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An Interactive Informed Consent and Education Program for Pregnant Women

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ClinicalTrials.gov Identifier: NCT01176019
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : November 7, 2014
Information provided by (Responsible Party):
William Grobman, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Pregnancy Down Syndrome Device: Information about Prenatal Screening and Diagnosis Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: An Interactive Informed Consent and Education Program for Pregnant Women
Study Start Date : August 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Interactive Video
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.
Device: Information about Prenatal Screening and Diagnosis
15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.
No Intervention: Control
A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.

Primary Outcome Measures :
  1. Difference in understanding/knowledge gain as compared to control [ Time Frame: Post-test and 2 week follow-up ]
    Open-ended and T/F questionnaire designed to determine if the ArchieMD Interactive Informed Consent and Education Program for Pregnant Women improves understanding and expectations of prenatal screening and diagnostic tests in a group of pregnant women patients.

Secondary Outcome Measures :
  1. eHEALS [ Time Frame: Post-test ]
    The eHEALS is a self-report tool that can be administered by a health professional and is based on an individual's perception of her or his own skills and knowledge within each measured domain. The instrument is designed to provide a general estimate of consumer eHealth-related skills that can be used to inform clinical decision making and health promotion planning with individuals or specific populations.

  2. Attitudes towards/satisfaction with interactive video [ Time Frame: Post-test ]
    Multiple-choice questionnaire designed to determine if the ArchieMD Interactive Informed Consent and Education Program for Pregnant Women enhances satisfaction with and attitudes toward the patient education process.

  3. REALM [ Time Frame: Post-test ]
    The REALM (Rapid Estimate of Adult Health Literacy in Medicine) is a word recognition test designed to provide a valid and quick assessment of participant health literacy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176019

United States, Illinois
Northwestern Memorial Faculty Foundation (NMFF)
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital (NMH)
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Bill Grobman, M.D., M.B.A Northwestern University
Principal Investigator: Michael Wolf, Ph.D, M.P.H Northwestern University
Principal Investigator: Robert Levine, M.D. ArchieMD, Inc.

Responsible Party: William Grobman, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01176019     History of Changes
Other Study ID Numbers: NIH-291
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014

Keywords provided by William Grobman, Northwestern University:
Chorionic Villus Sampling
First trimester screening
Down syndrome

Additional relevant MeSH terms:
Down Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn