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Aligning Pulse Oximetry With Guidelines (EMO Pilot)

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ClinicalTrials.gov Identifier: NCT04178941
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Behavioral: Audit and Feedback Behavioral: Educational outreach Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: 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.
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.

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.




Primary Outcome Measures :
  1. 4-item Feasibility of Intervention Measure (FIM) [ Time Frame: 6 months ]
    The participant rates the feasibility of the intervention based on 4 statements, with 5 options for each statement ranging from (1) Completely Disagree to (5) Completely Agree.

  2. 4-item Acceptability of Intervention Measure (AIM) [ Time Frame: 6 months ]
    The participant rates the acceptability of the intervention based on 4 statements, with 5 options for each statement ranging from (1) Completely Disagree to (5) Completely Agree.

  3. 4-item Intervention Appropriateness Measure (IAM) [ Time Frame: 6 months ]
    The participant rates the appropriateness of the intervention based on 4 statements, with 5 options for each statement ranging from (1) Completely Disagree to (5) Completely Agree.


Secondary Outcome Measures :
  1. Continuous pulse oximetry use rates [ Time Frame: 6 months ]
    Continuous pulse oximetry use rates in children with bronchiolitis who are not requiring supplemental oxygen administration.

  2. Sensitivity of the presence of electronic health record data from the medical monitoring device for actual monitoring at the bedside in bronchiolitis. Sensitivity is also referred to as the "true positive rate." [ Time Frame: 6 months ]
    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).

  3. 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." [ Time Frame: 6 months ]
    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).

  4. Positive predictive value of the presence of electronic health record data from the medical monitoring device for actual monitoring at the bedside in bronchiolitis. [ Time Frame: 6 months ]
    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).

  5. 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. [ Time Frame: 6 months ]
    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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178941


Contacts
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Contact: Canita Brent, MPH 267-426-2901 brentc@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christopher P Bonafide, MD, MSCE Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04178941    
Other Study ID Numbers: 19-016718
5U01HL143475-02 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections