Multi-Level Interventions to Reduce Caries Disparities in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,108
- 试验地点
- 2
- 主要终点
- Dental Attendance
研究概览
简要总结
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.
详细描述
Study Design:
This study will utilize a cluster randomized clinical trial design (Phase III) in primary care settings. Eighteen practices will be randomized to 2 arms: A) provider-level CSM theory-based didactic and skills training to deliver oral health facts to parents, a prescription and a list of dentists accepting Medicaid + practice-level EMR changes for documenting oral health; B) AAP based didactic training with no provision of resources or changes to the practice EMR. Arm A parents/caregivers will receive oral health facts and prescription to take their child to the dentist and improve oral health behaviors in the home, while Arm B parent/caregivers will receive usual AAP-based care for oral health. Each arm will consist of 9 practices (n= 18), 33 to 34 providers (n= 67), and 512 parent/caregiver and child dyads (n= 1024). Each parent/caregiver and child dyads will be recruited at the first WCV and then followed for two consecutive WCVs (for a 24 month duration). Each provider will complete training prior to enrolling any parent/caregiver and will participate in the study for a total of 24 months duration. Immediately after randomization of practices, recruitment will be rolled-out, i.e. parent/caregivers will be recruited during a 3-month period in 6 practices at a time, with recruitment at all 18 practices expected to be completed in 9 months.
The primary outcome is receipt of dental care assessed through data abstracted from Medicaid claims files, clinical dental screenings and parent/caregiver Dental Attendance Questionnaire responses. The secondary outcomes are development of new caries, changes in oral health behaviors and oral health quality of life, dental care costs, and implementation of the interventions.
Participants:
Subjects will be pediatric providers (Pediatricians/Nurse Practitioners) and parent/caregivers and their 3-6 year old Medicaid-enrolled children from 18 primary care practices located in 6 counties in NE Ohio. The study is offered to all pediatricians/nurse practitioners in the recruited practices and will be offered to all eligible caregivers and their children excluding those with serious medical or behavioral conditions which would preclude them from participating in the dental screening. All provider and parent participants meeting the eligibility criteria will be enrolled in the study upon signing the consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Use Electronic Medical Record (EMR)
- •Have ≥ 20% of pediatric patients covered by Medicaid
- •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
- •Ages 3-6 years
- •Enrolled in Medicaid
排除标准
- •● Presence of any serious medical or behavioral condition (e.g. cerebral palsy, autism) that precludes participation in the dental screening
结局指标
主要结局
Dental Attendance
时间窗: Data will be abstracted from Clinical Exams and Medicaid Claims data at baseline and the exit visit at the 24 month follow-up visit.
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.
次要结局
- 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))
研究者
Suchitra Nelson
Professor and Assistant Dean for Clinical and Translational Research
Case Western Reserve University