Decision Support for Lower Respiratory Infections in Children

(ROADS Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Derek J Williams, MD, MPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

Eliminating inappropriate antibiotic use in pediatric lower respiratory tract infections (LRTI) is the central focus of this research. LRTIs (pneumonia, bronchiolitis, and infection-related exacerbations of asthma) account for nearly one-third of all emergency department (ED) visits and 40% of all infection-related hospitalizations in US children. LRTIs also account for more antibiotic use in children's hospitals than any other condition, despite most LRTIs being viral in nature. Inappropriate antibiotics are associated with substantial adverse effects. Accordingly, national guidelines strongly discourage routine antibiotic use for bronchiolitis and acute asthma and argue for significantly reducing antibiotic exposure (initiation, spectrum, and duration) in pneumonia. To address the problem of inappropriate antibiotic use, hospital-based antimicrobial stewardship programs (ASPs) are now common nationwide, and these programs have demonstrated effectiveness in some hospital settings. Unfortunately, traditional ASP approaches do not translate well to the fast-paced and unpredictable ED environment, and hospital-based ASP resources are finite and not always immediately available. Clinical decision support (CDS) embedded within the electronic health record (EHR) is a strategy that could address the ED antibiotic stewardship gap. Informed by a deep understanding of the key facilitators and barriers to using CDS to support appropriate antibiotic use in ED and hospital settings, the investigators have developed two stewardship-focused CDS interventions for pediatric LRTI. The overarching goal of this research is to rigorously evaluate the implementation and effectiveness of these CDS tools, alone and in combination, against usual care only in a pragmatic randomized clinical trial at 3 U.S. children's hospitals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing inappropriate antibiotic use for certain infections in children.

What data supports the effectiveness of the treatment ED Clinical Decision Support (CDS-ED) and Transitions Clinical Decision Support (CDS-Tr) for lower respiratory infections in children?

Research shows that clinical decision support (CDS) systems can help reduce unnecessary antibiotic prescribing for acute respiratory infections and improve guideline-adherent antibiotic prescribing for pediatric infections, suggesting potential benefits for managing lower respiratory infections in children.

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Is the clinical decision support system safe for use in children?

Clinical decision support systems (CDSS) have been studied for their potential to reduce medical errors, but improper design can introduce new errors. Usability issues in CDSS for conditions like pneumonia have been noted, which could lead to adverse medical events if not properly addressed.

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How is the ED Clinical Decision Support (CDS-ED) treatment for lower respiratory infections in children different from other treatments?

The ED Clinical Decision Support (CDS-ED) treatment is unique because it uses technology to guide healthcare providers in making better decisions about antibiotic use, aiming to reduce unnecessary prescriptions and improve adherence to guidelines, which is not a standard approach in treating lower respiratory infections in children.

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Eligibility Criteria

This trial is for children visiting the emergency department (ED) with lower respiratory tract infections like pneumonia, bronchiolitis, or asthma-related infections. It aims to reduce unnecessary antibiotic use in these patients.

Inclusion Criteria

I have been to the emergency department or admitted to the hospital.

My electronic health records show signs of a lung infection based on my symptoms and nurse's notes.

Exclusion Criteria

Not applicable.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clinical decision support interventions in the ED and hospital settings to reduce inappropriate antibiotic use

10 days

Ongoing monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including antibiotic exposure and clinical outcomes

42 days

Extension

Long-term monitoring of antibiotic use and clinical outcomes

Up to 42 days post-discharge

Participant Groups

The study tests two electronic Clinical Decision Support systems: one used in the ED (CDS-ED), and another during hospital transitions (CDS-Tr). The goal is to see if they help doctors prescribe antibiotics appropriately compared to usual care.

Group I: CDS-Tr Experimental Treatment 1 Intervention

The Transitions clinical decision support tool will be offered to inpatient/ICU providers in these enrolled encounters.

Group II: CDS-ED Experimental Treatment 1 Intervention

The ED clinical decision support tool will be offered to emergency department providers in these enrolled encounters.

Group III: Usual Care: Emergency Department Active Control 1 Intervention

No experimental decision support will be provided to the emergency medicine providers in encounters randomized to the control arm. All patients will receive usual care and treatment will not be restricted or altered in any way by the study.

Group IV: Usual Care: Inpatient Active Control 1 Intervention

No experimental decision support will be provided to the inpatient/ICU providers in encounters randomized to the control arm. All patients will receive usual care and treatment will not be restricted or altered in any way by the study.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Benioff Children's Hospital - Oakland Oakland, CA

Monroe Carell Jr Children's Hospital at Vanderbilt Nashville, TN

Benioff Children's Hospital - San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center Lead Sponsor

Agency for Healthcare Research and Quality (AHRQ) Collaborator

University of California, San Francisco Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an Antimicrobial Stewardship Decision Support for Pediatric Infections. [2023] Clinical decision support (CDS) has promise for the implementation of antimicrobial stewardship programs (ASPs) in the emergency department (ED). We sought to assess the usability of a newly developed automated CDS to improve guideline-adherent antibiotic prescribing for pediatric community-acquired pneumonia (CAP) and urinary tract infection (UTI).

2. Germany pubmed.ncbi.nlm.nih.gov

Examining Workflow in a Pediatric Emergency Department to Develop a Clinical Decision Support for an Antimicrobial Stewardship Program. [2019] Clinical decision support (CDS) embedded into the electronic health record (EHR), is a potentially powerful tool for institution of antimicrobial stewardship programs (ASPs) in emergency departments (EDs). However, design and implementation of CDS systems should be informed by the existing workflow to ensure its congruence with ED practice, which is characterized by erratic workflow, intermittent computer interactions, and variable timing of antibiotic prescription.

3. Canada pubmed.ncbi.nlm.nih.gov

Clinical Decision Support to Reduce Opioid Prescriptions for Dental Extractions using SMART on FHIR: Implementation Report. [2023] Clinical decision support (CDS) has the potential to improve clinical decision-making consistent with evidence-based care. CDS can be designed to save health care providers time and help them provide safe and personalized analgesic prescribing.

4. United States pubmed.ncbi.nlm.nih.gov

Antibiotic clinical decision support for pneumonia in the ED: A randomized trial. [2023] Electronic health record-based clinical decision support (CDS) is a promising antibiotic stewardship strategy. Few studies have evaluated the effectiveness of antibiotic CDS in the pediatric emergency department (ED).

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial. [2021] Clinical decision support (CDS) is a promising tool for reducing antibiotic prescribing for acute respiratory infections (ARIs).

6. United States pubmed.ncbi.nlm.nih.gov

How usability of a web-based clinical decision support system has the potential to contribute to adverse medical events. [2022] Clinical decision support systems (CDSS) have the potential to reduce adverse medical events, but improper design can introduce new forms of error. CDSS pertaining to community acquired pneumonia and neutropenic fever were studied to determine whether usability of the graphical user interface might contribute to potential adverse medical events.

7. Canada pubmed.ncbi.nlm.nih.gov

Pediatricians' Understanding and Experiences of an Electronic Clinical-Decision-Support-System. [2022] Subsequent dosing errors after implementing an Electronic Medical Record (EMR) at a pediatric hospital in Sweden led to the development, in close collaboration with the clinical profession, of a Clinical Decision Support System (CDSS) with Dose Range Check and Weight Based Dose Calculation integrated directly in the EMR. The aim of this study was to explore the understanding and experiences of the CDSS among Swedish pediatricians after one year of practice.

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a computerized template on antibiotic prescribing for acute respiratory infections in children and adolescents. [2018] Computerized decision support (CDS) can potentially improve patient safety and guideline adherence. The authors developed an acute respiratory illness interactive template (ARI-IT) within an electronic health record (EHR) to manage pediatric ARIs and assessed the impact on antibiotic prescribing.

9. United States pubmed.ncbi.nlm.nih.gov

Clinical decision support systems and infection prevention: to know is not enough. [2015] Clinical decision support (CDS) systems are an increasingly used form of technology designed to guide health care providers toward established protocols and best practices with the intent of improving patient care. Utilization of CDS for infection prevention is not widespread and is particularly focused on antimicrobial stewardship. This article provides an overview of CDS systems and summarizes key attributes of successfully executed tools. A selection of published reports of CDS for infection prevention and antimicrobial stewardship are described. Finally, an individual organization describes its CDS infrastructure, process of prioritization, design, and development, with selected highlights of CDS tools specifically targeting common infection prevention quality improvement initiatives.