Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04717596 |
| Other study ID # |
STUDY00001603 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2021 |
| Est. completion date |
September 15, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Nationwide Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is a hybrid trial that examines both the clinical effectiveness and the
implementation of BC4Teens Contraception Care. The investigators use a naturalistic one-group
longitudinal study design to maximize feasibility and external validity, which is important
for understanding implementation and effectiveness in real-world service delivery settings.
Description:
Approximately one in five American youth have experienced severe impairment due to mental
health disorders, with anxiety and mood disorders being most common among female adolescents.
Mental health disorders are associated with a range of sexual risk behaviors and unintended
pregnancy. Youth with mental health disorders have higher rates of condom and contraception
non-use (especially short acting), earlier sexual debut, and higher fertility rates.
Avoiding an unwanted or unintended pregnancy is particularly important for women with
underlying mental health disorders. Experiencing a pregnancy exacerbates underlying mental
health disorders in women with mental health disorder. And children born out of an unintended
pregnancy or in context of mother with active mental health disorder face additional risks to
their wellbeing. Long acting reversible contraceptives (LARCs), i.e. contraceptive implants
and intrauterine devices, have attributes that may be particularly attractive to adolescents
with mental health disorders. In particular, they are highly effective and do not require
ongoing maintenance. However, adolescents with mental health disorders face multiple barriers
to accessing contraception care. Novel solutions are needed to improve access to
contraception care, including LARC, for adolescents with mental disorders.
The inpatient pediatric hospitalization setting is a missed opportunity for improving
adolescent sexual and reproductive health. Nearly 10% of pediatric hospitalizations are for a
primary mental health diagnosis, and mood disorders are the most common primary mental health
diagnosis among these hospitalizations. Sexual and reproductive healthcare is rarely provided
to hospitalized adolescents. At Nationwide Children's Hospital, a chart audit completed in
December 2019 found that no adolescents hospitalized for mental health disorders on the
Hospital Pediatrics service had documentation they were screened for sexual activity.
Adolescents are interested in learning about sexual and reproductive health and receiving
sexual and reproductive healthcare in the hospital setting regardless of age, gender, and
prior sexual experiences. Two studies of pediatric hospitalists found that the majority of
those physicians felt that sexual and reproductive services are appropriate for hospitalized
adolescents, with high support for referrals and starting contraception in the hospital.
Numerous barriers to inpatient provision of contraceptives/sexual reproductive healthcare
were endorsed, including: concerns about follow up after discharge, lack of knowledge about
confidentiality, lack of knowledge about contraception, interference with the treatment plan,
time constraints, and pregnancy risk in lesbian, gay, bisexual, and transgender youth. Riese
et al. conducted a trial of an interactive patient-facing electronic sexual health module and
found that it was acceptable to adolescents and their parents, and that most participants
requested a sexual health service after completing the module. (The most requested service
was viewing a contraception video made by this PI.) There are no published studies of
interventions to improve contraception care to hospitalized adolescents with mental health
disorders.
The PI designed an adolescent-friendly contraceptive counseling training course, called
BC4Teens Counseling, in use since 2014 by outpatient family planning clinicians in BC4Teens
Clinic at Nationwide Children's Hospital, the second largest children's hospital in the US.
BC4Teens Counseling is adapted from Contraceptive Choice Project materials and employs
efficacy-based counseling, which is endorsed by WHO and American Academy of Pediatrics. This
training will be adapted to current best practice recommendations, including shared-decision
making. The PI, with a multidisciplinary team, has also designed a comprehensive
Contraception Clinical Guideline, contraception initiation job aid, and electronic health
record order set with decision support for contraception initiation. These are currently used
in outpatient care across several departments at Nationwide Children's Hospital. The PI is a
Nexplanon Clinical Trainer and has extensive experience with clinical teaching on
contraception care and Nexplanon procedures, and this site is a Merck Center of Experience.
The investigators propose the following BC4Teens Contraception Care Intervention. All
healthcare professionals participating the intervention will receive training in the
following:
- BC4Teens Counseling is a set of adolescent-friendly contraception counseling and
provision protocols for all FDA-approved prescription contraceptives. The training
includes up-to-date information about maintaining adolescent confidentiality, coding,
and care for sexually transmitted infections.
- Nationwide Children's Contraception Clinical Guideline, a contraception initiation job
aid, and electronic health record order set and decision support for contraception
initiation. These materials are evidence-based and reference established best practices
for contraception care, pregnancy options counseling, and preconception care.
- Nexplanon Clinical Training and credentialing in Nexplanon procedures during planning
phase.
- Information about institutional policies, adolescent confidentiality and consent, and
local sexual health resources will be provided to participating healthcare
professionals.
- Ongoing technical and procedural support from institutional BC4Teens expert trainer.
More than 2000 female adolescents with mental health disorders were hospitalized in 2019 at
Nationwide Children's Hospital. In February 2020 The Big Lots Behavioral Health Pavilion
(BHP) at Nationwide Children's Hospital opened its doors. The BHP is America's largest center
dedicated exclusively to child and adolescent behavioral and mental health on a pediatric
medical campus. Due to the impact of COVID and the simultaneous opening of the BHP,
adolescents with mental health disorders are now hospitalized differently within the
Nationwide Children's Hospital system than before. Presently at Nationwide Children's
Hospital adolescents with mental health disorders are admitted to the Psychiatry Unit, the
observation unit of the psychiatric crisis department, or the Youth Crisis Stabilization Unit
(YCSU). The investigators anticipate that once the initial COVID impact has passed,
adolescent patients with mental health disorders may overflow onto the Hospital Pediatrics
service within the main hospital as they previously did.
The primary goal of this study is to examine an intervention to improve access to
contraception care among female adolescents hospitalized with mental health disorders within
Nationwide Children's Hospital.
One of the investigators' long term goals is to scale-up effective contraceptive counseling
interventions like BC4Teens Contraception Care beyond Nationwide Children's Hospital to other
inpatient settings. This type of scale up has potential to expand the reach of contraceptive
care to a broader population of adolescent females with mental health concerns. However,
evidence-based psychosocial interventions sometimes fail to yield the same benefits observed
in controlled studies when they are transported to new settings. Limited resources, poor
alignment with organizational structures and missions, concerns about the interventions'
acceptability, and heterogeneity of patient needs and professional skill can lead to
difficulty delivering the intervention with fidelity (as it was intended with all core
components and at prescribed dosage). This "voltage drop" in intervention effectiveness as it
moves into routine care is often attributed to failure to optimize the intervention in its
new context.
In this study, the secondary goal is to examine the strategies and processes used to
implement BC4Teens at Nationwide Children's Hospital, and create an implementation manual
that can be used to scale up this intervention in other settings. Thus, the investigators are
embedding a naturalistic observational study of BC4Teens implementation within the
effectiveness research. This study component will focus on specifying the procedures used to
tailor the intervention and training supports, and monitoring the outcomes of implementation
(including the degree to which professionals adopt BC4Teens, deliver it with fidelity, and
reach the target population). In addition to informing an implementation manual, these
results will also advance understanding of the model including the degree to which the model
must be delivered as intended in order to generate clinical benefit, identify types of
professionals best suited for delivering BC4Teens, and patients for whom this intervention is
considered acceptable.
