NCT06932341

Brief Summary

The goal of this experimental study is to learn whether different types of best practice advisories (BPAs) that direct clinicians to reference clinical guidelines embedded in the electronic health record (EHR) increase the delivery of evidence-based care in children presenting to the hospital with bronchiolitis. The main questions it aims to answer are:

  • Do BPAs improve clinicians' delivery of guideline-concordant care in bronchiolitis?
  • Do interruptive BPAs improve guideline-concordant care of bronchiolitis more than non-interruptive BPAs? Researchers will compare the treatment and outcomes of patients whose clinicians did not receive a BPA, to those whose clinicians received a non-interruptive BPA, to those whose clinicians received an interruptive BPA. Patients will continue to receive standard hospital care for bronchiolitis. Clinicians will:
  • retain access to an EHR-embedded clinical guideline for bronchiolitis care
  • be exposed to either no BPA, a non-interruptive BPA, or an interruptive BPA promoting the EHR-embedded clinical guideline (randomized per patient encounter)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Study Progress87%
May 2025Jul 2026

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
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

April 10, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

best practice advisoryclinical decision supportclinical guidelineclinical pathway

Outcome Measures

Primary Outcomes (1)

  • Composite score of guideline-discordant care per hospital encounter

    Guideline-discordant care will be defined as a composite score incorporating number of chest X-rays, number of bronchodilator treatments, and numbers of hours spent on subtherapeutic rates of 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

Secondary Outcomes (8)

  • Hospital length of stay (hours)

    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

  • Duration of oxygen treatment (hours)

    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

  • Duration of high-flow nasal cannula treatment (hours)

    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

  • Number of Participants Transferred to intensive care unit

    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

  • Number of chest X-rays

    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

  • +3 more secondary outcomes

Other Outcomes (1)

  • Number of clinician interactions with clinical guideline

    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

Study Arms (3)

No BPA

NO INTERVENTION

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

Interruptive BPA

EXPERIMENTAL

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

Other: Interruptive

Non-interruptive BPA

EXPERIMENTAL

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

Other: Non-interruptive

Interventions

Non-interruptive BPA (appears as a visual cue but does not require clinicians to alter workflows) directing clinicians to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.

Non-interruptive BPA

Interruptive BPA (requires clinicians to interact with the alert to continue the workflow) directing clinicians to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.

Interruptive BPA

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 bronchiolitis at one of three study sites.

You may not qualify if:

  • Current encounter is birth-encounter
  • Currently hospitalized in an ICU
  • Hospitalized with length of stay \>14 days
  • Physicians and advanced practice providers entering the patient's chart or orders entry activity for Emergency Department (ED) and inpatient encounters
  • Physicians and advanced practice providers who do not enter the patient's chart or orders entry activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Benjamin Bodnar, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clea D Harris, MD

CONTACT

Benjamin Bodnar, MD

CONTACT

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

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations