Clinical trial NCT01176019: An Interactive Informed Consent and Education Program for Pregnant Women
Official title: An Interactive Informed Consent and Education Program for Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pregnancy
Down Syndrome
Keywords: Amniocentesis
Chorionic Villus Sampling
First trimester screening
Down syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: ArchieMD
First posted: 2010-08-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.

Detailed description: Women face a variety of medical decisions during pregnancy and childbirth. While there are extensive educational resources for pregnant women, modern medicine presents decisions that many women are poorly equipped to make. Issues such as prenatal screening and mode of birth after a cesarean delivery require a significant degree of patient education to enable a truly informed medical decision. Studies have shown that women have a poor understanding of screening for birth defects and mode of birth after a cesarean delivery. Women with a low level of education or poor health literacy are significantly more likely to demonstrate inadequate understanding of prenatal screening. ArchieMD, Inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of medical procedures and educate patients on the consequences of their behavior. We hypothesize that such an interactive medical simulation patient education program can improve patient understanding allowing pregnant women to make informed decisions. In Phase I, we will prototype an interactive patient education program for prenatal screening and amniocentesis.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman (6-26 weeks gestation)
* Over 18 years of age

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Difference in understanding/knowledge gain as compared to control
timeFrame: Post-test and 2 week follow-up
Secondary outcomes:
measure: eHEALS
timeFrame: Post-test
measure: Attitudes towards/satisfaction with interactive video
timeFrame: Post-test
measure: REALM
timeFrame: Post-test
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Faculty Foundation (NMFF)
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital (NMH)
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bill Grobman, M.D., M.B.A
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Michael Wolf, Ph.D, M.P.H
role: PRINCIPAL_INVESTIGATOR
affiliation: ArchieMD, Inc.
name: Robert Levine, M.D.
role: PRINCIPAL_INVESTIGATOR
References: