Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck

NCT02488174 | Completed

• 2 other identifiers: 2015-4775UH3HL125119
• Study Type: interventional
• Target: 34,040
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Failure; Multiple Organ Failure

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  up to 1 year

Secondary Outcomes (4)

• Hospital Length of Stay

  up to 1 year

• Organ Failure

  up to 7 days

• Ventilator Free Days

  up to 28 days

• 6 Month Mortality

  up to 6 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

PROOFcheck

EXPERIMENTAL

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

Interventions

PROOFcheck OTHER

PROOFcheck

Standard Care OTHER

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged \> 18 in the hospital
• Identified as being at high risk for developing severe ARF requiring prolonged MV

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (2)

• 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.

  PMID: 30373653 DERIVED

• 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.

  PMID: 27288382 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Multiple Organ Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: July 2, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (3)