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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
9,265
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.
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.
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.
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.
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.
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.
Time frame: This measure used data from the baseline phase (approximately 7 months).
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
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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.
Children's of Alabama
Birmingham, Alabama, United States
University of California Davis
Davis, California, United States
Rady Children's Hospital/UCSD
Encinitas, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hospital Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
...and 41 more locations
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.
Time frame: Data from the active deimplementation phase (approximately 5 months).
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.
Time frame: Data from the sustainment phase (approximately 4 months).
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.
Time frame: Up to 4 years
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.
Time frame: Up to 4 years