Enhanced Intervention to Improve Adolescent Outcomes: A Clinical Trial

 描述(由申请人提供)：有限的护理机会是美国青少年性传播感染(STI)、人类免疫缺陷病毒(HIV)感染和意外怀孕的主要原因，并导致显著的健康差距，包括未参保青年的STI发病率是投保青年的6-7倍。种族/族裔差异也存在，非洲裔美国人和西班牙裔青少年就是明证。 怀孕率是白人青年的4倍。急诊科是一个重要但未得到充分利用的场所，可以接触到大量有性危险的青少年，但获得循证护理的机会有限，越来越多的人支持使用急诊室来改善青少年的性健康结果。由于教育署几乎没有行之有效的干预措施来激励青少年进行更安全的性行为和提供健康服务(例如性病检测、避孕套)，因此需要新的干预措施。米勒医生是一名儿科急诊医生，也是本次职业发展奖的候选人，他致力于 开展以患者为导向的行为研究，以改善青少年的健康状况，重点关注服务不足的社区。与强大的多学科指导团队一起，Miller博士创建了一个为期四年的职业发展计划，其中包括结构化的指导，完成临床研究的理学硕士学位，以及集中培训使用健康行为改变理论，为行为干预试验制定多层次的干预措施、研究方法和统计分析，针对健康行为改变的有效咨询战略，医疗保健系统和支付模式，以及负责任的行为 研究。米勒博士的培训活动将得到一个创新项目的补充，该项目将促进这些新技能的实际应用。该项目的目标是加强和测试以前试行的ED SexHealth干预措施，该干预措施使用一名专门的健康教育人员提供降低风险的咨询、护理点健康服务和持续护理的转介。在改进干预措施后，米勒博士将对加强干预措施和标准信息部门进行随机试验，以确定卫生服务接受率和加强干预可行性的影响大小。我们假设，与标准信息臂相比，干预将导致更高的卫生服务接受率和更多的避孕套使用。这个 理由是，它将产生第一个受控数据，旨在使用一种新的有效的护理方法改善青春期性健康结果的干预措施。我们希望使用这些临界效应大小估计来指导设计一项更大规模的临床试验来评估疗效。米勒博士的培训努力最终将提交一份R01提案，以资助这项试验。这一培训和研究计划与国家 美国卫生研究院和国家儿童健康与人类发展研究所、美国卫生与公众服务部制定的2020年健康人目标，以及2009年学术急诊医学共识会议。

 DESCRIPTION (provided by applicant): Limited access to care is a major contributor to sexually transmitted infections (STIs), human immunodeficiency virus (HIV) infection, and unintended pregnancy for U.S. adolescents and contributes to significant health disparities, including rates of STIs that are 6-7 times higher for uninsured youths than for insured youths. Racial/ethnic disparities also exist, with African American and Hispanic adolescents evidencing pregnancy rates that are 4 times higher than White youths. The emergency department (ED) represents an important but underutilized location for reaching large numbers of sexually at-risk adolescents with limited access to evidence-based care and there is growing support for use of the ED to improve adolescent sexual health outcomes. Because few proven interventions are available in the ED to motivate youth to safer sexual behavior and provide health services (e.g., STI testing, condoms), novel interventions are needed. Dr. Miller, a pediatric emergency medicine physician and the candidate for this Career Development Award, is committed to conducting patient-oriented behavioral research to improve adolescent health outcomes, focusing on underserved communities. Together with a strong multi-disciplinary mentorship team, Dr. Miller has created a four-year career development plan which includes structured mentoring, completion of a Master of Science in Clinical Research, and focused training in the use of health behavior change theories to develop multi-level interventions, research methods and statistical analyses for behavioral intervention trials, effective counseling strategies for health behavior change, health care system and payment models, and responsible conduct of research. Dr. Miller's training activities will be complemented by an innovative project that will facilitate practical application of these new skills. The goal of the project is to enhance and tes a previously piloted ED SexHealth intervention that uses a dedicated health educator to provide risk reduction counseling, point-of care health services, and referral for ongoing care. Following intervention refinement, Dr. Miller will conduct a randomized trial of the enhanced intervention versus a standard information arm to determine the effect size of rates of health service uptake and enhanced intervention feasibility. We hypothesize that the intervention will result in higher health service uptake and increased condom use versus a standard information arm. The rationale is that it will produce the first controlled data on an intervention designed to improve adolescent sexual health outcomes using a novel and effective method of delivering care. We expect to use these critical effect size estimates to inform the design of a larger clinical trial o evaluate efficacy. Dr. Miller's training efforts will culminate in the submission of an R01 proposa to fund this trial. This training and research plan are consistent with the mission of the National Institutes of Health and the National Institute of Child Health and Human Development, the Healthy People 2020 objectives from the United States Department of Health and Human Services, and the 2009 Academic Emergency Medicine consensus conference.