Trial Outcomes & Findings for Eliminating Monitor Overuse Trial (EMO Trial) (NCT NCT05132322)

Last Updated: 2026-02-13

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

9265 participants

Primary outcome timeframe

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.

Results posted on

2026-02-13

Participant Flow

This is a cluster-randomized trial with randomization at the hospital level. The trial had 4 phases: Baseline, Active Deimplementation, Sustainment, and Exploratory. Each phase had a mutually exclusive, separate group of participants enrolled - participants did not continue their participation across phases. For example, all of the patients in the baseline phase are different from all of the patients in the sustainment phase.

The trial had 4 phases: Baseline, Active Deimplementation, Sustainment, and Exploratory. The primary outcome uses data from bronchiolitis patients from the first 3 phases only. The fourth phase, labeled Exploratory, included a subset of sites and was used exclusively for exploratory outcome measurement in bronchiolitis patients. The trial also included other populations, including parents/guardians, and staff/coaches. These other populations were exclusively used for exploratory outcomes.

Unit of analysis: Hospitals

Participant milestones

Participant milestones
Measure	Unlearning Only Includes educational outreach and audit \& feedback.	Unlearning + Substitution Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
Baseline Dec '21-Jun '22 STARTED	982 19	888 19
Baseline Dec '21-Jun '22 Bronchiolitis Patients (for Primary Outcome)	982 19	888 19
Baseline Dec '21-Jun '22 Bronchiolitis Patients (for Exploratory Outcomes)	0 0	0 0
Baseline Dec '21-Jun '22 Parents/Guardians (for Exploratory Outcomes)	0 0	0 0
Baseline Dec '21-Jun '22 Staff/Coaches (for Exploratory Outcomes)	0 0	0 0
Baseline Dec '21-Jun '22 COMPLETED	982 19	888 19
Baseline Dec '21-Jun '22 NOT COMPLETED	0 0	0 0
Active Deimplementation Jan-May '23 STARTED	2545 19	2525 19
Active Deimplementation Jan-May '23 Bronchiolitis Patients (for Primary Outcome)	861 18	720 18
Active Deimplementation Jan-May '23 Bronchiolitis Patients (for Exploratory Outcomes)	0 0	0 0
Active Deimplementation Jan-May '23 Parents/Guardians (for Exploratory Outcomes)	0 0	0 0
Active Deimplementation Jan-May '23 Staff/Coaches (for Exploratory Outcomes)	1684 19	1805 18
Active Deimplementation Jan-May '23 COMPLETED	2545 19	2525 19
Active Deimplementation Jan-May '23 NOT COMPLETED	0 0	0 0
Sustainment Dec '23-Mar '24 STARTED	964 19	707 19
Sustainment Dec '23-Mar '24 Bronchiolitis Patients (for Primary Outcome)	955 19	701 19
Sustainment Dec '23-Mar '24 Bronchiolitis Patients (for Exploratory Outcomes)	0 0	0 0
Sustainment Dec '23-Mar '24 Parents/Guardians (for Exploratory Outcomes)	9 6	6 5
Sustainment Dec '23-Mar '24 Staff/Coaches (for Exploratory Outcomes)	0 0	0 0
Sustainment Dec '23-Mar '24 COMPLETED	964 19	707 19
Sustainment Dec '23-Mar '24 NOT COMPLETED	0 0	0 0
Exploratory Dec '24-Mar '25 STARTED	309 7	345 9
Exploratory Dec '24-Mar '25 Bronchiolitis Patients (for Primary Outcome)	0 0	0 0
Exploratory Dec '24-Mar '25 Bronchiolitis Patients ((for Exploratory Outcomes)	309 7	345 9
Exploratory Dec '24-Mar '25 Parents/Guardians (for Exploratory Outcomes)	0 0	0 0
Exploratory Dec '24-Mar '25 Staff/Coaches (for Exploratory Outcomes)	0 0	0 0
Exploratory Dec '24-Mar '25 COMPLETED	309 7	345 9
Exploratory Dec '24-Mar '25 NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The row groupings represent the different populations included in the trial, and match the different populations included in the participant flow for clarity and transparency in reporting.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Population: Each hospital has multiple participants. Each participant may have 1 or more observations of pulse oximetry use.

Outcome measures

Outcome measures
Measure	Unlearning Only - Baseline Phase n=1225 pulse oximetry use observations Includes educational outreach and audit \& feedback during the trial's first period or phase, titled "Baseline."	Unlearning + Substitution - Baseline Phase n=1117 pulse oximetry use observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's first period or phase, titled "Baseline."	Unlearning Only - Active Deimplementation Phase n=1091 pulse oximetry use observations Includes educational outreach and audit \& feedback during the trial's second period or phase, titled "Active Deimplementation."	Unlearning + Substitution - Active Deimplementation Phase n=960 pulse oximetry use observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's second period or phase, titled "Active Deimplementation."	Unlearning Only - Sustainment Phase n=1189 pulse oximetry use observations Includes educational outreach and audit \& feedback during the trial's third period or phase, titled "Sustainment."	Unlearning + Substitution - Sustainment Phase n=927 pulse oximetry use observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's third period or phase, titled "Sustainment."
Deimplementation Sustainment	610 pulse oximetry use observations	564 pulse oximetry use observations	277 pulse oximetry use observations	243 pulse oximetry use observations	376 pulse oximetry use observations	317 pulse oximetry use observations

SECONDARY outcome

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

Population: This outcome is restricted to the baseline phase of the trial. Hence the total participants and observations is lower than the primary outcome total participants and observations. In addition, each hospital has multiple participants. Each participant may have 1 or more observations of pulse oximetry use. Hence the different units.

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.

Outcome measures

Outcome measures
Measure	Unlearning Only - Baseline Phase n=1225 observations Includes educational outreach and audit \& feedback during the trial's first period or phase, titled "Baseline."	Unlearning + Substitution - Baseline Phase n=1117 observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's first period or phase, titled "Baseline."	Unlearning Only - Active Deimplementation Phase Includes educational outreach and audit \& feedback during the trial's second period or phase, titled "Active Deimplementation."	Unlearning + Substitution - Active Deimplementation Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's second period or phase, titled "Active Deimplementation."	Unlearning Only - Sustainment Phase Includes educational outreach and audit \& feedback during the trial's third period or phase, titled "Sustainment."	Unlearning + Substitution - Sustainment Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's third period or phase, titled "Sustainment."
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	610 observations	564 observations	—	—	—	—

SECONDARY outcome

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

Population: This outcome is restricted to the active deimplementation phase of the trial. Hence the total participants and observations is lower than the primary outcome total participants and observations. In addition, each hospital has multiple participants. Each participant may have 1 or more observations of pulse oximetry use. Hence the different units.

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.

Outcome measures

Outcome measures
Measure	Unlearning Only - Baseline Phase n=1091 observations Includes educational outreach and audit \& feedback during the trial's first period or phase, titled "Baseline."	Unlearning + Substitution - Baseline Phase n=960 observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's first period or phase, titled "Baseline."	Unlearning Only - Active Deimplementation Phase Includes educational outreach and audit \& feedback during the trial's second period or phase, titled "Active Deimplementation."	Unlearning + Substitution - Active Deimplementation Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's second period or phase, titled "Active Deimplementation."	Unlearning Only - Sustainment Phase Includes educational outreach and audit \& feedback during the trial's third period or phase, titled "Sustainment."	Unlearning + Substitution - Sustainment Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's third period or phase, titled "Sustainment."
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	277 observations	243 observations	—	—	—	—

SECONDARY outcome

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

Population: This outcome is restricted to the sustainment phase of the trial. Hence the total participants and observations is lower than the primary outcome total participants and observations. In addition, each hospital has multiple participants. Each participant may have 1 or more observations of pulse oximetry use. Hence the different units.

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.

Outcome measures

Outcome measures
Measure	Unlearning Only - Baseline Phase n=1189 observations Includes educational outreach and audit \& feedback during the trial's first period or phase, titled "Baseline."	Unlearning + Substitution - Baseline Phase n=927 observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's first period or phase, titled "Baseline."	Unlearning Only - Active Deimplementation Phase Includes educational outreach and audit \& feedback during the trial's second period or phase, titled "Active Deimplementation."	Unlearning + Substitution - Active Deimplementation Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's second period or phase, titled "Active Deimplementation."	Unlearning Only - Sustainment Phase Includes educational outreach and audit \& feedback during the trial's third period or phase, titled "Sustainment."	Unlearning + Substitution - Sustainment Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's third period or phase, titled "Sustainment."
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	376 observations	317 observations	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Population: Counts of participants and observations differ from the primary outcome because patients included for this outcome underwent a different data collection process.

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.

Outcome measures

Outcome measures
Measure	Unlearning Only - Baseline Phase n=1697 observations Includes educational outreach and audit \& feedback during the trial's first period or phase, titled "Baseline."	Unlearning + Substitution - Baseline Phase n=1305 observations Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's first period or phase, titled "Baseline."	Unlearning Only - Active Deimplementation Phase Includes educational outreach and audit \& feedback during the trial's second period or phase, titled "Active Deimplementation."	Unlearning + Substitution - Active Deimplementation Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's second period or phase, titled "Active Deimplementation."	Unlearning Only - Sustainment Phase Includes educational outreach and audit \& feedback during the trial's third period or phase, titled "Sustainment."	Unlearning + Substitution - Sustainment Phase Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry during the trial's third period or phase, titled "Sustainment."
Underuse of Pulse Oximetry Monitoring in High Risk Patients	1.36 percentage of observations Interval 0.86 to 2.03	1.46 percentage of observations Interval 0.88 to 2.26	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.