Shifting Options Study (NCT07225595) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Shifting Options Study
United States78 participantsStarted 2025-01-01
Plain-language summary
The goal of Shifting Options is to create strategies and resources that will facilitate informed decision-making about prenatal screening and diagnostic testing (PS\&D) for all pregnant patients. Shifting Options will determine how rapid changes in PS\&D and post-diagnosis options affect the nature and timing of resources and support patients need to make informed PS\&D decisions.
To achieve this goal, patient participants will be interviewed to identify their PS\&D decision-making needs. Then, clinician participants input will be added on how best to implement strategies that address those needs.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older
. Ability to read and speak English
. Able to provide consent to participate in the study
. Have a viable intrauterine pregnancy (IUP) or 1-12 postpartum
. Offered routine aneuploidy screening and diagnostic testing
. Seeking care at one of the participating study sites
Exclusion criteria
. \<18 years of age or older
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Qualitative analysis completed using Grounded Theory in examining patient participant interviews to uncover emerging codes, memos, and themes that build strategies to support prenatal screening and diagnostic testing informed decision-making.
Timeframe: 12 months
2
Qualitative analysis completed using Grounded Theory in examining provider participant interviews to uncover emerging codes, memos, and themes that build strategies or tools to support prenatal screening and diagnostic testing informed decision-making.