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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Longitudinal stepped-wedge trial design
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Zuckerberg Chan San Francisco General Hospital
San Francisco, California 94158
Contact:
Miriam Kuppermann, MPH, PhD
415-502-4089
miriam.kuppermann@ucsf.edu

University of Florida Health
Jacksonville, Florida 32209
Contact:
Niamh Condon, DO, FACOOG
904-383-1037
Niamh.Condon@jax.ufl.edu

University of North Carolina
Chapel Hill, North Carolina 27599
Contact:
Neeta Vora, MD
(984) 974-2131
Neeta_vora@med.unc.edu

More Details

Status
Recruiting
Sponsor
Case Western Reserve University

Study Contact

Sabina Rubeck, MPH
216-368-2547
sabina.rubeck@case.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.