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OpenTrials
Completed

NCT Number: NCT01454947

Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)

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 (i.e. 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 provider's 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altamed Anaheim Lincoln, Anaheim, California, United States

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About this study

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 patient's 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 laryngopharyngitis/acute 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 patient's 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A practicing attending physician or advanced practice nurse ("provider") at a participating clinic in 2011-2013 who sees acute respiratory infection patients.

Exclusion criteria

  • None.

Treatment and study plan

Clinical Decision Support (CDS): Accountable Justifications

Behavioral

Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).

Other names: AJ, Accountable Justification

Audit and Feedback: Peer Comparison

Behavioral

Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).

Other names: PC, Peer Comparison

CDS Order Sets: Suggested Alternatives

Behavioral

Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).

Other names: SA, Suggested Alternatives

Primary outcomes

  1. Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses

    Time frame: 18 months

    Assess inappropriate antibiotic prescribing rates (relative to all practices that did not receive the intervention) for antibiotic-inappropriate acute respiratory tract infection visits and no concomitant reason for antibiotic prescribing. based on the following non-antibiotic-appropriate International Statistical Classification of Diseases, version 9 (ICD-9) diagnoses:

    460 Acute nasopharyngitis (common cold)

    465 Acute laryngopharyngitis/acute upper respiratory infection

    466 Acute bronchitis

    490 Bronchitis not specified as acute or chronic

    487 Flu

Secondary outcomes

  1. Encounters Closely Following the Index Encounter for Serious Diagnoses

    Time frame: 18 months

    Within intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed, we will monitor return visit rates for the specified diagnoses and other acute respiratory infection diagnoses (ICD-9), including whooping cough (033.9), rheumatic fever (390-392) and pneumonia (481-487).

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: BEARI

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 19, 2011
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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