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

Primary Purpose

Respiratory Failure, Multiple Organ Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROOFcheck
Standard Care
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic
  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

PROOFcheck

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Mortality

Secondary Outcome Measures

Hospital Length of Stay
Organ Failure
SOFA score
Ventilator Free Days
6 Month Mortality

Full Information

First Posted
March 18, 2015
Last Updated
February 6, 2019
Sponsor
Albert Einstein College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02488174
Brief Title
Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck
Acronym
PROOFcheck
Official Title
Prevention of Severe Acute Respiratory Failure in Patients With PROOFcheck - an Electronic Checklist to Prevent Organ Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Multiple Organ Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PROOFcheck
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PROOFcheck
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Hospital Mortality
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Time Frame
up to 1 year
Title
Organ Failure
Description
SOFA score
Time Frame
up to 7 days
Title
Ventilator Free Days
Time Frame
up to 28 days
Title
6 Month Mortality
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30373653
Citation
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.
Results Reference
derived
PubMed Identifier
27288382
Citation
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.
Results Reference
derived

Learn more about this trial

Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck

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