Clinical trial NCT01454947: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)
Official title: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Infections (ARIs)
Keywords: Antibiotics
Inappropriate Prescribing
Respiratory Tract Infections
Behavioral Research
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-10-19
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses
timeFrame: 18 months
Secondary outcomes:
measure: Encounters Closely Following the Index Encounter for Serious Diagnoses
timeFrame: 18 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Altamed Anaheim Lincoln
state: California
city: Anaheim
country: United States
facility: Altamed Anaheim West
state: California
city: Bell
country: United States
facility: Altamed Bell Clinic
state: California
city: Commerce
country: United States
facility: Altamed Mobile Unit Primary Care
state: California
city: El Monte
country: United States
facility: Altamed DVL El Monte
state: California
city: El Monte
country: United States
facility: Altamed El Monte Clinic
state: California
city: Garden Grove
country: United States
facility: Altamed Garden Grove Harbor
state: California
city: Huntington Beach
country: United States
facility: Altamed Huntington Beach Clinic
state: California
city: Huntington Park
country: United States
facility: Altamed PACE Rugby
state: California
city: Long Beach
country: United States
facility: The Children's Clinic Family Health Center at Cesar Chavez Elementary School
state: California
city: Long Beach
country: United States
facility: The Children's Clinic Family Health Center at Hamilton Middle School
state: California
city: Long Beach
country: United States
facility: The S. Mark Taper Foundation Children's Clinic Family Health Center
state: California
city: Long Beach
country: United States
facility: The Children's Clinic at the Long Beach Multi-Service Center for the Homeless
state: California
city: Long Beach
country: United States
facility: The Vasek Polak Children's Clinic Family Health Center
state: California
city: Los Angeles
country: United States
facility: Altamed PACE Grand Plaza
state: California
city: Los Angeles
country: United States
facility: Altamed William Mead Homes
state: California
city: Los Angeles
country: United States
facility: Altamed Commerce Clinic
state: California
city: Los Angeles
country: United States
facility: Altamed DVL Commerce
state: California
city: Los Angeles
country: United States
facility: Altamed PACE Pomona
state: California
city: Los Angeles
country: United States
facility: Altamed Boyle Heights Clinic
state: California
city: Los Angeles
country: United States
facility: Altamed Estrada Courts
state: California
city: Los Angeles
country: United States
facility: Altamed Ramona Gardens
state: California
city: Los Angeles
country: United States
facility: AltaMed 1st St Boyle Heights Clinic
state: California
city: Los Angeles
country: United States
facility: Altamed Zonal Clinic
state: California
city: Montebello
country: United States
facility: Altamed Montebello Clinic
state: California
city: Orange
country: United States
facility: Altamed El Modena Clinic
state: California
city: Pico Rivera
country: United States
facility: Altamed Pico Clinic
state: California
city: Pico Rivera
country: United States
facility: Altamed DVL Pico
state: California
city: Santa Ana
country: United States
facility: Altamed Santa Ana Main
state: California
city: Santa Ana
country: United States
facility: Altamed Clinic For Women
state: California
city: Santa Ana
country: United States
facility: Altamed Santa Ana Broadway
state: California
city: Santa Ana
country: United States
facility: Altamed Santa Ana Central
state: California
city: Boston
country: United States
facility: Brigham and Women's Primary Care Associates at Foxborough
state: Massachusetts
city: Boston
country: United States
facility: MGH Downtown
state: Massachusetts
city: Boston
country: United States
facility: Mass General Medial Group
state: Massachusetts
city: Boston
country: United States
facility: MGH Beacon Hill
state: Massachusetts
city: Boston
country: United States
facility: MGH Senior Health
state: Massachusetts
city: Boston
country: United States
facility: Women's Health Associates
state: Massachusetts
city: Boston
country: United States
facility: Brigham Circle Medical Associates
state: Massachusetts
city: Boston
country: United States
facility: Brigham Internal Medicine Associates
state: Massachusetts
city: Boston
country: United States
facility: Spanish Clinic
state: Massachusetts
city: Boston
country: United States
facility: MGH Back Bay
state: Massachusetts
city: Brookline
country: United States
facility: Brigham and Women's Primary Care Associates of Brookline
state: Massachusetts
city: Charlestown
country: United States
facility: MGH Charlestown HealthCare Center
state: Massachusetts
city: Chelsea
country: United States
facility: MGH Chelsea HealthCare Center
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Women's Physician Group
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Gretchen and Edward Fish Center for Women's Health
state: Massachusetts
city: Everett
country: United States
facility: Everett Family Practice
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Brigham Primary Physicians at Faulkner
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Brookside Community Health Center
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Faulkner Community Physicians
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Southern Jamaica Plain Health Center
state: Massachusetts
city: Newton
country: United States
facility: Brigham and Women's Primary Care Associates of Newton Corner
state: Massachusetts
city: Revere
country: United States
facility: Mass General Revere HealthCare Center
state: Massachusetts
city: Waltham
country: United States
facility: Mass General West Medical Group
state: Massachusetts
Study officials:
affiliation: University of Southern California
name: Jason N Doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.