Contraception Initiation Feasibility in the Pediatric ED

NCT03559634 | Completed

• 1 other identifier: 201805104
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception; Contraception Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Delivery process related outcomes #1

  At initial encounter.

• Delivery process related outcomes #2

  At initial encounter.

• Delivery process related outcomes #3

  At initial encounter and at follow up at 3, 6, and 12 months.

• Delivery process related outcomes #4

  At initial encounter.

• Contraceptive continuation

  At 3,6, and 12 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

Using an electronic application, participants answer survey questions about their sexual history, medical history, and contraceptive preferences. They will watch a video that overviews the types of hormonal contraception. Then, based on survey answers, they will be able to watch more in-depth educational videos on methods that they qualify for. Participants will only be offered methods that are considered low risk and without any contraindication based upon responses to survey screening. This may include, contraceptive implant, medroxyprogesterone acetate injection, microgestin pills, xulane patch, or intravaginal ring. Participants will then be given the opportunity to initiate contraception in the ED. All participants will be referred for follow up outpatient health services. Subjects who have medical contraindications to certain contraceptive medications will be given a standardized handout that explains why they were not eligible for the medication(s) while in the ED.

Diagnostic Test: Intervention Group

Control Group

OTHER

Using an electronic application, participants answer survey questions about their background, sexual history, medical history, and contraceptive preferences. They will watch a video that overviews the types of hormonal contraception with brief pros and cons of each method. Then, based on participants medical history and contraceptive preferences they will be able to watch more in-depth counseling and educational videos on contraceptive methods that they qualify for. After these videos they will be given information on where they will be able to follow up to receive these contraceptive methods if they wish to start a method. Subjects who have medical contraindications to certain hormonal contraceptive medications will be given a standardized handout that explains why they were not eligible for the medication(s), should this come up in future discussions with their providers.

Other: Control Group

Interventions

Intervention Group DIAGNOSTIC_TEST

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.

Intervention group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 15 Years - 21 Years
• Gender Eligibility Details: Must be a biological female that identifies as a female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Washington Univeristy at St Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (10)

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

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

  PMID: 25266430 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24656535 BACKGROUND

• 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.

  PMID: 25499588 BACKGROUND

• 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.

  PMID: 25860108 BACKGROUND

• 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.

  PMID: 24612901 BACKGROUND

• 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.

  PMID: 28801483 BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility trial

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 18, 2018
• Study Start: May 20, 2019
• Primary Completion: January 26, 2021
• Study Completion: January 30, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)