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A Trial of Academic Detailing to Promote Prescribing of Biosimilars 1325 Biológicos Académico Virtual

Activo, no reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07221890 es un estudio intervencionista para Enfermedades Autoinmunes, Artritis Reumatoide (AR), Enfermedad inflamatoria intestinal (EII), Psoriasis (PsO). Su estado actual es: activo, no reclutando. El estudio se inició el 6 de noviembre de 2025, con el objetivo de reclutar a 1325 participantes. Dirigido por el Hospital Brigham and Women's, se espera que finalice el 31 de marzo de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 8 de diciembre de 2025.
Resumen
The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are:

  1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
  2. Do in-person or virtual visits work better?

Researchers will compare clinicians...

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Descripción detallada
This is a parallel, cluster randomized controlled trial in which medical practices with clinicians who prescribed adalimumab (Humira) to patients in a Humana Medicare Prescription Drug Plan (PDP) will be randomized to have eligible clinicians within the practice invited to participate in the educational module about biosimilars (the intervention group). Practices with eligible physicians that are not offered the educ...Mostrar más
Título oficial

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

Condiciones médicas
Enfermedades AutoinmunesArtritis Reumatoide (AR)Enfermedad inflamatoria intestinal (EII)Psoriasis (PsO)
Otros ID del estudio
  • 2025P002143
Número del NCT
NCT07221890
Inicio del estudio (real)
2025-11-06
Última actualización
2025-12-08
Fecha de finalización (estimada)
2027-03-31
Inscripción (prevista)
1325
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Palabras clave
biosimilar
biologic
academic detailing
clinician education
prescribing
Medicare Part D
Objetivo principal
Investigación de servicios de salud
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalIntervention
Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan.
Offered an academic detailing session
Clinicians will be offered an academic detailing session that will be delivered by a specially trained pharmacist, nurse, or physician (i.e., detailer). These academic detailers will be provided and trained by an independent non-profit organization. After a clinician agrees to participate in an academic detailing session, the detailer will schedule a 1-on-1 meeting lasting 15-20 minutes during which the detailer will...Mostrar más
Standard-of-care outreach from the insurance plan
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
Comparador activoControl
Not offered an academic detailing session. Standard-of-care outreach from the insurance plan.
Standard-of-care outreach from the insurance plan
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Number of biosimilar adalimumab prescriptions per clinician
12 months
Number of originator adalimumab (Humira) prescriptions per clinician
12 months
Total spending (payer + patient) on adalimumab
12 months
Patient out-of-pocket spending on adalimumab
12 months
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Number of participants in the intervention arm who participated in an educational meeting with an academic detailer
6 months
Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab
12 months
Number of filled prescriptions for other brand-name disease-modifying medications that are FDA approved to treat 1 or more of the same indications as adalimumab, such as TNF-alpha inhibitors and interleukin inhibitors
12 months
Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic
12 months
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Niño, Adulto, Adulto mayor
Criterios de sexo
Todos
  • Wrote 7 or more adalimumab prescriptions that were filled by patients enrolled in research-eligible Humana Medicare Part D plans in the calendar year 2025

  • Retired
  • Not able to identify active clinical practice in the US (50 states plus Washington DC)
Brigham and Women's Hospital logoHospital Brigham and Women's
Humana Healthcare Research, Inc. logoHumana Healthcare Research, Inc.
Parte responsable del estudio
Benjamin Rome, Investigador principal, Assistant Professor of Medicine, Brigham and Women's Hospital
No hay datos de contacto.
2 Centros del estudio en 1 países

Kentucky

Humana Healthcare Research, Inc., Louisville, Kentucky, 40202, United States

Massachusetts

Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States