Linking Novel Diagnostics With Data-Driven Clinical Decision Support in the Emergency Department
NCT ID: NCT05335135
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
300000 participants
OBSERVATIONAL
2022-02-01
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
(Aim 1) Validate the TriageGO-MDW algorithm locally using retrospective data at ED study sites.
(Aim 2) Deploy TriageGO-MDW integrated with the electronic medical record (EMR) and perform user assessment.
(Aim 3) Evaluate TriageGO-MDW in steady state with respect to clinical, process, and perceived utility outcomes.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CV-SQuISH-ED: Clinical Validation Study
NCT04933760
Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Treatment in Pediatric Septic Shock
NCT05065333
Sepsis Electronic Prompting for Timely Intervention and Care for Emergency Department Patients
NCT06117605
Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events
NCT05502107
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
NCT04094818
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-Implementation
Usual care will be provided during all ED patient encounters.
Usual Care
Clinical care without decision support provided by TriageGo-MDW
Post-Implementation
TriageGo-MDW CDS will be made available during all ED patient encounters at two points in the ED care continuum: (1) shortly after arrival during initial ED triage (First Triage) and (2) after initial laboratory results have been populated within the EHR. General illness severity estimates will be provided to nurses at ED triage in the form of recommended triage acuity scores (CDS for First Triage). General illness severity estimates along with estimated risk for specific outcomes including sepsis and septic shock will be presented to clinicians after laboratory results have populated (CDS for Early Assessment). TriageGO-MDW risk estimates will be generated by machine learning algorithms using routinely available clinical data as predictor inputs. Nurses and clinicians will receive risk estimates within existing EHR workflows, along with brief and rapidly interpretable explanations of the logic driving each risk estimate.
TriageGO-MDW Clinical Decision Support
TriageGO-MDW is non-device clinical decision support that provides patient-level clinical risk estimates based on clinical data derived from the electronic health record
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TriageGO-MDW Clinical Decision Support
TriageGO-MDW is non-device clinical decision support that provides patient-level clinical risk estimates based on clinical data derived from the electronic health record
Usual Care
Clinical care without decision support provided by TriageGo-MDW
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria: None
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Kansas
OTHER
Beckman Coulter, Inc.
INDUSTRY
Truman Medical Center
OTHER
Stocastic, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Levin, PhD
Role: PRINCIPAL_INVESTIGATOR
Stocastic, LLC
Jeremiah Hinson, PhD/MD
Role: PRINCIPAL_INVESTIGATOR
Stocastic, LLC
Nima Sarani, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas
Kevin O'Rourke, MD
Role: PRINCIPAL_INVESTIGATOR
Truman Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kansas University Medical Center
Kansas City, Kansas, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Nima Sarani, MD
Role: primary
Kevin O'Rourke, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Levin S, Toerper M, Hamrock E, Hinson JS, Barnes S, Gardner H, Dugas A, Linton B, Kirsch T, Kelen G. Machine-Learning-Based Electronic Triage More Accurately Differentiates Patients With Respect to Clinical Outcomes Compared With the Emergency Severity Index. Ann Emerg Med. 2018 May;71(5):565-574.e2. doi: 10.1016/j.annemergmed.2017.08.005. Epub 2017 Sep 6.
Dugas AF, Kirsch TD, Toerper M, Korley F, Yenokyan G, France D, Hager D, Levin S. An Electronic Emergency Triage System to Improve Patient Distribution by Critical Outcomes. J Emerg Med. 2016 Jun;50(6):910-8. doi: 10.1016/j.jemermed.2016.02.026. Epub 2016 Apr 25.
Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-STOC-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.