An Interactive Informed Consent and Education Program for Pregnant Women
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pregnancy Down Syndrome |
Device: Information about Prenatal Screening and Diagnosis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
| Official Title: | An Interactive Informed Consent and Education Program for Pregnant Women |
- 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.
- 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.
| Enrollment: | 150 |
| Study Start Date: | August 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital (NMH) | |
| Chicago, Illinois, United States, 60611 | |
| Northwestern Memorial Faculty Foundation (NMFF) | |
| Chicago, Illinois, United States, 60611 | |
| 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. |
More Information
No publications provided
| Responsible Party: | William Grobman, Associate Professor, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01176019 History of Changes |
| Other Study ID Numbers: | NIH-291 |
| Study First Received: | August 3, 2010 |
| Last Updated: | September 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Amniocentesis Chorionic Villus Sampling First trimester screening Down syndrome |
Additional relevant MeSH terms:
|
Down Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 19, 2013