NCT Number: NCT03349567
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.
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Interventional
Not applicable
Richard Roudebush VAMC, Indianapolis, Indiana, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
--An ED provider at one of the intervention or control sites.
Exclusion criteria
--An ED provider who sees less than 100 patients in the ED per year.
We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter.
Other names: Academic detailing
Time frame: This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.
This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Time frame: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider more than 24 hours after but within 30 days of the patient's ED visit.
Time frame: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Hospitalization is defined as the need for hospitalization for any indication at a VA-facility more than 24 hours after but within 30 days of the patient's index visit to the ED.
Time frame: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit.
Time frame: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered more than 24 hours after but within 30-days of the patient's ED visit.
Time frame: For the baseline and intervention periods, this outcome will be reported as the percentage of patients who received guideline-concordant management among the sample of qualifying ED visits that were randomly selected for manual chart review.
This outcome was assessed using blinded manual chart reviews in a randomly selected sample of patients that met inclusion criteria, as outlined in our study protocol. For this reason, the denominators for this outcome will not match the patient counts for the other outcomes. If a patient received an antimicrobial when indicated or did not receive an antimicrobial when not indicated, the patient was deemed to have received guideline-concordant management. During the baseline period, 497 charts were randomly selected for review, and 480 ultimately underwent adjudication. During the intervention period, 576 charts were randomly selected for review, and 455 underwent adjudication.
Time frame: This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.
This outcomes is defined as the total number of antibacterial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Iowa City Veterans Affairs Medical Center
Fed
The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
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