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临床试验/NCT04717596
NCT04717596已完成不适用

Implementation and Examination of Contraception Care for Hospitalized Adolescents With Mental Health Disorders

Elise Berlan1 个研究点 分布在 1 个国家目标入组 455 人开始时间: 2021年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
455
试验地点
1
主要终点
Interest BC4Teens Care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female adolescents, ages 14 and up, receiving care in Psychiatric Unit, Youth Crisis Stabilization Unit (YCSU), Psychiatric Crisis Department Extended Observation Care Unit, and Hospital Pediatrics service

排除标准

  • unable to consent due to mental health disorder, serious medical condition, non-English speaking, known pregnancy

结局指标

主要结局

Interest BC4Teens Care

时间窗: Baseline

% participants who answer yes to the following question "Interest in learning more about contraception during your hospital stay". Investigators will calculate the percentage of participants who answer yes to the Interest in Contraption Initiation question.

次要结局

未报告次要终点

研究者

发起方
Elise Berlan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elise Berlan

Principal Investigator

Nationwide Children's Hospital

研究点 (1)

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