Clinical trial NCT02488174: Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck
Official title: Prevention of Severe Acute Respiratory Failure in Patients With PROOFcheck - an Electronic Checklist to Prevent Organ Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Multiple Organ Failure
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-07-02
Enrollment: 34040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Hospital Mortality
timeFrame: up to 1 year
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: up to 1 year
measure: Organ Failure
timeFrame: up to 7 days
measure: Ventilator Free Days
timeFrame: up to 28 days
measure: 6 Month Mortality
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
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.
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.