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The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care.
The secondary aims include assessing the impact of the video educational tool versus standard care on pregnant participants': perception of likelihood of having a baby affected by a genetic problem, intended plan for genetic testing, patient-provider communication, retention of prenatal genetics knowledge, and perception of genetic data privacy.
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Prenatal Care | No Intervention | The patient will receive routine prenatal care with no video education. | |
| Video Educational Tool Arm | Experimental | The patient receives routine prenatal care plus video education on prenatal genetics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Educational Tool Regarding Prenatal Genetics | Other | Video education about prenatal genetics will include content regarding aneuploidy screening and diagnostic testing options, how to make a values-based choice, and specifics of risks/benefits/limitations of each type of testing option. |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Decisional Conflict Scale (low health literacy version of the tool) | The investigators will assess the decisional conflict scale score around the time when patients make a decision about prenatal genetic screening options. The resulting score ranges from 0 to 100, with 0 indicating no decisional conflict (best outcome) and 100 indicating extremely high decisional conflict (worst outcome). | After enrollment and up to 14 days after their first obstetric appointment in that pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of likelihood of having a baby affected by a genetic problem | The investigators will use a Likert scale to assess patient's perception of likelihood of having a baby affected by a genetic problem (score ranges from 1 [not likely at all] to 4 [very likely]). | After enrollment and up to 14 days after their first obstetric appointment in that pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Infants | Providence | Rhode Island | 02905 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2024 | Oct 31, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2024 | Oct 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000782 | Aneuploidy |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Percent of patients opting to pursue genetic testing | The investigators will assess the percent of participants who decide to pursue screening or diagnostic genetic testing options | After enrollment and up to 14 days after their first obstetric appointment in that pregnancy |
| Patient-provider communication | The investigators will use a modified doctor-patient communication questionnaire to assess how patients perceived communication and comprehension of counseling with their prenatal care provider (score 0 to 8, with higher score reflecting better communication). | Six to ten weeks from follow up survey #1 |
| Retention of Prenatal Genetics Knowledge | The investigators will assess prenatal genetics knowledge remote from the intervention to assess retention of its content (score 0 to 12 with a higher score reflecting more knowledge). The questionnaire was created by the investigators. It is six questions that query the participants on key content highlighted in the educational intervention; the content covered is also considered standard of care to receive in counseling in routine prenatal care (for those who were not randomized to the intervention). | Six to ten weeks from follow up survey #1 |
| Perception of genetic data privacy | The investigators will assess on a Likert scale how important privacy of participants' own genetic data and that of their baby were in making a decision about prenatal genetic testing (score 0 to 8 with higher score reflecting more importance) | Six to ten weeks from follow up survey #1 |