Providers Against Cavities in Children's Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

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.
    

Detailed description: 
      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.

      Procedures:

      WCV #1 (Baseline): Before WCV #1, Providers (pediatrician/nurse practitioners) will receive
      oral health didactic education and skills training (based on study arm) to communicate core
      OH facts to parents/caregivers. They will complete pre- and post-tests before and after the
      OH didactic education session. During the well-child visit, caregivers will complete the
      following self-administered Baseline questionnaires: Illness Perception Questionnaire-Revised
      for Dental (IPQ-RD) and Parent Questionnaire. A dental hygienist will perform the child
      dental screening examination and study staff will record results on the ICDAS Form. During
      the WCV, the provider will deliver oral health facts, give a prescription to take the child
      to the dentist + list of local Medicaid-accepting dentists, and document oral health in EMR,
      based on study arm. Following the provider encounter, caregivers will provide feedback about
      the OH information given to them during the visit with a short self-administered Exit
      Questionnaire. At the end of the WCV, caregivers will be given the Follow-up IPQ-RD to be
      completed and returned within 2 weeks (in postage paid envelope). At six months, caregivers
      will report whether the child visited the dentist and also complete an annotated cost
      questionnaire.

      WCV #2 (12 month follow-up): Before WCV #2 Providers will receive an OH didactic education
      booster session.

      During and after the well child visit, providers and parent/child dyads will complete the
      same assessments and procedures done in WCV #1.

      WCV #3 (24 month follow-up): There is no provider education booster session before WCV #3.

      During the well child visit, providers and parent/child dyads will complete the same
      assessments and procedures done in WCV #1 and #2, except the IPQ-RD follow-up questionnaire.
      The 6 month assessments will not be completed during the third well child visit.

      Analysis Plan:

      Primary Statistical Analysis: For the primary outcome, the investigators will use as an
      overall dental attendance score the number of years (over the 24 months of follow-up) in
      which the child visited the dentist. This will be an ordinal outcome with possible scores of
      0, 1 or 2. To assess the intervention effect, the investigators will use a generalized
      estimating equations (GEE) approach, with practices as clusters, based on a proportional odds
      marginal model. The model covariates will include an intervention indicator variable (equal
      to 1 for bundled intervention, 0 for enhanced usual care) and a set of baseline variables
      representing potential confounders. A standard error correction (for example, the method by
      Morel et al. 2003) will be used to adjust for a small number of clusters and 95% confidence
      intervals will be computed. This will be an intent-to treat analysis as all randomized
      participants providing the necessary measurements - regardless of any lack of compliance -
      will be included in the analysis.

      In the event of missing data (for either year) for dental attendance, the investigators will
      conduct sensitivity analyses by imputing responses under conservative assumptions (favoring
      the null hypothesis) and re-running the analysis described above on the completed data.

      Analysis of Secondary Outcomes: Summary statistics (including means and standard errors) for
      secondary outcomes will be calculated by intervention group. The same approach as above will
      be used for binary or ordinal secondary outcomes (oral hygiene, frequency of sweet snacks and
      beverages). Namely, ordinal outcomes for each variable will be defined that summarize
      outcomes over time. For continuous outcomes (e.g., OH quality of life, cost), the above
      method will be modified by using a linear model (identify link) for GEE, modeling the mean
      response over time as a summary measure. These outcomes will each be tested for normality
      using the Shapiro-Wilk statistic; outcomes for which normality is violated will be
      transformed where appropriate or an alternative model used. For count outcomes (e.g., dft
      accumulated over time), the investigators will use a loglinear model (log link) assuming a
      negative binomial or other appropriate (e.g., zero-inflated negative binomial) distribution.
      For proportion outcomes (e.g., dt/dft), the investigators will use GEE with a logit link,
      assuming the proportion follows a beta binomial or zero-inflated beta binomial distribution.
      Similarly, the investigators will fit appropriate GEE models to test for the effect of each
      implementation strategy on the corresponding outcome (e.g., % prescriptions given as a
      measure of adoption). As in the dental attendance analysis, the intervention indicator as
      well as pertinent baseline variables will be included in the model. In addition, interaction
      terms (baseline variables by intervention) will be included to test for possible effect
      modification.

      For secondary analyses, a GLIMMIX model approach will be considered as an alternative, which
      may more easily allow for more than one cluster level if needed. Another alternative approach
      is to model the repeated measurements (again using GEE or GLIMMIX) which will add an
      additional cluster level - namely, for individuals). Goodness of fit of alternative models
      will be compared using QIC for GEE (or AIC for GLIMMIX).

      Missing Data: In the likely event of missing responses, the investigators will first assess
      (In the context of repeated measures analyses) whether the data are missing completely at
      random (MCAR), that is, whether missingness of the given outcome is dependent only on
      participant baseline characteristics and not further on the observed outcome at an earlier
      time. This will be done by modeling missing data indicators for the repeated measurements of
      each outcome using a GEE (or GLIMMIX) approach with a logit link and including appropriate
      baseline (control) variables and the outcome at the previous time if available. The MCAR null
      hypothesis will be rejected if the previous outcome has a statistically significant effect on
      the probability of missing. A nonsignificant effect would support the use of GEE (which
      assumes MCAR). In addition to assessing the overall effects of the interventions, the
      investigators will investigate the mechanisms (or paths) through which interventions impact
      dental attendance.

      Data Management:

      The study staff will collaborate and interact with the NIH-appointed Coordinating Center (CC)
      to perform data management and quality control activities. Study data will be collected and
      stored using the REDCap platform hosted by University of California-San Francisco, the home
      institution of the CC. REDCap is a secure, web-based application designed to support remote
      data capture for research studies.

      Study forms will be completed by participants on paper, and subsequently entered into REDCap
      by study staff, or on a tablet directly into REDCap. Paper forms will be securely stored in a
      locked file cabinet. Recorded audio will be deleted from the digital recording device
      immediately after being stored on a secure CWRU School of Dental Medicine network drive.

      Data for this study will include: (1) dental screening data, (2) study questionnaires, (3)
      abstracted medical data, (4) abstracted Medicaid dental claims data, (5) cost data (6) data
      from observation/audiotaping of providers, and (7) EMR audit data. Additionally, audio
      recordings will be used for fidelity monitoring. Form revisions should be minimal; however,
      should they occur, changes will be submitted to the CC for updating and dissemination to
      study staff.

      Quality control is primarily conducted at the study team level through internal processes of
      data review/data monitoring using periodic custom reports generated by the CC. The CC will
      assist with the design of project-specific custom reports. The CC will run regular validation
      reports to detect data anomalies and will work with the local project staff to resolve any
      data anomalies that arise during data entry. REDCap's native data resolution workflow will be
      used to document and fix any data anomalies. The Data Manager will also respond to data
      queries generated by the PI, Study Coordinator, or other study staff.

      The CC will generate regular reports showing enrollment and potential data anomalies, which
      will be sent to PIs, Project Coordinators, and other relevant study staff.
    

Intervention name(s): CSM theory-based didactic education and skills training; AAP-based didactic education; Practice EMR changes
Intervention type(s): Behavioral; Other; Other
Intervention description(s): 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.; American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Dental Care; Dental Caries; Common Sense Model of Self-Regulation