NCT03022929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

January 11, 2017

Last Update Submit

December 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Antibiotic Prescribing Trends

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

    Up to 2 years

Study Arms (2)

Adapted Intervention

NO INTERVENTION

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.

Enhanced Intervention

EXPERIMENTAL

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.

Behavioral: Enhanced Antimicrobial Stewardship Commitment and Feedback

Interventions

Goes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon.

Enhanced Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

UCLA Harbor Medical Center

Torrance, California, 90509, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Larissa S May, MD,MSPH,MSHS

    Associate Professor and Director of Emergency Department Antibiotic Stewardship

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 18, 2017

Study Start

January 1, 2017

Primary Completion

September 24, 2018

Study Completion

September 24, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

No IPD planned.

Locations