Clinical trial NCT04420858: Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics
Official title: Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneuploidy
Genetic Disease
Pregnancy Related
Keywords: Genetic privacy
Aneuploidy screening
Pregnancy
Data use
Data sharing
Protected health information
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge about broad sharing of genetic data for non-clinical research purposes
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Acceptability of broad sharing of genetic data for non-clinical research purposes
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
Secondary outcomes:
measure: Acceptability of retention of genetic data for non-clinical purposes
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Acceptability of use of genetic data for non-clinical purposes
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Knowledge and understanding of aneuploidy screening and results
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Knowledge and understanding of carrier testing and results
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Maternal rationale for pursuing cfDNA
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Maternal knowledge of different commercial cfDNA providers
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
measure: Maternal perceptions of the de-identifiability of genetic data
timeFrame: This outcome will be assessed immediately after exposure to education (day 0)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Department of OB/GYN, Women and Infants Hospital
name: Christian Parobek
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.