Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients (SEPTIC-IP)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sepsis; Electronic Health Records; Clinical Decision Support Systems
• Intervention / Treatment: Other: Nurse SIRS alert; Other: Prescribing clinician SIRS alert

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).

• Study Type: Interventional
• Enrollment (Estimated): 7200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • NewYork-Presbyterian Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No alert; Participants will receive no physician alert or registered nurse (RN) alert.
Experimental: Nurse alert; Participants will receive RN alert.	Other: Nurse SIRS alert; An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.
Experimental: Prescribing clinician alert; Participants will receive physician alert.	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.
Experimental: Nurse alert and prescribing clinician alert; Participants will receive physician alert and RN alert.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	24 hours

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Study Director: Benjamin L Ranard, MD, MSHP, Columbia University; Principal Investigator: Jason S Adelman, MD, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Actual): April 22, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: sepsis; informatics; health information technology; clinical decision support systems; alerts
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: AAAU1002 - IP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No