Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study

Обзор

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: * Do participants who use the intervention feel more confident when they make a decision about screening? 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? * Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening. * Some participants will use the intervention before their first doctor's visit. Other participants will not use it. * All participants will talk with a researcher on the phone after their first doctor's visit. * Participants who use the intervention will answer a short survey on their phone. * A few participants who use the intervention will talk with a researcher a second time on the phone.

Вмешательства

• Поведенческое Mobile-based Educational Intervention
  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.

Первичные конечные точки

• Decision Self-Efficacy [Срок оценки: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.]

Критерии участия

Критерии включения

• Currently pregnant and receiving care at a participating collaborative site - University of North Carolina, Chapel Hill; Zuckerberg Chan San Francisco General Hospital; University of Florida Health, Jacksonville.
• 18 years of age and older
• Able to read, speak, and understand English or Spanish
• Has not previously been offered prenatal genetic screening for the current pregnancy
• 24 weeks (6 months) gestational age or less

Критерии исключения

• Not pregnant, not a patient at a partner clinical site
• Younger than 18 years of age
• Not being able to read, speak, and understand English or Spanish
• Has previously been offered prenatal genetic screening for the current pregnancy
• Greater than 24 weeks gestational age (6 months)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 3 центра

• Zuckerberg Chan San Francisco General Hospital — San Francisco
• University of Florida Health — Jacksonville
• University of North Carolina — Chapel Hill

Публикации

• 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. PMID 41252505
• 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. PMID 40245273

Идентификаторы

NCT: NCT07557303 · STUDY20251580 · R01HG013718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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