Pediatric Bronchiolitis Quality Improvement

May 12, 2022 updated by: University of California, Davis

Pediatric Bronchiolitis Quality Improvement to Reduce Unnecessary Use of Diagnostic Testing and Treatment

Bronchiolitis is a respiratory illness characterized by acute inflammation of the airways, typically caused by a virus. By definition, it impacts children between 2 months and 2 years of age and is the most common cause of hospitalization among infants in the first year of life (American Academy of Pediatrics). Children with this illness may exhibit respiratory distress, as well as symptoms of viral respiratory illness, such as sneezing, nasal congestion, and cough. Often, hospitalization is required for respiratory distress and to support hydration needs.

Evidence based guidelines for the treatment of acute viral bronchiolitis primarily involve supportive care, which most often includes supplemental oxygen, hydration, and suctioning of secretions. However, in practice, bronchiolitis care is highly variable, often involving therapies such as inhaled bronchodilators, systemic corticosteroids, inhaled hypertonic saline, continuous pulse oximetry, chest physiotherapy, antibacterial medications, and use of intravenous fluids, all of which have been shown to be unnecessary and costly. Unnecessary care remains although multiple published quality improvement studies centered on acute bronchiolitis have proven successful. Quality improvement interventions have shown reduced use of unnecessary treatments and reduced resource allocation. Therefore, the investigators will conduct a quality improvement process to improve adherence to bronchiolitis treatment guidelines for children with bronchiolitis treated at University of California Davis Children's Hospital.

Study Overview

Status

Completed

Conditions

Detailed Description

A multidisciplinary team, involving pediatric hospitalists, pediatric emergency physicians, residents, medical students, nurses and nurse managers, and respiratory therapists will be assembled. The investigators will participate in a value stream mapping process, to map out the current pediatric bronchiolitis care process and identify areas for improvement in efficiency and effectiveness. The investigators will then begin the iterative process of implementing improvements to the bronchiolitis care process. Interventions will be evidence-based and designed to improve compliance with bronchiolitis care guidelines, as set forth by the American Academy of Pediatrics. Examples of possible interventions may include creation of a bronchiolitis admission order set, implementation of an evidence-based bronchiolitis clinical pathway, and/or institution of standardized bronchiolitis discharge criteria. Interventions will be implemented in a stepwise fashion, utilizing successive plan-do-study-act cycles, with a minimum 2 month period between interventions to monitor outcomes. The investigators will track utilization of diagnostic testing and treatments within our intervention group, as compared to historical controls who also meet inclusion criteria.

Study Type

Interventional

Enrollment (Actual)

1321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • UC David Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children less than 2 years of age admitted to UC Davis Children's Hospital with any diagnosis of bronchiolitis

Exclusion Criteria:

  • Children or adults greater than 2 years of age
  • Children born at less than 35 weeks gestational age
  • Children with underlying illnesses, such as chronic lung disease, congenital heart disease, other congenital anomalies including airway anomalies, or immunodeficiencies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Retrospective Controls
A retrospective control group of patients with a diagnosis of bronchiolitis and meeting inclusion criteria will be used as a comparison group. These patients received usual care for bronchiolitis at our institution.
EXPERIMENTAL: Quality Improvement
All patients diagnosed with bronchiolitis and meeting inclusion criteria will undergo the intervention of a bronchiolitis quality improvement process to improve bronchiolitis care quality at our institution.
Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest x-ray utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received a chest x-ray
Through study completion, an average of 19 months
Antibiotic utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received antibiotics
Through study completion, an average of 19 months
Bronchodilator utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received bronchodilators
Through study completion, an average of 19 months
Steroid utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received steroids
Through study completion, an average of 19 months
Hypertonic saline utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.
Through study completion, an average of 19 months
Chest physiotherapy utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received chest physiotherapy
Through study completion, an average of 19 months
Intravenous fluid utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received intravenous fluid
Through study completion, an average of 19 months
Continuous pulse oximetry utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received continuous pulse oximetry
Through study completion, an average of 19 months
Supplemental oxygen utilization
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received supplemental oxygen
Through study completion, an average of 19 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay index
Time Frame: Through study completion, an average of 19 months
A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards
Through study completion, an average of 19 months
Readmission rate
Time Frame: Within 30 days following the index hospitalization discharge date
Same hospital readmission rate for patients with a diagnosis of bronchiolitis
Within 30 days following the index hospitalization discharge date
Emergency room revisit rate
Time Frame: Within 30 days following the index hospitalization discharge date
Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis
Within 30 days following the index hospitalization discharge date
Bronchiolitis specific discharge instructions
Time Frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge
Through study completion, an average of 19 months
Timely completion of discharge summary
Time Frame: Within 48 hours of discharge from the index hospitalization
Percentage of patients meeting inclusion criteria who had a discharge summary completed
Within 48 hours of discharge from the index hospitalization
Timely routing of discharge summary
Time Frame: Within 48 hours of discharge from the index hospitalization
Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider
Within 48 hours of discharge from the index hospitalization
CC capture rate
Time Frame: Through study completion, an average of 19 months
The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis
Through study completion, an average of 19 months
MCC capture rate
Time Frame: Through study completion, an average of 19 months
The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis
Through study completion, an average of 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michelle Hamline, MD, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2018

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (ACTUAL)

May 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared, as data will be collected and reported in aggregate.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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