---
title: Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck
nct_id: NCT02488174
overall_status: COMPLETED
phase: NA
sponsor: Albert Einstein College of Medicine
study_type: INTERVENTIONAL
primary_condition: Respiratory Failure
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02488174.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02488174"
ct_last_update_post_date: 2019-02-08
last_seen_at: "2026-05-12T06:52:25.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02488174](https://clinicaltrials.gov/study/NCT02488174)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 34040
- **Lead Sponsor:** Albert Einstein College of Medicine
- **Collaborators:** National Heart, Lung, and Blood Institute (NHLBI)
- **Conditions:** Respiratory Failure, Multiple Organ Failure
- **Start Date:** 2015-08
- **Completion Date:** 2018-09
- **CT.gov Last Update:** 2019-02-08

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **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.
- **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.

## Interventions

- **PROOFcheck** (OTHER)
- **Standard Care** (OTHER)

## Primary Outcomes

- **Hospital Mortality** _(time frame: up to 1 year)_

## Secondary Outcomes

- **Hospital Length of Stay** _(time frame: up to 1 year)_
- **Organ Failure** _(time frame: up to 7 days)_
- **Ventilator Free Days** _(time frame: up to 28 days)_
- **6 Month Mortality** _(time frame: up to 6 months)_

## Locations (3)

- Mayo Clinic, Jacksonville, Florida, United States
- Mayo Clinic, Rochester, Minnesota, United States
- Montefiore Medical Center, The Bronx, New York, United States

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mayo clinic|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.mayo clinic|rochester|minnesota|united states` — added _(2026-05-12)_
- `locations.montefiore medical center|the bronx|new york|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02488174*  
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