The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Behavioral: De-implementation Strategy for Bronchiolitis

• Registration Number: NCT04302207
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Over-testing and over-treatment costs the US healthcare system hundreds of billions of dollars a year, and has measurable negative impacts on patients' physical, emotional, and financial health making it a significant public health concern. The proposed research will advance "de-implementation" science by identifying processes and strategies to stop or reduce over-testing and over-treatment that can be broadly adapted to varied contexts and disease processes to improve the delivery of guideline concordant, evidence-based care and improve patient outcomes.

Detailed Description

The overarching goal of this proposal is to use bronchiolitis as a case study to advance the science of de-implementation by identifying strategies and processes for reducing over-testing and over-treatment in bronchiolitis that can later be broadly adapted to varied contexts and disease processes. The challenge in bronchiolitis is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements. Therefore, bronchiolitis which is the most common cause of hospitalization among infants, is an ideal condition to study de-implementation.

In her set of projects, Dr. Tyler proposes the innovative application of dissemination and implementation (D\&I) science to the unique problem of de-implementation. Within a learning health system called PEDSnet, Dr. Tyler will use the PRISM D\&I model as a guide to: 1) use qualitative methods to define contextual factors influencing over-utilization in bronchiolitis from the perspective of healthcare providers, parents, and healthcare organizations, 2) develop a set of pragmatic, feasible, and effective de-implementation strategies for bronchiolitis that includes guidance on how to adapt the strategies to local contexts, and 3) conduct a pilot study to determine the feasibility, acceptability, and de-implementation effectiveness of the de-implementation strategies. As one of the first explorations of contextual factors fostering overuse or enabling successful de-implementation, this study is expected to generate valuable knowledge relevant to de- implementation across diseases and healthcare settings. The results will provide pilot data for a large-scale, pragmatic, randomized-controlled trial of the de-implementation strategies so that ineffective and potentially harmful medical practices are reduced.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Study Start: 2020-09-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Patients age 1-23 months seen at a participating site for bronchiolitis
• Providers at participating sites that see eligible patients (defined above)
• Parents who have an eligible child at participating study sites (parent interviews)

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Exclusion Criteria

• Patients outside the age limits and do not have bronchiolitis
• Providers not at participating site
• Parents who do not have an eligible child at participating study site.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High use hospitals	De-implementation Strategy for Bronchiolitis	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

Primary Outcome Measures

Name	Time	Method
Using survey instruments developed by the research team, measure acceptability of the de-implementation strategies for bronchiolitis patients at high-use hospital	through study completion, an average of 1 year	Online surveys will be given to providers care team members that experience the de-implementation strategies at the high-use hospitals to determine acceptability and appropriateness

Secondary Outcome Measures

Name	Time	Method
Measure feasibility of deploying ROUTT-B from the perspectives of the quality improvement team who will deploy it.	through study completion, an average of 1 year	Measured through mixed methods approach (qualitative interviews or focus groups and provider surveys)
Measure de-implementation effectiveness	through study completion, an average of 1 year	Looking at electronic health records, review the change in the utilization rates of CXR, bronchodilators, and VT for patients affected with bronchiolitis at all hospitals

Trial Locations

Locations (3)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States