CENTERS FOR RESEARCH TO REDUCE ORAL HEALTH DISPARITIES

CENTERS FOR RESEARCH TO REDUCE ORAL HEALTH DISPARITIES is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH). This initiative supports research to understand factors associated with oral health disparities and to develop, test, and evaluate interventions designed to reduce these disparities, with a particular interest in oral, dental, and craniofacial diseases and disorders among divers…

RFA-DE-99-003: CENTERS FOR RESEARCH TO REDUCE ORAL HEALTH DISPARITIES Release Date: September 30, 1999 May 3, 2007 - This RFA has been reissued as (RFA-DE-08-008).

National Institute of Dental and Craniofacial Research Health Resources and Services Administration National Institute of Child Health and Human Development National Institute of Nursing Research Centers for Diseases Control and Prevention Office of Research on Minority Health Office of Behavioral and Social Science Research Office of Research on Women"s Health Letter of Intent Receipt Date: July 17, 2000 Application Receipt Date: November 15, 2000 The National Institute of Dental and Craniofacial Research (NIDCR) along with the Health Resources and Services Administration (HRSA), the National Institute of Child Health and Human Development (NICHD), the National Institute of Nursing Research (NINR), the Centers for Disease Control and Prevention (CDC), the Office of Behavioral and Social Science Research (OBSSR), the Office of Research on Minority Health (ORMH), and the Office of Research on Women"s Health (ORWH) invites applications for research designed to lead to a reduction in health disparities among the peoples of the United States by focussing on craniofacial, oral and dental diseases, disorders and health.

This Request for Applications (RFA) represents the natural evolution of philosophy in the previously funded Regional Research Centers for Minority Oral Health (RRCMOH) initiative. Receipt of an RRCMOH grant, however, is not a prerequisite for submission of an application in response to this RFA.

The overall objectives of the Centers for Research to Reduce Oral Health Disparities (CRROHD) initiative are to support research that will lead to an understanding of the factors associated with health disparities as well as to support the development, testing and evaluation of interventions designed to reduce health disparities with a particular interest in oral, dental and craniofacial diseases and disorders.

It is expected that each center will be a training and mentoring resource for developing and strengthening the biomedical, clinical and behavioral health research capacity of the nation by expanding research opportunities for scientists in underrepresented groups within the scientific workforce through required collaborations with minority institutions as well as through other career development activities.

Although the overall focus of the initiative is on reducing health disparities in children and their caregivers, research proposed by individual centers may fit within the scope of the initiative by focussing on one aspect of issue (e.g., examining factors contributing to or reducing the health disparities of caregivers alone, assessing oral health status of children in specific SES/cultural/regional/community groups, collecting data and/or developing interventions that address a specific health disparity in a defined group) or they may address the full range of research possibilities (e.g., role of oral health of mothers and/or other family members in the health of neonates and children, access to health care issues as they related to the craniofacial, oral or dental health of children and their caregivers).

The focus of this new center initiative is on reducing health disparities through basic, translational, clinical, patient-oriented health services and community-based research.

It is envisioned that realization of this central focus will be accomplished through the development of knowledge that will lead to an understanding of biological, behavioral, psychological, anthropological, sociological and economic causes of health disparities in the United States.

It is also envisioned that the new knowledge will lead to the design and testing of interventions that rely on and take advantage of the cultural competencies involved in the health of members of various groups. A major hallmark of the initiative is national research and training networks.

These may be fostered by increased collaborations across the health professions (e.g., dentistry, medicine, nursing, pharmacy, behavioral and social sciences, public health) both within and between institutions as well as between the health professions and social services (e.g., State and Local health and health financing agencies) directed at health promotion.

Finally, the initiative is inclusive with respect to populations of interest in that it spans the racially, ethnically and culturally diverse populations of our nation including populations of recent immigrants, individuals at all socioeconomic status (SES) levels, those from both rural and urban settings, and individuals who are medically challenged or compromised.

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Centers for Research to Reduce Oral Health Disparities, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.

osophs. dhhs. gov/pubs/hp2000 .

Research grant applications may be submitted by domestic for-profit and non- profit organizations, public and private, such as academic health centers, dental schools, universities, colleges, laboratories, units of State and Local governments, and eligible agencies of the Federal Government. It is expected that the applicant institution will have received support for research from NIH or other federal agencies.

Although currently funded RRCMOH institutions are encouraged to apply for a CRROHD, prior receipt of a RRCMOH grant is not a prerequisite for applying for or receiving grant under the terms of this RFA. Applications from foreign institutions are not eligible but collaborations between domestic and foreign institutions may be scientifically necessary and justifiable.

Applications from minority individuals, women, and persons with disabilities as principal investigators are strongly encouraged. To be responsive to this RFA, an applicant must propose collaborative affiliations with other entities.

The collaboration can be with entities from within the parent institution as well as with other institutions and should be for the purpose of facilitating and addressing the scientific objectives of the proposed center.

Collaborations may encompass colleges/schools/departments representing the entire spectrum of the health professions (e.g., dentistry, medicine, nursing, pharmacy, veterinary sciences, behavioral and social sciences) or academic institutions and State and Local health and health financing agencies (e.g., state Medicaid agencies and Children"s Health Insurance Programs).

To be eligible for this initiative, each center is required to involve a partnership with one or more minority institutions (e.g., Historically Black Colleges and Universities, Hispanic serving institutions, Tribal Colleges and Universities). The applicant may be either a minority institution or a non-minority institution.

Additional details about this aspect of the initiative are contained in the section titled "Center Characteristics." Regional proximity of the affiliated institutions is not required but, for a variety of reasons, may be an asset. However, such an arrangement may not be possible.

In those instances, applicants are urged to provide compelling evidence of procedures and/or processes that will be used to overcome any potential problems associated with the geographical separation. The mechanism of support utilized will be the Specialized Center (P50) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant and collaborating institutions.

However, consultation with NIDCR staff will be expected in the form of periodic site visits and annual meetings of center directors. Although this RFA is a one-time solicitation for new and competing renewal awards, depending on the availability of funds, it is expected that a subsequent competition among funded CRROHD centers will be held.

The total project period for an application submitted in response to this RFA may not exceed seven years and it is anticipated that the subsequent competition will be for funding for a similar period. The earliest possible date for funding is Up to five awards will be made if a sufficient number of highly meritorious applications are received and sufficient funds are available.

Additional centers may be funded depending on the availability of funds and highly meritorious applications. Each award may not exceed $1. 5 million total costs (i.e., direct plus indirect costs including those indirect costs associated with consortia and/or contracts) for research projects, pilot projects and cores in the first year.

Increases in costs for subsequent years may not exceed three percent. All applicants must include costs associated with annual meetings in Bethesda of center directors and their key scientific personnel.

In addition, centers that propose a prospective, randomized clinical trial must include funds for annual meetings of an independent Data and Safety Monitoring Board (DSMB) to provide oversight and review of patient safety and progress of the trial. Information about the structure and function of the DSMB is available from NIDCR staff listed under INQUIRIES or from the NIDCR home page ( http://www. nidcr.

nih. gov ). It is strongly urged that additional funds be sought from other federal agencies as well as from institutional, corporate and foundation sources to augment support from the NIDCR.

Award of grants pursuant to this RFA is contingent upon the Dental and craniofacial diseases and disorders are among the most common health problems affecting the people of the United States.

The burden imposed by a variety of dental and craniofacial diseases and disorders range from birth defects such as cleft lip and palate, which occurs in every 1 in 525 to 714 live births, to injuries to the head and face, resulting in nearly 20 million emergency room visits per year, to devastating head and neck cancers, accounting for 8000 deaths and over 30,000 new cases per year. The treatment of over 1.

2 million cancer patients each year can lead to complications such as painful mouth ulcers, mucositis, rampant dental caries, fungal infections, impaired taste and loss of function of the salivary glands. Oral infections still remain common in our populations. Dental caries is experienced by 45% of elementary aged school children and 94% of adults have experienced this infection at some point in life.

Periodontal infections occur in 90% of individuals older than 13 years and may be associated with other systemic diseases or conditions such as diabetes, cardiovascular disease, respiratory infections, and pre-term/low birth weight babies.

Orofacial pain is likely to have been experienced by over 20% of adults in the past six months, is a major component of temporomandibular joint diseases (TMD) for at least 6% of adults, and is a major component of Bell"s palsy, trigeminal neuralgia and fibromyalgia.

Salivary gland dysfunction in the form of Sjogren"s syndrome affects between 1 and 4 million Americans while over 30,000 individuals who have cystic fibrosis are also at higher risk for concomitant salivary gland dysfunction. Further, over 500 prescription drugs have xerostomic (dry mouth) side effects, increasing the risk for both bacterial and fungal oral infections as well as other oral conditions.

Oral candidiasis is commonly found in HIV-infected patients. Many of these craniofacial, oral and dental diseases and disorders have a disproportionately higher burden on particular population subgroups. Addressing disparities in craniofacial, oral and dental health among the diverse populations of the United States continues to be a major focus of the research supported by the NIDCR.

Strategic Initiative I (Research ( http://www. nidcr. nih.

gov ), focuses on, among other areas, the importance of oral health promotion and disease prevention, behavioral research, and epidemiological research as areas of importance to the Institute. Strategic Initiative III (Health Promotion) calls for research that addresses the health needs of all segments of the United States population.

Furthermore, Strategic that, in developing the human and technological resources needed to realize the full potential of scientific opportunities, one of the primary objectives of the Institute is to facilitate the participation of women, ethnic and racial minorities, and individuals with disabilities in research.

As such, the current initiative continues a focus on the development of collaborations that can strengthen the capacity of institutions to plan and conduct scientifically meritorious research and to engage in appropriate research training and career development of individuals associated with these It is still evident that in the United States the burden of disease falls disproportionately among racial and ethnic minorities, individuals from lower socioeconomic classes, women and children.

Nearly 50 million Americans suffer from disproportionately high incidence and prevalence of a wide range of diseases and disorders.

Among these are inherited and acquired birth defects, craniofacial/oral trauma, infectious diseases, severe malocclusion and orthognathic conditions, oral complications of systemic diseases, oral and pharyngeal cancer, temporomandibular diseases, chronic facial pain and other diseases and conditions of the oral and craniofacial complex and the rest of the body.

A recent report issued by the Department of Health and Human Services titled "Racial and Ethnic Disparities in Health: Response to the President"s Initiative on Race" recognizes the need for new knowledge about the determinants of disease and effective interventions for prevention and treatment to eliminate health disparities.

The report targets six goals aimed at addressing specific health disparities including infant mortality, cancer, cardiovascular disease, diabetes, HIV/AIDS, and immunization.

As documented in the publication, "Women of Color Health Data Book," women and men of color are disproportionately represented among the nearly 41 million Americans without health insurance and it is known that there is uneven access to health care and heath care resources among the diverse populations of the United States (NIH Publication 98-4247, 1998, p. 68).

Similar documentation, particularly that pertaining to the health of women and children, is available through the home page for the Public Health Service Office of Women"s Health ( http://www. 4women. gov/owh/index.

htm ). While it is estimated that 14% of all whites did not have coverage in 1995, the same was true for 21% of African Americans and 33% of Hispanics (NIH Publication 98-4247, 1998, p. 68).

These percentages increase for all groups for individuals of lower socioeconomic status. Furthermore, African Americans (20%) than whites (13%) reported that they used hospital emergency departments as their source of primary health care. Conversely, 58% percent of whites and 48% percent of African Americans make their usual contact with physicians in a non-hospital setting such as the typical office (NIH Publication 98-4247, 1998, p.

70). The impact of these differences on health is profound and may account for many of the increased risk factors for disease among underserved populations. For example, it has been reported (NIH Publication 98-4247, p.

73-76) that white women exhibit among the highest incidence of all forms of cancer (i.e., 346/100,000) yet mortality rates are lower for them (i.e., 140/100,000) than for Alaskan Natives (i.e., 179/100,000), Native Hawaiians (i.e., 168/100,000), and African Americans (i.e., 168/100,000). A similar picture emerges when comparisons are made for specific forms of cancer, including breast and cervical cancer.

It has been speculated that this pattern can be accounted for by several interrelated factors including later detection of disease, unequal access to health care resulting from lower access to health insurance, geographically more remote health care facilities for women of color than white women, and problems associated with the reliability of surveys on low SES individuals (e.g., underreporting, misidentification of race or ethnicity, misidentification of causes of mortality).

Other factors involved in the causes of health disparities are varied and complex (Haynes & Smedley, 1999, Williams & Collins, 1995). Traditional variables have included race, ethnicity or culture, socioeconomic status (SES), gender/sex and age. Yet it appears that none of these alone can account for all of the documented differences.

Williams and Collins (1995) note that even socioeconomic status as a measure of class leaves much of the variability in health status unexplained. They note that research on the determinants of health indicates that stress in family home and work environments, health practices, social support systems, access to health care, and attitudes toward health are all important determinants of health status.

Another example, highlighted in a chapter outlining a research agenda on women"s oral health in a publication from the Office of Research on Women"s Health, NIH points to the potential role of gender/sex in health disparities and the need for much research involving women (Redford, Jeffcoat & Silverton, 1999).

In many instances a woman is not only the major caregiver of children but she is also the source of much health information for others in the family group. This coupled with the fact that there is still much to be learned about factors influencing women"s oral health, points to a need for research involving this very important segment of our population.

As noted by Anderson (1998) discovering the interrelationships among the multitude of variables that affect health and disease, their relationship(s) to more traditional variables, and, ultimately, the relationship between all of these factors and the underlying biological and physiological processes involved in health and disease is critical in our understanding of disease and hence for understanding the bases for health disparities as well as providing a pathway to preventing and reducing them.

Research from within the field of oral health illustrates some of the complexities that are emerging from research on health disparities. Race and ethnicity appear to influence health beliefs and perceptions of health. Beliefs and perceptions, in turn, can determine when or if an individual seeks treatment (Kuthy, Odom, Salsberry, Nickel, & Polivka, 1998, Kwan, Williams & Duggal, 1996, Gift, Atchison & Drury, 1998).

Perceptions of oral health, particularly of those conditions which an individual believes to be "normal", can be influenced by age, race, ethnicity, education, general health, and utilization of the health care system (Atchison & Gift, 1997).

While it is known that the lack of health care providers from with a given racial/ethnic group influences health status in persons from within those groups obtaining timely and appropriate health care (Grumbach, Coffman, Young, Vranizan & Blick, 1998) little is known about similar influences on craniofacial, oral and dental diseases and disorders.

Similarly, while it is known functional health literacy influences health status among the elderly (Gazmararian, Baker, Williams, Parker, Scott, Green, Fehrenbach, Ren, & Koplan, 1999), the low-income elderly (Weiss, Reed & Kligman, 1995) as well as individuals of various racial/ethnic groups (Williams, Parker, Baker, Parikh, Pitkin, Coates & Nurss, 1995) little is known about the influence of these factors on craniofacial, oral and dental diseases and disorders.

According to the draft version of "Healthy People 2010," the level of untreated dental caries among racial and ethnic minority groups is greater than the national average, smaller proportions of minority and poor children have dental sealants, African Americans have a poorer five-year survival rate for oral and pharyngeal cancer than whites (31% vs. 55%), and almost nine percent of low SES adults have lost all their teeth compared with five percent in the total adult population.

Forty-two percent of the poor elderly were edentulous in 1993 compared with 36% of all persons 65 years and older. The proportion of the U.S. population that makes at least an annual dental visit as well as the average number of dental visits made per year vary significantly by age, race, and family income.

The proportion of the population with an annual dental visit is highest among children between 5 and 17 years and lowest among children between 2 and 4 years. About 57% of the total U.S. population over 2 years report a dental visit in the past year, but fewer than one-half of those over 65 years have made such a visit.

Only 41% of those with annual family incomes below $10,000 report a dental visit in the past year compared with 73% with family incomes above $35,000. As noted in the draft version of "Healthy People 2010," dental insurance coverage is a strong predictor of the use of dental services.

Because dental insurance is typically employment-based, persons who do not work or who work only part time or who are self-employed are less likely to be insured and hence less likely to use dental services than full-time employees. The National Association of Dental Plans estimates that 45% of the 1995 U.S. population had dental insurance and Medicaid coverage for adults varies from state to state.

Lower proportions of low SES children and members of racial and ethnic minority groups have private dental insurance than the national average. Although public sector programs such as Medicaid, and more recently Children"s Health Insurance Program (CHIP), hold great promise for improving the oral health of many low income and minority children, access barriers may temper that potential.

Low SES children make 37% fewer visits of dental offices than do those from higher SES groups and children from families below 200 percent of the Federal Poverty Level have substantially more unmet dental treatment needs than children from families with higher income levels (Vargas, et. al, 1998).

Similarly, lower proportions of members of racial and ethnic minorities and low SES adults than the general population have made dental visits in the past year. Visits to dentists by elderly African Americans (22%) and all poor elderly (26%) during the past year are approximately one- half of the national average for the elderly.

Only 15% of the elderly have any private dental insurance and Medicare does not provide reimbursement for The relatively poor health status of underserved populations may also reflect the lack of research on these individuals, particularly with respect to craniofacial, oral and dental diseases and disorders.

This may, in turn, be a reflection of the relative scarcity of culturally and economically sensitive, well-trained scientists engaging in craniofacial, oral and dental health research.

Limited opportunities for individuals from various racial/ethnic groups to receive training and mentoring in research activities not only because of a lack of research resources at their home institutions but also because of a lack of opportunities to engage in research play a large role in the shortage of culturally sensitive and competent scientists.

While the NIDCR continues to encourage the participation of minority scientists in health research through various training programs as well as through the Research Supplements for Underrepresented Minorities initiative, additional opportunities are also needed.

Thus, in addition to the principal aim of this initiative to support research to reduce health disparities, a complementary research intensive institutions by pairing them, through collaborative affiliations, with individuals at research intensive institutions.

It is anticipated that accomplishment of this aim will not only enhance the research careers of individuals underrepresented in the scientific workforce but it will also attract qualified underrepresented undergraduate and graduate students to careers related to reducing health disparities, especially those related to craniofacial, oral and dental diseases and disorders.

The Centers for Research to Reduce Oral Health Disparities are viewed as a national and all encompassing resource. Even though funds provided through this RFA are restricted to the support of research activities, it is expected that each application will include specific plans for developing training and career development opportunities.

Each center is required to involve a partnership with one or more minority institutions (e.g., Historically Black Colleges and Universities, Hispanic serving institutions, Tribal Colleges and Universities). The applicant may be either the minority or non-minority institution. An application that does not include such a collaboration will not be considered for funding and be returned to the applicant unreviewed.

For the purposes of this RFA a minority institution is defined as: (a) providing education or training for individuals from underrepresented groups within the craniofacial, oral and dental scientific workforce (i.e., an educational, health care, academic health center, medical school, dental school, nursing school, public health school or research institution whose student enrollment and faculty consists of 50 percent or more individuals from underrepresented groups such as American Indians and Alaskan Natives, African Americans, Hispanics, and Asian Americans/Pacific Islanders), and/or (b) serving large underserved populations (i.e., an educational, health care, academic health center, medical school, dental school, nursing school, public health school or research institution whose patient population consists of 50 percent or more of individuals from groups traditionally considered to be under served with respect to their craniofacial, oral and dental health Each center will represent a consortium consisting of two or more institutions as well as collaborations between departments, divisions and schools within a single institution.

Examples of components of research and institutional o inter-institutional networks such as partnerships among colleges and universities, State and Local health financing agencies, State departments of education, HRSA Community/Migrant Health Centers, CDC Prevention Research Centers, tribal urban and direct Indian Health Service clinics and hospitals, and academic health centers, o inter-disciplinary health professions networks such as partnerships among dental, medical, nursing, pharmacy, and public health colleges and schools, o multi-disciplinary networks such as partnerships among basic and social science programs and clinical and epidemiologic science programs.

The grantee institution must be an educational, academic health center, medical school, dental school, nursing school, and public health school or Institutions comprising the consortia should be selected to facilitate the attainment of the scientific objectives of the center and may include community health centers, State and Local health and health financing agencies (e.g., CHIP, Medicaid), HMOs or PPOs, nursing homes or other government funded organizations (e.g., HRSA Community/Migrant Health Centers, CDC Prevention Research Centers, tribal urban and direct Indian Health Service clinics and hospitals).

The specific combination of the above elements included in the design of an individual center will be determined by the scientific aims of that center and the resources that the participating partners have to offer in addressing these aims. Each application must justify the specific pattern of collaboration in light of the scientific goals of the center. Center Administration.

A director, affiliated with the applicant institution, and a co-director(s), affiliated with the principal collaborating institution(s), will be responsible for the scientific and administrative leadership of the center. An administrative advisory committee of senior staff from the principal participating institutions will assist the director.

Membership on this committee may be supplemented as needed by individuals from outside the participating institutions. The role of this committee is to provide administrative advice to the director by assisting in the preparation of the application as well as advising the director on scientific and related issues including faculty development activities.

In addition, an independent scientific advisory committee consisting of consultants with appropriate research experience and accomplishments, but who are not associated with the participating institutions, will conduct an annual review of the: (1) broad goals and accomplishments of the center including outreach, mentoring, career development and training activities, (2) asses interim progress of all scientific projects and their relevance to the broad objectives of this initiative, and (3) aid in the review of pilot projects proposed after initiation of the grant.

NIDCR staff will serve as ex officio members of the steering committee. Also, a Data and Safety Monitoring Board (DSMB), formed in accordance with NIDCR guidelines, is required for any prospective randomized clinical trials research included within a center. Applicants anticipating including a clinical trial as part of the center should obtain a copy of the guidelines from the NIDCR staff listed under "INQUIRIES."

Research Projects. The center will consist of a series of related research projects and cores which, overall, focus on reducing craniofacial, oral and dental health disparities. At least four (4) of them will be R01-type research projects.

Each project will involve participation by co- investigators from the collaborating institutions. Applicants must develop a central theme around which the research projects are organized.

In being consistent with the intent of this initiative, the theme should address basic, translational and clinical, patient-oriented, health services, and community- based research issues relating to health disparities (e.g., molecular epidemiological studies, health promotion research, clinical trials).

In addition, each center is strongly encouraged to include, under its administrative umbrella, related but already funded research as well as research training and career development activities related to the specific aims of the research. Reference to and descriptions of these grants along with the specific scientific aims to which they apply should be contained in the Pilot Projects.

Each center may, in addition to regular research projects, include short-term pilot projects. The purpose of these projects is to support pilot studies that can lead to regular research projects funded as part of the center grant or as freestanding grants. Each pilot project may not be funded for more than $15,000 and for no longer than one year.

No more than a total of five such projects may be supported in any single grant year. Administration of the projects should be within an administrative core as part of the center development activities (see below). Applicants are limited to a one-page description of each of the initially proposed pilot project.

The major focus of each description should be the overall purpose, specific aims and general approach of the proposed pilot research. Applicants also must provide a detailed description of the process involved in selecting pilot projects included in the center application as well as the process that will be used in evaluating their outcomes and in selecting a new set of projects. Core Facilities.

Core resources supporting center development activities, outreach and educational activities, administrative services, unique clinical facilities, biostatistical and computer services and shared equipment should be included. The level of support for core resources must be commensurate with the level of research proposed and funded.

The center administrative core must include support of meetings or other activities to explore new and expanded collaborative research, research training, and career development opportunities.

Travel for the director, co-director and developing scientists to an annual meeting of center directors in Bethesda must be budgeted in the administrative core as should support of travel for annual meetings of a Data and Safety Monitoring Board for those centers that involve prospective randomized clinical trials. Equipment and Facilities.

No funding will be provided for major pieces of equipment or renovation of existing facilities or building of new facilities. Research and Training Networks Receipt of a CRROHD carries with it the expectation that the center will provide the impetus and core for research and training networks on health disparities. These networks can take on many forms and serve a variety of purposes.

The purpose of the networks is to leverage the resources available through the center, and in so doing to, facilitate research and research training by linking these resources with other sites around the country where the necessary expertise, facilities, capabilities and research opportunities may be readily available.

Another function of the networks is to enhance the opportunities by center staff for access to populations and communities that may not be available locally. One approach in forming a network could be the establishment of collaborations among the centers that are funded through this RFA. In facilitating this activity, NIDCR staff will organize annual scientific meetings of center directors and staff in