Aligning Pulse Oximetry With Guidelines (EMO Pilot)

Feasibility Pilot of Audit and Feedback With Educational Outreach to Align Continuous Pulse Oximetry Use in Stable Bronchiolitis With Evidence and Guideline Recommendations

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Behavioral: Audit and Feedback; Behavioral: Educational outreach

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.

• Study Type: Interventional
• Enrollment (Actual): 1898
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary subjects - Hospital staff

  1. Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists
  2. Providing care to patients on units included in the study.

• Secondary subjects - Patients

  1. Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (ICU) wards
  2. Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  3. Primary diagnosis of acute bronchiolitis according to hospital chart
  4. 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

  1. Premature birth: <28 weeks completed gestation
  2. Cyanotic congenital heart disease
  3. Pulmonary hypertension
  4. Home oxygen or positive pressure ventilation requirement
  5. Tracheostomy
  6. Neuromuscular disease
  7. Immunodeficiency
  8. Cancer
  9. Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia
  10. Historical, current, or suspected diagnosis of Coronavirus disease 2019 (COVID-19)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention (Single Arm); 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.

Behavioral: Audit and Feedback; 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.; Behavioral: Educational outreach; Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after intervention
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.	1 month after intervention
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.	1 month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months
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.	4 months
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.	4 months
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.	4 months
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.	4 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Chris Bonafide, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 19-016718; 5U01HL143475-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No