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Increasing Contraception Utilization Among Women Prescribed Teratogenic Medications (TLC)

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ClinicalTrials.gov Identifier: NCT01624155
Recruitment Status : Unknown
Verified February 2013 by Christina Chambers, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE June 1, 2012
First Posted Date  ICMJE June 20, 2012
Last Update Posted Date February 22, 2013
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Change in Contraception Utilization [ Time Frame: one week, one month, three months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
Contraception Utilization [ Time Frame: one week, one month, three months ]
Does specialized counseling improve the utilization of more effective contraception among women in this population. We will measure contraception utilization via a survey that participant will complete at each time frame.
Change History Complete list of historical versions of study NCT01624155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Proportion of women identified through Electronic Medical Record who are able to be contacted of Electronic Medical Record Referral [ Time Frame: one week ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
Feasibility of Electronic Medical Record Referral [ Time Frame: one week ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Contraception Utilization Among Women Prescribed Teratogenic Medications
Official Title  ICMJE Utilizing the Electronic Medical Record to Collaborate With a Community- Based Organization to Increase More Effective Contraception Utilization Among Women Prescribed Teratogenic Medications
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Teratogenesis
Intervention  ICMJE Behavioral: Education
EMR referral to teratogen and contraception counseling
Study Arms  ICMJE Experimental: Women taking teratogens
Women taking teratogens
Intervention: Behavioral: Education
Publications * Mody SK, Wu J, Ornelas M, Kernahan C, Salas E, Kao K, Felix R, Chambers C. Using the electronic medical record to refer women taking category D or X medications for teratogen and contraceptive counseling. Birth Defects Res A Clin Mol Teratol. 2015 Jul;103(7):644-7. doi: 10.1002/bdra.23396. Epub 2015 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01624155
Other Study ID Numbers  ICMJE 11808
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christina Chambers, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sheila Mody, MD MPH University of California, San Diego
PRS Account University of California, San Diego
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP