Contraception Initiation Feasibility in the Pediatric ED
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 15 - 21 |
| Updated: | 1/26/2019 |
| Start Date: | April 2019 |
| End Date: | April 2021 |
| Contact: | Kayleigh A Fischer, MD |
| Email: | k.fischer@wust.edu |
| Phone: | 314-454-2341 |
Feasibility Trial of Hormonal Contraceptive Initiation Program in the Pediatric Emergency Department
Many female adolescents using the pediatric emergency department (ED) are at higher risk for
unintended pregnancy. This is a significant public health issue and hormonal contraception is
the mainstay of prevention. Many barriers to hormonal contraception exist and other studies
have demonstrated that referral from the ED for hormonal contraception leads to poor follow
up.
This study will be a pilot study to assess the feasibility of initiating hormonal
contraception in the pediatric ED.
unintended pregnancy. This is a significant public health issue and hormonal contraception is
the mainstay of prevention. Many barriers to hormonal contraception exist and other studies
have demonstrated that referral from the ED for hormonal contraception leads to poor follow
up.
This study will be a pilot study to assess the feasibility of initiating hormonal
contraception in the pediatric ED.
This study will assess the feasibility of initiating hormonal contraception in the pediatric
ED. Currently, all 15-21-year-old patients receiving care in our ED are asked to complete an
adolescent heath questionnaire to identify risk-factors for sexually transmitted infections
(STIs). Sexually active female patients who indicate on this questionnaire they are not
currently using hormonal contraception will be eligible for participation in this study.
Potential participants will be screened using the EMR and eligible patients will be
approached. Consent will be obtained from adults directly and from a parent or guardian for
minors that have one present. For minors that present without a parent or guardian, assent
only with be obtained from the minor. Participants will be randomized into two groups, an
intervention group and a control group. Participants in both groups will be given tablet
computer and, through a software application on the tablet, answer questions electronically
about their background, medical history, and contraceptive preferences. They will then be
shown a video that provides an overview of hormonal contraceptive options. Depending on the
participants medical history and contraceptive preferences, they may be offered more in-depth
educational videos about specific types of hormonal contraception for which they are eligible
(e.g. pill, transdermal patch, intravaginal ring, injection, and implant).
Once they have completed watching the videos, participants in the intervention group will
have the option of initiating one of the offered forms of birth control during the ED visit.
They will only be offered medications considered low risk and for which they do not have any
medical contraindications. Urine pregnancy testing will be done before any method is given.
They will be able to start any contraceptive method from among those offered after their
screening. Participants in the control group will be offered outpatient referral to initiate
contraception, the current standard of care in our ED. All patients in both arms of the study
will be given referral/follow up options for further contraceptive care.
All participants in this study will then be followed up at 1, 3, 6, and 12 months to
determine continuation of contraception practices, follow up practices, satisfaction, and
pregnancy rates.
ED. Currently, all 15-21-year-old patients receiving care in our ED are asked to complete an
adolescent heath questionnaire to identify risk-factors for sexually transmitted infections
(STIs). Sexually active female patients who indicate on this questionnaire they are not
currently using hormonal contraception will be eligible for participation in this study.
Potential participants will be screened using the EMR and eligible patients will be
approached. Consent will be obtained from adults directly and from a parent or guardian for
minors that have one present. For minors that present without a parent or guardian, assent
only with be obtained from the minor. Participants will be randomized into two groups, an
intervention group and a control group. Participants in both groups will be given tablet
computer and, through a software application on the tablet, answer questions electronically
about their background, medical history, and contraceptive preferences. They will then be
shown a video that provides an overview of hormonal contraceptive options. Depending on the
participants medical history and contraceptive preferences, they may be offered more in-depth
educational videos about specific types of hormonal contraception for which they are eligible
(e.g. pill, transdermal patch, intravaginal ring, injection, and implant).
Once they have completed watching the videos, participants in the intervention group will
have the option of initiating one of the offered forms of birth control during the ED visit.
They will only be offered medications considered low risk and for which they do not have any
medical contraindications. Urine pregnancy testing will be done before any method is given.
They will be able to start any contraceptive method from among those offered after their
screening. Participants in the control group will be offered outpatient referral to initiate
contraception, the current standard of care in our ED. All patients in both arms of the study
will be given referral/follow up options for further contraceptive care.
All participants in this study will then be followed up at 1, 3, 6, and 12 months to
determine continuation of contraception practices, follow up practices, satisfaction, and
pregnancy rates.
Inclusion Criteria:
- Female patients, 15-21 years old that present to the SLCH pediatric ED
- Report history of vaginal sex on the ED routine screening questionnaire
- Not currently using hormonal contraception
Exclusion Criteria:
- Pregnant
- Currently using hormonal contraception
- Foster care
- Non-English speaking
- Chief complaint of psychiatric concern, physical abuse or sexual abuse
- Triage acuity level 1 or 2 as they are likely to be too ill to participate
- Those with history of stroke, venous thromboembolism, actively being treated for
cancer, or who have an organ transplant
- Too ill to participate as determined by the pediatric ED health care provider
(attending physician or advanced practice nurse)
- Already participated in the study
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