Clinical trial NCT05909566: Respiratory Support and Treatment for Efficient and Cost-Effective Care
Official title: Respiratory Support and Treatment for Efficient and Cost-Effective Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Beckwith Foundation
First posted: 2023-06-18
Enrollment: 198
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* \<2 years of age Bronchiolitis WOB Score \>2

Exclusion Criteria:

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

Primary outcomes:
measure: HFNC duration
timeFrame: 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 outcomes:
measure: Respiratory support free days
timeFrame: From date the start of respiratory support until the first documented respiratory support free day, up to 30 days
measure: Hospital length of stay
timeFrame: From date of admission until discharge or date of death from any cause, whichever came first, assessed up to 90 days.
measure: Organ support free days
timeFrame: From date of admission until the first day of ICU-based respiratory or cardiovascular organ support or discharge or date of death from any case, whichever came first, assessed up to 30 days
measure: Time to oral intake
timeFrame: From date of ending HHFNC until first documented oral intake, assessed up to 30 days
measure: Ostensible respiratory distress measured by a respiratory severity score
timeFrame: Through study completion, an average of 1 week
measure: Cost of hospitalization
timeFrame: Days from admission to discharge from hospital or date of death, up to 90 days. Of note, an earlier outcome was listed for 90-day cost of care and the redundancy with this outcome was recognized, so the 90-day cost of care outcome was removed.
measure: Mortality
timeFrame: From date of admission until death from any cause, assessed up to 90 days
measure: PICU length of stay
timeFrame: From data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: UPMC Children's Hospital of Pittsburgh
name: Christopher Horvat, MD
role: PRINCIPAL_INVESTIGATOR
References: