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

Part of paid clinical trials in San Francisco, California.

Sponsor
Case Western Reserve University
Study ID
NCT07557303
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
1,400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.

Primary Outcome Measure

Decision Self-Efficacy [ Time Frame: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Zuckerberg Chan San Francisco General HospitalSan FranciscoCalifornia94158
Miriam Kuppermann, MPH, PhD
[email protected]
415-502-4089
Kimberly Coleman-Phox, MPH
[email protected]
415-476-6406
University of Florida HealthJacksonvilleFlorida32209
Niamh Condon, DO, FACOOG
[email protected]
904-383-1037
Julie Nowak
[email protected]
University of North CarolinaChapel HillNorth Carolina27599
Neeta Vora, MD
[email protected]
(984) 974-2131
Amber Ivins, MSCR
[email protected]

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