An Interactive Informed Consent and Education Program for Pregnant Women

Northwestern University

Status and phase: Completed; Phase 1

Conditions: Down Syndrome; Pregnancy

Treatments: Device: Information about Prenatal Screening and Diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01176019

NIH-291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Non-English speaking

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Interactive Video

Experimental group

Description:

In addition to standard care, the experimental arm will receive an interactive video designed to inform and educate patients about the choices that exist concerning prenatal screening and diagnosis.

Treatment:

Device: Information about Prenatal Screening and Diagnosis

Control

No Intervention group

Description:

A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.