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

项目总结/摘要 数十年的研究支持以家庭为中心的预防干预措施（FCPI）在限制 心血管疾病（CVD）的风险。儿科初级保健提供了理想的输送系统， 在目标一致、父母信任和纵向联系的情况下， 儿科医生，并深入面临心血管疾病差异的社区。尽管美国支持 预防服务工作队，很少FCPI已广泛实施的初级保健，导致有限的 对家庭和公共卫生的影响。该应用程序的重点是促进广泛的 实施以证据为基础的家庭健康检查4（FCU 4 Health），这是一项FCPI， 对家庭和儿童健康行为的积极影响。为了测试FCU 4 Health，我们进行了一项随机对照试验， 主要是墨西哥裔美国人和低收入家庭与多个初级保健系统合作。儿童 ≥5.5至<13岁，最近一次BMI升高（年龄和性别≥第85百分位数） 初级保健访问。与常规护理相比，FCU 4 Health显著改善了儿童和家庭的健康行为， 儿童社会情绪健康，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成为 越来越关注它的通过。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岁子女的低收入家庭正在综合初级保健系统中接受治疗。 在这两项试验中，在RE-AIM框架和社区咨询委员会的指导下， 监督FCU 4 Health的开发和测试，确定了影响其 范围忠诚度和参与度基于技术的实施策略（临床决策支持工具， 自动化保真度监测和电子健康记录（EHR）集成的SMS文本消息平台） 旨在促进大规模交付。在拟定的双相研究中，R61相涉及整合 这些策略与EHR和可用性测试。在R33阶段，混合型3簇随机化 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 忠诚和参与（主要实施成果）和儿童健康行为（主要临床 结果），家庭健康常规，育儿技巧和儿童BMI。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个月后检查与BMI的关联- 起来大样本量将使我们能够通过基线特征（BMI， 发育阶段、种族/民族和性别）。结果可能会对公共卫生产生重大影响 通过促进在初级保健环境中扩大对家庭的有效干预，降低心血管疾病风险。

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.