Improving Antimicrobial-Prescribing in Emergency Departments

Respiratory Tract Infections Clinical Trial

Official title:

The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349567
• Other study ID #: 201708772
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2021
• Source: Iowa City Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anti-Bacterial Agents
• Emergencies
• Respiratory Tract Infections

Intervention

Behavioral:
• Audit-and-feedback
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.

Locations

Country	Name	City	State
United States	Richard Roudebush VAMC	Indianapolis	Indiana
United States	Sioux Falls VA	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Iowa City Veterans Affairs Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit	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.	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.
Secondary	Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit	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.	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.
Secondary	Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit	Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's 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.
Secondary	Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit	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.	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.
Secondary	Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management	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.	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.
Secondary	Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit	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.	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.