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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS029188 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Intervention Phase | No Intervention | PICU patients who are intubated without the Smart checklist | |
| Post-Intervention Phase | Active Comparator | PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Checklist | Other | 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. |
| 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 |
| 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) |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akira Nishisaki, MD, MSCE | Contact | 215-590-1000 | nishisaki@chop.edu | |
| Hayley Buffman, MPH | Contact | 215-590-1000 | buffmanh@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Akira Nishisaki, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Recruiting | Little Rock | Arkansas | 72205 | United States |
The PI will share unique research resources developed through this Agency for Healthcare Research and Quality (AHRQ)-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with AHRQ policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
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Data will be available after study completion
The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
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| During the ICU stay, up to 180 days |
| ICU mortality | ICU mortality (all cause) | During the ICU stay, up to 180 days |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Akron Children's Hospital | Recruiting | Akron | Ohio | 44308 | United States |
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| Hasbro Children's Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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