Respiratory Support and Treatment for Efficient and Cost-Effective Care (REST EEC)

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Clinical Decision Support (CDS); Device: HHFNC Weaning

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Horvat, MD; Phone Number: 4126925298; Email: christopher.horvat@chp.edu
• Study Contact Backup: Name: India Loar; Phone Number: 4126480613; Email: idl1@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital of Pittsburgh
      • Contact: Christopher Horvat, MD; Phone Number: 412-692-5298; Email: christopher.horvat@chp.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• <2 years of age Bronchiolitis WOB Score >2

Exclusion Criteria:

• Immunocompromised
• Immunosuppressed
• Chronic lung disease
• Congenital heart disease with baseline cardiorespiratory manifestations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HHFNC + Clinical decision Support; 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); 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.; Device: HHFNC Weaning; Wean patient off oxygen and flow as oxygenation and work of breathing improves.
Active Comparator: HHFNC Weaning; Team does not receive clinical decision support reminders to wean the HHFNC	Other: Clinical Decision Support (CDS); 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.; Device: HHFNC Weaning; Wean patient off oxygen and flow as oxygenation and work of breathing improves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HFNC duration	Amount of time patient is on HFNC	Timeframe consists of a start time of either randomization or the last documentation of positive pressure ventilation (whichever is later) and the last documentation of HFNC in the electronic flowsheet, up to 30 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

Collaborators and Investigators

• Sponsor: Christopher Horvat
• Collaborators: Beckwith Foundation
• Investigators: Principal Investigator: Christopher Horvat, MD, UPMC Children's Hospital of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: STUDY23010030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes