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.
This study will test innovative theory-driven multi-level interventions at the parent/caregiver, provider (physician), practice (pediatric) levels to increas dental attendance and reduce untreated caries among 3 to 6 year old Medicaid-enrolled children attending well-child visits in the pediatrician's offices. The behavioral interventions at the parent and provider levels, and implementation strategies at the practice level will help parent to seek dental care for child. These novel interventions have the potential for a new oral health care model for physicians providing care for young children.
