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

Bronchiolitis Clinical Trial

— ROUTT-B  

Official title:

The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study: Developing a Roadmap for De-Implementation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04302207
• Other study ID #: 19-0728
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements.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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 80 Years

Eligibility

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)

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.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Behavioral:
• De-implementation Strategy for Bronchiolitis
De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tyler A, Krack P, Bakel LA, O'Hara K, Scudamore D, Topoz I, Freeman J, Moss A, Allen R, Swanson A, Bajaj L. Interventions to Reduce Over-Utilized Tests and Treatments in Bronchiolitis. Pediatrics. 2018 Jun;141(6):e20170485. doi: 10.1542/peds.2017-0485. Epub 2018 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients receiving antibiotics	using electronic health records of patient population at both hospitals	through study completion, an average of 1 year
Other	Median length of hospitalization in hours	using electronic health records of patient population at all hospitals	through study completion, an average of 1 year
Other	Unintended consequences	7 day ED/UC all cause revisits, 7 day all cause readmissions, ICU level care at index visit at all hospitals	through study completion, an average of 1 year
Other	Stakeholders' perceptions of impact on patient outcomes	measured through provider and care team survey at high-use hospitals.	through study completion, an average of 1 year
Primary	Using survey instruments developed by the research team, measure acceptability of the de-implementation strategies for bronchiolitis patients at high-use hospital	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	through study completion, an average of 1 year
Secondary	Measure de-implementation effectiveness	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	through study completion, an average of 1 year
Secondary	Measure feasibility of deploying ROUTT-B from the perspectives of the quality improvement team who will deploy it.	Measured through mixed methods approach (qualitative interviews or focus groups and provider surveys)	through study completion, an average of 1 year