Status:
COMPLETED
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate if implementation of the Sepsis Transition and Recovery (STAR) program within a large healthcare system will improve outcomes for high-risk patients with suspe...
Detailed Description
BACKGROUND Sepsis is a common and life-threatening condition defined by organ dysfunction due to a dysregulated response to infection (Fleischmann, 2016). Aggressive early sepsis identification and t...
Eligibility Criteria
Inclusion
- At least 18 years of age upon admission
- Suspected infection
- Oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation; and
- Evidence of systemic inflammatory response (i.e., at least two abnormal of temperature; heart rate; respiratory rate; and WBC count or bands)
- Evidence of organ dysfunction (i.e., at least two points on either Quick Sepsis-related Organ Failure Assessment or Sepsis-related Organ Failure Assessment risk tools)
- Deemed as high risk for 90-day readmission using risk-scoring models
- Not discharged at the time of patient list generation
Exclusion
- Patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after infection onset due to presumed limitation of aggressive treatment
- Patients who reside \> 2.5 hours drive time from the treating hospital
- Patients actively enrolled in a different care management program at time of admission
- Patient has been randomized previously.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
3894 Patients enrolled
Trial Details
Trial ID
NCT04495946
Start Date
July 1 2020
End Date
April 1 2024
Last Update
September 19 2025
Active Locations (1)
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1
Atrium Health
Charlotte, North Carolina, United States, 28203