Clinical trial NCT03559634: Contraception Initiation Feasibility in the Pediatric ED
Official title: Feasibility Trial of Hormonal Contraceptive Initiation Program in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Contraception Behavior
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-06-18
Enrollment: 55
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Initiation of contraception in the ED using the electronic application
timeFrame: 12 months
Secondary outcomes:
measure: Delivery process related outcomes #1
timeFrame: At initial encounter.
measure: Delivery process related outcomes #2
timeFrame: At initial encounter.
measure: Delivery process related outcomes #3
timeFrame: At initial encounter and at follow up at 3, 6, and 12 months.
measure: Delivery process related outcomes #4
timeFrame: At initial encounter.
measure: Contraceptive continuation
timeFrame: At 3,6, and 12 months.
measure: Pregnancy rates
timeFrame: 12 months.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington Univeristy at St Louis
state: Missouri
Study officials:
References:
citation: Centers for Disease Control and Prevention. Reproductive Health: Teen Pregnancy. http://www.cdc.gov/teepregnancy/about/index.htm. Accessed Sept 2016.
citation: American College of Obstetricians and Gynecologists. Guidelines for adolescent health care. 2011; http://www.acog.org/About-ACOG/ACOG-Departments/Adolescent-Health-Care. Accessed Dec 2016.
citation: American Congress of Obstetricians and Gynecologists. Statement on Teen Pregnancy and Contraception. 2015; http://www.acog.org/About-ACOG/News-Room/Statements/2015/ACOG-Statement-on-Teen-Pregnancy-and-Contraception. Accessed Dec 2016.
citation: Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1244-56. doi: 10.1542/peds.2014-2299.
citation: Healthy People 2020. Family Planning, Adolescent Health. 2014; https://www.healthypeople.gov/2020, 2017.
citation: Society for Adolescent Health and Medicine; Burke PJ, Coles MS, Di Meglio G, Gibson EJ, Handschin SM, Lau M, Marcell AV, Tebb KP, Urbach K. Sexual and reproductive health care: a position paper of the Society for Adolescent Health and Medicine. J Adolesc Health. 2014 Apr;54(4):491-6. doi: 10.1016/j.jadohealth.2014.01.010. No abstract available.
citation: Chernick LS, Schnall R, Higgins T, Stockwell MS, Castano PM, Santelli J, Dayan PS. Barriers to and enablers of contraceptive use among adolescent females and their interest in an emergency department based intervention. Contraception. 2015 Mar;91(3):217-25. doi: 10.1016/j.contraception.2014.12.003. Epub 2014 Dec 12.
citation: Chernick LS, Westhoff C, Ray M, Garcia M, Garth J, Santelli J, Dayan PS. Enhancing referral of sexually active adolescent females from the emergency department to family planning. J Womens Health (Larchmt). 2015 Apr;24(4):324-8. doi: 10.1089/jwh.2014.4994.
citation: Ahmad FA, Jeffe DB, Plax K, Collins KK, Schechtman KB, Doerhoff DE, Garbutt J, Jaffe DM. Computerized self-interviews improve Chlamydia and gonorrhea testing among youth in the emergency department. Ann Emerg Med. 2014 Oct;64(4):376-84. doi: 10.1016/j.annemergmed.2014.01.031. Epub 2014 Mar 6.
citation: Ahmad FA, Jeffe DB, Plax K, Schechtman KB, Doerhoff DE, Garbutt JM, Jaffe DM. Characteristics of youth agreeing to electronic sexually transmitted infection risk assessment in the emergency department. Emerg Med J. 2018 Jan;35(1):46-51. doi: 10.1136/emermed-2016-206199. Epub 2017 Aug 11.