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Ensuring Patients' Informed Access to Noninvasive Prenatal Testing (NEST)

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ClinicalTrials.gov Identifier: NCT03420274
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : June 28, 2019
Sponsor:
Collaborators:
Indiana University
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
Noninvasive prenatal genetic testing (NIPT) is an important new screening test option provided to pregnant women in the first trimester of pregnancy. The advantage of this screen is that is provides information about the risk of trisomy 13, trisomy 18, and trisomy 21 with greater accuracy than conventional screens. At the same time, NIPT can produce information about the risk of a cohort of other fetal genetic variants, including sex chromosome aneuploidies and microdeletion syndromes. While not yet clinically available for whole exome sequencing, the potential for this next clinical application already exists. The challenge is that, while this is an important new test, there are little data about how to best structure patient-centered decisions about its use, including decisions if to use this screen and how the information may directly inform subsequent prenatal care decisions. The purpose of this study is to gain formative data about current practice patterns with respect to how NIPT is discussed in the clinical visit and to use these data to help inform best practices for its continued use in the clinical setting.

Condition or disease Intervention/treatment Phase
Genetic Disease Genetic Syndrome Prenatal Disorder Prenatal Maternal Abnormality Pregnancy Complications Behavioral: NEST Behavioral: Usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a cluster randomized trial examining a shared decision-making intervention.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Ensuring Patients' Informed Access to Noninvasive Prenatal Testing
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Intervention
This arm will utilize a point-of-care shared decision-making tool (NEST).
Behavioral: NEST
This is a point-of-care shared decision-making instrument.

Placebo Comparator: Control
This group will utilize usual care with respect to healthcare provider practice for education and counseling.
Behavioral: Usual care
This group will utilize usual care with respect to healthcare provider practice for education and counseling.




Primary Outcome Measures :
  1. Shared decision-making (SDM) [ Time Frame: 40 weeks estimated gestational age ]
    This will be measured using the OPTIONS scale, a validated scale developed to measure different components of a shared decision-making process in a clinical encounter as part of a direct observation approach.


Secondary Outcome Measures :
  1. Informed choice [ Time Frame: 40 weeks estimated gestational age ]
    This will be measured using the Multidimensional Measure of Choice (MMIC). The MMIC, a well-established and validated instrument, measures informed choice with respect to prenatal testing by assessing four factors: (1) patient knowledge, (2) attitudes, and (3) deliberation of alternatives, advantages, and disadvantages, of different testing options in the context of (4) decision about test utilization. It has subsequently been modified and validated to assess informed choice for NIPT.

  2. Decisional regret: [ Time Frame: 40 weeks estimated gestational age ]
    This will be measured using the validated Decisional Conflict Scale (DCS).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The investigators will recruit 1) pregnant women, 2) self-identified partners of pregnant women (not limited to male partner), and 3) prenatal healthcare providers.
Accepts Healthy Volunteers:   No
Criteria

I. Pregnant women

Inclusion criteria:

  1. 18 years of age or older
  2. Present for their initial prenatal visit care with one of the providers enrolled in the study
  3. Able to provide consent to participate in the study
  4. Available for a follow up in the 1st or 2nd trimester of pregnancy
  5. Have a viable intrauterine pregnancy
  6. Present for care between 7-12 weeks estimated gestation age (EGA)

Since criteria 5 and 6 will not be determined until the conclusion of the first prenatal visit, women who meet criteria 1-4 will be eligible for participation.

Exclusion Criteria:

Women who are:

  1. Less than 18 years of age
  2. Not currently pregnant or an intrauterine pregnancy has not yet been established
  3. Inability to provide informed consent for research participation

II. Self-identified partners of pregnant women

Inclusion criteria:

  1. 18 years of age or older
  2. The male or female partner (such as partner or mother/aunt/grandmother serving in the role of primary collaborative decision-maker in place of a partner) of a pregnant woman who has participated in the research
  3. Participating in decision-making about the pregnancy
  4. Ability to read and speak English
  5. Ability to provide informed consent for research participation

Exclusion criteria:

  1. Younger than 18 years of age
  2. Not currently involved in the pregnancy or decision-making about prenatal care
  3. Inability to speak or read English
  4. Inability to provide informed consent for research participation

III. Prenatal healthcare providers

Inclusion criteria:

  1. Board certified or board-eligible CNM, OB/GYNs or MFMs
  2. Deliver outpatient prenatal care at one of the regional practices of the Cleveland Clinic
  3. Able to read and speak English
  4. Able to provide consent for research participation

Exclusion criteria:

  1. OB/GYNs who do not currently provide prenatal care
  2. Medical students, residents, and fellows
  3. Hospitalists who do not provide outpatient obstetric care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420274


Contacts
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Contact: Patricia Agatisa, PhD 216-444-0890 agatisp@ccf.org
Contact: Research Line 216-445-8090

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ruth M. Farrell, M.D.    216-444-2615    farrelr@ccf.org   
Contact: Patricia Agatisa, PhD    216-444-0890    agatisp@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Indiana University
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Ruth M Farrell, M.D., M.A. The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03420274     History of Changes
Other Study ID Numbers: 17-987
R01HG010092 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Shared decision-making
Prenatal genetic testing
Noninvasive prenatal testing (NIPT)
Cell free fetal DNA (cfDNA)
Informed consent
Additional relevant MeSH terms:
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Pregnancy Complications
Genetic Diseases, Inborn