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Completed

NCT Number: NCT04420858

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

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.

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Key information

Conditions

Aneuploidy Chromosome Aberrations Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Disease Genetic Diseases, Inborn Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced (experimental) education

Behavioral

See arm description.

Standard (control) education.

Behavioral

See arm description.

Primary outcomes

  1. Knowledge about broad sharing of genetic data for non-clinical research purposes

    Time frame: 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.

  2. Acceptability of broad sharing of genetic data for non-clinical research purposes

    Time frame: 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.

Secondary outcomes

  1. Acceptability of retention of genetic data for non-clinical purposes

    Time frame: 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.

  2. Acceptability of use of genetic data for non-clinical purposes

    Time frame: 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.

  3. Knowledge and understanding of aneuploidy screening and results

    Time frame: 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.

  4. Knowledge and understanding of carrier testing and results

    Time frame: 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.

  5. Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes

    Time frame: 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.

  6. Maternal rationale for pursuing cfDNA

    Time frame: 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.

  7. Maternal knowledge of different commercial cfDNA providers

    Time frame: 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.

  8. Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.

    Time frame: 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.

  9. Maternal perceptions of the de-identifiability of genetic data

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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