Clinical trial NCT04359641: Predictive Monitoring - IMPact in Acute Care Cardiology Trial
Official title: Predictive Monitoring - IMPact in Acute Care Cardiology Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Clinical Deterioration
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Advanced Medical Predictive Devices, Diagnostics and Displays, Inc.
First posted: 2020-04-24
Enrollment: 10424
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Hours free of events of clinical deterioration
timeFrame: within 21 days of the admission
Secondary outcomes:
measure: Hours to proactive clinical response
timeFrame: through study completion, on average one week
measure: Subgroup secondary outcome: post-ICU transfer event-free survival
timeFrame: through study completion, on average one week
measure: Proportion of Emergent ICU transfer at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of emergent intubation at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of 3 units or more of blood ordered in 24 hours at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of IV inotropes or pressors at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportions of Shock requiring inotropes or pressors at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of Sepsis 2 criteria at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of septic shock at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of Cardiac arrest at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of death at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of Congestive heart failure at any point in the hospital stay
timeFrame: through study completion, on average one week
measure: Proportion of Inotropes or pressors for refractory heart failure at any point in the hospital
timeFrame: through study completion, on average one week
measure: Hospital length of stay
timeFrame: through study completion, on average one week
measure: Length of stay on floor
timeFrame: through study completion, on average one week
measure: ICU length of stay
timeFrame: through study completion, on average one week
measure: Hospital readmission
timeFrame: within 72 hours post-discharge
measure: Shock in sepsis
timeFrame: through study completion, on average one week
measure: Death in sepsis
timeFrame: through study completion, on average one week
measure: Cost of Care
timeFrame: through study completion, on average one week
measure: Number of days on IV antibiotics
timeFrame: through study completion, on average one week
measure: duration of mechanical intubation
timeFrame: through study completion, on average one week
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Jamieson M Bourque, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.