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

30 de marzo de 2017 actualizado por: Jason Doctor, University of Southern California

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

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

Intervencionista

Inscripción (Actual)

248

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • Anaheim, California, Estados Unidos, 92801
        • Altamed Anaheim Lincoln
      • Anaheim, California, Estados Unidos, 92801
        • Altamed Anaheim West
      • Bell, California, Estados Unidos, 90201
        • Altamed Bell Clinic
      • City of Commerce, California, Estados Unidos, 90040
        • Altamed Mobile Unit Primary Care
      • El Monte, California, Estados Unidos, 91731
        • Altamed DVL El Monte
      • El Monte, California, Estados Unidos, 91731
        • Altamed El Monte Clinic
      • Garden Grove, California, Estados Unidos, 92840
        • Altamed Garden Grove Harbor
      • Huntington Beach, California, Estados Unidos, 92647
        • Altamed Huntington Beach Clinic
      • Huntington Park, California, Estados Unidos, 90255
        • Altamed PACE Rugby
      • Long Beach, California, Estados Unidos, 90802
        • The Children's Clinic Family Health Center at Cesar Chavez Elementary School
      • Long Beach, California, Estados Unidos, 90805
        • The Children's Clinic Family Health Center at Hamilton Middle School
      • Long Beach, California, Estados Unidos, 90806
        • The S. Mark Taper Foundation Children's Clinic Family Health Center
      • Long Beach, California, Estados Unidos, 90813
        • The Children's Clinic at the Long Beach Multi-Service Center for the Homeless
      • Long Beach, California, Estados Unidos, 90813
        • The Vasek Polak Children's Clinic Family Health Center
      • Los Angeles, California, Estados Unidos, 90012
        • Altamed PACE Grand Plaza
      • Los Angeles, California, Estados Unidos, 90012
        • Altamed William Mead Homes
      • Los Angeles, California, Estados Unidos, 90022
        • Altamed Commerce Clinic
      • Los Angeles, California, Estados Unidos, 90022
        • Altamed DVL Commerce
      • Los Angeles, California, Estados Unidos, 90022
        • Altamed PACE Pomona
      • Los Angeles, California, Estados Unidos, 90023
        • Altamed Boyle Heights Clinic
      • Los Angeles, California, Estados Unidos, 90023
        • Altamed Estrada Courts
      • Los Angeles, California, Estados Unidos, 90023
        • Altamed Ramona Gardens
      • Los Angeles, California, Estados Unidos, 90033
        • AltaMed 1st St Boyle Heights Clinic
      • Los Angeles, California, Estados Unidos, 90033
        • Altamed Zonal Clinic
      • Montebello, California, Estados Unidos, 90640
        • Altamed Montebello Clinic
      • Orange, California, Estados Unidos, 92869
        • Altamed El Modena Clinic
      • Pico Rivera, California, Estados Unidos, 90060
        • Altamed Pico Clinic
      • Pico Rivera, California, Estados Unidos, 90660
        • Altamed DVL Pico
      • Santa Ana, California, Estados Unidos, 92701
        • Altamed Santa Ana Main
      • Santa Ana, California, Estados Unidos, 92706
        • Altamed Clinic For Women
      • Santa Ana, California, Estados Unidos, 92707
        • Altamed Santa Ana Broadway
      • Santa Ana, California, Estados Unidos, 92707
        • Altamed Santa Ana Central
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02035
        • Brigham and Women's Primary Care Associates at Foxborough
      • Boston, Massachusetts, Estados Unidos, 02108
        • MGH Downtown
      • Boston, Massachusetts, Estados Unidos, 02114
        • Mass General Medial Group
      • Boston, Massachusetts, Estados Unidos, 02114
        • MGH Beacon Hill
      • Boston, Massachusetts, Estados Unidos, 02114
        • MGH Senior Health
      • Boston, Massachusetts, Estados Unidos, 02114
        • Women's Health Associates
      • Boston, Massachusetts, Estados Unidos, 02115
        • Brigham Circle Medical Associates
      • Boston, Massachusetts, Estados Unidos, 02115
        • Brigham Internal Medicine Associates
      • Boston, Massachusetts, Estados Unidos, 02115
        • Spanish Clinic
      • Boston, Massachusetts, Estados Unidos, 02228
        • MGH Back Bay
      • Brookline, Massachusetts, Estados Unidos, 02446
        • Brigham and Women's Primary Care Associates of Brookline
      • Charlestown, Massachusetts, Estados Unidos, 02129
        • MGH Charlestown HealthCare Center
      • Chelsea, Massachusetts, Estados Unidos, 02150
        • MGH Chelsea Healthcare Center
      • Chestnut Hill, Massachusetts, Estados Unidos, 02467
        • Brigham and Women's Physician Group
      • Chestnut Hill, Massachusetts, Estados Unidos, 02467
        • Gretchen and Edward Fish Center for Women's Health
      • Everett, Massachusetts, Estados Unidos, 02149
        • Everett Family Practice
      • Jamaica Plain, Massachusetts, Estados Unidos, 02130
        • Brigham Primary Physicians at Faulkner
      • Jamaica Plain, Massachusetts, Estados Unidos, 02130
        • Brookside Community Health Center
      • Jamaica Plain, Massachusetts, Estados Unidos, 02130
        • Faulkner Community Physicians
      • Jamaica Plain, Massachusetts, Estados Unidos, 02130
        • Southern Jamaica Plain Health Center
      • Newton, Massachusetts, Estados Unidos, 02458
        • Brigham and Women's Primary Care Associates of Newton Corner
      • Revere, Massachusetts, Estados Unidos, 02151
        • Mass General Revere HealthCare Center
      • Waltham, Massachusetts, Estados Unidos, 02451
        • Mass General West Medical Group

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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:
  • Justificación responsable
  • AJ
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Otros nombres:
  • Ordenador personal
  • Peer Comparison
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
  • SA
  • Suggested Alternatives
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:
  • Justificación responsable
  • AJ
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
  • SA
  • Suggested Alternatives
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:
  • Ordenador personal
  • Peer Comparison
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Otros nombres:
  • SA
  • Suggested Alternatives
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:
  • Justificación responsable
  • AJ
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Otros nombres:
  • Ordenador personal
  • Peer Comparison
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:
  • Ordenador personal
  • Peer Comparison
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:
  • SA
  • Suggested Alternatives
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:
  • Justificación responsable
  • AJ
Sin intervención: Education Control
Participants do not receive any of the 3 interventions.

¿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
We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.
18 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2011

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de septiembre de 2014

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2011

Primero enviado que cumplió con los criterios de control de calidad

14 de octubre de 2011

Publicado por primera vez (Estimar)

19 de octubre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de junio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

30 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

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. .

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