Predictive Monitoring - IMPact in Acute Care Cardiology Trial (PM-IMPACCT)

Jamieson Bourque, MD

Status: Active, not recruiting

Conditions: Clinical Deterioration

Treatments: Device: CoMET Display

Study type: Interventional

Funder types: Other

Identifiers

NCT04359641

22196

Details and patient eligibility

About

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.

Enrollment: 10,424 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Assigned for clinical purposes to a beds which is part of a randomized cluster

Exclusion criteria

• none

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,424 participants in 2 patient groups

CoMET Display

Experimental group

Description:

Display of Continuous Monitoring of Event Trajectories (CoMET) predictive monitoring score, with standard CoMET device training.Risk scores will also be presented daily during rounds to members of the care team.

Treatment:

Device: CoMET Display

No Display

No Intervention group

Description:

Standard CoMET device training but no display or presentation of predictive monitoring score.