CompletedNot Applicable

Using AI to Improve Sepsis Quality of Care in the Emergency Department

United States66 participantsStarted 2024-12-01

Plain-language summary

Sepsis is a life-threatening condition caused by the body's response to infection and is a leading cause of death worldwide. Hospitals use a complex quality measure called SEP-1 to track whether patients with severe sepsis or septic shock receive recommended care, such as timely antibiotics, fluids, and laboratory testing. However, evaluating SEP-1 is difficult. It requires manual review of medical records, is time-consuming and expensive, and typically provides feedback to clinicians months after care is delivered. This delay limits the ability to improve care in real time. This study tested whether artificial intelligence (AI), specifically a type of system called a large language model (LLM), could improve the quality of sepsis care by providing faster and more detailed feedback to physicians. The study was conducted at two emergency departments within a large academic health system. Sixty-six attending physicians were randomly assigned to one of two groups. In the intervention group, the AI system reviewed each patient's medical record at the time of hospital discharge and determined whether SEP-1 care standards were met. Physicians then received near real-time, individualized feedback about their performance, including specific areas for improvement. In the control group, physicians received standard feedback based on a small sample of cases reviewed months later using traditional methods.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (≥18 years) evaluated in the emergency department Clinical diagnosis of severe sepsis or septic shock during the emergency department encounter Cases meeting Centers for Medicare \& Medicaid Services (CMS) SEP-1 inclusion criteria Patient encounter managed by an attending emergency physician participating in the study Sepsis "time zero" occurring during the emergency department visit Exclusion Criteria: * Patients who do not meet CMS SEP-1 criteria for severe sepsis or septic shock Sepsis onset occurring prior to emergency department arrival or after hospital admission Encounters without sufficient clinical documentation to assess SEP-1 compliance Patients transferred from another facility with ongoing sepsis care already initiated Cases in which the attending physician of record is not assigned to a study arm

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SEP-1 Compliance

Timeframe: This was assessed from time of the event (e.g., development of severe sepsis / septic shock) up to 1 month after the event.

Trial details

NCT IDNCT07581340

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Sepsis trials