Supporting Pregnant Patients as They Face a Changing Landscape of Prenatal Genetic Tests and Post-diagnosis Options (Shifting Options)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Study overview:
Prenatal genetic screening and diagnostic tests (PS&D) contribute to optimal fetal/neonatal outcomes through the delivery of high-quality prenatal care. While PS&Ds are an important part of prenatal care delivery, advances in PS&D present a challenge to ensure pregnant patients have the information and resources to make informed decisions about their use. This complexity is due to significant advances in prenatal genomics that continue to introduce new PS&D, increasing the number of conditions that can be detected before birth. It is also due to parallel changes in maternal-fetal medicine, pediatrics, and reproductive policy that rapidly change the options available if a fetal genetic condition is diagnosed. Consequently, patients face a growing challenge in making informed decisions about a moving target of testing and post-diagnosis options. As a result, a serious and urgent unmet clinical problem has emerged: There is a lack of evidence-based guidance to support an individualized informed decision-making process for patients amidst an increasingly complex set of reproductive healthcare choices. The objective of our study is to generate strategies and resources that will facilitate informed decision-making about PS&D by diverse populations of pregnant patients. This project is a first step to identifying what strategies may be needed to best prepare patients for this increasingly complex decision-making landscape.
Methods:
The study will engage with two populations: (Group 1) the investigators will conduct in-depth interviews with patients to identify key factors that impact the decision-making and the resources needed to support that process, and (Group 2) with prenatal clinicians to obtain input on patient-reported decision-making priorities and resources to frame a set of initial considerations for strategy and tool implementation. Since this is an observational study, there will be no intervention, neither group will be randomized.
Study Population
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Group 1 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
排除标准
- •<18 years of age or older
- •Inability to read and speak English
- •Not able to provide consent to participate in the study
- •Does not have a viable intrauterine pregnancy (IUP) or is not 1-12 postpartum
- •Was not offered routine aneuploidy screening and diagnostic testing
- •Is not seeking care at one of the participating study sites
- •Group 2 Inclusion Criteria:
- •Board eligible clinicians who provide prenatal care (includes OB/GYNs, CNMs, NPs, MFMs, GC, etc.)
- •Provide outpatient obstetric care
- •Practice at one of the study sites
- •Group 2 Exclusion Criteria:
- •Not board eligible clinicians who provide prenatal care (includes OB/GYNs, CNMs, NPs, MFMs, GC, etc.)
- •Does not provide outpatient obstetric care
- •Does not practice at one of the study sites
研究组 & 干预措施
Clinician participants, Group 2 (N=50)
Participants (N=50) include primary OB providers, maternal-fetal specialists, genetic counselors and genetic specialists who provide outpatient obstetric care and practice at one of the outpatient clinics of the study sites.
Patient participants, Group 1 (N=60)
Group 1 consists of patient participants. Patient participants will be fit into one of the following sub-categories: (Group 1A, N=20) patients who initiate care in the 1st or 2nd trimester of pregnancy, (Group 1B, N=20) pregnant patients with similar characteristics to category 1, but who have scheduled their 2nd trimester anatomical ultrasound at one of the study sites, and (Group 1C, N=20) patients who are 1-12 months postpartum and delivered at one of the participating sites.
结局指标
主要结局
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.
时间窗: 12 months
The study outcome will include qualitative interview data about the prenatal screening and diagnostic testing decision-making process and a foundation for innovative strategies to support patients' informed decision-making with tandem changes in prenatal genomics and available post-diagnosis options. This work will allow researchers to characterize how patients conceptualize the shifting landscape of testing and post-diagnosis options about prenatal screening and diagnostic testing.
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.
时间窗: 12 months
The study outcome will include qualitative interview data about the prenatal screening and diagnostic testing decision-making process and a foundation for innovative strategies to support patients' informed decision-making with tandem changes in prenatal genomics and available post-diagnosis options. This work will allow researchers to characterize how providers can support patients with the shifting landscape of testing and post-diagnosis options about prenatal screening and diagnostic testing and how these resources would best be implemented into prenatal care delivery within the clinical setting.
次要结局
未报告次要终点