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| ID | Type | Description | Link |
|---|---|---|---|
| 7R01HG013718-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
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This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor.
The study has one main question:
Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor.
What will participants do?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile-based Educational Intervention | Experimental | Participants in the intervention arm will access a mobile-based educational tool that provides concise, culturally appropriate information about prenatal genetic screening prior to their clinical visit. Immediately after viewing the intervention, participants will complete an online, 6-question acceptability survey. Participants will then complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience with the intervention and to measure decisional self-efficacy. A select subset of participants will participate in an additional qualitative telephone interview to assess the efficacy and usability of the intervention. |
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| Standard of Care | No Intervention | Participants in the standard-of-care arm will receive routine clinical care, including the usual information and counseling provided by clinicians regarding prenatal genetic screening. Participants will complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience being offered prenatal genetic screening and measure decisional self-efficacy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile-based Educational Intervention | Behavioral | A mobile-based informational tool that participants will access through a Quick Response (QR) code prior to the clinical encounter in which they will be offered prenatal genetic screening. This tool will provide clear and concise information about prenatal genetic screening to support pregnant participants in making an informed decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Self-Efficacy | Decision self-efficacy is measured using a slightly adapted version of the "Decision Self-Efficacy Scale" developed by A. O'Connor and colleagues at the Ottawa Hospital Research Institute and is available at https://decisionaid.ohri.ca. The scale contains eleven questions about a patient's decision-making process. The scale was adapted to ask questions about the context of prenatal genetic screening and utilizes a three-point response scale. Response choices and corresponding point values are: "A lot confident (4), a little confident (2), and not confident (0)". The values from each response are summed, divided by 11 and multiplied by 100 to give a score range from 0 to 100. Zero indicates no confidence and 100 indicates extreme confidence. A researcher administers the scale over the phone, once to each participant, within 168-hours after the medical appointment where participants are offered prenatal genetic screening. It should take no more than 5-10 minutes to complete. | The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabina Rubeck, MPH | Contact | 216-368-2547 | sabina.rubeck@case.edu | |
| Harlie Custer, MA, MPH | Contact | (216) 368-5914 | harlie.custer@case.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marsha Michie, PhD | Case Western Reserve University | Principal Investigator |
| Megan Allyse, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg Chan San Francisco General Hospital | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41252505 | Background | Allyse MA, Sengupta S, Michie M. The Challenges of Reproductive Autonomy in an Unjust System. Am J Bioeth. 2025 Dec;25(12):67-69. doi: 10.1080/15265161.2025.2570681. Epub 2025 Nov 18. No abstract available. | |
| 40245273 | Background | Allyse M, Riggan K, Bonhomme N, Michie M. Rethinking the Burden of Traditional Informed Consent Prior to Prenatal Genetic Screening. Hastings Cent Rep. 2025 Mar;55(2):29-38. doi: 10.1002/hast.4976. |
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Data will be shared via the Inter-university Consortium for Political and Social Research. To the extent the context of data collection can be revealed without compromising the privacy and identity of research participants, it will be included in study protocols. Data will be anonymized.
Qualitative data such as de-identified and redacted transcripts, coding summaries, and metadata will be shared. Quantitative, including de-identified individual and aggregate survey data (including raw and recoded data) will be shared.
Approximately six to twelve months after the completion of data analysis. Methods and data collection instruments will be available to the research community before the completion of the study. Published outcomes as well as data deposited in the Inter-university Consortium for Political and Social Research will be available indefinitely.
Access to all deposited materials will be available to researchers registered and verified through the Inter-university Consortium for Political and Social Research (ICPSR). The ICPSR, a digital repository, utilizes a "Reference Model for an Open Archival Information System (OAIS), an International Organization for Standardization (ISO) standard that provides the functional framework for sustaining digital objects in managed repositories." Detailed access criteria can be found here: https://www.icpsr.umich.edu/sites/icpsr/about/policies/access-policy-framework
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Longitudinal stepped-wedge trial design
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| University of Florida Health | Jacksonville | Florida | 32209 | United States |
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| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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