NCT06117618

Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients

Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Inpatients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,284 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the inpatient setting. 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 inpatient setting? 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.

Detailed description

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

Interventions

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

Timeline

• Start date: 2023-11-14
• Primary completion: 2024-04-22
• Completion: 2024-07-22
• First posted: 2023-11-07
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States