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BinkleyandJohnsonarticleonoralhealthPRECEDE1.pdf
Application of the PRECEDE-PROCEED Planning Model in Designing an Oral Health Strategy
Catherine J. Binkley1 and Knowlton W. Johnson2
1 Department of Surgical & Hospital Dentistry, University of Louisville, Louisville, KY, USA
2 Pacific Institute for Research & Evaluation, Louisville, KY , USA
Abstract
Background—Although the poor oral health of adults with intellectual and developmental
disabilities (IDD) constitutes a significant health disparity in the United States, few interventions
to date have produced lasting results. Moreover, there is minimal application of planning models
to inform and design a theory-based strategy that has the potential to be effective and sustainable
in this population.
Methods—The PRECEDE-PROCEED planning model is being used to design and evaluate an
oral health strategy for adults with IDD. The PRECEDE component involves assessing social,
epidemiological, behavioral, environmental, educational, and ecological factors that informed the
development of an intervention with underlying social cognitive theory assumptions. The
PROCEED component consists of pilot-testing and evaluating the implementation of the strategy,
its impact on mediators and outcomes of the population under study.
Results—A The PRECEDE assessment and strategy design results are presented including a
conceptual framework and oral health strategy that are linked to social cognitive theory and Health
Action Process Approach. We have developed a strategy consisting of a planned actions, capacity
building, environmental adaptations, and caregiver reinforcement within group homes. The
strategy is designed to increase caregiver self-efficacy, outcome expectancies, and behavioral
capability, and also to create environmental influences that will lead to improved self-care
behavior of the adult with IDD. It is anticipated that this strategy will improve the oral health and
quality of life, including respiratory health, of individuals with IDD. The planned PROCEED
component of the planning model includes a description of an in-process pilot study to refine the
oral health strategy, along with a future randomized controlled clinical trial to demonstrate its
effectiveness.
Conclusions—The application of the PRECEDE-PROCEED planning model presented here
demonstrates the feasibility of this planning model for developing and evaluating interventions for
adults within the IDD population.
Keywords
Oral health; Adults with intellectual and developmental disabilities; PRECEDE-PROCEED planning model; Social cognitive theory; Health Action Process Approach; Oral health strategy
Corresponding Author: Catherine J. Binkley. [email protected].
NIH Public Access Author Manuscript J Theory Pract Dent Public Health. Author manuscript; available in PMC 2014 October 16.
Published in final edited form as: J Theory Pract Dent Public Health. ; 1(3): .
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The poor oral health of adults with intellectual and developmental disabilities (IDD) living
in community settings constitutes a significant health disparity in the United States (1, 2).
Efforts have been made to develop and evaluate various strategies to improve the oral
hygiene and oral health of this vulnerable population with minimal to moderate success
(3-7). None of these interventions used a planning model or theory-based behavior change
intervention for caregivers of individuals with IDD. To the best of our knowledge there are
only a few reports of how a planning model is used in dental public health (8, 9), but these
reports are not used to develop a theory-based oral health strategy or intervention for
individuals with IDD.
Planning, designing, and evaluating interventions to impact public dental health can be a
challenging and time-consuming undertaking. The National Institute for Dental and
Craniofacial Research (NIDCR) places emphasis on the importance of using intervention
planning models such as PRECEDE-PROCEED, the role of health behavior theory in
developing interventions, and mediators, moderators, and testing for mechanisms of action.
Moreover, the NIDCR strongly encourages investigators “to utilize methods that allow for a
test of mechanisms of action. Mechanisms of action are causal explanations for behavior.
These are distinguished from correlates, predictors, risk and protective factors, etc., which
may be candidate mechanisms, but have not been demonstrated to have a causal link with
the outcome(s) of interest” (http://www.nidcr.nih.gov/Research/DER/bssrb.htm) (10).
The PRECEDE-PROCEED model can be used to design and evaluate an oral health
promotion effort. The PRECEDE component allows a researcher to work backward from the
ultimate goal of the research (distal outcomes) to create a blueprint to instruct the formation
of the intervention or strategy (11). The PROCEED component may lay out the evaluation,
including pilot study and efficacy study methodologies. The model has been used by Watson
and colleagues to design an oral health promotion program in an inner-city Latino
community (12); by Cannick and colleagues to guide the training of health professional
students (13); and by Sato (9) and Dharamsi (14) to analyze attitudes and prediction factors
regarding oral health. Although this planning model has been applied in oral health, there
are others such as RE-AIM (15) and the Stage Model of Behavioral Therapy (16) that
achieve the same goal of organizing the framework for an oral health promotion program. It
is important to remember that planning models are not health behavior theories because they
cannot test mechanisms of action or causal relationships (10).
Of particular importance to the PRECEDE-PROCEED planning model is the role of theory
in creating a conceptual framework that guides construction of an intervention and its
evaluation (11). We believe it is important to develop a planned intervention for oral health
that draws from multiple theories. Several behavioral change theories have reportedly been
used in designing oral health intervention strategies. One of the most common is Bandura's
Social Cognitive Theory (SCT), which posits that the process of human adaptation and
change is a dynamic interplay of personal, behavioral, and environmental factors (17). The
literature suggests that interventions designed to impact these three factors are more likely to
produce desired changes in outcomes (17-19). Personal factors may play a major role in a
person's capability to perform behaviors. Environmental factors may hinder a person's
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ability to adequately perform a behavior and impact their self-efficacy (a personal factor) in
performing the behavior of interest. The reciprocal nature of these determinants of human
functioning make it possible to design interventions to impact personal, behavioral, or
environmental factors. Schwarzer's Health Action Process Approach (HAPA) (20, 21) uses
social cognitive constructs, including outcome expectancies and self-efficacy as well as
planned actions, in predicting behavior change. This approach provides a framework for
prediction of behavior and reflects the assumed causal mechanisms of behavior change (21).
HAPA has been used to describe, explain, and predict changes in health behaviors in a
variety of settings (21) including oral health (22).
METHODS
This article presents the application of the PRECEDE-PROCEED Model (23) as a planning
tool for oral health. (11) PRECEDE (Predisposing, Reinforcing, and Enabling Constructs in
Educational Diagnosis) outlines a diagnostic planning process to assist in the development
of targeted and focused public health programs. PROCEED (Policy, Regulatory, and
Organizational Constructs in Educational and Environmental Development) highlights the
implementation and evaluation of the intervention designed in the PRECEDE component.
Although an eight-phase planning model as presented in the literature is being used, we have
tweaked the PROCEED component (phase 5) to include pilot testing for revising the original
strategy before implementing and evaluating the intended processes, impact, and outcomes
of the intervention. Soliciting input from key informants of the community actively involved
with the population of interest is important in all phases of assessment. The Institutional
Review Board of the University of Louisville reviewed the research (11.0338) and approved
the study including all consent forms for the pilot test of the oral health strategy.
PRECEDE Planning Model Component
We used an extensive literature review and informal discussions with selected community
leaders and staff who work with IDD population in a targeted Midwestern city. These
participants consisted of one vice president, one residential director, and three caregivers
working in group homes of one IDD service organization, and two dentists and three dental
hygienists/assistants who work with IDD population. In total, interview data were collected
from 10 IDD and dental care persons. Each of these participants engaged in an informal
discussion that posed questions central to the assessment of phases 1-4. A content analysis
of the literature and discussions produced the results presented later.
Phase 1 - Social Assessment—The PRECEDE portion of the Model begins with
diagnostic activities that identify desirable outcomes or goals of the intervention or ask,
“What can be achieved?” These activities determined the primary or distal outcomes of the
oral health strategy for the individual with disabilities.
Phase 2 - Epidemiological, Behavioral, and Environmental Assessment—We
searched the literature and asked questions of the selected community leaders and healthcare
staff noted above about what problems or issues affect the oral health-related quality of life
for persons with IDD? - OR - What needs to change to achieve optimal oral health for these
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individuals? This phase determined epidemiological, behavioral, and environmental factors
that may well have an impact on the oral health and quality of life of individuals with IDD.
This phase contributed to the identification of the factors that an oral health strategy needs to
impact (mediating outcomes) in order to achieve the primary outcomes.
Phase 3 - Educational and Ecological Assessment—This phase determined factors
that, if modified, would be most likely to result in behavior change and to sustain this
change process. These factors are generally classified as predisposing, enabling, and
reinforcing factors (23). “Predisposing factors are antecedents to behavior that provide the
rationale or motivation for the behavior” (p.415) (24) and include individuals’ existing skills
and self-efficacy. “Enabling factors are antecedents to behavioral or environmental change
that allow a motivation or environmental policy to be realized” (p.415) (24) and may include
new skills, services, resources, and programs. Reinforcing factors are those factors following
a behavior that provide continuing reward or incentive for the persistence or repetition of the
behavior” (p.415) (24) and they include social support, praise, and vicarious reinforcement.
Change theory(ies) for designing the intervention after this assessment includes individual,
interpersonal, and community theories. Individual-level theories are best used to address
predisposing factors, while interpersonal-level theories, such as social cognitive theory,
address reinforcing factors well; community-level theories are most appropriate for
addressing enabling factors. (24).
Phase 4 - Intervention Alignment and Administrative and Policy Assessment
Phase 4a - Intervention Alignment: This phase matched appropriate strategies and
interventions with the projected changes and outcomes identified in phases 1-3 (23). Using
assessment results from phases 1-3, the oral health strategy presented in the results section
emerged as our intervention of choice.
Phase 4b - Administrative and Policy Assessment: In this phase, resources, organizational
barriers and facilitators, and policies that were needed for the strategy or intervention
implementation and sustainability were identified (24). The organizational and
environmental systems that could affect the desired outcomes (enabling factors) were taken
into account. The administrative diagnosis assessed resources, policies, budgetary needs,
and organizational situations that could hinder or facilitate the development and
implementation of the strategy or program (25). The policy diagnosis assessed the
compatibility of the oral health strategy with those of the organizations providing services to
individuals with IDD.
PROCEED Planning Model Component
Phase 5 - Pilot Study—Although we did not recognize the inclusion of a pilot study as
essential to the PRECEDE-PROCEED planning model, we believe that it is an important
planning phase. These results and lessons learned are important to revising both the pilot
oral health strategy and its evaluation for an efficacy study. To this end, we have provided a
description of our inprogress pilot study in the results section of this article.
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Phase 6 - Implementation—This phase presents a description of the implementation of
the oral health strategy in an efficacy study. Key roles in the implementation phase are
highlighted.
Phases 7 and 8 - Process and Outcome Evaluation—Our planned efficacy study is
designed as a cluster randomized control trial that includes a process and outcome
evaluation. The study of both the implementation process and outcome achievements is
important. The implementation process assessment should address the amount of
intervention exposure of the oral health strategy (dosage), extent to which an intervention is
implemented as designed (fidelity), and participant appraisal of intervention quality or
usefulness (participant reaction), all of which are discussed in the evaluation literature (26).
In addition, we measured adequacy of implementation by recruiting an expert panel who has
published implementation articles to assess the adequacy of our implementation (27). The
outcome evaluation should be composed of an assessment of oral health strategy direct
effects on outcomes, mediation of outcomes designated as mechanisms of change, and
moderation of contextual factors. Our evaluation plans are highlighted in the results section
of this article.
RESULTS & DISCUSSION
We present the results of the PRECEDE component of the planning model being
demonstrated. The planned PROCEED component is also described.
PRECEDE Phase 1 - Social Assessment
Our social diagnosis began while we were conducting previous studies in long-term care
facilities and in community settings for persons with IDD. During this planning phase, we
solicited input from the community (direct care staff, administrators, and dental
professionals who care for persons with IDD), and they all stated that poor oral health is one
of the greatest unmet health care needs of their population (28). The community was also
becoming aware of the association of aspiration of bacteria from the mouth into the lungs
with respiratory infections, and it wanted to improve oral health and oral health-related
quality of life including respiratory health.
PRECEDE Phase 2 - Epidemiological, Behavioral, and Environmental Assessment
A. Epidemiological Assessment—Historically, children and adults with mild to
profound intellectual and developmental disabilities (IDD) either lived at home or were
placed in large state institutions with fully staffed medical and dental facilities and stable,
well-trained workers. Over the past several decades, a major effort to deinstitutionalize these
individuals and place them in smaller community residences has been successful. Although
overall quality of life may have been improved for this vulnerable population, their access to
dental care has become limited or non-existent, and their oral health has suffered (29). A
majority of persons with IDD are insured by Medicaid, and many dentists either do not
accept Medicaid or do not believe they are adequately trained to treat special-needs patients.
The oral health of this population is compromised not only by the lack of preventive dental
treatment every six months but also by their inability to adequately brush and/or floss their
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own teeth. The oral hygiene provided or supervised by caregivers is thus critical to
maintaining oral health and reducing the need for extensive restoration or extraction of teeth.
Providing oral care for individuals with IDD is challenging, not only because they may have
physical impairments but also because they exhibit uncooperative behaviors (30). Caregivers
often only clean the anterior teeth, ignoring the posterior teeth and causing the posterior
oropharyngeal area to be at risk for colonization with bacteria and infection (31-33).
Swallowing disorders (dysphagia) are common in persons with developmental disabilities,
putting them at risk for aspiration and respiratory infections, a major cause of morbidity and
mortality in this population (34, 35). Similar to what occurs with elderly persons residing in
nursing homes and patients in intensive care units, (36, 37) potentially pathogenic bacteria
colonize the oropharyngeal area of people with IDD. (38) Rigorous oral hygiene can reduce
oral colonization with bacteria and yeasts, thus reducing pneumonia in at-risk individuals
(39, 40).
Although social initiatives that focus on increasing the number of dentists who will treat
special-needs patients are needed, it remains the purview of the caregiver to supervise and/or
provide oral hygiene. Thus, theoretically sound strategies or interventions that address the
caregiver's behavioral capability in providing oral health support may reduce disparities and
could be imperative for improving health and quality of life in this population.(28, 41)
B. Behavioral Assessment—We determined key behavioral factors of the individual
with IDD that affect mechanisms impacting their oral health and quality of life. Individuals
with IDD have physical, behavioral, and cognitive disabilities that negatively impact their
ability to perform their own oral hygiene practices at an optimal level (42). Those with mild
disability, who are capable of performing their oral hygiene, frequently do not prioritize
brushing or flossing their teeth on a regular basis and often do not know how to perform
these practices optimally. Those with moderate to profound disabilities may be able to
partially perform their oral hygiene, but they often require assistance and/or supervision
provided by caregivers to adequately clean their teeth. Also, due to their emotional and
unpredictable episodes, as the caregivers call them, all IDD persons may exhibit
uncooperative and/or resistant behaviors from time to time that prevent them from engaging
in oral hygiene practices regularly.
Like the parents of very young children, caregivers also play a key role in shaping the
behavior of adults with IDD, who frequently have a mental age lower than that of a 5-year-
old child without disability. Adults with disabilities generally do not achieve an acceptable
standard of oral health on their own. However, Shaw and colleagues demonstrated that if
these IDD persons are supervised, encouraged, and motivated by caregivers, their oral
hygiene can be improved (43). Caregiver behavior in the form of support of the adult with
IDD oral health, coupled with the caregiver's self-efficacy in promoting the adult's self-care
behavior, should improve the residents’ oral hygiene practices.
C. Environmental Assessment—We identified environmental barriers or influences
that are key factors in social cognitive theory. First, the physical environment in group
homes is frequently not conducive to optimal oral hygiene practices. Materials available for
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oral hygiene usually include only over-the-counter toothbrushes, which may not be adequate
to address the residents’ disabilities.
Second, our assessment of the social environment in the group homes determined that there
were no policies or procedures in place concerning oral health or oral hygiene practices.
Implementation of policies and procedures related to oral health by the organizations that
manage the group homes would provide all caregivers with guidelines for and expectations
of their performance. We found that all caregivers are responsible for preparing either
breakfast or dinner during the week, and on weekends they must prepare all meals and/or
take the residents out to lunch. As such, they are the primary persons responsible for
determining what the residents eat and drink while in their care and they hold the
responsibility of ensuring the availability of an appropriate diet in the group home setting to
reduce the risk of tooth decay.
PRECEDE Phase 3 - Educational and Ecological Assessment
A. Predisposing Factors—We identified potential factors that may need to be modified
to effect changes in caregiver behavior. We identified these factors based on discussions
with our community leaders and a review of the literature. These social cognitive factors-
self-efficacy, outcome expectancies, and behavioral capability-may be important because
merely providing education to caregivers in oral hygiene provision for dependent persons
has been shown to be minimally effective in improving oral health (5, 44).
Self-efficacy is defined as “people's judgments of the capabilities to organize and execute
courses of action required to attain designated types of performances” (17, p. 391). Self-
efficacy in oral hygiene, or the perceived ability or confidence of an individual to perform
good tooth brushing and flossing, has been shown to be important in previous oral health
studies (45-48). Caregivers reported to us that they had knowledge of the importance of oral
health but stated that they were not comfortable supervising or assisting the residents in oral
hygiene procedures. The literature reports that parental/caregiver self-efficacy in supporting
or supervising young children's oral hygiene can be a strong predictor of parental/caregiver
oral hygiene support (49, 50).
Outcome expectancies are defined as “a person's estimate that a given behavior will lead to
certain outcomes” (p.193) (51) or beliefs about the likelihood and value of behavioral
choices. Caregiver psychosocial factors, such as expectations of poor oral health in their
residents/clients, may serve as a barrier to optimal oral hygiene behavior (52-54). Outcome
expectancies may be impacted by individuals seeing like individuals perform the behavior
and/or encouragement to them that they are capable of performing the behavior (55, 56).
Demonstrations of oral health behaviors by a dental hygienist and the subsequent modeling
of the behavior by the caregivers may impact their outcome expectancies of providing oral
health support.
Behavioral capability is defined as someone's actual ability to perform a behavior in real-life
situations. A caregiver must know what oral health support behavior is and have the skills to
perform it. Informal interviews conducted with caregivers (direct care staff) in the group
homes revealed that they received virtually no training or support in supervising or
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providing oral health services or dietary supervision for their adults with IDD. As previously
stated, we know that providing only didactic training to caregivers does not result in
improved resident oral health (5), which suggests that building behavioral capability is also
necessary.
B. Enabling Factors—Our literature review identified factors external to the caregivers
and adults with IDD that could be impacted by our strategy to improve oral health. These
factors-planned action, capacity building, and environmental adaptation-would be
antecedents to the behavior change we hoped to impact. We believe these enabling factors
should be intervention components of our oral health strategy.
Planned action is an enabling factor that has been shown to impact caregiver behavior and is
a key construct of the Health Action Process Approach (20). Interventions reported in the
obesity and cardiovascular literature that begin with a plan and a behavioral contract
between the parents/ caregivers and researchers to complete the plan have been effective
(19, 57, 58). In addition, young children whose parents had set goals using an action plan
demonstrated significantly reduced plaque scores and improved gingival health compared to
a control group who had no planned actions (59). Similarly, children with plans for asthma
and obesity actions showed marked improvement in their health (60, 61). Glassman and
colleagues recommend that adults with IDD should have an oral health care action plan (31).
Capacity building is the process through which the abilities to do certain things are obtained,
strengthened, adapted, and maintained over time (62). Capacity building was used by
community health workers to promote oral health among women and mothers, and this
resulted in significant changes in oral health expectancies, self-efficacy, and oral health
behaviors (63). We believe that the strategy must include a comprehensive capacity-building
component that will provide not only didactic training but also observational learning and
skill development throughout the duration of the strategy. In addition, providing the
caregiver with training and skills in dietary supervision may enable him/her to improve the
oral health of the residents.
Environmental adaptation utilizing oral hygiene aids, such as special toothbrush handles for
individuals who have poor coordination or diminished ability to grip, mouth props, multi-
surface brushes (Surround or Collis), powered brushes, dental floss alternatives, and
flavored toothpaste, may also improve caregiver behavioral capability and the oral health of
adults with IDD (64). Caregivers may also need to alter the physical environment where
they provide oral hygiene for residents who are partially or fully dependent by performing
these procedures in an area of the home other than the restroom (31). Reclining the resident
on a bean bag or sofa can facilitate resident's cooperation and reduce potential for injury to
the resident or care-giver. Finally, the social environment in the home could be adapted by
the implementation of policies and procedures regarding oral health to influence the
caregivers’ behavior.
C. Reinforcing Factors—Reinforcing a desired behavior is an important construct in
social cognitive theory, and it encourages a behavior to be repeated and sustained. We
identified two intervention components-coaching and monitoring oral health practices-that
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could impact caregiver self-efficacy, outcome expectancies, behavioral capabilities, and
environmental influences.
The literature suggests that ongoing coaching of the caregiver and resident is essential to the
success of an oral health strategy for persons with IDD (5). There is some evidence that
continued follow-up with caregivers and feedback on plaque removal are needed to improve
oral hygiene practices, as well as to effect significant and sustainable change in oral health
(6, 43, 65).
In addition to coaching, a web-based monitoring system can enable the ability to provide
constructive reinforcement to caregivers on a regular basis. Residents also need
reinforcement from the caregiver when they perform their oral hygiene or when they
cooperate with caregiver-provided oral hygiene (43). The proposed oral health strategy will
also include coaching and monitoring of the caregivers, and building the caregiver's capacity
to reinforce and monitor the residents’ oral health and oral hygiene practices.
PRECEDE Phase 4a - Intervention Alignment
Based on the analysis of the assessments in phase 1-3, we constructed an intervention
strategy. The PRECEDE activities identified predictors of the caregivers’ and individual
residents’ targeted health behaviors. We then conducted a search of the literature for health
behavior theories that would allow for testing of mechanisms of change and thereby inform
our intervention techniques. We determined that two theories, SCT and HAPA, incorporate
concepts that are aligned with the results of our assessments during PRECEDE activities.
We used four constructs from the two theories to assess their impact as mechanisms of
change or mediating variables in the strategy framework: self-efficacy, behavioral
capability, and environmental influences from SCT, and outcome expectancies constructs
from both SCT and HAPA. We posit links between the determinants of the targeted oral
health of an IDD population and our theory-based oral health strategy described below. We
took into account factors identified during the PRECEDE activities including enabling
factors (planned actions from HAPA, capacity building, environmental adaptation, and
reinforcement from SCT). These enabling factors formed our four-component oral health
strategy-planned action, capacity building, environmental adaptations, and reinforcement
activities.
Planned action will involve a behavioral contract with the caregivers, who will be asked to
make a contract with the research team to participate in the oral health strategy and the
development, implementation, and monitoring of oral health plans for each consented
individual with IDD in their care. Capacity building will be facilitated by a dental hygienist
who will provide training to increase the behavioral capability of the caregiver in providing
oral health support to the individuals with IDD. Environmental adaptations will occur when
the hygienist works with caregivers to select and use various oral hygiene aids and dental
devices to improve oral hygiene practices. The implementation of oral health policies and
procedures will adapt the group home environment to impact caregiver outcome
expectations. Reinforcement will occur during follow-up coaching visits by the hygienist
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with the caregivers and individuals with IDD, and the web-based monitoring will also
provide reinforcement to the caregivers.
Figure 1 presents our conceptual framework, which shows the assumed interrelationships
between the oral health strategy and proximal, intermediate, and distal outcomes. The
framework posits that the strategy will impact caregiver proximal outcomes of self-efficacy,
outcome expectancies, behavioral capabilities, and environmental influences. Assuming the
caregiver proximal outcomes (i.e., mediators) are positively impacted, we posit that the oral
health support of caregivers will improve, thereby improving oral hygiene practices of adults
with IDDs and subsequently improving the overall oral self-care behavior of an individual
with IDD according to his/her ability.
Since there may be some strategy influence on the oral health of the adult with IDD that is
not accounted for by the SCT mediators, the model also suggests that the strategy will
directly affect the oral health support of caregivers. Finally, we believe that contextual
factors, including demographics, caregiver oral health status, and group home environmental
characteristics, may be associated with the efficacy of the strategy; therefore, these factors
should be statistically controlled in a randomized controlled study and/or considered as
moderators of the strategy effects.
PRECEDE Phase 4b - Administrative and Policy Assessment
We determined in our administrative assessment that an oral health strategy would need the
following key factors: (1) support of the organizations that provide community services for
the individual residents with IDD and (2) behavioral contracts with the Directors of
Residential Services of these organizations to delineate the roles and responsibilities of these
key individuals.
Our policy assessment determined that if the oral health strategy were to be successful, the
following would be needed: (1) a randomized controlled trial to produce evidence of impact
on oral health outcomes, (2) implementation of a monitoring policy by the organization
providing services for the adults with IDD, and (3) preliminary evidence of the sustainability
of the strategy.
PROCEED Model Component
The PROCEED component entails conducting a pilot study to refine the oral health strategy
(phase 5a), implementing the strategy (phase 5b), and testing the efficacy of the strategy
under experimental conditions (phases 6-8). The larger study would be designed to assess
intervention processes (phase 6), impact on mediators (phase 7), and outcomes relating to
the oral health and quality of life of adults with IDD (phase 8).
PROCEED 5 - Pilot Study—The pilot study is part of an in-process R34 grant from the
NIDCR. This study is examining the oral health strategy described in this article using a pre-
post intervention design only. The participants are consented caregivers and adults with IDD
in 12 group homes managed by a large organizational network serving the IDD population
in one Midwestern city. The pilot study assesses (a) dosage [amount of intervention
exposure of each strategy component], (b) implementation fidelity [extent to which each
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component is implemented as designed], and (c) participant reactions [appraisal of the
quality or usefulness of the strategy] that are associated with implementing the strategy over
a condensed one-month time period. In addition, we are assessing change in the study
outcomes as preliminary results to guide development of the final oral health strategy. Also,
the reliability and validity of our process and outcome measures and the feasibility of
various data-collection procedures (such as using video cameras to collect observation data
in a group home setting) are being examined in this in-process NIDCR grant. The analytical
strategies for the pilot test will involve the use of simple descriptive statistics in the form of
frequencies and percentages for the process assessment (phase 5a) and linear or logistic
regression for assessing changes in the proximal, intermediate, and distal outcomes.
PROCEED 6 - Implementation of the Oral Health Strategy—Assuming the pilot
study results demonstrate the feasibility of a larger RCT study, we plan to apply for a second
NIDCR grant in the near future. In sequence, the oral health strategy will be implemented
after obtaining written informed consent and HIPAA authorization from the caregivers and
the parents or guardians of the adults with IDD. First, a behavioral contract will be
negotiated with the caregivers to participate in a program to improve the oral health of their
residents.
Second, the strategy is designed to promote capacity building in the caregiver by requiring
skills training in providing and/or supervising oral hygiene practices for the IDD resident,
dietary supervision, and planning and monitoring goals for oral health care. All components
and Key Points of the following three capacity-building parts of the intervention are
included in a Manual of Procedures for the study, which is required in the NIDCR-funded
pilot study. Initially, didactic training will be provided in the group homes to groups of
caregivers. The training has been adapted from the Overcoming Obstacles program (5),
which includes a PowerPoint presentation and a 20-minute DVD demonstrating oral hygiene
and behavioral management techniques. Caregiver capacity building will continue during in-
home training immediately after the didactic training and will be provided by the dental
hygienist with at least two caregivers and the three adults with IDD residing in the home.
The in-home training begins with a discussion of each resident's current oral hygiene
practices and any existing behavioral challenges to oral health. The hygienist and caregivers
will then cooperatively develop individualized oral healthcare plan goals for each resident.
During this initial in-home visit the dental hygienist will provide opportunities for
observational learning by performing oral hygiene procedures for each IDD resident while
the caregivers watch. The caregivers will then be encouraged to model the same hygiene
practices while the hygienist watches and offers suggestions for improvement, praise,
reassurance, and encouragement.
Third, because each resident will have unique needs for environmental adaptation, the dental
hygienist will work with each caregiver throughout the intervention to find and evaluate
adaptive devices and/or behavioral strategies that will produce the greatest benefit for the
resident by increasing participation and cooperation. The environment in the group homes
will also be adapted by providing caregivers on-line technology to document on a daily basis
the resident's self-care behavior, including oral hygiene practices and diet. The on-line
technology will also facilitate reinforcement of the caregivers’ study activities.
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Fourth, the dental hygienist will also assist the caregivers in selecting and assessing
reinforcements that will improve IDD participant cooperation. During this time, there will
also be training for the caregivers on how to record video observations and daily logs that
capture the IDD residents’ oral hygiene practices. During the subsequent four in-home
capacity-building visits (coaching visits), the dental hygienist will coach the caregivers in
ways to improve supervising and/or providing oral hygiene practices, supervising residents’
diets, and planning and monitoring the residents’ oral health. At the end of the intervention,
the caregivers and dental hygienist will review the behavioral contract, evaluating how well
each caregiver met the expectations of participation in the intervention.
PROCEED 7 and 8 - Process and Outcome Evaluation—For the efficacy study, we
propose an oral health strategy to be implemented over a four-month period. The
implementation process measures include dosage, fidelity, and participant reaction as
described above. To test for effects on the proximal outcomes or mediators/mechanisms of
change (i.e., caregiver self-efficacy, outcome expectancies, behavioral capability, and
environmental influence), we plan to conduct a cluster randomized controlled trial that
randomly assigns group homes to experimental conditions within organizations. Outcomes
will be measured at baseline, at post-implementation, and at a six-month follow-up. The
control group will be implemented first over a nine-month period, followed by the
intervention group over the same length of time. This will reduce contamination between the
control and intervention group participants.
We estimate that approximately 80 group homes with an average of three caregivers and two
to three adults with IDD must be recruited to obtain sufficient power to detect small- to
medium-size effects. With such a large sample of group homes, we will need to implement
the RCT in two cohorts with pairs of group homes matched and randomly assigned to
control and experimental conditions within cohorts. Members of the research team have
successfully used this research strategy in another large-scale NIH study (66).
The analysis of the anticipated larger RCT study will be more involved in both the process
and outcome evaluations. For the process analysis (phase 7), we will produce frequency and
percentages for all process measures. These results will be presented to an expert panel of 16
authors who have published implementation quality papers in order to assess the adequacy
of the implementation quality of our larger study (67). Expert panels usually consist of a
small number of members, which precludes performing inferential analyses from which
inferences can be drawn (68). To increase our confidence in the results from our small
sample of experts, we will analyze the observed data and then perform a bootstrap analysis
(27, 68). Using Excel, we will draw 1,000 bootstrapped samples of size 16, sampling with
replacement, for each of our results. We will calculate average test values across all
bootstrapped samples, except for p values that stem from the average t-statistic.
The outcome evaluation (phase 8) will produce outcome data for caregivers and adults with
IDD nested in group homes. To answer research questions about intervention direct effects,
we plan to use a three-level hierarchical linear model (HLM) random intercept regressions
(69), which will assess whether there have been differential changes between the
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intervention and control groups on proximal, intermediate, or distal outcomes. Hierarchical
non-linear modeling (HNLM) will be used for dichotomous outcomes.
Phase 8 of the larger study analysis also concerns the assessment of mediating and
moderating effects. We plan to use multilevel structural equation model (MSEM)
procedures to determine whether social cognitive factors (e.g., caregiver self-efficacy)
mediate the relationship between intervention exposure and intermediate and/or distal
outcomes (70). MSEM solves for parameters at both an adult with IDD level and group
home level, and constraints are placed across models to represent the effects of random
variability.
CONCLUSIONS
In this paper we present an eight-phase planning model that is an adaptation of the
PRECEDE-PROCEED model described in the literature. The PRECEDE component
involves assessing social, epidemiological, behavioral, environmental, educational, and
ecological factors that inform the development of an oral health strategy for the IDD
population with underlying social cognitive theory and health action planning approach
assumptions (phases 1-4). The PROCEED component consists of pilot-testing,
implementing, and evaluating the implementation of the strategy and its impact on outcomes
of the population under study (phases 5-8). The results of the PRECEDE assessment, a
conceptual framework, and an oral health strategy are summarized. In addition, we describe
the phases of our PROCEED component that will guide the refinement of the oral health
strategy and the testing of the strategy under experimental conditions. Importantly, members
of various sectors of the community that work with the IDD population have had input into
the development of the strategy being presented.
We believe that our application of an adapted PRECEDE-PROCEED planning model will
be useful to others in dental public health and to those who are working to improve the oral
health of the IDD population.
Acknowledgments
This research was funded by a National Institute of Dental and Craniofacial Research grant R34DE022274. We wish to thank our research team members .Melissa Abadi, Henry Hood, Steve Shamblen, Kirsten Thompson, Linda Young and Brigit Zaksek for their input into the development of our oral health strategy. In addition, we thank participating members of the community, especially the Community Alternatives of Kentucky administrative staff, group home caregivers, and adults with IDD for their assistance in the diagnostic and pilot testing phases of the planning process.
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Figure 1. Conceptual Framework of the Oral Health Strategy for Adults with Intellectual and/or
Development Disabilities.
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