Discharge Stewardship in Children's Hospitals (DISCO)

January 8, 2026 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Clinician Inclusion Criteria

  1. >18 year old
  2. 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

  1. <18 years old
  2. Not employed by the hospital

Patient Inclusion Criteria

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

Patient Exclusion Criteria

  1. Subjects >18 years of age
  2. Hospital length of stay >7 days
  3. Requiring intensive care unit level of care

Parent Inclusion Criteria 1. Parent of eligible child

Parent Exclusion Criteria

1. Parent of ineligible child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pediatric Hospitalists
Prescribing physicians and hospital employees will be recruited during regularly held staff meetings prior to the data collection period. The study team will briefly introduce the study aims and methods and let the hospitalists know that the study team will be emailing them separately to ask permission for Dr. Szymczak to shadow them. Only those who have agreed will participate in the ethnographic observations. For the interviews and surveys, the study team will recruit respondents via contact made during ethnographic observations. The study team will also utilize a snowball approach by asking respondents if they know of any other staff who might be interested in participating in an interview. Approximately 120 clinicians will participate in the interviews and surveys.
Behavioral: Discharge antibiotic stewardship intervention
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.
No Intervention: Families of hospitalized children
Families of children who were hospitalized at one of the four participating sites will be approached for consent to participate in the study. Families who consent will complete 2 brief REDCap surveys and a wellness tracker after their child is discharged from the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 3 years
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)
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

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

Investigators

  • Principal Investigator: Jeffrey S Gerber, MD, PhD, Associate Professor, Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

December 16, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-017269
  • R01HS027428-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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