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

NCT04420858 | Completed

• 1 other identifier: 1500909-1
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneuploidy; Genetic Disease; Pregnancy Related

Keywords

Genetic privacy; Aneuploidy screening; Pregnancy; Data use; Data sharing; Protected health information

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Acceptability of retention of genetic data for non-clinical purposes

  This outcome will be assessed immediately after exposure to education (day 0)

• Acceptability of use of genetic data for non-clinical purposes

  This outcome will be assessed immediately after exposure to education (day 0)

• Knowledge and understanding of aneuploidy screening and results

  This outcome will be assessed immediately after exposure to education (day 0)

• Knowledge and understanding of carrier testing and results

  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

  This outcome will be assessed immediately after exposure to education (day 0)

Study Arms (2)

Control

OTHER

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.

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

Interventions

Enhanced (experimental) education BEHAVIORAL

See arm description.

Experimental

Standard (control) education. BEHAVIORAL

See arm description.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (2)

• 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.

  PMID: 35351406 DERIVED

• 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.

  PMID: 34051169 DERIVED

MeSH Terms

Conditions

Aneuploidy; Genetic Diseases, Inborn

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Christian Parobek

  Department of OB/GYN, Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 9, 2020
• Study Start: July 21, 2020
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: De-identified study data will be shared with researchers upon request.

Locations

US (1)