Reducing Adolescent Pregnancy in the Emergency Department
Condition: Contraception; Adolescent Behavior; Emergency Department
MeSH terms: Emergencies
Study type: Interventional

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.
    

Intervention name(s): Multi-Level Intervention; Enhanced Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral intervention that assesses uptake of contraception and seeks follow-up care.; Behavioral intervention that assesses uptake of contraception from follow-up care.
Allocation: Randomized
Intervention model: Parallel Assignment
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)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention