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

 描述（由申请人提供）：俄亥俄州东北部的贫困和少数民族<6岁的儿童中，未经治疗的蛀牙率最高。虽然美国儿科学会和美国儿科牙科学会建议在6岁以下儿童的初级保健环境中采用口腔健康评估，但此类活动的证据不足或缺乏。初级保健临床医生可以发挥重要作用，沟通口腔健康（OH）的事实，家长/照顾者在良好的儿童访问（WCV），以减少在牙科保健的差距。儿童龋齿的起源是多因素的，但有证据表明，创新的理论驱动的干预措施没有针对性的决定因素，在儿童家长，供应商（医生），实践/组织水平。干预映射框架用于开发多层次干预：父母：提高认知和技能-基于自我调节常识模型（CSM）的OH事实信+牙科信息指南（DIG）;提供者（医生）：提高知识和技能-基于CSM的教育和技能，沟通OH事实，提供处方去牙医;实践（儿科）：质量改进-整合OH的系统EMR文档，实践量身定制的促进。一个群集随机临床试验的混合设计，提出了测试行为（父母，供应商）和实施（实践）干预，以增加低收入儿童的牙科就诊率。20个儿科实践将用于以下主要目的：1）UH 2，通过社区参与和在2个实践中对干预措施和方案进行试点测试，开展形成性工作; UH 3，将18个实践随机分为4组，以调查：2）捆绑治疗的效果（父母+提供者+实践水平）干预与加强常规护理; 3）干预的行为和实施组成部分的效果。次要目标（UH 3）是：评估干预措施对次要结局（新的腐烂、口腔卫生、OHRQL、甜食和饮料的频率、成本）的有效性;评估潜在的中介者和调节者，以调查途径;评估采用、覆盖、忠诚度、维护措施。样本包括88个提供者和1584个父母/照顾者（参加医疗补助的3-6岁儿童）。数据分析（UH 2）将采用混合方法设计，对来自焦点小组、访谈和试点测试的定量数据进行定性和描述性/分析性统计。数据收集（UH 3）将遵循RE-AIM框架：儿童（牙科筛查/医疗补助索赔的主要、次要结局）;父母、提供者、实践（问卷调查的调解人、主持人）;提供者、实践（审计的忠诚度和实施措施）。广义线性混合效应模型将评估多层次干预措施对牙科就诊和其他结果的影响，同时考虑家庭，提供者和实践中的聚类。其次，调解方法，伴随着敏感性分析，将确定干预效果是否发生通过假设的调解人。一个全面的和创新的可扩展的口腔卫生保健模式，提出了广泛使用的一线初级保健临床医生。

 DESCRIPTION (provided by applicant): Northeast Ohio has one of the highest rates of untreated cavities among poor and minority <6 yr old children. While the American Academy of Pediatrics and the American Academy of Pediatric Dentistry recommend adoption of oral health assessment within the primary care setting for children up to 6 yrs old, the 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) to reduce disparities in dental care access. Childhood caries is multifactorial in origin, but evidence suggests that innovative theory-driven interventions have not targeted determinants at the child-parent, provider (physician), practice/organization levels. The intervention mapping framework was used to develop the multi-level interventions: Parent: improve perception and skills - a common-sense model of self-regulation (CSM)-based OH facts letter + dental information guide (DIG); Provider (Physician): improve knowledge and skills -CSM-based education and skills, communicate OH facts, provide prescription to go to dentist; Practice (Pediatric): quality improvement -integrate systematic EMR documentation of OH, practice-tailored facilitation. A cluster-randomized clinical trial with a hybrid design is proposed to test behavioral (parent, provider) and implementation (practice) intervention to increase dental attendance among low-income children. Twenty pediatric practices will be utilized for the following primary aims: 1) UH2, Conduct formative work through community engagement and pilot-testing of the interventions and protocols in 2 practices; UH3, randomize 18 practices to four arms to investigate: 2) effect of bundled (parent + provider + practice level) interventions vs. enhanced usual care; 3) effect of behavioral and implementation components of the intervention. Secondary aims (UH3) are: 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 measures. The sample includes 88 providers and 1584 parent/caregivers (of Medicaid- enrolled 3-6 year old children). Data analysis (UH2) will utilize a mixed method design for qualitative and descriptive/analytical statistics for quantitative data resulting from focus groups, interviews, and pilot-testing. Data collection (UH3) 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). Generalized linear mixed effects models will assess effects of multi-level interventions on dental attendance and other outcomes, while accounting for clustering within family, provider and practice. Secondarily, mediation methods, accompanied by sensitivity analyses, will determine if intervention effects occur through hypothesized mediators. A comprehensive and innovative scalable oral health care model is proposed for widespread use by front-line primary care clinicians.