Improving Antimicrobial-Prescribing in Emergency Departments

NCT03349567 | Completed Results

• 1 other identifier: 201708772
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Anti-Bacterial Agents; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit

  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.

  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.

Secondary Outcomes (6)

• Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit

  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.

• Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit

  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.

• Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit

  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.

• Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit

  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.

• Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management

  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.

Study Arms (2)

Audit-and-feedback

EXPERIMENTAL

The experimental arm will consist of Emergency Department providers who do receive the intervention.

Behavioral: Audit-and-feedback

Control

NO INTERVENTION

The control arm will consist of providers who do not receive the intervention.

Interventions

Audit-and-feedback BEHAVIORAL

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.

Also known as: Academic detailing

Audit-and-feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An ED provider at one of the intervention or control sites.

You may not qualify if:

• An ED provider who sees less than 100 patients in the ED per year.

Sponsors & Collaborators

• Iowa City Veterans Affairs Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Richard Roudebush VAMC

Indianapolis, Indiana, 46202, United States

Location

Sioux Falls VA

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

Because the study was not randomized, we cannot exclude temporal confounding or selection bias. By conducting a time-series analysis, we tried to account for confounders that may change over time, and by including a matched-control group, we tried to minimize the possibility of regression to the mean. Second, we cannot exclude the possibility that sites had any other processes in place that could have influenced our outcomes.

Results Point of Contact

• Title: Daniel Livorsi
• Organization: Iowa City VA Health Care System

daniel-livorsi@uiowa.edu

319-688-3871

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-investigator

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: October 9, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 31, 2019
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)