NCT05471726

Brief Summary

One in five hospitalized patients is prescribed an antimicrobial at the time of discharge, and a large proportion of these post-discharge antimicrobials are unnecessary. The investigators will evaluate a novel method for reviewing post-discharge antimicrobial prescriptions in real-time with the goal of improving antimicrobial selection and duration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

July 13, 2022

Last Update Submit

October 4, 2024

Conditions

Keywords

antibiotic prescriptionshospital dischargeantibiotic stewardship

Outcome Measures

Primary Outcomes (1)

  • Post-discharge antibiotic length of therapy

    The primary outcome will be post-discharge antimicrobial length of therapy (LOT) per 100 admissions. The investigators will calculate this by adding post-discharge LOT across all patients on the participating services and dividing by the number of patient-admissions discharged from those services during the study period.

    Every 2-week-period through study completion (48 weeks total)

Secondary Outcomes (2)

  • Inpatient antibiotic length of therapy

    Every two-week period through study completion (48 weeks total)

  • Percentage of participants with hospital readmission

    30 days from discharge

Study Arms (2)

Prospective audit-and-feedback at discharge

EXPERIMENTAL

When hospitals are in the intervention arm, they will perform the audit-and-feedback process focused on patients receiving antimicrobials who have an anticipated discharge.

Behavioral: Prospective audit-and-feedback

Standard of care

NO INTERVENTION

When hospitals are in the control arm, they will not perform a stewardship process that focuses on hospital discharge.

Interventions

The stewardship team will review patients who are on antibiotics, have an uncomplicated infection, and are eligible to continue antibiotics after discharge. Any recommendations from the stewardship team about optimizing antibiotic therapy will be presented to the primary prescriber in real-time with the goal of improving antibiotic selection and duration at hospital discharge.

Prospective audit-and-feedback at discharge

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll patients on a participating inpatient service at the participating hospitals will be included, regardless of gender, race, or age.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The local stewardship team agrees to implement the discharge stewardship intervention on at least one inpatient service or ward.

You may not qualify if:

  • The hospital already has an audit-and-feedback process in place that focuses on antimicrobial prescribing at hospital discharge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Richard Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Baltimore VA Medical Center

Baltimore, Maryland, 21201-1524, United States

Location

Barnes Jewish Hospital and affiliated hospitals

St Louis, Missouri, 63110, United States

Location

Audie L Murphy VA Medical Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Livorsi DJ, Thompson AM, Green MS, Hoelscher AC, Chu KK, Neuner E, Burnett Y, Hopkins T, Walter E, Dave R, Tripathi R, Lohmar H, Dysangco A, Percival K, Ince D, Kolkmeyer J, Newland H, Hendrix MJ, Clore G, Poe C, O'Shea A, Tholany J, Prasidthrathsint K, Rachmiel E, Bongu J, Bewley A, Hsueh K. Prospective Audit and Feedback by Antibiotic Stewardship Teams to Reduce Antibiotic Overuse at Hospital Discharge: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549655. doi: 10.1001/jamanetworkopen.2025.49655.

MeSH Terms

Conditions

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 25, 2022

Study Start

May 22, 2023

Primary Completion

November 19, 2023

Study Completion

September 9, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

All data will be aggregated to the hospital-level without including patient identifiers. This is a requirement for transmitting data across the institutions participating in this trial.

Locations