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Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck (PROOFcheck)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02488174
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : February 8, 2019
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michelle Gong, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Multiple Organ Failure Other: PROOFcheck Other: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34040 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prevention of Severe Acute Respiratory Failure in Patients With PROOFcheck - an Electronic Checklist to Prevent Organ Failure
Actual Study Start Date : August 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard Care
The pre-intervention control condition will be usual care: that is, clinicians practice as usual without clinician notification of risk and without prompting on care practices as recommended by PROOFcheck.
Other: Standard Care
Experimental: PROOFcheck
The intervention for this study will consist of 3 parts: 1) Education of clinicians on prevention of severe ARF and MOF in and out of the ICU, and best practice with regards to patients with severe ARF; 2) Clinicians will be notified that a patient they are taking care of has been identified as being at high risk for developing severe ARF requiring prolong MV; 3) Notified clinicians will be directed to PROOFcheck with a bundle of recommendations for best care for patients with ARF.
Other: PROOFcheck

Primary Outcome Measures :
  1. Hospital Mortality [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: up to 1 year ]
  2. Organ Failure [ Time Frame: up to 7 days ]
    SOFA score

  3. Ventilator Free Days [ Time Frame: up to 28 days ]
  4. 6 Month Mortality [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02488174

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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michelle Gong, Professor, Albert Einstein College of Medicine Identifier: NCT02488174    
Other Study ID Numbers: 2015-4775
UH3HL125119 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Respiratory Insufficiency
Multiple Organ Failure
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes