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NCT03385629 · ClinicalTrials.gov registry record · NA
Providers Against Cavities in Children's Teeth
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 2,108
- Enrollment target
NCT03385629 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 2,108 participants.
The verdict
NCT03385629, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,108 participants
- Enrollment target
Study 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 pr
Interventions
- BEHAVIORAL CSM theory-based didactic education and skills training
- OTHER AAP-based didactic education
- OTHER Practice EMR changes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,108 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03385629
The ClinicalTrials.gov registry entry for NCT03385629 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which CSM theory-based didactic education and skills training is the first listed.
NCT03385629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03385629 about?
NCT03385629 is a clinical study titled "Providers Against Cavities in Children's Teeth". 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 addressin...
What is the current status of trial NCT03385629?
This trial is currently completed. It is a NA study. The enrollment target is 2,108 participants. The study started on 2017-11-15. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03385629?
The interventions under investigation include: CSM theory-based didactic education and skills training (BEHAVIORAL), AAP-based didactic education (OTHER), Practice EMR changes (OTHER).
Who is sponsoring clinical trial NCT03385629?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
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