Real-time NOMA Evaluation
Real-time Evaluation of an Outlier-based Alerting System
2 other identifiers
interventional
3,000
1 country
2
Brief Summary
Alerts related to outlier clinician behavior are generated in real-time by an intelligent system continuously scraping EHR (electronic health record) data. These alerts are passed to the bedside and their potential impact on bedside clinical behavior is evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedStudy Start
First participant enrolled
June 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 9, 2025
June 1, 2025
1 year
May 14, 2025
July 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Clinical Actions Following Revealed vs. Non-Revealed Alerts
The primary outcome compares the proportion of alerts that lead to documented clinical actions when revealed to treating ICU clinicians versus when not revealed. Alerts are generated by a decision support system and reviewed daily by ICU study clinicians. On average, 30 alerts are reviewed per ICU per day, with approximately 5 alerts revealed to the treating clinicians. The analysis uses a stepped wedge design with ICU beds as the unit of analysis, where each ICU acts as its own control. The outcome will assess whether revealing alerts increases the rate of appropriate clinical actions taken, as compared to when alerts are withheld.
From time of ICU admission until ICU discharge
Secondary Outcomes (10)
Rate of Any Clinically Responsive Action Following Alerts
Up to 90 days after ICU admission
True Positive Alert Rate (TPAR) by Study Group and Alert Type
Up to 90 days after ICU admission
Rate of Non-Responsive Actions Following Alerts
Up to 90 days after ICU admission
Overall Alert Rate
Through study completion, an average of 2 years
Alert Rate per Alerting Model
Daily, up to 90 days
- +5 more secondary outcomes
Study Arms (2)
Unrevealed Alerts
ACTIVE COMPARATORRevealed Alerts
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- All patients in the Presbyterian and Montefiore ICUs
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UPMC Montefiore
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Huang, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 14, 2025
First Posted
May 30, 2025
Study Start
June 23, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
July 9, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
The investigators do not currently have a data sharing plan for sharing with future investigators. If the investigators decide to share data in the future with investigators conducting similar research both inside and outside of the University of Pittsburgh, the investigators will contact the Office of Sponsored Programs before sharing de-identified research data to determine whether an agreement needs to be executed.