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ContraceptionNCT04744155

Reducing Adolescent Pregnancy in the Emergency Department

A study testing Multi-Level Intervention in people with Contraception and Adolescent Behavior, run by Children's Mercy Hospital Kansas City at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 18 years, women onlyHealthy volunteers can take part
What is being tested?
Multi-Level Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
12 May 2021to 1 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents: A Feasibility Trial in the Emergency Department

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).

Read the 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.

Being tested
Multi-Level Intervention, Enhanced Standard of Care
Medical subject headings
Adolescent Behavior, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Level InterventionBehavioural

    Behavioral intervention that assesses uptake of contraception and seeks follow-up care.

  • Enhanced Standard of CareBehavioural

    Behavioral intervention that assesses uptake of contraception from follow-up care.

Study groups in NCT04744155
Study groupRoleWhat they receive
Multi-Level InterventionExperimentalAll 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)
Receives: Behavioral: Multi-Level Intervention
Enhanced Standard of CareActive comparatorAll adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral.
Receives: Behavioral: Enhanced Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adolescent Feasibility of Intervention

    The intervention will be deemed feasible if the median score across all items is ≥ 3. Individual responses range from 1 to 5. Higher scores indicate greater feasibility using the investigator created Feasibility Assessment.

    Measured: 1 visit on day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start12 May 2021
  3. Primary completion31 Oct 2022
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04744155
Sponsor's protocol ID
STUDY00001169
Other IDs
1R21HD098086-01A1
Status last verified
Sep 2023
First submitted
28 Dec 2020
Last updated
28 Sep 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Level Intervention in people with Contraception and Adolescent Behavior, run by Children's Mercy Hospital Kansas City at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent Feasibility of Intervention (time frame: 1 visit on day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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