Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03449225 |
| Other study ID # |
115217B3E |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2018 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
April 2019 |
| Source |
Wayne State University |
| Contact |
Manesha Putra, MD |
| Phone |
7732419231 |
| Email |
manesha.putra[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
