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Bronchiolitis Acute ViralNCT05132322

Eliminating Monitor Overuse Trial (EMO Trial)

A study testing Educational Outreach, Audit & Feedback (unit level) and Audit & Feedback (real time, individual-level) in people with Bronchiolitis Acute Viral, run by Children's Hospital of Philadelphia at 51 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen. Read more about this study

Who is it for?
Ages 2 months and older
Conditions the study is for
Bronchiolitis Acute Viral
What is being tested?
Educational Outreach, Audit & Feedback (unit level) and Audit & Feedback (real time, individual-level)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,265 participants
Where
51 sitesin 2 countries
Study dates
1 Dec 2021to Aug 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 2 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Infants and children 2 months through 23 months old
  • Hospitalized on non-ICU wards participating in the trial
  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  • Primary diagnosis of bronchiolitis in most recent physician progress note
  • Not actively receiving supplemental oxygen ("in room air")
  • Last documented receipt of supplemental oxygen >1 hour prior to direct observational data collection
Show all 11Show fewer
  • Infants and children 2 months through 23 months old
  • Hospitalized on non-ICU wards participating in the trial
  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  • Primary diagnosis of bronchiolitis in most recent physician progress note
  • Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow

Who cannot join

  • Documented apnea or cyanosis during the current illness
  • Extreme prematurity (<28 weeks completed gestation)
  • Cardiac disease
  • Pulmonary hypertension
  • Chronic lung disease
  • Home oxygen requirement
Show all 20Show fewer
  • Neuromuscular disease
  • Immunodeficiency
  • Cancer
  • Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)
  • Population b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).
  • Extreme prematurity (<28 weeks completed gestation)
  • Cardiac disease
  • Pulmonary hypertension
  • Chronic lung disease
  • Home oxygen requirement
  • Neuromuscular disease
  • Immunodeficiency
  • Cancer
  • Severe Acute Respiratory Syndrome Coronavirus 2 [Covid-19 / SARS-CoV-2 (known or suspected)]

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States50 sites
  • Akron Children's Hospital

    Akron, Ohio, 44308

  • Albany Medical Center

    Albany, New York, 12208

  • CS Mott Children's Hospital

    Ann Arbor, Michigan, 48108

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Children's of Alabama

    Birmingham, Alabama, 35233

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • University of Vermont Children's Hospital

    Burlington, Vermont, 05401

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

  • University of California Davis

    Davis, California, 95616

  • Rady Children's Hospital/UCSD

    Encinitas, California, 92024

  • Inova Children's Hospital

    Falls Church, Virginia, 22042

  • Children's Memorial Hermann

    Houston, Texas, 77030

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Texas Children's Hospital West Campus

    Houston, Texas, 77094

  • Hoops Family Children's Hospital at Marshall University

    Huntington, West Virginia, 25701

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202

  • Children's Mercy Kansas City

    Kansas City, Missouri, 64108

  • CHOP King of Prussia Hospital

    King of Prussia, Pennsylvania, 19406

  • Children's Hospital at Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Valley Children's Hospital

    Madera, California, 93636

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226

  • Children's Minnesota

    Minneapolis, Minnesota, 55404

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232

  • Yale-New Haven Children's Hospital

    New Haven, Connecticut, 06510

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040

  • NYP-Morgan Stanley Children's Hospital

    New York, New York, 10032

  • Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine

    New York, New York, 10065

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

  • Children's Hospital at Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital Orange County

    Orange, California, 92868

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • CHOP Pediatric Care at Penn Medicine/Princeton Health

    Princeton, New Jersey, 08536

  • Children's Hospital of Richmond at VCU

    Richmond, Virginia, 23298

  • University of Rochester Golisano Children's Hospital

    Rochester, New York, 14642

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • CHOP Grand View Hospital

    Sellersville, Pennsylvania, 18960

  • Lucile Packard Children's Hospital Stanford

    Stanford, California, 94304

  • Upstate Golisano Children's Hospital

    Syracuse, New York, 13210

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467

  • Texas Children's Hospital The Woodlands

    The Woodlands, Texas, 77384

  • CHOP Care Network at Virtua

    Voorhees Township, New Jersey, 08043

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada1 site
  • Alberta Children's Hospital

    Calgary, AB T3B 6A8

Other trials in Canada

About this study

Official title: Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial

The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.

Being tested
Educational Outreach, Audit & Feedback (unit level), Audit & Feedback (real time, individual-level), Clinical Pathway Integrated into Electronic Health Record
Keywords
pulse oximetry, deimplementation, cluster-randomized trial, effectiveness-implementation hybrid trial, implementation science

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational OutreachBehavioural

    Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.

  • Audit & Feedback (unit level)Behavioural

    Weekly unit-level feedback of each hospital's guideline-concordant practice will be distributed to sites in the form of a visual dashboard that includes comparisons over time and between hospitals. The dashboard will then be shared locally on a weekly basis with clinicians in person and electronically.

  • Audit & Feedback (real time, individual-level)Behavioural

    Real-time feedback will occur at the individual clinician level. When collecting data on an individual patient, data collectors encountering guideline-discordant continuous monitoring are empowered to briefly ask any available clinician responsible for that patient's care, in a nonjudgmental way, about indications for monitoring that patient. The clinician is ultimately responsible for deciding if any changes are indicated.

  • Clinical Pathway Integrated into Electronic Health RecordBehavioural

    Clinical pathways guide clinicians step-by-step through evidence-based care. Based on the existing guidelines for physiologic monitoring in bronchiolitis, the pathway will clearly specify (a) situations when it is appropriate to initiate intermittent SpO2 measurement instead of continuous SpO2 monitoring, and (b) when it is appropriate to discontinue continuous SpO2 monitoring altogether, and transition to intermittent SpO2 measurement. In order to be visible to clinicians as they perform patient care, the pathway will be integrated into the electronic health record at sites randomized to this intervention.

Study groups in NCT05132322
Study groupRoleWhat they receive
Unlearning OnlyActive comparatorIncludes educational outreach and audit \& feedback.
Receives: Behavioral: Educational Outreach; Behavioral: Audit & Feedback (unit level); Behavioral: Audit & Feedback (real time, individual-level)
Unlearning + SubstitutionExperimentalIncludes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
Receives: Behavioral: Educational Outreach; Behavioral: Audit & Feedback (unit level); Behavioral: Audit & Feedback (real time, individual-level); Behavioral: Clinical Pathway Integrated into Electronic Health Record

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deimplementation Sustainment

    The primary outcome specified in the protocol is deimplementation sustainment, a "difference in differences" outcome based on statistical comparisons based on pulse oximetry overuse across trial phases and arms. Pulse oximetry overuse is operationally defined as percent of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation).

    The least metabolized form of the data for pulse oximetry overuse, raw proportions across trial phases and arms, is reported here. Results of the specific analysis used to report the trial's pre-specified primary outcome of deimplementation sustainment is reported in Statistical Analysis 1.

    Measured: Data from the baseline phase (approximately 7 months) was compared to data from the sustainment phase (approximately 4 months). Only data from baseline and sustainment phases are used in this calculation.

Secondary outcomes (5)
  1. Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Baseline Phase of the Trial

    This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the baseline phase.

    In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system.

    Measured: This measure used data from the baseline phase (approximately 7 months).

  2. Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Active Deimplementation Phase of the Trial

    This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the active deimplementation phase.

    In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system.

    Measured: Data from the active deimplementation phase (approximately 5 months).

  3. Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Sustainment Phase of the Trial

    This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the sustainment phase.

    In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system.

    Measured: Data from the sustainment phase (approximately 4 months).

  4. Duration of Oxygen Supplementation

    The oxygen supplementation duration is the total duration of time during which a patient is documented as receiving supplemental oxygen during hospitalization.

    Measured: Up to 4 years

  5. Length of Hospital Stay

    The length of hospital stay is the duration of time that elapses between the time a patient is admitted with bronchiolitis to an inpatient unit of the hospital until the time they are discharged from the hospital, using data manually abstracted from the electronic health record chart.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion31 Mar 2024
  4. Study completionAug 2026 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9,265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05132322
Sponsor's protocol ID
21-018560
Other IDs
U01HL159880
Status last verified
Feb 2026
First submitted
10 Nov 2021
Last updated
13 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final Research Data (the dataset necessary to document and support the primary research findings).

Publications

  • Xiao R, Bonafide CP, Williams NJ, Cidav Z, Landrigan CP, Faerber J, Makeneni S, Wolk CB, Schondelmeyer AC, Brady PW, Beidas RS, Schisterman EF. Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan. Contemp Clin Trials Commun. 2023 Oct 2;36:101219. doi: 10.1016/j.conctc.2023.101219. eCollection 2023 Dec.

    PubMed 37842322
  • Faerber JA, Xiao R, Makeneni S, Schisterman EF, Brady PW, Schondelmeyer AC, Landrigan CP, Lucey K, Lee V, Gregory PF, Prasto J, Parthasarathy P, Greenfield M, Solomon C, Brent CR, Albanowski K, Beidas RS, Bonafide CP; Pediatric Research in Inpatient Settings (PRIS) Network. Sustainment of continuous pulse oximetry deimplementation: Analysis of Eliminating Monitor Overuse study data from six hospitals. J Hosp Med. 2023 Aug;18(8):724-729. doi: 10.1002/jhm.13154. Epub 2023 Jun 28.

    PubMed 37380625
  • Bonafide CP, Xiao R, Schondelmeyer AC, Pettit AR, Brady PW, Landrigan CP, Wolk CB, Cidav Z, Ruppel H, Muthu N, Williams NJ, Schisterman E, Brent CR, Albanowski K, Beidas RS; Pediatric Research in Inpatient Settings (PRIS) Network. Sustainable deimplementation of continuous pulse oximetry monitoring in children hospitalized with bronchiolitis: study protocol for the Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial. Implement Sci. 2022 Oct 21;17(1):72. doi: 10.1186/s13012-022-01246-z.

    PubMed 36271399

Questions about this trial

What is this clinical trial studying?

A study testing Educational Outreach, Audit & Feedback (unit level) and Audit & Feedback (real time, individual-level) in people with Bronchiolitis Acute Viral, run by Children's Hospital of Philadelphia at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Deimplementation Sustainment (time frame: Data from the baseline phase (approximately 7 months) was compared to data from the sustainment phase (approximately 4 months). Only data from baseline and sustainment phases are used in this calculation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05132322, which also lists 3 linked publications.

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 13 Feb 2026.

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