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.
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.



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.



The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.



NCT02488174.
Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
M N
MN
Gong
Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
L
L
Schenk
Department of Anesthesia, Mayo Clinic, Rochester, Minnesota, USA.
O
O
Gajic
Systems and Computational Biology, Albert Einstein College of Medicine, Bronx, New York, USA.
P
P
Mirhaji
Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
J
J
Sloan
Department of Anesthesia, Mayo Clinic, Rochester, Minnesota, USA.
Y
Y
Dong
Department of Critical Care Medicine, Mayo Clinic, Jacksonville, Florida, USA.
E
E
Festic
Division of Critical Care, Department of Anesthesia, Mayo Clinic, Rochester, Minnesota, USA.
V
V
Herasevich
D000293:Adolescent; D000328:Adult; D000368:Aged; D057189:Checklist; D016638:Critical Illness; D061345:Early Medical Intervention / Q000379:methods*; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure; D012107:Research Design; D012121:Respiration, Artificial / Q000379:methods*; D012131:Respiratory Insufficiency / Q000628:therapy*; D013997:Time Factors; D014481:United States; D055815:Young Adult
Acute respiratory failure; EMR-based early alerts; acute critical illness; mechanical ventilation; multiple organ failure