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

Acute Respiratory Infections (ARIs) Clinical Trial

— BEARI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454947
• Other study ID #: 1RC4AG039115-01
• Secondary ID: 1RC4AG039115-01
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Infections (ARIs)
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

Behavioral:
• Clinical 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).
• Audit and Feedback: Peer Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
• CDS Order Sets: Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	18 months
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).	18 months