Providing Adolescent Contraception in the Emergency Room

NCT02475980 | Completed Results

• 2 other identifiers: 14-2483RX15
• Study Type: observational
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this pilot study is to determine the feasibility of comprehensive contraceptive counseling intervention in a pediatric emergency department and to determine the impact of comprehensive contraception counseling on initiation of contraception among sexually active adolescents presenting to a pediatric emergency department.

Conditions

Contraception

Keywords

Adolescent; Contraception; Counseling

Outcome Measures

Primary Outcomes (4)

• Length of Stay

  Emergency department length of stay for participants

  Measured at time of chart review for patient follow-up, approximately 4 weeks after enrollment.

• Proportion of Eligible Girls Offered Counseling Intervention

  Proportion of girls eligible to participate in study who were offered contraceptive counseling

  Approximately 4 weeks after enrollment

• Participant Satisfaction

  Participant ratings of acceptability of contraceptive counseling in the emergency department and satisfaction with counseling

  4 weeks after enrollment

• Contraceptive Initiation

  Proportion of participants who report initiating contraception or changing to a more effective method of contraception

  4 weeks after enrollment

Secondary Outcomes (2)

• Descriptive Statistics of Participants

  At conclusion of study data collection, approximately 8 weeks after enrollment

• Follow-up Adherence

  4 weeks after enrollment

Study Arms (1)

Adolescent girls

Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling

Behavioral: Comprehensive contraception counseling

Interventions

Comprehensive contraception counseling BEHAVIORAL

The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician.

Adolescent girls

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent girls presenting to a pediatric emergency department for non-emergent complaints

You may qualify if:

• Ages 13 to 18 years old
• Speaks English or Spanish
• Has menstrual periods
• Has Medicaid insurance

You may not qualify if:

• Seeking contraception as their primary complaint
• Currently pregnant based on urine or serum pregnancy testing
• Has an IUD or contraceptive implant (Implanon/Nexplanon)
• Critically ill, hemodynamically unstable, altered mental status, developmentally delayed, severe pain or distress, or have major trauma
• In juvenile justice custody

Sponsors & Collaborators

• University of New Mexico: lead
• Society of Family Planning: collaborator

Results Point of Contact

• Title: Nancy Sokkary, MD
• Organization: University of New Mexico Health Sciences Center

HSC-FamilyPlanningResearch@salud.unm.edu

email

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 19, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-05