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Active Not RecruitingNCT04359641

Predictive Monitoring - IMPact in Acute Care Cardiology Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
10,424 (actual)
Sponsor
Jamieson Bourque, MD · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICECoMET DisplayDisplay and presentation of predictive monitoring score CoMET

Timeline

Start date
2021-01-04
Primary completion
2022-11-03
Completion
2028-03-01
First posted
2020-04-24
Last updated
2024-05-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04359641. Inclusion in this directory is not an endorsement.

Predictive Monitoring - IMPact in Acute Care Cardiology Trial (NCT04359641) · Clinical Trials Directory