Formative and Pilot Study for an Effectiveness-Implementation Hybrid Cluster Randomized Trial to Incorporate Oral Health Activities into Pediatric Well-Child Visits

Abstract

Background: Dental caries in pediatric patients are noted to have broad impacts on systemic health and well-being. Thus, utilizing an effectiveness-implementation hybrid I design, the Pediatric Providers Against Cavities in Children’s Teeth (PACT) trial is investigating multi-level interventions at the practice (incorporation of oral health in electronic medical record [EMR]) and provider levels (theory-based didactic and skills training to communicate oral health facts to parent/caregiver, give a prescription to see a dentist and a list of area dentists) to increase dental utilization among 3 to 6 year old Medicaid-enrolled children attending well-child visits (WCV). The formative and pilot work for the larger main trial are presented. Methods: Formative work—Focus groups with 26 participants (Community leaders, providers, parent/caregivers); and key informant interviews with practice leadership (n = 4). Topics discussed were: core oral health (OH) information to communicate at WCVs and study logistics. Transcripts were coded and analyzed using Atlas.ti; Pilot study was refined using the formative findings and was conducted at two pediatric practices to test the implementation of: the provider didactic and skills training curriculum; EMR incorporation of four OH questions; logistics of incorporating OH activities at a WCV; and parent/caregiver recruitment. Results: Formative work showed that providers and parent/caregivers required knowledge of dental caries, and a list of area Medicaid-accepting dentists. Providers and practice leadership advised on the logistics of incorporating oral health into WCVs. All groups suggested asking parent/caregivers their preferred method of contact and emphasizing importance of OH to motivate participation. Utilizing these findings, the curriculum and protocol was revised. The pilot study in two practices successfully implemented the protocol as follows: all seven providers were trained in two 45 min didactic education and skills session; incorporation of OH questions into practices EMR; recruited 86 child-parent dyads (95% participation) at the WCV; providers delivered the OH intervention to parent/caregivers in <2 min and 90% completed EMR documentation of OH questions. These findings were instrumental in finalizing the main PACT trial in 18 practices. The RE-AIM framework is used in the main trial to collect effectiveness and implementation measures at baseline and follow-up visits. Conclusions: The formative and pilot findings were instrumental in refining the OH intervention and protocol which has resulted in successful implementation of the main trial. Trial Registration: Clinical trials.gov, Registered 9 November 2017, NCT03385629.

Dental Caries in Medicaid-Insured Preschool Children With or Without Special Health Care Needs in Northeast Ohio

“…This cross-sectional study used baseline data from the Pediatric Providers Against Cavities in Children’s Teeth study, a pragmatic parallel-group cluster randomized clinical trial that aimed to assess the effectiveness of a multilevel intervention bundle to increase use of dental care among children ages 3 through 6 years enrolled in Medicaid ( NCT03385629 ). 20 The institutional review board of University Hospitals Cleveland Medical Center approved the study protocol. Written consent in English was obtained from clinicians and parents or caregivers.…”

Recruitment strategies for a pragmatic cluster randomized oral health trial in pediatric primary care settings

“…Participants are being followed for 24 months or completion of three well-child visits. This clinical trial utilizes the RE-AIM framework for evaluation and has been published previously [ 33 ]. The study sites are 18 primary care practices located in NE Ohio.…”

“…Several pragmatic trials addressing physical activity, obesity, blood pressure and weight loss in primary care have employed the RE-AIM framework to report on implementation and adoption [ [29] , [30] , [31] , [32] ]. In this oral health pragmatic trial in primary care settings we are also using the RE-AIM framework to evaluate the implementation of multi-level interventions for widespread application in these settings [ 33 ].…”

Caries disparities among Medicaid‐enrolled young children from pediatric primary care settings

“…The present study utilized cross-sectional baseline data from a larger pragmatic, parallel two-arm, cluster randomized clinical trial to assess the effectiveness of multilevel interventions at the practice-(EMR incorporation of oral health questions) and provider-level (theory based education and skills training to deliver oral health facts) versus enhanced usual care (American Association of Pediatrics based education for providers) to increase dental utilization among 3-6 -year-old Medicaid-enrolled children. 21 The study sites included 18 pediatric primary care practices in Northeast Ohio. Pediatric primary care providers and parent/caregiver-child dyads from these practices were recruited over a 21-month period, from November 2017 to August 2019.…”