DISCO: Discharge Stewardship in Children's Hospitals

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05826873

Collaborator

Seattle Children's Hospital (Other), Primary Children's Hospital (Other), St. Louis Children's Hospital (Other), University of Pennsylvania (Other), Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

5,720

Enrollment

Locations

Arms

60.7

Anticipated Duration (Months)

1144

Patients Per Site

18.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Bacterial Pneumonia Childhood Urinary Tract Infections Soft Tissue Infections Skin Infections Community-acquired Pneumonia	Behavioral: Discharge antibiotic stewardship intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5720 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Mixed methods implementation science study with a multicenter, quasi-experimental interrupted time-series design.Mixed methods implementation science study with a multicenter, quasi-experimental interrupted time-series design.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Implementing a Discharge Stewardship Bundle to Improve Antibiotic Use at Transition From Hospital to Home

Actual Study Start Date :

Jun 10, 2020

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Pediatric Hospitalists 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.	Behavioral: Discharge antibiotic stewardship intervention Hospitalists will be provided with group-level, quarterly feedback reports illustrating the number of prescriptions that had the appropriate antibiotic duration and appropriate antibiotic choice for each of the three conditions.
No Intervention: Families of hospitalized children 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.

Arm

Intervention/Treatment

Other: Pediatric Hospitalists

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.

Behavioral: Discharge antibiotic stewardship intervention

Hospitalists will be provided with group-level, quarterly feedback reports illustrating the number of prescriptions that had the appropriate antibiotic duration and appropriate antibiotic choice for each of the three conditions.

No Intervention: Families of hospitalized children

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.

Outcome Measures

Primary Outcome Measures

Rate of suboptimal prescribing [up to 3 years]
The primary objective of this study is to determine the impact of a discharge stewardship intervention on antibiotic prescribing and patient outcomes for three common pediatric infection after developing and implementing the intervention across four geographically diverse children's hospitals. Impact will be measured by the rate of suboptimal prescribing (drug, dose, route, and duration) for CAP, UTI, and SSTI across the four hospitals. Suboptimal prescribing will be measured using data collected from the electronic health record. The discharge prescription data (choice and duration) will be compared to the recommended guidelines to determine if the discharge prescription was on or off guideline.

Secondary Outcome Measures

Impact of the discharge stewardship intervention on post-discharge treatment failure [up to 3 years]
Using a quasi-experimental design, the study team will assess the rate and trajectory of post-discharge treatment failure for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)
Impact of the discharge stewardship intervention on adverse drug events [up to 3 years]
Using a quasi-experimental design, the study team will assess the rate and trajectory of adverse drug events for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Clinician Inclusion Criteria

18 year old
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

<18 years old
Not employed by the hospital

Patient Inclusion Criteria

Subjects less than 18 years
Diagnosed with either uncomplicated community acquired pneumonia, urinary tract infections, skin/soft tissue infections
Admitted and discharged from study site

Patient Exclusion Criteria

Subjects >18 years of age
Hospital length of stay >7 days
Requiring intensive care unit level of care

Parent Inclusion Criteria 1. Parent of eligible child

Parent Exclusion Criteria

Parent of ineligible child

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
2	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
4	Primary Children's Hospital	Salt Lake City	Utah	United States	84113
5	Seattle Children's Hospital	Seattle	Washington	United States	98105