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

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is that providing high-quality, evidenced-based care requires a less is more approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements.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

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

Conditions
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Bronchiolitis

Intervention / Treatment
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* Behavioral: De-implementation Strategy for Bronchiolitis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-randomized controlled trial of ROUTT-B using a parallel experimental and control interrupted time series study design extending over baseline, intervention, and post-intervention period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High use hospitals<br>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<br>* De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis<br>|
| No Intervention: Low use hospital (Children's Hospital Colorado)<br>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?
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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 |