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

a study on Delivery of Health Care Genetic Testing Pregnancy Noninvasive Prenatal Testing Informed Consent Internet-Based Intervention Self Efficacy Decision Making Health Education Education as Topic/Method

Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
study ends around

Description

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.

Keywords

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, Non-invasive prenatal screening (NIPS), Non-Invasive Prenatal Testing (NIPT), Cell-free DNA (cfDNA), Prenatal genetic screening, Surveys and Questionnaires, Informed choice, Educational intervention, Decision Regret, Decision Satisfaction, Mobile-based Educational Intervention

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join 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)

Locations

  • Zuckerberg Chan San Francisco General Hospital accepting new patients
    San Francisco California 94158 United States
  • University of Florida Health accepting new patients
    Jacksonville Florida 32209 United States
  • University of North Carolina accepting new patients
    Chapel Hill North Carolina 27599 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Case Western Reserve University
ID
NCT07557303
Study Type
Interventional
Participants
Expecting 1400 study participants
Last Updated
Contact us about this trial