NewYork-Presbyterian Hospitals
New York, 10032, United States
NCT Number: NCT06117618
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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.
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.
Time frame: 24 hours
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
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 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 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 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 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 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: Up to 90 days
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
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
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
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
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
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
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
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
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
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.
Columbia University
Other
Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Inpatients
Acronym: SEPTIC-IP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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