Clinical trial NCT00177515: Computer-assisted Preventive Health Education for Women of Reproductive Age in Urgent Care Settings
Official title: Preventive Health Education for Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preconception Care
Keywords: emergency contraception
folic acid
education
preventive health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2005-09-15
Enrollment: 446
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of Emergency Contraception
timeFrame: 7 months
measure: Use of Folate supplements
timeFrame: 7 months
Secondary outcomes:
measure: Access to Emergency Contraception at home
timeFrame: 7 months
measure: Knowledge of emergency contraception
timeFrame: 7 months
measure: Knowledge of the benefits of folate supplementation
timeFrame: 7 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of Pittsburgh
name: Eleanor B Schwarz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schwarz EB, Sobota M, Gonzales R, Gerbert B. Computerized counseling for folate knowledge and use: a randomized controlled trial. Am J Prev Med. 2008 Dec;35(6):568-71. doi: 10.1016/j.amepre.2008.06.034.