Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| DEVICE | CoMET Display | Display 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.