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.

50% 的青少年会在高中毕业前使用某种形式的非法药物，20-25% 会符合抑郁症标准，而许多其他人会从事危害健康的行为，例如犯罪和暴力——这会对他们的长期健康产生影响，基于证据的干预措施被证明可以预防。如果在儿科广泛实施，这些行为健康问题可以改善青少年的健康轨迹美国儿科学会的光明未来建议儿科医生提供初级保健。为所有父母提供针对孩子健康发展的针对性发展预期指导，但是提供指导的程序并未普遍提供。此 UG3-UH3 应用程序测试了可行性和有效性。实施“良好选择指南”的有效性，这是一种普遍的、基于证据的预期指南为青少年早期家长提供的课程，在三个大型综合医疗保健系统中提供服务这种干预措施减少了青少年酗酒、吸烟和大麻的使用，先前两项严格的随机对照试验也强化了抑郁症和一般犯罪的影响。养育方式和父母与青少年的关系质量，两者都广泛地预防行为健康指导良好选择有能力对青少年健康产生人口层面的影响，如果通过儿科初级保健广泛提供。家长相信儿科医生关于他们的建议。儿童的福祉，目前对社会多元化群体的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。调查小组与 NIH 医疗系统研究合作实验室密切合作，医疗保健系统合作伙伴将在 72 名儿科患者中开展一项“指导良好选择”整群随机试验一半将被随机分配，向青少年家长普遍提供该计划。 11 至 12 岁，一半将作为常规护理对照该研究将使用易于采用的工作流程，由初级保健诊所实施和维护，让家庭参与青少年健康访视的干预措施。我们预计将招募超过 4,500 个家庭参与试验。该团队将使用 RE-AIM 框架进行测试。实施成果和有效性，包括若干行为健康方面的进展问题（例如，开始使用药物、心理健康症状和诊断）和急诊室我们将使用 EHR 和补充行为健康调查的数据来我们还将评估干预后 3 年内的结果。在每个 HCS 中实施干预措施，包括健康经济评估以了解相关成本在整个试验过程中，调查团队将与 HCS 领导人进行持续对话，儿科医生和临床工作人员，以确保干预和实施过程符合每个 HCS 的需求。我们预计三种不同 HCS 的可行性和有效性证据将促进广泛传播以实现公共卫生影响。