Providers Against Cavities in Children's Teeth (PACT)
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|ClinicalTrials.gov Identifier: NCT03385629|
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : December 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Behavioral: CSM theory-based didactic education and skills training Other: AAP-based didactic education Other: Practice EMR changes||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Multi-Level Interventions to Reduce Caries Disparities in Primary Care Settings|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: CSM theory-based Arm
CSM theory-based didactic education and skills training Practice EMR changes
Behavioral: CSM theory-based didactic education and skills training
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.
Other: Practice EMR changes
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.
Active Comparator: AAP-based Arm
AAP-based didactic education
Other: AAP-based didactic education
American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
- Dental Attendance [ Time Frame: Data will be abstracted from Medicaid Claims data at the 24 month follow-up visit (i.e. exit visit at well-child visit: WCV #3) ]Receipt of dental care as number of visits through Medicaid Claims data (Current Dental Terminology (CDT) codes for preventive or restorative procedures in the past 12 months).
- Change in primary and permanent decayed and filled teeth [ Time Frame: Dental exams will assess change in dft/DFT between baseline well-child visit (WCV#1) and 24 month follow-up exit visit (well-child visit: WCV#3) ]dft/DFT: number of new cavitated lesions or restorations on primary and permanent teeth that were previously sound and number of new restorations on teeth that were previously decayed at the baseline WCV)
- Change in oral hygiene [ Time Frame: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3) ]Frequency of tooth brushing
- Change in diet [ Time Frame: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit:WCV#3) ]Frequency of intake of sweet food and drinks
- Change in oral health-related quality of life [ Time Frame: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3) ]Change in numeric score on ECOHIS questionnaire
- Direct and indirect dental costs [ Time Frame: Assessed at 24 month follow-up exit visit (well-child visit: WCV#3) ]Caregiver reported costs associated with taking their child to the dentist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385629
|Contact: Suchitra Nelson, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Suchitra Nelson, PhD 216-368-3469 email@example.com|
|Principal Investigator:||Suchitra Nelson, PhD||Case Western Reserve University|