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

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05909566
Collaborator
Beckwith Foundation (Other)
198
1
2
35
5.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical Decision Support (CDS)
  • Device: HHFNC Weaning
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. ICU length of stay [From date admitted into ICU until the date of discharge from ICU or death from any cause, assessed up to 90 days]

    Days in ICU

Secondary Outcome Measures

  1. Respiratory support free days [Days from start of respiratory support to respiratory support free day]

    Days alive and free of intensive care unit-based respiratory

  2. Hospital length of stay [Days from admission to discharge from hospital or death]

    Days admitted in hospital

  3. Organ support free days [Days from admission to organ support free days]

    Days alive and free of ICU-based respiratory or cardiovascular organ support

  4. Time to oral intake [Days from being off HFNC until oral intake]

    Time from HHFNC and oral intake

  5. Ostensible respiratory distress measured by a respiratory severity score [Through study completion, an average of 1 week]

    The product of mean airway pressure and the fraction of inspired oxygen

  6. Cost of hospitalization [Days from admission to discharge from hospital or date of death, up to 90 days]

    Totality of expenses incurred by a hospital in providing its services and care

  7. 90-day cost of care [Days of care from admission to 90 days]

    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 populationâ‘ , time period, and unit(s) of clinical accountability for 90 days

  8. Mortality [Days from admission to death]

    Patient Death

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • <2 years of age Bronchiolitis WOB Score >2
Exclusion Criteria:
  • Immunocompromised

  • Immunosuppressed

  • Chronic lung disease

  • Congenital heart disease with baseline cardiorespiratory manifestations

Contacts and Locations

Locations

Site City State Country Postal Code
1 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224

Sponsors and Collaborators

  • University of Pittsburgh
  • Beckwith Foundation

Investigators

  • Principal Investigator: Christopher Horvat, MD, UPMC Children's Hospital of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Horvat, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05909566
Other Study ID Numbers:
  • STUDY23010030
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023