Aligning Pulse Oximetry With Guidelines

Bronchiolitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178941
• Other study ID #: 19-016718
• Secondary ID: 5U01HL143475-02
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1898
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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