Aligning Pulse Oximetry With Guidelines

NCT04178941 | Completed Results DMC

• 2 other identifiers: 19-0167185U01HL143475-02
• Study Type: interventional
• Target: 1,898
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Hospital-level Percentage of Patients Continuously Monitored 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."

  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."

  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.

  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.

  4 months

Study Arms (1)

Intervention (Single Arm)

EXPERIMENTAL

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; Behavioral: Educational outreach

Interventions

Audit and Feedback BEHAVIORAL

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 (Single Arm)

Educational outreach BEHAVIORAL

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

Intervention (Single Arm)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Primary subjects - Hospital staff
• \) 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)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 37380625 DERIVED

• 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.

  PMID: 34473258 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Chris Bonafide, MD, MSCE
• Organization: Children's Hospital of Philadelphia

bonafide@chop.edu

267-426-2901

Study Officials

• Chris Bonafide, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: December 2, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)