- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07511621
Una Estrategia Multinivel para Desimplementar el Uso Excesivo de Mamografías entre Mujeres Mayores
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
Estado
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Parisa Tehranifar, DrPH
- Número de teléfono: 212-305-1018
- Correo electrónico: pt140@cumc.columbia.edu
Copia de seguridad de contactos de estudio
- Nombre: Anita G Karr, MPH
- Correo electrónico: ak5074@cumc.columbia.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Reclutamiento
- Columbia University Irving Medical Center
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Contacto:
- Nathalie Moise, MD, MS
- Correo electrónico: nm2562@cumc.columbia.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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 |
|---|---|
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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. |
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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 |
|---|---|---|
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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
|
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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
Patrocinador
Colaboradores
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
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
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)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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