Respiratory Support and Treatment for Efficient and Cost-Effective Care

NCT ID: NCT05909566

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2026-05-31

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.

Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Clinical Decision Support (CDS)

Intervention Type OTHER

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.

HHFNC Weaning

Intervention Type DEVICE

Wean patient off oxygen and flow as oxygenation and work of breathing improves.

HHFNC Weaning

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

Group Type ACTIVE_COMPARATOR

Clinical Decision Support (CDS)

Intervention Type OTHER

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.

HHFNC Weaning

Intervention Type DEVICE

Wean patient off oxygen and flow as oxygenation and work of breathing improves.

Interventions

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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.

Intervention Type OTHER

HHFNC Weaning

Wean patient off oxygen and flow as oxygenation and work of breathing improves.

Intervention Type DEVICE

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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckwith Foundation

UNKNOWN

Sponsor Role collaborator

Christopher Horvat

OTHER

Sponsor Role lead

Responsible Party

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Christopher Horvat

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christopher Horvat, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Children's Hospital of Pittsburgh

Locations

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UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christopher Horvat, MD

Role: CONTACT

4126925298

India Loar

Role: CONTACT

4126480613

Facility Contacts

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Christopher Horvat, MD

Role: primary

4126925298

References

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Horvat CM, Suresh S, James N, Aneja RK, Au AK, Berry S, Blumer A, Bricker K, Clark RSB, Dolinich H, Hahner S, Jockel C, Kalivoda J, Loar I, Marasco D, Marcinick A, Marroquin O, O'brien J, Pelletier J, Ramgopal S, Venkataraman S, Angus DC, Butler G. A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan. Trials. 2024 Jul 16;25(1):484. doi: 10.1186/s13063-024-08327-y.

Reference Type DERIVED
PMID: 39014495 (View on PubMed)

Other Identifiers

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STUDY23010030

Identifier Type: -

Identifier Source: org_study_id

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