Trial Outcomes & Findings for Providing Adolescent Contraception in the Emergency Room (NCT NCT02475980)

Results Overview

Emergency department length of stay for participants

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome timeframe

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

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	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 Comprehensive contraception counseling: 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.
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Comprehensive contraception counseling: 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.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Providing Adolescent Contraception in the Emergency Room

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adolescent Girls n=13 Participants 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 Comprehensive contraception counseling: 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.
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.85 years STANDARD_DEVIATION 1.675 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

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

Emergency department length of stay for participants

Outcome measures

Outcome measures
Measure	Adolescent Girls n=13 Participants 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 Comprehensive contraception counseling: 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.
Length of Stay	287 minutes Interval 103.0 to 895.0

PRIMARY outcome

Timeframe: Approximately 4 weeks after enrollment

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

Outcome measures

Outcome measures
Measure	Adolescent Girls n=13 Participants 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 Comprehensive contraception counseling: 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.
Proportion of Eligible Girls Offered Counseling Intervention	13 participants

PRIMARY outcome

Timeframe: 4 weeks after enrollment

Population: Number of girls available for follow-up at 4-week phone call.

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

Outcome measures

Outcome measures
Measure	Adolescent Girls n=8 Participants 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 Comprehensive contraception counseling: 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.
Participant Satisfaction Reported Extremely Satisfied	4 participants
Participant Satisfaction Reported Somewhat Satisfied	3 participants
Participant Satisfaction Reported Neither satisfied nor dissatisfied	1 participants
Participant Satisfaction Reported Somewhat dissatisfied	0 participants
Participant Satisfaction Reported Extremely Dissatisfied	0 participants

PRIMARY outcome

Timeframe: 4 weeks after enrollment

Population: Of the 13 girls consented to the study, 1 initiated a new contraception method following the intervention.

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

Outcome measures

Outcome measures
Measure	Adolescent Girls n=13 Participants 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 Comprehensive contraception counseling: 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.
Contraceptive Initiation	1 participants

SECONDARY outcome

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

Population: Participants consented for project

Frequencies and descriptive statistics of participant demographics, comorbidities associated with unintended adolescent pregnancy, and contraceptive use

Outcome measures

Outcome measures
Measure	Adolescent Girls n=13 Participants 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 Comprehensive contraception counseling: 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.
Descriptive Statistics of Participants Reported unintended adolescent pregnancy	2 participants
Descriptive Statistics of Participants Reported a history of abortion	1 participants
Descriptive Statistics of Participants Reported having used a condom	2 participants
Descriptive Statistics of Participants Reported current use of non-LARC contraception	5 participants

SECONDARY outcome

Timeframe: 4 weeks after enrollment

Population: Number of participants given a referral to Adolescent Gynecology in PED

Proportion of girls who present for follow-up appointment after referral to Adolescent Gynecology outpatient clinic

Outcome measures

Outcome measures
Measure	Adolescent Girls n=5 Participants 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 Comprehensive contraception counseling: 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.
Follow-up Adherence Appointment not scheduled	3 participants
Follow-up Adherence Appointment scheduled	2 participants
Follow-up Adherence Presented to Adolescent Gynecology follow-up appt	0 participants

Adverse Events

Adolescent Girls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Sokkary, MD

University of New Mexico Health Sciences Center

Phone: email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place