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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Clinical Deterioration
• Intervention / Treatment: Device: CoMET Display

• Study Type: Interventional
• Enrollment (Actual): 10424
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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.; 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
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
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

Collaborators and Investigators

• Sponsor: Jamieson Bourque, MD
• Collaborators: Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.
• Investigators: Principal Investigator: Jamieson M Bourque, MD, University of Virginia Health System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: 22196 (London School of Hygiene and Tropical Medicine)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No