An interventional study of Nurse SIRS alert and Prescribing clinician SIRS alert in Sepsis, Electronic Health Records and Clinical Decision Support Systems, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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).
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 25,668 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Participants will receive no physician alert or registered nurse (RN) alert.
Participants will receive RN alert.
Other: Nurse SIRS alert
Participants will receive physician alert.
Other: Prescribing clinician SIRS alert
Participants will receive physician alert and RN alert.
Other: Nurse SIRS alert · Other: Prescribing clinician SIRS alert
An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.
An electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.
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.
Time frame: Up to 3 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
Plan to share: No
Ran from Nov 2023 to primary completion in Apr 2024, 5 months.
Of 246 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's 5 months is below that.
Counting every sponsor, half of 267 studies reached it within 22 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.