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NCT04359641 · ClinicalTrials.gov registry record · NA
Predictive Monitoring - IMPact in Acute Care Cardiology Trial
A NA study of Clinical Deterioration, sponsored by Jamieson Bourque, MD.
- Active
- Registry status
- NA
- Development phase
- 10,424
- Enrollment target
- 1
- Study location
NCT04359641: Active NA study of Clinical Deterioration, sponsored by Jamieson Bourque, MD.
NCT04359641 is a NA study of Clinical Deterioration that is active but no longer recruiting, run by Jamieson Bourque, MD. The registered enrollment target is 10,424 participants, roughly in line with the 11,052-participant average among 3 other Clinical Deterioration trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04359641, a NA study of Clinical Deterioration, is active but no longer recruiting, sponsored by Jamieson Bourque, MD.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 10,424 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypothesis: display of predictive analytics monitoring on acute care cardiology wards improves patient outcomes and is cost-effective to the health system. The investigators have developed and validated computational models for predicting key outcomes in adults, and a useful display has been developed, implemented and iteratively optimized. These models estimate risk of imminent patient deterioration using trends in vital signs, labs and cardiorespiratory dynamics derived from readily available continuous bedside monitoring. They are presented on LCD monitors using software called CoMET (Continuous Monitoring of Event Trajectories; AMP3D, Advanced Medical Predictive Devices, Diagnostics, and Displays, Charlottesville, VA) To test the impact on patient outcomes, the investigators propose a 22-month cluster-randomized control trial on the 4th floor of UVa Hospital, a medical-surgical floor for cardiology and cardiovascular surgery patients. Clinicians will receive standard CoMET device training. Three- to five-bed clusters will be randomized to intervention (predictive display plus standard monitoring) or control (standard monitoring alone) for two months at a time. In addition, risk scores for patients in the intervention clusters will be presented daily during rounds to members of the care team of physicians, residents, nurses, and other clinicians. Data on outcomes will be statistically compared between intervention and control clusters.
Primary Outcome
(1) The number of hours free of acute clinical events within 21 day of admission. Hours of acute clinical events are defined as time when one or more of the following occur: * An emergent ICU transfer (emergent defined as urgent, unplanned) and ICU stay * Emergent intubation (emergent is defined by clinician's notes as a non-planned procedure) * Cardiac arrest, if prior to ICU transfer or death * Death A maximum score will be 21 event-free days (504 hours). Patients who are discharged from the
Conditions Studied
Interventions
- DEVICE CoMET Display
Study Locations (1)
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,424 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2028-03 |
| Phase | NA |
What the registry record for NCT04359641 still lists
NCT04359641 is an interventional study that assigns participants to a tested intervention. Its 10,424 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 11,052-participant average among 3 other Clinical Deterioration trials with a reported enrollment target.
The record links to 1 condition, with Clinical Deterioration appearing as the primary indexed condition, and to 1 intervention - of which CoMET Display is the first listed.
NCT04359641 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04359641 about?
NCT04359641 is a clinical study titled "Predictive Monitoring - IMPact in Acute Care Cardiology Trial". Hypothesis: display of predictive analytics monitoring on acute care cardiology wards improves patient outcomes and is cost-effective to the health system. The investigators have developed and validated computational models for predicting key outcomes in adults, and a useful display has been develo...
What is the current status of trial NCT04359641?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10,424 participants. The study started on 2021-01-04. Estimated completion is 2028-03.
What conditions does trial NCT04359641 study?
This clinical trial studies the following conditions: Clinical Deterioration.
What interventions are being tested in trial NCT04359641?
The interventions under investigation include: CoMET Display (DEVICE).
Who is sponsoring clinical trial NCT04359641?
This trial is sponsored by Jamieson Bourque, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04359641 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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