Prenatal Computer-Aided Genetics Education Module

Brief Title

Prenatal Computer-Aided Genetics Education Module

Official Title

Development of a Computer-Aided Genetics Education Module (CAGEM) on Screening and Testing for Fetal Chromosome Conditions and Carrier Status: A Clinical Trial

Brief Summary

      A standard part of obstetrical care is offering prenatal genetic screening. Numerous
      professional guidelines have emphasized the importance of pretest counseling for prenatal
      genetic screenings. Informed consent includes the optional nature of the test, information on
      the conditions being screened, possible test results, implication of each result, and the
      type of test offered (screening or diagnostic). This responsibility falls on the physician in
      a busy clinic. Technology may be able to address this limitation and give consistent pretest
      counseling for patients waiting for their appointment. This study is looking to evaluate the
      use of computer-aided genetics education module for facilitating decision making about
      prenatal genetic screening and testing for fetal chromosome conditions and carrier status.
    

Detailed Description

      Rationale Cytogenetic abnormalities are present in nearly 1% of live births, in approximately
      2% of pregnancies in women older than 35 years who undergo prenatal diagnosis, and in fully
      half of all spontaneous, first-trimester abortions. Genetic counseling and screening for
      cytogenetic abnormalities are an integral part of routine obstetrical care. There are various
      screening options and strategy available commercially, including screening for the fetus and
      parental carrier screening. Currently American College of Obstetrics and Gynecology (ACOG)
      recommends that all pregnant women should be offered screening for fetal aneuploidy. ACOG
      also recommends panethnic screening for cystic fibrosis, hemoglobinopathies and spinal
      muscular atrophy carrier status. For other conditions, glycogen storage diseases and fragile
      X syndrome, the recommendation currently is to screen based on ethnicity and family history.
      Without thorough counseling, pregnant women may accept multiple screenings without
      considering the downstream consequences, including anxiety created by additional, sometimes
      uncertain, information.

      Numerous professional societies guidelines have emphasized the importance of pre-test
      counseling in this setting due to the delicate and complicated nature of genetic conditions.
      Along with these guidelines, typically minimal recommended information to be provided during
      a pre-test counseling was included. Generally it involves, the optional nature of the test,
      general information about condition tested, nature of testing (screening, carrier screening
      or diagnostic), testing options, possible testing result, implication of each result, cost
      and availability of genetic counseling should needed. The responsibility of offering these
      tests and to perform pre-test counseling lie primarily on the obstetrical care providers and
      has become more burdensome as the number of testing options expands and also due to limited
      time for discussion during a prenatal care.

      Technology may be able to address these limitations. Various studies have evaluated the use
      of Computerized Decision Aids (CDAs) in facilitating high-quality decision making in various
      health related contexts with promising results (17-20). CDAs are generally superior to
      traditional decision aids such as, paper-based or video-based, due to the possibility to
      tailor CDAs based on the information provided, the ease of information dissemination and also
      their interactive features which reinforce participation. This study is looking to evaluate
      the use of computer-based pre-test education for prenatal cytogenetic abnormalities
      screening.

      Statement of Problem Per professional society guidelines, all women should be offered
      prenatal screening and/or diagnostic testing for fetal aneuploidy (chromosome conditions such
      as Down syndrome, trisomy 18, trisomy 13, and sex chromosome abnormalities) during pregnancy.
      Women should also be offered population-based carrier screening but have the option of
      expanded carrier screening as well. There are an increasing number of testing and screening
      options available during pregnancy. The obstetrics provider is primarily responsible for
      ensuring patients are informed about their options and the benefits, risks, and limits of
      each. These discussions can be time intensive in a setting where the time available is often
      limited. As such, there is a need to find alternate ways to educate women about their
      prenatal testing and screening options.

      Objectives The overarching purpose of the full project is to determine whether a computer
      aided genetics education module can improve pregnant women's knowledge about their options
      for fetal aneuploidy (chromosome) screening and testing and carrier screening and facilitate
      informed decision making.

      The specific aims of the current study are to:

        -  To develop a computer-aided genetics education module for prenatal cytogenetic
           abnormalities screening and testing and carrier screening

        -  To determine the acceptability of the computer-aided genetics educational module for
           women presenting for care in an obstetrics clinic

        -  To determine the feasibility of using the computer-aided genetics educational module in
           a busy obstetrics clinic

        -  To assess whether use of the module increases knowledge and enhances informed decision
           making

        -  To compare the effectiveness of the computer-aided education module to standard care in
           terms of knowledge gained and impact on decision making

      This study will be done in two phases. Phase 1 will involve evaluating the acceptability of
      the computer-aided genetics education module. Changes will be made to the module based on the
      feedback obtained. The revised module will then be used for Phase 2. Phase 2 will involve
      comparing the effectiveness of the computer-aided genetics education module to standard care.

      Methodology

      A clinician who has access to the daily clinic patient list will identify patients eligible
      to participate in the study and notify an onsite study team member. Eligible study
      participants will then be approached by one of the study team members (either a genetic
      counselor, a genetic counseling student, a medical student, or a maternal-fetal medicine
      fellow) and be invited to participate in the study. The potential participant will be given
      the study information sheet and the study team member will review it with her. If the
      approached participant agrees to take part, participant will be randomized into one of the
      two arms of the study-control versus tests arm. Randomization will be performed using
      Qualtrics platform.

        -  Control arm: The participant will be given a digital device (IPad or Kindle Fire) to
           complete a pre-education survey (web-based pre-intervention survey housed on the
           Qualtrics platform). Once the survey is complete, the participant will proceed with
           standard education, provided by a resident/physician in the clinic, about prenatal
           screening and testing for chromosome conditions and for carrier status. Once the
           standard education has been completed, the participant will be approached to complete a
           post-education survey which includes questions about knowledge, intent to have or
           decline screening or testing, and demographic variables. Once the post-education survey
           is completed, the participant will be given a $5 gift card for her time. Participation
           in the study is then complete.

        -  Test arm: The participant she will be given a digital device on which to access the
           computer-aided genetics educational module. Prior to accessing the module, the
           participant will be asked to complete a pre-education survey (web-based pre-intervention
           survey housed on the Qualtrics platform). Once she has completed the survey, she will
           interact with the module which is tailored for her clinical situation. Once the
           participant has completed reviewing the module, she will be asked to complete the
           web-based post-module survey which includes questions about knowledge, intent to have or
           decline screening or testing, acceptability of the module, and demographic variables.

        -  All responses (control and test) will be recorded using a unique participant
           identification number in order to pair pre- and post-intervention responses. The
           identifier will not be linked to any identifiable information. Of note, all subjects
           will receive standard provider counseling after completion of the study module (standard
           of care).

      Phase 1: During Phase 1, The investigators will assess the acceptability of the
      computer-aided genetics educational module in our target study population. During this
      initial phase, The investigators will only be doing the test arm of the study. Quantitative
      and qualitative responses from the pre- and post-surveys will be obtained from batches of 10
      samples; the module will then be optimized based on the qualitative feedback and overall
      results on the knowledge, acceptability, and informed consent questions. This will be
      repeated until user acceptability reaches 80% of the maximum score.

      The computerized educational module has been developed based on counseling points recommended
      by the American College of Obstetrics and Gynecology and is based on a previous study
      investigating computer-aided education. The application can be accessed at
      https://interva-online.mobi/CAGEM/participant/guestLogin.do?packageId=178

      Survey Instruments There are three separate survey instruments, all of which have been
      developed on the Qualtrics survey platform. The pre-education survey instrument is the same
      for control and test participants and includes basic knowledge questions about genetic
      testing and screening for chromosome conditions and carrier status. The questions are based
      on the standard information that should be presented when providing genetic counseling on
      these topics.

      There are two versions of the post-intervention survey. Both versions include knowledge
      questions (same as pre-test questions) and demographic questions. The surveys differ in that
      the survey for those taking part in the test arm include questions about the acceptability of
      the computer-aided genetics educational module.
    


Study Type

Interventional


Primary Outcome

Knowledge of Genetics

Secondary Outcome

 Testing Intention

Condition

Autosomal Recessive Disorder

Intervention

Computer-Aided Genetic Education Module

Study Arms / Comparison Groups

 Control Arm
Description:  The participant will be given a digital device (IPad or Kindle Fire) to complete a pre-education survey (web-based pre-intervention survey housed on the Qualtrics platform). Once the survey is complete, the participant will proceed with standard education, provided by a resident/physician in the clinic, about prenatal screening and testing for chromosome conditions and for carrier status. Once the standard education has been completed, the participant will be approached to complete a post-education survey which includes questions about knowledge, intent to have or decline screening or testing, and demographic variables.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

March 7, 2018

Completion Date

December 31, 2019

Primary Completion Date

December 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Pregnant with gestational age of less than 24 weeks

          -  Good understanding of spoken English

        Exclusion Criteria:

          -  Known history of genetic disorder
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Manesha Putra, MD, 7732419231, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03449225

Organization ID

115217B3E


Responsible Party

Principal Investigator

Study Sponsor

Wayne State University


Study Sponsor

Manesha Putra, MD, Principal Investigator, Wayne State University


Verification Date

April 2019