Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening (DAAS)

September 25, 2020 updated by: University of North Carolina, Chapel Hill

Use of a Novel Decision Aid for Prenatal Aneuploidy Screening

The investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based decision aid in addition to routine counseling or routine counseling only during a single study visit. This decision aid was developed at a 10th grade literacy level using input from Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20 English and Spanish speaking women of varying education levels. Following completion of genetic counseling, participants will complete several surveys assessing knowledge and decision conflict. Data will be abstracted regarding demographics, screening and diagnostic testing uptake, and testing results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy at less than 22 weeks gestation
  • English or Spanish speaking
  • Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy screening

Exclusion Criteria:

  • Known fetal anomalies
  • Known multiple gestations
  • Prior genetic counseling or aneuploidy screening in current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Routine care
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Other: Genetic counseling appointment
All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
Experimental: Experimental
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
Other: Genetic counseling appointment
All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
Other: iPad-based decision aid
This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge Score
Time Frame: At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes
All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.
At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decisional Conflict Score
Time Frame: At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes
A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.
At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes
Test Chosen
Time Frame: At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes
For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.
At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes
Supplementary Tests Performed
Time Frame: 22 weeks gestation
Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.
22 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North Carolina Translational and Clinical Sciences Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura M Carlson, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-1745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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