Leveraging Electronic Health Record Tools to Improve the Evidence-Based Treatment of Children Hospitalized With Bronchiolitis

NCT ID: NCT06932341

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-07-31

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)

Detailed Description

Bronchiolitis, a viral respiratory illness affecting infants and toddlers, is the most common reason children less than 2 years old are hospitalized. However, many children admitted with bronchiolitis receive unnecessary treatments that do not hasten recovery and may even cause harm. Despite evidence that the best treatment for bronchiolitis is supportive care (i.e. oxygen and hydration support), clinicians continue to overuse certain therapies, leading to longer hospital stays, higher costs, and increased stress for families.

The investigators will study the effects of BPAs, which are real-time alerts within the EHR. The BPAs in this study promote the use of an evidence-based care guideline for bronchiolitis that is embedded within the EHR. There are multiple BPA designs commonly used in EHRs: 1) interruptive BPAs, which require clinicians to interact with the alert to continue the clinician's workflow; and 2) non-interruptive BPAs, which appear as visual cues but do not require clinicians to alter workflows.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No BPA

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interruptive BPA

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.

Group Type: EXPERIMENTAL

Interruptive

Intervention Type: OTHER

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.

Non-interruptive BPA

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.

Group Type: EXPERIMENTAL

Non-interruptive

Intervention Type: OTHER

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.

Interventions

Non-interruptive

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.

Intervention Type: OTHER

Interruptive

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Physicians and advanced practice providers entering the patient's chart or orders entry activity for Emergency Department (ED) and inpatient encounters

Exclusion Criteria

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

• Physicians and advanced practice providers who do not enter the patient's chart or orders entry activity

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Bodnar, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status: RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clea D Harris, MD

Role: CONTACT

charr163@jh.edu

203-606-4322

Benjamin Bodnar, MD

Role: CONTACT

benjamin.bodnar@jhmi.edu

410-614-4474

Facility Contacts

Johns Hopkins IRB Office

Role: primary

jhmeirb@jhmi.edu

410-502-2092

Johns Hopkins IRB Office

Role: primary

jhmeirb@jhmi.edu

410-502-2092

Johns Hopkins IRB Office

Role: primary

jhmeirb@jhmi.edu

410-502-2092

Other Identifiers

IRB00456658

Identifier Type: -

Identifier Source: org_study_id