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

Women and Infants Hospital of Rhode Island

Status: Completed

Conditions: Aneuploidy; Pregnancy Related; Genetic Disease

Treatments: Behavioral: Enhanced (experimental) education; Behavioral: Standard (control) education.

Study type: Interventional

Funder types: Other

Identifiers

NCT04420858

1500909-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups

Control

Other group

Description:

The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.

Treatment:

Behavioral: Standard (control) education.

Experimental

Experimental group

Description:

The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).

Treatment:

Behavioral: Enhanced (experimental) education