Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
2 other identifiers
interventional
1,400
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 5, 2026
April 1, 2026
2.2 years
April 22, 2026
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Mobile-based Educational Intervention
EXPERIMENTALParticipants 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 INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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
- weeks (6 months) gestational age or less
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Zuckerberg Chan San Francisco General Hospital
San Francisco, California, 94158, United States
University of Florida Health
Jacksonville, Florida, 32209, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Related Publications (2)
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: 41252505BACKGROUNDAllyse 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: 40245273BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marsha Michie, PhD
Case Western Reserve University
- PRINCIPAL INVESTIGATOR
Megan Allyse, PhD
Case Western Reserve University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director, Department of Bioethics, Bioethics Center for Community Health ANd Genomic Equity (CHANGE), School of Medicine
Study Record Dates
First Submitted
April 22, 2026
First Posted
April 29, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- 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.
- 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
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.