Clinical trial NCT04120376: Reducing Adolescent Pregnancy
Official title: An Emergency Department-Based Study to Reduce Adolescent Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy in Adolescence
Counseling
Contraception Behavior
Keywords: Contraception counseling
Adolescent pregnancy
Contraception initiation
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
name: University of Pittsburgh
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-10-09
Enrollment: 144
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Contraception counseling will occur for all adolescent participants and APPs will be enrolled to conduct counseling. The number of participants enrolled includes the final number of participants including adolescent and APPs.
Primary purpose: PREVENTION

Brief summary: This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).

Detailed description: This study is a prospective cohort study involving females who present to one of two emergency departments (ED) between the ages of 16 and 18, who are at risk of unintended pregnancy.

Our primary objective is to assess intention to initiate contraception ("high"=very/somewhat likely vs "low"=unsure/not likely/definitely not on Likert scale survey) among females aged 15 to 18 years who receive emergency department-based contraceptive counseling.

Our secondary objectives are as follows:

1. Among the same population, assess completion of a referral for any contraceptive care, defined as attendance at a referral site within 4 weeks after the index ED visit.
2. Assess the proportion who ultimately initiate contraception through electronic medical record documentation (i.e., visit note, procedure note, medication review) and participant report (follow-up calls).
3. Use qualitative interview methodology to explore attitudes, barriers, and facilitators that affect decisions to A) express intention to initiate contraception, B) complete a referral for contraceptive care, and C) ultimately initiate contraception among this unique group of high-risk adolescents.

Eligibility criteria: Inclusion Criteria:

1. Females aged 15-18 years who are at high-risk of pregnancy, defined as sexual activity within the last 6 months or likely future sexual activity.
2. Females who do not desire to become pregnant within the next year.
3. Eligible individuals must be proficient in speaking and reading in English.
4. Consent of the adolescent.

Exclusion Criteria:

1. Females who are currently using hormonal contraception or an intrauterine device.
2. Females who are pregnant.
3. Patient has a developmental delay limiting participation.
4. Patient is presenting in the ED after sexual assault.
5. Patient is too ill to be screened.

APPs: \[no age limit\]\] Have been working in ED 6 months

Primary outcomes:
measure: Intention to Initiate Contraception
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Contraceptive Care Referral Completion
timeFrame: up to 8 weeks
measure: Initiation of Contraception
timeFrame: up to 12 weeks
Other outcomes:
measure: Number of Unique Themes Affecting Decision-Making
timeFrame: up to 12 weeks
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Cynthia J Mollen, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
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