Shifting Options Study

NCT07225595 | Active Not Recruiting

• 1 other identifier: 24-826
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prenatal Care; Prenatal Diagnosis

Keywords

shared decision-making; informed decision-making; prenatal screening and diagnostic testing

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

• 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.

  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.

  12 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant or postpartum females
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 participants include those who are in their 1st or 2nd trimester of pregnancy or are 1-12 months post partum (Groups 1A, 1B and 1C). These participants will be seeking prenatal or postpartum care at one of the participating study sites. Group 2 participants will be practicing and seeing patients at one of the study sites outpatient locations.

You may qualify if:

• 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

You may not qualify if:

• \<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
• 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
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Ruth M Farrell, MD, MA

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (2)