Trial record 2 of 34 for:    Open Studies | Prenatal Exposure OR Exposure During Pregnancy OR Teratogenesis

Increasing Contraception Utilization Among Women Prescribed Teratogenic Medications (TLC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01624155
First received: June 1, 2012
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Teratogenesis
Behavioral: Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Change in Contraception Utilization [ Time Frame: one week, one month, three months ] [ Designated as safety issue: No ]
    Does specialized counseling improve (change) the utilization of more effective contraception among women in this population. We will measure the change in contraception utilization via a survey that participant will complete at each time frame.


Secondary Outcome Measures:
  • Proportion of women identified through Electronic Medical Record who are able to be contacted of Electronic Medical Record Referral [ Time Frame: one week ] [ Designated as safety issue: No ]
    Can an electronic medical record referral to a Teratogen Information Line facilitate access to specialized counseling on the medication and effective contraception. We will measure the feasibility of the Electronic Medical Record Referral by assessing how many referrals are requested and how many referrals successfully result in teratogen/contraception counseling.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women taking teratogens
Women taking teratogens
Behavioral: Education
EMR referral to teratogen and contraception counseling

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age of participants: 18-45 years old
  2. Gender of participants: Female
  3. Ethnic Background: No limitation, will include minorities and Spanish speaking participants
  4. Health Status: no limitation
  5. Sexually active with men

Exclusion Criteria:

  1. Currently Pregnant
  2. Not sexually active with men
  3. History of hysterectomy
  4. Removal of both ovaries
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624155

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Sheila Mody, MD MPH    619-543-6960    smody@ucsd.edu   
Sub-Investigator: Sheila Mody         
Sponsors and Collaborators
University of California, San Diego
Investigators
Study Director: Sheila Mody, MD MPH University of California, San Diego
  More Information

No publications provided

Responsible Party: Christina Chambers, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01624155     History of Changes
Other Study ID Numbers: 11808
Study First Received: June 1, 2012
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
teratogens
contraception
electronic medical record

ClinicalTrials.gov processed this record on July 20, 2014