen C Polito, MD, MSc
• Phone: 404-616-4891
• Email: cpolito[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Behavioral:
• PRESS Intervention
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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Iowa	Iowa City	Iowa
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EMS Documentation of Sepsis	Among eligible EMS patients with sepsis, the proportion with EMS documentation of suspected or possible sepsis or positive PRESS screen will be assessed.	During ED stay on Day 1
Secondary	EMS Documentation of a Prehospital Sepsis Alert	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.	During ED stay on Day 1
Secondary	Time to Sepsis Bundle from ED Arrival	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.	During ED stay on Day 1
Secondary	Time to First Care Provider Documentation	Among all eligible EMS patients, the time from ED arrival to first care provider documentation in the ED will be assessed.	During ED stay on Day 1
Secondary	Proportion of Patients Without Sepsis Receiving Antibiotics in the ED	Among all eligible EMS patients without sepsis, the proportion who receive antibiotic administration (parenteral only) in the ED will be assessed.	During ED stay on Day 1
Secondary	Antibiotic Days of Therapy	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.	Up to 10 days (on average)
Secondary	Proportion of Patients Admitted to the ICU	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.	During hospital stay (up to 20 days, on average)
Secondary	Hospital Length of Stay	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.	During hospital stay (up to 20 days, on average)
Secondary	In-hospital Death	In-hospital death among patients with and without sepsis will be assessed, stratified by sepsis status.	During hospital stay (up to 20 days, on average)