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

Emory University

Status: Enrolling

Conditions: Sepsis

Treatments: Behavioral: PRESS Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05502107

CDC-STUDY00004512 (Other Identifier)

U54CK000601-01-01 (Other Grant/Funding Number)

STUDY00004512

U54CK000601-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

PRESS Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: PRESS Intervention

Standard of Care

No Intervention group

Description:

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.