SepsisIMPRESSNCT05502107
Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events
A study testing PRESS Intervention in people with Sepsis, run by Emory University at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- PRESS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jun 2023to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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'
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Iowa
Iowa City, Iowa, 52242
Washington University
St Louis, Missouri, 63130
About this study
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
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).
Read the 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.
- Conditions
- Sepsis
- Being tested
- PRESS Intervention
- Keywords
- Sepsis screening, EMS-based screening
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESS InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PRESS Intervention | Experimental | 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. Receives: Behavioral: PRESS Intervention |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During ED stay on Day 1
Secondary outcomes (9)
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.
Measured: During ED stay on Day 1
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.
Measured: During ED stay on Day 1
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.
Measured: During ED stay on Day 1
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.
Measured: During ED stay on Day 1
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.
Measured: During ED stay on Day 1
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.
Measured: Up to 10 days (on average)
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.
Measured: During hospital stay (up to 20 days, on average)
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.
Measured: During hospital stay (up to 20 days, on average)
In-hospital Death
In-hospital death among patients with and without sepsis will be assessed, stratified by sepsis status.
Measured: During hospital stay (up to 20 days, on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start27 Jun 2023
- Primary completion28 May 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Carmen Polito, Emory University
- Investigators
- Carmen C Polito, MD, MSc, Principal investigator, Emory UniversityJonathan E Sevransky, MD, MHS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502107
- Sponsor's protocol ID
- STUDY00004512
- Other IDs
- U54CK000601-01-01, U54CK000601-01
- Acronym
- IMPRESS
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A limited, de-identified, participant-level dataset will be shared. This dataset will include participant demographics, EMS physiologic data, as well as sepsis screening, classification, and outcomes data.
Publications
Das S, Ahmed A, Capurro O, Carr MJ, Castedo FB, Fridkin SK, Hall A, House S, Kellogg J, Kroll M, Kurtzman N, Manjunath R, Mehta CC, Mohr NM, Prakash-Asrani R, Rudolph CC, Spainhour C, Trehan T, Sevransky JE, Polito CC. Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol. Trials. 2025 Nov 11;26(1):491. doi: 10.1186/s13063-025-09172-3.
PubMed 41220003
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05502107
- Acronym / sponsor ID
- IMPRESS / STUDY00004512
- Conditions
- Sepsis
- Keywords
- Sepsis screening, EMS-based screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRESS Intervention | Experimental | Behavioral: PRESS InterventionStudy 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (8 listed)
- Any of the following EMS conditions present:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESS InterventionThe 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. | Behavioural | PRESS Intervention |
Primary outcome
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.
9 secondary outcomes
EMS Documentation of Sepsis
Time frame: During ED stay on Day 1
EMS Documentation of a Prehospital Sepsis Alert
Time frame: During ED stay on Day 1
Time to Sepsis Bundle from ED Arrival
Time frame: During ED stay on Day 1
Time to First Care Provider Documentation
Time frame: During ED stay on Day 1
Proportion of Patients Without Sepsis Receiving Antibiotics in the ED
Time frame: During ED stay on Day 1
Antibiotic Days of Therapy
Time frame: Up to 10 days (on average)
Proportion of Patients Admitted to the ICU
Time frame: During hospital stay (up to 20 days, on average)
Hospital Length of Stay
Time frame: During hospital stay (up to 20 days, on average)
In-hospital Death
Time frame: During hospital stay (up to 20 days, on average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 41220003Das S, Ahmed A, Capurro O, Carr MJ, Castedo FB, Fridkin SK, Hall A, House S, Kellogg J, Kroll M, Kurtzman N, Manjunath R, Mehta CC, Mohr NM, Prakash-Asrani R, Rudolph CC, Spainhour C, Trehan T, Sevransky JE, Polito CC. Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol. Trials. 2025 Nov 11;26(1):491. doi: 10.1186/s13063-025-09172-3.
- Individual participant dataSharing planned: Yes. A limited, de-identified, participant-level dataset will be shared. This dataset will include participant demographics, EMS physiologic data, as well as sepsis screening, classification, and outcomes data.
Related trials for Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen C Polito, MD, MSc principal investigator
Emory University
Jonathan E Sevransky, MD, MHS principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRESS Intervention in people with Sepsis, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Antibiotic Administration in the ED (time frame: During ED stay on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.