Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients
- Conditions
- Clinical Decision Support SystemsElectronic Health RecordsSepsis
- Interventions
- Other: Nurse SIRS alertOther: Prescribing clinician SIRS alert
- Registration Number
- NCT06117618
- Lead Sponsor
- Columbia University
- Brief 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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 7200
- age > 18 years-old
- meets SIRS criteria
- physically located in an inpatient area of the hospital
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Nurse alert Nurse SIRS alert Participants will receive RN alert. Prescribing clinician alert Prescribing clinician SIRS alert Participants will receive physician alert. Nurse alert and prescribing clinician alert Nurse SIRS alert Participants will receive physician alert and RN alert. Nurse alert and prescribing clinician alert Prescribing clinician SIRS alert Participants will receive physician alert and RN alert.
- Primary Outcome Measures
Name Time Method Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle 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.
- Secondary Outcome Measures
Name Time Method Time to blood culture collection 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 to lactate order 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.
Percentage of patients discharged as deceased or discharged to hospice 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 to blood culture order 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.
Percentage of patients discharged home 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.
Percentage of patients discharged to rehab 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.
Percentage of patients discharged to skilled nursing facility 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.
Percentage of patients transferred to ICU transfer 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 to modified SSC hour-1 bundle completion 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 to lactate collection 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 to antibiotic treatment 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.
Sepsis incidence 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.
Median number of days of hospitalization 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.
Percentage inpatient mortality at 90 days 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 to antibiotic order 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.
Number of positive blood cultures 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.
Adverse antibiotic events 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.
Trial Locations
- Locations (1)
NewYork-Presbyterian Hospitals
🇺🇸New York, New York, United States