Status:
COMPLETED
Improving Morbidity During Post-Acute Care Transitions for Sepsis
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Clinical Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to improve transitions of care for the highest risk, complex patients with suspected sepsis. Atrium Health has developed a nurse-navigator facilitated care transition stra...
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
- Admitted from the emergency department to inpatient or observation status at one of: Carolinas Medical Center, Carolinas Medical Center - Mercy, or Atrium Health Northeast;
- ≥18 years of age upon admission;
- oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation and
- culture drawn first, antibiotics ordered within 48 hours or
- antibiotics ordered first, culture ordered within 48 hours (adapted from criteria applied in development of the Third International Consensus Definitions for Sepsis and Septic Shock)
- deemed as high-risk for 30-day readmission (i.e., ≥ 20%) or 30-day mortality (i.e., ≥ 10%) using risk-scoring models
- not discharged at the time of patient list generation
Exclusion
- prior randomization to either STAR or usual care study arms;
- not a North Carolina resident or residence \>2.5-hour drive time from treating hospital;
- the only antibiotic associated with patient is administered in the operating room as this likely represents pre-operative infection prophylaxis and not presumed infection;
- patients transferred from other acute care hospitals;
- patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after admission due to the general assumption of increased risk of exposure to less aggressive treatment;
- patients with infection ruled out during the index hospitalization.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
712 Patients enrolled
Trial Details
Trial ID
NCT03865602
Start Date
January 29 2019
End Date
December 31 2021
Last Update
April 25 2022
Active Locations (1)
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1
Atrium Health
Charlotte, North Carolina, United States, 28203