An Interactive Informed Consent and Education Program for Pregnant Women

This study has been completed.
Sponsor:
Collaborator:
ArchieMD
Information provided by (Responsible Party):
William Grobman, Northwestern University
ClinicalTrials.gov Identifier:
NCT01176019
First received: August 3, 2010
Last updated: September 13, 2011
Last verified: September 2011

August 3, 2010
September 13, 2011
August 2010
March 2011   (final data collection date for primary outcome measure)
Difference in understanding/knowledge gain as compared to control [ Time Frame: Post-test and 2 week follow-up ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01176019 on ClinicalTrials.gov Archive Site
  • eHEALS [ Time Frame: Post-test ] [ Designated as safety issue: No ]
    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.
  • Attitudes towards/satisfaction with interactive video [ Time Frame: Post-test ] [ Designated as safety issue: No ]
    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.
  • REALM [ Time Frame: Post-test ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
An Interactive Informed Consent and Education Program for Pregnant Women
An Interactive Informed Consent and Education Program for Pregnant Women

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
  • Pregnancy
  • Down Syndrome
Device: Information about Prenatal Screening and Diagnosis
15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.
  • 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.
    Intervention: Device: Information about Prenatal Screening and Diagnosis
  • No Intervention: Control
    A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01176019
NIH-291
Yes
William Grobman, Northwestern University
Northwestern University
ArchieMD
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.
Northwestern University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP