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Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics

3 de noviembre de 2020 actualizado por: Women and Infants Hospital of Rhode Island
The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes. Pregnant women undergoing specialized fetal anatomic ultrasound surveys at Women and Infants' maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate. Volunteers will be randomized to receive either standard education about prenatal genetic testing or standard education plus additional education about federal genetic privacy protections. Next, the participants view the educational materials to which they were randomized. Finally, all volunteers will take the same survey, which will assess baseline demographic variables as well as their knowledge of and attitudes toward broad sharing of data obtained from prenatal genetic testing. Once finished with the survey, volunteers will have completed their participation in this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

162

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

  • Estados Unidos
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02905
        • Women and Infants Hospital

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

Femenino

Descripción

Inclusion Criteria:

  • Pregnant patients undergoing a scheduled L2 ultrasound at the Women and Infants Prenatal Diagnosis Center (PDC)
  • Singleton pregnancies
  • English speaking
  • Results available from cell-free DNA screening for this pregnancy

Exclusion Criteria:

  • Prior L2 ultrasound at the PDC during the current pregnancy (to avoid test-retest or multiple approach)
  • Prior participation in this study
  • Gestational age <17'0 weeks or >23'6 weeks
  • Suboptimally dated pregnancies (i.e. dated by ultrasound after 22 weeks gestation)
  • Unscheduled / add-on L2 ultrasounds

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Control
The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.
Conductual: Standard (control) education.
See arm description.
Experimental: Experimental
The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).
Conductual: Enhanced (experimental) education
See arm description.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knowledge about broad sharing of genetic data for non-clinical research purposes
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient knowledge about the potential sharing of their genetic data for non-clinical research purposes? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of broad sharing of genetic data for non-clinical research purposes
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of laboratory-initiated sharing of their de-identified genetic data for non-clinical purposes? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acceptability of retention of genetic data for non-clinical purposes
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of retaining their de-identified genetic data to potentially use it for non-clinical purposes? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of use of genetic data for non-clinical purposes
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of using their de-identified genetic data for non-clinical purposes such as research and development? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Knowledge and understanding of aneuploidy screening and results
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Are patients aware that they underwent aneuploidy screening with cell-free fetal DNA (cfDNA)? Are they aware of their results? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Knowledge and understanding of carrier testing and results
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patients aware that they underwent carrier testing? Are they aware of their results? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Assess maternal acceptance of each of these outcomes. Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal rationale for pursuing cfDNA
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What prompted patient to pursue cfDNA testing? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal knowledge of different commercial cfDNA providers
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patents who have undergone cfDNA testing aware that multiple companies offer this service? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening and are participating in this study understand these topics? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal perceptions of the de-identifiability of genetic data
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening believe that deidentified genetic information is not re-identifiable? Outcome will be measured on the Likert scale.
This outcome will be assessed immediately after exposure to education (day 0)

Colaboradores e Investigadores

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

Patrocinador

Women and Infants Hospital of Rhode Island

Investigadores

  • Investigador principal: Christian Parobek, Department of OB/GYN, Women and Infants Hospital

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.

Publicaciones Generales

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)

21 de julio de 2020

Finalización primaria (Actual)

16 de octubre de 2020

Finalización del estudio (Actual)

16 de octubre de 2020

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2020

Publicado por primera vez (Actual)

9 de junio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2020

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

3 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1500909-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Non-identifiable data will be freely shared with other researchers upon request for facilitate reproducibility or future systemic review, pending approval from local institutional review board.

Marco de tiempo para compartir IPD

De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.

Criterios de acceso compartido de IPD

De-identified study data will be shared with researchers upon request.

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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