Clinical DeteriorationPM-IMPACCTNCT04359641
Predictive Monitoring - IMPact in Acute Care Cardiology Trial
A study testing CoMET Display in people with Clinical Deterioration, run by Jamieson Bourque, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Deterioration
- What is being tested?
- CoMET Display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,424 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Assigned for clinical purposes to a beds which is part of a randomized cluster
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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.
- Conditions
- Clinical Deterioration
- Being tested
- CoMET Display
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoMET DisplayDevice
Display and presentation of predictive monitoring score CoMET
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CoMET Display |
| No Display | No intervention | Standard CoMET device training but no display or presentation of predictive monitoring score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 21 days of the admission
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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:
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, on average one week
Hospital length of stay
Hospital length of stay
Measured: 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.
Measured: through study completion, on average one week
ICU length of stay
ICU length of stay
Measured: through study completion, on average one week
Hospital readmission
Readmission to hospital within 72 hours post-discharge
Measured: 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
Measured: through study completion, on average one week
Death in sepsis
In patients who meet the Sepsis 2 criteria, the proportion of death
Measured: through study completion, on average one week
Cost of Care
Observed:Expected ratio
Measured: through study completion, on average one week
Number of days on IV antibiotics
Number of days on IV antibiotics
Measured: through study completion, on average one week
duration of mechanical intubation
Total duration of mechanical intubation (emergent and non-emergent)
Measured: through study completion, on average one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start4 Jan 2021
- Primary completion3 Nov 2022
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clinical DeteriorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamieson Bourque, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.
- Responsible party
- Sponsor-investigator, Jamieson Bourque, MD, University of Virginia
- Investigators
- Jamieson M Bourque, MD, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359641
- Sponsor's protocol ID
- 22196
- Acronym
- PM-IMPACCT
- Status last verified
- May 2024
- First submitted
- 20 Mar 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41644641Keim-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.
PubMed 34043525
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Monitoring - IMPact in Acute Care Cardiology Trial
- ClinicalTrials.gov ID
- NCT04359641
- Acronym / sponsor ID
- PM-IMPACCT / 22196
- Conditions
- Clinical Deterioration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,424 participants (actual)
- Lead sponsor
- Jamieson Bourque, MDUniversity, hospital or other
- Collaborators
- Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoMET Display | Experimental | Device: CoMET DisplayDisplay 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Assigned for clinical purposes to a beds which is part of a randomized cluster
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoMET DisplayDisplay and presentation of predictive monitoring score CoMET | Device | CoMET Display |
Primary outcome
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.
22 secondary outcomes
Hours to proactive clinical response
Time frame: 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
Proportion of Emergent ICU transfer at any point in the hospital stay
Time frame: 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 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 IV inotropes or pressors at any point in the hospital stay
Time frame: 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
Proportion of Sepsis 2 criteria at any point in the hospital stay
Time frame: 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 Cardiac arrest at any point in the hospital stay
Time frame: 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 Congestive heart failure at any point in the hospital stay
Time frame: 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
Hospital length of stay
Time frame: through study completion, on average one week
Length of stay on floor
Time frame: through study completion, on average one week
ICU length of stay
Time frame: through study completion, on average one week
Hospital readmission
Time frame: within 72 hours post-discharge
Shock in sepsis
Time frame: through study completion, on average one week
Death in sepsis
Time frame: through study completion, on average one week
Cost of Care
Time frame: through study completion, on average one week
Number of days on IV antibiotics
Time frame: through study completion, on average one week
duration of mechanical intubation
Time frame: through study completion, on average one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 41644641Keim-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.
- Derived from this study: PubMed 34043525Keim-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamieson M Bourque, MD principal investigator
University of Virginia Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoMET Display in people with Clinical Deterioration, run by Jamieson Bourque, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hours free of events of clinical deterioration (time frame: within 21 days of the admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359641, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.