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The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).
The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBC-Diff Monocyte Volume Width Distribution | MDW measurement used to detect sepsis. Results will not be used to manage patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBC-DIFF Monocyte Volume Width Distribution (MDW) | Diagnostic Test | MDW measurement used to detect sepsis. Results will not be used to manage patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Potential reduction of Time to Antibiotics | Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated | 12 hrs after ED presentation |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Validate MDW's ability to identify incidence of patients diagnosed as Sepsis vs Non-Sepsis, including SIRS and milder forms of infection (non-SIRS) meeting Sepsis EMR definition of >=2 SIRS criteria within 12 hours of ED presentation and any microbial testing collected within 24 hours of triage in the ED | 12 hrs after ED presentation |
| Measure | Description | Time Frame |
|---|---|---|
| Health & Economic Benefits for Time to Antibiotics - Simulated | Determine MDW's ability to potentially reduced hospital stay using a simulated economic model. | 12 hrs after ED presentation |
| Health & Economic Benefits for Hospital Stay - Simulated |
Inclusion Criteria:
Exclusion Criteria:
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All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Amin A Mohammad, Ph. D | Baylor Scott & White Medical Center, Temple | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White MEdical Center | Temple | Texas | 76508 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004194 | Disease |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model.
| 12 hrs after ED presentation |
| Health & Economic Benefits for Mortality - Simulated | Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model. | 12 hrs after ED presentation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |