Clinical trial NCT06117618: Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients
Official title: Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Electronic Health Records
Clinical Decision Support Systems
Keywords: sepsis
alerts
clinical decision support systems
informatics
health information technology
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 12284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: If a patient is randomized to a group without an alert, the alert will instead be a hidden "silent" alert that does not display. However, a timestamp of when the alert was triggered is still recorded even though the alert did not display. This timestamp is used for the primary and secondary outcomes.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: Patient Inclusion Criteria:

* 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 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)

Primary outcomes:
measure: Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle
timeFrame: Up to 3 hours
Secondary outcomes:
measure: Time to modified SSC hour-1 bundle completion
timeFrame: 24 hours
measure: Time to blood culture order
timeFrame: 24 hours
measure: Time to blood culture collection
timeFrame: 24 hours
measure: Time to lactate order
timeFrame: 24 hours
measure: Time to lactate collection
timeFrame: 24 hours
measure: Time to antibiotic order
timeFrame: 24 hours
measure: Time to antibiotic treatment
timeFrame: 24 hours
measure: Sepsis incidence
timeFrame: Up to 90 days
measure: Percentage of patients transferred to ICU transfer
timeFrame: Up to 90 days
measure: Median number of days of hospitalization
timeFrame: Up to 90 days
measure: Percentage of patients discharged as deceased or discharged to hospice
timeFrame: Up to 90 days
measure: Percentage of patients discharged home
timeFrame: Up to 90 days
measure: Percentage of patients discharged to rehab
timeFrame: Up to 90 days
measure: Percentage of patients discharged to skilled nursing facility
timeFrame: Up to 90 days
measure: Percentage inpatient mortality at 90 days
timeFrame: Up to 90 days
measure: Number of positive blood cultures
timeFrame: Up to 90 days
measure: Adverse antibiotic events
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Hospitals
state: New York
Study officials:
affiliation: Columbia University
name: Benjamin L Ranard, MD, MSHP
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Jason S Adelman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: