RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-06
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06382636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to read and speak English
  2. * Able to provide consent to participate in the study
  3. * Offered routine aneuploidy screening and diagnostic testing
  1. * Less than 18 years of age
  2. * Not currently pregnant or an intrauterine pregnancy has not yet been established
  3. * Unable to provide informed consent for research participation
  4. * Unable to read and speak English

Contacts and Locations

Study Contact

Ruth Farrell, MD, MA
CONTACT
216-445-7085
farrelr@ccf.org
Christina Collart, MEd
CONTACT
216-470-9796
collarc@ccf.org

Principal Investigator

Ruth Farrell, MD, MA
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Neighborhood Family Practice
Cleveland, Ohio, 44102
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Ruth Farrell, MD, MA, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-06
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-05-06
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • Prenatal Genetic Screening
  • Prenatal Diagnostic Testing
  • Shared Decision Making
  • Informed Choice
  • Decisional Regret

Additional Relevant MeSH Terms

  • Prenatal Disorder