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.
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
- Conditions the study is for
- Contraception, Adolescent Behavior, Emergency Department
- What is being tested?
- Multi-Level Intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- 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
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.
- Conditions
- Contraception, Adolescent Behavior, Emergency Department
- 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 group | Role | What they receive |
|---|---|---|
| Multi-Level Intervention | Experimental | 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) Receives: Behavioral: Multi-Level Intervention |
| Enhanced Standard of Care | Active comparator | All 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.
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.
- First posted8 Feb 2021
- Study start12 May 2021
- Primary completion31 Oct 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Melissa Miller, Children's Mercy Hospital Kansas City
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents: A Feasibility Trial in the Emergency Department
- ClinicalTrials.gov ID
- NCT04744155
- Acronym / sponsor ID
- STUDY00001169
- Conditions
- Contraception, Adolescent Behavior, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Multi-Level Intervention | Experimental | Behavioral: Multi-Level InterventionAll 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) |
| Enhanced Standard of Care | Active comparator | Behavioral: Enhanced Standard of CareAll adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Level InterventionBehavioral intervention that assesses uptake of contraception and seeks follow-up care. | Behavioural | Multi-Level Intervention |
| Enhanced Standard of CareBehavioral intervention that assesses uptake of contraception from follow-up care. | Behavioural | Enhanced Standard of Care |
Primary outcome
Adolescent Feasibility of Intervention
Time frame: 1 visit on day 1
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.