Back to resultsAligning Pulse Oximetry With Guidelines (EMO Pilot)
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit and Feedback
Educational outreach
Sponsored by
About this trial
This is an interventional other trial for Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
Primary subjects - Hospital staff
- Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists
- Providing care to patients on units included in the study.
Secondary subjects - Patients
- Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (ICU) wards
- Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
- Primary diagnosis of acute bronchiolitis according to hospital chart
- Not currently requiring supplemental oxygen therapy or nasal cannula flow at an fraction of inspired oxygen in the air (FiO2) of 21% (room air flow)
Exclusion Criteria:
Primary subjects - Hospital staff
1) None. Staff may self-exclude by choosing not to interact with the electronic communications and may choose to not attend meetings where the intervention is discussed.
Secondary subjects - Patients
- Premature birth: <28 weeks completed gestation
- Cyanotic congenital heart disease
- Pulmonary hypertension
- Home oxygen or positive pressure ventilation requirement
- Tracheostomy
- Neuromuscular disease
- Immunodeficiency
- Cancer
- Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia
- Historical, current, or suspected diagnosis of COVID-19
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention (Single Arm)
Arm Description
The intervention is a combined educational outreach and audit and feedback strategy that includes providing the hospital's own continuous pulse oximetry use data back to them on a weekly basis. The data will be accompanied by staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis.
Outcomes
Primary Outcome Measures
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
The participant rates the feasibility of the intervention based on this statement: "Data feedback about our use of continuous pulse oximetry in patients with bronchiolitis is easy to implement." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
The participant rates the acceptability of the intervention based on this statement: "I like the data feedback." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
The participant rates the appropriateness of the intervention based on this statement: "Data feedback about our use of continuous pulse oximetry in bronchiolitis seems like a good match for our non-ICU floors that care for bronchiolitis." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.
Secondary Outcome Measures
Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen
Continuous pulse oximetry use rates in children with bronchiolitis who are not requiring supplemental oxygen administration. This is calculated as the number of patients continuously monitored when not receiving supplemental oxygen divided by the total number of patients observed when not receiving supplemental oxygen.
Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the "True Positive Rate."
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with EHR data from the medical monitoring device.
The denominator is the number of patients who were truly monitored.
Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the "True Negative Rate."
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with absence of EHR data from the medical monitoring device. The denominator is the number of patients who were truly not monitored.
Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis.
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were continuously monitored at the bedside.
The denominator is the number of patients who had EHR data suggesting that they were continuously monitored.
Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis.
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were not observed to be continuously monitored at the bedside. The denominator is the number of patients who had EHR data suggesting that they were NOT continuously monitored.
Full Information
NCT ID
NCT04178941
First Posted
November 25, 2019
Last Updated
August 16, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04178941
Brief Title
Aligning Pulse Oximetry With Guidelines
Acronym
EMO Pilot
Official Title
Feasibility Pilot of Audit and Feedback With Educational Outreach to Align Continuous Pulse Oximetry Use in Stable Bronchiolitis With Evidence and Guideline Recommendations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to measure the feasibility, acceptability, and appropriateness of audit and feedback with educational outreach as a strategy to align continuous pulse oximetry use in stable bronchiolitis patients with evidence and guideline recommendations.
Detailed Description
Continuous pulse oximetry (SpO2) monitoring has revolutionized detection of oxygen desaturation in operating rooms and other high-risk areas, improving outcomes in those settings. However, research suggests that overuse of continuous SpO2 monitoring in stable children with bronchiolitis who are unlikely to benefit from it is low-value care that places some children at risk of adverse outcomes. Despite national guidelines discouraging continuous pulse oximetry use in stable bronchiolitis patients, 46% of those infants and children are continuously monitored. This pragmatic, prospective, non-randomized, single-arm feasibility pilot will be performed on non-Intensive Care Unit (ICU) hospital units that care for bronchiolitis patients. The primary subjects are hospital staff who order or manage continuous pulse oximetry monitoring for bronchiolitis patients; secondary subjects are patients age 2 through 23 months with a primary diagnosis of bronchiolitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1898 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (Single Arm)
Arm Type
Experimental
Arm Description
The intervention is a combined educational outreach and audit and feedback strategy that includes providing the hospital's own continuous pulse oximetry use data back to them on a weekly basis. The data will be accompanied by staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis.
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback
Intervention Description
The audit and feedback intervention includes providing each hospital's own continuous pulse oximetry use data back to them on a weekly basis for review and action.
Intervention Type
Behavioral
Intervention Name(s)
Educational outreach
Intervention Description
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis.
Primary Outcome Measure Information:
Title
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
Description
The participant rates the feasibility of the intervention based on this statement: "Data feedback about our use of continuous pulse oximetry in patients with bronchiolitis is easy to implement." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.
Time Frame
1 month after intervention
Title
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
Description
The participant rates the acceptability of the intervention based on this statement: "I like the data feedback." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.
Time Frame
1 month after intervention
Title
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
Description
The participant rates the appropriateness of the intervention based on this statement: "Data feedback about our use of continuous pulse oximetry in bronchiolitis seems like a good match for our non-ICU floors that care for bronchiolitis." Data was only collected from the "STAFF SURVEYED - Intervention (Single Arm)" Arm/Group for this Outcome Measure.
Time Frame
1 month after intervention
Secondary Outcome Measure Information:
Title
Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen
Description
Continuous pulse oximetry use rates in children with bronchiolitis who are not requiring supplemental oxygen administration. This is calculated as the number of patients continuously monitored when not receiving supplemental oxygen divided by the total number of patients observed when not receiving supplemental oxygen.
Time Frame
4 months
Title
Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the "True Positive Rate."
Description
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with EHR data from the medical monitoring device.
The denominator is the number of patients who were truly monitored.
Time Frame
4 months
Title
Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the "True Negative Rate."
Description
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with absence of EHR data from the medical monitoring device. The denominator is the number of patients who were truly not monitored.
Time Frame
4 months
Title
Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis.
Description
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were continuously monitored at the bedside.
The denominator is the number of patients who had EHR data suggesting that they were continuously monitored.
Time Frame
4 months
Title
Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis.
Description
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were not observed to be continuously monitored at the bedside. The denominator is the number of patients who had EHR data suggesting that they were NOT continuously monitored.
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary subjects - Hospital staff
Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists
Providing care to patients on units included in the study.
Secondary subjects - Patients
Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (ICU) wards
Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
Primary diagnosis of acute bronchiolitis according to hospital chart
Not currently requiring supplemental oxygen therapy or nasal cannula flow at an fraction of inspired oxygen in the air (FiO2) of 21% (room air flow)
Exclusion Criteria:
Primary subjects - Hospital staff
1) None. Staff may self-exclude by choosing not to interact with the electronic communications and may choose to not attend meetings where the intervention is discussed.
Secondary subjects - Patients
Premature birth: <28 weeks completed gestation
Cyanotic congenital heart disease
Pulmonary hypertension
Home oxygen or positive pressure ventilation requirement
Tracheostomy
Neuromuscular disease
Immunodeficiency
Cancer
Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia
Historical, current, or suspected diagnosis of Coronavirus disease 2019 (COVID-19)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Bonafide, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34473258
Citation
Schondelmeyer AC, Bettencourt AP, Xiao R, Beidas RS, Wolk CB, Landrigan CP, Brady PW, Brent CR, Parthasarathy P, Kern-Goldberger AS, Sergay N, Lee V, Russell CJ, Prasto J, Zaman S, McQuistion K, Lucey K, Solomon C, Garcia M, Bonafide CP; Pediatric Research in Inpatient Settings (PRIS) Network. Evaluation of an Educational Outreach and Audit and Feedback Program to Reduce Continuous Pulse Oximetry Use in Hospitalized Infants With Stable Bronchiolitis: A Nonrandomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122826. doi: 10.1001/jamanetworkopen.2021.22826.
Results Reference
derived
Learn more about this trial
Aligning Pulse Oximetry With Guidelines
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