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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01454947
Acronym
BEARI
Enrollment
248
Registered
2011-10-19
Start date
2011-08-31
Completion date
2014-09-30
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infections (ARIs)

Keywords

Antibiotics, Inappropriate Prescribing, Respiratory Tract Infections, Behavioral Research

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.

Interventions

BEHAVIORALClinical 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).

Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).

Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses18 monthsAssess 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 laryngopharyngitis/acute upper respiratory infection 466 Acute bronchitis 490 Bronchitis not specified as acute or chronic 487 Flu

Secondary

MeasureTime frameDescription
Encounters Closely Following the Index Encounter for Serious Diagnoses18 monthsWithin intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed, we will monitor return visit rates for the specified diagnoses and other acute respiratory infection diagnoses (ICD-9), including whooping cough (033.9), rheumatic fever (390-392) and pneumonia (481-487).

Countries

United States

Participant flow

Participants by arm

ArmCount
Education Control
Participants do not receive any of the 3 interventions.
27
Suggested Alternatives (SA)
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
42
Accountable Justification (AJ)
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
35
Peer Comparison (PC)
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
20
SA, AJ
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
34
SA, PC
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
35
AJ, PC
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
27
SA, AJ, PC
Participants are given all 3 interventions.
28
Total248

Baseline characteristics

CharacteristicEducation ControlSuggested Alternatives (SA)Accountable Justification (AJ)Peer Comparison (PC)SA, AJSA, PCAJ, PCSA, AJ, PCTotal
Age, Continuous47 years
STANDARD_DEVIATION 12
49 years
STANDARD_DEVIATION 10
49 years
STANDARD_DEVIATION 9
46 years
STANDARD_DEVIATION 9
48 years
STANDARD_DEVIATION 9
51 years
STANDARD_DEVIATION 11
48 years
STANDARD_DEVIATION 10
46 years
STANDARD_DEVIATION 9
48 years
STANDARD_DEVIATION 10
Sex: Female, Male
Female
13 Participants30 Participants22 Participants12 Participants24 Participants25 Participants15 Participants16 Participants157 Participants
Sex: Female, Male
Male
14 Participants12 Participants13 Participants8 Participants10 Participants10 Participants12 Participants12 Participants91 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
14 / 3,24516 / 4,57916 / 4,62213 / 3,78122 / 5,71723 / 5,99348 / 3,39815 / 4,164
serious
Total, serious adverse events
0 / 3,2450 / 4,5790 / 4,6220 / 3,7810 / 5,7170 / 5,9930 / 3,3980 / 4,164

Outcome results

Primary

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 laryngopharyngitis/acute upper respiratory infection 466 Acute bronchitis 490 Bronchitis not specified as acute or chronic 487 Flu

Time frame: 18 months

Population: We identified a total of 16,959 non-antibiotic-appropriate acute respiratory infection (ARI) visits. Visits were categorized as inappropriate if there were diagnosis codes for non-specific upper respiratory infections, acute bronchitis, and/or influenza.

ArmMeasureValue (NUMBER)
ControlInappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.20 proportion of visits
Suggested Alternatives (SA)Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.19 proportion of visits
Accountable Justification (AJ)Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.08 proportion of visits
Peer Comparison (PC)Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.09 proportion of visits
Suggested Alternatives + Accountable JustificationInappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.07 proportion of visits
Suggested Alternatives + Peer ComparisonInappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.01 proportion of visits
Accountable Justification + Peer ComparisonInappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.03 proportion of visits
SA+AJ+PCInappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses0.03 proportion of visits
Secondary

Encounters Closely Following the Index Encounter for Serious Diagnoses

Within intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed, we will monitor return visit rates for the specified diagnoses and other acute respiratory infection diagnoses (ICD-9), including whooping cough (033.9), rheumatic fever (390-392) and pneumonia (481-487).

Time frame: 18 months

Population: Overall number of units analyzed is the number of intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed. Intervention-qualifying ARI encounters include all ARI visits eligible for the suggested alternatives and accountable justification interventions (not limited to the antibiotic-inappropriate ARI diagnoses that define the primary outcome).

ArmMeasureValue (COUNT_OF_UNITS)
ControlEncounters Closely Following the Index Encounter for Serious Diagnoses14 Qualifying encounters
Suggested Alternatives (SA)Encounters Closely Following the Index Encounter for Serious Diagnoses16 Qualifying encounters
Accountable Justification (AJ)Encounters Closely Following the Index Encounter for Serious Diagnoses16 Qualifying encounters
Peer Comparison (PC)Encounters Closely Following the Index Encounter for Serious Diagnoses13 Qualifying encounters
Suggested Alternatives + Accountable JustificationEncounters Closely Following the Index Encounter for Serious Diagnoses22 Qualifying encounters
Suggested Alternatives + Peer ComparisonEncounters Closely Following the Index Encounter for Serious Diagnoses23 Qualifying encounters
Accountable Justification + Peer ComparisonEncounters Closely Following the Index Encounter for Serious Diagnoses48 Qualifying encounters
SA+AJ+PCEncounters Closely Following the Index Encounter for Serious Diagnoses15 Qualifying encounters
p-value: 0.0072 proportion Z-test

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026