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Una Estrategia Multinivel para Desimplementar el Uso Excesivo de Mamografías entre Mujeres Mayores

22 de septiembre de 2026 actualizado por: Parisa Tehranifar, Columbia University

Desimplementación del uso excesivo de la mamografía de cribado en mujeres mayores racial y étnicamente diversas

This project aims to advance methodological and theoretical approaches for developing, selecting, refining, and piloting a multilevel de-implementation strategy to reduce the overuse of screening mammography in women aged ≥75 years. Informed by an innovative participatory, stakeholder-driven innovation tournament and a discrete choice experiment, the research team identified, prioritized, and tailored a multilevel de-implementation strategy. The research team will conduct a cluster randomized controlled trial (at the provider level) to test the impact of the provider- and patient-level components of the multilevel strategy on screening mammography use, and secondarily, on provider referrals/orders for screening mammography. The organizational level components of the multilevel strategy will be implemented among all participants, not via random assignment.

Descripción general del estudio

Descripción detallada

De-implementation, defined as "reducing (frequency and/or intensity) or stopping the use or delivery of health services or practices that are ineffective, unproven, harmful, overused, inappropriate, and/or low-value by practitioners and delivery systems to patients", is recognized as a critical but understudied area within implementation science. Despite growing research on determinants of and strategies for implementation of evidence-based practices, there has been little empirical work on factors that influence de-implementation, or effective strategies for facilitating de-implementation. Further, there are gaps in knowledge in determining optimal methods and approaches for identifying and selecting de-implementation strategies to match barriers to de-implementation. Addressing screening mammography overuse among older women offers excellent opportunities for both improving healthcare delivery and outcomes among older women and advancing the science of de-implementation.

Routine screening mammography is widely implemented among older women despite the following: 1) screening mammography does not significantly reduce breast cancer mortality among older women who have shorter life expectancies, greater competing health risks, and lower risk for clinically significant or rapidly progressive breast tumors, and 2) screening mammography among older women poses substantial harms including anxiety and complications from follow-up diagnostic tests, false positive results, and potential over-diagnosis and over-treatment of tumors that would not have progressed. The current American College of Physicians guidelines recommend discontinuation (e.g., removal) of mammography in women aged ≥75 years at average risk for breast cancer; other national guidelines (e.g., United States Preventive Services Task Force, American Cancer Society) do not support routine screening mammography in older women and recommend consideration of morbidities, life expectancy and patients' informed preferences.

Informed by (1) multi-level qualitative interviews among patients and providers on the drivers of routine screening mammography in older women (n=36); (2) the Knowledge-to-Action Model and the Dual Process Model; (3) an innovation tournament - a crowdsourcing method, successfully applied as an emerging participatory approach for generating implementation solutions (n=47); and (4) a discrete choice experiment among patients (n=673), the research team identified, designed, and tailored a multilevel de-implementation strategy involving the patient, provider, and organizational levels. The research team will conduct a cluster randomized controlled trial (at the provider level) to test the impact of the provider- and patient-level components of the multilevel strategy on screening mammography use, and secondarily, on provider referrals/orders for screening mammography, across a large New York City healthcare system serving a racially and ethnically diverse population. The organizational level components of the multilevel strategy will be implemented among all participants, not via random assignment.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

500

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • Columbia University Irving Medical Center
        • Contacto:

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

Sí

Géneros elegibles para el estudio

Todos

Descripción

Patient level criteria

Inclusion criteria

  • English- or Spanish-speaking women based on preferred language in electronic health record
  • Aged 75 and older at the time of their scheduled primary care visit
  • Women who have a primary care visit scheduled within the next 2-4 weeks
  • Women who have not had a screening mammogram 6 months prior to their scheduled primary care visit but have had a screening mammogram 7-18 months prior to their scheduled primary care visit

Exclusion Criteria

  • Women with a history of atypical ductal hyperplasia (ADH) or non-invasive or invasive breast cancer (assessed via ICD 10 code)
  • Women with dementia (assessed via ICD 10 code)
  • ICD codes to use across exclusion criteria: F01-F03, Z85.3, G30-G31, N60, C50, or D05

Provider level criteria

Inclusion Criteria

• Primary care clinicians attributed to the 2 intervention clinics that serve adult patients, including those ≥75 years

Exclusion Criteria

  • Specialists
  • Primary care clinicians for patients < 18 years old
  • Non-clinicians
  • Physician assistants

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Enhanced Usual Care (EUC)

The EUC group of providers and their patients from 2 clinics who are eligible for this study will receive the organizational level components of the multilevel de-implementation strategy.

EUC entails the organizational level components of the multilevel de-implementation strategy. These organizational components have been implemented within the overarching New York City healthcare system where the 2 clinics receiving the provider and patient components are located. The organizational level components are: 1) Grand Rounds Education: providers and clinic leadership received Grand Rounds education on screening mammography overuse among older women, and 2) Task Force: a multidisciplinary task force (e.g., radiologists, breast oncologists, primary care providers, clinic leadership) have been collaborating with the research team to build consensus around guidelines for clinical practice and revisions to the screening mammography results and reminder letters sent to patients.

Experimental: Multilevel De-Implementation Strategy

The intervention group of providers and their patients from 2 clinics who are eligible for this study will receive the organizational level components of the multilevel de-implementation strategy (i.e., EUC as described above) as well as the provider and patient level components of the multilevel de-implementation strategy.

This multilevel de-implementation strategy includes the organizational level components that comprise EUC (described above) as well as provider and patient level components. At the provider level, the research team will disseminate educational newsletters including the latest guidelines, information, and resources on screening mammography for older women. At the patient level, the research team will disseminate a brief brochure titled the 'Rethink Resource' in which patients are activated and encouraged to speak with their providers about whether continuing to get mammograms is best for them given current guidelines.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Screening mammography overuse
Periodo de tiempo: 18 months

Screening mammography overuse will be defined as the percentage of patients eligible for this study who receive a screening mammogram within 24 months of their prior screening mammogram in the Enhanced Usual Care (EUC) vs. intervention arms.

18 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Provider mammography ordering
Periodo de tiempo: 18 months

Provider mammography ordering will be defined as the percentage of patients eligible for this study whose primary care provider orders a screening mammogram within 24 months of their prior screening mammogram in the EUC vs. intervention arms.

18 months
Mammography screening discussion
Periodo de tiempo: 18 months

Mammography screening discussion will be defined as the percentage of patients eligible for this study whose primary care provider documents mammography screening discussion at the time of the scheduled primary care visit based on chart extraction in the intervention vs. EUC arms.

18 months

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Nathalie Moise, MD, MS, Columbia University
  • Investigador principal: Parisa Tehranifar, DrPH, Columbia University
  • Investigador principal: Rachel C Shelton, ScD, MPH, Columbia University

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 (Actual)

11 de marzo de 2026

Finalización primaria (Estimado)

1 de marzo de 2028

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

25 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de marzo de 2026

Publicado por primera vez (Actual)

6 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

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

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AAAT2119
  • R01CA255382 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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