PROOFcheck: Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02488174
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 34,040
• Locations: 3
• Arms: 2
• Actual Duration (Months): 37
• Patients Per Site: 11346.7
• Patients Per Site Per Month: 306.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2015
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hospital Mortality [up to 1 year]

Secondary Outcome Measures

1. Hospital Length of Stay [up to 1 year]

2. Organ Failure [up to 7 days]

   SOFA score

3. Ventilator Free Days [up to 28 days]

4. 6 Month Mortality [up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224
2	Mayo Clinic	Rochester	Minnesota	United States	55902
3	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Albert Einstein College of Medicine
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle Gong, Professor, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT02488174
• Other Study ID Numbers: 2015-4775; UH3HL125119
• First Posted: Jul 2, 2015
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Respiratory Insufficiency; Multiple Organ Failure

Study Results

No Results Posted as of Feb 8, 2019