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
Conditions
Keywords
Non-invasive prenatal screening (NIPS), Non-Invasive Prenatal Testing (NIPT), Cell-free DNA (cfDNA), Prenatal genetic screening, Informed consent, Decision making, Surveys and Questionnaires, Informed choice, Educational intervention, Decision Regret, Decision Satisfaction
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.
Interventions
BEHAVIORALMobile-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.
Sponsors
Case Western Reserve University
National Human Genome Research Institute (NHGRI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Longitudinal stepped-wedge trial design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Self-Efficacy | The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit. | 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. |
Countries
United States
Contacts
CONTACTSabina Rubeck, MPH
CONTACTHarlie Custer, MA, MPH
PRINCIPAL_INVESTIGATORMarsha Michie, PhD
Case Western Reserve University
PRINCIPAL_INVESTIGATORMegan Allyse, PhD
Case Western Reserve University
Outcome results
None listed