Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Video Education for Prenatal Testing Choices

21 de agosto de 2020 actualizado por: Monica Lutgendorf, United States Naval Medical Center, San Diego

The Effect of Standardized Video Education on Prenatal Genetic Testing Choices, Decisional Conflict, and Decisional Regret

The purpose of the investigator's study is to assess the effect of a standardized prenatal testing educational video on the use of prenatal genetic testing and decision-making.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a prospective randomized trial of video education on prenatal testing vs. usual care, with the goal to assess women's prenatal testing choices, understanding of testing options and decisional conflict and regret. Participants will be recruited from a convenience sample of patients presenting for prenatal care at Naval Medical Center San Diego (NMCSD).

While receiving prenatal care at NMCSD, all women are offered the option of screening for aneuploidy (serum screen (with or without nuchal translucency ultrasound) or cell free DNA testing) or diagnostic testing (chorionic villous sampling or amniocentesis) or no testing in pregnancy.

After providing consent, participants will be randomized to video education or usual care. Randomization will be completed using a random number table. Women randomized to the intervention group (video education) will view the prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit. The educational video was created with input from clinicians including licensed genetic counselors, obstetricians, maternal fetal medicine physicians, and patients. Extensive testing and reviewing was completed to ensure adequate comprehension by a wide range of audiences and minimize counseling bias. Women randomized to the control group will receive routine prenatal care with no additional study intervention other than completion of the study related surveys at baseline (initial prenatal testing). Current national guidelines recommend offering all women prenatal diagnosis and prenatal screening at the beginning of the pregnancy.1

The primary outcome for this study will be screening uptake rates, and will be based on review of the patient's electronic medical record. Secondary outcomes will include invasive diagnostic test rates, participant knowledge about testing (as assessed using the Maternal Serum Screening Knowledge Questionnaire,2 and decisional conflict (as assessed by the Decisional Conflict Scale) and decisional regret (as assessed by the Decision Regret Scale). These assessments will be conducted at time of prenatal testing (< 20 weeks). (Appendix A)

The study questionnaire will include a check box for participants to indicate if they would be willing to participate in a follow on qualitative study to assess participant's personal experience related to their method of education about prenatal testing. This component of the study will aim to determine personal and social reasoning behind their decisions, and to further explore their experience, beliefs and behaviors. Interested participants from each group (both intervention and control) will be contacted to arrange a telephone or in person interview. (Appendix C) Participants will be interviewed in person or over the phone.

Tipo de estudio

Intervencionista

Inscripción (Actual)

210

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

    • California
      • San Diego, California, Estados Unidos, 92134
        • Naval Medical Center San Diego

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

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • Gestational age less than or equal to 20 weeks
  • Singleton gestation
  • Not completed aneuploidy screening in this pregnancy
  • Available to watch the 15 minute video
  • Ability to read, write, and understand English

Exclusion Criteria:

  • Pregnant women not eligible for care at Military Treatment Facility
  • Less than 18 years of age
  • Gestational age greater than 20 weeks
  • Multiple gestation
  • Aneuploidy testing in current pregnancy

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Video education
Women randomized to the intervention group (video education) will view the prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit.
Prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .
Sin intervención: Usual care
Women randomized to the control group will receive routine prenatal care with no additional study intervention other than completion of the study related surveys at baseline (initial prenatal testing).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
screening uptake rates
Periodo de tiempo: 24-36 weeks gestation
Genetic screening
24-36 weeks gestation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Invasive diagnostic test rates
Periodo de tiempo: 24-36 weeks gestation
Diagnostic testing such as Chorinonic Villus Sampling and amniocentesis
24-36 weeks gestation
Participant knowledge about prenatal testing
Periodo de tiempo: up to 20 weeks gestation
Assessed by using the Maternal Serum Screening knowledge Questionnaire. Scores range from 0 to 15, reflecting the number of correct answers. A score of zero would indicate zero correct answers, where a score of 15 would indicate all answers were correct. Higher scores are considered better outcome indicating higher knowledge.
up to 20 weeks gestation
Decisional conflict
Periodo de tiempo: up to 20 weeks gestation
Assessed by the Decisional Conflict Scale. Questions are scored on a Likert scale of 1 to 5, with 1 equating to Strongly Agree and 5 equating to Strongly Disagree. Thus, lower scores indicate lower decisional conflict. Subscale Decisional Uncertainty score range 3 to 15. Subscale Percieved Effective Decision range 4 to 20.
up to 20 weeks gestation
Decisonal regret
Periodo de tiempo: up to 20 weeks gestation
Assessed by the Decisional Regret Scale. Questions are scored on a Likert scale of 1 to 5, with 1 equating to Strongly Agree and 5 equating to Strongly Disagree. Thus, lower scores indicate lower decisional regret. Decisional Regret scores range 0 to 100.
up to 20 weeks gestation

Colaboradores e Investigadores

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

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)

12 de enero de 2017

Finalización primaria (Actual)

1 de enero de 2020

Finalización del estudio (Actual)

1 de agosto de 2020

Fechas de registro del estudio

Enviado por primera vez

7 de agosto de 2019

Primero enviado que cumplió con los criterios de control de calidad

19 de agosto de 2019

Publicado por primera vez (Actual)

20 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2020

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

21 de agosto de 2020

Última verificación

1 de agosto de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • NMCSD.2016.0070

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. .

Ensayos clínicos sobre Video education

3
Suscribir