Viewing Study NCT01454947



Ignite Creation Date: 2024-05-05 @ 11:57 PM
Last Modification Date: 2024-10-26 @ 10:42 AM
Study NCT ID: NCT01454947
Status: COMPLETED
Last Update Posted: 2024-05-23
First Post: 2011-08-04

Brief Title: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections Main Study
Sponsor: University of Southern California
Organization: University of Southern California

Study Overview

Official Title: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections Main Study
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BEARI
Brief Summary: Bacteria resistant to antibiotic therapy are a major public health problem The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains Though providers are adequately trained to know when antibiotics are and are not comparatively effective this has not been sufficient to affect critical provider practices

The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics Specifically targeted are infections that are likely to be viral

The objective of this study is to improve provider decisions around treatment of acute respiratory infections

The participants are practicing attending physicians or advanced practice nurses ie providers at participating clinics who see acute respiratory infection patients A maximum of 550 participants will be recruited for this study

Providers consenting to participate will fill out a baseline questionnaire online Subsequent to baseline data collection and enrollment participating clinic sites will be randomized to the study arms as described below

There will be a control arm with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record Order Sets that are triggered by electronic health record EHR workflow containing exclusively guideline concordant choices SA for Suggested Alternatives Accountable Justifications triggered by discordant prescriptions that populate the note with providers rationale for guideline exceptions AJ and performance feedback that benchmarks providers own performance to that of their peers PC for Peer Comparisons

The outcomes of interest are antibiotic prescribing patterns including prescribing rates and changes in prescribing rates over time

The intervention period will be over one year with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts
Detailed Description: Each consented provider will be randomized to 1 of 8 cells in a factorial design with equal probability If results of retrospective data analysis imply that design will be improved by stratification randomization will be stratified by factors that could influence outcomes

Data will be collected from the clinics Enterprise Data Warehouses which store copies of data recorded in the electronic health record Data elements from qualifying office visits will be collected from coded portions of the electronic health record

An encounter is eligible for intervention if the patients diagnosis is in the selected group of acute respiratory infections The intervention EHR functions will be triggered when clinicians initiate an antibiotic prescription or enter a diagnosis for an acute respiratory infection that has a defined Order Set If an antibiotic from a list of frequently misprescribed antibiotics is ordered and a diagnosis has not yet been entered providers will be prompted to enter a diagnosis If the diagnosis entered is acute nasopharyngitis acute laryngopharyngitisacute upper respiratory infection acute bronchitis bronchitis not specified as acute or chronic or flu the interventions will be triggered The diagnosis-appropriate order set will pop-up for providers in the SA arm while clinicians randomized to the AJ arm will receive an alert and be required to enter a brief statement justifying their antibiotic prescription if antibiotics are not indicated for the diagnosis entered This note will then be added to the patients medical record

Clinicians randomized to the Peer Comparison condition will receive email updates about their antibiotic prescribing practices relative to other clinicians in their practice

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1RC4AG039115-01 NIH None httpsreporternihgovquickSearch1RC4AG039115-01