Discharge Antibiotic Stewardship for Pediatric Infections

(DISCO Trial)

Not currently recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve antibiotic prescriptions for children leaving the hospital. It targets kids treated for common infections such as pneumonia, urinary tract infections, or skin infections. The goal is to ensure children receive the correct antibiotics and avoid unnecessary ones, helping to prevent antibiotic resistance and improve recovery. Families with children treated for these infections and discharged from participating hospitals may qualify for this study. As an unphased trial, it offers families the chance to contribute to important research that could enhance antibiotic prescribing practices for children.

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.

What prior data suggests that this discharge antibiotic stewardship intervention is safe for children?

Research has shown that programs in children's hospitals aimed at managing antibiotic use are generally safe and well-received. These programs help reduce unnecessary antibiotic use, which is crucial for preventing antibiotic resistance. For example, studies have found that these programs can lower antibiotic use without harming patients.

A national survey revealed that, in many cases, the right antibiotics were chosen, but there is still room to improve the duration of their use. No specific reports of negative effects from these programs have emerged, indicating they are safe for children. Overall, these programs are designed to ensure correct antibiotic use, benefiting children's health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how antibiotics are used after children are discharged from the hospital. Unlike current practices, which often don't monitor antibiotic use closely after a patient leaves the hospital, this stewardship intervention involves tracking and guiding antibiotic use to ensure it's both necessary and effective. The goal is to reduce unnecessary antibiotic use, which can help prevent antibiotic resistance and improve overall patient outcomes. By involving both families and hospital staff, this approach could lead to more responsible antibiotic use and healthier kids.

What evidence suggests that this discharge antibiotic stewardship intervention is effective for reducing inappropriate antibiotic prescriptions for pediatric infections?

Research shows that programs in children's hospitals aimed at managing antibiotic use can effectively reduce unnecessary prescriptions and improve children's health. This trial will evaluate a discharge antibiotic stewardship intervention. One study found that these programs help cut down on over-prescribing and lead to better health outcomes for kids. In some hospitals, about 20% to 27% of prescriptions given at discharge were unnecessary, highlighting the need for clearer guidelines. By using specific guidelines for discharge, the goal is to lower these numbers. Evidence supports that similar efforts have successfully improved how antibiotics are prescribed and have enhanced patient health. ^{1 2 3 4 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05826873

Discharge Stewardship in Children's Hospitals (DISCO) To measure the impact of the discharge stewardship intervention on antibiotic prescribing and patient outcome for three common pediatric infections.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12561173/

Establishing Priority Pediatric Antimicrobial Stewardship ... This study aimed to systematically identify and prioritize the most critical, actionable interventions for improving antimicrobial stewardship ...

3. publications.aap.org publications.aap.org/pediatrics/article/147/1/e2020040295/33434/Antibiotic-Stewardship-in-Pediatrics

Antibiotic Stewardship in Pediatrics A growing body of evidence demonstrates that antibiotic stewardship programs (ASPs) reduce antibiotic overuse while improving patient outcomes. Consistent with ...

4. pediatrics.vumc.org pediatrics.vumc.org/sites/default/files/Discharge%20Stewardship%20ICHE%202021.pdf

Pediatric antimicrobial stewardship practices at discharge Pediatric antimicrobial stewardship programs (ASPs) have been shown to improve patient outcomes and reduce antibiotic over- use.1 Despite these ...

5. cambridge.org cambridge.org/core/product/2A63168C0B1E2AB34BBD78380B8F0301/core-reader

Discharge antibiotic prescribing at children's hospitals with ... Discharge prescribing patterns at children's hospitals are not well described. Single center studies have found that 20%–27% of discharge ...

6. researchgate.net researchgate.net/publication/353315815_Pediatric_antimicrobial_stewardship_practices_at_discharge_A_national_survey

Pediatric antimicrobial stewardship practices at discharge Antibiotic choice was optimal for 77%, and DOT was optimal for 26%. Only 20% of antibiotic courses included both optimal DOT and antibiotic ...