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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Behavioral: De-implementation Strategy for Bronchiolitis

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is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements.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 Type: Interventional
• Enrollment (Actual): 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High use hospitals; 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	Behavioral: De-implementation Strategy for Bronchiolitis; De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis
No Intervention: Low use hospital (Children's Hospital Colorado); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients receiving antibiotics	using electronic health records of patient population at both hospitals	through study completion, an average of 1 year
Median length of hospitalization in hours	using electronic health records of patient population at all hospitals	through study completion, an average of 1 year
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Amy Tyler, MD, Nationwide Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 19-0728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No