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

测试基于技术的社区初级保健中基于家庭的儿科健康行为干预的实施策略：整群随机析因试验

• 批准号: 10738964
• 负责人: Cady Berkel
• 金额: $ 159.22万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10738964
• 关键词: 13 year old; 5 year old; Address; Adolescence; Adoption; Affect; Age; Area; Behavior Therapy; Cardiovascular Diseases; Caring; Characteristics; Child; Child Health; Child Rearing; Childhood; Clinical; Clinical effectiveness; Code; Collaborations; Communities; Cost Analysis; Data; Development; Educational Curriculum; Effectiveness; Electronic Health Record; Emotional; Enrollment; Ethnic Origin; Ethnic Population; Family; Family Demographies; Family health status; Gender; Goals; Health; Health Promotion; Health behavior; Health behavior and outcomes; Home; Hybrids; Individual; Informal Social Control; Integrated Health Care Systems; Intervention; Learning; Link; Low Income Population; Machine Learning; Mexican Americans; Modeling; Monitor; Motivation; Outcome; Parents; Patients; Phase; Population; Prevention trial; Primary Care; Process; Public Health; Race; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Research Support; Resources; Risk; Risk Factors; Role; Sample Size; Sampling; Suggestion; Supervision; System; Technology; Testing; Text Messaging; Time; Training; Translating; Trust; United States Preventative Services Task Force; aged; automated text message; behavioral health; budget impact; cardiovascular disorder prevention; cardiovascular disorder risk; care systems; checkup examination; clinical decision support; cost; cost effectiveness; disease disparity; economic cost; economic impact; effective intervention; effectiveness evaluation; effectiveness-implementation randomized trial; effectiveness/implementation hybrid; effectiveness/implementation study; evidence base; follow-up; implementation barriers; implementation cost; implementation design; implementation outcomes; implementation strategy; implementation/effectiveness; improved; individualized medicine; interest; lower income families; motivational enhancement therapy; pediatrician; practice setting; prevent; preventive intervention; primary care setting; primary care visit; primary outcome; programs; prospective; racial population; scale up; skills; social; social health determinants; support tools; treatment as usual; treatment planning; universal prevention; usability

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.

项目摘要/摘要 数十年的研究支持以家庭为中心的预防性干预措施（FCPI）在限制中的有效性 儿童的心血管疾病（CVD）风险。小儿初级保健提供理想的分娩系统 要嵌入有效的FCPI，以达到目标对准的CVD风险，父母对 儿科医生，进入面临CVD差异的社区。尽管来自美国的认可 预防服务工作队，很少有FCPI在初级保健中广泛实施，从而有限 访问家庭和公共卫生影响。该应用程序着重于促进宽度 实施基于证据的家庭检查4 Health（FCU4Health），这是一个有证明的FCPI 对家庭和儿童健康行为的积极影响。为了测试FCU4Health，我们进行了240的RCT 初级墨西哥裔美国人和低收入家庭与多个​​初级保健系统合作。孩子们 在其最新的 初级保健访问。与通常的护理相比，FCU4Health显着改善了儿童和家庭健康行为， 儿童社会情感健康，并导致儿童BMI的有意义的变化与 其他干预措施。鉴于这些积极的证据，综合的初级保健组织已经成为 对采用的越来越感兴趣。我们与217个初级墨西哥裔美国人和 目前，具有2至5岁儿童的低收入家庭正在综合初级保健系统中。 在这两个试验中，在Re-Aim框架的指导下，以及一个社区顾问委员会 监督FCU4Health的开发和测试，确定了几个实施障碍，影响了其 接触，忠诚和参与。基于技术的实施策略（一种临床决策支持工具， 自动保真监控和电子健康记录（EHR）集成的SMS文本消息平台） 开发以大规模促进分娩。在拟议的双相研究中，R61阶段涉及整合 通过EHR和可用性测试的这些策略。在R33阶段，混合3型群集随机分组 阶乘试验将与150个协调员和1200个家庭进行，以检查策略对 保真度和参与度（主要实施结果）和儿童健康行为（主要临床） 结果），家庭健康习惯，育儿技能和儿童BMI。预期实施成本分析将 进行检查，以检查每种策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 - 向上。大型样本量将使我们能够通过基线特征检查这些关联（BMI， 发展阶段，种族/种族和性别）。结果有可能产生重大的公共卫生影响 通过支持在初级保健环境中为家庭的有效干预措施扩大规模来进行CVD风险。