Multi-Level Interventions to Reduce Caries Disparities in Primary Care Settings
Phase: NA
Conditions: Dental Caries
Sponsor: Case Western Reserve University

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Multi-Level Interventions to Reduce Caries 
Disparities in Primary Care Settings (Project PACT) 
NIDCR Protocol Number: 17-082-E 
NIDCR Grant Number: UH3DE025487 
Principal Investigator: Dr. Suchitra Nelson 
Trial Registration: clinicaltrials.gov (NCT03385629) 
Draft or Version Number:  9.0 
4 April 2022 
 
CONFIDENTIAL No part of it may be transmitted, reproduced, published, 
or used without prior written authorization from the Principal Investigator. 
 

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TABLE OF CONTENTS 
PAGE 
TABLE OF CONTENTS 
2 
2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
12 
2.1 Background Information 
12 
2.2 Rationale 
14 
2.3 Potential Risks and Benefits 
15 
2.3.1 Potential Risks 
15 
2.3.2 Potential Benefits 
16 
3 OBJECTIVES 
16 
3.1 Study Objectives 
16 
3.2 Study Outcome Measures 
16 
3.2.1 Primary Outcome Measures 
17 
3.2.2 Secondary Outcome Measures 
17 
3.2.3  Mediators, Moderators, Confounders, & Implementation Measures 
17 
4 STUDY DESIGN 
18 
4.1 Study participants 
18 
4.2 Model and Design 
19 
5 STUDY ENROLLMENT AND WITHDRAWAL 
23 
5.1 Subject Inclusion Criteria 
23 
5.2 Subject Exclusion Criteria 
23 
5.3 Strategies for Recruitment and Retention 
23 
5.4 Treatment Assignment Procedures 
25 
5.4.1 Randomization Procedures 
25 
5.4.2 Masking Procedures 
26 
5.5   Subject Withdrawal 
26 

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5.5.1 Reasons for Withdrawal 
26 
5.5.2 Handling of Subject Withdrawals or Subject Discontinuation of Study Intervention34 
26 
5.6 Premature Termination or Suspension of Study 
27 
6 STUDY INTERVENTION 
28 
6.1 Study Behavioral or Social Intervention(s) Description 
28 
6.2 Administration of Intervention 
29 
6.3 Procedures for Training Interventionists and Monitoring Intervention Fidelity 
30 
6.3.1 Procedures for Training Interventionists 
31 
6.3.2 Procedures for Monitoring Intervention Fidelity 
31 
6.4 Assessment of Provider Compliance with Study Intervention 
32 
7 STUDY SCHEDULE 
33 
7. 1 Provider 
33 
7.1.1 Baseline Visit: WCV #1 
33 
Before WCV #1 (T-1: Day -30 to -1) 
33 
At WCV #1 (T0: Day 0) 
33 
7.1.2 Follow-up Visit: WCV #2 
33 
Before WCV #2 (T2: Day 364 ± 90) 
33 
At WCV #2 (T3: Day 365 ± 90) 
33 
7.1.3 Final Visit: WCV #3 
33 
At WCV #3 (T6: Day 730 ± 90) 
33 
7.1.4 Provider Withdrawal Visit 
34 
7.2  Parent/Caregiver and Child 
34 
7.2.1 Baseline Visit: WCV #1 
34 
At WCV #1 (T0:  Day 0) 
34 
Before Provider Encounter 
34 
During Provider Encounter in the Exam Room 
35 
After Provider Encounter in the Exam Room/Waiting Area 
35 
After WCV #1 (T1) 
35 
7.2.2 Follow-up Visit: WCV #2 
36 

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At WCV #2 (T3: Day 365 ± 90) 
36 
Before Provider Encounter in the Exam Room 
36 
During Provider Encounter in the Exam Room 
36 
After Provider Encounter in the Exam Room/Waiting Area 
36 
After WCV #2 (T4): 
36 
7.2.3 Final Visit: WCV #3 
37 
At WCV #3 (T6: Day 730 ± 90) 
37 
Before Provider Encounter in the Exam Room 
37 
During Provider Encounter in the Exam Room 
37 
After Provider Encounter in the Exam Room/Waiting Area 
37 
7.2.4 Parent/Caregiver and Child Withdrawal Visit 
37 
7.2.5 Parent/Caregiver and Child Unscheduled Visit 
38 
8 STUDY PROCEDURES / EVALUATIONS 
38 
8.1 Study Procedures/Evaluations 
38 
8.1.1 Child-level 
40 
8.1.2 Parent/caregiver 
42 
8.1.3 Provider 
42 
8.1.4 Practice 
43 
9 ASSESSMENT OF SAFETY 
43 
9.1 Specification of Safety Parameters 
43 
9.1.1 Unanticipated Problems 
43 
9.1.2 Adverse Events 
44 
9.1.3 Serious Adverse Events 
44 
9.2 Time Period and Frequency for Event Assessment and Follow-Up 
44 
9.3 Characteristics of an Adverse Event 
44 
9.3.1 Relationship to Study Intervention 
44 
9.3.2 Expectedness of SAEs 
45 
9.3.3 Severity of Event 
45 
9.4 Reporting Procedures 
45 

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9.4.1 Unanticipated Problem Reporting to IRB and NIDCR 
45 
9.4.2 Serious Adverse Event Reporting to NIDCR 
48 
10 STUDY OVERSIGHT 
48 
11 CLINICAL SITE MONITORING 
50 
12 STATISTICAL CONSIDERATIONS 
51 
12.1 Study Hypotheses 
51 
12.2 Sample Size Considerations 
51 
12.4 Final Analysis Plan 
52 
13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
55 
14 QUALITY CONTROL AND QUALITY ASSURANCE 
57 
14.1 Definitions 
57 
14.2 Study Intervention and Study Questionnaires 
57 
14.2.1 Quality Assurance Procedures 
57 
14.2.2 Quality Control Procedures 
58 
15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
60 
15.1 Ethical Standard 
60 
15.2 Institutional Review Board 
60 
15.3 Informed Consent Process 
60 
15.4 Subject Confidentiality 
60 
16 DATA HANDLING AND RECORD KEEPING 
62 
16.1 Data Management Responsibilities 
62 
16.2 Data Capture Methods 
62 
16.3 Types of Data 
62 
16.4 Schedule and Content of Reports 71 
63 
16.5 Study Records Retention 
64 
 
16.6 
Protocol Deviations 
72 

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17 PUBLICATION/DATA SHARING POLICY 
75 
18 LITERATURE REFERENCES 76 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
AAP 
American Academy of Pediatrics 
AAPD 
The American Academy of Pediatric Dentistry 
CC 
Coordinating Center 
CME 
Continuing Medical Education 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CSM 
The Common-Sense Model of Self-Regulation 
CTSC 
Clinical and Translational Science Collaborative 
DMFT 
Decayed, Missing, Filled Teeth 
EDC 
Electronic Data Capture 
EMR 
Electronic Medical Record 
FWA 
Federal wide Assurance 
GAO 
U.S. Government Accountability Office 
GCP 
Good Clinical Practice 
HHS 
The U.S. Department of Health and Human Services 
ICH 
International Conference on Harmonisation 
IPQ-RD 
The Illness Perception Questionnaire – Revised for Dental 
IRB 
Institutional Review Board 
MOC 
Maintenance of Certification 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIDCR 
National Institute of Dental and Craniofacial Research 
NIH 
National Institutes of Health 
OH 
Oral Health 
OHRP 
Office for Human Research Protections 
PACT 
Protecting All Children’s Teeth 
PI 
Principal Investigator 
POHS 
Preventive Oral Health Services 
PTF 
Practice-Tailored Facilitation 

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QA 
Quality Assurance 
QC 
Quality Control 
QI 
Quality Improvement 
RCC 
Rainbow Care Connection 
RCT 
Randomized Clinical Trial 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SCT 
Social Cognitive Theory 
UHCMC 
University Hospitals Cleveland Medical Center 
UP 
Unanticipated Problem 
USPSTF 
US Preventive Services Task Force 
WCV 
Well-Child Visit 
 

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PROTOCOL SUMMARY 
Title: 
Multi-Level Interventions to Reduce Caries Disparities in Primary  
Care Settings 
Précis: 
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 
Medicaidenrolled 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 or the 
completion of 3 consecutive WCV’s to determine dental utilization 
and changes in oral health status.  
Objectives: 
Primary:   
To examine the effectiveness of theory-based behavioral 
(providerlevel) 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. 
Secondary:   
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. 
3) Assess the adoption, reach, fidelity, and maintenance of providers 
and practices that affect child primary and secondary outcomes. 

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Population: 
Study participants: Pediatricians/Nurse Practitioners (n = 67) and 
child and parent/caregiver dyads (n = 1024) will be recruited from 18 
primary care practices with ≥ 20% Medicaid eligible children. 
Practices are selected from Rainbow Care Connection (RCC), a 
pediatric Medicaid accountable care organization that is part of the 
Rainbow Research Network (Clinical and Translational Science 
Collaborative [CTSC] supported practice-based pediatric research 
network), University Hospitals Cleveland Medical Center. The 
recruited practices have 60 pediatricians and 7 nurse practitioners 
who are 73% female and 27% male. We expect child and 
parent/caregiver demographics to be similar to Census and Medicaid 
data from northeast Ohio where Medicaid-enrolled children are 61% 
African American, 32% Caucasian, 5% Hispanic, and 2% other. 
Phase: 
Phase III 
Number of Sites: 
18 primary care practice sites  
Description of  
Intervention: 
The bundled intervention will impact providers, the practice and the 
parent/caregiver. The Common-Sense Model of Self-Regulation 
(CSM)-based education and skills training for the pediatrician or 
nurse practitioner are designed to educate them regarding chronicity 
of caries and teach them how to communicate core oral health facts 
to the parent/caregiver, provide a prescription to take the child to the 
dentist together with a list of area dentists who accept Medicaid, and 
document oral health in the EMR.  The parent/caregiver will receive 
the CSM-based facts from the providers and should take their child 
to the dentist and improve oral health behaviors in the home. The 
practice level intervention will be enhancements to the EMR system 
to include oral health status for quality improvement of records and 
to use for follow-up with the parent/caregiver at subsequent wellchild 
visits. 
Study Duration: 
Approximately 36 months  
Subject Participation 
Duration: 
Parent/Caregiver = 24 months or completion of 3 WCV’s 
Providers = 24 months or completion of 3 consecutive WCV’s of 
enrolled patients. Additionally, all providers will complete a follow-up 
structured interview and debriefing session. 
Estimated Time to  
Complete  
Enrollment: 
9 months 
Schematic of Study Design:   

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2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
Dental caries (tooth decay) is the leading chronic childhood disease (HHS, 2000). Its prevalence 
in the primary dentition among 2-8 year old children increased from 35% (1988-1994) to 37% 
(2011- 2012) and failed to meet Healthy People objectives (Dye et al., 2009). Although caries 
experience and untreated caries among 2-8 year old children have decreased nationally, poor 
and minority children still have a higher burden of disease compared to their affluent 
counterparts (Dye et al., 2017). In Cleveland, our community-wide study indicated an untreated 
primary caries rate of 42% (Nelson et al., 2012), much higher than the national average of 14% 
(Dye et al., 2015). Medicaid claims data from 2007 and 2008 indicates that median dental 
utilization among Medicaid-enrolled children was only 33-37% (Hakim et al., 2012; United 
States General Accounting Office, 2008). Recent self-reported surveys indicate that 50.6% of 
Medicaid-enrolled children compared to 69.0% of non-Medicaid enrolled children visited the 
dentist in the last six months (Yarbrough et al., 2014). For 13% of Medicaid-enrolled young 
children, their first dental visit was for emergency care (Divaris et al., 2014). There is clearly a 
dental care gap among 3-5 year-old Medicaid-enrolled children with 39% having had a dental 
visit (Hakim et al., 2012), despite anticipatory guidance for preventive dental visits starting from 
age 1 (AAPD, 2014), while 67% (3-6 year olds) received a well-child visit (USPHS, 2015). 
Due to the disparate burden of caries among young children (Dye et al., 2010), primary care 
pediatric settings have been recommended to provide preventive oral care including referral to a 
dentist. But, a recent systematic review by the U.S. Preventive Services Task Force (USPSTF) 
to update its recommendation for medical primary care clinicians concluded that there is lack of 
evidence on effectiveness of parent/caregiver educational interventions and primary care 
referral to dentists (Chou et al., 2014).  
The few retrospective cohort studies that have examined the effectiveness of non-dental primary 
care providers delivering preventive oral health services (POHS: such as screening exams, 
dentist referral, fluoride varnish) to young Medicaid-enrolled children have resulted in lower 
decayed missing filled teeth (dmft) in kindergarteners who received POHS compared to those 
who did not (Kranz et al., 2015). The number of dmft at age 5 was similar regardless of the type 
of provider (primary care vs. dentist) delivering POHS (Kranz, Rozier et al., 2014). Distance 
from physician-based POHS did not impact the likelihood of the child having a medical visit, 
while distance from a dental practice lowered dental utilization (Kranz, Lee et al., 2014).  
One  recent study found that caries-related expenditures (using Medicaid claims data from 
Alabama) among children <6 years were significantly higher for those receiving dentistdelivered 
early preventive care versus those not receiving early care, while there was no difference 
between receiving early preventive care from a primary care provider versus not (Blackburn et 
al., 2017). But, Milgrom and Cunha-Cruz (2017) in a letter to the editor regarding Blackburn et 
al.’s study, point out that there are several methodological limitations and that the efficacy of 
fluoride varnish is dependent on being delivered according to a periodic schedule that can be 
affected by missed well-child visits which may have impacted their study conclusions. Thus, our 
proposed randomized clinical trial has the potential to address the limitations of prior 
retrospective studies in terms of testing behavioral interventions in pragmatic settings with 

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careful control for confounders and longitudinal follow-up of children with clinical and claims 
data. The interventions being tested also offer the opportunity to lower untreated decay and 
increase dental utilization in 3-6 year-old Medicaid-enrolled children, two outcomes which were 
not able to be achieved in prior retrospective studies (Kranz, Rozier, et al., 2014; Kranz, Lee, et 
al., 2014; Kranz et al., 2015). Additionally, in dental settings the effectiveness of interventions 
with oral health (OH) education or motivational interviewing have been inconclusive and these 
interventions have had limited success in eliminating or reducing caries disparities in young 
children (Beauchamp et al., 2008; Casamassimo et al., 2014; Griffin et al., 2008; Kay & Locker, 
1996; Lee & Divaris, 2014; P. Milgrom et al., 2009; Sgan-Cohen et al., 2013). 
The literature is clear that most low-income parent/caregivers see dental diseases as acute to 
be responded to only when there is pain or visible decay (Hooley et al., 2012). One approach 
shown to be useful in changing this reasoning process and for self-management of chronic 
medical conditions is the Common-Sense Model of Self-Regulation (CSM) (Leventhal et al., 
1997; Leventhal et al., 2003). The CSM is a psychological approach where individuals create a 
mental representation (or perception) of their illness based on the abstract and concrete 
sources of information available to them. Six key domains guide the cognitive illness 
representation: identity, cause, consequence, timeline, cure or controllability, and illness 
coherence. The CSM being a “parallel-processing” model requires an emotional domain since 
individuals use past illness experience, cognitive, and emotional representation to self-manage 
their illness (Moss-Morris et al., 2002). In this manner the CSM is unique from other social 
cognitive and health behavior theories (Edgar & Skinner, 2003). A negative or positive illness 
perception is formed from three sources of information (Hagger & Orbell, 2003): cultural 
knowledge of illness; information from external environment such as doctor/dentist or parent; 
and illness threat from past and current experiences with the disease. Based on the CSM, the 
revised illness perception questionnaire (IPQ-R) was developed (Moss-Morris et al., 2002) and 
adapted for various chronic illnesses with good reliability and validity (Abubakari et al., 2012; 
Brink et al., 2011; Cabassa et al., 2008; Chen et al., 2008; Hurt et al., 2010; Lobban et al.,  
2005). Illness perception has been demonstrated empirically in other medical and psychological 
illnesses to predict health outcomes (Covic et al., 2004; Fowler & Baas, 2006; Giannousi et al., 
2010; Hou et al., 2010), and in development of behavioral interventions to change perception and 
improve health outcomes (Davies et al., 2008; Galli et al., 2010; Mosleh et al., 2014). Recently, 
our research team has shown that caregivers who believed baby teeth do not matter had 
significantly less accurate illness perception of dental caries compared to caregivers who believed 
baby teeth do matter utilizing the  illness perception questionnaire revised for dental (IPQ-RD) 
that the team developed and validated (Nelson et al., 2017). So, CSM-based behavioral 
interventions have the potential to modify caregiver caries perception, and improve dental 
utilization for young children. 
This multi-site, multi-level, and multi-component cluster randomized clinical trial (RCT) will 
assess dental utilization among children following oral health interventions in the primary care 
setting. The intervention mapping framework was used to develop the theory-based multi-level 
interventions at the provider and practice level (Bartholomew & Mullen, 2011). Drawing on 
emerging concepts from the medical literature, the common-sense model of self-regulation 
(CSM) was used as the underlying theory for the provider-level interventions. Traditionally, oral 
health education has provided disjointed factual knowledge at the parent/caregiver level. In this 

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study, providers are first trained in the organized CSM-based education to understand the 
chronicity of caries, and then taught to use the CSM framework to deliver key oral health facts to 
parent/caregivers with the goal of improving their cognitive and emotional representation with a 
chain of reasoning of the caries process. Other supporting theories such as the Social Cognitive 
Theory (SCT) are also used to improve the skills and self-efficacy at the provider level to 
communicate the oral health facts (Bandura, 1991). Providers will develop skills in 5 areas: 1) 
introduce the topic of dental care in routine clinical encounters, 2) strategies to effectively 
provide brief advice, 3) strategies to elicit and address parent/caregiver concerns in a 
nonconfrontational manner, 4) provide a prescription for the child to go to the dentist and a list of 
area Medicaid-accepting dentists, and 5) document oral health encounter in EMR. At a practice 
level, integration of OH documentation in EMR may be influenced by practice attributes and 
champion/s in accordance with Roger’s diffusion of innovation theory (Greenhalgh et al., 2005; 
Rogers, 2003). 
While the focus is on addressing factors at three levels of the child’s environment (practice, 
provider, parent/caregiver, the multilevel experimental study interventions are at the provider 
(behavioral) and practice (implementation) levels. The parent/caregiver will be the recipients of 
the provider- and practice- level study interventions. 
Provider (Pediatrician or Nurse Practitioner): (1) Providers will receive theory-based 
training to improve knowledge and skills using CSM and SCT frameworks; (2) Providers 
will communicate to parent/caregiver the CSM-based oral health facts, and provide 
prescription to go to the dentist + a list of Medicaid accepting dentists. 
Parent/caregiver: Parents/caregivers will receive from the provider, CSM-based oral 
health facts and a prescription + list of Medicaid- accepting dentists to increase the 
child’s dental attendance and improve oral health of the child, including oral hygiene 
behaviors in the home. 
Practice (Pediatric): Practices will integrate documentation of oral health status in the 
EMR for quality improvement and to inform the providers of the child’s oral health status 
and previous CSM-based oral health facts (maintenance of the intervention) .  
2.2 
Rationale 
Ten million U.S. preschool and school-age children have untreated caries and profound 
disparities exist by race, socioeconomic status, and geographic region. Our studies in Cleveland 
have found that school dental screenings have not been effective in stimulating dental 
attendance (Nelson et al., 2012) despite eligibility under the Affordable Care Act and coverage 
through Medicaid. Our pilot study results among 86 three to six year old Medicaid-enrolled 
children indicate that 36% (31 out of 86) had untreated dental caries (cavitation), much higher 
than the national average of 18% (Dye et al. 2017).  
There are three core parent (or caregiver) issues: (1) awareness of importance of caries-free 
primary teeth; (2) understanding dental caries as a chronic disease that can be present even 
without symptomatic tooth pain; (3) navigating resources for dental care access. Thus, an 
accurate perception of dental caries is required for parental self-management strategies to take 

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care of their child’s oral health needs. Also important is that parent/caregivers receive consistent 
OH facts from primary care settings, where young children are most often seen. In one study, 
two to five year old children were 3 times more likely to visit a dentist when advised by a primary 
health care provider, but this study also reported that low-income families were less likely to be 
advised (Beil & Rozier, 2010).  
Interventions that improve dental attendance among disparate populations are likely to reduce 
caries disparities. In this study, parents/caregivers are recipients of the intervention through a 
dissemination channel from providers to parents/caregivers. Parents/caregivers are not the 
direct target of the intervention, but indirectly benefit through the provider. This active 
dissemination strategy builds on evidence that parents/caregivers perceive healthcare providers 
to be trusted resources for health information (Nyhan et al. 2014). By enhancing dental 
knowledge and skills of the pediatric providers through the CSM-based education, interactive 
practice sessions with standardized patients, and training in EMR documentation, we 
hypothesize parents/caregivers will receive this new information along with coping and action 
supports (e.g., prescription to the dentist, list of Medicaid accepting dental providers) from the 
child’s provider. As a result, we hypothesize that providers with improved knowledge regarding 
the chronicity of caries and appropriate skills training will deliver consistent reinforcing oral 
health facts to parents (at annual WCVs) that will result in increased dental utilization for their 
child compared to those providers delivering usual care based on AAP education.  
There are three pathways to dissemination of evidence-based interventions: The first pathway 
which is the most common is the “direct to practice” through the development of an exportable 
package or toolkit distributed through professional or public-health organizations; The second 
pathway involves “policy to practice” through establishment of policies to be followed by 
organizations or communities; The third pathway is systematic “diffusion research” to assess the 
effectiveness of different dissemination methods, and one that is least frequently used. A 
qualitative study among primary care providers indicated that health professionals require a tool 
kit that is demonstrated to be effective, easy to tailor and apply, has a table of contents to 
navigate to the relevant content, infrastructure/organizational support, and availability of support 
from practice facilitators or other experts. Further, tool kits can be an effective knowledge 
transfer strategy. Few theory-based tool kits exist for oral health interventions in primary care, 
therefore to address this gap we will develop a tool kit according to the first pathway utilizing the 
evidence from our cluster randomized clinical trial and the qualitative findings. 
2.3 
Potential Risks and Benefits 
2.3.1 Potential Risks 
Children: Children may experience some discomfort during the screening exam from keeping 
their mouths open for up to two minutes. There is also a chance that confidential information 
can be lost but we will use every precaution to protect the information we collect. 
Parents/Caregivers: Some people are uncomfortable answering questions about themselves for 
research. We will try to make participants feel as comfortable as possible. There is also a 
chance that confidential information can be lost but we will use every precaution to protect the 

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information. The oral health portion will add increased time to the well child visit that may impact 
parent/caregiver schedule and parking fees (if required to pay for parking). 
Providers: Some people may feel uncomfortable being audiotaped or observed by study staff. 
We will try to make providers feel as comfortable as possible. There is also a chance that 
confidential information can be lost but we will use every precaution to protect the information 
we collect. As a result of participating in this study, there would be additional time added to the 
well-child visit that can potentially lead to some loss of productivity for providers. 
2.3.2 Potential Benefits 
Child participants may benefit by learning how to take care of his/her teeth and/or from their 
parent/caregiver learning about oral health. Parents/caregivers will receive information about 
taking the child to the dentist for preventive visits.  
Providers may benefit from participating in the study by learning about oral health facts, 
integrating an oral health protocol into practice routines, and best practices for communicating 
oral health facts to parents/caregivers. EMR Documentation of oral health will help the providers 
to follow-up with the parent at the next well-child visit and be useful for practice quality 
improvement.   
 
3 
OBJECTIVES 
3.1 
Study Objectives 
Primary Objectives: 
1) To examine the effectiveness of theory-based behavioral (provider-level) and 
implementation (practice-level) bundled interventions versus enhanced usual care 
(based on AAP oral health education) delivered by providers at WCVs in increasing 
dental attendance among 3-6 year old Medicaid-enrolled children. 
Secondary Objectives:  
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. 
3) 
Assess the adoption, reach, fidelity, and maintenance of providers and practices that 
affect child primary and secondary outcomes.  
3.2 
Study Outcome Measures 
Primary and secondary effectiveness outcomes will be assessed at the child level. 

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3.2.1 Primary Outcome Measures 
The primary outcome will be dental attendance (receipt of dental care as yes/no, and number of 
visits). The primary outcome will be determined through a hierarchical process where Medicaid 
dental claims data (Current Dental Terminology (CDT) codes for preventive or restorative 
procedures in the past 12 months) would be the primary measure, followed by assessments 
through clinical dental screenings (restoration or extraction between WCVs #1 and #2, and 
between WCVs #2 and #3), conducted by calibrated examiners (See Section 14.2).  
3.2.2 Secondary Outcome Measures 
Secondary outcomes will be assessed through clinical dental screenings for new primary and 
permanent decayed and filled teeth (dft/DFT: number of new cavitated lesions or restorations on 
teeth that were previously sound and number of new restorations on teeth that were previously 
decayed at the baseline WCV), questionnaire responses for oral hygiene (frequency of tooth 
brushing), diet (frequency of sweet food and drinks), and oral health-related quality of life 
(ECOHIS, numeric score) (Pahel et al., 2007). The direct and indirect dental costs will be 
assessed through various sources (See Table 8.1.2 for more details on cost elements and 
sources).  
3.2.3 Mediators, Moderators, Confounders, & Implementation Measures 
Mediators, moderators, confounders, and implementation measures will be assessed at the 
parent, provider and practice levels. The interventions are likely to influence mediators at the 
practice level (EMR documentation and practice readiness, climate, attitude) and at the provider 
level (oral health knowledge and self-efficacy). Subsequently, providers improved oral health 
knowledge and communication of oral health facts to parent is likely to influence parent-level 
mediators (illness perception and parent self-efficacy to take the child to the dentist). The 
moderators for the relationship between the interventions and the primary/secondary outcomes 
are parental socio-demographics, health literacy and social support and the confounders are 
child medical illness. Provider socio-demographics can also be a moderator to this relationship. 
See Sections 4 (Figure 4.2.1) for more details on mediators, moderators and confounders and 
Table 8.1.1 for implementation measures and for more details regarding how these measures 
will influence the primary and secondary outcomes. 
3.3 Additional Objective with Supplement 
To evaluate the process and outcomes data from the implementation of the cluster randomized 
clinical trial, together with additional provider qualitative data on barriers/enablers (using Roger’s 
Diffusion of Innovation framework) collected during this revision for the development of a toolkit 
for dissemination to stakeholders. 
As part of the supplement, providers will complete a follow-up structured interview and 
debriefing session.  
 

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4 
STUDY DESIGN 
This study will utilize a multi-site, multi-level, and multi-component cluster randomized clinical 
trial design (Phase III) to assess interventions intended 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), parent/caregiver and practice/organization levels. Eighteen practices will 
be randomized to 2 arms for provider training and practice/organization level study intervention 
changes: A) provider-level CSM training, provision of oral health facts to parents, a prescription 
and a list of dentists accepting Medicaid + practice-level EMR changes for documenting oral 
health; B) AAP training with no prescription or list of dentists accepting Medicaid and no 
changes to the 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 or until the subject has completed 
3 well child visits). Each provider will complete the didactic and skills training prior to enrolling 
any parent/caregiver and will participate in the study for a total of 24 months duration (includes 
initial and booster didactic and skills training: 3 months, WCV#1: 3 months, WCV#2: 3 months, 
WCV#3: 3 months). Data will be collected prior to WCVs, at WCVs, and follow-up visits. 
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. This strategy will maximize staff time and 
ensure that EMR integration of OH is complete at practices randomized to Arm A, and that 
providers receive the didactic and skills training prior to their practice’s rollout.  
4.1 
Study participants 
Subjects will be pediatric providers (Pediatricians/Nurse Practitioners) and parent/caregivers 
and their 3-6 year old children from 18 primary care practices located in Ashtabula, Cuyahoga, 
Geauga, Lorain, Medina, and Portage counties in Ohio (see Table 4.1.1 below). One additional 
practice not included in the table, Premier Pediatrics, has also agreed to participate and will be 
included if needed to replace a practice.  The majority of the practices are in Cuyahoga County 
(67%) and the remaining 33% are in surrounding counties in NE Ohio. All practices serve ≥ 20% 
Medicaid eligible children (9 practices with 20-40% and 9 practices with > 40% Medicaid-eligible 
children) and are from the Rainbow Care Connection (RCC). 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.  
Table 4.1.1 Practice Information 

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Practice/Site 
# 
Pediatricians 
# Nurse  
Practitioners 
Medicaid  
Patients 
(age 3-6) 
Medicaid  
Patients 
w/WCV 
(age 3-6) 
%  
Medicaid 
County 
Ashtabula Pediatrics 
1 
2 
592 
448 
63% 
Ashtabula 
Chardon Pediatrics 
4 
1 
387 
267 
34% 
Geauga 
Elyria Pediatric Care 
3 
0 
205 
168 
33% 
Lorain 
Healthy Kids Pediatrics 
1 
1 
121 
95 
31% 
Portage 
Ibrahim Elsheikh, MD 
1 
0 
344 
340 
80% 
Cuyahoga 
Medina Pediatrics 
4 
2 
338 
250 
23% 
Medina 
NEON 
5 
0 
1856 
357 
80% 
Cuyahoga 
Otis Moss 
2 
0 
297 
233 
82% 
Cuyahoga 
Pediatric and Adolescent Health  
Professionals 
3 
0 
157 
118 
22% 
Cuyahoga 
Pediatric Partners of Cleveland 
2 
0 
209 
165 
40% 
Cuyahoga 
Pediatric Services - Parma 
8 
0 
740 
588 
30% 
Cuyahoga 
Pediatricenter – Garfield 
2 
0 
561 
384 
24% 
Cuyahoga 
Rainbow Ambulatory Clinic  
4 
0 
2728 
2361 
86% 
Cuyahoga 
Rainbow Euclid Pediatrics 
1 
0 
246 
186 
68% 
Cuyahoga 
Suburban Pediatrics - Shaker 
7 
0 
408 
335 
23% 
Cuyahoga 
University Premier Pediatricians –  
Euclid 
4 
1 
504 
418 
49% 
Cuyahoga 
UH Westshore Primary Care ** 
4 
0 
424 
185 
45% 
Cuyahoga 
University Pediatrics of Lorain 
4 
0 
653 
523 
61% 
Lorain 
Totals 
60 
7 
10,302 
7,421 
 
 
Practice information data captured 1/1/2016 through 12/31/2016. 
**Data captured 1/1/2017 through 5/31/2017 
4.2 
Model and Design 
Figure 4.2.1 illustrates the pathway through which the behavioral (provider-level) and 
implementation (practice-level) interventions are intended to result in improved receipt of dental 
care. The theory-driven interventions were developed using two frameworks: socio-ecological 
(McLeroy et al., 1988; Sallis and Owen, 2002) and intervention mapping (Bartholomew & 
Mullen, 2011). Thus, on a provider-level, pediatricians’ and nurse practitioners’ communication 
of OH facts + prescription along with list of dentists are intended to change parental caries 
illness perception (from disjointed inaccurate → chronic organized understanding) and are 
intended to change self-efficacy to seek dental care for their child. On a practice level, the 
integration of oral health and systematic documentation in EMR supports uniform data collection 
and enhances continuous quality improvement to facilitate providers’ follow-up with the parent at 
the next WCV.  
Study measures/evaluations (See Table 8.1.1) will utilize the RE-AIM framework (Glasgow et 
al., 2001; Glasgow et al., 1999) similar to a hybrid designed study (Cully et al., 2014). Internal 
validity is assessed by effectiveness and implementation/fidelity; external validity is assessed by 

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reach, adoption, and maintenance (See Figure 4.2.1). Child primary (i.e. dental attendance) and 
secondary (i.e. development of new caries, changes in oral hygiene, frequency of sweetened 
food and drinks, oral health-related quality of life, and dental costs) effectiveness outcomes will 
be mediated by changes in parent’s illness perception and self-efficacy. Other external validity 
outcomes as a result of provider- and practice-level interventions via mediators (provider’s OH 
knowledge and self-efficacy; practice’s leadership completing the organization readiness, 
climate, and attitude questionnaire) will also influence the child outcomes. A literature search on 
the predictors of dental attendance identified moderating variables such as caregivers’ 
sociodemographics (Ismail et al. 2003), health literacy (Vann et al., 2013), social support 
(Duijster et al., 2014;Nelson et al., 2012) and child medical illness as a confounder (Chi et al., 
2011; Chi & Raklios, 2012). Thus, all measures and evaluations collected for this study will 
follow the conceptual model. 
For the purposes of dissemination of cRCT study results and the intervention components to all 
stakeholders, the study will utilize Roger’s Diffusion of Innovation3 framework for evaluation and 
development of a toolkit. Specifically, process outcomes collected as part of implementing the 
cRCT together with additional structured interview data (to be collected from participating 
providers) on barriers/enablers will help in understanding the characteristics of the intervention 
and any changes that would need to be made for dissemination purposes. 
Figure 4.2.1 Conceptual model describing the pathway mechanisms of the 
behavioral- (provider) and implementation- (practice) level interventions 
  

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Interventions to be tested:  
Arm A (N = 512): Practices will receive interventions at the provider and practice levels.  
Provider-level interventions will be: Common-Sense Model of Self-Regulation (CSM) 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.  
Practice-level interventions will be: 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.  
Arm B (N = 512): Enhanced usual care (AAP based) at the provider level, no practice level 
intervention.   
Providers in these practices will receive American Academy of Pediatrics (AAP) based oral 
health education and follow the usual care for oral health assessment recommended by AAP 
guidelines. The AAP based education is unlike the CSM based intervention education (given to 
Arm A) in that it is not theory based to provide understanding of the chronicity of dental caries.  

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4.3 Design of Supplementary Objective 3.3 
Qualitative data collection to evaluate dissemination strategies to translate trial results and 
resources to all stakeholders will also be completed. Specifically, we will use the final trial 
results, the process outcomes collected during the study, and additionally collect structured 
interview data from participating providers on implementation barriers/enablers to evaluate best 
strategies for dissemination of the oral health intervention. In addition to disseminating trial 
results, a tool kit will also be developed to translate the evidence based intervention among all 
primary care stakeholders.  
The 63 participating providers will be asked to participate in a structured interview to assess the 
characteristics of the intervention and implementation barriers/enablers according to Roger’s 
Diffusion of Innovation framework. These interviews will be collected from the providers after the 
completion of all parent/caregiver-child dyad WCV3 visits. A trained moderator will conduct the 
interviews (≈45 minutes) at the practices to assess the following: 1) relative advantage of the 
OH intervention; 2) compatibility of the OH intervention with the needs of the adopters; 3) 
Complexity of the OH intervention; 4) Trialability, i.e. implementing the OH intervention without a 
large investment; 5) observability, i.e if the results of the OH intervention are noticeable to 
parents and providers. The table below gives the list of questions that will be asked under each 
domain. All interviews will be audio-taped. Audio tapes from the interviews will be transcribed, 
and then coded in Atlas.ti, a software program which allows for the analysis of qualitative data. 
Analysis will be supervised by Drs. Nelson who has experience conducting qualitative work. A 
detailed summary of the ideas for implementation strategies and development of the tool kit will 
be produced. Interviews with providers will be conducted using zoom if in-person interviews are 
not possible due to the current COVID-19 outbreak.  
Diffusion of Innovations Theory Characteristics 
Structured interview Questions for Providers 
(1) Relative advantage; the degree to which 
the Innovation is viewed as better than the 
previously available ideas or programs. 
Is the information in the didactic oral health (OH) 
curriculum you received as part of training better 
than the ones available on professional websites 
(ADA, AAP, and AAPD)? 
a. Was anything new presented? 
b. Did you learn anything? 
Can the curriculum with the OH facts be delivered 
successfully to parents? Should the training be 
made available from experts? 
a. Has skills training been helpful? 
b. Does it give confidence in delivery? 
c. Is in-person training necessary? 
(2) Compatibility: the degree to which the 
innovation is consistent with the values, 
experiences, and needs of potential 
adopters. 
Are the OH activities in primary care compatible 
with physicians/NP’s goal of quality of care 
delivery? 
a. What are the enablers? 
b. What are the barriers? 

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(3) Complexity: How difficult the innovation is 
to understand or how complex it is to use. 
Are the OH activities simple to be followed in 
practice settings? 
a. What could be made simpler? 
b. What works and what does not? 
(4) Trialability: the degree to which the 
innovation can be experimented with on a 
limited basis without a large investment. 
Has the implementation of OH activities been 
cost-effective? 
(5) Observability: the degree to which the 
results of an innovation are visible to 
others. 
Do you think the OH activities have helped your 
parents to take their child to the dentist and also 
helped with Quality Improvement in your practice? 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, all of the following criteria must be met: 
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 
5.2 
Subject Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
Child: 
● Presence of any serious medical or behavioral condition (e.g. cerebral palsy, autism) 
that precludes participation in the dental screening 
5.3 
Strategies for Recruitment and Retention 
Practices: 

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During the pilot study phase, Medical Directors from the 26 RCC practices were invited to 
participate in an informational webinar led by the PI and a Co-Investigator (Medical Director of 
the RCC) to learn more about the opportunity for their practice to participate in the study. The 
PI, Project Manager and Study Coordinator then met with interested providers at practices 
which met the inclusion criteria. The 18 practices which met the inclusion criteria have provided 
letters of support indicating their commitment to participation. One practice will serve as a 
backup practice and has also given a letter of support. 
Retention strategies for the practices will include regular contact between the study staff and 
practice staff to ensure any issues which may arise are addressed immediately, and tailoring 
study logistics based on practice flow as learned from our two pilot practices. 
Practices also receive compensation for facility use for the trainings, for research staff being 
present at the practices to complete study visits, and for the structured interviews and debriefing 
sessions. 
Providers:  
During the pilot study phase, all pediatricians and nurse practitioners of the 18 practices were 
invited to attend the informational meetings which took place at their individual practices. The 
PI, Project Manager and Study Coordinator briefed the providers regarding the study goals and 
logistics. A total of 67 providers from the 18 practices to be randomized who met the inclusion 
criteria will participate in the main trial. An additional information session for providers will be 
held at each practice prior to the start of the main trial. At this time, informed consent will be 
obtained from each pediatrician/nurse practitioner participant.  
Retention strategies for providers include Continuing Medical Education (CME) credits for 
didactic OH education and Maintenance of Certification (MOC) credits for quality improvement 
initiatives. Twenty five (25) MOC credits have been approved by the American Academy of 
Pediatrics (AAP) for physicians participating in this dental project. The study staff will maintain 
regular contact with providers to address any concern or issue that may arise.   
CME credits will also be available for providers upon completion of briefing seminar.     
Parent/caregivers:  
All parents of 3-6 year-old Medicaid-enrolled children attending a WCV in the selected practices 
during the recruitment period will be invited to participate in the study. Based on the data from 
the 18 practices, we expect 7,421 Medicaid-enrolled children aged 3-6 years to have a WCV at 
the pediatric offices per year.  In our pilot study, the participation rate was 95%, hence similar 
strategies will be implemented in the main trial.  
A team consisting of a research assistant and dental hygienist will be assigned to one practice 
at a time to be on-site daily for recruitment of caregiver-child dyads at larger practices. A floating 
team will recruit at multiple smaller practices simultaneously. The available sample pool for the 
3-month recruitment period is 1,855 (25% of 7,421). We anticipate that 5% will be ineligible 
based on inclusion and exclusion criteria, thus reducing the potential sample to 1,762 (95% of 
1,855). Based on our experiences recruiting and enrolling parent/caregivers in 2 pilot practices, 

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we expect a participation rate of 95% (of 1,762), giving us an available potential sample size of 
1,674 per 6 practices enrolled. For the total of 18 practices, we can expect a potential sample 
size of 5,022 from whom we can recruit the target sample size of 1024 participants (512 per arm 
for 2 arms) required to test the hypothesis of the study. Therefore, our goal of recruiting 56 to 57 
participants per practice given the potentially large population pool of each practice is an 
achievable approach to meet the main trial sample size. The recruitment is expected to be 
completed within a 9-month time frame. 
The recruitment and enrollment strategies proved to be effective in the pilot study will be used 
for the main trial as follows: 
● When making appointment reminder calls, practice staff will give a brief overview of the 
study (using a recruitment script) and ask caregivers to come early to fill out the consent 
forms and questionnaires. 
● Tailored to the practice’s or provider’s preference, the medical assistant may approach 
caregivers first, before study staff explain and obtain consent. An alternative approach is 
that study staff will approach caregivers in the waiting room. 
● All 3 questionnaires, i.e. Illness Perception Questionnaire-Revised for Dental (IPQ-RD), 
Parent Questionnaire, and Parent Exit Questionnaire, can be completed on paper or 
tablet according to the caregiver’s preference. 
● At each WCV, study staff will give caregivers an incentive (i.e. cash or gift card) and a 
small gift for their child for completing the study visit questionnaires. 
Retention strategies for parent/caregivers, lessons learned from the pilot study and best 
practices identified in the literature will be followed as below: 
● Parents/caregivers will be given promotional items (i.e. pens, magnets) with the study 
logo and contact phone number at recruitment. 
● Alternate contact information for family/friends that may be able to reach the participant if 
primary contact information becomes invalid will be obtained at recruitment. 
● Annual birthday/holiday cards will be sent to parent and child participants to maintain 
contact. 
● Newsletters will be sent twice a year with updates on the study’s progress (i.e.  
recruitment), and a reminder to update their contact information (by phone or mail). 
● Study staff will contact parents/caregivers during follow-up to remind them to schedule 
and attend their annual WCV. 
● Assistance from practice staff will also be solicited for hard to reach/contact participants. 
5.4 
Treatment Assignment Procedures 
5.4.1 Randomization Procedures  
Eighteen practices (comprising the clusters) will be included in the study. Practices will be 
randomized to one of the two arms using a restricted randomization scheme with the constraint 
that 9 practices will be assigned to each arm. This approach will involve the computation of a 
balance score (for each candidate randomization) based on marginal differences in three key 

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practice-level variables: % Medicaid-enrolled patients [20% to 40% and >40%], ratio of patients 
to providers, county [Cuyahoga vs. other]). We use the first generated (constrained) 
randomization that provides good balance according to a pre-selected balance criterion; it may 
be reasonable to require perfect marginal balance, if (as we expect) there are a reasonably 
large number of randomizations that yield this.   
5.4.2 Masking Procedures 
Parent/caregiver participants will be blinded to the intervention arms of the main trial. 
Furthermore, parent/caregiver participants will not be aware of what is involved in the study 
procedures being followed at other clinics. Study staff conducting dental screenings will also be 
blinded.  
5.5   Subject Withdrawal 
5.5.1 Reasons for Withdrawal 
Participants are free to withdraw from participation in the study at any time upon request, as 
outlined in the consent form documents. 
Participants who drop out (or withdraw) from the study by their own choice will be considered 
dropouts/withdrawals.  Participants who are discontinued from the study by one of the study 
personnel will be also be considered a dropout/withdrawal.   
An investigator may terminate a study subject’s participation in the study if: 
● Any medical condition or situation occurs such that continued participation in the study 
would not be in the best interest of the participant. 
● The subject meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
5.5.2 Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
All reasons for dropout/withdrawal or discontinuation of the study intervention will be 
documented in the tracking database and reviewed by the study team and reported to the 
NIDCR Medical Monitor and DSMB.  For gathering information on discontinuation, study staff 
will be contacting subjects at several time points. Study staff will contact parent/caregivers 
within 2 weeks of WCVs #1 and #2 to collect B1 questionnaires not previously returned, 6 
months after WCVs #1 and #2 to complete B2 questionnaires, and 3 months and 2 weeks 
before WCVs #2 and #3 to remind caregivers to schedule/attend WCV. 
In the event of a subject telling study staff that he/she is dropping out of the study, the study 
staff should gather the following information as much as the participant allows. 
● Record the reason for dropping out of the study. 
● Record any adverse event reported by the subject. 

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● Complete the appropriate questionnaire nearest the drop out time point. 
If it is determined by study staff that a participant should be discontinued from the study, the 
decision to withdraw a participant must be discussed and confirmed by the PI. 
Caregiver/child dyads that withdraw during the baseline (T0) data collection window will be 
replaced by recruitment of additional parent/child dyads to reach enrollment goals.  
Caregiver/child dyads that withdraw or that are lost to follow-up any time after the baseline data 
collection window will not be replaced, but data collected up to the point of withdrawal will be 
used for analysis.  
Providers that withdraw after receiving the study intervention will not be replaced. See Section  
7.1.4. 
5.6 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable cause.  
Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to the Principal Investigator (PI), Medical 
Monitor/DSMB, or NIDCR. If the study is prematurely terminated or suspended, the principal 
investigator will promptly inform the IRB and will provide the reason(s) for the termination or 
suspension.  
Circumstances that may warrant termination include, but are not limited to: 
● Determination of unexpected, significant, or unacceptable risk to subjects. 
● Insufficient adherence to protocol requirements. 
● Data that are not sufficiently complete and/or evaluable.  
● Determination of futility.   
 

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6 
STUDY INTERVENTION 
Refer to Appendix B for more details on section 6 in the Fidelity Monitoring Plan. 
6.1 
Study Behavioral or Social Intervention(s) Description 
Complete descriptions of the interventions are given in the fidelity monitoring plan (Appendix B). 
The interventions for this study are on two levels as follows: Provider: Common-Sense Model of 
Self-Regulation (CSM) based education and skills training for the pediatrician/nurse practitioner 
to understand chronicity of caries, and communicate the core OH facts to the parent, provide a 
prescription to take the child to the dentist together with a list of area dentists accepting  
Medicaid, and document OH in EMR. Practice: enhancements to the EMR system to include OH 
status will be implemented prior to enrolling any parent into the study. This will promote 
adoption of systematic EMR documentation of OH status that can facilitate follow-up with parent 
at subsequent WCVs.  
 

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Table 6.1.1:  Theoretical perspectives for behavioral interventions at each level 
Socio-ecological 
levels 
Change objectives 
Theoretical methods  
(theory) 
Practical application and 
delivery of interventions 
Individual 
(parent/caregiver) 
● Learn chronicity of 
caries and seriousness 
regarding  primary 
teeth 
● Behavioral capability / 
awareness for seeking 
dental care 
● Skills & self-efficacy for 
taking child to dentist  
● Information 
processing and  
transfer (CSM) 
● Self-management  
(CSM, SCT) 
● Active learning with 
images  (CSM, SCT) 
● Reinforcement (SCT) 
● OH assessment and  
facts from primary care 
doctors 
● Educational materials 
with illustrations 
● List of dentists   
Interpersonal 
(provider) 
● Behavioral capability / 
knowledge of core OH 
facts 
● Skills & self-efficacy to 
communicate core OH 
facts 
● Refer to dentist for 
dental care 
● Information processing 
and transfer (CSM) 
● Active learning (SCT) 
● Persuasion  
(communication) 
● Reinforcement (SCT) 
● Brief lectures through 
seminars, lunch and 
learn, webinars etc. 
● Skills 
and 
communication training 
to impart one-on-one 
OH 
facts 
to 
parent/caregivers  
● Referral  to dentist 
together with list of 
Medicaid 
accepting 
dentists  
Organization  
(practice) 
● Awareness of OH in 
practices 
● Integrate 
OH 
assessment in EMR 
● Systematically 
document 
OH 
for 
quality 
improvement 
and monitoring 
● Information transfer  
(CSM) 
● Identifying practice 
attributes and 
champion/s  
(Diffusion of  
Innovation theory) 
● Active learning (SCT) 
● Feedback (SCT) 
● Creating OH protocols 
(SCT) 
● 
EMR enhancement  
and prompts for OH 
documentation  
● 
Skills training of 
practice providers and  
staff to document 
● 
Standardized OH 
protocols  
● 
Newsletters to 
communicate progress 
in practices 
CSM – Common Sense Model of Self-Regulation, SCT – Social Cognitive Theory    
6.2 
Administration of Intervention 
Arm A 
The provider-level intervention consists of CSM theory based didactic education and skills 
training for providers to learn about the chronicity of caries, to communicate core oral health 
facts to parent/caregivers at the well-child visit (WCV), to provide a prescription to take their 
child to the dentist together with a list of area Medicaid-accepting dentists, and to document OH 
in EMR. By enhancing dental knowledge and skills of the pediatric providers through the 
CSMbased education, interactive practice sessions with standardized patients, and training in 

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EMR documentation, parents/caregivers will receive the core OH facts along with coping and 
action supports (e.g., prescription to dentist, list of Medicaid accepting dental providers) from the 
child’s provider. Providers will receive didactic education with pre- and post-tests and interactive 
skills training with standardized patients (SPs). Providers will also be given materials (Appendix 
D) to help them implement the intervention including: training manual that includes a didactic 
section on oral health and skills section on communication (more specifics on the training 
manual will be detailed in the MOP), pocket card (with core oral health facts listed), and flip 
chart (to use during oral health communication to caregivers). The training will be delivered to 
providers in two 45-minute sessions (didactic education first and then skills training) at their 
individual practice prior to study enrollment of caregiver and child participants at WCV #1. There 
will be a booster education session before WCV #2. The final WCV #3 will serve as the 
maintenance visit.  
Arm A will also have practice-level intervention that includes incorporation of four oral health 
questions into the practice EMR. As a result of this practice-level intervention, Arm A providers 
will receive EMR training to document the oral health encounter. The EMR training will occur 
simultaneously with the didactic and skills training sessions prior to WCV #1 and the booster 
session before WCV #2. Providers will receive an EMR training manual for documentation 
(more specifics on the EMR training manual will be detailed in the MOP; see Appendix D for 
EMR screenshots). While the majority of University Hospitals based practices have oral health 
questions incorporated in their EMR, the OH questions are hidden and will be available only to 
providers with appropriate training in practices in study Arm A. The other non-UH based 
practices randomized to study Arm A will have the OH questions incorporated prior to 
enrollment of caregiver and child participants.  
Parents/caregivers of the providers and practices in Arm A are the recipients of the provider and 
practice level interventions. Parent/caregivers will receive CSM-based oral health facts, 
prescription to go to the dentist together with a list of Medicaid-accepting dentist. 
Arm B 
Providers will receive the standard AAP based didactic education in a 45-minute session prior to 
WCV #1and a booster session prior to WCV #2. Arm B providers will not receive any 
CSMbased education, skills training or the practice-level intervention. 
Parents/caregivers in this arm will receive the usual care for oral health as followed by the 
providers and practices currently. 
6.3 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity  
Refer to Appendix B for the Fidelity Monitoring Plan for the study. 
All study staff will receive Human Subject Protection, Good Clinical Practice (GCP), protocol, 
and MOP training.  

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6.3.1 Procedures for Training Interventionists 
Provider training (Arm A) will be conducted by experts on the curriculum team: Drs. Nelson (who 
has more than 20 years of experience as an oral health researcher), Ferretti (who has spent 
more than 20 years teaching residents as chief of pediatric dentistry), and Lord (a 
communication specialist with more than 10 years of teaching experience in the area of primary 
care delivery). The provider will need to complete three components satisfactorily to be 
considered as trained: (1) didactic training (assessed through pre and post test); (2) skills 
training (assessed through standardized communication checklist, and self-efficacy pre and post 
test); (3) observation of the first OH encounter of the provider by study staff (assessed through 
the standardized communication checklist. A score card will be given that outlines the 
established target goals which are elaborated in detail in the Fidelity Monitoring Plan in 
Appendix B).  
Training materials, including scripts and narrated slides, will ensure that the curricula are 
delivered in the same way for each group of clinicians to ensure fidelity of the training delivery. 
A training manual (for Arm A) more specifics will be detailed in the MOP), EMR training (only 
Arm A) and flip chart and pocket card (Arm A) have been developed to provide information as 
needed (Appendix D, also includes EMR screen shot). Additional booster training for providers 
will be conducted, if necessary, to address deviations in protocol. 
6.3.2 Procedures for Monitoring Intervention Fidelity 
Arm A 
Providers’ implementation of the provider-level intervention will be assessed at all 3 WCVs.  
Two - three of each provider’s OH encounters with parent/caregiver will be observed or 
audiotaped and then evaluated by the study staff  using a standardized communication skills 
checklist (Appendix E) at WCV #1 and WCV#2. The results of the observation/audiotaping will 
be given to the provider as a scorecard to provide feedback regarding whether the provider met 
the established target goals which are elaborated in detail in the Fidelity Monitoring Plan 
(Appendix B). All enrolled caregivers will complete an exit questionnaire (Appendix E) after the 
OH encounter to assess whether the provider communicated the OH facts and gave them the 
prescription and list of dentists. So, Provider-level fidelity measures to assess whether providers 
communicated the core OH facts to caregivers and delivered the prescription to go to the dentist 
and list of area Medicaid-accepting dentists include: 1) standardized communication skills 
checklist completed by study staff and 2) parent exit questionnaire (Appendix E). 
Providers’ implementation of the practice-level intervention will be assessed at all 3 WCVs. 
Study staff will complete monthly EMR audits (at all 3 WCVs) of all enrolled patients’ EMR chart 
to assess whether providers’ OH documentation was complete.  
The practice-level fidelity measure to assess adoption of the intervention is the EMR Audit of 
Practice form completed by study staff (Appendix E).  
Arm B 

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Since Arm B does not receive the interventions, monitoring procedures outlined below will be 
used to monitor baseline rate and check for contaminations between study arms. 
Two - three of each provider’s OH encounters will be randomly selected for 
observation/audiotaping and evaluation by study staff using the same standardized 
communication skills checklist used in Arm A. Scorecards will not be given to Arm B providers, 
but evaluation with the checklist will serve to document the communication of OH facts due to 
enhanced usual care. 
Study staff will complete monthly EMR audits using the EMR Audits of Practice form (at all 3 
WCVs) for 20% of enrolled patients’ EMR chart to assess whether any oral health 
documentation was completed despite not receiving EMR training. (Appendix E).  
6.4 
Assessment of Provider Compliance with Study Intervention 
Arm A 
Compliance with the provider-level intervention: The study staff’s direct observation/audiotape of 
provider encounters will provide an assessment of whether providers communicated all 6 core 
OH facts and gave caregivers the prescription to go to the dentist along with list of area 
Medicaid-accepting dentists. It will also be used to assess whether the provider initiated the 
topic of the child’s dental care with the caregiver and used appropriate communication skills. 
The exit questionnaire completed by parent/caregivers will assess whether their 
pediatrician/nurse practitioner communicated OH facts and gave them the prescription to go to 
the dentist and list of dentists (i.e. whether the caregiver received and understood the main 
points of the provider’s oral health communication and the prescription they were being given). 
Compliance will also be verified with the numbered prescriptions and list of dentists to determine 
the total number given to each provider’s enrolled caregivers.  
Compliance with the practice-level intervention: The study staff will conduct EMR audits of all 
enrolled patients to determine whether the OH documentation was complete, i.e. provider 
documented whether or not they did the following during the OH encounter: 1) examined child’s 
teeth for white or brown spots, 2) asked whether child had a dental visit in the past 12 months, 
3) communicated core OH facts, and 4) gave caregiver a prescription to take their child to the 
dentist along with a list of Medicaid-accepting dentists in the area.  
Arm B 
Compliance with the provider-level intervention: Study staff evaluation of providers’ OH 
encounters and parent exit questionnaires completed by a random 20% selection of each 
provider’s enrolled patients will be used to assess whether Arm B providers communicated OH 
facts to identify possible contamination bias in delivery of the provider-level intervention (i.e. 
provider is giving caregivers provider-level intervention materials not associated with their 
assigned arm). 
Study staff will perform EMR audits on a random 20% selection of each provider’s enrolled 
patients to identify possible contamination bias in delivery of the practice-level intervention (i.e. 
providers are documenting patients’ OH without having received the practice-level intervention).  

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7 
STUDY SCHEDULE 
Prior to any of the following actions, practices will be randomized and EMR changes will be 
finalized.  
Refer to Appendix A for the Schedule of Events for providers and parents/caregivers. 
7. 1 
Provider 
7.1.1 Baseline Visit: WCV #1  
Before WCV #1 (T-1: Day -30 to -1) 
● Review the written consent form with the provider; study staff signs the consent form 
acknowledging that informed consent was reviewed and provider signs acknowledging 
consent was obtained (Appendix C: Consent forms). 
● Provide OH didactic education and skills training for pediatricians/nurse practitioners to 
communicate core OH facts (importance of baby teeth, chronicity of caries, dental visits) to 
parents/caregivers (Appendix D: Provider training) or AAP based didactic training, based on 
study arm. 
● Administer pre- and post-tests to pediatricians/nurse practitioners before and after the OH 
didactic education session (Appendix E: Questionnaires & forms). 
At WCV #1 (T0: Day 0) 
● Provider delivers oral health facts, based on study arm. 
● Provider documents OH in EMR, based on study arm. 
7.1.2 Follow-up Visit: WCV #2  
Before WCV #2 (T2: Day 364 ± 90) 
● 
Provide OH didactic education booster session for pediatricians/nurse practitioners.  
At WCV #2 (T3: Day 365 ± 90) 
● Provider delivers oral health facts, based on study arm. 
● Provider documents OH in EMR, based on study arm (Appendix D: Provider training) 
7.1.3 Final Visit: WCV #3 
At WCV #3 (T6: Day 730 ± 90)  
● Provider delivers oral health facts, based on study arm. 
● Provider documents OH in EMR, based on study arm (Appendix D: Provider training). 

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After WCV#3 (Day 731 +) 
• 
Revised consent form is reviewed with the provider; study staff signs the consent form 
acknowledging that informed consent was reviewed and provider signs acknowledging 
consent was obtained. 
• 
Provider completes structured interview conducted by a trained moderator. The interviews 
will be conducted at the pediatric practices at a time convenient for the provider. Interviews 
will be conducted using zoom if in-person interviews are not possible due to the current 
COVID-19 outbreak.  The interviews will contain questions to assess: o Relative 
advantage of the OH intervention 
o Compatibility of the OH intervention with the needs of the adopters 
o Complexity of the OH intervention o Trialability o Observability 
• 
Provider attends debriefing session held at the practice.  
7.1.4 Provider Withdrawal Visit 
The following procedures will be followed for providers who choose to withdraw early or whose 
participation is terminated by the PI: 
● Personal contact (by phone or in-person) by study staff will be made to confirm 
withdrawal. 
● Debrief about the interventions. 
● If a provider withdraws from the study and their patients are participants who see 
another provider at that practice, visits and data collection will continue. If the patient 
also withdraws by changing practices to a non-participating practice, visits and data 
collection will end with these participants being considered lost to follow-up. Data 
collected up to the point of withdrawal will be used for analysis. 
7.2  
Parent/Caregiver and Child  
7.2.1 Baseline Visit: WCV #1  
At WCV #1 (T0:  Day 0) 
Before Provider Encounter 
● Study Staff will recruit 1024 parent/caregivers and their children from the 18 practices 
(approximately 56-57 participants/practice) using an in-person approach. 
Parents/caregivers attending well-child visits with 3-6 year old children will be 
approached for participation.   

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○ In the waiting area/exam room of the pediatric practice, study staff will review 
inclusion/exclusion criteria as outlined on the screening survey to determine 
parent/caregiver and child eligibility (Refer to Sections 5.1, 5.2). 
○ Review the written consent form with the potential participant; study staff signs 
the consent form acknowledging that informed consent was reviewed and 
caregiver signs acknowledging consent was obtained (Appendix C: Consent 
forms). 
○ In the waiting area/exam room of the pediatric practice, study staff will obtain 
contact information. 
○ In the exam room, caregivers will complete the following self-administered 
Baseline questionnaires: A1: Illness Perception Questionnaire-Revised for Dental 
(IPQ-RD) and A2: Parent Questionnaire (Appendix E: Questionnaires & forms). 
● In the exam room, dental hygienist will perform child dental screening examination and 
study staff will record results of the dental screening examination. Results will not be 
available to the provider, unless the hygienist finds that the child has urgent needs that 
require immediate attention.  (Appendix E: Questionnaires & forms). 
During Provider Encounter in the Exam Room 
● Caregivers attending WCV’s will receive OH information, prescription to take the child to 
the dentist + list of local Medicaid-accepting dentists from provider, based on study arm. 
● Caregivers attending WCV’s may have study staff audiotape or directly observe the 
provider encounter to evaluate provider’s delivery of OH communication (for a sample of 
visits). 
After Provider Encounter in the Exam Room/Waiting Area 
● Caregivers will provide feedback about the OH information given to them during the 
medical visit with a short self-administered exit questionnaire (A3: [Appendix E: 
Questionnaires & forms]). 
● Caregivers will be given the B1: Follow-up IPQ-RD (Appendix E: Questionnaires & 
forms) to be completed and returned (in postage paid envelope or in person, based on 
participant preference). 
After WCV #1 (T1) 
● B1 (Day 0 ± 120): Caregivers will receive telephone calls and text messages from study 
staff to remind them to complete and return the B1: Follow-up IPQ-RD if it has not 
already been returned. 
● B2 (Day 180 + 60): Caregivers will receive telephone calls and text messages from 
study staff 6 months after the WCV to complete the B2: Dental Attendance & Cost 
Questionnaire (Appendix E: Questionnaires & forms). 

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7.2.2 Follow-up Visit: WCV #2 
At WCV #2 (T3: Day 365 ± 90) 
Before Provider Encounter in the Exam Room 
● If a different parent/caregiver brings the child to the well child visit and they are the 
child’s legal guardian, consent will be obtained from that parent/caregiver and they will 
complete all components of the visit. 
● Parent/caregivers will complete the following self-administered questionnaires: A1: 
Illness Perception Questionnaire-Revised for Dental (IPQ-RD) and A2: Parent 
Questionnaire. 
● Dental hygienist will perform child dental screening examination and study staff will 
record results of the dental screening examination. Results will not be available to the 
provider unless the hygienist finds that the child has urgent needs that require immediate 
attention.   
During Provider Encounter in the Exam Room 
● Caregivers attending WCV’s will receive OH information, prescription to take the child to 
the dentist + list of local Medicaid-accepting dentists from provider, based on study arm. 
● Caregivers attending WCV’s may have study staff audiotape or directly observe the 
provider encounter to evaluate the provider’s delivery of OH communication (for a 
sample of visits). 
After Provider Encounter in the Exam Room/Waiting Area 
● Caregivers will provide feedback about the OH information given to them during the 
medical visit using a short self-administered exit questionnaire (A3). 
● Parents will be given the B1: Follow-up IPQ-RD to be completed and returned within 2 
weeks (in postage paid envelope or in person, based on participant preference). 
After WCV #2 (T4): 
● B1 (Day 365 ± 120): Caregivers will receive telephone calls and text messages from 
study staff to remind them to complete and return the B1: Follow-up IPQ-RD if it has not 
already been returned. 
● B2 (Day 545 ± 90): Caregivers will receive telephone calls and text messages from 
study staff 6 months after the WCV to complete the B2: Dental Attendance & Cost 
Questionnaire (Appendix E: Questionnaires & forms). 

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7.2.3 Final Visit: WCV #3 
At WCV #3 (T6: Day 730 ± 90) 
Before Provider Encounter in the Exam Room 
 If a parent/caregiver will be asked to complete the COVID-19 questionnaire, they will be 
re-consented with the updated consent form (12/7/20).  
● Parent/caregivers will complete the following self-administered questionnaires: A1:  
Illness Perception Questionnaire-Revised for Dental (IPQ-RD) and A2: Parent  
Questionnaire, COVID-19 Dental Visit Questionnaire (if applicable) 
● Dental hygienist will perform child dental screening examination and study staff will 
record results of the dental screening examination. Results will not be available to the 
provider unless the hygienist finds that the child has urgent needs that requires 
immediate attention  
During Provider Encounter in the Exam Room 
● Caregivers attending WCV’s will receive OH information, prescription to take the child to 
the dentist + list of local Medicaid-accepting dentists, based on study arm. 
● Caregivers attending WCV’s may have study staff audiotape or directly observe the 
provider encounter to evaluate the provider’s delivery of OH communication (for a 
sample of visits). 
After Provider Encounter in the Exam Room/Waiting Area 
● Caregivers will provide feedback about the OH information given to them during the 
medical visit using a short self-administered exit questionnaire (A3). Actively enrolled 
parents will also complete a short (7 item) COVID-19 Questionnaire which asks if they 
have altered their behavior related to taking their child to the dentist due to the COVID19 
pandemic.  
7.2.4 Parent/Caregiver and Child Withdrawal Visit 
The following procedures will be followed for participants who choose to withdraw early or 
whose participation is terminated by the PI: 
● Personal contact (by phone or in-person) by study staff will be made to confirm 
withdrawal. 
● Record any adverse event reported by participant. 
● Debrief about the interventions. 
● Obtain responses to the study questionnaires (if applicable)  

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● If a parent/caregiver and child withdraws or changes to a practice not participating, visits 
and data collection will end with these participants being considered lost to follow-up. 
Data collected up to the point of withdrawal will be used for analysis. 
7.2.5 Parent/Caregiver and Child Unscheduled/Missed Visit 
Unscheduled visits for parent/caregiver and child may occur if an enrolled child could not 
complete the oral health portion during the WCV. But, this is unlikely to happen due to the short 
amount time required for the oral health activities. Another possibility would be if a child is 
scheduled by the practice for a well child visit much sooner or later than the visit window. In 
these cases, study data would be collected per guidelines outlined in the MOP, but the time 
length between visits will be accounted for in the analysis stage. 
Other instances of unscheduled visits at follow-up, i.e.WCV2 or WCV3, may occur if a well child 
visit is missed by project staff (for example, a child comes in for a sick visit near the time a well 
child visit is due and the provider completes the well visit also) or another non-participating 
provider at the practice is scheduled to see the child for a well child visit.  In these cases, the 
ICDAS, A2, A3 and B1 questionnaires will be completed when possible, either in person, by 
mail or through a link sent via text or e-mail to the parent/caregiver. The B2 follow-up will be 
completed as planned. In extreme situations, if we have missed the WCV2 or WCV3 and the 
child is scheduled to come in to see the enrolled provider for follow-up for a problematic issue 
within 3 months of the missed well child visit, we will arrange to complete the study visit at the 
follow-up visit. This determination will be made on a case-by-case basis. Arrangements will be 
made to have the parent/caregiver bring the child to the Dental Research Building for 
completion of the ICDAS dental screening. Also, due to scheduling irregularities in the part of 
the parent/caregiver, every child may not be scheduled for an annual WCV. In cases such as 
this, the parent/caregiver-child dyad may remain enrolled in the study and be seen for 
completion of 3 consecutive WCV’s regardless of their timing. The time length between visits 
will be accounted for in the analysis stage.  
COVID-19 Visits 
Visits missed due to the COVID-19 pandemic will follow the protocol outlined above for 
unscheduled/missed visits.  
8 
STUDY PROCEDURES / EVALUATIONS 
8.1 
Study Procedures/Evaluations 
The following is a summary of the study procedures and evaluations.  Study procedures include 
interventions, and procedures performed to assess the primary outcome, secondary outcomes, 
mediators, moderators and confounders. Measures or interventions will occur at the 
socioecological levels of child, parent/caregiver, provider, and practice. There will also be 
implementation evaluation at each of these levels except the parent/caregiver. See Table 8.1.1 
for more details on the measures, sources, and timeline. According to the timeline of study 
procedures and evaluations, WCV #1: Baseline Visit = T0; WCV #2: Follow-up Visit = T3; and 
WCV #3: Final Study Visit = T6. 
 

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Table 8.1.1 Summary of measures, sources, and timeline 
Socioecological 
levels 
Implementation 
Evaluation 
Measures 
Score 
Source 
Timeline 
Child 
Reach 
# recruited 
% attrition 
Participant characteristics  
(socio-demographics) 
Effectiveness 
Primary outcome: 
Dental attendance 
Secondary 
outcomes: 
New caries 
Oral hygiene 
Frequency of sweet 
food & drinks 
OH-related quality of  
life 
Cost 
% frequency 
# of decayed,  
filled teeth (dft) 
% freq. tooth 
brushing 
% freq. sweet 
food  
& drinks 
ECOHIS overall 
score 
Direct dental 
costs 
Non-dental direct 
& dental indirect 
costs 
ICDAS (Pitts, 2004);  
Medicaid claims 
ICDAS (Pitts, 2004) 
NHANES III (CDC) 
Food Frequency Qx,  
NHANES 2003-2004 (Dye 
et al., 2010); YRBS 
2017(CDC, 2017) 
Pahel et al., 2007) 
Medicaid claims 
Annotated Cost Qx  
(Thompson & Wordsworth,  
2001) 
T0, T1,  
T3, 
T4, 
T6, T7 
T0, T3,  
T6 
T0, T3 
T1, T4,  
T7 
 
Confounder: 
Child medical illness 
Overall score 
Chi & Raklios, 2012 
T0, T3,  
T6 
Parent/ 
caregiver 
 
Mediators: IPQ-
RD 
Self-efficacy 
Moderators: 
Socio-demographics  
Health literacy 
Social support 
Overall & mean 
construct scores 
Overall score 
% categories 
% mean scores 
Nelson, 2016 
(Detroit Dental Health  
Project, 2004) 
NHANES III (CDC) 
Morris et al., 2006 
Zimet et al., 1988 
T0, T1,  
T3, T4, 
T6 
T0, T3,  
T6 
Provider 
Implementation/ Fidelity  
Observation/  audiotape 
Parent Exit Qx 
Adoption & Maintenance 
% prescriptions + list of  
dentists given 
Mediators: 
OH knowledge 
Self-efficacy 
Confounder: 
Socio-demographics 
% mean scores 
% categories 
Open Wide (NMCOHRC)  
PACT (AAP)  
(Lewis et al., 
2009)(Quinonez et al., 
2014) 
NHANES III (CDC) 
T-1, T2 
T-1 
Practice 
Adoption & 
Maintenance % 
complete EMR 
documentation 
Practice Qx 
Mediators: 
EMR Documentation 
Practice 
readiness, 
climate, and  attitude 
% mean scores 
% mean scores 
Stamatakis et al., 2012 
Aarons, 2004 
T4  and T6 
T-1, T2 ,  
T0 = WCV #1: Baseline Visit (1st intervention) 
T3 = WCV #2: Follow-up Visit (Booster intervention); 
T6 = WCV #3: Final Visit (Follow-up) 
T-1 = Before WCV #1; T0 = At WCV #1; T1 = After WCV #1 
T2 = Before WCV #2; T3 = At WCV #2; T4 = After WCV #2 T5 
= Before WCV #3; T6 = At WCV #3; T7 = After WCV #3 

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8.1.1 Child-level 
The primary (i.e. dental attendance) and secondary outcomes (i.e. new decay, oral hygiene, 
frequency of sweet food and drinks, oral health-related quality of life, and dental-related costs) 
are also implementation measures of effectiveness. Child medical illness is a confounder. 
Child dental attendance (i.e. receipt of dental care) will be assessed through: 
● Clinical dental screenings will be performed at all 3 WCVs (T0, T3, and T6) by a trained and 
calibrated dental hygienist according to the International Caries Detection and Assessment 
System (ICDAS). The screenings will be used to identify a change in oral health status 
between WCVs #1 and #2 (T0 and T3) and WCVs #2 and #3 (T3 and T6) which is defined as a 
restoration (ICDAS ≥ 3) or extraction of ≥ 1 tooth previously identified with an active ICDAS 
lesion code ≥ 3 at T0 or T3 that would not be exfoliated naturally based on child’s age. See 
ICDAS Assessment form (Appendix E). More details on the screening and decision 
algorithm will be outlined in the MOP Section 5.  
● B2: Dental Attendance & Cost Questionnaire: Study staff will contact caregivers 6 months 
after WCVs #1 and #2 (T1 and T4) to ask whether their child had a dental visit or if they made 
a dental appointment for their child since the previous WCV (Appendix E).  
● Medicaid claims files: Data will be abstracted by study staff to verify child’s receipt of dental 
care after each WCV (T1, T4, and T7) and entered on the Medicaid Claims Abstraction form. 
Current Dental Terminology (CDT) codes used for billing will be used to determine if the 
child received preventive or restorative procedures in the past 12 months. Dental 
emergency department (ED) visits will be identified by linking diagnosis codes (Appendix E) 
to ED claims using the International Classification of Diseases, Tenth Revision, Clinical 
Modification (ICD-10-CM). See Medicaid Claims Abstraction form (Appendix E) for 
preventive and restorative CDT codes and ICD-10-CM codes. 
● COVID-19 Questionnaire: At WCV3, actively enrolled parent/caregivers will complete a short 
(7 item) COVID-19 Questionnaire which asks if they have altered their behavior related to 
taking their child to the dentist due to the COVID-19 pandemic.  
Secondary outcomes and child medical illness (i.e. confounder) will be assessed as 
follows: 
● A newly carious tooth is defined as any tooth receiving an ICDAS lesion code ≥ 3 that 
received a sound code on the previous dental screening or any tooth surface with an ICDAS 
filling code ≥ 3 that previously did not have one. Number of teeth with new decay or filling 
will be assessed through the clinical dental screenings (T0, T3, and T6) and recorded on the 
ICDAS Assessment form (Appendix E). 
● Questions on frequency of tooth brushing (NHANES III)(CDC), frequency of consumption of 
sweet food and drinks (NHANES 2009-2010; Youth Risk Behavior Survey 2017)(CDC,  
2017; CDC, 2014), and the 13-item Early Childhood Oral Health Impact Scale  
(ECOHIS)(Pahel et al., 2007) will be used to measure oral hygiene, frequency of sweet food 
and drinks, and oral health-related quality of life (OHRQoL), respectively. Higher scores on 

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the ECOHIS indicate poorer OHRQoL. These questions are included on the A2: Parent 
Questionnaire (Appendix E) which will be completed at all 3 WCVs (T0, T3, and T6). 
● Direct dental costs include costs of preventive and restorative procedures, and dentalrelated 
ED visits. These costs will be abstracted from Medicaid claims files as part of the verification 
of child’s dental care receipt (described above) and recorded on the Medicaid  
Claims Abstraction form. Non-dental direct costs (transportation) and dental indirect costs 
(time away from work, household, or leisure activities) are measured using questions 
adapted from the Annotated Cost Questionnaire (Thompson & Wordsworth, 2001) which are 
incorporated into the B2 Follow-up Questionnaire. The B2 Questionnaire will be 
administered after WCVs #1 and #2 (T1 and T4). Study staff will administer the cost 
questionnaire at WCV #3 (T6) to identify any lags in receipt of dental care.  Cost data from 
Medicaid claims files will be abstracted at 3 time points (T1, T4, and T7). See the Annotated 
Cost Questionnaire and Medicaid Claims Abstraction form (Appendix E) for more details. 
 Table 8.1.2 Cost elements and sources 
Cost Category 
Cost Element 
Source 
Implementation/ 
training costs 
Training providers in communicating oral 
health facts 
Study training records/logs 
IT system modifications 
Vendor invoices, clinic 
personnel time logs 
Staff training 
Study staff time/training logs 
Intervention costs 
Time required to provide education and give 
prescription 
Review of audiotaped 
encounters 
Cost of dental prescription pads, flip charts, 
pocket cards 
Study/practice expense 
records 
Dental costs 
Direct dental costs - Dental utilization costs  
(including emergency) 
Medicaid claims data for 
participants  
Non-dental direct costs (e.g. transportation to 
dental visits) 
Annotated Cost Questionnaire 
Dental Indirect costs (e.g. time away from 
work, household, or leisure activities) 
Annotated Cost Questionnaire 
Note: If training/study staff time logs conflict for a given activity, the arithmetic mean of the two figures will 
be used in analysis. 
● Medical illness data will be abstracted from the child’s medical charts (i.e. EMR) and 
classified into a 10 clinical risk grouping system (Chi & Raklios, 2012). EMR abstraction will 
be performed by study staff after each WCV (T0, T3, and T6). See EMR Abstraction form 
(Appendix E).  

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8.1.2 Parent/caregiver  
Measures at the parent/caregiver-level are mediators (IPQ-RD and self-efficacy) and 
moderators (socio-demographic characteristics, health literacy, and social support).  
● The Illness Perception Questionnaire-Revised for Dental (IPQ-RD) (Nelson et al., 2016) is 
comprised of 5 main cognitive constructs (i.e. identity, cause, timeline, consequences, and 
cure/controllability) and will be used to assess the impact of the provider-level intervention 
on caregivers’ perception of their child’s dental caries. Overall and construct-specific scores 
will be calculated with higher scores indicating caregivers’ less accurate/inaccurate 
perception of the caries disease process and its chronicity. Caregivers will complete the A1: 
IPQ-RD before the OH encounter with their provider at WCVs #1 - #3 (T0, T3, and T6). The 
B1: Follow-up IPQ-RD will be completed after WCVs #1 and #2 (T1 and T4). See A1: IPQ-RD 
and B1: Follow-up IPQ-RD in Appendix E. 
● Self-efficacy (Detroit Dental Health Project, 2004) will include 9 items in which parents 
assess their confidence in their ability to take the child to the dentist despite personal 
barriers. Questions on self-efficacy are included in the A2: Parent Questionnaire (Appendix 
E) completed at all 3 WCVs (T0, T3, and T6). 
● Moderators include: caregiver health literacy (Morris et al., 2006), social support (Zimet et 
al., 1988), and socio-demographics (CDC), i.e. sex, age, race, education, occupation, and 
marital status. The A2: Parent Questionnaire (Appendix E) includes questions to collect data 
on all 3 moderators at all 3 WCVs (T0, T3, and T6). 
8.1.3 Provider 
Provider-level measures include mediators (OH knowledge and self-efficacy), a confounder 
(socio-demographic characteristics), and evaluation of implementation/fidelity (observation and 
audiotape of OH encounters) and adoption & maintenance (i.e. percentage of enrolled patients 
given a prescription and list of dentists). 
● Providers’ OH knowledge and self-efficacy to perform OH activities will be assessed through 
pre- and post-tests (Appendix E) administered before and after the didactic education 
session prior to WCV #1 (T-1) and booster sessions before WCV #2 (T2). 
● Providers’ socio-demographic characteristics (Appendix E) will be collected at the didactic 
training sessions prior to WCV#1 (T-1).  
● As an evaluation of the implementation/fidelity of the intervention, providers’ oral health 
encounters will be observed or audiotaped by study staff and evaluated using the 
ParentProvider Communication Checklist (Appendix E), the same standardized skills 
checklist used during the skills training session (T0, T3, and T6).  
● Parent/caregivers will evaluate their provider’s oral health communication and delivery of 
prescription and list of dentists on the A3: Parent exit questionnaire (Appendix E) completed 
at WCVs #1 - #3 (T0, T3, and T6). This is also an evaluation of implementation/fidelity. 
● Providers’ EMR documentation of prescriptions and lists of dentists given will be audited 
throughout the main trial (T0, T3, and T6), based on study arm. The percentage of enrolled 
caregivers who received the prescription and list of dentists will be calculated as an 

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evaluation of providers’ adoption and maintenance of the provider-level intervention and 
recorded on the EMR Audit of Practice form (Appendix E). 
 Providers will complete structured interviews with a trained moderator on implementation 
barriers/enablers to evaluate best strategies for dissemination of the oral health 
intervention. The interviews will be conducted at the pediatric practices at a time convenient 
for the provider and will contain interview questions to assess relative advantage of the OH 
intervention, compatibility of the OH intervention with the needs of the adopters, complexity 
of the OH intervention, trialability, and observability. Interviews will be conducted using 
zoom if in-person interviews are not possible due to the current COVID-19 outbreak. 
8.1.4 Practice 
Practice-level measures include mediators (organization readiness, organizational climate, and 
practice attitude) and evaluation of adoption and maintenance (percentage of enrolled patients 
with complete oral health documentation in EMR).  
● Mediators of organization readiness and organization climate (Stamatakis et al., 2012) and 
practice attitudes toward adopting evidence-based interventions (EBI)(Aarons, 2004) will be 
assessed on the Practice Questionnaire (Appendix E) among leaders and providers from all 
18 practices prior to enrollment of caregiver participants (T-1). 
● Audits of providers’ documentation of all 4 questions in EMR will be performed throughout 
the main trial (T0, T3, and T6), based on study arm. The percentage of enrolled patients with 
complete documentation (i.e. all 4 questions) will be recorded on the EMR Audit of Practice 
form (Appendix E) and serve as an evaluation of the practice’s adoption and maintenance of 
systematic documentation of OH in EMR for Arm A. 
9 ASSESSMENT OF SAFETY 
9.1 
Specification of Safety Parameters 
The principal investigator (PI) will report safety events for the study (unanticipated problems 
[UPs], adverse events [AEs], serious adverse events [SAEs]) to the Institutional Review Board 
(IRB) in accordance with the IRB’s requirements as outlined below. 
The PI will also report UPs involving risks to subjects to NIDCR. This will include UPs that meet 
the definition of a serious adverse event. 
9.1.1 Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving 
risks to subjects or others to include, in general, any incident, experience, or outcome that 
meets all of the following criteria: 
● unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved 
research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 

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● related or possibly related to participation in the research (“possibly related” means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
● suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
9.1.2 Adverse Events 
OHRP defines an adverse event as any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal sign (for example, abnormal physical exam or laboratory 
finding), symptom, or disease, temporally associated with the subject’s participation in the 
research, whether or not considered related to the subject’s participation in the research, 
(modified from the definition of adverse events in the 1996 International Conference on 
Harmonization E-6 Guidelines for Good Clinical Practice). 
9.1.3 Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
● Results in death 
● Is life-threatening (places the subject at immediate risk of death from the event as it 
occurred) 
● Results in inpatient hospitalization or prolongation of existing hospitalization 
● Results in a persistent or significant disability or incapacity 
● Results in a congenital anomaly or birth defect   
An important medical event that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, 
the event may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up 
Unanticipated problems, AE and SAEs will be recorded in the data collection system throughout 
the study. Events will be followed for outcome information until resolution or stabilization. 
Given the nature of the interventions (EMR changes, education with skills training, and 
prescription + list of dentists) it is unlikely that intervention-related SAEs or AEs will occur. 
However, throughout the study, if a caregiver or provider reports an event to any study staff; it 
will be communicated to the PI immediately. The PI will record all reportable events occurring 
any time after informed consent is obtained until the last day of study participation. 
9.3 
Characteristics of an Adverse Event 
9.3.1 Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are used: 

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1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset. 
b. An alternate etiology has been established. 
9.3.2 Expectedness of SAEs 
Given the nature of the interventions (EMR changes, education with skills training, and 
prescription + list of dentists) it is unlikely that intervention-related SAEs or AEs will occur. The 
PI is initially responsible for determining SAE/AE expectedness, and NIDCR medical 
monitor/DSMB will then review and make their determination.  An adverse event will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the intervention. 
9.3.3 Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on  
ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks medical 
attention, needs major assistance with ADL 
9.4 
Reporting Procedures 
9.4.1 Unanticipated Problem Reporting to IRB and NIDCR 
Incidents or events that meet the OHRP criteria for unanticipated problems require the creation 
and completion of an unanticipated problem report form.  The following information will be 
included when reporting an adverse event, or any other incident, experience, or outcome as an 
unanticipated problem to the IRB: 
● appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
● a detailed description of the adverse event, incident, experience, or outcome;  
● an explanation of the basis for determining that the adverse event, incident, experience, 
or outcome represents an unanticipated problem;  

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● a description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the unanticipated problem. 
 

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To satisfy the requirement for prompt reporting, unanticipated problems will be reported using 
the following timeline:   
● All unanticipated problems involving risks to subject or others must be reported to the 
UHCMC IRB within fourteen (14) calendar days of discovery of the problem or event. 
The only exception to the above timeframe is for the reporting of deaths. All internal, 
unexpected, study-related deaths must be reported to the IRB within seven calendar 
days of their discovery. Reporting to NIDCR and the CC must also occur within 7 
calendar days if death or a life-threatening event occurs or within 14 calendar days for all 
other SAEs.   
The following are examples of unanticipated problems that need to be reported by the PI to the 
UHCMC IRB as soon as possible, but in all cases within 14 calendar days: 
• 
Adverse events, which in the opinion of the PI, are both unexpected and related or 
possible related. 
o An adverse event is “unexpected” when its specificity and severity are not 
accurately reflected in the IRB approved informed consent document. 
o An adverse event is “related to the research procedures” if in the opinion of the 
PI, it was more likely than not to be caused by the research procedures, or if it 
more likely than not that the event affects the rights and welfare of current 
participants. 
o All fatal events determined to be not study-related and expected should be kept 
in the PI’s file and do not need to be reported to the IRB. 
o All fatal events determined to be not study-related and unexpected must be 
reported to the IRB at the next continuing review or study closure, whichever is 
first. 
• 
Information that indicates a change to the risks or potential benefits of the research. 
• 
A breach of confidentiality including inappropriate disclosure, lost or stolen confidential 
information. 
• 
Changes to the protocol taken without prior IRB review to eliminate apparent immediate 
hazard to a research participant. 
• 
Incarceration of a participant in a protocol not approved to enroll prisoners. 
• 
Event that requires prompt reporting to the sponsor such as disqualification or 
suspension of investigator. 
• 
Complaint of a participant when the complaint indicates unexpected risks or the 
complaint cannot be resolved by the research team. 
Protocol deviation (including accidental or intentional protocol deviation) that caused harm to 
participants or others or indicates participants or others are at increased risk of harm.All UPs 
should be reported to appropriate institutional officials (as required by an institution’s written 
reporting procedures), the supporting agency head (or designee), and OHRP within one 
month of the IRB’s receipt of the report of the problem from the PI. 
All UPs will be reported to NIDCR’s centralized reporting system via Rho Product Safety, and to 
the CC: 
● Product Safety Fax Line (US):  1-888-746-3293 

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● Product Safety Fax Line (International):  919-287-3998 
● Product Safety Email:  rho_productsafety@rhoworld.com 
● CC Safety Email:  OHDCSAE@ucsf.edu 
● CC Safety Fax Line: 1-415-502-8447 
General questions about UP reporting can be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time):   
● US:  1-888-746-7231 
● International: 919-595-6486 
9.4.2 Serious Adverse Event Reporting to NIDCR 
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an SAE form 
to NIDCR’s centralized safety system via Rho Product Safety. This report may be sent by fax or 
email. Once submitted, Rho Product Safety will send a confirmation email to the investigator 
within 1 business day. The investigator should contact Rho Product Safety if this confirmation is 
not received. This process applies to both initial and follow-up SAE reports. 
SAE Reporting Contact Information: 
● Product Safety Fax Line (US):  1-888-746-3293 
● Product Safety Fax Line (International):  919-287-3998 
● Product Safety Email:  rho_productsafety@rhoworld.com  
General questions about SAE reporting can be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time):   
● US:  1-888-746-7231 
● International: 919-595-6486 
The study clinician will complete a Serious Adverse Event Form and submit via fax or email 
within the following timelines:   
● All study-related deaths and immediately life-threatening events, , will be recorded on 
the Serious Adverse Event Form and submitted to Product Safety within 7 calendar days  
of site awareness.  
● Study-related serious adverse events other than death and immediately life-threatening 
events,  will be reported by fax within 14 calendar days  of site awareness.  
All SAEs will be followed until resolution or stabilization.  
10 
STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of a 
Data and Safety Monitoring Board (DSMB) composed of members with appropriate clinical, 
statistical, scientific, and ethical expertise. The NIDCR will appoint the Board. The DSMB will 

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meet at least annually to assess safety and effectiveness data, study progress, and data 
integrity for the study. If concerns arise, more frequent meetings may be held. The DSMB will 
operate under the rules of an NIDCR-approved charter that will be approved at the 
organizational meeting of the DSMB. The DSMB will provide recommendations to the NIDCR.   

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11 
CLINICAL SITE MONITORING 
Clinical site monitoring is conducted to ensure that the rights of human subjects are protected, 
that the study is implemented in accordance with the protocol and/or other operating 
procedures, and that the quality and integrity of study data and data collection methods are 
maintained.  Monitoring for this study will be performed by NIDCR’s Clinical Research 
Operations and Management Support (CROMS) contractor. The monitor will evaluate study 
processes and documentation based on NIDCR standards and the International Conference on 
Harmonisation (ICH), E6: Good Clinical Practice guidelines (GCP). 
Details of clinical site monitoring will be documented in a Clinical Monitoring Plan (CMP) 
developed by the CROMS contractor, in collaboration with the NIDCR Office of Clinical Trials 
and Operations Management (OCTOM) and the NIDCR Program Official. The CMP will specify 
the frequency of monitoring, monitoring procedures, the level of clinical site monitoring activities 
(e.g., the percentage of subject data to be reviewed), and the distribution of monitoring reports.  
Some monitoring activities may be performed remotely, while others will take place at the study 
site(s).  Staff from the CROMS contractor will conduct monitoring activities and provide reports 
of the findings and associated action items in accordance with the details described in the CMP.  
Documentation of monitoring activities and findings will be provided to the site study team, the 
study PIs, OCTOM, and the NIDCR. The NIDCR reserves the right to conduct independent 
audits as necessary. 
 

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12 
STATISTICAL CONSIDERATIONS 
12.1 
Study Hypotheses 
We hypothesize that providers with improved knowledge regarding the chronicity of caries and 
appropriate skills training (through bundled provider- and practice-level interventions) will deliver 
consistent reinforcing oral health facts to parents (at annual WCVs) that will result in increased 
dental utilization for their child compared to those providers delivering usual care based on AAP 
education.  
12.2 
Sample Size Considerations 
The study design will involve a cluster randomization to two arms: 
1. Bundled (Practice + provider) interventions, 2. Enhanced usual care. The assumed 
response rates (proportion of children who have dental attendance) are Arm A: 0.46 (The dental 
utilization reported among Medicaid-enrolled children by Vujicic and Nasseh, 2015 was 48%, 
but we used 46% to be conservative), Arm B: 0.30 (based on  pilot study where 30% of parent 
reported routine dental visit for child in the past year). 
Eighteen practices (comprising the clusters) will be included in the study. Practices will be 
randomized to one of the two arms using a restricted randomization scheme with the constraint 
that 9 practices will be assigned to each arm. This approach will involve the computation of a 
balance score (for each candidate randomization) based on marginal differences in three key 
practice-level variables: % Medicaid-enrolled patients [20% to 40% and >40%], ratio of patients 
to providers, county [Cuyahoga vs. other]). We use the first generated (constrained) 
randomization that provides good balance according to a pre-selected balance criterion; it may 
be reasonable to require perfect marginal balance, if (as we expect) there are a reasonably 
large number of randomizations that yield this.  
The primary objective is to compare dental care attendance between the two arms.  For 
simplicity in the power calculation we consider the binary outcome of any dental attendance in 
the two year period of follow-up. Dental attendance  will be based on a single summary score 
(number of years - out of two -  in which the child visits the dentist at least once a year). We thus 
suppose the use of a two-sided 0.05 alpha level z test (with pooled variance) for a difference in 
proportions. We assume, as a rough approximation, that the study will recruit an equal number 
of patients in each practice. Making conservative allowances for an intra-cluster (within-practice) 
correlation (ICC: in the binary dental attendance outcome) of 0.04 and a 25% drop-out rate, a 
sample size of 512 participants per arm (total n= 1024) will provide an estimated 80% power to 
detect the above difference in proportions. Alternatively, this sample size (actually 438 per 
group) will provide 90% power to detect this same effect size if the ICC is only 0.02. If the 
intervention effect is only 0.12 (0.42 versus 0.30), a sample size of 457 per group (914 total) will 
still provide 80% power with a dropout rate of 25% if the ICC is only 0.01. For the purposes of 
this study, a sample size of 512/arm (n=1024) will be recruited. 
For sample size estimates, an important secondary outcome will be incidence of new decayed 
or filled teeth (dft). Mean dft is hypothesized to decrease for Arm A relative to Arm B. Our 

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previous data (Lee et al. 2015) among 5 to 7 year old low-income children suggests a mean dft 
for usual care of 4.5 (standard deviation = 7) which we assume to be a reasonable value for the 
enhanced usual care arm in the present study. We assume the same standard deviation for the 
new intervention group, assuming normally distributed responses for the power calculation. In 
fact, as dft is a count (possibly following a distribution such as Poisson or negative binomial) it is 
likely that the standard deviation will decrease with the mean, making our approach 
conservative (McCullagh and Nelder 1989).  
We suppose the use of a two-sided 0.05 alpha level t test, to test for a difference in mean dft 
between the two groups. As done for the primary outcome, we assume an equal number of 
patients in each practice and allow for 25% dropout. For dft, a robust clinical outcome, we use a 
smaller ICC of 0.02. Then for the planned recruitment sample of 512 per arm, we will have 74% 
power to detect a 40% decrease in the mean dft (i.e., a mean dft of 2.7 in the Bundled 
intervention arm). If the ICC is only 0.1, this power will increase to 84%. 
12.3 
Planned Interim Analysis 
No interim analysis is planned. 
12.4 
Final Analysis Plan 
Primary Statistical Analysis:  
Descriptive statistics will include frequencies (categorical variables) and means (continuous 
variables) of baseline covariates among the three intervention groups. Chi-square tests (for 
categorical variables) and t- or F-tests (via ANOVA for continuous variables) will be performed 
in a preliminary analysis to test for group differences.  
For the primary outcome, we will use as an overall dental attendance score the number of years 
(over the two years 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, we 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, we 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 

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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), 
we 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), we will use 
GEE with a logit link, assuming the proportion follows a beta binomial or zero-inflated beta 
binomial distribution (Albert et al 2014). Similarly, we 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). 
In the likely event of missing responses, we 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). The missing at 
random (MAR) assumption (that missing is not related to unobserved measurements), which is 
made in the GLIMMIX approach or under certain multiple imputation approaches, is not readily 
tested empirically, but will be evaluated via scientific/contextual considerations. 
If the MCAR assumption is found to be violated we will use a multiple imputation (MI) approach 
in conjunction with the given GLIMMIX or GEE analysis using a suitable imputation model (i.e., 
using nonmissing outcome measurements as predictors of missing values). MI may also be 
considered if the MAR assumption is questioned for either GLIMMIX or GEE analyses.  
In addition to assessing the overall effects of the interventions, we will investigate the 
mechanisms (or paths) through which interventions impact dental attendance. As represented in 
Figure 4.2.1, we hypothesize that significant portions of the intervention effect will occur through 
each of several paths. For example, intervention may affect provider variables (such as 
knowledge and self-efficacy) or practice variables (such as EMR documentation, practice 
readiness, climate, and attitude) which may in turn affect caregiver illness representation which 
may in turn affect child dental attendance. Alternatively, provider variables may affect child 
dental attendance via implementation outcomes. Summary measures may be used for some 
related mediators. For example, we will consider an overall average score for the multiple item 
scores for caregiver illness representation. We will also include and assess mediators that will 

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help reveal the importance of each of the multiple components of the bundled intervention. For 
example, we can estimate the proportion of intervention effect mediated by ‘compliance’ with 
regard to EMR documentation. A relatively high mediation proportion will suggest efficacy of the 
corresponding component.  
We have previously developed a generalized causal mediation (GCM) analysis methodology 
and an accompanying R package(Albert & Nelson, 2011; Albert, Unpublished; Cho & Albert, 
Unpublished) which we will use to estimate and test each path effect and its proportion of the 
total intervention effect. The GCM method allows mediators and final outcomes of different 
types, including continuous, binary, and count (assumed to have normal, Bernoulli, and Poisson 
or negative binomial distributions, respectively). These options will accommodate the mediators 
and final outcome (dental attendance, summarized as a binary response) in our model. Each 
outcome (including mediators) is modeled using a generalized linear model that includes as 
covariates possible baseline confounders as well as causally preceding variables according to 
the causal model (as in Figure 4.2.1). The method uses an extended version of the mediation 
formula and assumes an extended version of the sequential ignorability assumption.(Albert et 
al., Unpublished) Bootstrap resampling is used to compute confidence intervals and a cluster 
bootstrap option is available to account for unexplained between-cluster (e.g. provider) 
variability.  
Adjustment for Baseline Characteristics:  Estimated intervention effects will be adjusted for the 
following baseline socio-demographic variables: child’s age, race, and caregiver SES, 
education, and marital status.  
Model Assumptions: We will assume that the probabilities of dental care receipt follow a logistic 
regression model with the included covariates and random effects. Per the standard approach, 
random effects will be assumed to be independent, normally distributed, and outcomes 
assumed conditionally independent given the random effects. If multiple random effects (e.g., 
for different cluster levels) are used, they will be assumed to be independent. For secondary 
outcomes, analogous assumptions, including the assumption of the correct link function, will be 
made. 
Evaluations for the development of the Tool Kit: We will develop a tool kit containing the oral 
health didactic and skills curriculum, and resources (for providers and parents) that can be 
distributed to professional organizations (AAP, AAPD, ADA, AANP). This tool kit will be based 
on the results of the cRCT and will contain OH activities that have demonstrated to be effective, 
have content that is easy to tailor and apply for stakeholders beyond the study participants, and 
a table of contents for navigation to the relevant content. Specifically, the results of the cRCT 
(effectiveness of arm A vs. arm B), process outcomes from the cRCT (provider adoption, 
implementation metrics such as score cards of EMR audits and parent exit survey, 
costeffectiveness analysis) will be combined with the structured interview data that will be 
collected from the providers to evaluate the dissemination/diffusion strategy to be used for the 
tool kit. The newly developed OH tool kit would be reviewed by a random sample of 20% of 
participating primary care providers (≈12 providers) to obtain their views and input on whether 
the tool kit is easy to understand; use; provides the necessary information for the delivery of 
evidence-based oral health care in primary care settings; and to solicit any changes to be made. 

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13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate research records for this study, in compliance with ICH E6, 
Section 4.9 and regulatory and institutional requirements for the protection of confidentiality of 
subjects. CWRU will permit authorized representatives of NIDCR, the CC at UCSF and 
regulatory agencies to examine (and when required by applicable law, to copy) research 
records for the purposes of quality assurance reviews, audits, and evaluation of the study 
safety, progress, and data validity. 
All records with identifiable information will be kept in secured locked storage units or stored in 
secure online databases. Only local (i.e. study staff) at CWRU, the Medical Monitor/DSMB, and 
NIDCR staff appointed to the trial will have access to the records.  Access by the DSMB and 
NIDCR staff is for the purposes of quality assurance reviews, audits, and evaluation of the study 
safety and progress. 
Specific original documents and data records include, but are not limited to: 
▪ 
Parent Consent chart contains all participant-identifying information. The chart includes 
the signed consent form, Consent Documentation form, the Parent Contact Info form, 
Unanticipated Problem or Serious Adverse Event forms, Telephone Contact log and 
Parent Reimbursement form. These documents will contain the participant’s name and 
other confidential information (i.e. names of child/children and other family members). 
(Electronic and Paper Based) 
 
▪ 
Parent/Child Research chart includes Case Report Forms (CRFs) and the Progress  
Notes Checklist. Examples are: child’s ICDAS caries dental assessment form (WCVs #1, 
#2, & #3); and parent/caregiver’s IPQ-RD and Parent Questionnaire (WCVs #1, #2 & #3) 
along with follow-up questionnaires (WCVs #1 & #2). (Electronic and Paper Based).  
Medical abstraction for child illnesses will be from the EMR of the participating practices. 
Medicaid dental claims data will be used to assess dental attendance for the child. 
▪ 
Provider Consent chart contains all participant-identifying information for providers. 
The chart includes the signed consent form, consent documentation form, and provider 
sociodemographic questionnaire. (Electronic and Paper Based). 
▪ 
Provider Research chart will include the provider training pre- and post-tests, and data 
from the provider score card from the study staff observations. (Electronic and Paper  
Based). Structured interview transcripts will also be stored in the provider research chart. 
 
▪ 
Tracking logs (in RedCap) (Electronic) 
▪ 
Electronic Audio Recording of patient encounter to evaluate implementation of 
delivery of oral health facts. Recordings of structured interviews will be kept until the 
interview has been transcribed. 
 
▪ 
Memoranda (paper-based) 
Some case report forms and all abstractions from EMR and Medicaid dental claims will be 
completed by study staff (Research Assistants, the Research Associate, or Project Coordinator, 
depending on the event).  Exceptions will be the questionnaires (IPQ-RD and Caregiver 

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Questionnaires), Parent Contact information and Consent form(s) that will be completed by the 
parent/caregiver. The study staff will complete all provider audit forms. Completion of essential 
documents will follow the guidelines outlined in Section 10.4 of the MOP for Case Report forms.  
Data will be handled in accordance with GCP, U.S. federal regulations, local regulations (if 
applicable), and instructions from NIH.  All essential documents should be filled out completely 
and signed by the study staff collecting or recording the data.  When necessary, essential 
documents (like consent/assent forms) will be reviewed, signed and dated by the principal 
investigators or study staff designated by the principal investigators.  
 

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14 
QUALITY CONTROL AND QUALITY ASSURANCE 
14.1 
Definitions 
Quality Assurance (QA) 
The process to ensure the quality of the intervention meets the study design expectations. 
Quality Control (QC)  
A set of routine technical activities to measure and control the quality of the intervention and 
accuracy of data acquisition as the intervention is being implemented.   
14.2 
Study Intervention and Study Questionnaires 
14.2.1 Quality Assurance Procedures 
Study-Site Specific: 
Study staff who will recruit and interact with parents/caregivers at the practices, and document 
study activities will attend in-person training which will incorporate the topics of human subject 
protection, Good Clinical Practice (GCP), and adherence to the study protocol. As part of 
tracking and managing study records, staff members will learn how to document activities that 
occur with subjects, update study documentation and use the tracking and audit logs. To assess 
proficiency, the study staff will be certified in the topics presented to ensure their comprehension 
of the expectations.  
In addition, all study staff will be trained to make calls during the dedicated staff training. A script 
for each type of call will be created and adherence to the script for study staff telephone contact 
with caregivers will be assessed throughout the study to ensure that they have not provided 
additional information to the children’s’ caregivers that might influence the outcome. (To be 
detailed further in MOP section 5). 
Additionally, the dental hygienists will undergo calibration exercises prior to the main study to 
become proficient in exam related study procedures and to maintain intra- and inter-examiner 
agreement.  The gold standard examiner will calibrate/train the examiners in the ICDAS protocol 
in a 4-day training session. Detailed caries assessment and examiner training, calibration and 
reproducibility protocols will be outlined in the section 5 of the MOP. Hygienists will not utilize 
dental radiographs. At the follow-up and final WCV screenings, the hygienists will not have 
access to the results of the baseline examination to avoid detection bias.  
On the practice level, enhancements to the EMR system to include OH will be implemented 
prior to enrolling any parent/child dyad into the study. Providers will be trained and given a 
manual for EMR documentation for future reference. Study staff will receive formal training to 
evaluate providers’ oral health encounters (through observation or audiotaping), perform audits 
of EMR documentation, and provide score card feedback to providers. Prior to enrollment of 
parent/caregivers, study staff will be trained by the communication specialist in a 60-minute 
session. Training will focus on evaluation of providers’ skills during oral health encounters with 
caregivers. 

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In education sessions for the provider, instructors will follow scripts to ensure that the curricula 
are delivered in the same way for each group of clinicians to ensure fidelity. The training will be 
conducted by Drs. Nelson, Ferretti, and Lord. Booster training will be conducted yearly or as 
needed if there are deviations in protocol.  
CC Specific: 
Before formal data entry begins, appropriate study staff will be trained on a custom-configured, 
study-specific Electronic Data Capture (EDC) test system. This procedure is for data entry 
training and user acceptance testing, concurrently. After completing didactic training, staff 
trainees will enter pre-specified test data into the test EDC system, including invalid data, to 
provide additional training and familiarity with the data entry process. Their entered data will be 
compared against the pre-specified test data. After completion of training, staff members will be 
granted permission to use the EDC production environment for collection of project data. 
14.2.2 Quality Control Procedures 
Study-Site Specific: 
Data quality control is primarily conducted at the study team level through internal processes of 
data review/data monitoring as the data is collected and through periodic custom reports 
generated by the CC (See Table 16.4.1). Dental screening data will be reviewed for accuracy 
and completeness after each study visit by the Dental Hygienist.  The Research Assistants will 
review the questionnaires after the participants have completed them. Each paper form and 
questionnaire will be entered and verified by two separate individuals.  Forms completed 
electronically via tablets will be checked by study staff prior to the parent/caregiver leaving the 
WCV. Any field that is unclear will be clarified with the parent/caregiver who completed the 
document.   
In addition, the first five (5) study staff telephone contacts (reminder calls to return the B1 
questionnaires) will be audio recorded in digital media and reviewed. Then, the first five (5) B2 
follow-up calls will be recorded and reviewed for each staff member.  At the beginning of the 
study, the Project Coordinator will review the first five telephone contacts to ensure fidelity of the 
calls and accuracy of data recording. Study staff will be provided with feedback on their 
performance and conduct including but not limited to these specific areas; adherence to 
telephone script, adherence to protocol/MOP, adherence to good clinical practice. Study staff 
with telephone contact with less than acceptable quality will receive a private training session 
focused on problematic areas.  This QC activity will take place until the first five sessions have 
been completed.  This will ensure that any weaknesses in study protocol will be addressed 
early.   
All study forms and questionnaires collected and entered into the database will be checked for 
inconsistencies and range and assessed for missing data.  Any inconsistencies, outliers, or 
missing data observed will be compared to the paper document and appropriate corrective 
actions carried out. 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. 

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CC Specific:  
The CC will assist with the design of custom reports. Utilization of an EDC system, such as 
REDCap, means that automated data checks can be implemented within the data entry system. 
This helps to prevent most errors immediately. The automated checks are also supported by an 
extensive system of custom reports and manual validation procedures that help to assist in the 
resolution of any additional errors.   
The CC will create a standalone Data Validation Plan (DVP). The DVP will describe in more 
specific detail the edit-checks that will be performed within the EDC system and the SOPs for 
data entry and quality management. The CC Clinical Research Specialist and the Data Manager 
assigned to the specific project, together with the study team, will be responsible for the 
creation, testing, and finalization of the DVP for the project. 
Following collection of all data from a project, additional data processing will be required by the 
CC, e.g., longitudinal coding of dental examination data, creation of psychosocial scale scores.  
In conjunction with that data processing, 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. Following PI concurrence, the database will be locked. 
 

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15 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human  
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 
46 and/or the ICH E6.  
15.2 
Institutional Review Board 
  The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the University Hospitals Cleveland Medical Center (FWA#: 00004428) IRB for 
review and approval.  Approval of both the protocol and the consent form must be obtained 
before any subject is enrolled.  Any amendment to the protocol will require review and approval 
by the IRB before the changes are implemented in the study.   
15.3 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the 
study and continues throughout study participation.  Extensive discussion of risks and possible 
benefits of study participation will be provided to subjects and their families, if applicable.  A 
consent form describing in detail the study procedures and risks will be given to the subject.  
Consent forms will be IRB-approved, and the subject is required to read and review the 
document or have the document read to him or her.  The investigator or designee will explain 
the research study to the subject and answer any questions that may arise.  The subject will 
sign the informed consent document prior to any study-related assessments or procedures.  
Subjects will be given the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate.  They may withdraw consent at any time throughout the course 
of the study.  A copy of the signed informed consent document will be given to subjects for their 
records.  The rights and welfare of the subjects will be protected by emphasizing to them that 
the quality of their clinical care will not be adversely affected if they decline to participate in this 
study. The consent process will be documented in the research record.   
Active participants completing WCV3 that will be asked to complete the COVID-19 Dental Visit 
Questionnaire will be re-consented with the consent form updated 12/7/20.  
All active providers that will be asked to complete a structured interview will be re-consented 
prior to the structured interview session.  
15.4 
Subject Confidentiality 
Subject confidentiality is strictly held in trust by the investigators, study staff, representatives for 
University Hospitals Cleveland Medical Center Institutional Review Board, and the 
representatives of the study sponsor (NIDCR).   
The study protocol, documentation, data, and all other information generated will be held in strict 
confidence.  No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. 

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The study monitor or other authorized representatives of the sponsor may inspect all study 
documents and records required to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) for the study subjects.  The clinical study site will 
permit access to such records. 
All information about the provider and parent/caregiver will be kept strictly confidential and be 
used only for study purposes. When study results are published or presented, all information will 
be presented in group form, without identifiable information. 
 

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16 
DATA HANDLING AND RECORD KEEPING 
The investigators are responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported.  All source documents should be completed in a neat, legible 
manner to ensure accurate interpretation of data.  The investigators will maintain adequate case 
histories of study subjects, including accurate case report forms (CRFs), and source 
documentation. (Will be detailed in the MOP) 
The study staff will collaborate and interact with the CC to perform data management and 
quality control activities. 
16.1 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the Research Assistants, 
Data Manager and Study Coordinator under the supervision of the PI. All source documents 
must be reviewed by the study team and data entry staff, who will ensure that they are accurate 
and complete. Unanticipated problems and adverse events must be reviewed by the PI.   
16.2 
Data Capture Methods 
Data for this study will be captured using dental screenings, forms, questionnaires, and audio 
recordings.  Study data will be collected and stored using the REDCap platform hosted by 
University of California-San Francisco, the home institution of the CC. The UCSF Coordinating 
Center will end its coordinating activities at the conclusion of their funding period. However, our 
study activities and funding will go on beyond the time when CC ends its activities, therefore the 
CC has indicated that it will transfer all data from UCSF REDCap to UHHS REDCap so that the 
study team can complete its data collection, entry, checking, and analysis activities. The data 
will be transferred in a secure manner to UHHS REDCap and all data for the study will then 
reside in UHHS REDCap. REDCap is a secure, web-based application designed to support 
remote data capture for research studies, providing: 1) an intuitive interface for validated data 
entry, 2) audit trails for tracking data manipulation and export procedures, 3) automated export 
procedures for seamless data downloads to common statistical packages, and 4) procedures for 
importing data from external sources. 
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.   
16.3 
Types of Data 
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, (7) EMR audit data, and (8) structured interview 
transcripts.  Additionally, audio recordings will be used for fidelity monitoring and to capture 
responses from the provider structured interviews. Form revisions should be minimal; however, 
should they occur, changes will be submitted to the CC for updating and dissemination to study 
staff. 

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16.4 
Schedule and Content of Reports 
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. See Table 16.4.1 for the project-specific 
custom reports for the main trial. 
 

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Table 16.4.1 Project-specific custom reports created by CC 
Responsible 
for Addressing  
Name of Report 
Frequency 
CC 
Weekly Enrollment  
Weekly during recruitment 
CC 
Cumulative Enrollment  
Weekly during recruitment 
CWRU 
Informed Consent & Documentation Errors 
Weekly during recruitment 
CWRU 
Fidelity Monitoring  -Provider Level 
As Required by CWRU 
CWRU 
Fidelity Monitoring  - Practice Level 
As Required by CWRU 
CWRU 
B1 Calls  
As Required by CWRU 
CWRU 
B1 Incentive Mailing  
As Required by CWRU 
CWRU 
B2 Calls 
As Required by CWRU 
CWRU 
B2 Incentive Mailing 
As Required by CWRU 
CWRU 
Child Illness EMR Abstraction  
As Required by CWRU 
CWRU 
Audit of OH Documentation  
As Required by CWRU 
CWRU 
WCV to  be scheduled 
As Required by CWRU 
Study-Site Specific: 
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. 
At the completion of the study, the study Biostatistician will conduct analyses of the data and 
assist in preparation of study publications and presentations. The Data Manager will provide 
technical and data support for the Biostatistician throughout the study. 
Coordinating Center (CC): 
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. The CC will generate a 
monthly enrollment report (or as requested by the DSMB or NIDCR Program Official) for sharing 
progress of the study (see table 16.4 above). 
16.5 
Study Records Retention 
Study documents should be retained for 3 years after the final financial report for the grant. 
These documents may be retained for a longer period, however, if required by local regulations 
or UHCMC IRB.     
16.6 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol or Good Clinical  

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Practice requirements.  The noncompliance may be on the part of the subject, the investigator, 
or study staff (e.g., Project Coordinators, Research Assistants).  As a result of deviations, 
corrective actions are to be developed by the PI and/or Project Coordinator, and implemented 
promptly. 
These practices are consistent with investigator and sponsor obligations in ICH E6: 
● Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
● Quality Assurance and Quality Control, Section 5.1.1 
● Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents and 
promptly reported to NIDCR and the UHCMC IRB, according to their requirements as outlined 
below 
According to UHCMC IRB, Major Deviations are reported to the IRB within 14 calendar days of 
discovery. Minor Deviations are kept in the investigator’s file to be reported at the time of 
continuing review. 
Examples of Major Deviations: 
• 
Failure to obtain informed consent, i.e., there is not documentation of informed consent  
or informed consent was obtained  after initiation of study procedures; 
• 
Informed consent obtained by someone not approved to obtain consent for the protocol; 
• 
Use of invalid consent form, i.e. consent form without IRB approval; or outdated/expired 
consent form; 
• 
Enrollment of a participant who was ineligible for the study; 
• 
Performing a research procedure not in the approved protocol; 
• 
Failure to report serious adverse event to IRB; sponsor; and/or regulatory agencies; 
• 
Failure to follow the approved study protocol that affect participant safety or data 
integrity (e.g., study visit missed or conducted outside of required timeframe, or failure to 
perform a laboratory test); 
• 
Failure to follow safety monitoring plan; 
• 
Continuing research activities after IRB approval has expired; 
• 
Use of recruitment procedures that have not been approved by the IRB; 
• 
Enrolling significantly more subjects than proposed in the IRB protocol; 
Examples of Minor Deviations: 
• 
Missing original signed and dated consent form (only a photocopy available); 
• 
Missing pages of executed consent form; 
• 
Failure to follow the approved study protocol that does not affect participant safety (e.g., 
study procedure conducted out of sequence, failure to perform a required test, missing 
laboratory results, study visit conducted outside of required timeframe.). 
 
 

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17 
PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public has 
access to the published results of NIH funded research. It requires scientists to submit final 
peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed 
Central upon acceptance for publication. 
Data from this study will be shared in accordance with the NIH Data Sharing Policy.  
https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm 
This study will be registered and results updated periodically through ClinicalTrials.gov in 
accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information to 
promote broad and responsible dissemination of information from NIH-funded clinical trials.  
https://www.federalregister.gov/documents/2016/09/21/2016-22379/nih-policy-on-
thedissemination-of-nih-funded-clinical-trial-information 
 

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18 
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