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Reducing Adolescent Pregnancy in the Emergency Department

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04744155
Enrollment
37
Registered
2021-02-08
Start date
2021-05-12
Completion date
2023-05-01
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Contraception, Emergency Department

Brief 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).

Detailed 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.

Interventions

Behavioral intervention that assesses uptake of contraception and seeks follow-up care.

BEHAVIORALEnhanced Standard of Care

Behavioral intervention that assesses uptake of contraception from follow-up care.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor will not be aware.

Intervention model description

Adolescents will be enrolled into one of two arms: The Multi-level intervention (MLI) or Enhanced Standard of Care (eSOC). Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the MLI arm will be offered immediate ED-based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adolescent Feasibility of Intervention1 visit on day 1The 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Multi-Level Intervention
All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral.Those randomized to MLI will be offered immediate, ED-based contraception (i.e., oral pill, transdermal patch, vaginal ring, injection, subdermal implant) in addition to receive a warm referral (provider helping to schedule follow-up appointment) to follow-up on selected method (or to initiate in clinic, if preferred) Multi-Level Intervention: Behavioral intervention that assesses uptake of contraception and seeks follow-up care.
25
Enhanced Standard of Care
All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral. Enhanced Standard of Care: Behavioral intervention that assesses uptake of contraception from follow-up care.
12
Total37

Baseline characteristics

CharacteristicMulti-Level InterventionEnhanced Standard of CareTotal
Age, Continuous16.5 years
STANDARD_DEVIATION 0.9
16.7 years
STANDARD_DEVIATION 1
16.6 years
STANDARD_DEVIATION 1
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants3 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants9 Participants30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Previous hormonal contraception use11 Participants7 Participants18 Participants
Previous sexual activity15 participants9 participants24 participants
Race/Ethnicity, Customized
Black
19 Participants8 Participants27 Participants
Race/Ethnicity, Customized
other
3 Participants4 Participants7 Participants
Race/Ethnicity, Customized
White
3 Participants0 Participants3 Participants
Sex: Female, Male
Female
25 Participants12 Participants37 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 25
other
Total, other adverse events
0 / 120 / 25
serious
Total, serious adverse events
0 / 120 / 25

Outcome results

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.

Time frame: 1 visit on day 1

ArmMeasureValue (MEAN)
Multi-level InterventionAdolescent Feasibility of Intervention4.5 score on a scale
Enhanced Standard of CareAdolescent Feasibility of Intervention4.7 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026