Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study

Study Overview
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Brief Summary
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The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).

Detailed Description
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More than 20% of the critically ill children who require tracheal intubation suffer from adverse events. To reduce the adverse event risk, and optimize bedside team performance investigators will implement a digitized Smart Checklist that has three specific features: (1) prompts based on patient characteristics, (2) direct display of difficult airway status and airway information, and (3) high-risk warning based on predictive analytics. This is a stepped-wedge cluster randomized trial of PICU patients who are intubated across 6 participating hospitals to determine if the Smart Checklist reduces the incidence of adverse tracheal intubation associated events. The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on the occurrence of Adverse Airway Outcomes (AAOs) in the pediatric ICU. The secondary objective is to characterize work systems and processes that affect clinical impact of the digitized Smart Checklist.

Official Title
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Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study

Conditions
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Intubation Complication

Intervention / Treatment
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* Other: Smart Checklist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients intubated in the PICU at participating sites Exclusion Criteria: Endotracheal tube exchanges, as this represents a distinct procedure

Ages Eligible for Study
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Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Intervention Phase<br>PICU patients who are intubated without the Smart checklist | |
| Active Comparator: Post-Intervention Phase<br>PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit. | Other: Smart Checklist<br>* The digitized Smart Checklist includes three new features that currently do not exist on a paper checklist: 1) decision support prompts based on patient-provider dyad characteristics, 2) real time display of patient pertinent airway information from the EHR, and 3) high-risk warning alerts based on predictive analytics with potential explanatory factors from the model.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Airway Outcomes | A composite outcome for adverse events or acute oxygen desaturation <80% | During the intubation procedure and up to 20 minutes after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of invasive mechanical ventilation | Duration of invasive mechanical ventilation (time to extubation or tracheostomy) | During the ICU stay, up to 180 days | 
| Duration of ICU stay | Duration of ICU stay (days) | During the ICU stay, up to 180 days | 
| ICU mortality | ICU mortality (all cause) | During the ICU stay, up to 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, PICU, Safety, Pediatric