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The INFORM Study: Supporting Decisions for Prenatal Genetic Screening

This study, called The INFORM Study, is for pregnant individuals and aims to help them make decisions about prenatal genetic screening. It tests a mobile-based educational tool that provides clear information about screening. You would access this tool on your phone before your doctor's visit where screening is offered. The main goal is to see if using this tool makes you feel more confident in your decision about screening. Researchers will compare those who use the tool to those who don't, but everyone receives their usual medical care. You can join if you are at least 18 years old, pregnant, and can read English or Spanish. This study is currently recruiting participants.

Study design
This interventional study plans to enroll 1400 pregnant individuals. It compares participants who use a mobile-based educational tool to those who do not.
What's involved
You would sign up for the study before your first doctor's visit for your pregnancy. If in the intervention group, you would use a mobile-based educational tool before your clinical encounter.
Compensation
Not stated in the trial record.
Follow-up
Your decision self-efficacy will be measured up to 168 hours (7 calendar days) after your prenatal screening visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07557303

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

Not Yet Recruiting
NAAges 18+InterventionalHealth services
Case Western Reserve University
~1,400 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Mobile-based Educational Intervention

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decision Self-Efficacy
Measured over The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.

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

Explore related trials

Pregnancy

Where it's being run

3 sites across 3 states
California1
Florida1
North Carolina1

Study leadership

  • Marsha Michie, PhD · PRINCIPAL_INVESTIGATOR · Case Western Reserve University
  • Megan Allyse, PhD · PRINCIPAL_INVESTIGATOR · Case Western Reserve University

Who to contact

Sabina Rubeck, MPH
[email protected]
216-368-2547
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Decision Self-EfficacyThe scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.

    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.