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

Primary Purpose

Bronchiolitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support (CDS)
HHFNC Weaning
Sponsored by
Christopher Horvat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HHFNC + Clinical decision Support

HHFNC Weaning

Arm Description

Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC

Team does not receive clinical decision support reminders to wean the HHFNC

Outcomes

Primary Outcome Measures

ICU length of stay
Days in ICU

Secondary Outcome Measures

Respiratory support free days
Days alive and free of intensive care unit-based respiratory
Hospital length of stay
Days admitted in hospital
Organ support free days
Days alive and free of ICU-based respiratory or cardiovascular organ support
Time to oral intake
Time from HHFNC and oral intake
Ostensible respiratory distress measured by a respiratory severity score
The product of mean airway pressure and the fraction of inspired oxygen
Cost of hospitalization
Totality of expenses incurred by a hospital in providing its services and care
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
Mortality
Patient Death

Full Information

First Posted
May 24, 2023
Last Updated
July 24, 2023
Sponsor
Christopher Horvat
Collaborators
Beckwith Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05909566
Brief Title
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Acronym
REST EEC
Official Title
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Horvat
Collaborators
Beckwith Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HHFNC + Clinical decision Support
Arm Type
Experimental
Arm Description
Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC
Arm Title
HHFNC Weaning
Arm Type
Active Comparator
Arm Description
Team does not receive clinical decision support reminders to wean the HHFNC
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support (CDS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HHFNC Weaning
Intervention Description
Wean patient off oxygen and flow as oxygenation and work of breathing improves.
Primary Outcome Measure Information:
Title
ICU length of stay
Description
Days in ICU
Time Frame
From date admitted into ICU until the date of discharge from ICU or death from any cause, assessed up to 90 days
Secondary Outcome Measure Information:
Title
Respiratory support free days
Description
Days alive and free of intensive care unit-based respiratory
Time Frame
Days from start of respiratory support to respiratory support free day
Title
Hospital length of stay
Description
Days admitted in hospital
Time Frame
Days from admission to discharge from hospital or death
Title
Organ support free days
Description
Days alive and free of ICU-based respiratory or cardiovascular organ support
Time Frame
Days from admission to organ support free days
Title
Time to oral intake
Description
Time from HHFNC and oral intake
Time Frame
Days from being off HFNC until oral intake
Title
Ostensible respiratory distress measured by a respiratory severity score
Description
The product of mean airway pressure and the fraction of inspired oxygen
Time Frame
Through study completion, an average of 1 week
Title
Cost of hospitalization
Description
Totality of expenses incurred by a hospital in providing its services and care
Time Frame
Days from admission to discharge from hospital or date of death, up to 90 days
Title
90-day cost of care
Description
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
Time Frame
Days of care from admission to 90 days
Title
Mortality
Description
Patient Death
Time Frame
Days from admission to death

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Horvat, MD
Phone
4126925298
Email
christopher.horvat@chp.edu
First Name & Middle Initial & Last Name or Official Title & Degree
India Loar
Phone
4126480613
Email
idl1@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Horvat, MD
Organizational Affiliation
UPMC Children's Hospital of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Horvat, MD
Phone
412-692-5298
Email
christopher.horvat@chp.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Respiratory Support and Treatment for Efficient and Cost-Effective Care

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