Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics
3 novembre 2020 mis à jour par: Women and Infants Hospital of Rhode Island
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
162
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Rhode Island
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Providence, Rhode Island, États-Unis, 02905
- Women and Infants Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Control
The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.
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See arm description.
|
|
Expérimental: Experimental
The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).
|
See arm description.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knowledge about broad sharing of genetic data for non-clinical research purposes
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acceptability of retention of genetic data for non-clinical purposes
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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)
|
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Knowledge and understanding of aneuploidy screening and results
Délai: This outcome will be assessed immediately after exposure to education (day 0)
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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
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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)
|
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Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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)
|
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Maternal rationale for pursuing cfDNA
Délai: This outcome will be assessed immediately after exposure to education (day 0)
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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)
|
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Maternal knowledge of different commercial cfDNA providers
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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)
|
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Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.
Délai: This outcome will be assessed immediately after exposure to education (day 0)
|
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)
|
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Maternal perceptions of the de-identifiability of genetic data
Délai: This outcome will be assessed immediately after exposure to education (day 0)
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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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Christian Parobek, Department of OB/GYN, Women and Infants Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 juillet 2020
Achèvement primaire (Réel)
16 octobre 2020
Achèvement de l'étude (Réel)
16 octobre 2020
Dates d'inscription aux études
Première soumission
18 mai 2020
Première soumission répondant aux critères de contrôle qualité
3 juin 2020
Première publication (Réel)
9 juin 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1500909-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.
Critères d'accès au partage IPD
De-identified study data will be shared with researchers upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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