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

 描述(由申请者提供)：俄亥俄州东北部是贫困和少数民族中未治疗龋齿比率最高的地区之一，6岁儿童。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，但此类活动的证据很少或缺乏。初级保健临床医生可以发挥重要作用，在健康儿童就诊(WCV)时向父母/照顾者传达口腔健康(OH)事实，以减少获得牙科保健的差距。儿童龋病的成因是多因素的，但有证据表明，创新的理论驱动的干预措施并没有针对儿童-父母、提供者(医生)、实践/组织层面的决定因素。干预地图框架被用来制定多层次的干预措施：家长：改善知觉和技能-基于自我调节(CSM)的常识性自我调节模型(CSM)事实信函+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，交流OH事实，提供去看牙医的处方；实践(儿科)：质量改进-整合OH的系统EMR文档，实践量身定制的便利。一项采用混合设计的整群随机临床试验旨在测试行为(父母、提供者)和实施(实践)干预，以增加低收入儿童的牙科护理。20个儿科实践将被用于以下主要目标：1)UH2，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，进行形成性工作；UH3，将18个实践随机分成四个分支，以调查：2)捆绑(父母+提供者+实践层面)干预的效果与加强的日常护理；3)干预的行为和实施部分的影响。次级目标(UH3)是：评估干预措施对次要结果(新的腐烂、口腔卫生、OHRQL、甜食和饮料的频率、成本)的有效性；评估潜在的调解人和调解人，以调查途径；评估采用、覆盖、保真度、维护措施。样本包括88名提供者和1584名父母/照顾者(参加医疗补助的3-6岁儿童)。数据分析(UH2)将采用混合方法设计，对来自重点小组、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(UH3)将遵循RE-AIM框架：儿童(牙科筛查/医疗补助索赔的主要和次要结果)；父母、提供者、做法(调解人、问卷主持人)；提供者、做法(来自审计的保真度和执行措施)。广义线性混合效应模型将评估多水平干预对牙科护理和其他结果的影响，同时考虑家庭、提供者和诊所内的聚集。其次，调解方法伴随着敏感性分析，将决定干预效果是否通过假想的调解人发生。提出了一种全面创新、可扩展的口腔保健模式，供一线初级保健临床医生广泛使用。

 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.