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

Michelle Ng Gong, L. Schenk, O. Gajic, Parsa Mirhaji, J. Sloan, Y. Dong, E. Festic, V. Herasevich

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death. Methods and analysis: A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV 48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist-PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time. Ethics and dissemination: The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.

Original languageEnglish (US)
Article numbere011347
JournalBMJ Open
Volume6
Issue number6
DOIs
StatePublished - Jun 1 2016

Fingerprint

Checklist
Artificial Respiration
Respiratory Insufficiency
Ventilation
Critical Illness
Electronic Health Records
Evidence-Based Practice
Research Ethics Committees
Operating Rooms
Mechanical Ventilators
Hospital Mortality
Practice Guidelines
Intubation
Ethics
Intensive Care Units
Cluster Analysis
Length of Stay
Clinical Trials
Mortality

Keywords

  • acute critical illness
  • Acute respiratory failure
  • EMR-based early alerts
  • mechanical ventilation
  • multiple organ failure

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{3aac0d8acf04400fb5c7258dea3dbfbd,
title = "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",
abstract = "Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death. Methods and analysis: A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV 48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist-PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time. Ethics and dissemination: The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.",
keywords = "acute critical illness, Acute respiratory failure, EMR-based early alerts, mechanical ventilation, multiple organ failure",
author = "Gong, {Michelle Ng} and L. Schenk and O. Gajic and Parsa Mirhaji and J. Sloan and Y. Dong and E. Festic and V. Herasevich",
year = "2016",
month = "6",
day = "1",
doi = "10.1136/bmjopen-2016-011347",
language = "English (US)",
volume = "6",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "6",

}

TY - JOUR

T1 - Early intervention of patients at risk for acute respiratory failure and prolonged mechanical ventilation with a checklist aimed at the prevention of organ failure

T2 - Protocol for a pragmatic stepped-wedged cluster trial of PROOFCheck

AU - Gong, Michelle Ng

AU - Schenk, L.

AU - Gajic, O.

AU - Mirhaji, Parsa

AU - Sloan, J.

AU - Dong, Y.

AU - Festic, E.

AU - Herasevich, V.

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death. Methods and analysis: A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV 48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist-PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time. Ethics and dissemination: The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.

AB - Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death. Methods and analysis: A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV 48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist-PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time. Ethics and dissemination: The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.

KW - acute critical illness

KW - Acute respiratory failure

KW - EMR-based early alerts

KW - mechanical ventilation

KW - multiple organ failure

UR - http://www.scopus.com/inward/record.url?scp=84974817515&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84974817515&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2016-011347

DO - 10.1136/bmjopen-2016-011347

M3 - Article

VL - 6

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 6

M1 - e011347

ER -