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An Interactive Informed Consent and Education Program for Pregnant Women

Primary Purpose

Pregnancy, Down Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Information about Prenatal Screening and Diagnosis
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy focused on measuring Amniocentesis, Chorionic Villus Sampling, First trimester screening, Down syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Sites / Locations

  • Northwestern Memorial Faculty Foundation (NMFF)
  • Northwestern Memorial Hospital (NMH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interactive Video

Control

Arm Description

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.

A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 3, 2010
Last Updated
November 5, 2014
Sponsor
Northwestern University
Collaborators
ArchieMD
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1. Study Identification

Unique Protocol Identification Number
NCT01176019
Brief Title
An Interactive Informed Consent and Education Program for Pregnant Women
Official Title
An Interactive Informed Consent and Education Program for Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
ArchieMD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Down Syndrome
Keywords
Amniocentesis, Chorionic Villus Sampling, First trimester screening, Down syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive Video
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.
Intervention Type
Device
Intervention Name(s)
Information about Prenatal Screening and Diagnosis
Intervention Description
15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.
Primary Outcome Measure Information:
Title
Difference in understanding/knowledge gain as compared to control
Description
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.
Time Frame
Post-test and 2 week follow-up
Secondary Outcome Measure Information:
Title
eHEALS
Description
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.
Time Frame
Post-test
Title
Attitudes towards/satisfaction with interactive video
Description
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.
Time Frame
Post-test
Title
REALM
Description
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.
Time Frame
Post-test

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant woman (6-26 weeks gestation) Over 18 years of age Exclusion Criteria: Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill Grobman, M.D., M.B.A
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Wolf, Ph.D, M.P.H
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Levine, M.D.
Organizational Affiliation
ArchieMD, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Faculty Foundation (NMFF)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital (NMH)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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An Interactive Informed Consent and Education Program for Pregnant Women

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