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Active, Not Recruiting

NCT Number: NCT05826873

Discharge Stewardship in Children's Hospitals

The goal of this interventional study is to test if a discharge stewardship bundle is effective at reducing inappropriate antibiotic prescriptions at hospital discharge for children with the three common infections: community-acquired pneumonia (CAP), urinary tract infections (UTI), and skin/soft tissue infections (SSTI). The goals of this study are:

* To develop, locally adapt, and implement a discharge stewardship intervention across four geographically diverse children's hospitals. * To measure the impact of the discharge stewardship intervention on antibiotic prescribing and patient outcome for three common pediatric infections.

Families who are enrolled in the study will be asked to:

* complete a one question wellness track on days 3, 7, and 21 after hospital discharge * complete a brief survey on days 7 and 21 after hospital discharge

The study team will conduct interviews with the hospitalists at each of the four participating hospitals to create a "discharge stewardship" bundle. Once the bundle intervention is implemented, the hospitalists will be asked to follow prescribing guidelines for CAP, UTI, and SSTI. They will receive regular group-level feedback reports to show how well they follow the guidelines and motivate the hospitalists to follow the guidelines better.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

Pediatric antibiotic stewardship programs (ASPs) in hospital and outpatient settings optimize the use of antibiotics to improve clinical outcomes, decrease adverse drug events, and reduce the emergence of antibiotic resistant bacteria. However, stewardship for patients at the transition from hospital discharge to home, or "discharge stewardship," is an unmet need for several reasons. First, few pediatric stewardship programs perform discharge stewardship. Second, approximately 30% of pediatric patients receive antibiotics at hospital discharge. Third, the majority of antibiotic days prescribed for hospitalized patients occur after discharge. Fourth, up to half of discharge antibiotic prescriptions are suboptimal, which includes choosing the wrong drug, dose, route, or duration of therapy.

This project will use an implementation science framework to develop, implement, and test the effectiveness of a multifaceted discharge stewardship intervention for hospitalized children with the three most common indications for antibiotic prescribing in hospitalized children - community acquired pneumonia (CAP), urinary tract infections (UTI), and skin/soft tissue infections (SSTI) - at four children's hospitals to establish a foundation for future expansion to additional target populations. Antibiotic choice, dose, route, and duration of therapy will be addressed.

Aim 1 is to develop, locally adapt, and implement a discharge stewardship intervention across the four participating sites. The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide a rapid formative evaluation to identify contextual factors likely to facilitate or hinder the implementation of a discharge stewardship intervention at each site. Based on these results, local facilitators will work to develop and implement a discharge stewardship intervention comprised of consensus driven clinical prescribing guidelines for CAP, UTI, and SSTI plus quarterly feedback of prescribing data based on these guidelines. Aim 2 is to measure the impact of the discharge stewardship intervention on antibiotic prescribing (the primary outcome) and patient-centered balancing measures (post-discharge treatment failure and adverse events).

This project will form the foundation for future dissemination of discharge stewardship to a broader array of patient populations. Investigators on this proposal form the leadership of the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative, a network comprised of more than 60 children's hospitals across North America that is uniquely positioned to adopt antimicrobial stewardship interventions designed to target prescribing at hospital discharge.

Who can participate

Healthy volunteers accepted: No

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

Clinician Inclusion Criteria

  • >18 year old
  • Employed by the hospital as an attending physician, advanced practice provider, resident trainee or other clinical stakeholder (e.g. pharmacist, infectious diseases attending)

Clinician Exclusion Criteria

  • <18 years old
  • Not employed by the hospital

Patient Inclusion Criteria

  • Subjects less than 18 years
  • Diagnosed with either uncomplicated community acquired pneumonia, urinary tract infections, skin/soft tissue infections
  • Admitted and discharged from study site

Patient Exclusion Criteria

  • Subjects >18 years of age
  • Hospital length of stay >7 days
  • Requiring intensive care unit level of care

Parent Inclusion Criteria 1. Parent of eligible child

Parent Exclusion Criteria

  • Parent of ineligible child

Treatment and study plan

Discharge antibiotic stewardship intervention

Behavioral

Hospitalists will be provided with group-level, quarterly feedback reports illustrating the number of prescriptions that had the appropriate antibiotic duration and appropriate antibiotic choice for each of the three conditions.

Primary outcomes

  1. Rate of suboptimal prescribing

    Time frame: up to 3 years

    The primary objective of this study is to determine the impact of a discharge stewardship intervention on antibiotic prescribing and patient outcomes for three common pediatric infection after developing and implementing the intervention across four geographically diverse children's hospitals. Impact will be measured by the rate of suboptimal prescribing (drug, dose, route, and duration) for CAP, UTI, and SSTI across the four hospitals. Suboptimal prescribing will be measured using data collected from the electronic health record. The discharge prescription data (choice and duration) will be compared to the recommended guidelines to determine if the discharge prescription was on or off guideline.

Secondary outcomes

  1. Impact of the discharge stewardship intervention on post-discharge treatment failure

    Time frame: up to 3 years

    Using a quasi-experimental design, the study team will assess the rate and trajectory of post-discharge treatment failure for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)

  2. Impact of the discharge stewardship intervention on adverse drug events

    Time frame: up to 3 years

    Using a quasi-experimental design, the study team will assess the rate and trajectory of adverse drug events for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Primary Children's Hospital
  • Seattle Children's Hospital
  • St. Louis Children's Hospital
  • University of Pennsylvania

Registry information

Official study title

Implementing a Discharge Stewardship Bundle to Improve Antibiotic Use at Transition From Hospital to Home

Acronym: DISCO

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Jan 9, 2026

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.

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