What side effects are associated with this type of intervention?

Common treatments for bronchiolitis include supportive care such as hydration and oxygen therapy, as well as medications like bronchodilators and corticosteroids. However, over-treatment and over-testing are significant concerns. Bronchodilators can cause side effects such as increased heart rate and tremors, while corticosteroids may lead to weight gain, high blood pressure, and increased risk of infections. The ROUTT-B study aims to reduce unnecessary interventions, which can help minimize these potential side effects and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to de-implementation strategies for bronchiolitis patients in 2024 include: 1) Advanced diagnostic tools such as point-of-care ultrasound to accurately diagnose and monitor bronchiolitis, reducing the need for unnecessary tests. 2) Use of high-flow nasal cannula (HFNC) therapy as a non-invasive respiratory support, which has shown effectiveness in managing bronchiolitis symptoms and reducing hospital admissions. 3) Implementation of telemedicine for remote monitoring and management, allowing for timely interventions and reducing the need for in-person visits and hospitalizations. 4) Development of targeted antiviral therapies that can specifically address the viral causes of bronchiolitis, potentially reducing the severity and duration of the illness.

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Evidence-Based Care Strategy for Bronchiolitis (ROUTT-B Trial)

Q: What prior FDA approvals exist?

Bronchiolitis, primarily caused by respiratory syncytial virus (RSV), is commonly managed with supportive care, including hydration and oxygen therapy. The FDA has not approved specific antiviral drugs for bronchiolitis treatment in children. The ROUTT-B trial focuses on reducing unnecessary tests and treatments, aligning with current guidelines that recommend against routine use of bronchodilators, corticosteroids, and antibiotics in typical bronchiolitis cases. This approach emphasizes evidence-based care to avoid over-treatment and improve patient outcomes.

N/A

Waitlist Available

Led By Amy Tyler, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients age 1-23 months seen at a participating site for bronchiolitis

Must not have

Patients outside the age limits and do not have bronchiolitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce unnecessary medical tests and treatments for infants with bronchiolitis. It will find out why these tests are used, create ways to stop them, and see if these new methods work well.

Who is the study for?

The ROUTT-B Study is for babies and toddlers aged 1-23 months diagnosed with bronchiolitis, seen at specific participating locations. Healthcare providers who treat these young patients at the sites are also involved, as well as parents of eligible children for interviews.

What is being tested?

This study focuses on reducing unnecessary tests and treatments in bronchiolitis care. It aims to identify effective ways to align healthcare practices with evidence-based guidelines, potentially improving patient outcomes and cutting down on healthcare costs.

What are the potential side effects?

Since this trial involves de-implementation strategies rather than medications or medical procedures, traditional side effects are not a concern. The focus is on changing healthcare provider behaviors and treatment approaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 1-23 months old and has bronchiolitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am outside the specified age range and do not have bronchiolitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Using survey instruments developed by the research team, measure acceptability of the de-implementation strategies for bronchiolitis patients at high-use hospital

Secondary study objectives

Measure de-implementation effectiveness

Measure feasibility of deploying ROUTT-B from the perspectives of the quality improvement team who will deploy it.

Other study objectives

Median length of hospitalization in hours

Proportion of patients receiving antibiotics

Stakeholders' perceptions of impact on patient outcomes

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High use hospitalsExperimental Treatment1 Intervention

patients 1-23 months with Bronchiolitis seen in emergency department, urgent care or admitted patients will be included; provider surveys measuring the acceptability, appropriateness, feasibility, and perceived burden of piloted strategies; review of patient data extracted from electronic health record to include baseline, intervention and post-intervention data

Group II: Low use hospital (Children's Hospital Colorado)Active Control1 Intervention

patients 1-23 months with Bronchiolitis seen in emergency department, urgent care or admitted patients will be included; review of patient data extracted from electronic health record to include data over the same time periods as the experimental groups' baseline, intervention, and post-intervention data

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

De-implementation Strategy for Bronchiolitis

2020

N/A

~20000

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bronchiolitis include supportive care such as hydration and oxygen therapy, as well as medications like bronchodilators and corticosteroids. Supportive care helps maintain adequate oxygen levels and hydration, which are crucial for recovery. Bronchodilators work by relaxing the muscles around the airways, making it easier to breathe, although their effectiveness in Bronchiolitis is debated. Corticosteroids reduce inflammation in the airways but are not routinely recommended due to limited evidence of benefit. Understanding these mechanisms is important for Bronchiolitis patients to avoid unnecessary treatments that may not provide significant benefits and could lead to adverse effects, aligning with the goals of de-implementation strategies to reduce over-testing and over-treatment.