Hospital-Onset Sepsis Systematic Detection and Structured Interventions

Part of paid clinical trials in Portland, Oregon.

Sponsor
Patricks Lyons
Study ID
NCT07804251
Status
Not Yet Recruiting

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Conditions

  • Critical Illness
  • Deterioration, Clinical
  • Early Warning Score
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Algorithm-triggered sepsis alert with structured critical care team activation — OTHER
    When a commercially deployed sepsis prediction score crosses a pre-specified threshold, an electronic health record alert is delivered to the assigned bedside nurse, presenting structured response options including declining activation with a captured reason. Serum lactate and complete blood count are ordered automatically. If the nurse does not respond within a pre-specified timeout window, a 24-hour critical care rapid response team is paged automatically. The team evaluates the patient at the bedside, may place diagnostic and therapeutic orders directly including antibiotics, and documents the encounter in a structured note. The primary team is notified simultaneously and retains clinical authority. The prediction score runs identically in both arms and is not modified by the study.

Study Details

Sepsis is a life-threatening reaction to an infection. It can begin while a person is already in the hospital for some other reason. Sepsis that starts in the hospital is often recognized late, and treatment can be delayed. On the general wards at the study hospital, patients who develop sepsis may benefit from receiving earlier treatments. Patients who are getting sicker but do not have sepsis also might benefit. The hospital's electronic health record already runs an automated sepsis screening tool in the background. The tool gives each patient a score that rises when the record shows possible signs of sepsis. Today that score can be seen by staff, but it does not prompt any particular action. This study tests whether connecting the score to a rapid bedside response improves how patients do. When a patient's score crosses a set level, the electronic health record sends an alert to that patient's bedside nurse. The nurse can bring in the Critical Care Activation Team, a group of critical care clinicians available at all hours. If the nurse does not respond within a short window, the team is paged automatically. The team comes to the bedside, examines the patient, and can order tests and treatments directly, including antibiotics. The patient's regular medical team is told at the same time and continues taking care of the patient with this additional assistance. The study compares this alert-and-response pathway against the care the hospital provides today. Every adult on the participating units is included automatically when their score crosses the set level. A computer assigns each patient to one of two groups. In one group the alert is sent and the response pathway begins. In the other group the alert is not sent, and care goes on exactly as it does at the hospital now. The main measure is each patient's condition five days after the score crossed the set level, sorted into five levels: discharged from the hospital, in the hospital without organ support, in the hospital with organ support, in intensive care, or died. The study also looks at how quickly antibiotics were started, how many days patients spend alive and out of the hospital, and whether the pathway leads to antibiotic use that was not needed. Patients are not asked to do anything and are not seen by the study team. No extra visits, tests, or procedures are added beyond the tests the response team may order as part of ordinary care. All study information comes from the medical record. Both groups receive care that is within accepted practice, and asking each patient for permission ahead of time would change the very thing being studied. For those reasons the study is conducted under a waiver of informed consent granted by the hospital's institutional review board, and the hospital notifies patients about its use of these tools through its general admission materials.

Key Dates

First listed
Sep 4, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
3,700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Sepsis alert with critical care team activation
    Crossing the sepsis algorithm threshold triggers an electronic health record alert (Best Practice Advisory) to the assigned bedside nurse, presenting structured response options including declining activation with a captured reason. Orders for serum lactate and complete blood count with differential are generated automatically. If the nurse does not respond within a pre-specified timeout window, the Critical Care Activation Team is paged automatically. The team performs a bedside evaluation, may place diagnostic and therapeutic orders directly including antibiotics, and documents the encounter in a structured note. The primary team is notified simultaneously and retains authority to modify or discontinue any team-initiated order at any time.
  • No Intervention: Usual care with study alert suppressed
    Current standard care. The study alert is suppressed silently: no advisory is displayed, no automatic orders are generated, and no page is sent. Suppression is limited to the study's own alert and its two downstream actions. No pre-existing alert, alarm, order set, score display, or item of clinical information is altered or withheld. Algorithm scores remain visible on patient lists exactly as they are today, and the separately deployed deterioration index continues to trigger the existing rapid response pathway at its established thresholds. Clinicians caring for these patients are not informed that a threshold crossing occurred, and assignment is never operationally visible during care.

Primary Outcome Measure

Clinical status at day 5 on a five-level ordinal scale [ Time Frame: 120 hours (Day 5) after the qualifying algorithm threshold crossing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU HospitalPortlandOregon97239-

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