Clinical trial NCT04302207: The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study
Official title: The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study: Developing a Roadmap for De-Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-03-10
Enrollment: 20000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements.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

Eligibility criteria: 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.

Primary outcomes:
measure: Using survey instruments developed by the research team, measure acceptability of the de-implementation strategies for bronchiolitis patients at high-use hospital
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Measure de-implementation effectiveness
timeFrame: through study completion, an average of 1 year
measure: Measure feasibility of deploying ROUTT-B from the perspectives of the quality improvement team who will deploy it.
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Proportion of patients receiving antibiotics
timeFrame: through study completion, an average of 1 year
measure: Median length of hospitalization in hours
timeFrame: through study completion, an average of 1 year
measure: Unintended consequences
timeFrame: through study completion, an average of 1 year
measure: Stakeholders' perceptions of impact on patient outcomes
timeFrame: through study completion, an average of 1 year
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Nationwide Children's Hospital
name: Amy Tyler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.