Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 3
- 主要终点
- Decision Self-Efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Mobile-based Educational Intervention (Behavioral)
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.
结局指标
主要结局
Decision Self-Efficacy
时间窗: 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.
次要结局
未报告次要终点
研究者
Marsha Michie
Associate Director, Department of Bioethics, Bioethics Center for Community Health ANd Genomic Equity (CHANGE), School of Medicine
Case Western Reserve University