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

Primary Purpose

Acute Respiratory Infections (ARIs)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support: Accountable Justification
Audit and Feedback: Peer Comparison
CDS Order Sets: Suggested Alternatives
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Infections (ARIs) focused on measuring Antibiotics, Inappropriate Prescribing, Respiratory Tract Infections, Behavioral Research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern Medical Faculty Foundation General Internal Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

SA, AJ, PC

SA, AJ

SA, PC

AJ, PC

Peer Comparison

Suggested Alternatives

Accountable Justification

Control

Arm Description

Participants are given all 3 interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison.

Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.

Participants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention.

Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention.

Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.

Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.

Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.

Participants do not receive any of the 3 interventions.

Outcomes

Primary Outcome Measures

Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses
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
We will monitor overall prescribing for the specified diagnoses and other Acute Respiratory Infection diagnoses, including cough/fever and pneumonia.

Full Information

First Posted
August 4, 2011
Last Updated
March 31, 2017
Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01454960
Brief Title
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)
Acronym
BEARI
Official Title
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 (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 (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison). 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 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 Suggested Alternatives (SA) arm, while clinicians randomized to the Accountable Justification (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 (PC) condition will receive monthly updates about their antibiotic prescribing practices relative to other clinicians in their practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infections (ARIs)
Keywords
Antibiotics, Inappropriate Prescribing, Respiratory Tract Infections, Behavioral Research

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SA, AJ, PC
Arm Type
Experimental
Arm Description
Participants are given all 3 interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison.
Arm Title
SA, AJ
Arm Type
Experimental
Arm Description
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
Arm Title
SA, PC
Arm Type
Experimental
Arm Description
Participants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention.
Arm Title
AJ, PC
Arm Type
Experimental
Arm Description
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention.
Arm Title
Peer Comparison
Arm Type
Experimental
Arm Description
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
Arm Title
Suggested Alternatives
Arm Type
Experimental
Arm Description
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
Arm Title
Accountable Justification
Arm Type
Experimental
Arm Description
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants do not receive any of the 3 interventions.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Decision Support: Accountable Justification
Other Intervention Name(s)
AJ, Accountable Justification
Intervention Description
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback: Peer Comparison
Other Intervention Name(s)
PC, Peer Comparison
Intervention Description
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Intervention Type
Behavioral
Intervention Name(s)
CDS Order Sets: Suggested Alternatives
Other Intervention Name(s)
SA, Suggested Alternatives
Intervention Description
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Primary Outcome Measure Information:
Title
Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
Description
We will monitor overall prescribing for the specified diagnoses and other Acute Respiratory Infection diagnoses, including cough/fever and pneumonia.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Persell, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason N Doctor, PhD
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Medical Faculty Foundation General Internal Medicine Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2923
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27495917
Citation
Persell SD, Doctor JN, Friedberg MW, Meeker D, Friesema E, Cooper A, Haryani A, Gregory DL, Fox CR, Goldstein NJ, Linder JA. Behavioral interventions to reduce inappropriate antibiotic prescribing: a randomized pilot trial. BMC Infect Dis. 2016 Aug 5;16:373. doi: 10.1186/s12879-016-1715-8.
Results Reference
derived

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

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