Computer-assisted Preventive Health Education for Women of Reproductive Age in Urgent Care Settings

Preconception Care Clinical Trial

Official title:

Preventive Health Education for Women of Reproductive Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177515
• Other study ID #: H2582-25916-01A
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 4, 2010
• Start date: March 2005
• Est. completion date: January 2007

Study information

• Verified date: May 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether "video doctor" programs can effectively deliver preventive health messages to women of reproductive age while they wait to be seen in urgent care settings. In this study, the specific hypotheses being tested are: 1) is the video doctor program effective in improving women's knowledge about emergency contraception, and 2) is the video doctor program effective in improving women's knowledge about the importance of folate.

Description:

We will randomly assign participants to interact with one of two "video doctor" programs which have been been developed to convey messages appropriate for women of reproductive age.

The "video doctor" is an actress (not UCSF staff) following a script that has been designed through interdisciplinary collaboration here at UCSF. These particular video programs have not been used before, but similar ones have been studied and shown to be effective by Dr. Gerber in providing patients with information about how to decrease sexual risks and the harms of alcohol and drug use. Before interacting with the "video doctor" program, we will assess participants baseline knowledge of the importance of peri-conception folate and the option of emergency contraception. Participants will then interact with their "video doctor" and be provided with a free sample of the pills their video doctor discussed.

The first "video doctor" will educate women about the ability of folate to reduce birth defects. The discovery that peri-conception folate supplementation significantly decreases rates of neural tube defects has inspired multiple educational campaigns. However, recent work has shown that knowledge of the benefits of folate remains low, especially among minority populations.

The second "video doctor" message will inform women of the option of emergency contraception. Emergency contraception using high doses of progesterone has been shown to reduce the risk of pregnancy to less than 2% when used up to five days after a condom failure or an episode of unprotected sex.

This medication is not teratogenic and will not cause a miscarriage if used by a woman who does not know she is pregnant. Use of emergency contraception poses no long-term health risks to women and is available over-the-counter in seven European countries. Prior studies in family planning clinics , as well as the post-partum setting have shown that education about and advance provision of emergency contraceptive pills can increase knowledge and appropriate use of these pills, without adversely affecting sexual risk taking or other health behaviors. However, knowledge of emergency contraception remains limited, leading some to call it America's "best kept secret." Participants will be contacted by phone six months after interacting with the "video doctor" and asked to provide information about their use of folate and/or emergency contraception. One year after interacting with the "video doctor" participants will be contacted again and asked to provide further information about their use of folate and/or emergency contraception.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 year old English-speaking women

Exclusion Criteria:

• current pregnancy

• history of tubal ligation

• hysterectomy

• partner with a vasectomy

• no sex with men

• will not be able to be reached by telephone in 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Preconception Care

Intervention

Behavioral:
• "video doctor," computer module
computerized counseling about emergency contraception and peri-conception folate

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schwarz EB, Gerbert B, Gonzales R. Computer-assisted provision of emergency contraception a randomized controlled trial. J Gen Intern Med. 2008 Jun;23(6):794-9. doi: 10.1007/s11606-008-0609-x. Epub 2008 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Emergency Contraception		7 months	No
Primary	Use of Folate supplements		7 months	No
Secondary	Access to Emergency Contraception at home		7 months	No
Secondary	Knowledge of emergency contraception		7 months	No
Secondary	Knowledge of the benefits of folate supplementation		7 months	No

External Links

•   Computerized Counseling for Folate Knowledge and Use