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A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings (MITIGATE)

Primary Purpose

Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Antimicrobial Stewardship Commitment and Feedback
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Clinicians will be eligible for the study if they meet the following Inclusion Criteria:

  1. Must be a clinician at one of the study sites.
  2. Must treat adult and/or pediatric patients with an acute respiratory infections.

Individual patient encounters will be ineligible for analysis if they meet any of the following Exclusion Criteria:

  1. Medical co-morbidities that make acute respiratory infection (ARI) guidelines less likely to apply.
  2. Concomitant visit diagnoses indicating a non-ARI possible bacterial infection.
  3. Concomitant visit diagnoses indicating potentially antibiotic appropriate ARI. diagnoses or other ARI diagnoses suggestive of a bacterial infection.
  4. Visit occurred within 30 days of an earlier ARI diagnosis.

Sites / Locations

  • UC Davis Medical Center
  • UCLA Harbor Medical Center
  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Adapted Intervention

Enhanced Intervention

Arm Description

The investigators will use GetSmart materials published by the CDC appropriate to the emergency department and urgent care settings and select and adapt brochures and other campaign messages for acute care providers.

The investigators will use all of the methods of the Adapted Intervention. In addition to these methods, the investigators will add posters within exam rooms which will include modified GetSmart content and other nudges such as physician pictures with their signed public commitment to antibiotic stewardship or flair denoting commitment to stewardship. The investigators will also provide physicians with personalized monthly performance ranking with each physician receiving the designation of "top performer" or "not a top performer" based on their appropriate antibiotic prescribing practices for acute respiratory infections. This will be the Enhanced Antimicrobial Stewardship Commitment and Feedback intervention.

Outcomes

Primary Outcome Measures

Antibiotic Prescribing Trends
The investigators will measure the likelihood that an antibiotic is prescribed in an antibiotic-nonresponsive acute respiratory infection visit.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2017
Last Updated
December 18, 2018
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03022929
Brief Title
A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings
Acronym
MITIGATE
Official Title
A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Inappropriate antibiotic use is a major public health concern. Excessive exposure to antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable adverse drug reactions, and increased healthcare utilization and cost. As antibiotic prescribing in emergency departments and urgent care centers remains unchecked, national professional organizations including the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of the United States, recommend expansion of antimicrobial stewardship to these ambulatory care settings. The goal of antimicrobial stewardship is to effectively promote judicious antibiotic use in all healthcare settings, yet stewardship programs have not achieved their potential in terms of either reach or effectiveness. Reach has been limited by implementation mostly in inpatient settings; at the same time, recent critical experiments in behavioral science suggest that the effectiveness of existing stewardship programs could be greatly augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and peer-to-peer comparisons.
Detailed Description
In this proposed acute care project, the investigators will compare a package consisting of education for providers using existing materials from Center for Disease Control and Prevention's (CDC) GetSmart campaign adapted for the acute care setting led by a physician champion at each site (the adapted intervention), to a more intensive intervention that incorporates adapted GetSmart materials enhanced with individualized audit and feedback, peer comparisons, and behavioral nudges (the enhanced intervention). The comparative effectiveness of the enhanced intervention will be evaluated in a multicenter cluster randomized trial nested within a quasi-experimental study of acute care stewardship. The investigators' hypothesis is that both interventions will reduce inappropriate antibiotic prescribing for antibiotic nonresponsive acute respiratory infections (ARIs) in emergency departments and urgent care centers, but that the enhanced one will be more effective. The investigators will use an interrupted time series study design to measure the impact of their interventions against the baseline period of usual care as well as against seasonally-adjusted historical controls. The cluster randomized design for the two types of acute care stewardship interventions will allow measurement of the difference- in-differences in antibiotic prescribing rates for acute bronchitis, acute bronchiolitis, viral pharyngitis, influenza, and nonspecific upper respiratory infection (URI). Translation of proven behavioral techniques is a new and innovative approach to improving prescribing decisions. This project will expand stewardship to a new setting using innovative and effective approaches including the adaptation of behavioral techniques for emergency department (ED) and urgent care settings. The investigators will also further establish their research group as a network for developing novel tools, measuring outcomes for antimicrobial stewardship, and disseminating research findings through acute care setting-specific toolkits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapted Intervention
Arm Type
No Intervention
Arm Description
The investigators will use GetSmart materials published by the CDC appropriate to the emergency department and urgent care settings and select and adapt brochures and other campaign messages for acute care providers.
Arm Title
Enhanced Intervention
Arm Type
Experimental
Arm Description
The investigators will use all of the methods of the Adapted Intervention. In addition to these methods, the investigators will add posters within exam rooms which will include modified GetSmart content and other nudges such as physician pictures with their signed public commitment to antibiotic stewardship or flair denoting commitment to stewardship. The investigators will also provide physicians with personalized monthly performance ranking with each physician receiving the designation of "top performer" or "not a top performer" based on their appropriate antibiotic prescribing practices for acute respiratory infections. This will be the Enhanced Antimicrobial Stewardship Commitment and Feedback intervention.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Antimicrobial Stewardship Commitment and Feedback
Intervention Description
Goes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon.
Primary Outcome Measure Information:
Title
Antibiotic Prescribing Trends
Description
The investigators will measure the likelihood that an antibiotic is prescribed in an antibiotic-nonresponsive acute respiratory infection visit.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Clinicians will be eligible for the study if they meet the following Inclusion Criteria: Must be a clinician at one of the study sites. Must treat adult and/or pediatric patients with an acute respiratory infections. Individual patient encounters will be ineligible for analysis if they meet any of the following Exclusion Criteria: Medical co-morbidities that make acute respiratory infection (ARI) guidelines less likely to apply. Concomitant visit diagnoses indicating a non-ARI possible bacterial infection. Concomitant visit diagnoses indicating potentially antibiotic appropriate ARI. diagnoses or other ARI diagnoses suggestive of a bacterial infection. Visit occurred within 30 days of an earlier ARI diagnosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa S May, MD,MSPH,MSHS
Organizational Affiliation
Associate Professor and Director of Emergency Department Antibiotic Stewardship
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCLA Harbor Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD planned.

Learn more about this trial

A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings

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