Teratogenesis Clinical Trial
Official title:
Utilizing the Electronic Medical Record to Collaborate With a Community- Based Organization to Increase More Effective Contraception Utilization Among Women Prescribed Teratogenic Medications
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04043572 -
The Biomarkers of Neurological Disease in Utero Study
|