Skip to main content
OpenTrials
Completed

NCT Number: NCT04302207

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

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is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

De-implementation Strategy for Bronchiolitis

Behavioral

De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis

Primary outcomes

  1. Using survey instruments developed by the research team, measure acceptability of the de-implementation strategies for bronchiolitis patients at high-use hospital

    Time frame: 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 outcomes

  1. Measure de-implementation effectiveness

    Time frame: 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

  2. Measure feasibility of deploying ROUTT-B from the perspectives of the quality improvement team who will deploy it.

    Time frame: through study completion, an average of 1 year

    Measured through mixed methods approach (qualitative interviews or focus groups and provider surveys)

Other outcomes

  1. Proportion of patients receiving antibiotics

    Time frame: through study completion, an average of 1 year

    using electronic health records of patient population at both hospitals

  2. Median length of hospitalization in hours

    Time frame: through study completion, an average of 1 year

    using electronic health records of patient population at all hospitals

  3. Unintended consequences

    Time frame: through study completion, an average of 1 year

    7 day ED/UC all cause revisits, 7 day all cause readmissions, ICU level care at index visit at all hospitals

  4. Stakeholders' perceptions of impact on patient outcomes

    Time frame: through study completion, an average of 1 year

    measured through provider and care team survey at high-use hospitals.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: ROUTT-B

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2020
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.