- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01454947
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study) (BEARI)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Anaheim, California, Estados Unidos, 92801
- Altamed Anaheim Lincoln
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Anaheim, California, Estados Unidos, 92801
- Altamed Anaheim West
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Bell, California, Estados Unidos, 90201
- Altamed Bell Clinic
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City of Commerce, California, Estados Unidos, 90040
- Altamed Mobile Unit Primary Care
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El Monte, California, Estados Unidos, 91731
- Altamed DVL El Monte
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El Monte, California, Estados Unidos, 91731
- Altamed El Monte Clinic
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Garden Grove, California, Estados Unidos, 92840
- Altamed Garden Grove Harbor
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Huntington Beach, California, Estados Unidos, 92647
- Altamed Huntington Beach Clinic
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Huntington Park, California, Estados Unidos, 90255
- Altamed PACE Rugby
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Long Beach, California, Estados Unidos, 90802
- The Children's Clinic Family Health Center at Cesar Chavez Elementary School
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Long Beach, California, Estados Unidos, 90805
- The Children's Clinic Family Health Center at Hamilton Middle School
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Long Beach, California, Estados Unidos, 90806
- The S. Mark Taper Foundation Children's Clinic Family Health Center
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Long Beach, California, Estados Unidos, 90813
- The Children's Clinic at the Long Beach Multi-Service Center for the Homeless
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Long Beach, California, Estados Unidos, 90813
- The Vasek Polak Children's Clinic Family Health Center
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Los Angeles, California, Estados Unidos, 90012
- Altamed PACE Grand Plaza
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Los Angeles, California, Estados Unidos, 90012
- Altamed William Mead Homes
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Los Angeles, California, Estados Unidos, 90022
- Altamed Commerce Clinic
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Los Angeles, California, Estados Unidos, 90022
- Altamed DVL Commerce
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Los Angeles, California, Estados Unidos, 90022
- Altamed PACE Pomona
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Los Angeles, California, Estados Unidos, 90023
- Altamed Boyle Heights Clinic
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Los Angeles, California, Estados Unidos, 90023
- Altamed Estrada Courts
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Los Angeles, California, Estados Unidos, 90023
- Altamed Ramona Gardens
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Los Angeles, California, Estados Unidos, 90033
- AltaMed 1st St Boyle Heights Clinic
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Los Angeles, California, Estados Unidos, 90033
- Altamed Zonal Clinic
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Montebello, California, Estados Unidos, 90640
- Altamed Montebello Clinic
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Orange, California, Estados Unidos, 92869
- Altamed El Modena Clinic
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Pico Rivera, California, Estados Unidos, 90060
- Altamed Pico Clinic
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Pico Rivera, California, Estados Unidos, 90660
- Altamed DVL Pico
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Santa Ana, California, Estados Unidos, 92701
- Altamed Santa Ana Main
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Santa Ana, California, Estados Unidos, 92706
- Altamed Clinic For Women
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Santa Ana, California, Estados Unidos, 92707
- Altamed Santa Ana Broadway
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Santa Ana, California, Estados Unidos, 92707
- Altamed Santa Ana Central
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02035
- Brigham and Women's Primary Care Associates at Foxborough
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Boston, Massachusetts, Estados Unidos, 02108
- MGH Downtown
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Boston, Massachusetts, Estados Unidos, 02114
- Mass General Medial Group
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Boston, Massachusetts, Estados Unidos, 02114
- MGH Beacon Hill
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Boston, Massachusetts, Estados Unidos, 02114
- MGH Senior Health
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Boston, Massachusetts, Estados Unidos, 02114
- Women's Health Associates
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham Circle Medical Associates
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham Internal Medicine Associates
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Boston, Massachusetts, Estados Unidos, 02115
- Spanish Clinic
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Boston, Massachusetts, Estados Unidos, 02228
- MGH Back Bay
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Brookline, Massachusetts, Estados Unidos, 02446
- Brigham and Women's Primary Care Associates of Brookline
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Charlestown, Massachusetts, Estados Unidos, 02129
- MGH Charlestown HealthCare Center
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Chelsea, Massachusetts, Estados Unidos, 02150
- MGH Chelsea Healthcare Center
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Brigham and Women's Physician Group
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Gretchen and Edward Fish Center for Women's Health
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Everett, Massachusetts, Estados Unidos, 02149
- Everett Family Practice
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Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Brigham Primary Physicians at Faulkner
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Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Brookside Community Health Center
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Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Faulkner Community Physicians
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Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Southern Jamaica Plain Health Center
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Newton, Massachusetts, Estados Unidos, 02458
- Brigham and Women's Primary Care Associates of Newton Corner
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Revere, Massachusetts, Estados Unidos, 02151
- Mass General Revere HealthCare Center
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Waltham, Massachusetts, Estados Unidos, 02451
- Mass General West Medical Group
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: SA, AJ, PC
Participants are given all 3 interventions.
|
Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).
Otros nombres:
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Otros nombres:
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
|
Experimental: SA, AJ
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
|
Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).
Otros nombres:
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
|
Experimental: SA, PC
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
|
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Otros nombres:
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
|
Experimental: AJ, PC
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
|
Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).
Otros nombres:
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Otros nombres:
|
Experimental: Peer Comparison (PC)
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Otros nombres:
|
Experimental: Suggested Alternatives (SA)
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
|
Experimental: Accountable Justification (AJ)
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).
Otros nombres:
|
Sin intervención: Education Control
Participants do not receive any of the 3 interventions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses
Periodo de tiempo: 18 months
|
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 |
18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
Periodo de tiempo: 18 months
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We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.
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18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1RC4AG039115-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Clinical Decision Support (CDS): Accountable Justifications
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