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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Multiple Organ Failure
• Intervention / Treatment: Other: Standard Care; Other: PROOFcheck

• Study Type: Interventional
• Enrollment (Actual): 34040
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Mortality	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay		up to 1 year
Organ Failure	SOFA score	up to 7 days
Ventilator Free Days		up to 28 days
6 Month Mortality		up to 6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Dziadzko MA, Novotny PJ, Sloan J, Gajic O, Herasevich V, Mirhaji P, Wu Y, Gong MN. Multicenter derivation and validation of an early warning score for acute respiratory failure or death in the hospital. Crit Care. 2018 Oct 30;22(1):286. doi: 10.1186/s13054-018-2194-7.
• Gong MN, Schenk L, Gajic O, Mirhaji P, Sloan J, Dong Y, Festic E, Herasevich V. 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. 2016 Jun 10;6(6):e011347. doi: 10.1136/bmjopen-2016-011347.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (ESTIMATE): July 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Shock; Respiratory Insufficiency; Multiple Organ Failure
• Other Study ID Numbers: 2015-4775; UH3HL125119 (NIH)