Clinical trial NCT03022929: A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings
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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antibiotic Prescribing Trends
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Torrance
country: United States
facility: UCLA Harbor Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Associate Professor and Director of Emergency Department Antibiotic Stewardship
name: Larissa S May, MD,MSPH,MSHS
role: PRINCIPAL_INVESTIGATOR
References: