SepsisSEPTIC-EDNCT06117605

Sepsis Electronic Prompting for Timely Intervention and Care for Emergency Department Patients

A study testing Nurse SIRS alert and Prescribing clinician SIRS alert in people with Sepsis and Electronic Health Records, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the emergency department (ED). The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis, Electronic Health Records, Clinical Decision Support Systems
What is being tested?: Nurse SIRS alert and Prescribing clinician SIRS alert
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25,668 participants
Where: 1 siteUnited States
Study dates: 14 Nov 2023to 22 Jul 2024
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

Patient Inclusion Criteria:

age > 18 years-old
meets SIRS criteria
physically located in the emergency department
not located in a hospital unit that takes care of pregnant and peri-partum patients
not SARS-COV-2 PCR positive in past 7 days
does not have an active order for "comfort measures only"

Patient Exclusion Criteria:

already having sepsis treatment ordered (if prescribing clinician alert) or collected/completed (if nurse alert)
already enrolled in the SEPTIC study (including as an emergency department patient or as an inpatient)

Trial locations and contacts

1 site in 1 country.

United States1 site

NewYork-Presbyterian Hospitals
New York, New York, 10032

Other trials in United States

About this study

Official title: Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Emergency Department Patients

Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.

Read the detailed description

SEPTIC is a master protocol for two trials on distinct subpopulations: emergency department (ED) patients and inpatients. This protocol "ID: AAAU1002 - ED" describes the ED subpopulation study while "ID: AAAU1002 - IP" describes the inpatient subpopulation study.

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving outcomes. International guidelines recommend hospital sepsis screening programs, which are commonly implemented in the electronic health record (EHR) as an interruptive screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care. This study tests interruptive (pop-up) EHR alerts. Epic Systems, the company that produces the EHR, refers to these types of alerts as BestPractice Advisories (BPAs).

Conditions: Sepsis, Electronic Health Records, Clinical Decision Support Systems
Being tested: Nurse SIRS alert, Prescribing clinician SIRS alert
Keywords: sepsis, alerts, clinical decision support systems, informatics, health information technology
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nurse SIRS alertOther
An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.
Prescribing clinician SIRS alertOther
An electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.

Study groups in NCT06117605
Study group	Role	What they receive
No alert	No intervention	Participants will receive no physician alert or registered nurse (RN) alert.
Nurse alert	Experimental	Participants will receive RN alert. Receives: Other: Nurse SIRS alert
Prescribing clinician alert	Experimental	Participants will receive physician alert. Receives: Other: Prescribing clinician SIRS alert
Nurse alert and prescribing clinician alert	Experimental	Participants will receive physician alert and RN alert. Receives: Other: Nurse SIRS alert; Other: Prescribing clinician SIRS alert

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle
The primary outcome is whether a patient receives a modified SSC hour-1 bundle within three hours from the time of first SIRS alert. The modified SSC hour-1 bundle includes (1) lactate lab collected, (2) two blood cultures collected, (3) new intravenous antimicrobial administration (from the Centers for Disease Control and Prevention (CDC) Adult Sepsis Event (ASE) list). Patients will be tallied.
Measured: Up to 3 hours

Secondary outcomes (17)

Time to blood culture order
Time from the first SIRS alert until two blood cultures ordered in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours
Time to blood culture collection
Time from the first SIRS alert until two blood cultures collected in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours
Time to lactate order
Time from the first SIRS alert until lactate lab ordered in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours
Time to lactate collection
Time from the first SIRS alert until lactate lab collected in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours
Time to antibiotic order
Time from the first SIRS alert until new antibiotic order in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours
Time to antibiotic treatment
Time from the first SIRS alert until new antibiotic administration in all patients and the subgroups of patients with CDC ASE, CDC BSE, and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours
Sepsis incidence
Sepsis incidence (CDC ASE, CDC BSE, Sepsis-3) across all alerting groups. Events will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Percentage of patients transferred to ICU transfer
Intensive care unit (ICU) transfers for patients not in the ICU at the time of first SIRS alert will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Median number of days of hospitalization
This is to determine the average length of stay in the hospital. Days will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Percentage of patients discharged as deceased or discharged to hospice
This is to measure the outcomes ended in death or hospice. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Percentage of patients discharged home
This is to measure the outcomes ended in returning to home. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Percentage of patients discharged to rehab
This is to measure the outcomes ended in rehab. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Percentage of patients discharged to skilled nursing facility
This is to measure the outcomes ended in skilled nursing facility. Outcomes will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Percentage inpatient mortality at 90 days
This is to measure inpatient mortality. Deaths will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Number of positive blood cultures
Positive blood cultures will be determined by blood tests. Positive cultures will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Adverse antibiotic events
This is defined as new antibiotic allergy documented in 14 days after first SIRS alert or C. difficile infection or multi-drug resistant organism infection within 7-90 days of first SIRS alert. Events will be recorded and tallied up to 90 days from first SIRS alert or discharge, whichever occurs first.
Measured: Up to 90 days
Time to modified SSC hour-1 bundle completion
Time interval from first SIRS alert to a modified SSC hour-1 bundle completion, censored at 24 hours after the first alert time, in all patients and the subgroups of patients with CDC ASE, CDC Bacteraemia/Fungemia Shock Event (BSE), and Sepsis-3 sepsis definitions. This will be measured in minutes.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 202322 Jul 2024

First posted7 Nov 2023
Study start14 Nov 2023
Primary completion22 Apr 2024
Study completion22 Jul 2024

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 Columbia 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: Factorial
Model description: If a patient is randomized to a group without an alert, the alert will instead be a hidden "silent" alert that does not display. However, a timestamp of when the alert was triggered is still recorded even though the alert did not display. This timestamp is used for the primary and secondary outcomes.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 25,668 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06117605
Sponsor's protocol ID: AAAU1002 - ED
Acronym: SEPTIC-ED
Status last verified: Aug 2024
First submitted: 31 Oct 2023
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ranard BL, Qian M, Cummings MJ, Zhang DY, Lee SM, Beitler JR, Applebaum JR, Schenck EJ, Mohamed H, Trepp R, Hsu H, Scofi J, Southern WN, Rossetti SC, Yip NH, Brodie D, Sharma M, Fertel BS, Adelman JS. Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol. BMJ Open. 2025 Aug 11;15(8):e088792. doi: 10.1136/bmjopen-2024-088792.
PubMed 40789731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Emergency Department Patients
ClinicalTrials.gov ID: NCT06117605
Acronym / sponsor ID: SEPTIC-ED / AAAU1002 - ED
Conditions: Sepsis, Electronic Health Records, Clinical Decision Support Systems
Keywords: sepsis, alerts, clinical decision support systems, informatics, health information technology
Study type: Interventional
Recruitment status: Completed
Enrolment: 25,668 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: 14 Nov 2023 (actual)
Primary completion: 22 Apr 2024 (actual)
Study completion: 22 Jul 2024 (actual)
First posted: 7 Nov 2023 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: If a patient is randomized to a group without an alert, the alert will instead be a hidden "silent" alert that does not display. However, a timestamp of when the alert was triggered is still recorded even though the alert did not display. This timestamp is used for the primary and secondary outcomes.

Arm	Type	Receives
No alert	No intervention	–Participants will receive no physician alert or registered nurse (RN) alert.
Nurse alert	Experimental	Other: Nurse SIRS alertParticipants will receive RN alert.
Prescribing clinician alert	Experimental	Other: Prescribing clinician SIRS alertParticipants will receive physician alert.
Nurse alert and prescribing clinician alert	Experimental	Other: Nurse SIRS alert, Other: Prescribing clinician SIRS alertParticipants will receive physician alert and RN alert.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Nurse SIRS alertAn electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.	Other	Nurse alert, Nurse alert and prescribing clinician alert
Prescribing clinician SIRS alertAn electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.	Other	Nurse alert and prescribing clinician alert, Prescribing clinician alert

Primary outcome

Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle
Time frame: Up to 3 hours
The primary outcome is whether a patient receives a modified SSC hour-1 bundle within three hours from the time of first SIRS alert. The modified SSC hour-1 bundle includes (1) lactate lab collected, (2) two blood cultures collected, (3) new intravenous antimicrobial administration (from the Centers for Disease Control and Prevention (CDC) Adult Sepsis Event (ASE) list). Patients will be tallied.

17 secondary outcomes

Time to blood culture order
Time frame: 24 hours
Time to blood culture collection
Time frame: 24 hours
Time to lactate order
Time frame: 24 hours
Time to lactate collection
Time frame: 24 hours
Time to antibiotic order
Time frame: 24 hours
Time to antibiotic treatment
Time frame: 24 hours
Sepsis incidence
Time frame: Up to 90 days
Percentage of patients transferred to ICU transfer
Time frame: Up to 90 days
Median number of days of hospitalization
Time frame: Up to 90 days
Percentage of patients discharged as deceased or discharged to hospice
Time frame: Up to 90 days
Percentage of patients discharged home
Time frame: Up to 90 days
Percentage of patients discharged to rehab
Time frame: Up to 90 days
Percentage of patients discharged to skilled nursing facility
Time frame: Up to 90 days
Percentage inpatient mortality at 90 days
Time frame: Up to 90 days
Number of positive blood cultures
Time frame: Up to 90 days
Adverse antibiotic events
Time frame: Up to 90 days
Time to modified SSC hour-1 bundle completion
Time frame: 24 hours

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 19 Sep 2024.
Derived from this study: PubMed 40789731Ranard BL, Qian M, Cummings MJ, Zhang DY, Lee SM, Beitler JR, Applebaum JR, Schenck EJ, Mohamed H, Trepp R, Hsu H, Scofi J, Southern WN, Rossetti SC, Yip NH, Brodie D, Sharma M, Fertel BS, Adelman JS. Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol. BMJ Open. 2025 Aug 11;15(8):e088792. doi: 10.1136/bmjopen-2024-088792.
Individual participant dataSharing planned: No

Related trials for Sepsis

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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
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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.

Benjamin L Ranard, MD, MSHP study director

Columbia University

Jason S Adelman, MD, MS principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nurse SIRS alert and Prescribing clinician SIRS alert in people with Sepsis and Electronic Health Records, run by Columbia University at 1 site 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?

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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle (time frame: Up to 3 hours). 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 NCT06117605, 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 19 Sep 2024.