Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck

Brief Summary
Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the most common form of acute organ dysfunction in the hospital, and is often associated with multiple organ failure (MOF), high mortality, and functional impairment. Most studies on ARF have focused on patients in the intensive care unit (ICU) after they have been on mechanical ventilation for days and end organ damage is already established. The overall goal of this proposed project is to improve the outcomes of patients at high risk for developing severe ARF and prolonged mechanical ventilation in and outside of the ICU. The project aims to intervene early in high risk patients with an electronic medical records (EMR)-based, patient-centered checklist of common critical care practices aimed at preventing lung injury and hospital acquired adverse events that commonly lead to organ failure (Prevention of Organ Failure checklist -PROOFcheck). This application proposes a stepped-wedge, clustered randomized control trial to determine the utility of PROOFcheck to improve survival and reduce the duration of mechanical ventilation and multiple organ failure in patients identified as high risk for progressing to severe ARF and prolonged mechanical ventilation. The aims in the UH2 phase are: 1) to refine a previously validated Lung Injury Prediction Score into a pragmatic, EMR-based early prediction model to Accurately Predict Prolonged Ventilation (APPROVE), which will automatically identify patients anywhere in the hospital who are at high risk for developing severe ARF requiring mechanical ventilation \>48 hours; 2) to incorporate PROOFcheck into the EMR to prompt clinicians on care practices to limit lung injury, prevent adverse events, and avoid additional organ failure; and 3) to establish the infrastructure for the proposed trial. The proposed pragmatic trial will harness the hospital-wide EMR to identify patients at high risk for prolonged mechanical ventilation with APPROVE for intervention with PROOFcheck. As such, the proposed trial aims to break out of the clinical silos by which care is currently organized in the hospital and bring patient-centered, context appropriate care to the acutely ill patient wherever and whenever the patient's condition requires it.
Brief Title
Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck
Completion Date
Completion Date Type
Actual
Conditions
Respiratory Failure
Multiple Organ Failure
Eligibility Criteria
Inclusion Criteria:

* Adult patients aged \> 18 in the hospital
* Identified as being at high risk for developing severe ARF requiring prolonged MV

Exclusion Criteria:

* Patients who are chronically ventilated
* Patients who have DNI orders on hospital admission
* Patients in areas of the hospital that are unable or unwilling to participate
Inclusion Criteria
Inclusion Criteria:

* Adult patients aged \> 18 in the hospital
* Identified as being at high risk for developing severe ARF requiring prolonged MV

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02488174
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-4775
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prevention of Severe Acute Respiratory Failure in Patients With PROOFcheck - an Electronic Checklist to Prevent Organ Failure
Primary Outcomes
Outcome Measure
Hospital Mortality
Outcome Time Frame
up to 1 year
Secondary Ids
Secondary Id
UH3HL125119
Secondary Outcomes
Outcome Time Frame
up to 1 year
Outcome Measure
Hospital Length of Stay
Outcome Description
SOFA score
Outcome Time Frame
up to 7 days
Outcome Measure
Organ Failure
Outcome Time Frame
up to 28 days
Outcome Measure
Ventilator Free Days
Outcome Time Frame
up to 6 months
Outcome Measure
6 Month Mortality
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michelle Gong
Investigator Email
mgong@montefiore.org
Investigator Phone
718-920-5464