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SepsisNCT07581340

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

A study testing Near-real time automated feedback on SEP-1 performance in people with Sepsis, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
Near-real time automated feedback on SEP-1 performance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
1 Dec 2024to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC San Diego Health

    San Diego, California, 92103-1911

Other trials in United States

About this study

Official title: Impact of Automated Sepsis Metric Evaluation on Provider Performance

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.

Read the detailed description

Sepsis is a leading cause of morbidity and mortality worldwide and remains a major focus of hospital quality improvement efforts. In the United States, the Centers for Medicare \& Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) is a publicly reported quality measure that evaluates adherence to evidence-based processes of care, including timely antibiotic administration, fluid resuscitation, and laboratory testing. Despite its importance, SEP-1 is widely recognized as a complex measure, consisting of dozens of individual elements that must be completed within specific timeframes. Assessment of compliance typically relies on manual chart abstraction, which is resource-intensive, subject to variability, and performed on a small subset of cases with delays of several months. These limitations reduce the ability of SEP-1 reporting to drive timely improvements in clinical care.

Advances in artificial intelligence (AI), particularly large language models (LLMs), offer an opportunity to automate the extraction and interpretation of clinical information from unstructured medical records. Prior work has demonstrated that LLMs can achieve high agreement with expert reviewers when applied to complex clinical abstraction tasks. Building on this foundation, this study evaluates whether integrating AI-enabled chart abstraction into a real-world clinical workflow can improve performance on a complex quality measure by providing near real-time feedback to clinicians.

This study was conducted as a prospective, cluster randomized quality improvement initiative across two academic emergency departments within a single health system. Attending emergency physicians were randomized at the provider level to either an intervention group receiving AI-generated feedback or a control group receiving standard quality reporting feedback. Randomization at the physician level was selected to minimize contamination while preserving real-world clinical workflows.

All adult patients presenting to the emergency department who met CMS criteria for severe sepsis or septic shock were eligible for inclusion. Cases were identified using clinical encounter diagnoses and evaluated according to SEP-1 specifications. Each case was classified as meeting or failing the measure based on completion of required elements within defined time windows.

In the intervention arm, an LLM-based system automatically reviewed each eligible patient encounter at the time of emergency department discharge. The system analyzed structured and unstructured clinical data to determine SEP-1 compliance and identify specific elements of care that were incomplete or not documented. Physicians received individualized feedback shortly after patient care was completed. Feedback included a summary of the case, the determination of compliance, and targeted recommendations for improvement when deficiencies were identified. In selected cases, additional follow-up communication was provided to reinforce learning and clarify opportunities for improvement.

In the control arm, physicians received feedback through standard institutional processes. This consisted of manual chart abstraction of a limited number of cases selected for CMS reporting, with results communicated weeks to months after the clinical encounter. This approach reflects the current standard of care in most health systems.

The primary objective of the study was to evaluate whether near real-time, AI-enabled feedback improves SEP-1 compliance compared to standard delayed feedback. Secondary objectives included assessing the agreement between AI-generated determinations and expert human reviewers, as well as evaluating selected patient-centered outcomes, including intensive care unit (ICU) admission and 30-day mortality.

Because randomization occurred at the physician level and outcomes were measured at the patient encounter level, analyses accounted for clustering of patients within physicians. Mixed-effects modeling was used to estimate the effect of the intervention while accounting for this hierarchical structure.

The intervention is grounded in established principles of audit-and-feedback, a widely used strategy for improving clinician performance. Prior research suggests that audit-and-feedback interventions are more effective when feedback is timely, individualized, and actionable. The AI-enabled system in this study was designed to address known limitations of traditional feedback approaches by evaluating all eligible cases rather than a small sample, reducing delays between care delivery and feedback, and providing specific guidance tailored to individual clinician performance.

Importantly, this study focuses on improving adherence to a process-based quality measure rather than directly modifying clinical decision-making at the point of care. As such, the intervention is intended to support clinician learning and quality improvement without introducing real-time clinical decision support alerts that may contribute to alert fatigue.

This study also evaluates the feasibility of integrating AI tools into routine clinical operations at scale. By automating chart review and feedback generation, the intervention has the potential to reduce the administrative burden associated with quality reporting and to enable continuous performance monitoring across all eligible patients.

While improved compliance with SEP-1 may have implications for hospital quality metrics and reimbursement, the relationship between SEP-1 adherence and patient-centered outcomes remains an area of ongoing investigation. This study is not powered to detect differences in mortality or other clinical outcomes, but it provides an important step in understanding how AI can be leveraged to improve quality measurement and feedback processes.

The findings of this study may have broader implications beyond sepsis care. The ability of AI systems to extract clinical context from electronic health records and deliver timely, targeted feedback could be applied to a wide range of quality and safety measures. This approach may support the development of learning health systems in which data generated during routine care are continuously used to inform and improve clinical practice.

In summary, this study evaluates a novel application of AI to enhance quality measurement and feedback in sepsis care. By addressing key limitations of existing reporting systems, this approach aims to improve clinician performance on a complex quality measure and to establish a scalable model for AI-enabled quality improvement in healthcare.

Conditions
Sepsis
Being tested
Near-real time automated feedback on SEP-1 performance
Keywords
Sepsis, Artificial intelligence, Implementation science, Large language model, Quality improvement
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near-real time automated feedback on SEP-1 performanceBehavioural

    Participants in the intervention arm receive near-real-time, individualized feedback on SEP-1 performance generated by a large language model (LLM) that performs automated chart abstraction at the time of emergency department discharge.

Study groups in NCT07581340
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention arm receive near-real-time, individualized feedback on SEP-1 performance generated by a large language model (LLM) that performs automated chart abstraction at the time of emergency department discharge.
Receives: Behavioral: Near-real time automated feedback on SEP-1 performance
Control groupNo interventionParticipants in the control arm receive standard sepsis quality feedback processes without real-time augmentation. This is much less than the intervention group and typically 3-4 months after a particular interaction.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SEP-1 Compliance

    SEP-1 (the Severe Sepsis and Septic Shock Early Management Bundle) is a quality measure developed by the Centers for Medicare \& Medicaid Services that evaluates whether patients with sepsis receive a set of time-sensitive interventions and diagnostic tests. It is a binary process measure (e.g., either a "pass" or "fail").

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

Secondary outcomes (1)
  1. In-hospital mortality

    Whether a patient survives or dies during a hospitalization.

    Measured: From when the patient arrives to the hospital to their discharge, either alive or expired, up to 6 months after the event (development of severe sepsis / septic shock).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 Dec 2024
  3. Primary completion1 Aug 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Model description
Randomized quality improvement study on the physician level within a group.
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07581340
Sponsor's protocol ID
1403
Status last verified
Oct 2024
First submitted
13 Apr 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a quality improvement investigation completed at UCSD. Although registered, a key component of our quality approval is that the data be only for UCSD patients and healthcare workers. Thus, we have elected not to share information of patients or healthcare workers.

Publications

  • Boussina A, Krishnamoorthy R, Quintero K, Joshi S, Wardi G, Pour H, Hilbert N, Malhotra A, Hogarth M, Sitapati AM, VanDenBerg C, Singh K, Longhurst CA, Nemati S. Large Language Models for More Efficient Reporting of Hospital Quality Measures. NEJM AI. 2024 Oct 24;1(11):10.1056/aics2400420. doi: 10.1056/aics2400420. Epub 2024 Oct 21.

    PubMed 39703686
  • Boussina A, Allison C, Quintero K, Jain S, VanDenBerg C, Hogarth M, Sitapati AM, Singh K, Malhotra A, McCurdy MT, Longhurst CA, Ford JS, Chan T, Ishimine P, Childers R, Nemati S, Wardi G. Medical Record Abstraction for Quality Improvement in Sepsis Care Using Artificial Intelligence: A Cluster Randomized Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2611885. doi: 10.1001/jamanetworkopen.2026.11885.

    PubMed 42348212

Questions about this trial

What is this clinical trial studying?

A study testing Near-real time automated feedback on SEP-1 performance in people with Sepsis, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SEP-1 Compliance (time frame: This was assessed from time of the event (e.g., development of severe sepsis / septic shock) up to 1 month after the event.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07581340, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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