NCT03528083

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

April 9, 2018

Last Update Submit

May 12, 2022

Conditions

Keywords

BronchiolitisChildrenHospital

Outcome Measures

Primary Outcomes (9)

  • Chest x-ray utilization

    Percentage of patients meeting inclusion criteria who received a chest x-ray

    Through study completion, an average of 19 months

  • Antibiotic utilization

    Percentage of patients meeting inclusion criteria who received antibiotics

    Through study completion, an average of 19 months

  • Bronchodilator utilization

    Percentage of patients meeting inclusion criteria who received bronchodilators

    Through study completion, an average of 19 months

  • Steroid utilization

    Percentage of patients meeting inclusion criteria who received steroids

    Through study completion, an average of 19 months

  • Hypertonic saline utilization

    Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.

    Through study completion, an average of 19 months

  • Chest physiotherapy utilization

    Percentage of patients meeting inclusion criteria who received chest physiotherapy

    Through study completion, an average of 19 months

  • Intravenous fluid utilization

    Percentage of patients meeting inclusion criteria who received intravenous fluid

    Through study completion, an average of 19 months

  • Continuous pulse oximetry utilization

    Percentage of patients meeting inclusion criteria who received continuous pulse oximetry

    Through study completion, an average of 19 months

  • Supplemental oxygen utilization

    Percentage of patients meeting inclusion criteria who received supplemental oxygen

    Through study completion, an average of 19 months

Secondary Outcomes (8)

  • Length of stay index

    Through study completion, an average of 19 months

  • Readmission rate

    Within 30 days following the index hospitalization discharge date

  • Emergency room revisit rate

    Within 30 days following the index hospitalization discharge date

  • Bronchiolitis specific discharge instructions

    Through study completion, an average of 19 months

  • Timely completion of discharge summary

    Within 48 hours of discharge from the index hospitalization

  • +3 more secondary outcomes

Study Arms (2)

Retrospective Controls

NO INTERVENTION

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.

Quality Improvement

EXPERIMENTAL

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.

Other: Bronchiolitis quality improvement

Interventions

Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.

Quality Improvement

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC David Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Michelle Hamline, MD, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The investigators will conduct a quality improvement process for all children diagnosed with bronchiolitis at our hospital who meet inclusion criteria. Outcomes for these patients will be compared with retrospective controls.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 17, 2018

Study Start

May 31, 2018

Primary Completion

May 30, 2020

Study Completion

December 31, 2021

Last Updated

May 16, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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

Locations