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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04359641
Other study ID # 22196
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 4, 2021
Est. completion date March 2028

Study information

Verified date May 2024
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10424
Est. completion date March 2028
Est. primary completion date November 3, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Assigned for clinical purposes to a beds which is part of a randomized cluster Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CoMET Display
Display and presentation of predictive monitoring score CoMET

Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
Jamieson Bourque, MD Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hours free of events of clinical deterioration (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.
within 21 days of the admission
Secondary Hours to proactive clinical response We will use a Kaplan Meier or Cox Proportional Hazard Curve to determine differences in response time between display and control.
Time to the 1st order for transfusion of 3 units or more of blood ordered within 24 hours
Time to first order for IV inotropes or pressors administered
Time to first order for blood or urine culture obtained for suspicion of infection
Time to first order for lactate drawn
Time to first order for antibiotics given for suspicion of infection
Time to first order for fluid resuscitation given for suspicion of shock
Time to rapid response team (RRT or MET) call initiation.
through study completion, on average one week
Secondary Subgroup secondary outcome: post-ICU transfer event-free survival A subgroup secondary outcome will be a Kaplan Meier or Cox Proportional Hazard curve showing post-ICU transfer, event-free survival, hours free of the following events:
Time of emergent intubation post-ICU transfer (emergent is defined by clinician's notes as a non-planned procedure)
Time of the 1st order post-ICU transfer for transfusion of 3 units or more of blood ordered within 24 hours
Time of first order post-ICU transfer of IV inotropes or pressors
Time of cardiac arrest post-ICU transfer
Time of CHF escalation, defined by the time of first order for diuretic drip, time of first order for CVVHD, or time of dialysis initiation
Time of death post-ICU transfer
Discharge from the ICU without an event will count as "infinite" event-free survival.
through study completion, on average one week
Secondary Proportion of Emergent ICU transfer at any point in the hospital stay Proportion of patients experiencing emergent ICU transfer (emergent defined as urgent, unplanned) at any point in the hospital stay after admission to the fourth floor: through study completion, on average one week
Secondary Proportion of emergent intubation at any point in the hospital stay Proportion of patients experiencing emergent intubation (emergent is defined by clinician's notes as a non-planned procedure) at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of 3 units or more of blood ordered in 24 hours at any point in the hospital stay Proportion of patients with 3 units or more of blood ordered in 24 hours at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of IV inotropes or pressors at any point in the hospital stay Proportion of patients receiving IV inotropes or pressors at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportions of Shock requiring inotropes or pressors at any point in the hospital stay Proportions of patients with shock requiring inotropes or pressors at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of Sepsis 2 criteria at any point in the hospital stay Proportion of patients meeting Sepsis 2 criteria at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of septic shock at any point in the hospital stay Proportion of patients with septic shock requiring inotropes or pressors (defined by a combination of Outcome 8 and 9) at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of Cardiac arrest at any point in the hospital stay Proportion of patients experiencing cardiac arrest at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of death at any point in the hospital stay Proportion of patients experiencing death at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of Congestive heart failure at any point in the hospital stay Proportion of patients receiving diuretic drip indicating Congestive Heart Failure escalation at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Proportion of Inotropes or pressors for refractory heart failure at any point in the hospital Proportion patients receiving inotropes or pressors for refractory heart failure at any point in the hospital stay after admission to the fourth floor through study completion, on average one week
Secondary Hospital length of stay Hospital length of stay through study completion, on average one week
Secondary Length of stay on floor In patients who are never transferred to the ICU, the length of stay on the floor. through study completion, on average one week
Secondary ICU length of stay ICU length of stay through study completion, on average one week
Secondary Hospital readmission Readmission to hospital within 72 hours post-discharge within 72 hours post-discharge
Secondary Shock in sepsis In patients who meet the Sepsis 2 criteria, the proportion of Shock, i.e. Hypotension requiring inotropes or pressors through study completion, on average one week
Secondary Death in sepsis In patients who meet the Sepsis 2 criteria, the proportion of death through study completion, on average one week
Secondary Cost of Care Observed:Expected ratio through study completion, on average one week
Secondary Number of days on IV antibiotics Number of days on IV antibiotics through study completion, on average one week
Secondary duration of mechanical intubation Total duration of mechanical intubation (emergent and non-emergent) through study completion, on average one week
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