Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT05997420
Eligibility Criteria:
Inclusion Criteria:
* adults 18 years of age and older;
* clinically suspected infection
1. two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND
2. antibiotics initiated within 24 hours and continued for at least one additional day
* organ dysfunction
1. two or more points on admission Sequential Organ Failure Assessment (SOFA); OR
2. two or more points on admission quick-SOFA
* deemed to be at high risk of hospital readmission within 90 days, defined as readmission risk probability of at least 25%
* not discharged from the hospital at the time of patient identification each morning.
Exclusion Criteria:
* change in code status (i.e., initially full code followed by change to do not resuscitate and/or do not intubate) within 24 hours after index presentation due to presumed limitation of aggressive treatment and exposure to STAR program components;
* reside \> 2.5 hours drive time from the treating hospital due to the maximum reach of the community services leveraged within the STAR program and the general assumption that these patients may have less comprehensive utilization tracking within available electronic record systems for study outcomes;
* are actively participating in a different care management program (e.g., cancer care patient navigation) documented in the electronic health record (EHR) at time of hospital admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05997420
Study Brief:
Protocol Section:
NCT05997420