Clinical trial NCT04178941: Aligning Pulse Oximetry With Guidelines
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-11-26
Enrollment: 1898
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
timeFrame: 1 month after intervention
measure: Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
timeFrame: 1 month after intervention
measure: Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
timeFrame: 1 month after intervention
Secondary outcomes:
measure: Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen
timeFrame: 4 months
measure: 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."
timeFrame: 4 months
measure: 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."
timeFrame: 4 months
measure: 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.
timeFrame: 4 months
measure: 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.
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Chris Bonafide, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.