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Improving Antimicrobial-Prescribing in Emergency Departments

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ClinicalTrials.gov Identifier: NCT03349567
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Daniel Livorsi, Iowa City Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE October 9, 2018
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
Antimicrobial-prescribing volume [ Time Frame: It will be calculated for the entire 12-months of both the pre-intervention period and the intervention period. ]
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.
Change History Complete list of historical versions of study NCT03349567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Antimicrobial-Prescribing in Emergency Departments
Official Title  ICMJE The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Anti-Bacterial Agents
  • Respiratory Tract Infections
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Audit-and-feedback
    The experimental arm will consist of Emergency Department providers who do receive the intervention.
    Intervention: Behavioral: Audit-and-feedback
  • No Intervention: Control
    The control arm will consist of providers who do not receive the intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2019)
27
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
60
Actual Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03349567
Other Study ID Numbers  ICMJE 201708772
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Livorsi, Iowa City Veterans Affairs Medical Center
Study Sponsor  ICMJE Iowa City Veterans Affairs Medical Center
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE Not Provided
PRS Account Iowa City Veterans Affairs Medical Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP