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

NCT07557303 — Not applicable, Recruiting, 1400 participants, Case Western Reserve University

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Registry	NCT07557303
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, health services research
Enrollment	1400 (Estimated)
Sponsor	Case Western Reserve University (Other); collaborators: National Human Genome Research Institute (NHGRI)
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	Mobile-based Educational Intervention (Behavioral)
Dates	start 2026-09-10, primary completion 2028-06-30 (estimated), completion 2028-06-30 (estimated), first posted 2026-04-29, last updated 2026-09-22
Locations	3 sites in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Mobile-based Educational Intervention	Experimental	Behavioral: Mobile-based Educational Intervention	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.
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.

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.

+Outcome measures

Primary outcomes

Decision Self-Efficacy [The 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.

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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 Criteria:

* 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)

+Locations (3)

Facility	City	Country	Status
Zuckerberg Chan San Francisco General Hospital	San Francisco, California	United States	Recruiting
University of Florida Health	Jacksonville, Florida	United States	Recruiting
University of North Carolina	Chapel Hill, North Carolina	United States	Recruiting

+Publications

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

+Investigators

Marsha Michie, PhD, Principal investigator, Case Western Reserve University
Megan Allyse, PhD, Principal investigator, Case Western Reserve University

+Funding

NIH grants: R01HG013718