Bronchiolitis Clinical Trial
Official title:
Pediatric Bronchiolitis Quality Improvement to Reduce Unnecessary Use of Diagnostic Testing and Treatment
NCT number | NCT03528083 |
Other study ID # | 1219188 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2018 |
Est. completion date | December 31, 2021 |
Verified date | May 2022 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1321 |
Est. completion date | December 31, 2021 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UC David Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chest x-ray utilization | Percentage of patients meeting inclusion criteria who received a chest x-ray | Through study completion, an average of 19 months | |
Primary | Antibiotic utilization | Percentage of patients meeting inclusion criteria who received antibiotics | Through study completion, an average of 19 months | |
Primary | Bronchodilator utilization | Percentage of patients meeting inclusion criteria who received bronchodilators | Through study completion, an average of 19 months | |
Primary | Steroid utilization | Percentage of patients meeting inclusion criteria who received steroids | Through study completion, an average of 19 months | |
Primary | Hypertonic saline utilization | Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline. | Through study completion, an average of 19 months | |
Primary | Chest physiotherapy utilization | Percentage of patients meeting inclusion criteria who received chest physiotherapy | Through study completion, an average of 19 months | |
Primary | Intravenous fluid utilization | Percentage of patients meeting inclusion criteria who received intravenous fluid | Through study completion, an average of 19 months | |
Primary | Continuous pulse oximetry utilization | Percentage of patients meeting inclusion criteria who received continuous pulse oximetry | Through study completion, an average of 19 months | |
Primary | Supplemental oxygen utilization | Percentage of patients meeting inclusion criteria who received supplemental oxygen | Through study completion, an average of 19 months | |
Secondary | Length of stay index | 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 | |
Secondary | Readmission rate | Same hospital readmission rate for patients with a diagnosis of bronchiolitis | Within 30 days following the index hospitalization discharge date | |
Secondary | Emergency room revisit rate | Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis | Within 30 days following the index hospitalization discharge date | |
Secondary | Bronchiolitis specific discharge instructions | Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge | Through study completion, an average of 19 months | |
Secondary | Timely completion of discharge summary | Percentage of patients meeting inclusion criteria who had a discharge summary completed | Within 48 hours of discharge from the index hospitalization | |
Secondary | Timely routing of discharge summary | 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 | |
Secondary | CC capture rate | The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis | Through study completion, an average of 19 months | |
Secondary | MCC capture rate | The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis | Through study completion, an average of 19 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04989114 -
Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis
|
N/A | |
Recruiting |
NCT06016244 -
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
|
N/A | |
Not yet recruiting |
NCT05902702 -
Isotonic Saline for Children With Bronchiolitis
|
N/A | |
Recruiting |
NCT02366715 -
Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research
|
Phase 3 | |
Terminated |
NCT02219334 -
Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
|
N/A | |
Recruiting |
NCT01944995 -
Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis
|
N/A | |
Terminated |
NCT02834819 -
Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
|
N/A | |
Terminated |
NCT01757496 -
Cough Assist in Bronchiolitis
|
N/A | |
Not yet recruiting |
NCT01414322 -
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
|
N/A | |
Completed |
NCT00369759 -
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
|
N/A | |
Completed |
NCT00347880 -
Atrial and Brain Natriuretic Peptides in Bronchiolitis
|
Phase 1 | |
Recruiting |
NCT05548036 -
A Feasibility RCT of Aerobika Verses ACBT in People With COPD
|
N/A | |
Active, not recruiting |
NCT04302207 -
The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study
|
N/A | |
Completed |
NCT02858531 -
Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
|
||
Withdrawn |
NCT05994183 -
The Bronchiolitis in Hospitalized Infants Study
|
Early Phase 1 | |
Terminated |
NCT03614507 -
Automation Oxygen Flow Titration in Spontaneously Breathing Infants
|
N/A | |
Completed |
NCT02856165 -
High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis
|
N/A | |
Recruiting |
NCT05909566 -
Respiratory Support and Treatment for Efficient and Cost-Effective Care
|
N/A | |
Recruiting |
NCT04437641 -
Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
|
||
Not yet recruiting |
NCT06083077 -
Chest and Abdominal Wall Strapping in Infant With Bronchiolitis
|
N/A |