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

May 8, 2024 updated by: Jamieson Bourque, MD

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10424

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
within 21 days of the admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, on average one week
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.
through study completion, on average one week
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:
through study completion, on average one week
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
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
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
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
through study completion, on average one week
Hospital length of stay
Time Frame: through study completion, on average one week
Hospital length of stay
through study completion, on average one week
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.
through study completion, on average one week
ICU length of stay
Time Frame: through study completion, on average one week
ICU length of stay
through study completion, on average one week
Hospital readmission
Time Frame: within 72 hours post-discharge
Readmission to hospital within 72 hours post-discharge
within 72 hours post-discharge
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
through study completion, on average one week
Death in sepsis
Time Frame: through study completion, on average one week
In patients who meet the Sepsis 2 criteria, the proportion of death
through study completion, on average one week
Cost of Care
Time Frame: through study completion, on average one week
Observed:Expected ratio
through study completion, on average one week
Number of days on IV antibiotics
Time Frame: through study completion, on average one week
Number of days on IV antibiotics
through study completion, on average one week
duration of mechanical intubation
Time Frame: through study completion, on average one week
Total duration of mechanical intubation (emergent and non-emergent)
through study completion, on average one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jamieson Bourque, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamieson M Bourque, MD, University of Virginia Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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