Improving Post-discharge Antimicrobial Use

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections
• Intervention / Treatment: Behavioral: Prospective audit-and-feedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel J Livorsi, MD; Phone Number: 319-688-3871; Email: daniel-livorsi@uiowa.edu
• Study Contact Backup: Name: Cody Poe, MS; Phone Number: (319)356-1707; Email: cody-poe@uiowa.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Richard Roudebush VA Medical Center
      • Contact: Andrew Dysangco, MD; Phone Number: 317-988-9434; Email: andrew.dysangco@va.gov
      • Contact: Tamra Pierce, PharmD; Phone Number: 317-988-4472; Email: tamra.pierce@va.gov
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Dilek Ince, MD; Phone Number: 319-356-7740; Email: dilek-ince@uiowa.edu
      • Contact: Kelly Percival, PharmD; Phone Number: (319) 356-7328; Email: kelly-percival@uiowa.edu
  • Maryland
    • Baltimore, Maryland, United States, 21201-1524
      • Not yet recruiting
      • Baltimore VA Medical Center
      • Contact: Jacqueline Bork, MD; Email: jabork@som.umaryland.edu
      • Contact: Rohini Dave, PharmD; Phone Number: 410-605-7000; Email: rohini.dave@va.gov
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Barnes Jewish Hospital and affiliated hospitals
      • Contact: Kevin Hsueh, MD; Phone Number: 314-747-5447; Email: KHsueh@dom.wustl.edu
      • Contact: Tracey Habrock-Bach; Email: habrockt@wustl.edu
  • Texas
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • Audie L Murphy VA Medical Center
      • Contact: Teri Hopkins, PharmD; Phone Number: 16487 210-617-5300; Email: teri.hopkins@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Standard of care; When hospitals are in the control arm, they will not perform a stewardship process that focuses on hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Collaborators and Investigators

• Sponsor: Iowa City Veterans Affairs Medical Center
• Collaborators: Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): November 19, 2023
• Study Completion (Estimated): December 19, 2023

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: antibiotic stewardship; antibiotic prescriptions; hospital discharge
• Other Study ID Numbers: IRB 202109288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No