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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454947
First Posted: October 19, 2011
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jason Doctor, University of Southern California
  Purpose

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.


Condition Intervention
Acute Respiratory Infections (ARIs) Behavioral: Clinical Decision Support (CDS): Accountable Justifications Behavioral: Audit and Feedback: Peer Comparison Behavioral: CDS Order Sets: Suggested Alternatives

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)

Resource links provided by NLM:


Further study details as provided by Jason Doctor, University of Southern California:

Primary Outcome Measures:
  • 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 laryngeopharyngitis/acute upper respiratory infection

    466 Acute bronchitis

    490 Bronchitis not specified as acute or chronic

    487 Flu



Secondary Outcome Measures:
  • Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses [ Time Frame: 18 months ]
    We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.


Enrollment: 248
Study Start Date: August 2011
Study Completion Date: September 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SA, AJ, PC
Participants are given all 3 interventions.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications
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
Behavioral: Audit and Feedback: Peer Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Other Names:
  • PC
  • Peer Comparison
Behavioral: CDS Order Sets: Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Other Names:
  • SA
  • Suggested Alternatives
Experimental: SA, AJ
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications
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
Behavioral: CDS Order Sets: Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Other Names:
  • SA
  • Suggested Alternatives
Experimental: SA, PC
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
Behavioral: Audit and Feedback: Peer Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Other Names:
  • PC
  • Peer Comparison
Behavioral: CDS Order Sets: Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Other Names:
  • SA
  • Suggested Alternatives
Experimental: AJ, PC
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications
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
Behavioral: Audit and Feedback: Peer Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Other Names:
  • PC
  • Peer Comparison
Experimental: Peer Comparison (PC)
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
Behavioral: Audit and Feedback: Peer Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Other Names:
  • PC
  • Peer Comparison
Experimental: Suggested Alternatives (SA)
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
Behavioral: CDS Order Sets: Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Other Names:
  • SA
  • Suggested Alternatives
Experimental: Accountable Justification (AJ)
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications
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
No Intervention: Education Control
Participants do not receive any of the 3 interventions.

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454947


  Show 55 Study Locations
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
Investigators
Principal Investigator: Jason N Doctor, PhD University of Southern California
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jason Doctor, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01454947     History of Changes
Other Study ID Numbers: 1RC4AG039115-01 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2011
First Posted: October 19, 2011
Results First Submitted: July 20, 2015
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: March 2017

Keywords provided by Jason Doctor, University of Southern California:
Antibiotics
Inappropriate Prescribing
Respiratory Tract Infections
Behavioral Research

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases