BronchiolitisNCT03528083
Pediatric Bronchiolitis Quality Improvement
A study testing Bronchiolitis quality improvement in people with Bronchiolitis, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Bronchiolitis quality improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,321 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 2 years of age admitted to UC Davis Children's Hospital with any diagnosis of bronchiolitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC David Medical Center
Sacramento, California, 95817
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- Bronchiolitis quality improvement
- Keywords
- Bronchiolitis, Children, Hospital
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchiolitis quality improvementOther
Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bronchiolitis quality improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest x-ray utilization
Percentage of patients meeting inclusion criteria who received a chest x-ray
Measured: Through study completion, an average of 19 months
Antibiotic utilization
Percentage of patients meeting inclusion criteria who received antibiotics
Measured: Through study completion, an average of 19 months
Bronchodilator utilization
Percentage of patients meeting inclusion criteria who received bronchodilators
Measured: Through study completion, an average of 19 months
Steroid utilization
Percentage of patients meeting inclusion criteria who received steroids
Measured: Through study completion, an average of 19 months
Hypertonic saline utilization
Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.
Measured: Through study completion, an average of 19 months
Chest physiotherapy utilization
Percentage of patients meeting inclusion criteria who received chest physiotherapy
Measured: Through study completion, an average of 19 months
Intravenous fluid utilization
Percentage of patients meeting inclusion criteria who received intravenous fluid
Measured: Through study completion, an average of 19 months
Continuous pulse oximetry utilization
Percentage of patients meeting inclusion criteria who received continuous pulse oximetry
Measured: Through study completion, an average of 19 months
Supplemental oxygen utilization
Percentage of patients meeting inclusion criteria who received supplemental oxygen
Measured: Through study completion, an average of 19 months
Secondary outcomes (8)
Length of stay index
A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards
Measured: Through study completion, an average of 19 months
Readmission rate
Same hospital readmission rate for patients with a diagnosis of bronchiolitis
Measured: Within 30 days following the index hospitalization discharge date
Emergency room revisit rate
Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis
Measured: Within 30 days following the index hospitalization discharge date
Bronchiolitis specific discharge instructions
Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge
Measured: Through study completion, an average of 19 months
Timely completion of discharge summary
Percentage of patients meeting inclusion criteria who had a discharge summary completed
Measured: Within 48 hours of discharge from the index hospitalization
Timely routing of discharge summary
Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider
Measured: Within 48 hours of discharge from the index hospitalization
CC capture rate
The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis
Measured: Through study completion, an average of 19 months
MCC capture rate
The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis
Measured: Through study completion, an average of 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start31 May 2018
- Primary completion30 May 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Hamline, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528083
- Sponsor's protocol ID
- 1219188
- Status last verified
- May 2022
- First submitted
- 9 Apr 2018
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as data will be collected and reported in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Bronchiolitis Quality Improvement to Reduce Unnecessary Use of Diagnostic Testing and Treatment
- ClinicalTrials.gov ID
- NCT03528083
- Acronym / sponsor ID
- 1219188
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Children, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,321 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Bronchiolitis quality improvementAll 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. |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children less than 2 years of age admitted to UC Davis Children's Hospital with any diagnosis of bronchiolitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchiolitis quality improvementPatients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital. | Other | Quality Improvement |
Primary outcome
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
Antibiotic utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received antibiotics
Bronchodilator utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received bronchodilators
Steroid utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received steroids
Hypertonic saline utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.
Chest physiotherapy utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received chest physiotherapy
Intravenous fluid utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received intravenous fluid
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
Supplemental oxygen utilization
Time frame: Through study completion, an average of 19 months
Percentage of patients meeting inclusion criteria who received supplemental oxygen
8 secondary outcomes
Length of stay index
Time frame: Through study completion, an average of 19 months
Readmission rate
Time frame: Within 30 days following the index hospitalization discharge date
Emergency room revisit rate
Time frame: Within 30 days following the index hospitalization discharge date
Bronchiolitis specific discharge instructions
Time frame: Through study completion, an average of 19 months
Timely completion of discharge summary
Time frame: 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
CC capture rate
Time frame: Through study completion, an average of 19 months
MCC capture rate
Time frame: Through study completion, an average of 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as data will be collected and reported in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Hamline, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchiolitis quality improvement in people with Bronchiolitis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest x-ray utilization (time frame: Through study completion, an average of 19 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.