Respiratory Support and Treatment for Efficient and Cost-Effective Care

Study Overview
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Brief Summary
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This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems. REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes.

Official Title
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Respiratory Support and Treatment for Efficient and Cost-Effective Care

Conditions
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Bronchiolitis

Intervention / Treatment
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* Other: Clinical Decision Support (CDS)
* Device: HHFNC Weaning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <2 years of age Bronchiolitis WOB Score >2 Exclusion Criteria: Immunocompromised Immunosuppressed Chronic lung disease Congenital heart disease with baseline cardiorespiratory manifestations

Ages Eligible for Study
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Maximum Age: 2 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will be providing clinical decision support tools for children receiving HHFNC for bronchiolitis, testing the impact of decision support compared to usual care in a pragmatic randomized trial. All subjects will receive standard of care. Decisions regarding management will be at the discretion of the treating provider and will not be restricted or altered in any way.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HHFNC + Clinical decision Support<br>Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC | Other: Clinical Decision Support (CDS)<br>* Education to front line clinicians and staff on standardized implementation and weaning of HHFNC and standardized assessments of patient work of breathing. HHFNC implementation and weaning strategies will be based on age-specific practices recommended by the American Academy of Pediatrics. Education will be undertaken by dedicated clinical educators.<br>Device: HHFNC Weaning<br>* Wean patient off oxygen and flow as oxygenation and work of breathing improves.<br>|
| Active Comparator: HHFNC Weaning<br>Team does not receive clinical decision support reminders to wean the HHFNC | Other: Clinical Decision Support (CDS)<br>* Education to front line clinicians and staff on standardized implementation and weaning of HHFNC and standardized assessments of patient work of breathing. HHFNC implementation and weaning strategies will be based on age-specific practices recommended by the American Academy of Pediatrics. Education will be undertaken by dedicated clinical educators.<br>Device: HHFNC Weaning<br>* Wean patient off oxygen and flow as oxygenation and work of breathing improves.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | Days in ICU | From date admitted into ICU until the date of discharge from ICU or death from any cause, assessed up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory support free days | Days alive and free of intensive care unit-based respiratory | Days from start of respiratory support to respiratory support free day | 
| Hospital length of stay | Days admitted in hospital | Days from admission to discharge from hospital or death | 
| Organ support free days | Days alive and free of ICU-based respiratory or cardiovascular organ support | Days from admission to organ support free days | 
| Time to oral intake | Time from HHFNC and oral intake | Days from being off HFNC until oral intake | 
| Ostensible respiratory distress measured by a respiratory severity score | The product of mean airway pressure and the fraction of inspired oxygen | Through study completion, an average of 1 week | 
| Cost of hospitalization | Totality of expenses incurred by a hospital in providing its services and care | Days from admission to discharge from hospital or date of death, up to 90 days | 
| 90-day cost of care | Total cost is your premium + deductible + out-of-pocket costs + any total resource use and unit price(s), by payer or consumer, for a healthcare service or group of healthcare services, associated with a specified patient population①, time period, and unit(s) of clinical accountability for 90 days | Days of care from admission to 90 days | 
| Mortality | Patient Death | Days from admission to death |