Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-03 @ 12:33 AM
Study NCT ID:
NCT03349567
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Antimicrobial-Prescribing in Emergency Departments
Sponsor:
Iowa City Veterans Affairs Medical Center
Organization:
Study Overview
Official Title:
The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Antimicrobial resistance is one of today's most urgent public health problems. One of the most important strategies to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use. There are tremendous opportunities to reduce unnecessary antimicrobial-prescribing, particularly in Emergency Departments (EDs). In this study, the investigators will work collaboratively with ED providers in the Veterans Health Administration (VHA) to reduce unnecessary antimicrobial use. Academic-detailing and an audit-and-feedback intervention will be implemented, and the study will assess how overall antimicrobial-prescribing changes once these interventions are performed. ED providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions. To assess the impact of this intervention, the study will monitor providers' antimicrobial-prescribing behavior through an automated metric, i.e. number of antimicrobial prescriptions per number of patient-visits. To assess changes in the appropriateness of antimicrobial-prescribing, the study team will also perform manual chart reviews and compare prescribing decisions to published guidelines.
Detailed Description:
Using a quasi-experimental design, the study team will work collaboratively with ED providers in the Veterans Health Administration (VHA) to improve antimicrobial-prescribing. Academic-detailing and an audit-and-feedback intervention will be implemented. Through audit-and-feedback, providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions.
The study will use a pretest-posttest design (quasi-experimental design with a non-equivalent control group) to assess the effect of our pilot intervention at 2 participating EDs and 2 control EDs. For each ED, the pretest period will be the 12 months prior to the intervention. The intervention itself will last 12 months.
There will be an estimated 30 ED providers at the 2 study sites and 30 ED providers at the 2 control sites. Only antimicrobial prescriptions to patients discharged from the ED will be evaluated.
The primary outcome will be antimicrobial-prescribing volume adjusted for the total number of patient-visits. Secondary outcomes include the frequency of guideline-discordant antimicrobial-prescribing and adverse events.
At the conclusion of the pilot trial, a quasi-experimental interrupted time-series (ITS) analysis will be performed to assess the change in monthly antimicrobial usage for the 2 intervention sites combined and the 2 control sites combined. The time frame for this ITS analysis will be the one-year prior to the pilot trial's initiation through the trial's 1-year intervention period for a total of 24 months. In addition, a multivariable analysis will be performed to identify predictors of guideline-discordant therapy.
The study will use a pretest-posttest design (quasi-experimental design with a non-equivalent control group) to assess the effect of our pilot intervention at 2 participating EDs and 2 control EDs. For each ED, the pretest period will be the 12 months prior to the intervention. The intervention itself will last 12 months.
There will be an estimated 30 ED providers at the 2 study sites and 30 ED providers at the 2 control sites. Only antimicrobial prescriptions to patients discharged from the ED will be evaluated.
The primary outcome will be antimicrobial-prescribing volume adjusted for the total number of patient-visits. Secondary outcomes include the frequency of guideline-discordant antimicrobial-prescribing and adverse events.
At the conclusion of the pilot trial, a quasi-experimental interrupted time-series (ITS) analysis will be performed to assess the change in monthly antimicrobial usage for the 2 intervention sites combined and the 2 control sites combined. The time frame for this ITS analysis will be the one-year prior to the pilot trial's initiation through the trial's 1-year intervention period for a total of 24 months. In addition, a multivariable analysis will be performed to identify predictors of guideline-discordant therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: