Multi-Level Interventions to Reduce Caries Disparities in Primary Care Settings

项目总结/摘要 本竞争修订版（UH3 DE 025487）旨在完成随机分组的数据收集活动 临床试验（cRCT），以及额外的定性数据收集，以评价传播策略， 将试验结果和资源转化给所有利益相关者。俄亥俄州东北部是未经治疗的 贫困儿童和6岁以下少数民族儿童的龋齿。美国儿科学会（AAP）和 美国儿科牙科学会（AAPD）建议在小学采用口腔健康活动 为6岁以下儿童提供的照料环境，但开展这类活动的证据很少或缺乏。初级 护理临床医生可以发挥重要作用，在沟通口腔健康（OH）的事实，家长/照顾者在良好的， 儿童就诊（WCV），并提供资源，以减少在获得牙科保健方面的差距。干预映射 框架被用于制定提供者（医生/执业护士）的多层次干预措施： 提高知识和技能-基于自我调节常识模式理论教育和 技能，沟通OH的事实，给处方，和资源的父母/照顾者带孩子去看牙医; 实践（儿科）：质量改进-整合OH的系统EMR文档。这一簇- 一项随机临床试验将18个诊所随机分为两组。因此，主要目的是检查 基于理论的行为（提供者层面）和实施（实践层面）多层面有效性 干预措施与加强常规护理（基于AAP的口腔健康教育），由WCV的提供者提供， 增加3 - 6岁参加医疗补助的儿童的牙科就诊率。次要目的是：评估 干预措施对次要结局的有效性（新发龋齿、口腔卫生、OHRQL、甜食频率） 零食和饮料，成本）;评估潜在的调解人和主持人调查途径;评估 采用、达到、保真、维护相关工艺措施。本次修订还将收集更多 定性数据，以评估干预措施的特点和执行障碍/促进因素， 传播目的。cRCT样本包括18个实践，63个提供者和1024个父母/子女 二分体cRCT的数据收集将遵循RE-AIM框架：儿童（主要、次要结局） 牙科筛查/医疗补助索赔）;父母，提供者，实践（调解员，调查问卷的主持人）; 提供者、实践（审计的忠诚度和实施措施）。对于cRCT，广义线性混合 效应模型将评估多层次干预对牙科就诊和其他结果的影响， 考虑到提供者和实践中的集群。其次，调解方法， 敏感性分析，将确定是否通过假设的介质发生干预效果。证据 将利用cRCT结果和本修订申请的定性数据开发工具包 向利益攸关方传播。提出了一个全面的、创新的、可扩展的口腔卫生保健模式 供一线初级保健临床医生广泛使用。

PROJECT SUMMARY/ABSTRACT This competitive revision (UH3 DE025487) is to complete data collection activities for a cluster-Randomized Clinical Trial (cRCT), together with additional qualitative data collection to evaluate dissemination strategies to translate trial results and resources to all stakeholders. Northeast Ohio has one of the highest rates of untreated cavities among poor and minority <6 year old children. The American Academy of Pediatrics (AAP) and the American Academy of Pediatric Dentistry (AAPD) recommend adoption of oral health activities in the primary care setting for children up to 6 years old, but evidence for such activities have been poor or lacking. Primary care clinicians can play an important role in communicating oral health (OH) facts to parent/caregivers at well- child visits (WCV) and provide resources to reduce disparities in dental care access. The intervention mapping framework was used to develop the multi-level interventions at the Provider (Physician/Nurse Practitioner): improve knowledge and skills –Common-Sense Model of Self-Regulation (CSM) theory-based education and skills, communicate OH facts, give prescription, and resources to parent/caregiver to take the child to the dentist; Practice (Pediatric): quality improvement -integrate systematic EMR documentation of OH. The cluster- randomized clinical trial randomized 18 practices to two arms. Therefore, the primary aim is to examine the effectiveness of theory-based behavioral (provider-level) and implementation (practice-level) multi-level interventions versus enhanced usual care (AAP based oral health education) delivered by providers at WCVs in increasing dental attendance among 3-6 year old Medicaid-enrolled children. The secondary aims are to: assess effectiveness of interventions on secondary outcomes (new decay, oral hygiene, OHRQL, frequency of sweet snacks and beverages, cost); assess potential mediators and moderators to investigate pathways; assess adoption, reach, fidelity, maintenance related process measures. This revision will also collect additional qualitative data to assess the characteristics of the intervention and implementation barriers/enablers for dissemination purposes. The cRCT sample includes 18 practices, 63 providers and 1024 parent/caregivers-child dyads. Data collection for the cRCT will follow the RE-AIM framework: child (primary, secondary outcomes from dental screening/Medicaid claims); parent, provider, practice (mediators, moderators from questionnaires); provider, practice (fidelity and implementation measures from audits). For the cRCT, generalized linear mixed effects models will assess effects of multi-level interventions on dental attendance and other outcomes, while accounting for clustering within provider and practice. Secondarily, mediation methods, accompanied by sensitivity analyses, will determine if intervention effects occur through hypothesized mediators. The evidence from the cRCT results and the qualitative data from this revision application will be utilized to develop a tool kit for dissemination to stakeholders. A comprehensive and innovative scalable oral health care model is proposed for widespread use by front-line primary care clinicians.