Aligning Pulse Oximetry With Guidelines (EMO Pilot)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Bronchiolitis

Treatments: Behavioral: Educational outreach; Behavioral: Audit and Feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04178941

5U01HL143475-02 (U.S. NIH Grant/Contract)

19-016718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,898 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,898 participants in 1 patient group

Intervention (Single Arm)

Experimental group

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.

Treatment:

Behavioral: Audit and Feedback

Behavioral: Educational outreach