Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck

Respiratory Failure Clinical Trial

— PROOFcheck  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488174
• Other study ID #: 2015-4775
• Secondary ID: UH3HL125119
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2019
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34040
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Organ Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• PROOFcheck

• Standard Care

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality		up to 1 year
Secondary	Hospital Length of Stay		up to 1 year
Secondary	Organ Failure	SOFA score	up to 7 days
Secondary	Ventilator Free Days		up to 28 days
Secondary	6 Month Mortality		up to 6 months