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NCT04120376 Clinical Trial

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
First received
Last updated
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
Health authority
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.

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Study Design

Related Conditions & MeSH terms

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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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
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