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

Summary

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.

Conditions

• Delivery of Health Care
• Genetic Testing
• Humans
• Pregnancy
• Noninvasive Prenatal Testing
• Informed Consent
• Internet-Based Intervention
• Self Efficacy
• Pregnant People
• Decision Making
• Health Education
• Patient Education as Topic/Method

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• Case Western Reserve University

  lead OTHER

Principal Investigators

• Marsha Michie, PhD · Case Western Reserve University

• Megan Allyse, PhD · Case Western Reserve University

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• United States

Study Locations