Improving Post-discharge Antimicrobial Use

NCT ID: NCT05471726

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2024-09-09

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.

Detailed Description

Antimicrobial stewardship programs (ASPs) work to improve antibiotic prescribing within hospitals. ASPs often restrict their activities to inpatient antimicrobial-prescribing. However, at least 40% of all antimicrobial exposure associated with an acute-care hospital stay is prescribed at the time of hospital discharge (i.e., post-discharge). Post-discharge antimicrobials mediate clinical outcomes after discharge and may facilitate the spread of antimicrobial resistance.

Several studies have shown that post-discharge antimicrobial use is often inappropriate. For example, using national VA data, the investigators found that 61% of fluoroquinolone treatment days were prescribed at hospital discharge; manual chart reviews at 9 hospitals found that 40% of these post-discharge fluoroquinolone prescriptions were either unnecessary or sub-optimal. Other studies have found that 53-79% of all post-discharge antimicrobials are either unnecessary or sub-optimal.

Post-discharge antimicrobials are an important target for antimicrobial stewardship. However, inpatient stewardship metrics do not capture post-discharge antimicrobials and ASPs frequently do not evaluate these prescriptions. A 2016 VA survey found that less than 50% of hospitals routinely reviewed targeted antimicrobials at discharge. According to a 2016 survey in Michigan, only 17% of 48 hospitals had a process for reviewing outpatient antimicrobial orders at discharge.

It is unclear how inpatient stewardship resources can be effectively leveraged to improve post-discharge antimicrobial use. If the goal is to improve post-discharge antimicrobial use, a potentially effective strategy may be an audit-and-feedback process focused solely on prescriptions for patients who will soon be discharged. In this trial, the investigators will evaluate the feasibility and effectiveness of such a process.

Conditions

Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Prospective audit-and-feedback at discharge

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.

Group Type: EXPERIMENTAL

Prospective audit-and-feedback

Intervention Type: BEHAVIORAL

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.

Standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prospective audit-and-feedback

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Iowa City Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Richard Roudebush VA Medical Center

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Baltimore VA Medical Center

Baltimore, Maryland, United States

Barnes Jewish Hospital and affiliated hospitals

St Louis, Missouri, United States

Audie L Murphy VA Medical Center

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB 202109288

Identifier Type: -

Identifier Source: org_study_id