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

Sponsor

Emory University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05502107

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

1,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

333.3

Patients Per Site

12.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Behavioral: PRESS Intervention	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRESS Intervention 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 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.
No Intervention: Standard of Care 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.

Arm

Intervention/Treatment

Experimental: PRESS Intervention

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

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.

No Intervention: Standard of Care

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.

Outcome Measures

Primary Outcome Measures

Time to First Antibiotic Administration in the ED [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 Outcome Measures

EMS Documentation of Sepsis [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.
EMS Documentation of a Prehospital Sepsis Alert [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.
Time to Sepsis Bundle from ED Arrival [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.
Time to First Care Provider Documentation [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.
Proportion of Patients Without Sepsis Receiving Antibiotics in the ED [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.
Antibiotic Days of Therapy [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.
Proportion of Patients Admitted to the ICU [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.
Hospital Length of Stay [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.
In-hospital Death [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322
2	University of Iowa	Iowa City	Iowa	United States	52242
3	Washington University	Saint Louis	Missouri	United States	63130

Sponsors and Collaborators

Emory University
Centers for Disease Control and Prevention

Investigators

Principal Investigator: Carmen C Polito, MD, MSc, Emory University
Principal Investigator: Jonathan E Sevransky, MD, MHS, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carmen Polito, Assistant Professor, Emory University

ClinicalTrials.gov Identifier:

NCT05502107

Other Study ID Numbers:

STUDY00004512
U54CK000601-01-01
U54CK000601-01

First Posted:

Aug 16, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carmen Polito, Assistant Professor, Emory University

Sepsis screening

EMS-based screening

Additional relevant MeSH terms:

Sepsis

Toxemia

Study Results

No Results Posted as of Aug 16, 2022