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Facilitating the Implementation of Population-wide Genomic Screening (FOCUS)

2 de septiembre de 2026 actualizado por: Wake Forest University Health Sciences
This is a multi-site hybrid implementation-effectiveness trial that uses a stepped-wedge cluster randomized design to evaluate the impact of the FOCUS toolkit, a multicomponent implementation guide, on improving the implementation of population-wide genomic screening (PGS) programs across diverse healthcare settings. The trial will assess program-level outcomes using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) and explore mechanisms of change and implementation process progression. The study involves program-level and individual-level data collection and will not alter clinical care or treatment decisions of individuals made by participating sites.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

To help facilitate growth of population-wide genomic screening (PGS) programs and enhance recruitment and retention of representative populations into genomic initiatives, this study propose to identify best practices for PGS implementation and develop and test a freely available, online multicomponent implementation guide (FOCUS toolkit). This project will establish a gold standard approach for integrating PGS and offer the field generalizable methods and knowledge about PGS implementation. Specifically, using a stakeholder-engaged Implementation Mapping approach we will: 1) conduct a qualitative needs assessment among ten PGS programs (FOCUS design sites) at various implementation stages (emerging, implementing, sustaining) guided by the Consolidated Framework for Implementation Research, 2) develop and produce the FOCUS toolkit consisting of implementation strategies, materials, and protocols, and 3) evaluate the impact of the FOCUS toolkit on Reach, Effectiveness, Implementation, Adoption, Maintenance outcomes for PGS in 12 PGS sites (FOCUS test sites) using a stepped wedge cluster randomized trial design. These findings will: 1) provide a standardized approach and evaluation framework for programs seeking to strategically implement and expand population-based approaches for identifying individuals and families at high risk of serious, yet preventable disease, 2) provide generalizable methods and knowledge about PGS, and 3) support efforts to bring the promise of precision health to all.

Tipo de estudio

De observación

Inscripción (Estimado)

8

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

Ubicaciones de estudio

  • Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina
        • Contacto:
      • Greensboro, North Carolina, Estados Unidos, 27401
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Atrium Health Wake Forest Baptist
        • Contacto:
    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos, 18015
        • St. Luke's University Hospital
        • Contacto:
      • York, Pennsylvania, Estados Unidos, 17403
        • WellSpan York Hospital
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Baylor College of Medicine
        • Contacto:
      • Houston, Texas, Estados Unidos, 77030

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

This study will include specific sites population genomic screening (PGS) rather than individual participants.

Descripción

Inclusion Criteria:

  • Operate an active or population genomic screening (PGS) program.
  • Agree to utilize the FOCUS Toolkit throughout the trial and engage staff in its use and fidelity tracking.
  • Ability to understand and willingness to sign a data use agreement and comply with study procedures for the entire length of the study.
  • Ability to provide program-level data (Reach, Effectiveness, Adoption, Implementation, Maintenance) quarterly.
  • Confirmation of implementing or sustaining stage, as determined by the investigator.
  • Capacity to participate in stakeholder surveys and interviews at study conclusion.
  • Ability to read and understand the English language.

Exclusion Criteria:

  • They lack infrastructure to collect and share required data.
  • They cannot commit to toolkit use or quarterly reporting.
  • They are unable to comply with study timelines

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
FOCUS Toolkit
Otro: FOCUS Toolkit Training
The FOCUS toolkit is a multicomponent implementation guide on improving the implementation of population-wide genomic screening programs across diverse healthcare settings.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of People Participating in PGS Program
Periodo de tiempo: Month 4
Reach is measured as the total number of people who have consented to participate in the population-based genomic screening (PGS) program. Data will be collected from PGS program data collection form
Month 4
Number of People Participating in PGS Program
Periodo de tiempo: Month 10
Reach is measured as the total number of people who have consented to participate in the population-based genomic screening (PGS) program. Data will be collected from PGS program data collection form
Month 10
Number of People Participating in PGS Program
Periodo de tiempo: Month 16
Reach is measured as the total number of people who have consented to participate in the population-based genomic screening (PGS) program. Data will be collected from PGS program data collection form
Month 16
Proportion of Eligible Individuals Tested
Periodo de tiempo: Month 4
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 4
Proportion of Eligible Individuals Tested
Periodo de tiempo: Month 10
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 10
Proportion of Eligible Individuals Tested
Periodo de tiempo: Month 16
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 16
Proportion of Positive Genomic Screening Results
Periodo de tiempo: Month 4
Number of individuals with positive results after genomic screening
Month 4
Proportion of Positive Genomic Screening Results
Periodo de tiempo: Month 10
Number of individuals with positive results after genomic screening
Month 10
Proportion of Positive Genomic Screening Results
Periodo de tiempo: Month 16
Number of individuals with positive results after genomic screening
Month 16
Proportion of Negative Genomic Screening Results
Periodo de tiempo: Month 4
Number of individuals with negative results after genomic screening
Month 4
Proportion of Negative Genomic Screening Results
Periodo de tiempo: Month 10
Number of individuals with negative results after genomic screening
Month 10
Proportion of Negative Genomic Screening Results
Periodo de tiempo: Month 16
Number of individuals with negative results after genomic screening
Month 16
Proportion of VUS Genomic Screening Results
Periodo de tiempo: Month 4
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 4
Proportion of VUS Genomic Screening Results
Periodo de tiempo: Month 10
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 10
Proportion of VUS Genomic Screening Results
Periodo de tiempo: Month 16
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 16
Number of Sites Participating in PGS
Periodo de tiempo: Month 19
Adoption is defined as the uptake of population-based genomic screening (PGS) at each site, measured by the number of sites participating in PGS relative to those eligible. Measured through stakeholder surveys
Month 19
Acceptability of Intervention Measure (AIM)
Periodo de tiempo: Month 19
Implementation will be assessed using the Acceptability of Intervention Measure survey includes 4 items with the total score range 4-20. Higher scores indicate higher level of acceptability.
Month 19
Intervention Appropriateness Measure (IAM)
Periodo de tiempo: Month 19
Implementation will be assessed using the Intervention Appropriateness Measure survey includes 4 items with a total score range 4-20. Higher scores indicate higher level of appropriateness.
Month 19
Feasibility of Intervention Measure (FIM)
Periodo de tiempo: Month 19
Implementation will be assessed using the Feasibility of Intervention Measure survey includes 4 items with a total score range 4-20. Higher scores indicate higher level of feasibility.
Month 19
Number of Individuals that Completed High-Risk Management
Periodo de tiempo: Month 19
Maintenance will be assessed by the number of individuals with positive results that completed high-risk management
Month 19
Program Sustainability Assessment
Periodo de tiempo: Month 19
Maintenance will be assessed by using the Program Sustainability Assessment survey has 40 items with a total score range of 40-280. Higher scores indicate greater sustainability capacity.
Month 19

Colaboradores e Investigadores

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

Patrocinador

Wake Forest University Health Sciences

Colaboradores

National Human Genome Research Institute (NHGRI)

Investigadores

  • Investigador principal: Caitlin Allen, PhD, Atrium Health Wake Forest Baptist

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 (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

1 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

2 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de septiembre de 2026

Publicado por primera vez (Actual)

8 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de septiembre de 2026

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

2 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB00143953
  • R01HG013851-03 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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