Aligning Pulse Oximetry With Guidelines

Not Applicable

Completed

Conditions: Bronchiolitis

Interventions: Behavioral: Audit and Feedback
Behavioral: Educational outreach

Registration Number: NCT04178941

Lead Sponsor: Children's Hospital of Philadelphia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1898

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention (Single Arm)	Audit and Feedback	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 (Single Arm)	Educational outreach	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.

Primary Outcome Measures

Name	Time	Method
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)	1 month after intervention	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)	1 month after intervention	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)	1 month after intervention	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

Name	Time	Method
Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen	4 months	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."	4 months	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."	4 months	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.	4 months	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.	4 months	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.