University of Virginia Health System
Charlottesville, Virginia, 22908, United States
NCT Number: NCT04359641
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.
This study is active but is not currently recruiting participants.
Notify MeAll sexes
Interventional
Not applicable
Charlottesville, Virginia, 22908, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Display and presentation of predictive monitoring score CoMET
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:
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.
Time frame: through study completion, on average one week
We will use a Kaplan Meier or Cox Proportional Hazard Curve to determine differences in response time between display and control.
Time frame: through study completion, on average one week
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 frame: through study completion, on average one week
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:
Time frame: through study completion, on average one week
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
Time frame: through study completion, on average one week
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
Time frame: through study completion, on average one week
Proportion of patients receiving IV inotropes or pressors at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
Proportions of patients with shock requiring inotropes or pressors at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
Proportion of patients meeting Sepsis 2 criteria at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
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
Time frame: through study completion, on average one week
Proportion of patients experiencing cardiac arrest at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
Proportion of patients experiencing death at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
Proportion of patients receiving diuretic drip indicating Congestive Heart Failure escalation at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
Proportion patients receiving inotropes or pressors for refractory heart failure at any point in the hospital stay after admission to the fourth floor
Time frame: through study completion, on average one week
Hospital length of stay
Time frame: through study completion, on average one week
In patients who are never transferred to the ICU, the length of stay on the floor.
Time frame: through study completion, on average one week
ICU length of stay
Time frame: within 72 hours post-discharge
Readmission to hospital within 72 hours post-discharge
Time frame: through study completion, on average one week
In patients who meet the Sepsis 2 criteria, the proportion of Shock, i.e. Hypotension requiring inotropes or pressors
Time frame: through study completion, on average one week
In patients who meet the Sepsis 2 criteria, the proportion of death
Time frame: through study completion, on average one week
Observed:Expected ratio
Time frame: through study completion, on average one week
Number of days on IV antibiotics
Time frame: through study completion, on average one week
Total duration of mechanical intubation (emergent and non-emergent)
Jamieson Bourque, MD
Other
Acronym: PM-IMPACCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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