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

项目摘要/摘要 此竞争性修订(UH3 DE025487)旨在完成群集的数据收集活动-随机 临床试验(CRCT)，以及额外的定性数据收集，以评估传播策略 将试验结果和资源翻译给所有利益相关者。俄亥俄州东北部是未接受治疗的比率最高的州之一 贫困和少数民族6岁儿童中的龋齿。美国儿科学会(AAP)和 美国儿科牙科学会建议在小学开展口腔健康活动 6岁以下儿童的照料环境，但这类活动的证据很少或缺乏。主要 护理临床医生可以在向家长/照顾者传达口腔健康(OH)事实方面发挥重要作用- 儿童就诊(WCV)，并提供资源，以减少在获得牙科护理方面的差距。干预性地图 框架用于在提供者(医生/护士从业者)制定多层次的干预措施： 提高知识和技能-以自我调节(CSM)理论为基础的教育常识模式和 技能，沟通事实，给父母/照顾者处方和资源，带孩子去看牙医； 实践(儿科)：质量改进--整合系统的医疗卫生病历文件。该集群- 随机临床试验将18种做法随机分成两组。因此，主要目标是检查 基于理论的行为(提供者层面)和实施(实践层面)多层次的有效性 年由WCVS提供者提供的干预措施与增强型常规护理(基于AAP的口腔健康教育) 增加3-6岁参加医疗补助的儿童的牙科护理。次要目标是：评估 干预措施对次要结果的有效性(新的腐烂、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以调查途径；评估 采用、覆盖、保真、维护相关流程措施。这一修订还将收集额外的 用于评估以下项目的干预和实施障碍/推动因素特征的定性数据 传播目的。CRCT样本包括18个诊所、63个提供者和1024个父母/照顾者-儿童 双子星。CRCT的数据收集将遵循RE-AIM框架：儿童(主要、次要成果来自 牙科筛查/医疗补助申请)；父母、提供者、诊所(调解人、问卷主持人)； 提供者、实践(来自审计的忠诚度和实施措施)。对于CRCT，广义线性混合 效果模型将评估多层次干预措施对牙科护理和其他结果的影响，而 在提供商和实践中对集群进行核算。其次，调解方法，伴随着 敏感度分析将确定干预效果是否通过假设的中介发生。证据 根据CRCT结果和本次修订申请的定性数据，将开发一个工具包 分发给利益攸关方。提出了一种全面创新的可扩展口腔保健模式 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.