Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05826873
Study type Interventional
Source Children's Hospital of Philadelphia
Contact
Status Enrolling by invitation
Phase N/A
Start date June 10, 2020
Completion date July 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04495699 - Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Terminated NCT05254808 - EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care Phase 3
Completed NCT03680612 - Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI Phase 2
Completed NCT03282006 - Treating Pyelonephritis an Urosepsis With Pivmecillinam Phase 4
Completed NCT03526484 - The Utility of Urinalysis Prior to In-Office Procedures N/A
Completed NCT05397782 - Effects of Flourish on Recurrent Urinary Tract Infection N/A
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03687255 - Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections Phase 3
Recruiting NCT05227937 - Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT03131609 - Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01333254 - A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients N/A
Terminated NCT00594594 - Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury Phase 1
Completed NCT00216853 - A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection N/A
Completed NCT00787085 - The Significance of Funguria in Hospitalized Patients N/A
Completed NCT05719753 - The Effectiveness of a Bacteriophobic Coating on Urinary Catheters N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Not yet recruiting NCT05880329 - DIagnoSing Care hOme UTI Study
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine