EMR Referrals for Teratogen and Contraceptive Counseling for Category D or X Medication Users: RCT
Condition: Chemical Teratogen Exposure; Contraception Behavior; Contraception
Study type: Interventional

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.
    

Detailed description: 
      Approximately 6% of pregnancies in the United States are exposed to potentially teratogenic
      medications. Birth defects due to prenatal exposure to teratogenic medications are among the
      only truly preventable types of congenital anomalies. However, despite the risk of unintended
      pregnancies exposed to potentially teratogenic medications, women prescribed category D or X
      medications do not use more effective contraception then the general population. These women
      also are not more compliant with short acting methods such as oral contraceptives. The
      electronic medical record provides an unique opportunity to identify women taking potentially
      teratogenic medications and offer interdisciplinary teratogen and contraceptive counseling.
      These women specifically may benefit from more counseling about long acting reversible
      contraception while they are taking a potentially teratogenic medication.

      Previous studies have revealed that women want more counseling regarding a potentially
      teratogenic medication when it is prescribed even if they are not planning a pregnancy or
      sexually active. In addition to desiring more teratogen counseling, these women may benefit
      from more contraceptive counseling. Eisenberg et al. identified that time constraint is one
      of the major barriers to providing adequate contraceptive counseling by an internist to women
      taking potentially teratogenic medications. Many internists in the Eisenberg study believed
      that an EMR alert would be worthwhile. In addition, approximately two-thirds of the
      internists in the Eisenberg study agreed that "a referral or telephone consultation service
      for assistance in providing appropriate contraception for women on potential teratogens would
      be useful." In order to improve the contraceptive counseling among women prescribed
      potentially teratogenic medications, the investigators for the proposed project have been
      conducting collaborative research for the past two years with the Family Medicine and the
      California Teratogen Information Service (CTIS). First, the investigators conducted a
      cross-sectional study to assess contraceptive utilization among women prescribed category D
      or X medications. Investigators obtained access to the EMR of women seen in an academic
      Family Medicine Department between April 2011 to April 2012 who were taking a category D or X
      medication. Information was abstracted regarding the specific category D or X medication,
      demographics, sexual activity and the contraceptive method. There were a total of 610 women
      included in this study. Among the 610 women, 72 (11.8%) of women had documentation in the EMR
      that they were not asked about their sexual activity. Sexual activity with men was documented
      in 407 of the 610 women. Of the 407 women who were sexually active with men, 132 (32.4%) had
      no contraceptive method documented in the EMR. Despite the importance of avoiding an
      unintended pregnancy in women taking teratogens, the contraceptive utilization rate is
      similar to the national average (38% of 15-44 year olds reported not using a contraceptive
      method). In addition, among the women using contraception, the most common contraceptive
      method was oral contraceptives, which is very user dependent with a typical failure rate of
      9%. In fact, the oral contraceptive compliance rate for women taking teratogens is the same
      as the national compliance rate.

      Next, we conducted a descriptive pilot study to evaluate the feasibility and patient
      satisfaction with an EMR alert and referral system. This intervention was chosen since the
      Eisenberg study identified the time constraint issue, the acceptability of EMR alert, and the
      acceptability of the telephone consultation service. Women of reproductive age who were seen
      by a Family Medicine clinician at a UCSD Medical Center clinic with access to the EMR were
      included in the pilot study. If a woman of reproductive age was seen by a Family Medicine
      clinician and she was currently taking or was newly prescribed a category D or X medications,
      an EMR electronic alert was be generated for the clinician. The alert said "This patient may
      benefit from a referral to the CTIS Information Line for counseling," click "Accept" or
      "Decline". The alert was purposefully created so it is easier to accept the referral. If the
      Family Medicine clinician clicked "Decline" then a reason must be given for declining the
      referral. If the clinician decided a referral is appropriate, he/she clicked "Accept" and
      informed the patient that she will be contacted by CTIS. The referral was also included in
      the patient instructions.

      Within one month of the referral, a CTIS counselor contacted the patient and reviewed the
      category D or X medication and potential effects if the patient were to become pregnant as
      well as contraceptive options. The counseling included some information about the efficacy of
      each contraceptive method. She was instructed that she could return to her Family Medicine
      clinician for contraceptive service delivery. She was also offered a referral to Reproductive
      Medicine at UCSD for further counseling. The referring Family Medicine clinician was then
      informed of the outcome of the referral via an EMR communication. Following counseling a
      phone interview was used to assess contraceptive utilization and motivation. In addition a
      satisfaction survey completed. Contraceptive utilization was assessed using a modified
      version of Module 5 of Behavioral Risk Factor Surveillance System. Participant satisfaction
      was assessed using a Likert scale.

      Among 25 participants in the pilot study, 11 (44%) women were using oral contraceptives, 7
      (28%) women were using condoms, 3 (12%) women were using withdrawal, 2 (8%) women were using
      the IUD, 1 (4%) woman was using vaginal contraceptive ring and 1 (4%) woman was not using
      contraception. Among the women using oral contraceptive, the majority of the women
      underestimated the typical failure rate. Among the women using contraception, only 2 women
      stated that they chose their current contraceptive method based on the effectiveness in
      preventing pregnancy. After receiving the teratogen and contraceptive counseling, 25% of
      women using contraception were considering using a more effective contraceptive method. The
      women were also asked about when they would want a child, the most common response was
      wanting a child in 2-5 years. Satisfaction with the referral system and counseling was high.
      Approximately 96% of participants strongly agreed or agreed that the information they
      received on contraceptive options was helpful.

      The conclusion from this descriptive pilot study is that an EMR referral system for teratogen
      and contraceptive counseling for women prescribed category D or X medications is feasible and
      has high patient satisfaction. Women taking category D or X medications are not currently
      choosing a contraceptive method based on efficacy of preventing pregnancy, therefore efficacy
      should emphasized more in future contraceptive counseling interventions. Most participants
      indicated that they wanted a child in 2-5 years. The results of this pilot study support
      promoting long-acting reversible contraception in this population. In addition, the pilot
      study revealed that the contraceptive counseling can motivate women taking potentially
      teratogenic medications to consider using more effective contraception. Now we need to focus
      on helping these women go from thinking about using more effective to actually using more
      effective contraception.

      The proposed project incorporates the findings of this pilot study to facilitate intention to
      use more effective contraception into behavior change. It utilizes the EMR to not only
      identify and counsel women exposed to high risk medications, but also facilitates behavior
      change by incorporating a clinic visit to further discuss and receive more effective
      contraception. The primary objective for the study is to determine if an EMR referral to
      teratogen counseling, contraceptive counseling and a follow up contraceptive appointment will
      increase the utilization of more effective contraception among women prescribed category D or
      X medications. The Internal Medicine department and Family Medicine department have approved
      the proposed study.
    

Intervention name(s): EMR Referral; CTIS Counseling; Baseline Questionnaire; Contraception Provision Appointment; 3 Month Follow Up Questionnaire; 6 Month Follow Up Questionnaire
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): EMR referral to California Teratogen Information Services (CTIS) for use of category D or X medication.; Counseling from MotherToBaby teratogen information specialist.; Baseline Questionnaire capturing contraceptive use immediately after counseling with MotherToBaby; Appointment with contraception provider to discuss contraception options.; Questionnaire 3 months after CTIS counseling to assess contraception use and plans; Questionnaire 6 months after CTIS counseling to assess contraception use and plans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Category D; Category X; Electronic Medical Records; Long Acting Reversible Contraception