跳至主要内容
临床试验/NCT06382636
NCT06382636招募中不适用

Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes

The Cleveland Clinic4 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
4
主要终点
Patient activation

研究概览

简要总结

The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening & Diagnostic Testing (PS&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS&D and decreases decisional conflict associated with those decisions.

Using data from NEST (Ensuring Patients Informed Access to NIPT [non-invasive prenatal testing]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS&D options, and resources to learn about insurance coverage for PS&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer.

详细描述

Study overview:

The investigators will conduct a randomized cluster trial to examine the impact of the Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) on the decision-making process about Prenatal Screening & Diagnostic Testing (PS&D) from the perspectives of patients, partners, and providers. In doing so, the investigators will examine important changes that have taken place in genetic technology and healthcare. In-depth, semi-structured interviews will be conducted to gain greater insight into the decision-making process and strategies throughout pregnancy to gain a longitudinal understanding of how decision-making unfolds with the utilization of tests and gestational age. The investigators will employ a method that allows for the study of decision-making across diverse patient and provider populations, including urban and rural communities and academic and community practices, to understand how these factors in addition to social determinants of health influence patients' informed access to PS&D. The team will collaborate the Advisory Group and in consultation with the Data Safety monitoring Board (DSMB) assembled for this study, to ensure scientific rigor in the experimental design and conduct of the study, analysis and interpretation of the data, and dissemination of the final results and version of the tool.

Methods:

Study population and recruitment: Participants will include three groups: (1) Obstetric (OB) providers, (2) patients, and (3) patient partners. Subject recruitment will take place at the three study sites: (1) the Cleveland Clinic Health System, (2) the MetroHealth Medical System, and (3) the Neighborhood Family Practice Community Health Centers.

Randomization:

研究设计

研究类型
Interventional
分配方式
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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Able to read and speak English
  • Able to provide consent to participate in the study
  • Offered routine aneuploidy screening and diagnostic testing

排除标准

  • Less than 18 years of age
  • Not currently pregnant or an intrauterine pregnancy has not yet been established
  • Unable to provide informed consent for research participation
  • Unable to read and speak English

研究组 & 干预措施

Standard of care

Placebo Comparator

This group will utilize standard care with respect to healthcare provider practices for education and counseling surrounding prenatal screening and diagnostic testing options.

干预措施: Standard Care (Behavioral)

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

Experimental

This arm will utilize an artificial intelligence AI enabled healthcare chatbot that provides patients with personalized information and decision-making support at different stages of the prenatal screen and diagnostic testing pathways.

干预措施: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot (Behavioral)

结局指标

主要结局

Patient activation

时间窗: 1-day

Time spent in chatbot

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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