Aneuploidy, Genetic Disease, Pregnancy Related
Conditions
Keywords
Genetic privacy, Aneuploidy screening, Pregnancy, Data use, Data sharing, Protected health information
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEnhanced (experimental) education
See arm description.
BEHAVIORALStandard (control) education.
See arm description.
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge about broad sharing of genetic data for non-clinical research purposes | 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. |
| Acceptability of broad sharing of genetic data for non-clinical research purposes | 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
| Measure | Time frame | Description |
|---|---|---|
| Knowledge and understanding of aneuploidy screening and results | 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. |
| Knowledge and understanding of carrier testing and results | 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. |
| Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes | 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. |
| Acceptability of retention of genetic data for non-clinical purposes | 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. |
| Maternal knowledge of different commercial cfDNA providers | 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. |
| Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies. | 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. |
| Maternal perceptions of the de-identifiability of genetic data | 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. |
| Maternal rationale for pursuing cfDNA | 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. |
| Acceptability of use of genetic data for non-clinical purposes | 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. |
Countries
United States
Outcome results
None listed