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

Sepsis Clinical Trial

— SEPTIC-ED  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06117605
• Other study ID #: AAAU1002 - ED
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 time to sepsis treatment for patients in the ED?

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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 14800
• Est. completion date: July 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Clinical Decision Support Systems
• Electronic Health Records
• Emergencies
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hospitals	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	Up to 90 days
Secondary	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.	24 hours