Reducing Adolescent Pregnancy in the Emergency Department

Contraception Clinical Trial

Official title:

Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents: A Feasibility Trial in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744155
• Other study ID #: STUDY00001169
• Secondary ID: 1R21HD098086-01A
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-site randomized trial. Adolescents enrolled in this Clinical Trial will be enrolled into one of two arms. Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the Multi-level intervention arm will be offered immediate Emergency Department based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care).

Description:

Unintended adolescent pregnancy is a major public health problem linked to pregnancy-induced hypertension, low birthweight, and prematurity. In addition, adolescent pregnancies cost an estimated $9.4 billion annually. Though declining, U.S. rates remain among the highest in the developed world. Highly effective methods exist, but adolescents face unique, multi-level barriers to contraceptive access and use. Thus, the vast majority of pregnancies are due to contraceptive non-use or incorrect use. Many, especially minority and uninsured youth, do not attend health maintenance visits; among those who do, seconds is spent discussing sexuality and contraceptive use is not routinely assessed. Multi-level interventions to increase access to contraceptive counseling and all contraceptive types are desperately needed.

As adolescent access to affordable, confidential contraceptive care has worsened in recent years, one approach to increase access is to utilize non-traditional settings, such as Emergency Departments (EDs). The Society for Academic Medicine recognizes the ED as an "effective site for preventive care," evidenced by organizational conferences, consensus statements, and specialized training opportunities to reduce disparities stemming from social determinants of health. Adolescents make 19 million ED visits annually, commonly for non-urgent or reproductive complaints; for many, this may be their only contact with a provider. Adolescents in the ED frequently report unprotected intercourse. The pregnancy risk index (PRI), an estimate of pregnancy risk in the subsequent 12 months, for adolescent females in two EDs was more than three times greater than the national average. Lacking a primary provider was associated with higher PRI scores. While the need for reproductive care is evident, the majority of ED-based studies have focused on screening for sexually transmitted infections (STIs) including HIV and a few, primarily single-site studies have reported on acceptability of hypothetical reproductive care. Among the few addressing pregnancy prevention, most focused on emergency contraception or increasing clinic referral, with mixed results. A small open trial provided counseling and clinic referral for those wanting to initiate contraception. Only 22% completed the referral and one was found to be pregnant at her first clinic visit. Lack of transportation was the most common reason for not completing referral. Because interventions to address multi-level barriers and increase contraception access are sorely needed, the investigator aims to evaluate the feasibility of a novel ED-based intervention, utilizing a mixed methods approach.

Scientific Premise: Many adolescents in the ED are at high-risk of pregnancy yet accepting of reproductive intervention; however, no work describes best practices for ED-based contraceptive provision. Thus, the investigator proposes a randomized trial to evaluate MLI, which includes ED-based contraceptive initiation (i.e., oral pill, transdermal patch, vaginal ring, injection, or subdermal implant) vs. eSOC, for adolescents in two EDs utilizing APPs in a collaborative care model. Thus, the investigator will use a rigorous framework from Bowen et al. to evaluate feasibility constructs (see Table 1 for construct definitions) among adolescents and organizational personnel (i.e., study Advanced Practice Practitioners (APPs), adolescent medicine specialists, ED nursing and Reducing Adolescent Pregnancy in the Emergency Department leaders) in two unique EDs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 1, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

• Females who report past/anticipated intercourse with a male partner within previous year or intent to be sexually active with a male partner in next few months

• Do not desire pregnancy

• Not using intrauterine device (IUD) or Sub-dermal Implant

• English-speaking

Exclusion Criteria:

• Females who report current pregnancy or have positive urine pregnancy test

• Patient has a developmental delay limiting participation

• Patient is presenting in the ED after sexual assault

• Patient is too ill to be screened

Related Conditions & MeSH terms

• Adolescent Behavior
• Contraception
• Emergencies
• Emergency Department

Intervention

Behavioral:
• Multi-Level Intervention
Behavioral intervention that assesses uptake of contraception and seeks follow-up care.
• Enhanced Standard of Care
Behavioral intervention that assesses uptake of contraception from follow-up care.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolescent Feasibility of Intervention	The intervention will be deemed feasible if the median score across all items is = 3. Individual responses range from 1 to 5. Higher scores indicate greater feasibility using the investigator created Feasibility Assessment.	1 visit on day 1