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Article

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

1
Department of Community Dentistry, Case Western Reserve University School of Dental Medicine, Cleveland, OH 44106-4905, USA
2
Department of Sociology, California State University Northridge, Northridge, CA 91330, USA
3
University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA
*
Author to whom correspondence should be addressed.
Dent. J. 2020, 8(3), 101; https://doi.org/10.3390/dj8030101
Received: 30 June 2020 / Revised: 5 August 2020 / Accepted: 28 August 2020 / Published: 1 September 2020
(This article belongs to the Special Issue Study of Relationship between Oral Health and Systemic Health)
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. View Full-Text
Keywords: oral health; pediatric; qualitative research; pilot study; implementation oral health; pediatric; qualitative research; pilot study; implementation
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MDPI and ACS Style

Nelson, S.; Slusar, M.B.; Curtan, S.; Selvaraj, D.; Hertz, A. Formative and Pilot Study for an Effectiveness-Implementation Hybrid Cluster Randomized Trial to Incorporate Oral Health Activities into Pediatric Well-Child Visits. Dent. J. 2020, 8, 101. https://doi.org/10.3390/dj8030101

AMA Style

Nelson S, Slusar MB, Curtan S, Selvaraj D, Hertz A. Formative and Pilot Study for an Effectiveness-Implementation Hybrid Cluster Randomized Trial to Incorporate Oral Health Activities into Pediatric Well-Child Visits. Dentistry Journal. 2020; 8(3):101. https://doi.org/10.3390/dj8030101

Chicago/Turabian Style

Nelson, Suchitra, Mary B. Slusar, Shelley Curtan, David Selvaraj, and Andrew Hertz. 2020. "Formative and Pilot Study for an Effectiveness-Implementation Hybrid Cluster Randomized Trial to Incorporate Oral Health Activities into Pediatric Well-Child Visits" Dentistry Journal 8, no. 3: 101. https://doi.org/10.3390/dj8030101

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