Improving Post-discharge Antimicrobial Use

Infections Clinical Trial

Official title:

Improving Post-discharge Antimicrobial Use: a Multicenter Stepped Wedge Trial Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471726
• Other study ID #: IRB 202109288
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: May 2023
• Source: Iowa City Veterans Affairs Medical Center
• Contact: Daniel J Livorsi, MD
• Phone: 319-688-3871
• Email: daniel-livorsi[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 19, 2023
• Est. primary completion date: November 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland
United States	Richard Roudebush VA Medical Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Barnes Jewish Hospital and affiliated hospitals	Saint Louis	Missouri
United States	Audie L Murphy VA Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Iowa City Veterans Affairs Medical Center	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inpatient antibiotic length of therapy	Inpatient antibiotic LOT will be calculated by adding inpatient 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 two-week period through study completion (48 weeks total)
Secondary	Percentage of participants with hospital readmission	Hospital readmissions reflect the need for (re) admission to an acute-care bed at a participating facility for any indication within 30 days of the patient's discharge.	30 days from discharge