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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01454960
First received: August 4, 2011
Last updated: October 18, 2011
Last verified: October 2011
  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 EHR workflow containing exclusively guideline concordant choices (AP, for Alternative Prescriptions); Justification Alerts triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions (JA); and performance feedback that benchmarks providers' own performance to that of their peers (SN, for social norms).

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: Justification Alerts
Behavioral: Audit and Feedback: Social Norms
Behavioral: CDS Order Sets: Alternative Prescriptions

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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    Changes in antibiotic prescribing rate for the following 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: 2 years ] [ Designated as safety issue: No ]
    We will monitor overall prescribing for the specified diagnoses and other Acute Respiratory Infection diagnoses, including cough/fever and pneumonia.


Estimated Enrollment: 45
Study Start Date: July 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AP, JA, SN
Participants are given all 3 interventions.
Behavioral: Clinical Decision Support: Justification Alerts
Justification Alerts triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (JA).
Other Names:
  • JA
  • Justification Alerts
Behavioral: Audit and Feedback: Social Norms
Performance feedback that benchmarks providers' own performance to that of their peers (SN, for Social Norms).
Other Names:
  • SN
  • Social Norms
Behavioral: CDS Order Sets: Alternative Prescriptions
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (AP, for Alternative Prescriptions).
Other Names:
  • AP
  • Alternative Prescription
Experimental: AP, JA
Participants receive the Alternative Prescribing and Justification Alerts interventions, but not the Social Norms intervention.
Behavioral: Clinical Decision Support: Justification Alerts
Justification Alerts triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (JA).
Other Names:
  • JA
  • Justification Alerts
Behavioral: CDS Order Sets: Alternative Prescriptions
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (AP, for Alternative Prescriptions).
Other Names:
  • AP
  • Alternative Prescription
Experimental: AP, SN
Participants receive the Alternative Prescriptions and Social Norms interventions, but not the Justification Alerts intervention.
Behavioral: Audit and Feedback: Social Norms
Performance feedback that benchmarks providers' own performance to that of their peers (SN, for Social Norms).
Other Names:
  • SN
  • Social Norms
Behavioral: CDS Order Sets: Alternative Prescriptions
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (AP, for Alternative Prescriptions).
Other Names:
  • AP
  • Alternative Prescription
Experimental: JA, SN
Participants receive the Justification Alerts and Social Norms interventions, but not the Alternative Prescriptions intervention.
Behavioral: Clinical Decision Support: Justification Alerts
Justification Alerts triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (JA).
Other Names:
  • JA
  • Justification Alerts
Behavioral: Audit and Feedback: Social Norms
Performance feedback that benchmarks providers' own performance to that of their peers (SN, for Social Norms).
Other Names:
  • SN
  • Social Norms
Experimental: Social Norms
Participants receive the Social Norms intervention, but do not receive the Alternative Prescribing or Justification Alerts interventions.
Behavioral: Audit and Feedback: Social Norms
Performance feedback that benchmarks providers' own performance to that of their peers (SN, for Social Norms).
Other Names:
  • SN
  • Social Norms
Experimental: Alternative Prescriptions
Participants receive the Alternative Prescription intervention, but not the Justification Alerts or Social Norms interventions.
Behavioral: CDS Order Sets: Alternative Prescriptions
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (AP, for Alternative Prescriptions).
Other Names:
  • AP
  • Alternative Prescription
Experimental: Justification Alerts
Participants receive the Justification Alerts intervention, but do not receive the Alternative Prescriptions or Social Norms interventions.
Behavioral: Clinical Decision Support: Justification Alerts
Justification Alerts triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (JA).
Other Names:
  • JA
  • Justification Alerts
No Intervention: 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 Northwestern University's Enterprise Data Warehouse which houses copies of data recorded in the Epic 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 laryngeopharyngitis/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 AP arm, while clinicians randomized to the justification 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 social norm condition will receive monthly updates about their antibiotic prescribing practices relative to other clinicians in their practice.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A practicing attending physician or advanced practice nurse ("provider") at Northwestern University's NMFF GIM Clinic in 2011-2013 who sees acute respiratory infection patients.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454960

Locations
United States, Illinois
Northwestern Medical Faculty Foundation General Internal Medicine Clinic
Chicago, Illinois, United States, 60611-2923
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Stephen Persell, MD Northwestern University
Study Director: Jason N Doctor, PhD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01454960     History of Changes
Other Study ID Numbers: 1RC4AG039115-01-2, 1RC4AG039115-01
Study First Received: August 4, 2011
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014