BronchiolitisNCT06932341
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.
A study testing Non-interruptive and Interruptive in people with Bronchiolitis, run by Johns Hopkins University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Non-interruptive and Interruptive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,965 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 May 2025to 12 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: 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
Read more
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.
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- Non-interruptive, Interruptive
- Keywords
- best practice advisory, clinical decision support, clinical guideline, clinical pathway, practice advisory, EHR alert
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interruptiveOther
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.
InterruptiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Non-interruptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start5 May 2025
- Primary completion12 Jun 2026
- Study completion12 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin E Bodnar, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932341
- Sponsor's protocol ID
- IRB00456658
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06932341
- Acronym / sponsor ID
- IRB00456658
- Conditions
- Bronchiolitis
- Keywords
- best practice advisory, clinical decision support, clinical guideline, clinical pathway, practice advisory, EHR alert
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,965 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: InterruptiveClinicians 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. |
| Non-interruptive EHR-Alert | Experimental | Other: Non-interruptiveClinicians 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interruptiveThe 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. | Other | Non-interruptive EHR-Alert |
| InterruptiveThe 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. | Other | Interruptive EHR-Alert |
Primary outcome
Proportion of encounters provider utilizes EHR-integrated clinical decision support tool
Time frame: 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
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.
2 secondary outcomes
Proportion of encounters providers utilize the EHR-integrated clinical decision support tool for the care of bronchiolitis
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin E Bodnar, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-interruptive and Interruptive in people with Bronchiolitis, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of encounters provider utilizes EHR-integrated clinical decision support tool (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.