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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Aneuploidy; Genetic Disease
• Intervention / Treatment: Behavioral: Standard (control) education.; Behavioral: Enhanced (experimental) education

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.	Behavioral: Standard (control) education.; See arm description.
Experimental: Experimental; The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).	Behavioral: Enhanced (experimental) education; See arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about broad sharing of genetic data for non-clinical research purposes	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.	This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of broad sharing of genetic data for non-clinical research purposes	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.	This outcome will be assessed immediately after exposure to education (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of retention of genetic data for non-clinical purposes	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.	This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of use of genetic data for non-clinical purposes	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.	This outcome will be assessed immediately after exposure to education (day 0)
Knowledge and understanding of aneuploidy screening and results	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.	This outcome will be assessed immediately after exposure to education (day 0)
Knowledge and understanding of carrier testing and results	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.	This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes	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.	This outcome will be assessed immediately after exposure to education (day 0)
Maternal rationale for pursuing cfDNA	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.	This outcome will be assessed immediately after exposure to education (day 0)
Maternal knowledge of different commercial cfDNA providers	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.	This outcome will be assessed immediately after exposure to education (day 0)
Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.	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.	This outcome will be assessed immediately after exposure to education (day 0)
Maternal perceptions of the de-identifiability of genetic data	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.	This outcome will be assessed immediately after exposure to education (day 0)

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Christian Parobek, Department of OB/GYN, Women and Infants Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): October 16, 2020
• Study Completion (Actual): October 16, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Data use; Genetic privacy; Aneuploidy screening; Data sharing; Protected health information
• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Aneuploidy; Genetic Diseases, Inborn
• Other Study ID Numbers: 1500909-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Non-identifiable data will be freely shared with other researchers upon request for facilitate reproducibility or future systemic review, pending approval from local institutional review board.
• IPD Sharing Time Frame: De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.
• IPD Sharing Access Criteria: De-identified study data will be shared with researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No