Evaluation of the Impact of EHR-Alerts on Clinical Decision Support Pathway Use in Bronchiolitis, and the Impact of Pathway Use on the Prescription of High Flow Nasal Cannula and Other Elements of High Value Care.

The Impact of EHR-Alerts on the Use of an EHR-Integrated Clinical Decision Support Pathway and the Use of High Flow Nasal Cannula in Bronchiolitis

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Interruptive; Other: Non-interruptive

Detailed Description

Bronchiolitis is a viral respiratory illness affecting infants and toddlers and is the most common reason for hospitalization amongst children less than 2 years old. 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 EHR-alerts on clinical decision support (CDS) guideline use, and the effect of CDS guideline use on High Flow Nasal Cannula (HFNC) use and other clinical outcomes. EHR alerts are real-time alerts within the EHR which may be used for various purposes, but in this study are designed to remind providers that a detailed clinical decision support algorithm exists for the treatment of bronchiolitis. There are multiple BPA designs commonly used in EHRs: 1) interruptive alerts, which require clinicians to interact with the alert to continue the clinician's workflow; and 2) non-interruptive alerts, which appear as visual cues but do not require clinicians to alter workflows.

When patients meet criteria for the likely presence of bronchiolitis based on Electronic Medical Records (EMR) indicators of disease, the patient will be randomized into three groups in a 1:1:1 ratio. One group (control) will receive no EHR-alerts. In one group the providers will receive interruptive EHR-alerts reminding the provider that the CDS-guideline is available in the EHR and likely to be appropriate for the patient. In the last group, providers will be exposed to a non-interruptive alert (a highlighted textual banner presented to the provider when the providers are interacting with the patient's electronic medical record) reminding the provider that the CDS-guideline is available in the EHR and likely to be appropriate for the patient.

The randomized groups will be compared on an intention-to-treat basis to evaluate the impact of EHR-alert exposure on CDS-guideline usage as demonstrated by the number and nature of provider interactions with the CDS guideline tool. In addition, in a related non-randomized retrospective observational evaluation, we will compare the impact of CDS-guideline usage (the outcome of the randomized evaluation) on the provision of high-value care for bronchiolitis. Specifically, because the guideline emphasizes the use of high-value HFNC, and the avoidance of low-value HFNC treatments, this analysis with focus primarily on the use of HFNC in bronchiolitis. It will also evaluate whether CDS-guideline use impacts the rate of other low-value treatments for bronchiolitis, and outcomes such as ICU admission, length or stay and readmissions.

• Study Type: Interventional
• Enrollment (Estimated): 8000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin E Bodnar, MD; Phone Number: 410-614-4474; Email: bbodnar2@jh.edu

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • Recruiting
      • Johns Hopkins All Children's Hospital
      • Contact: Johns Hopkins IRB Office; Phone Number: 410-502-2092; Email: jhmeirb@jhmi.edu
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Contact: Johns Hopkins IRB Office; Phone Number: 410-502-2092; Email: jhmeirb@jhmi.edu
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Children's Center
      • Contact: Johns Hopkins IRB Office; Phone Number: 410-502-2092; Email: jhmeirb@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• 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)

Patient Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No EHR-Alert; 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.
Experimental: Interruptive EHR-Alert; 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; 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.
Experimental: Non-interruptive EHR-Alert; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of encounters providers utilize the EHR-integrated clinical decision support tool for the care of bronchiolitis	Multiple Use of the EHR-integrated clinical decision support guideline. The proportion of encounters in which providers utilize the EHR-integrated clinical decision support tool for the care of bronchiolitis multiple times (2 or more times) 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
Proportion of encounters a provider enters orders via the EHR-integrated clinical decision support tool	Order entry via the EHR-integrated clinical decision support guideline. The proportion of encounters a provider enters orders via 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who receive any subtherapeutic high flow nasal cannula (HFNC) treatment	Post-randomization - Individual Clinical Outcome 1 - Subtherapeutic HFNC. The proportion of patients who receive any subtherapeutic high flow nasal cannula (HFNC) treatment, defined as HFNC with a flow rate <1L/kg/min for patients <15kg or <15L/min for patients >15kg. Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.	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	Post Randomization - Individual Clinical Outcome 2 - Hours spent on subtherapeutic HFNC. The average number of hours during which a patient received subtherapeutic high flow nasal cannula (HFNC) treatment, defined as HFNC with a flow rate <1L/kg/min for patients <15kg or <15L/min for patients >15kg. Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.	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	Post Randomization - Systems Level Outcome 1 - Proportion Receiving any HFNC. The proportion of patients who receive any treatment with high flow nasal cannula. Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.	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 total time (in hours) during which patients received any treatment with high flow nasal cannula	Post Randomization - Systems Level Outcome 2 - Total time on HFNC. The total time (in hours) during which patients received any treatment with high flow nasal cannula. Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Benjamin E Bodnar, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): July 14, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: clinical decision support; clinical pathway; clinical guideline; best practice advisory; practice advisory; EHR alert
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: IRB00456658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No