CompletedNot Applicable

Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13

Canada887 participantsStarted 2023-02-01

Plain-language summary

This research project aims at assessing the effectiveness of a decision aid (DA) scaling intervention within the context of prenatal screening for trisomy 21, 18 and 13. The primary outcome is the level of involvement of pregnant women, their partners, and health professionals in shared decision-making (SDM) in the context of prenatal screening for trisomy 21, 18 and 13. The secondary outcome is the rate of use of online and paper versions of the DA by pregnant women, their partners and health professionals. The investigator hypothesize that the DA scaling strategies will increase the level of involvement of pregnant women, their partners (where appropriate), and health professionals in SDM.

Who can participate

Age range

18 Years

Sex

ALL

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: • Prenatal services (study sites) : To be eligible, prenatal services must * be located in Quebec province * be family medicine groups, gynecology and obstetrics departments or birth centers, other type of health facility involved in prenatal care * agree to participate in our study including the recruitment of approximately 35 pregnant women over a total period of 50 weeks * confirm that they will follow the research protocol. * Health professionals To be eligible, health professionals must: * be involved in prenatal care and working in a site participating in this study * be involved in the follow-up of pregnancies * be involved in the decision-making process in the context of prenatal screening for trisomiy 21, 18 and 13, * be referred by their prenatal service * understand French or English, * consent to participate in the study * medical residents and interns in midwifery practice, referred by participating prenatal service, are eligible too. • Pregnant women and their partners To be eligible, pregnant women and their partners must * be 18 years of age or older * have not yet decided whether or not to have prenatal testing for trisomy 21, 18 or 13 (usually before 13 weeks of pregnancy) * be followed in one of the prenatal services participating in this study * be able to read and understand French or English * have the capacity to verbally consent to participate in the study or sign the consent form Exclusion Criteria: * Pregnant women and…

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

Level of SDM adoption

Timeframe: At the 23rd week of pregnancy

Trial details

NCT IDNCT05859139

SponsorCHU de Quebec-Universite Laval

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Decision Aid trials