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

NCT04302207 | Completed

• 1 other identifier: 19-0728
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Bronchiolitis

Outcome Measures

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

  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 Outcomes (2)

• Measure de-implementation effectiveness

  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.

  through study completion, an average of 1 year

Other Outcomes (4)

• Proportion of patients receiving antibiotics

  through study completion, an average of 1 year

• Median length of hospitalization in hours

  through study completion, an average of 1 year

• Unintended consequences

  through study completion, an average of 1 year

Study Arms (2)

High use hospitals

EXPERIMENTAL

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

Low use hospital (Children's Hospital Colorado)

NO INTERVENTION

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

Interventions

De-implementation Strategy for Bronchiolitis BEHAVIORAL

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

High use hospitals

Eligibility Criteria

• Age: 1 Month - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 29752289 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Tyler, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 10, 2020
• Study Start: September 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)