TeratogenesisTLCNCT01624155
Increasing Contraception Utilization Among Women Prescribed Teratogenic Medications
A study testing Education in people with Teratogenesis, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Teratogenesis
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2012to 22 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of participants: 18-45 years old
- Gender of participants: Female
- Ethnic Background: No limitation, will include minorities and Spanish speaking participants
- Health Status: no limitation
- Sexually active with men
Who cannot join
- Currently Pregnant
- Not sexually active with men
- History of hysterectomy
- Removal of both ovaries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
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.
Read the 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.
- Conditions
- Teratogenesis
- Being tested
- Education
- Keywords
- teratogens, contraception, electronic medical record
- Medical subject headings
- Teratogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
EMR referral to teratogen and contraception counseling
| Study group | Role | What they receive |
|---|---|---|
| Women taking teratogens | Experimental | Women taking teratogens Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Contraception Utilization
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.
Measured: one week, one month, three months
Secondary outcomes (1)
Proportion of women identified through Electronic Medical Record who are able to be contacted of Electronic Medical Record Referral
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study start5 Jan 2012
- Primary completion30 Oct 2013
- Study completion22 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TeratogenesisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Chambers, University of California, San Diego
- Investigators
- Sheila Mody, MD MPH, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624155
- Sponsor's protocol ID
- 111808
- Acronym
- TLC
- Status last verified
- Oct 2019
- First submitted
- 1 Jun 2012
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26100297
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01624155
- Acronym / sponsor ID
- TLC / 111808
- Conditions
- Teratogenesis
- Keywords
- teratogens, contraception, electronic medical record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 30 Oct 2013 (actual)
- Study completion
- 22 Sep 2015 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Women taking teratogens | Experimental | Behavioral: EducationWomen taking teratogens |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age of participants: 18-45 years old
- Gender of participants: Female
- Ethnic Background: No limitation, will include minorities and Spanish speaking participants
- Health Status: no limitation
- Sexually active with men
Key exclusion criteria (4 listed)
- Currently Pregnant
- Not sexually active with men
- History of hysterectomy
- Removal of both ovaries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEMR referral to teratogen and contraception counseling | Behavioural | Women taking teratogens |
Primary outcome
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.
1 secondary outcome
Proportion of women identified through Electronic Medical Record who are able to be contacted of Electronic Medical Record Referral
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 26100297Mody 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila Mody, MD MPH study director
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Teratogenesis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Contraception Utilization (time frame: one week, one month, three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01624155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.