Gram Type Infection-Specific Sepsis Identification Using Machine Learning
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Change in time to antibiotic administration
Study Overview
Brief Summary
The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a Gram type infection-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, time to antibiotic administration. The secondary endpoint will be reduction in the administration of unnecessary antibiotics, which includes reductions in secondary antibiotics and reductions in total time on antibiotics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All adults above age 18 who are a member of one of the three subpopulations studied in this trial (patients with Gram-positive infection, patients with Gram-negative infection, and patients with mixed Gram-positive and Gram-negative infection) are eligible to participate in the study.
Exclusion Criteria
- •Under age 18
- •No record of Gram infection
Outcomes
Primary Outcomes
Change in time to antibiotic administration
Time Frame: Through study completion, an average of 8 months
Change in time period between diagnosis of Gram infection and administration of antibiotics to treat infection
Secondary Outcomes
- Change in administration of unnecessary antibiotics(Through study completion, an average of 8 months)