Aligning Pulse Oximetry With Guidelines

NCT ID: NCT04178941

Last Updated: 2023-09-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1898 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention (Single Arm)

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.

Group Type EXPERIMENTAL

Audit and Feedback

Intervention Type 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.

Educational outreach

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Bonafide, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37380625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34473258 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5U01HL143475-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-016718

Identifier Type: -

Identifier Source: org_study_id

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