Contraception Initiation Feasibility in the Pediatric ED

Contraception Clinical Trial

Official title:

Feasibility Trial of Hormonal Contraceptive Initiation Program in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559634
• Other study ID #: 201805104
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 30, 2023
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior

Intervention

Diagnostic Test:
• Intervention Group
The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. Contraceptive choices being offered include the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. The participant can then decide if they would like to start a medication they qualify for in the ED.

Other:
• Control Group
The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. This includes the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. Participants will then be given follow up information on outpatient locations where they can receive these contraceptive methods.

Locations

Country	Name	City	State
United States	Washington Univeristy at St Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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.

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.

Centers for Disease Control and Prevention. Reproductive Health: Teen Pregnancy. http://www.cdc.gov/teepregnancy/about/index.htm. Accessed Sept 2016.

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. — View 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. — View Citation

Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1244-56. doi: 10.1542/peds.2014-2299. — View Citation

Healthy People 2020. Family Planning, Adolescent Health. 2014; https://www.healthypeople.gov/2020, 2017.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of contraception in the ED using the electronic application	The proportion of enrolled patients that initiate contraception when offered same-day (intervention arm) compared to those that initiate contraception at follow up (the control arm) at 3 months.	12 months
Secondary	Delivery process related outcomes #1	Total length of time of the intervention beginning after consent and ending with provision of contraception, contraceptive script, or declining initiation of contraception.	At initial encounter.
Secondary	Delivery process related outcomes #2	Subject length of stay defined by arrival time to disposition (admit or discharge) from ED.	At initial encounter.
Secondary	Delivery process related outcomes #3	Patient experience and satisfaction survey both directly after program and at follow up at 3, 6, and 12 months. Likert 5 point scale will be used with the following rating options strongly agree, agree, no opinion, disagree, or strongly disagree. Data will be stored in original language and in a numerical scale, with a range of 1 to 5 with 5 for the question being better experience/satisfaction. Following completion of enrollment, all data will be aggregated and analyzed to determine mean and standard deviation of all questions.	At initial encounter and at follow up at 3, 6, and 12 months.
Secondary	Delivery process related outcomes #4	Providers (doctors and nurses) experience and satisfaction survey for initial visit in ED. Likert 5 point scale will be used with the following rating options strongly agree, agree, no opinion, disagree, or strongly disagree. Data will be stored in original language and in a numerical scale, with a range of 1 to 5 with 5 for the question being better experience/satisfaction. Following completion of enrollment, all data will be aggregated and analyzed to determine mean and standard deviation of all questions.	At initial encounter.
Secondary	Contraceptive continuation	Percentage of participants that are using hormonal contraception in the intervention group as compared to the control group at 1, 3, 6 and 12 months.	At 3,6, and 12 months.
Secondary	Pregnancy rates	The number of participants that become pregnant within 12 months in the intervention group verses the control group.	12 months.