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Clinical Trials/NCT02488174
NCT02488174
Completed
Not Applicable

Prevention of Severe Acute Respiratory Failure in Patients With PROOFcheck - an Electronic Checklist to Prevent Organ Failure

Albert Einstein College of Medicine2 sites in 1 country34,040 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Albert Einstein College of Medicine
Enrollment
34040
Locations
2
Primary Endpoint
Hospital Mortality
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
September 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Gong

Professor

Albert Einstein College of Medicine

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

Outcomes

Primary Outcomes

Hospital Mortality

Time Frame: up to 1 year

Secondary Outcomes

  • Hospital Length of Stay(up to 1 year)
  • Organ Failure(up to 7 days)
  • Ventilator Free Days(up to 28 days)
  • 6 Month Mortality(up to 6 months)

Study Sites (2)

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