Real-time NOMA Evaluation

NCT ID: NCT06996626

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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A clinician-informed AI model will generate outlier alerts from real-time review of the EHR (electronic health record) of UPMC Presbyterian/Montefiore ICU patients. These alerts will first be reviewed by an ICU clinician, along with the patients' EHR, for clinical relevance. For those alerts deemed potentially relevant, the ICU clinician will contact the treating ICU clinician (eg, an ICU pharmacist, physician, advanced practice provider) and discuss the alert. The treating ICU clinician will take whatever action, including no action, they deem best.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Step wedge RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unrevealed Alerts

Group Type ACTIVE_COMPARATOR

Unrevealed Alerts

Intervention Type DEVICE

Alerts will be generated but not revealed.

Revealed Alerts

Group Type EXPERIMENTAL

Revealed Alerts

Intervention Type DEVICE

Bedside reveal of alerts generated by the alerting system

Interventions

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Revealed Alerts

Bedside reveal of alerts generated by the alerting system

Intervention Type DEVICE

Unrevealed Alerts

Alerts will be generated but not revealed.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients in the Presbyterian and Montefiore ICUs

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

David T Huang

OTHER

Sponsor Role lead

Responsible Party

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David T Huang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Huang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Montefiore

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Huang, MD

Role: CONTACT

412-624-9459

Ernestine Smoot, MAEd

Role: CONTACT

412-624-9459

Facility Contacts

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David Huang, MD, MPH

Role: primary

412-624-9459

David Huang, MD, MPH

Role: primary

412-624-9459

Other Identifiers

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5R01EB032752-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY25020040

Identifier Type: -

Identifier Source: org_study_id

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