Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care: A Cluster Randomized Factorial Trial

项目摘要/摘要 几十年的研究支持以家庭为中心的预防干预措施(FCPIs)在限制 儿童的心血管疾病(CVD)风险。儿科初级保健提供了理想的提供系统，其中 在给定目标一致性、父母信任和纵向接触的情况下，为心血管疾病风险嵌入有效的FCPI 儿科医生，并接触到面临心血管疾病差距的社区。尽管得到了美国的支持 预防服务工作队，在初级保健中广泛实施的FCPIs很少，导致有限 对家庭和公共卫生的影响。这个应用程序的重点是促进广泛的 循证家庭体检4健康(FCU4Health)的实施 对家庭和儿童健康行为的积极影响。为了测试FCU4Health，我们对240人进行了RCT 主要是墨西哥、美国和低收入家庭与多种初级保健系统结成伙伴关系。儿童 是否为≥5.5岁至13岁，最近一次体重指数(≥85%年龄和性别)升高 初级保健探视。与常规护理相比，FCU4Health显著改善了儿童和家庭的健康行为， 儿童社交-情绪健康，并导致儿童BMI发生有意义的变化，其幅度与 其他干预措施。鉴于这一积极的证据，综合初级保健组织已经成为 对它的采用越来越感兴趣。我们的普遍预防试验有217名，主要是墨西哥裔美国人和 目前，有2至5岁孩子的低收入家庭正在综合初级保健系统中开展工作。 在这两个试验期间，在RE-AIM框架的指导下，社区咨询委员会 在FCU4Health开发和测试的监督下，确定了几个影响其 影响力、忠诚度和参与度。基于技术的实施策略(临床决策支持工具， 自动保真度监控和集成电子健康记录(EHR)的短信平台) 是为了促进大规模交付而开发的。在拟议的两阶段研究中，R61阶段涉及整合 通过EHR和可用性测试对这些策略进行评估。在R33阶段，混合类型3集群随机化 将对150名协调员和1200个家庭进行析因试验，以检查这些策略对 忠诚度和参与度(主要实施结果)和儿童健康行为(主要临床 结果)、家庭健康例行公事、育儿技巧和儿童体重指数。预期实施成本分析将 审查每项战略的经济影响和成本效益。最后，我们将建模 儿童和家庭健康行为的轨迹，并在18个月的随访中检查与BMI的相关性 向上。大样本量将使我们能够通过基线特征(BMI， 发展阶段、种族/族裔和性别)。结果有可能对公共健康产生重大影响 通过促进扩大初级保健环境中家庭的有效干预措施，提高心血管疾病风险。

Project Summary/Abstract Decades of research support the effectiveness of family-centered preventive interventions (FCPIs)in limiting cardiovascular disease (CVD) risk for children. Pediatric primary care offers the ideal delivery system in which to embed effective FCPIs for CVD risk given goal alignment, parents’ trust in and longitudinal contact with pediatricians, and reach into communities facing CVD disparities. Despite endorsement from the United States Preventive Services Task Force, few FCPIs have been widely implemented in primary care, resulting in limited access for families and public health impact. This application focuses on facilitating the widespread implementation of the evidence-based Family Check-Up 4 Health (FCU4Health), a FCPI with demonstrated positive effects on family and child health behaviors. To test the FCU4Health, we conducted an RCT with 240 primarily Mexican American and low-income families in partnership with multiple primary care systems. Children were ≥5.5 to <13 years old and had elevated BMI (≥85th percentile for age and gender) at their most recent primary care visit. Compared to usual care, FCU4Health significantly improved child and family health behaviors, child social-emotional health, and resulted in meaningful change in child BMI at a magnitude consistent with other interventions. Given this positive evidence, integrated primary care organizations have become increasingly interested in its adoption. Our universal prevention trial with 217 primarily Mexican American and low-income families with a 2- to 5-year-old child is currently underway in an integrated primary care system. During these two trials, with guidance from the RE-AIM framework, and a Community Advisory Board that has overseen FCU4Health development and testing, several implementation barriers were identified affecting its reach, fidelity, and engagement. Technology-based implementation strategies (a clinical decision support tool, automated fidelity monitoring, and an Electronic Health Record (EHR)-integrated SMS text messaging platform) were developed to promote delivery at scale. In the proposed biphasic study, the R61 phase involves integration of these strategies with the EHR and usability testing. In the R33 phase, a hybrid type 3 cluster randomized factorial trial will be conducted with 150 coordinators and 1200 families to examine effects of the strategies on fidelity and engagement (primary implementation outcomes) and child health behaviors (primary clinical outcomes), family health routines, parenting skills, and child BMI. Prospective implementation cost analyses will be performed to examine the economic impact and cost-effectiveness of each strategy. Finally, we will model trajectories of child and family health behaviors and examine the associations with BMI at the 18-month follow- up. The large sample size will allow us to examine these associations by baseline characteristics (BMI, developmental stage, race/ethnicity, and gender). Results have the potential for a significant public health impact on CVD risk by facilitating the scale-up of effective interventions for families in primary care settings.