Improving Post-discharge Antimicrobial Use

Sponsor
Iowa City Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05471726
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prospective audit-and-feedback
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped-wedgeStepped-wedge
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Post-discharge Antimicrobial Use: a Multicenter Stepped Wedge Trial Study
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Post-discharge antibiotic days of therapy [Every 2-week-period through study completion (48 weeks total)]

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

Secondary Outcome Measures

  1. Inpatient antibiotic days of therapy [Every two-week period through study completion (48 weeks total)]

    Inpatient antibiotic DOT will be calculated by adding inpatient DOT across all patients on the participating services and dividing by the number of patient-admissions discharged from those services during the study period.

  2. Percentage of participants with hospital readmission [30 days from discharge]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Richard Roudebush VA Medical Center Indianapolis Indiana United States 46202
2 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
3 Baltimore VA Medical Center Baltimore Maryland United States 21201-1524
4 Barnes Jewish Hospital and affiliated hospitals Saint Louis Missouri United States 63110
5 Audie L Murphy VA Medical Center San Antonio Texas United States 78229

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iowa City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT05471726
Other Study ID Numbers:
  • IRB 202109288
First Posted:
Jul 25, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Iowa City Veterans Affairs Medical Center

Study Results

No Results Posted as of Aug 12, 2022