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

Primary Purpose

Acute Respiratory Infections (ARIs)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support (CDS): Accountable Justifications
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 a participating clinic in 2011-2013 who sees acute respiratory infection patients.

Exclusion Criteria:

  • None.

Sites / Locations

  • Altamed Anaheim Lincoln
  • Altamed Anaheim West
  • Altamed Bell Clinic
  • Altamed Mobile Unit Primary Care
  • Altamed DVL El Monte
  • Altamed El Monte Clinic
  • Altamed Garden Grove Harbor
  • Altamed Huntington Beach Clinic
  • Altamed PACE Rugby
  • The Children's Clinic Family Health Center at Cesar Chavez Elementary School
  • The Children's Clinic Family Health Center at Hamilton Middle School
  • The S. Mark Taper Foundation Children's Clinic Family Health Center
  • The Children's Clinic at the Long Beach Multi-Service Center for the Homeless
  • The Vasek Polak Children's Clinic Family Health Center
  • Altamed PACE Grand Plaza
  • Altamed William Mead Homes
  • Altamed Commerce Clinic
  • Altamed DVL Commerce
  • Altamed PACE Pomona
  • Altamed Boyle Heights Clinic
  • Altamed Estrada Courts
  • Altamed Ramona Gardens
  • AltaMed 1st St Boyle Heights Clinic
  • Altamed Zonal Clinic
  • Altamed Montebello Clinic
  • Altamed El Modena Clinic
  • Altamed Pico Clinic
  • Altamed DVL Pico
  • Altamed Santa Ana Main
  • Altamed Clinic For Women
  • Altamed Santa Ana Broadway
  • Altamed Santa Ana Central
  • Brigham and Women's Primary Care Associates at Foxborough
  • MGH Downtown
  • Mass General Medial Group
  • MGH Beacon Hill
  • MGH Senior Health
  • Women's Health Associates
  • Brigham Circle Medical Associates
  • Brigham Internal Medicine Associates
  • Spanish Clinic
  • MGH Back Bay
  • Brigham and Women's Primary Care Associates of Brookline
  • MGH Charlestown HealthCare Center
  • MGH Chelsea HealthCare Center
  • Brigham and Women's Physician Group
  • Gretchen and Edward Fish Center for Women's Health
  • Everett Family Practice
  • Brigham Primary Physicians at Faulkner
  • Brookside Community Health Center
  • Faulkner Community Physicians
  • Southern Jamaica Plain Health Center
  • Brigham and Women's Primary Care Associates of Newton Corner
  • Mass General Revere HealthCare Center
  • Mass General West Medical Group

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 (PC)

Suggested Alternatives (SA)

Accountable Justification (AJ)

Education Control

Arm Description

Participants are given all 3 interventions.

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

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

Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative 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

Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses
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
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 30, 2017
Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01454947
Brief Title
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)
Acronym
BEARI
Official Title
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2014 (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 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.
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.

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
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SA, AJ, PC
Arm Type
Experimental
Arm Description
Participants are given all 3 interventions.
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 Alternative 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 Alternative intervention.
Arm Title
Peer Comparison (PC)
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 (SA)
Arm Type
Experimental
Arm Description
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
Arm Title
Accountable Justification (AJ)
Arm Type
Experimental
Arm Description
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Arm Title
Education 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 (CDS): Accountable Justifications
Other Intervention Name(s)
AJ, Accountable Justification
Intervention Description
Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (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
Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses
Description
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
Time Frame
18 months
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
18 months

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 a participating clinic in 2011-2013 who sees acute respiratory infection patients. Exclusion Criteria: None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason N Doctor, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altamed Anaheim Lincoln
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Altamed Anaheim West
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Altamed Bell Clinic
City
Bell
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Altamed Mobile Unit Primary Care
City
City of Commerce
State/Province
California
ZIP/Postal Code
90040
Country
United States
Facility Name
Altamed DVL El Monte
City
El Monte
State/Province
California
ZIP/Postal Code
91731
Country
United States
Facility Name
Altamed El Monte Clinic
City
El Monte
State/Province
California
ZIP/Postal Code
91731
Country
United States
Facility Name
Altamed Garden Grove Harbor
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Altamed Huntington Beach Clinic
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Altamed PACE Rugby
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
The Children's Clinic Family Health Center at Cesar Chavez Elementary School
City
Long Beach
State/Province
California
ZIP/Postal Code
90802
Country
United States
Facility Name
The Children's Clinic Family Health Center at Hamilton Middle School
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
The S. Mark Taper Foundation Children's Clinic Family Health Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
The Children's Clinic at the Long Beach Multi-Service Center for the Homeless
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
The Vasek Polak Children's Clinic Family Health Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Altamed PACE Grand Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Altamed William Mead Homes
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Altamed Commerce Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Altamed DVL Commerce
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Altamed PACE Pomona
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Altamed Boyle Heights Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90023
Country
United States
Facility Name
Altamed Estrada Courts
City
Los Angeles
State/Province
California
ZIP/Postal Code
90023
Country
United States
Facility Name
Altamed Ramona Gardens
City
Los Angeles
State/Province
California
ZIP/Postal Code
90023
Country
United States
Facility Name
AltaMed 1st St Boyle Heights Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Altamed Zonal Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Altamed Montebello Clinic
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Altamed El Modena Clinic
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Altamed Pico Clinic
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90060
Country
United States
Facility Name
Altamed DVL Pico
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Altamed Santa Ana Main
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Altamed Clinic For Women
City
Santa Ana
State/Province
California
ZIP/Postal Code
92706
Country
United States
Facility Name
Altamed Santa Ana Broadway
City
Santa Ana
State/Province
California
ZIP/Postal Code
92707
Country
United States
Facility Name
Altamed Santa Ana Central
City
Santa Ana
State/Province
California
ZIP/Postal Code
92707
Country
United States
Facility Name
Brigham and Women's Primary Care Associates at Foxborough
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
MGH Downtown
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02108
Country
United States
Facility Name
Mass General Medial Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MGH Beacon Hill
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MGH Senior Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Women's Health Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham Circle Medical Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham Internal Medicine Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Spanish Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MGH Back Bay
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02228
Country
United States
Facility Name
Brigham and Women's Primary Care Associates of Brookline
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States
Facility Name
MGH Charlestown HealthCare Center
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
MGH Chelsea HealthCare Center
City
Chelsea
State/Province
Massachusetts
ZIP/Postal Code
02150
Country
United States
Facility Name
Brigham and Women's Physician Group
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Gretchen and Edward Fish Center for Women's Health
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Everett Family Practice
City
Everett
State/Province
Massachusetts
ZIP/Postal Code
02149
Country
United States
Facility Name
Brigham Primary Physicians at Faulkner
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Brookside Community Health Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Faulkner Community Physicians
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Southern Jamaica Plain Health Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Brigham and Women's Primary Care Associates of Newton Corner
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02458
Country
United States
Facility Name
Mass General Revere HealthCare Center
City
Revere
State/Province
Massachusetts
ZIP/Postal Code
02151
Country
United States
Facility Name
Mass General West Medical Group
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26864410
Citation
Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
Results Reference
background
PubMed Identifier
29740788
Citation
Gong CL, Zangwill KM, Hay JW, Meeker D, Doctor JN. Behavioral Economics Interventions to Improve Outpatient Antibiotic Prescribing for Acute Respiratory Infections: a Cost-Effectiveness Analysis. J Gen Intern Med. 2019 Jun;34(6):846-854. doi: 10.1007/s11606-018-4467-x. Epub 2018 May 8.
Results Reference
derived
PubMed Identifier
27660322
Citation
Gong CL, Hay JW, Meeker D, Doctor JN. Prescriber preferences for behavioural economics interventions to improve treatment of acute respiratory infections: a discrete choice experiment. BMJ Open. 2016 Sep 22;6(9):e012739. doi: 10.1136/bmjopen-2016-012739.
Results Reference
derived
PubMed Identifier
23806017
Citation
Persell SD, Friedberg MW, Meeker D, Linder JA, Fox CR, Goldstein NJ, Shah PD, Knight TK, Doctor JN. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]--study protocol and baseline practice and provider characteristics. BMC Infect Dis. 2013 Jun 27;13:290. doi: 10.1186/1471-2334-13-290.
Results Reference
derived

Learn more about this trial

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

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