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Trial record 7 of 51 for:    tooth decay | NIH

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
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Suchitra Nelson, Case Western Reserve University

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Child:

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


Information from the National Library of Medicine

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


Contacts
Contact: Suchitra Nelson, PhD 216-368-3469 sxn15@case.edu

Locations
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Suchitra Nelson, PhD    216-368-3469    sxn15@case.edu   
Sponsors and Collaborators
Case Western Reserve University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Suchitra Nelson, PhD Case Western Reserve University

Responsible Party: Suchitra Nelson, Professor and Assistant Dean for Clinical and Translational Research, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03385629     History of Changes
Other Study ID Numbers: 08-15-37
UH3DE025487-03 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suchitra Nelson, Case Western Reserve University:
Dental Care
Dental Caries
Common Sense Model of Self-Regulation

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases