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

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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.