An Interactive Informed Consent and Education Program for Pregnant Women

Pregnancy Clinical Trial

Official title:

An Interactive Informed Consent and Education Program for Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176019
• Other study ID #: NIH-291
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2010
• Last updated: November 5, 2014
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman (6-26 weeks gestation)

• Over 18 years of age

Exclusion Criteria:

• Non-English speaking

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Down Syndrome
• Pregnancy

Intervention

Device:
• Information about Prenatal Screening and Diagnosis
15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.

Locations

Country	Name	City	State
United States	Northwestern Memorial Faculty Foundation (NMFF)	Chicago	Illinois
United States	Northwestern Memorial Hospital (NMH)	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	ArchieMD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in understanding/knowledge gain as compared to control	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.	Post-test and 2 week follow-up	No
Secondary	eHEALS	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.	Post-test	No
Secondary	Attitudes towards/satisfaction with interactive video	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.	Post-test	No
Secondary	REALM	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.	Post-test	No