A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care

儿科初级保健中以家长为中心的预防的务实试验

基本信息

批准号：
10431949
负责人：
Margaret Kuklinski
金额：
$ 142.43万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-05-15 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10431949
关键词：
12 year old Academy Accident and Emergency department Address Adolescent Adopted Adoption Advisory Committees Age American Anxiety Attitude Behavior California Caring Child Child Rearing Child Welfare Childhood Clinic Clinical Cluster randomized trial Colorado Data Development Diagnosis Education Educational Curriculum Effectiveness Enrollment Ensure Ethnic Origin Evidence based intervention Family Family Relationship Federally Qualified Health Center Fostering Future Gender Guidelines Health Health Care Costs Health Insurance Health Surveys Health system Healthcare Healthcare Systems Home Hospitalization Illicit Drugs Influentials Infrastructure Inpatients Insurance Coverage Integrated Health Care Systems Intervention Knowledge Language Maintenance Medical center Mental Depression Mental Health Modeling Monitor Outcome Parents Participant Pediatrics Persons Phase Pilot Projects Play Population Preparation Prevention Preventive Preventive service Primary Health Care Problem behavior Process Protocols documentation Provider Public Health Race Randomized Randomized Controlled Trials Reach Effectiveness Adoption Implementation and Maintenance Reporting Research Risk Behaviors Service delivery model Services Social Development Surveys Symptoms Teenagers Testing Time Tobacco use Trust United States National Institutes of Health Universities Violence Visit Washington adolescent health antisocial behavior arm base behavioral health collaboratory community setting cost depressive symptoms design economic evaluation evidence base externalizing behavior feasibility testing health care settings health economics high school implementation evaluation implementation outcomes implementation process implementation protocol improved inpatient service marijuana use multidisciplinary parental role patient oriented pediatrician population health post intervention pragmatic trial prevent programs recruit research and development service utilization skills social sociodemographics socioeconomics substance misuse substance use substance use prevention systems research treatment arm treatment as usual underage drinking universal prevention

项目摘要

Fifty percent of all adolescents will use some form of illicit drugs before the end of high school, 20-25% will meet criterial for depression, and many others will engage in health compromising behaviors like delinquency and violence—with consequences for their long-term health. Evidence-based interventions shown to prevent these behavioral health concerns could improve adolescent health trajectories if implemented widely in pediatric primary care. The American Academy of Pediatrics’ Bright Futures recommends that pediatricians offer developmentally tailored anticipatory guidance to all parents to support their children’s healthy development, but programs providing guidance are not offered universally. This UG3-UH3 application tests the feasibility and effectiveness of implementing Guiding Good Choices, a universal, evidence-based anticipatory guidance curriculum for parents of early adolescents, in three large, integrated healthcare systems serving socioeconomically diverse families. This intervention reduced adolescent alcohol, tobacco and marijuana use, depression, and general delinquency in two previous rigorous randomized controlled trials. It also strengthened parenting practices and parent-adolescent relationship quality, both broadly protective against behavioral health concerns. Guiding Good Choices has the capacity to achieve population-level impact on adolescent health if made widely available through pediatric primary care. Parents trust pediatricians’ advice regarding their children’s well-being, and current research with socioeconomically diverse groups suggests that they are eager to participate in family-focused programs offered in primary care clinics. Building on this body of research, the investigative team, in close cooperation with the NIH Healthcare Systems Research Collaboratory and healthcare systems partners, will conduct a cluster-randomized trial of Guiding Good Choices in 72 pediatric primary care practices. Half will be randomly assigned to offer the program universally to parents of adolescents ages 11 to 12, and half will serve as usual care controls. The study will use a workflow that is easy to adopt, implement, and maintain by primary care clinics to enroll families in the intervention at the adolescent well visit. We anticipate recruiting over 4,500 families into the trial. The team will use the RE-AIM framework to test implementation outcomes and effectiveness, including hypothesized reductions in several behavioral health problems (e.g., substance use initiation, mental health symptoms and diagnoses), and emergency department and inpatient service utilization. We will use data from the EHR and a supplemental behavioral health survey to monitor outcomes up to 3 years post intervention. We will also assess the feasibility and sustainability of implementing the intervention in each HCS, including health economic evaluation to understand costs in relation to value gained. Throughout the trial the investigative team will engage in ongoing dialog with HCS leaders, pediatricians, and clinic staff to ensure the intervention and implementation process fit the needs of each HCS. We anticipate that evidence of feasibility and effectiveness in three different HCS will foster broad dissemination to achieve public health impact.

在高中结束之前，所有青少年中有50％将使用某种形式的非法药物，20-25％将符合抑郁症的标准，许多其他人将从事健康妥协行为和暴力 - 对其长期健康的后果。证明的循证干预措施可防止如果在小儿中广泛实施，这些行为健康问题可能会改善青少年健康轨迹初级保健。美国儿科学会的明亮未来建议儿科医生提供向所有父母提供开发量身定制的预期指导，以支持孩子的健康发展，但提供指导的计划不普遍提供。此UG3-UH3应用程序测试可行性和实施指导良好选择的有效性，这是一种通用的，基于证据的预期指导早期青少年父母的课程，在三个大型综合医疗系统中社会经济多样化的家庭。这种干预措施减少了青少年酒精，烟草和大麻的使用，抑郁症和一般性犯罪在前两个严格的随机对照试验中。它也加强了育儿实践和父母关系质量，都广泛保护了行为健康关注。指导良好的选择有能力实现人口水平对青少年健康的影响通过小儿初级保健广泛使用。父母相信儿科医生关于他们的建议儿童的福祉以及与社会经济多样化群体的最新研究表明，他们渴望参与初级保健诊所提供的以家庭为中心的计划。在这一研究的基础上，调查团队与NIH Healthcare Systems研究合作组织密切合作医疗保健系统合作伙伴将进行共同指导72个小儿选择的群集试验初级保健实践。一半将随机分配给青少年的父母普遍提供该计划 11至12岁，一半将像往常一样护理控制。该研究将使用易于采用的工作流程，由初级保健诊所实施并维持在青少年访问的干预措施中招募家庭。我们预计将招募超过4,500个家庭参加审判。团队将使用Re-Aim框架进行测试实施结果和有效性，包括多种行为健康的假设减少问题（例如，药物使用启动，心理健康症状和诊断）和急诊科和住院服务利用率。我们将使用EHR的数据和补充行为健康调查干预后最多3年监测结果。我们还将评估在每个HCS中实施干预措施，包括健康经济评估以了解关系成本珍视获得的。在整个试验中，调查团队将与HCS领导人进行持续的对话，儿科医生和诊所工作人员，以确保干预和实施过程满足每个HCS的需求。我们预计三种不同HC的可行性和有效性的证据将促进广泛的传播实现公共卫生的影响。