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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Health Education; Self Efficacy; Decision Making; Informed Consent; Delivery of Health Care; Internet-Based Intervention; Genetic Testing; Humans; Noninvasive Prenatal Testing; Pregnant People; Patient Education as Topic/Method
• Intervention / Treatment: Behavioral: Mobile-based Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabina Rubeck, MPH; Phone Number: 216-368-2547; Email: sabina.rubeck@case.edu
• Study Contact Backup: Name: Harlie Custer, MA, MPH; Phone Number: (216) 368-5914; Email: harlie.custer@case.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Zuckerberg Chan San Francisco General Hospital
      • Contact: Kimberly Coleman-Phox, MPH; Phone Number: 415-476-6406; Email: kimberly.coleman-phox@ucsf.edu
      • Contact: Miriam Kuppermann, MPH, PhD; Phone Number: 415-502-4089; Email: miriam.kuppermann@ucsf.edu
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health
      • Contact: Niamh Condon, DO, FACOOG; Phone Number: 904-383-1037; Email: Niamh.Condon@jax.ufl.edu
      • Contact: Julie Nowak; Email: julie.nowak@jax.ufl.edu
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
      • Contact: Neeta Vora, MD; Phone Number: (984) 974-2131; Email: Neeta_vora@med.unc.edu
      • Contact: Amber Ivins, MSCR; Email: amber_ivins@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Marsha Michie, PhD, Case Western Reserve University; Principal Investigator: Megan Allyse, PhD, Case Western Reserve University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Decision making; Informed consent; Educational intervention; Surveys and Questionnaires; Cell-free DNA (cfDNA); Informed choice; Decision Regret; Decision Satisfaction; Non-invasive prenatal screening (NIPS); Non-Invasive Prenatal Testing (NIPT); Prenatal genetic screening
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Health Education
• Other Study ID Numbers: STUDY20251580; 7R01HG013718-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No