An Interactive Informed Consent and Education Program for Pregnant Women

November 5, 2014 updated by: William Grobman, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital (NMH)
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Faculty Foundation (NMFF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-test and 2 week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-test
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.
Post-test
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.
Post-test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

ArchieMD

Investigators

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH-291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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