Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
Completed · Not applicable
Conditions studied: Sepsis
In brief
The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a multiple interrupted time series (mITS) analysis to test the impact of implementing an adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in new hospital settings.
Key facts
- Study ID
- NCT05997420
- Run by
- Wake Forest University Health Sciences
- People needed
- 1820
- Starts
- 2024-01-16
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adults 18 years of age and older;
- clinically suspected infection
- two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND
- antibiotics initiated within 24 hours and continued for at least one additional day
- organ dysfunction
- two or more points on admission Sequential Organ Failure Assessment (SOFA); OR
- 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.
You may not qualify if…
- 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.
Where it is running
- Atrium Health — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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