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

NCT ID: NCT04420858

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2020-10-16

Brief Summary

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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

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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.

Conditions

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Aneuploidy Genetic Disease Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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

Group Type OTHER

Standard (control) education.

Intervention Type BEHAVIORAL

See arm description.

Experimental

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

Group Type EXPERIMENTAL

Enhanced (experimental) education

Intervention Type BEHAVIORAL

See arm description.

Interventions

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Enhanced (experimental) education

See arm description.

Intervention Type BEHAVIORAL

Standard (control) education.

See arm description.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Parobek

Role: PRINCIPAL_INVESTIGATOR

Department of OB/GYN, Women and Infants Hospital

Locations

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Women and Infants Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35351406 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34051169 (View on PubMed)

Other Identifiers

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1500909-1

Identifier Type: -

Identifier Source: org_study_id