Hospital-Onset Sepsis Systematic Detection and Structured Interventions

Registry record from ClinicalTrials.gov (NCT07804251). This is a study registration, not published results. Lead sponsor: Patricks Lyons. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 3700 participants (ESTIMATED). Conditions: Sepsis, Deterioration, Clinical, Critical Illness, Early Warning Score. Interventions: OTHER: Algorithm-triggered sepsis alert with structured critical care team activation. Primary outcome measures: Clinical status at day 5 on a five-level ordinal scale , 120 hours (Day 5) after the qualifying algorithm threshold crossing. Brief summary: 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.