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Predictive Monitoring - IMPact in Acute Care Cardiology Trial (PM-IMPACCT)

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ClinicalTrials.gov Identifier: NCT04359641
Recruitment Status : Enrolling by invitation
First Posted : April 24, 2020
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.
Information provided by (Responsible Party):
Jamieson Bourque, MD, University of Virginia

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.


Condition or disease Intervention/treatment Phase
Clinical Deterioration Device: CoMET Display Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Predictive Monitoring - IMPact in Acute Care Cardiology Trial
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : March 1, 2023

Arm Intervention/treatment
Experimental: CoMET Display
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.
Device: CoMET Display
Display and presentation of predictive monitoring score CoMET

No Intervention: No Display
Standard CoMET device training but no display or presentation of predictive monitoring score.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Hours to proactive clinical response [ 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 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.

  2. Subgroup secondary outcome: post-ICU transfer event-free survival [ 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 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.

  3. Proportion of Emergent ICU transfer at any point in the hospital stay [ 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:

  4. Proportion of emergent intubation at any point in the hospital stay [ 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

  5. Proportion of 3 units or more of blood ordered in 24 hours at any point in the hospital stay [ 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

  6. Proportion of IV inotropes or pressors at any point in the hospital stay [ 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

  7. Proportions of Shock requiring inotropes or pressors at any point in the hospital stay [ 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

  8. Proportion of Sepsis 2 criteria at any point in the hospital stay [ 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

  9. Proportion of septic shock at any point in the hospital stay [ 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

  10. Proportion of Cardiac arrest at any point in the hospital stay [ 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

  11. Proportion of death at any point in the hospital stay [ 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

  12. Proportion of Congestive heart failure at any point in the hospital stay [ 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

  13. Proportion of Inotropes or pressors for refractory heart failure at any point in the hospital [ 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

  14. Hospital length of stay [ Time Frame: through study completion, on average one week ]
    Hospital length of stay

  15. Length of stay on floor [ 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.

  16. ICU length of stay [ Time Frame: through study completion, on average one week ]
    ICU length of stay

  17. Hospital readmission [ Time Frame: within 72 hours post-discharge ]
    Readmission to hospital within 72 hours post-discharge

  18. Shock in sepsis [ 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

  19. Death in sepsis [ Time Frame: through study completion, on average one week ]
    In patients who meet the Sepsis 2 criteria, the proportion of death

  20. Cost of Care [ Time Frame: through study completion, on average one week ]
    Observed:Expected ratio

  21. Number of days on IV antibiotics [ Time Frame: through study completion, on average one week ]
    Number of days on IV antibiotics

  22. duration of mechanical intubation [ Time Frame: through study completion, on average one week ]
    Total duration of mechanical intubation (emergent and non-emergent)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Assigned for clinical purposes to a beds which is part of a randomized cluster

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359641


Locations
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United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Jamieson Bourque, MD
Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.
Investigators
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Principal Investigator: Jamieson M Bourque, MD University of Virginia Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jamieson Bourque, MD, Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT04359641    
Other Study ID Numbers: 22196
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Clinical Deterioration
Disease Progression
Disease Attributes
Pathologic Processes