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OpenTrials
Active, Not Recruiting

NCT Number: NCT05132322

Eliminating Monitor Overuse Trial (EMO 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bronchiolitis Acute Viral

Age range

2 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Population a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)

Inclusion criteria

  • 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

Exclusion criteria

  • Documented apnea or cyanosis during the current illness
  • 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)-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).

Inclusion criteria

  • 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

Exclusion criteria

  • 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)]

Treatment and study plan

Educational outreach

Behavioral

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)

Behavioral

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)

Behavioral

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 Record

Behavioral

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  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

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

    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.

  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

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

    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.

  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

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

    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.

  4. Duration of Oxygen Supplementation

    Time frame: Up to 4 years

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

  5. Length of Hospital Stay

    Time frame: Up to 4 years

    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.

Other outcomes

  1. Underuse of Pulse Oximetry Monitoring in High Risk Patients

    Time frame: This measure combines data from three sequential study phases: the baseline phase (approximately 7 months), the active deimplementation phase (approximately 5 months), and the sustainment phase (approximately 4 months).

    Underuse is defined as failing to continuously SpO2 -monitor bronchiolitis patients receiving ≥2L/min supplemental oxygen (a marker of more severe disease). It is calculated as the percentage of bronchiolitis patient observations in patients who are receiving ≥2L/min supplemental oxygen, and are not being continuously SpO2-monitored. It is measured using direct observation.

  2. Exploratory Long-term Sustainability

    Time frame: 4 years

    Exploratory long-term sustainability is calculated based on penetration. Penetration is the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units.

    In this exploratory outcome investigators are using an alternative definition of sustainability in which, in order to meet criteria for having successfully sustained a practice change, hospitals must first (a) experience a significant increase in penetration between baseline and active deimplementation, and then (b) maintain the increased penetration at ≥90% of the active deimplementation phase level through the end of the sustainability period.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Boston Children's Hospital
  • Children's Hospital Medical Center, Cincinnati
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pediatric Research in Inpatient Settings (PRIS) Network
  • University of Pennsylvania

Registry information

Official study title

Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Nov 24, 2021
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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