Clinical trial NCT05826873: Discharge Stewardship in Children's Hospitals
Official title: Implementing a Discharge Stewardship Bundle to Improve Antibiotic Use at Transition From Hospital to Home
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pneumonia, Bacterial
Pneumonia Childhood
Urinary Tract Infections
Soft Tissue Infections
Skin Infections
Community-acquired Pneumonia
Keywords: Stewardship
Discharge Stewardship
Group-level feedback
Antibiotic
Community-acquired pneumonia
Skin and soft tissue infections
Urinary Tract Infections
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: Primary Children's Hospital
name: St. Louis Children's Hospital
name: University of Pennsylvania
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-04-24
Enrollment: 1131
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Mixed methods implementation science study with a multicenter, quasi-experimental interrupted time-series design.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of suboptimal prescribing
timeFrame: up to 3 years
Secondary outcomes:
measure: Impact of the discharge stewardship intervention on post-discharge treatment failure
timeFrame: up to 3 years
measure: Impact of the discharge stewardship intervention on adverse drug events
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Associate Professor, Pediatrics
name: Jeffrey S Gerber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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