Sepsis Electronic Prompting for Timely Intervention and Care for Inpatients

NCT06117618 | Completed

• 1 other identifier: AAAU1002 - IP
• Study Type: interventional
• Target: 12,284
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Electronic Health Records; Clinical Decision Support Systems

Keywords

sepsis; alerts; clinical decision support systems; informatics; health information technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Time to modified SSC hour-1 bundle completion

  24 hours

• Time to blood culture order

  24 hours

• Time to blood culture collection

  24 hours

• Time to lactate order

  24 hours

• Time to lactate collection

  24 hours

Study Arms (4)

No alert

NO INTERVENTION

Participants will receive no physician alert or registered nurse (RN) alert.

Nurse alert

EXPERIMENTAL

Participants will receive RN alert.

Other: Nurse SIRS alert

Prescribing clinician alert

EXPERIMENTAL

Participants will receive physician alert.

Other: Prescribing clinician SIRS alert

Nurse alert and prescribing clinician alert

EXPERIMENTAL

Participants will receive physician alert and RN alert.

Other: Nurse SIRS alert; Other: Prescribing clinician SIRS alert

Interventions

Nurse SIRS alert OTHER

An electronic alert will display when a nurse opens the patient chart of a patient who meets SIRS criteria.

Nurse alert; Nurse alert and prescribing clinician alert

Prescribing clinician SIRS alert OTHER

An electronic alert will display when a prescribing clinician opens the patient chart of a patient who meets SIRS criteria.

Nurse alert and prescribing clinician alert; Prescribing clinician alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

NewYork-Presbyterian Hospitals

New York, New York, 10032, United States

Location

Related Publications (1)

• Ranard BL, Qian M, Cummings MJ, Zhang DY, Lee SM, Beitler JR, Applebaum JR, Schenck EJ, Mohamed H, Trepp R, Hsu H, Scofi J, Southern WN, Rossetti SC, Yip NH, Brodie D, Sharma M, Fertel BS, Adelman JS. Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol. BMJ Open. 2025 Aug 11;15(8):e088792. doi: 10.1136/bmjopen-2024-088792.

  PMID: 40789731 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin L Ranard, MD, MSHP

  Columbia University

  STUDY DIRECTOR

• Jason S Adelman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care providers will be unblinded in that nurses and clinicians will be aware if they receive an alert for the patient.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 7, 2023
• Study Start: November 14, 2023
• Primary Completion: April 22, 2024
• Study Completion: July 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)