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

Primary Purpose

Bronchiolitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
De-implementation Strategy for Bronchiolitis
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bronchiolitis

Eligibility Criteria

1 Month - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Colorado
  • Nationwide Children's Hospital
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High use hospitals

Low use hospital (Children's Hospital Colorado)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)

Full Information

First Posted
February 19, 2020
Last Updated
November 22, 2022
Sponsor
University of Colorado, Denver
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT04302207
Brief Title
The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study
Acronym
ROUTT-B
Official Title
The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study: Developing a Roadmap for De-Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Non-Randomized
Enrollment
20000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High use hospitals
Arm Type
Experimental
Arm Description
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
Arm Title
Low use hospital (Children's Hospital Colorado)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
De-implementation Strategy for Bronchiolitis
Intervention Description
De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis
Primary Outcome Measure Information:
Title
Using survey instruments developed by the research team, measure acceptability of the de-implementation strategies for bronchiolitis patients at high-use hospital
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Measure de-implementation effectiveness
Description
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
Time Frame
through study completion, an average of 1 year
Title
Measure feasibility of deploying ROUTT-B from the perspectives of the quality improvement team who will deploy it.
Description
Measured through mixed methods approach (qualitative interviews or focus groups and provider surveys)
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Proportion of patients receiving antibiotics
Description
using electronic health records of patient population at both hospitals
Time Frame
through study completion, an average of 1 year
Title
Median length of hospitalization in hours
Description
using electronic health records of patient population at all hospitals
Time Frame
through study completion, an average of 1 year
Title
Unintended consequences
Description
7 day ED/UC all cause revisits, 7 day all cause readmissions, ICU level care at index visit at all hospitals
Time Frame
through study completion, an average of 1 year
Title
Stakeholders' perceptions of impact on patient outcomes
Description
measured through provider and care team survey at high-use hospitals.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Tyler, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29752289
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.
Results Reference
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The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study

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