Increasing Contraception Utilization Among Women Prescribed Teratogenic Medications
Condition: Teratogenesis
MeSH terms: Teratogenesis
Study type: Interventional

Summary: 
      Typically, the CTIS Pregnancy Health Information Line in the Department of Pediatrics, School
      of Medicine at the University of California educates pregnant women who call the Information
      Line after an exposure to a medication that might be harmful to the developing baby has
      already taken place, and therefore the opportunity for prevention of that exposure no longer
      exists. Frequently these pregnancies are unintended and occur due to the lack of effective
      contraceptive use. This study facilitates patient access at UCSD to specialized and
      individualized contraceptive counseling for women of reproductive age who are currently
      taking a medication that might be risky in a future pregnancy. This study also measures the
      impact of individualized contraceptive counseling in changing contraceptive behavior.

      Primary Hypothesis: EPIC (EMR)/physician-facilitated referral of female patients of
      reproductive age to an existing specialized counseling service at UCSD will improve the
      utilization of more effective contraception among women of reproductive age who are
      prescribed medications that might be harmful to the developing fetus.
    

Detailed description: 
      This is a prospective cohort study to evaluate a) the effectiveness of the referral system
      from Family Medicine to the CTIS Pregnancy Health Information Line, and b) the impact of
      specialized counseling on contraceptive behavior change among the subset of women who accept
      the counseling and enroll in the follow-up study.

      If a woman of reproductive age is seen by a Family Medicine clinician and she is currently
      taking or is newly prescribed one of the target medications, an EMR electronic alert will be
      generated for the clinician. The alert will say "This patient may benefit from a referral to
      the CTIS Pregnancy Health Information Line for counseling," click "Accept" or "Decline". If
      the Family Medicine clinician clicks "Decline" then a reason must be given for declining. If
      the clinician decides a referral is appropriate, he/she clicks "Accept" and informs the
      patient that she will be contacted by CTIS. The referral is also included in the patient
      instructions. Within one week, a CTIS counselor will receive the referral through EPIC/EMR,
      and contact the patient.

      When the patient is contacted by the CTIS Pregnancy Health Information specialist, a brief
      patient interview will be conducted with a risk assessment and counseling regarding the
      medication and potential effects if the patient were to become pregnant, using the standard
      of care practices that are currently used for all callers to the CTIS Pregnancy Health
      Information Line. The patient will also be given information about contraception, efficacy of
      rates of each contraceptive method and the safety of each method based on the USMEC guidance
      for the patient's medical condition. She will be instructed that she can return to her Family
      Medicine clinician for contraceptive service delivery. She will also be offered a referral to
      Reproductive Medicine at UCSD for further counseling if desired/necessary. The referring
      Family Medicine clinician will be informed of the outcome of the referral via an EMR report.
      This report will include the USMEC contraceptive guidance for the patient's medical
      condition.

      After the counseling is completed, the patient will be asked if she is interested in
      participating in the research study. If the patient does not consent to participate in the
      study, she will still receive the counseling and an EMR report will still be sent to her
      referring provider but she will not be contacted at a later time regarding her contraceptive
      utilization.

      If the woman decides that she is interested in participating in the research study, she will
      be orally consented by CTIS Pregnancy Health Information Line Research Assistant in the
      Department of Pediatrics at UCSD. If the patient consents to participation, she will be
      contacted one week, one month and three months after the initial telephone interaction and
      asked several questions regarding her current contraceptive utilization and any changes from
      the time of the last interview. Upon completion of the three-month follow-up, participants
      will also be asked to complete a satisfaction survey.
    

Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): EMR referral to teratogen and contraception counseling
Intervention model: Single Group Assignment
Intervention model description: The patient is contacted by a specialist in the CTIS Pregnancy Health Information in the Department of Pediatrics at UCSD, and a brief patient interview is conducted with a risk assessment and counseling regarding her medication and the potential effects if she were to become pregnant. The patient is also given information about contraceptive methods, efficacy rates, and the safety of each method based on the USMEC guidance for the patient's medical condition.
After the counseling is completed, the patient is asked if she is interested in participating in the research study. If the patient consents to participation, she is contacted one week, one month, and three months after the initial telephone interaction and asked several questions regarding her current contraceptive utilization and any changes from the time of the last interview. Upon completion of the three-month follow-up, participants are asked to complete a satisfaction survey.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: teratogens; contraception; electronic medical record