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 i n 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.

Public Health Relevance

Severe acute respiratory failure with prolonged mechanical ventilation is a common and morbid condition with high mortality. By intervening in high risk patients early in their hospital course, before organ damage is established, by alerting providers to their patient's risk and prompting them towards greater adherence to proven therapies, this project aims to change the paradigm of how acute respiratory failure is managed and improve short and long term survival in a large proportion of patients admitted to the hospital.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Exploratory/Developmental Cooperative Agreement Phase I (UH2)
Project #
1UH2HL125119-01
Application #
8793043
Study Section
Special Emphasis Panel (ZHL1-CSR-G (S1))
Program Officer
Bonds, Denise
Project Start
2014-09-19
Project End
2015-07-31
Budget Start
2014-09-19
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
$611,559
Indirect Cost
$105,401
Name
Albert Einstein College of Medicine
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
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Gong, M N; Schenk, L; Gajic, O et al. (2016) Early intervention of patients at risk for acute respiratory failure and prolonged mechanical ventilation with a checklist aimed at the prevention of organ failure: protocol for a pragmatic stepped-wedged cluster trial of PROOFCheck. BMJ Open 6:e011347