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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL159880 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Pennsylvania | OTHER |
| Boston Children's Hospital | OTHER |
| Children's Hospital Medical Center, Cincinnati |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unlearning Only | Active Comparator | Includes educational outreach and audit & feedback. |
|
| Unlearning + Substitution | Experimental | Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Underuse of Pulse Oximetry Monitoring in High Risk Patients | 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. |
Population a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)
Inclusion Criteria:
Exclusion Criteria:
Population b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher P Bonafide, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Rinad S Beidas, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37842322 | Derived | 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. | |
| 37380625 | Derived | 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. |
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Final Research Data (the dataset necessary to document and support the primary research findings).
Starting within 6 months after publishing the primary outcome manuscript
We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) IRB approval; (3) a commitment to securing the data using appropriate computer technology; and (4) a commitment to and an agreed-upon plan for destroying the data after analyses are completed. Once a data sharing agreement is in place, in accordance with the policies determined by the study team, CHOP, PRIS, and NIH/NHLBI, we will provide releasable data to investigators under our own auspices via a secure file transfer mechanism approved by the Research Information Systems Department at CHOP and the receiving institution.
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Unlearning Only | Includes educational outreach and audit & feedback. |
| FG001 | Unlearning + Substitution | Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Dec '21-Jun '22 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2024 |
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| OTHER |
| Pediatric Research in Inpatient Settings (PRIS) Network | UNKNOWN |
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| 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. |
|
| 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 | 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. | 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. | 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. | 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. | Up to 4 years |
| 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). |
| Exploratory Long-term Sustainability | 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. | 4 years |
| Davis |
| California |
| 95616 |
| United States |
| Rady Children's Hospital/UCSD | Encinitas | California | 92024 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| Children's Hospital Orange County | Orange | California | 92868 | United States |
| Lucile Packard Children's Hospital Stanford | Stanford | California | 94304 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Yale-New Haven Children's Hospital | New Haven | Connecticut | 06510 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| CS Mott Children's Hospital | Ann Arbor | Michigan | 48108 | United States |
| Children's Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
| Children's Hospital at Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | United States |
| CHOP Pediatric Care at Penn Medicine/Princeton Health | Princeton | New Jersey | 08536 | United States |
| CHOP Care Network at Virtua | Voorhees Township | New Jersey | 08043 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Cohen Children's Medical Center | New Hyde Park | New York | 11040 | United States |
| NYP-Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine | New York | New York | 10065 | United States |
| University of Rochester Golisano Children's Hospital | Rochester | New York | 14642 | United States |
| Upstate Golisano Children's Hospital | Syracuse | New York | 13210 | United States |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| CHOP King of Prussia Hospital | King of Prussia | Pennsylvania | 19406 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| CHOP Grand View Hospital | Sellersville | Pennsylvania | 18960 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Children's Memorial Hermann | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Texas Children's Hospital West Campus | Houston | Texas | 77094 | United States |
| Texas Children's Hospital The Woodlands | The Woodlands | Texas | 77384 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| University of Vermont Children's Hospital | Burlington | Vermont | 05401 | United States |
| Inova Children's Hospital | Falls Church | Virginia | 22042 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23298 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Hoops Family Children's Hospital at Marshall University | Huntington | West Virginia | 25701 | United States |
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Alberta Children's Hospital | Calgary | AB T3B 6A8 | Canada |
| 36271399 | Derived | 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. |
| Bronchiolitis Patients (for Primary Outcome) |
|
| Bronchiolitis Patients (for Exploratory Outcomes) |
|
| Parents/Guardians (for Exploratory Outcomes) |
|
| Staff/Coaches (for Exploratory Outcomes) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Active Deimplementation Jan-May '23 |
|
| Sustainment Dec '23-Mar '24 |
|
| Exploratory Dec '24-Mar '25 |
|
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 bronchiolitis patients in the baseline phase are different from all of the patients in the sustainment phase. For this reason, this table includes participants from all 4 sub-populations and all 4 phases.
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| ID | Title | Description |
|---|---|---|
| BG000 | Unlearning Only | Includes educational outreach and audit & feedback. |
| BG001 | Unlearning + Substitution | Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The customized age labels reflect the different age ranges most relevant to the different populations of people included in this trial. | 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. | Count of Participants | Participants |
| ||||||||||||||
| Sex/Gender, Customized | 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. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Combined ethnicity-race variable | 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. | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Each hospital has multiple participants. Each participant may have 1 or more observations of pulse oximetry use. | Posted | Count of Units | pulse oximetry use observations | 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. | pulse oximetry use observations | pulse oximetry use observations |
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| Secondary | 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. | 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. | Posted | Count of Units | observations | This measure used data from the baseline phase (approximately 7 months). | observations | observations |
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| Secondary | 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. | 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. | Posted | Count of Units | observations | Data from the active deimplementation phase (approximately 5 months). | observations | observations |
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| Secondary | 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. | 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. | Posted | Count of Units | observations | Data from the sustainment phase (approximately 4 months). | observations | observations |
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| Secondary | 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. | Not Posted | Dec 2026 | Up to 4 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Dec 2026 | Up to 4 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Underuse of Pulse Oximetry Monitoring in High Risk Patients | 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. | Counts of participants and observations differ from the primary outcome because patients included for this outcome underwent a different data collection process. | Posted | Number | 95% Confidence Interval | percentage of observations | 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). | observations | observations |
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| Other Pre-specified | Exploratory Long-term Sustainability | 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. | Not Posted | Dec 2026 | 4 years | Participants |
Adverse event (AE) data were collected in the active deimplementation phase (approximately 5 months), the sustainment phase (approximately 4 months), and the exploratory phase (approximately 4 months). Within each phase, each participant was assessed during their entire period of hospitalization (with the duration varying by patient depending on their severity of illness) and for the 7 days following hospital discharge.
Per DSMB Charter, we report AEs in the following subpopulations only: Bronchiolitis Patients (for Primary Outcome in the active deimplementation and sustainment phases) and Bronchiolitis Patients (for Exploratory Outcomes in the exploratory phase). The other subpopulations: Bronchiolitis Patients (for Primary Outcome in the baseline phase), Parents/Guardians (for Exploratory Outcomes), and Staff/Coaches (for Exploratory Outcomes) were not considered at risk for and were not evaluated for AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unlearning Only: Bronchiolitis Patients (for Primary Outcome) in Active Deimplementation Phase | Bronchiolitis patients evaluated for the primary outcome in the trial arm that includes educational outreach and audit & feedback. These patients were assessed for adverse events in the active deimplementation phase. | 0 | 861 | 0 | 861 | 6 | 861 |
| EG001 | Unlearning + Substitution: Bronchiolitis Patients (for Primary Outcome) in Active Deimplement. Phase | Bronchiolitis patients evaluated for the primary outcome in the trial arm that includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. These patients were assessed for adverse events in the active deimplementation phase. | 0 | 720 | 0 | 720 | 6 | 720 |
| EG002 | Unlearning Only: Bronchiolitis Patients (for Primary Outcome) in Sustainment Phase | Bronchiolitis patients evaluated for the primary outcome in the trial arm that includes educational outreach and audit & feedback. These patients were assessed for adverse events in the sustainment phase. | 0 | 955 | 0 | 955 | 2 | 955 |
| EG003 | Unlearning + Substitution: Bronchiolitis Patients (for Primary Outcome) in Sustainment Phase | Bronchiolitis patients evaluated for the primary outcome in the trial arm that includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. These patients were assessed for adverse events in the sustainment phase. | 0 | 701 | 0 | 701 | 10 | 701 |
| EG004 | Unlearning Only: Bronchiolitis Patients (for Exploratory Outcomes) | Bronchiolitis patients evaluated for the primary outcome in the trial arm that includes educational outreach and audit & feedback. These patients were assessed for adverse events in the exploratory phase. | 0 | 309 | 0 | 309 | 3 | 309 |
| EG005 | Unlearning + Substitution: Bronchiolitis Patients (for Exploratory Outcomes) | Bronchiolitis patients evaluated for the primary outcome in the trial arm that includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. These patients were assessed for adverse events in the exploratory phase. | 0 | 345 | 0 | 345 | 0 | 345 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission of bronchiolitis patients with hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Readmission of bronchiolitis patients within 7 days of discharge from units with hypoxemia to <85% at the time of re-presentation to the emergency department. |
| |
| Code blue and rapid response activations for unmonitored bronchiolitis patients with hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Code blue and rapid response team activations occurring in bronchiolitis patients hospitalized on participating units while patient was unmonitored and subsequently found to be hypoxemic to <85% at the time of the event when SpO2 monitors applied |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Bonafide | Children's Hospital of Philadelphia | 215-590-1000 | bonafide@chop.edu |
| Jul 3, 2025 |
| Prot_SAP_000.pdf |
| 3-17 years old |
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| 18-65 years old |
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| >65 years old |
|
| Missing/declined to answer |
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| Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) |
|
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| Parents/Guardians (for exploratory outcomes) |
|
|
| Staff/Coaches (for exploratory outcomes) |
|
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| Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) |
|
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| Bronchiolitis patients (Sustainment Phase, for primary outcome) |
|
|
|
| Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) |
|
|
| Parents/guardians (for exploratory outcomes) |
|
|
| Staff/coaches (for exploratory outcomes) |
|
|
| Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) |
|
|
| Bronchiolitis patients (Sustainment Phase, for primary outcome) |
|
|
|
| Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) |
|
|
| Parents/guardians (for exploratory outcomes) |
|
|
| Staff/coaches (for exploratory outcomes) |
|
|
| Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) |
|
|
| Bronchiolitis patients (Sustainment Phase, for primary outcome) |
|
|
| pulse oximetry use observations |
|
The adjusted difference in differences across the unlearning + substitution versus unlearning arms between the baseline and sustainment phases was 3.1 (95% CI, -2.7 to +8.8, P=.29) percentage points. |
| Superiority |
We included dichotomous continuous pulse oximetry use as the outcome, and study arm, phase, and arm-by-phase interaction as fixed effects. We incorporated random intercepts to account for repeated pulse oximetry observations clustered within patients, and patients clustered within hospitals. We adjusted for: age, preterm birth, time since weaning from oxygen, presence of an enteral feeding tube, neurologic impairment, and an indicator of observation during overnight hours (11PM-7AM). |
| Unlearning + Substitution |
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
|
|
| OG001 |
| Unlearning + Substitution |
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
|
|
| Unlearning + Substitution |
Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
|
|
| Units |
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| Counts |
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| Participants |
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| observations |
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