Providers Against Cavities in Children's Teeth

NCT03385629 | Completed Results DMC

• 2 other identifiers: 08-15-37UH3DE025487-03
• Study Type: interventional
• Target: 2,108
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multi-site, multi-level, and multi-component cluster randomized clinical trial (RCT) to address poor dental utilization (attendance) and untreated caries among 3-6 year old Medicaid-enrolled children attending well-child visits (WCV) in primary care settings. The focus is on addressing factors (determinants) at the socio-ecological levels of the child's environment: provider (pediatrician and nurse practitioner), practice/organization level, and parent/caregiver level. Eighteen practices will be randomized to 2 arms: A) bundled multi-level intervention consisting of: 1. training medical providers in the Common-Sense Model of Self-Regulation theory-based education so that the provider delivers to the parent/caregiver the following: i) Core oral health facts about dental caries, and ii) prescription to visit the dentist and a list of dentists accepting Medicaid; 2. Integration of oral health assessments into EMR for the provider to document in the child's medical record; versus B) Control arm of medical providers receiving the American Academy of Pediatrics (AAP) based oral health education and providing usual AAP-based care for oral health. Each arm will consist of 9 practices. Children will be followed for 24 months to determine dental utilization and changes in oral health status. The primary aim is to examine the effectiveness of theory-based behavioral (provider-level) and implementation (practice-level) bundled 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 1) assess the effectiveness of interventions on secondary outcomes (e.g. development of new caries, changes in oral hygiene, oral health quality of life, frequency of sweet snacks and beverages, cost), 2) assess potential mediators and moderators to investigate the pathways through which the multi-level interventions affect child primary and secondary outcomes, and 3) assess the adoption, reach, fidelity, and maintenance of providers and practices that affect child primary and secondary outcomes. The hypothesis is that theory-based behavioral (provider-level) and implementation (practice-level) bundled interventions delivered by providers at WCVs will increase dental attendance among 3-6 year old Medicaid-enrolled children versus enhanced usual care (AAP based oral health education) delivered by providers at WCVs.

Conditions

Dental Caries

Keywords

Dental Care; Dental Caries; Common Sense Model of Self-Regulation

Outcome Measures

Primary Outcomes (1)

• Dental Attendance

  Receipt of any dental care (preventive and/or restorative) at approximately 24 months from baseline to the exit visit. Any dental care was defined as yes or no visit.

  Data will be abstracted from Clinical Exams and Medicaid Claims data at baseline and the exit visit at the 24 month follow-up visit.

Secondary Outcomes (4)

• Change in Primary Decayed and Filled Teeth

  Dental exams will assess change in dft between baseline well-child visit (WCV#1) and 24 month follow-up exit visit (well-child visit: WCV#3)

• Change in Oral Hygiene-brushing

  Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3)

• Change in Diet

  Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit:WCV#3)

• Change in Oral Health-related Quality of Life for Child

  Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3)

Study Arms (2)

CSM theory-based Arm

EXPERIMENTAL

CSM theory-based didactic education and skills training Practice EMR changes

Behavioral: CSM theory-based didactic education and skills training; Other: Practice EMR changes

AAP-based Arm

ACTIVE COMPARATOR

AAP-based didactic education

Other: AAP-based didactic education

Interventions

CSM theory-based didactic education and skills training BEHAVIORAL

Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR.

CSM theory-based Arm

AAP-based didactic education OTHER

American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.

AAP-based Arm

Practice EMR changes OTHER

Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.

CSM theory-based Arm

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Practices:
• Use Electronic Medical Record (EMR)
• Have ≥ 20% of pediatric patients covered by Medicaid
• Providers:
• Pediatrician or Nurse Practitioner with a minimum of 2 patient-care days per week
• Provide signed and dated consent form
• Parents or caregivers:
• Legal guardianship of Medicaid-enrolled children aged 3-6 years attending well-child visit (WCV)
• Must be ≥ 18 years
• Speak English or Spanish
• Provide signed and dated consent form
• Planning to stay in the immediate area (both parent/caregiver and child) for at least two years
• Child:
• Ages 3-6 years
• Enrolled in Medicaid

You may not qualify if:

• Child:
• ● Presence of any serious medical or behavioral condition (e.g. cerebral palsy, autism) that precludes participation in the dental screening

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Nelson S, Albert JM, Selvaraj D, Curtan S, Momotaz H, Bales G, Ronis S, Koroukian S, Rose J. Multilevel Interventions and Dental Attendance in Pediatric Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2418217. doi: 10.1001/jamanetworkopen.2024.18217.

  PMID: 38980678 DERIVED

• 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. Dent J (Basel). 2020 Sep 1;8(3):101. doi: 10.3390/dj8030101.

  PMID: 32882958 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Limitations and Caveats

As with any longitudinal studies there was follow-up losses at WCV2 and WCV3. But in the sample size calculation we accounted for 25% follow-up losses.

Results Point of Contact

• Title: Dr. Suchitra Nelson
• Organization: Case Western Reserve University

suchitra.nelson@case.edu

216-368-3469

Study Officials

• Suchitra Nelson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Assistant Dean for Clinical and Translational Research

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: December 28, 2017
• Study Start: November 15, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)