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Improving Antimicrobial-Prescribing in Emergency Departments

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ClinicalTrials.gov Identifier: NCT03349567
Recruitment Status : Not yet recruiting
First Posted : November 21, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Daniel Livorsi, Iowa City Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Anti-Bacterial Agents Respiratory Tract Infections Behavioral: Audit-and-feedback Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Audit-and-feedback
The experimental arm will consist of Emergency Department providers who do receive the 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.
Other Name: Academic detailing

No Intervention: Control
The control arm will consist of providers who do not receive the intervention.



Primary Outcome Measures :
  1. Change in antimicrobial-prescribing volume [ Time Frame: Change in antimicrobial-prescribing volume will be calculated across the 12-months of the intervention period in comparison to the 12-months of the pre-intervention period. An interrupted time-series analysis will be performed. ]
    Antimicrobial-prescribing volume reflects the volume of antimicrobials prescribed per patient-visits. It is defined as the total number of antimicrobial prescriptions divided by the total number of patient-visits. This metric will be calculated on the provider level. It will also be calculated as an aggregate across all intervention sites and separately across all control sites.


Secondary Outcome Measures :
  1. Guideline-discordant antimicrobial use [ Time Frame: It will be calculated for the entire 12-months of both the pre-intervention period and the intervention period. ]
    Guideline-discordant antimicrobial use is defined as the frequency of guideline-discordant antimicrobial-prescribing. To calculate this outcome, a trained chart abstractor will first manually review the medical records from a random sample of 25 visits for each provider. Visits that are audited will be associated with an ICD-10 code for an ARTI or cystitis.

  2. Late antimicrobial prescription [ Time Frame: It will be calculated for the entire 12-months of both the pre-intervention period and the intervention period. ]
    Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider within 30 days of the patient's index visit with the ED provider.

  3. Hospitalization [ Time Frame: It will be calculated for the entire 12-months of both the pre-intervention period and the intervention period. ]
    Hospitalization is defined as the need for hospitalization for any indication at a VA-facility within 30 days of the patient's index visit with the ED provider.

  4. Mortality [ Time Frame: It will be calculated for the entire 12-months of both the pre-intervention period and the intervention period. ]
    Mortality is defined as all-cause death within 30-days of the patient's index visit with the ED provider.

  5. Clostridium difficile [ Time Frame: It will be calculated for the entire 12-months of both the pre-intervention period and the intervention period. ]
    Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered within 30-days of the patient's index visit with the ED provider. Clostridium difficile infection (CDI) is defined as a positive laboratory test for Clostridium difficile within 30-days of the patient's index visit with the ED provider.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349567


Contacts
Contact: Daniel J Livorsi, MD 319-338-0581 ext 3866 daniel.livorsi@va.gov
Contact: Rajeshwair Nair, PhD, MBBS 319-338-0581 ext 3831 rajeshwari-nair@uiowa.edu

Sponsors and Collaborators
Iowa City Veterans Affairs Medical Center
Merck Sharp & Dohme Corp.

Responsible Party: Daniel Livorsi, Physician-investigator, Iowa City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03349567     History of Changes
Other Study ID Numbers: 201708772
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emergencies
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Infection
Respiratory Tract Diseases
Anti-Infective Agents
Anti-Bacterial Agents