Reducing Adolescent Pregnancy

Contraception Behavior Clinical Trial

Official title:

An Emergency Department-Based Study to Reduce Adolescent Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120376
• Other study ID #: 19-016314
• Secondary ID: 5R21HD095096-02
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: January 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 30, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior
• Counseling
• Pregnancy in Adolescence

Intervention

Behavioral:
• Contraception Counseling
Each participant will receive a 10 minute confidential contraception counseling session with an APP in the Emergency Department

Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (57)

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Unique Themes Affecting Decision-Making	Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants).; Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB.	up to 12 weeks
Primary	Intention to Initiate Contraception	Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses	up to 8 weeks
Secondary	Contraceptive Care Referral Completion	Participants completed a referral visit for any contraception care	up to 8 weeks
Secondary	Initiation of Contraception	Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys	up to 12 weeks