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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302207
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Behavioral: De-implementation Strategy for Bronchiolotis Not Applicable

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is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements.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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-randomized controlled trial of ROUTT-B using a parallel experimental (NCH) and control (CHCO) interrupted time series study design extending over two-years of baseline and a one-year intervention period.
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study: Developing a Roadmap for De-Implementation
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High intervention hospital (Nationwide Childrens Hospital)
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 1-year pilot, 10 months post-pilot data
Behavioral: De-implementation Strategy for Bronchiolotis
De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis

No Intervention: Low intervention hospital (Childrens 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 1-year pilot, 10 months post-pilot data



Primary Outcome Measures :
  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 and parents that experience the de-implementation strategies at the high-use hospital to determine acceptability and appropriateness


Secondary Outcome Measures :
  1. Measure de-implementation effectiveness at over-use hospital [ 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

  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 provider surveys (developed by research team)


Other Outcome Measures:
  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 both 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

  4. Stakeholders' perceptions of cost effectiveness & impact on patient outcomes [ Time Frame: through study completion, an average of 1 year ]
    measured through provider, care team and leadership survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 surveys)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302207


Contacts
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Contact: Amy Tyler, MD 720-777-2794 amy.tyler@coloradochildrens.org
Contact: Alison Saville, MSW, MSPH alison.saville@cuanschutz.edu

Sponsors and Collaborators
University of Colorado, Denver
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Amy Tyler, MD University of Colorado - Anschutz Medical Campus

Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04302207    
Other Study ID Numbers: 19-0728
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections