EMR Referrals for Teratogen and Contraceptive Counseling for Category D or X Medication Users: RCT

Summary

Investigators propose a randomized controlled trial of women taking category D or X medications seen in family medicine, internal medicine or in the Coumadin Clinic. Women in the intervention group will receive an electronic medical record referral for teratogen counseling and contraceptive counseling with a follow up contraceptive provision appointment. The contraceptive counseling will be adapted from The Contraceptive CHOICE Project script and promote the use of the long acting reversible contraception. The women in the control group will also receive an electronic medical record referral and receive the teratogen counseling but only be told that it is important to avoid becoming pregnant. An initial survey will assess contraceptive knowledge and utilization. In addition, there will be telephone survey at 3 months and 6 months to assess contraceptive utilization and continuation.

Conditions

• Chemical Teratogen Exposure
• Contraception Behavior
• Contraception

Interventions

BEHAVIORAL

EMR Referral

EMR referral to California Teratogen Information Services (CTIS) for use of category D or X medication.

BEHAVIORAL

CTIS Counseling

Counseling from MotherToBaby teratogen information specialist.

BEHAVIORAL

Baseline Questionnaire

Baseline Questionnaire capturing contraceptive use immediately after counseling with MotherToBaby

BEHAVIORAL

Contraception Provision Appointment

Appointment with contraception provider to discuss contraception options.

BEHAVIORAL

3 Month Follow Up Questionnaire

Questionnaire 3 months after CTIS counseling to assess contraception use and plans

BEHAVIORAL

6 Month Follow Up Questionnaire

Questionnaire 6 months after CTIS counseling to assess contraception use and plans

Sponsors & Collaborators

• University of California, San Diego

  lead OTHER

Principal Investigators

• Sheila Mody, MD MPH · UCSD Department of Reproductive Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-10-31

Completion

2013-10-31

Countries

• United States

Study Locations