Discharge Stewardship in Children's Hospitals (DISCO)

Children's Hospital of Philadelphia (CHOP)

Status: Invitation-only

Conditions: Urinary Tract Infections; Community-acquired Pneumonia; Skin Infections; Soft Tissue Infections; Pneumonia Childhood; Pneumonia, Bacterial

Treatments: Behavioral: Discharge antibiotic stewardship intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05826873

20-017269

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,720 estimated patients

Sex: All

Ages: 28 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,720 participants in 2 patient groups

Pediatric Hospitalists

Other group

Description:

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.

Treatment:

Behavioral: Discharge antibiotic stewardship intervention

Families of hospitalized children

No Intervention group

Description:

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.