Clinical trial NCT03349567: Improving Antimicrobial-Prescribing in Emergency Departments
Official title: The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-Bacterial Agents
Respiratory Tract Infections
Lead sponsor: Iowa City Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-11-21
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
timeFrame: 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:
measure: Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit
timeFrame: 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.
measure: Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit
timeFrame: 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.
measure: Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit
timeFrame: 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.
measure: Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit
timeFrame: 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.
measure: Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
timeFrame: 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.
measure: Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
timeFrame: 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.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard Roudebush VAMC
state: Indiana
city: Sioux Falls
country: United States
facility: Sioux Falls VA
state: South Dakota
Study officials:
References: