Viewing Study NCT05826873



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Last Modification Date: 2024-10-26 @ 2:57 PM
Study NCT ID: NCT05826873
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-04-25
First Post: 2023-04-12

Brief Title: Discharge Stewardship in Childrens Hospitals
Sponsor: Childrens Hospital of Philadelphia
Organization: Childrens Hospital of Philadelphia

Study Overview

Official Title: Implementing a Discharge Stewardship Bundle to Improve Antibiotic Use at Transition From Hospital to Home
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DISCO
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 skinsoft tissue infections SSTI The goals of this study are

To develop locally adapt and implement a discharge stewardship intervention across four geographically diverse childrens 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 skinsoft tissue infections SSTI - at four childrens 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 childrens hospitals across North America that is uniquely positioned to adopt antimicrobial stewardship interventions designed to target prescribing at hospital discharge

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HS027428-01 AHRQ None httpsreporternihgovquickSearchR01HS027428-01