Predictive Monitoring - IMPact in Acute Care Cardiology Trial

NCT04359641 | Active Not Recruiting DMC

• 1 other identifier: 22196
• Study Type: interventional
• Target: 10,424
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Deterioration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Hours to proactive clinical response

  through study completion, on average one week

• Subgroup secondary outcome: post-ICU transfer event-free survival

  through study completion, on average one week

• Proportion of Emergent ICU transfer at any point in the hospital stay

  through study completion, on average one week

• Proportion of emergent intubation at any point in the hospital stay

  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

  through study completion, on average one week

Study Arms (2)

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.

Device: CoMET Display

No Display

NO INTERVENTION

Standard CoMET device training but no display or presentation of predictive monitoring score.

Interventions

CoMET Display DEVICE

Display and presentation of predictive monitoring score CoMET

CoMET Display

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Jamieson Bourque, MD: lead
• Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.: collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 34043525 DERIVED

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamieson M Bourque, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 24, 2020
• Study Start: January 4, 2021
• Primary Completion: November 3, 2022
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

US (1)