Predictive Monitoring - IMPact in Acute Care Cardiology Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clinical Deterioration
- Sponsor
- Jamieson Bourque, MD
- Enrollment
- 10424
- Locations
- 1
- Primary Endpoint
- Hours free of events of clinical deterioration
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Jamieson Bourque, MD
Associate Professor of Medicine
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •Assigned for clinical purposes to a beds which is part of a randomized cluster
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hours free of events of clinical deterioration
Time Frame: within 21 days of the admission
(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 hospital prior to 21 days without an event will be counted as having 21 event-free days. Patients who die during the admission will be counted as having 0 event-free days. Patients will be censored (with no event observed) at the time of non-emergent ICU transfer, surgery transfer, or other transfer.
Secondary Outcomes
- Proportion of Emergent ICU transfer at any point in the hospital stay(through study completion, on average one week)
- Proportion of emergent intubation at any point in the hospital stay(through study completion, on average one week)
- Proportions of Shock requiring inotropes or pressors at any point in the hospital stay(through study completion, on average one week)
- Subgroup secondary outcome: post-ICU transfer event-free survival(through study completion, on average one week)
- Proportion of 3 units or more of blood ordered in 24 hours at any point in the hospital stay(through study completion, on average one week)
- Proportion of death at any point in the hospital stay(through study completion, on average one week)
- Proportion of Congestive heart failure at any point in the hospital stay(through study completion, on average one week)
- Hospital length of stay(through study completion, on average one week)
- Length of stay on floor(through study completion, on average one week)
- Proportion of IV inotropes or pressors at any point in the hospital stay(through study completion, on average one week)
- Proportion of Sepsis 2 criteria at any point in the hospital stay(through study completion, on average one week)
- Proportion of Inotropes or pressors for refractory heart failure at any point in the hospital(through study completion, on average one week)
- Hours to proactive clinical response(through study completion, on average one week)
- Hospital readmission(within 72 hours post-discharge)
- Death in sepsis(through study completion, on average one week)
- duration of mechanical intubation(through study completion, on average one week)
- Proportion of septic shock at any point in the hospital stay(through study completion, on average one week)
- Proportion of Cardiac arrest at any point in the hospital stay(through study completion, on average one week)
- ICU length of stay(through study completion, on average one week)
- Shock in sepsis(through study completion, on average one week)
- Cost of Care(through study completion, on average one week)
- Number of days on IV antibiotics(through study completion, on average one week)