Hospital-Onset Sepsis Systematic Detection and Structured Interventions

Clinical status at day 5 on a five-level ordinal scale

Each participant is assigned one ordinal clinical state at 120 hours after the qualifying algorithm threshold crossing. The scale has five mutually exclusive, ordered levels: 1 = discharged alive; 2 = hospitalized on a ward without organ support; 3 = hospitalized on a ward with organ support; 4 = intensive care unit; 5 = dead. Lower values indicate better status. Organ support is any of: vasopressor infusion, invasive mechanical ventilation, non-invasive positive pressure ventilation for acute respiratory failure, high-flow nasal cannula at FiO2 of 0.4 or greater, or renal replacement therapy started after threshold crossing. State is derived by rule from electronic health record data, identically in both arms, using admission-discharge-transfer records for location, an organ-support pipeline, and hospitalization records for mortality. State is ascertained at the closest clean data snapshot to the 120-hour mark. Discharge to hospice is coded as state 5.

Clinical status at day 14 on a five-level ordinal scale

Each participant is assigned one ordinal clinical state at 336 hours after the qualifying algorithm threshold crossing, using the same five-level scale as the primary outcome: 1 = discharged alive; 2 = hospitalized on a ward without organ support; 3 = hospitalized on a ward with organ support; 4 = intensive care unit; 5 = dead. Lower values indicate better status. Organ support is any of: vasopressor infusion, invasive mechanical ventilation, non-invasive positive pressure ventilation for acute respiratory failure, high-flow nasal cannula at FiO2 of 0.4 or greater, or renal replacement therapy started after threshold crossing. State is derived by rule from electronic health record data, identically in both arms. Discharge to hospice is coded as state 5. This measure assesses persistence of any effect observed at day 5.

Days alive and free of organ support through day 28

Number of days within the first 28 days after the qualifying algorithm threshold crossing on which the participant was alive and free of organ support, defined as being in the "ward without organ support" state or better (levels 1 or 2 of the primary ordinal scale). Organ support is any of: vasopressor infusion, invasive mechanical ventilation, non-invasive positive pressure ventilation for acute respiratory failure, high-flow nasal cannula at FiO2 of 0.4 or greater, or renal replacement therapy started after threshold crossing. Death at any point within 28 days scores 0. Range 0 to 28 days; higher values indicate better outcome. Derived by rule from electronic health record data, identically in both arms.

Time from threshold crossing to first new antibiotic administration

Hours from the qualifying algorithm threshold crossing to administration of the first new antibiotic, defined as an antibiotic not already being administered at the time of crossing. Analyzed as time to event, with death and hospital discharge without a new antibiotic treated as competing events. Participants are followed for this measure until first new antibiotic administration, hospital discharge, or death, through day 28. All participants who cross the threshold are included in the denominator regardless of whether an antibiotic was ever ordered, so that participants who die or are discharged early are retained rather than excluded. Derived from the medication administration record and order entry timestamps, identically in both arms.

Completion of all one- and three-hour sepsis bundle elements within one hour

Proportion of participants for whom all elements of the Surviving Sepsis Campaign one-hour bundle were completed within one and three hours of the qualifying algorithm threshold crossing. Elements are ascertained by rule from electronic health record data, identically in both arms.

Time from alert to critical care activation team bedside evaluation

Minutes from delivery of the electronic health record alert to documented bedside evaluation by the critical care team, derived from paging records and the structured team note. This measure is computable only for participants in the intervention arm, because the alert, the page, and the team note exist only when an alert is generated. It is reported as an implementation fidelity measure for that arm rather than as a between-arm comparison.

Distribution of bedside nurse responses to the alert

Distribution of bedside nurse responses to the alert across the available structured options, including declining activation with a captured reason, requesting team activation, and automatic activation following an unanswered alert. Reported as proportions per calendar month across the 18-month randomization period. Computable only for the intervention arm, because alerts are not generated in the control arm. Interpreted as an indicator of how nurses weigh alert salience against the clinical picture; a high decline rate may reflect clinical judgment, alert fatigue, or both.

Proportion of team-initiated orders modified by the primary team

Proportion of orders placed by the critical care rapid response team that were modified or discontinued by the primary team before the required four-hour reassessment, with reason captured in the structured team note. Computable only for the intervention arm. Reported as a governance and implementation fidelity measure.

Time to first new antibiotic among control-arm participants, compared with pre-launch baseline

Median hours from the qualifying algorithm threshold crossing to first new antibiotic administration among control-arm participants, summarized per calendar quarter across the 18-month randomization period and compared with the institutional pre-launch baseline for the same units. This measure probes whether uniform staff education and general awareness of the study shift care for participants whose alert was suppressed. A secular trend toward faster antibiotics in the control arm would indicate an attention effect not attributable to the alert-and-response pathway itself.