Discharge Antibiotic Stewardship for Pediatric Infections

(DISCO Trial)

Recruiting at 4 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Age >18, ICU care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1131 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on reducing inappropriate antibiotic prescriptions at hospital discharge.

Is discharge antibiotic stewardship safe for children?

Discharge antibiotic stewardship is generally considered safe as it focuses on reducing unnecessary antibiotic use, which can prevent potential harms like adverse drug events and antibiotic resistance. The goal is to ensure antibiotics are used only when needed, minimizing risks associated with overuse. ^{1 2 3 4 5}

How is the discharge antibiotic stewardship intervention different from other treatments for pediatric infections?

The discharge antibiotic stewardship intervention is unique because it focuses on reviewing and improving the appropriateness of antibiotic prescriptions specifically at the time of hospital discharge, which is a critical transition period often overlooked in traditional treatments. This approach aims to ensure that antibiotics are prescribed correctly and only when necessary, reducing unnecessary antibiotic use and resistance. ^{2 5 6 7 8}

What data supports the effectiveness of the discharge antibiotic stewardship intervention treatment for pediatric infections?

Research shows that improving antibiotic prescribing at hospital discharge can significantly increase appropriate antibiotic use, as seen in a study where appropriate prescribing improved from 47.5% to 85.2% after implementing stewardship services. This suggests that similar interventions could be effective for pediatric infections. ^{2 4 6 7 9}

Who Is on the Research Team?

Jeffrey S Gerber, MD, PhD

Principal Investigator

Associate Professor, Pediatrics

Are You a Good Fit for This Trial?

This trial is for children under 18 with common infections like pneumonia, UTIs, or skin infections who are being discharged from the hospital. It's also for their parents and healthcare providers over 18 working at the hospital. Children who stayed in the hospital longer than a week or needed intensive care are not eligible.

Inclusion Criteria

Parent: Parent of eligible child

I am under 18 and have pneumonia, a UTI, or a skin infection, treated and released.

Exclusion Criteria

Parent: Parent of ineligible child

I am under 18 and do not work for the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation of Discharge Stewardship

Development and implementation of a discharge stewardship intervention across four children's hospitals, including consensus-driven clinical prescribing guidelines and feedback reports.

up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after discharge, including completion of wellness trackers and surveys on days 3, 7, and 21 post-discharge.

3 weeks

3 virtual check-ins via surveys

Long-term Monitoring

Ongoing assessment of the impact of the discharge stewardship intervention on antibiotic prescribing and patient outcomes, including suboptimal prescribing rates and adverse events.

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Discharge antibiotic stewardship intervention

Trial Overview The study tests a 'discharge stewardship bundle' to see if it helps reduce unnecessary antibiotic prescriptions when kids leave the hospital after treatment for pneumonia, UTI, or skin infections. The intervention will be adapted and implemented across four children's hospitals.

How Is the Trial Designed?

Group I: Pediatric Hospitalists Experimental Treatment 1 Intervention

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.

Group II: Families of hospitalized children Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Primary Children's Hospital

Collaborator

Trials

22

Recruited

15,900+

St. Louis Children's Hospital

Collaborator

Trials

30

Recruited

83,200+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Citations

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

Optimal Antibiotics at Hospital Discharge for Children With Urinary Tract Infection. [2021]

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

Interventions to improve antibiotic prescribing at hospital discharge: A systematic review. [2021]

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

Impact of the expansion of antimicrobial stewardship services during transitions of care at an academic hospital. [2021]

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

Antibiotic Stewardship in Pediatrics. [2021]

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

Antibiotic assessment at hospital discharge-Room for stewardship intervention. [2021]

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

The Current State and Future Directions of Inpatient Pediatric Antimicrobial Stewardship. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of Discharge Antibiotic Prescribing at a Freestanding Children's Hospital: Opportunities for Stewardship. [2020]

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

Pediatric antimicrobial stewardship practices at discharge: A national survey. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Introducing an antibiotic stewardship program in a pediatric center in China. [2018]