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| Name | Class |
|---|---|
| Advanced Medical Predictive Devices, Diagnostics and Displays, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoMET Display | Experimental | 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. |
|
| No Display | No Intervention | Standard CoMET device training but no display or presentation of predictive monitoring score. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoMET Display | Device | Display and presentation of predictive monitoring score CoMET |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamieson M Bourque, MD | University of Virginia Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41644641 | Derived | Keim-Malpass J, Ratcliffe SJ, Clark MT, Krahn KN, Monfredi OJ, Hamil S, Yousefvand G, Jones MK, Nelson A, Moorman LP, Moorman JR, Bourque JM. A randomized controlled trial of artificial intelligence-based analytics for clinical deterioration. Sci Rep. 2026 Feb 5;16(1):7345. doi: 10.1038/s41598-026-39051-z. | |
| 34043525 | Derived |
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| ID | Term |
|---|---|
| D000075902 | Clinical Deterioration |
| ID | Term |
|---|---|
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| through study completion, on average one week |
| 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:
| through study completion, on average one week |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Hospital length of stay | Hospital length of stay | through study completion, on average one week |
| 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 |
| ICU length of stay | ICU length of stay | through study completion, on average one week |
| Hospital readmission | Readmission to hospital within 72 hours post-discharge | within 72 hours post-discharge |
| 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 |
| Death in sepsis | In patients who meet the Sepsis 2 criteria, the proportion of death | through study completion, on average one week |
| Cost of Care | Observed:Expected ratio | through study completion, on average one week |
| Number of days on IV antibiotics | Number of days on IV antibiotics | through study completion, on average one week |
| duration of mechanical intubation | Total duration of mechanical intubation (emergent and non-emergent) | through study completion, on average one week |
| Keim-Malpass J, Ratcliffe SJ, Moorman LP, Clark MT, Krahn KN, Monfredi OJ, Hamil S, Yousefvand G, Moorman JR, Bourque JM. Predictive Monitoring-Impact in Acute Care Cardiology Trial (PM-IMPACCT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 2;10(7):e29631. doi: 10.2196/29631. |