Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
- Women and Infants Hospital
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Otro: Control
The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.
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See arm description.
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Experimental: Experimental
The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).
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See arm description.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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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)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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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)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Knowledge and understanding of aneuploidy screening and results
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Knowledge and understanding of carrier testing and results
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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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)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Maternal rationale for pursuing cfDNA
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Maternal knowledge of different commercial cfDNA providers
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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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)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Maternal perceptions of the de-identifiability of genetic data
Periodo de tiempo: This outcome will be assessed immediately after exposure to education (day 0)
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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.
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This outcome will be assessed immediately after exposure to education (day 0)
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Christian Parobek, Department of OB/GYN, Women and Infants Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Parobek CM, Thorsen MM, Has P, Lorenzi P, Clark MA, Russo ML, Lewkowitz AK. Video education about genetic privacy and patient perspectives about sharing prenatal genetic data: a randomized trial. Am J Obstet Gynecol. 2022 Jul;227(1):87.e1-87.e13. doi: 10.1016/j.ajog.2022.03.047. Epub 2022 Mar 26.
- Parobek CM, Has P, Lorenzi P, Russo ML, Clark MA, Lewkowitz AK. What test did I have? Patient uncertainty about prenatal genetic screening. Am J Obstet Gynecol. 2021 Sep;225(3):341-342. doi: 10.1016/j.ajog.2021.05.030. Epub 2021 May 27. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 1500909-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de 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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