NCT06932341

Brief Summary

The goal of this experimental study is to learn whether different types of Electronic Health Record (EHR) alerts that direct clinicians to reference clinical guidelines embedded in the increase the use of these guidelines and the delivery of evidence-based care in children presenting to the hospital with bronchiolitis. The main questions it aims to answer are:

  • Do EHR-alerts increase clinicians' us of evidence-based EHR-integrated Clinical Decision Support (CDS) guidelines for the care of bronchiolitis and
  • Is the use of EHR-integrated CDS-guidelines for the care of bronchiolitis associated with deceases in low-value use of High Flow Nasal Cannula (HFNC) and improvement in other aspects of high-value care for this disease Patients will be randomized on the encounter-level to have the patient's treating providers receive no EHR-alert or one of two types of EHR-alert (non-interruptive or interruptive) reminding the provider that the EHR-integrated CDS guideline is available for the care or bronchiolitis. Researchers will compare the rate of use of EHR-integrated CDS guidelines in patients whose clinicians did not receive any EHR-alerts, to those whose clinicians received a non-interruptive alert and to those whose clinicians received an interruptive Best Practice Advisory (BPA). In addition, the study will evaluate whether the utilization of the EHR-integrated CDS guideline in a given encounter was associated with less low-value HFNC use, and differences in other elements of low-value care for bronchiolitis. Patients in all groups will continue to receive standard hospital care for bronchiolitis as determined by the patient's treating clinicians.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,965

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

April 10, 2025

Last Update Submit

July 16, 2026

Conditions

Keywords

best practice advisoryclinical decision supportclinical guidelineclinical pathwaypractice advisoryEHR alert

Outcome Measures

Primary Outcomes (1)

  • Proportion of encounters provider utilizes EHR-integrated clinical decision support tool

    Use of the EHR-integrated Clinical Decision Support Guideline. The proportion of encounters in which a provider utilizes the EHR-integrated clinical decision support tool for the care of bronchiolitis during a given encounter.

    From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients

Secondary Outcomes (2)

  • Proportion of encounters providers utilize the EHR-integrated clinical decision support tool for the care of bronchiolitis

    From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients

  • Proportion of encounters a provider enters orders via the EHR-integrated clinical decision support tool

    From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients

Other Outcomes (4)

  • Proportion of patients who receive any subtherapeutic high flow nasal cannula (HFNC) treatment

    From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients

  • The average number of hours during which a patient received subtherapeutic high flow nasal cannula (HFNC) treatment

    From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients

  • Proportion of patients who receive any treatment with high flow nasal cannula

    From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients

  • +1 more other outcomes

Study Arms (3)

No EHR-Alert

NO INTERVENTION

Clinicians will not be exposed to a any EHR-alert about the care of bronchiolitis. The participants will still have access to the EHR-embedded, evidence-based clinical guideline.

Interruptive EHR-Alert

EXPERIMENTAL

Clinicians will be exposed to an interruptive EHR-alert directing the clinician to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.

Other: Interruptive

Non-interruptive EHR-Alert

EXPERIMENTAL

Clinicians will be exposed to an non-interruptive EHR-Alert directing the clinician to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.

Other: Non-interruptive

Interventions

The non-interruptive EHR alert appears as a visual cue but does not require clinicians to alter workflows. The alert directs clinicians to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.

Non-interruptive EHR-Alert

The interruptive EHR alert requires clinicians to interact with the alert to continue the workflow. The alert directs clinicians to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.

Interruptive EHR-Alert

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children \<=24 months of age presenting to the emergency room and/or hospitalized (under observation or inpatient status) with EHR-indicators of bronchiolitis at one of three study sites. EHR-indicators of bronchiolitis include the use of bronchiolitis-specific order sets, or specific combinations of ED chief complaint, infection or isolation status, and the receipt of disease-relevant therapies (such as oxygen supplementation)

You may not qualify if:

  • Current encounter is birth-encounter
  • Currently hospitalized in an ICU
  • Hospitalized with length of stay \>14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Benjamin E Bodnar, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

May 5, 2025

Primary Completion

June 12, 2026

Study Completion

July 12, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations