Reducing Adolescent Pregnancy in the Emergency Department

• ClinicalTrials.gov Identifier: NCT04744155
• Recruitment Status: Recruiting
• First Posted: February 8, 2021
• Last Update Posted: February 21, 2022
• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: National Institutes of Health (NIH); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Melissa Miller, Children's Mercy Hospital Kansas City

Study Description

Brief Summary:

A multi-site randomized trial. Adolescents enrolled in this Clinical Trial will be enrolled into one of two arms. Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the Multi-level intervention arm will be offered immediate Emergency Department based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care).

Condition or disease	Intervention/treatment	Phase
Contraception; Adolescent Behavior; Emergency Department	Behavioral: Multi-Level Intervention; Behavioral: Enhanced Standard of Care	Not Applicable

Detailed Description:

Unintended adolescent pregnancy is a major public health problem linked to pregnancy-induced hypertension, low birthweight, and prematurity. In addition, adolescent pregnancies cost an estimated $9.4 billion annually. Though declining, U.S. rates remain among the highest in the developed world. Highly effective methods exist, but adolescents face unique, multi-level barriers to contraceptive access and use. Thus, the vast majority of pregnancies are due to contraceptive non-use or incorrect use. Many, especially minority and uninsured youth, do not attend health maintenance visits; among those who do, seconds is spent discussing sexuality and contraceptive use is not routinely assessed. Multi-level interventions to increase access to contraceptive counseling and all contraceptive types are desperately needed.

As adolescent access to affordable, confidential contraceptive care has worsened in recent years, one approach to increase access is to utilize non-traditional settings, such as Emergency Departments (EDs). The Society for Academic Medicine recognizes the ED as an "effective site for preventive care," evidenced by organizational conferences, consensus statements, and specialized training opportunities to reduce disparities stemming from social determinants of health. Adolescents make 19 million ED visits annually, commonly for non-urgent or reproductive complaints; for many, this may be their only contact with a provider. Adolescents in the ED frequently report unprotected intercourse. The pregnancy risk index (PRI), an estimate of pregnancy risk in the subsequent 12 months, for adolescent females in two EDs was more than three times greater than the national average. Lacking a primary provider was associated with higher PRI scores. While the need for reproductive care is evident, the majority of ED-based studies have focused on screening for sexually transmitted infections (STIs) including HIV and a few, primarily single-site studies have reported on acceptability of hypothetical reproductive care. Among the few addressing pregnancy prevention, most focused on emergency contraception or increasing clinic referral, with mixed results. A small open trial provided counseling and clinic referral for those wanting to initiate contraception. Only 22% completed the referral and one was found to be pregnant at her first clinic visit. Lack of transportation was the most common reason for not completing referral. Because interventions to address multi-level barriers and increase contraception access are sorely needed, the investigator aims to evaluate the feasibility of a novel ED-based intervention, utilizing a mixed methods approach.

Scientific Premise: Many adolescents in the ED are at high-risk of pregnancy yet accepting of reproductive intervention; however, no work describes best practices for ED-based contraceptive provision. Thus, the investigator proposes a randomized trial to evaluate MLI, which includes ED-based contraceptive initiation (i.e., oral pill, transdermal patch, vaginal ring, injection, or subdermal implant) vs. eSOC, for adolescents in two EDs utilizing APPs in a collaborative care model. Thus, the investigator will use a rigorous framework from Bowen et al. to evaluate feasibility constructs (see Table 1 for construct definitions) among adolescents and organizational personnel (i.e., study Advanced Practice Practitioners (APPs), adolescent medicine specialists, ED nursing and Reducing Adolescent Pregnancy in the Emergency Department leaders) in two unique EDs.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Adolescents will be enrolled into one of two arms: The Multi-level intervention (MLI) or Enhanced Standard of Care (eSOC). Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the MLI arm will be offered immediate ED-based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care)
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes assessor will not be aware.
• Primary Purpose: Prevention
• Official Title: Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents: A Feasibility Trial in the Emergency Department
• Actual Study Start Date: May 12, 2021
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: July 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Multi-Level Intervention; All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral.Those randomized to MLI will be offered immediate, ED-based contraception (i.e., oral pill, transdermal patch, vaginal ring, injection, subdermal implant) in addition to receive a warm referral (provider helping to schedule follow-up appointment) to follow-up on selected method (or to initiate in clinic, if preferred)	Behavioral: Multi-Level Intervention; Behavioral intervention that assesses uptake of contraception and seeks follow-up care.
Active Comparator: Enhanced Standard of Care; All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral.	Behavioral: Enhanced Standard of Care; Behavioral intervention that assesses uptake of contraception from follow-up care.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of Intervention Acceptability, Satisfaction, and Usefulness. [ Time Frame: 16 months ]
   The primary endpoint will be the determination of feasibility. Methods for establishing feasibility vary and include levels of acceptability, satisfaction, or usefulness. Drawing on similar published criteria, the intervention will be deemed feasible if the average score across all items is ≥ 3 on closed-ended survey items for adolescents, Advance Practice Providers, and Other Organizational Personnel. Higher scores indicate greater feasibility using the investigator created Feasibility Assessment. Individual responses range from 0 to 4. Total scores range from 0 to 20.

Secondary Outcome Measures :

1. Contraception Initiation [ Time Frame: 30 Days ]
   The proportion in each arm who initiates contraception and/or complete referral by day 30 after the index visit.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Females who report past/anticipated intercourse with a male partner within previous year or intent to be sexually active with a male partner in next few months
• Do not desire pregnancy
• Not using intrauterine device (IUD) or Sub-dermal Implant
• English-speaking

Exclusion Criteria:

• Females who report current pregnancy or have positive urine pregnancy test
• Patient has a developmental delay limiting participation
• Patient is presenting in the ED after sexual assault
• Patient is too ill to be screened

Contacts and Locations

Contacts

Contact: Melissa K Miller, MD, MSCr; 816-302-1342; mmiller@cmh.edu

Contact: Weston Kraly; wtkraly@cmh.edu

Locations

United States, Missouri

Children's Mercy Hospital; Recruiting

Kansas City, Missouri, United States, 64108

Contact: Weston Kraly wtkraly@cmh.edu

Principal Investigator: Melissa K Miller, MD, MsCr

United States, Pennsylvania

Children's Hospital of Philadelphia; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Tara Ketterer, MPH ketterert@chop.edu

Principal Investigator: Cynthia Mollen, MD, MSCE

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

• Responsible Party: Melissa Miller, Study Principal Investigator, Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT04744155
• Other Study ID Numbers: STUDY00001169; 1R21HD098086-01A1 ( U.S. NIH Grant/Contract )
• First Posted: February 8, 2021
• Last Update Posted: February 21, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Study information will be shared with other members on the research team. Study data will be collected and stored via the Research Electronic Data Capture (REDCap) system. De-identifiable information may also be shared with other researchers.
• Supporting Materials: Statistical Analysis Plan (SAP)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes