Full Text HL-93-02-P IMPROVING HYPERTENSIVE CARE FOR INNER CITY MINORITIES NIH GUIDE, Volume 21, Number 35, October 2, 1992 RFA: HL-93-02-P P.T. 34 Keywords: Hypertension Social Psychology Demography Community/Outreach Programs Health and Safety Education National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: November 30, 1992 Application Receipt Date: February 16, 1993 PURPOSE The Division of Epidemiology and Clinical Applications (DECA) invites applications for demonstration and education projects aimed at improvements in hypertensive care among inner city minority populations. The awards will be for a funding period of four years. The program will focus on community-based health education and/or other approaches for enhancing compliance and improving blood pressure control in urban minority populations. The intervention models should be widely applicable and economical. While hypertension is the focus of the program, a multiple risk factor approach may be used to assess changes in other cardiovascular risk factors. HEALTHY PEOPLE 2000 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, Improving Hypertensive Care for Inner City Minorities, is related to the priority area of heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply and domestic applications may not include international components. Applications from minority individuals, particularly African Americans, Hispanics, and women are encouraged. MECHANISM OF SUPPORT The support mechanism for this RFA will be the National Institutes of Health (NIH) demonstration and education (D&E) research grant (R18). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed four years. The anticipated award date is September 30, 1993. FUNDS AVAILABLE It is anticipated that three to five Centers will be supported over the four year period of this program. An estimated total cost (direct and indirect) of $2,500,000 will be available for the first year of funding for the entire program, with an estimated four year total cost of $10,600,000. This level of support is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the National Heart, Lung, and Blood Institute (NHLBI), awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Hypertension is a major independent risk factor for the development of cardiovascular disease, the leading cause of death in the U.S. Despite improvements in the treatment and control of hypertension in recent years, African Americans continue to experience higher morbidity and mortality from hypertension than the white population. Hypertension is more likely to appear earlier in life in African Americans. Adequate treatment is often hampered by socioeconomic factors. Complications of uncontrolled hypertension, including stroke and end-stage renal disease, occur earlier and more frequently in African Americans than in whites. In 1986, the age-adjusted stroke mortality rate was 83 percent higher in African Americans than in whites. While age-adjusted mortality rates for stroke are declining for both African Americans and whites, both for males and females, the rate of decline is lower for African Americans. The African American to white ratio of age-adjusted stroke mortality increased from 1.85 in 1980 to 1.93 in 1988 for males and from 1.75 to 1.83 over the same time for females (1,2). Although based on single blood pressure measurements, data regarding the prevalence, awareness, treatment, and control of hypertension in the U.S. are available from the 1976-80 National Health and Nutrition Examination Survey (NHANES II) (3). African Americans collectively have a higher prevalence of hypertension, based upon a 140/90 mm Hg cutpoint or taking antihypertensive medication, than whites (38 vs. 29 percent). Severe hypertension is four times as prevalent among African American males relative to white males. The following data on awareness, treatment, and control are for blood pressure cutpoints of 140/90 mm Hg; similar trends exist for the higher cutpoints of 160/95 mm Hg. Of those with hypertension, African Americans were shown to be slightly more aware of their hypertension (65.6 vs. 52.3 percent) than whites, and slightly more received pharmacologic therapy (38.5 vs. 32.6 percent). Nonpharmacologic therapy was not included in this analysis. While control rates for African Americans collectively were slightly better than for whites (13.3 vs. 10.9 percent), the hypertension of African American males was slightly less controlled than that of white males (5.8 vs. 6.1 percent). It is also noteworthy that these control rates were very low for all race-sex groups. An inverse relationship between socioeconomic status and health exists for a number of disease entities, findings that come primarily from studies of non-minority populations. Although data are somewhat limited for comparison between differing levels of socioeconomic status among African-Americans, a number of studies reveal that African Americans of lower socioeconomic status have a higher level of hypertension-related disease burden than more advantaged African Americans (6). The Hypertension Detection and Follow-Up Program (HDFP), which screened over 40,000 African Americans and entered over 4800 African Americans into the study, showed an inverse relationship between level of education, used as a measure for socioeconomic status, and severity of hypertension for both African Americans and whites. This inverse relationship between education and hypertension was more pronounced within the highest stratum of blood pressure. The gradient was essentially eliminated by stepped care antihypertensive drug therapy (7). Hispanics represent the second largest minority population in the U.S., and this group is rapidly growing. The Hispanic population is heterogenous. The Hispanic Health and Nutrition Examination Survey (HHANES) was conducted among three Hispanic subgroups (of Mexican, Cuban, and Puerto Rican origins) in the U.S. from 1982 to 1984 (8). Data from this survey reveal that Hispanics have lower prevalence of hypertension, higher awareness, higher treatment rates, and higher control rates compared to the rates for both whites and African Americans in NHANES II. It should be noted that the HHANES data are more recent than NHANES II. The San Antonio Heart Study provides additional data regarding hypertension among Mexican Americans. Data presented for four different definitions of hypertension (isolated and combined elevations using 160/95 and 140/90 mm Hg cutpoints) show a lower prevalence among Mexican Americans relative to non-Hispanic whites, although only two of the eight pairwise comparisons (four hypertensive definitions by gender) were statistically significant. After adjustment for age, body mass index, and non-insulin-dependent diabetes mellitus, Mexican Americans were shown to have a statistically significant lower prevalence of hypertension (9). Certainly these data indicate substantial room for improvement in the awareness, treatment, and control of hypertension for all Americans. African Americans, with both an increased burden of disease and problems with access to care, require special attention. While the data for Hispanics populations do not indicate excess disease burden, socioeconomic factors are likely to put many Hispanics at a disadvantage for optimal hypertension detection and management. Several investigators have shown improvement in the care for inner-city minority hypertensives. As an example, Levine and colleagues designed a long term program using a population-based intervention, administered under the direction of a task force of community leaders and organizations and the Johns Hopkins Medical Institutions. Five-year results demonstrate significant improvements in both behavioral objectives and blood pressure control. In summary, excess disease burden from hypertension in African Americans, combined with numerous socio-economic barriers to optimal care for many inner city individuals, provides a setting in which substantial improvements are both urgently needed and likely achievable. Objectives and Scope The primary objective of this four year demonstration and education research program is to develop, and to evaluate for feasibility, acceptability, and effectiveness, methods to maintain therapy and control of hypertension, for both newly and previously diagnosed individuals, in inner city, primarily minority populations. The focus will be on community-based health education and other approaches for enhancing compliance and improving blood pressure control among inner city minority populations. The delivery of and adherence to the interventions is the main objective, rather than clinical algorithms used to treat hypertension. While the improvement of hypertensive care is the focus of this program, other cardiovascular disease risk factors may be included in the interventions, and changes in these factors should be assessed. The role of non-pharmacologic approaches to reducing blood pressure, including drug and alcohol avoidance, should be addressed. Primary outcome measures to assess the interventions may include: percentages aware of hypertension, screened for hypertension, treated for hypertension, responding to treatment, and controlled to normal levels of blood pressure; clinic attendance; and compliance with therapy. Secondary outcomes include the assessment of: effects on other CVD risk factors, e.g., cigarette smoking, overweight, lipid profile, and diabetes; health quality of life measures; and cost effectiveness of the interventions. The experimental design is not restricted by this RFA. Applicants should develop their own independent design, and provide justification for the proposed design. The designs should focus on an integrated approach including various management factors that have previously been shown to be effective. Health education and other approaches for enhancing compliance and improving blood pressure control must be adequately described. A randomized design, comparing special interventions against usual care would be one appropriate study design to test intervention models. If justified by the nature of the proposed intervention, i.e., delivery of an intervention to a social group (e.g., neighborhood or employee group), other designs will be considered responsive. Annual meetings, to be held in Bethesda, MD, are planned for the exchange of information among investigators. Applicants must budget the travel costs associated with these meetings in their applications. STUDY POPULATIONS Because of their excess burden of hypertension, African Americans should comprise a large proportion of the study population. Although there is no compelling evidence of excess burden from hypertension among Hispanics compared to the population at large, socioeconomic factors for inner-city members of this group may result in less than optimal hypertension detection and treatment. Therefore the inclusion of Hispanics, which may be best accomplished by the inclusion of Hispanics as the majority of the sample at one of the study sites, may be proposed. Investigators should also consider other minority groups, as well as low socioeconomic whites, for inclusion. The inclusion of low socioeconomic status (SES) whites may provide some means to separate the effects of SES and ethnicity. As the lowest hypertension control rates are seen in young African Americans, investigators should address the advantages and disadvantages of oversampling this younger segment of the population. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of approximate percentages by gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited, to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained in the application the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by November 30, 1992, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the PI; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Review Branch, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548 Bethesda, MD 20892 Telephone: (301) 496-7363 FAX: (301) 402-1660 APPLICATION PROCEDURES The research grant application form 398 (rev. 9/91) is to be used in applying for this award. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the NHLBI Program Administrator named below. The RFA label available in the PHS 398 (rev. 9/91) application must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit the signed, typewritten original of the application, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies must also be sent to: C. James Scheirer, Ph.D. Review Branch, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548 Bethesda, MD 20892 It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by February 16, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are found to be responsive will be reviewed for scientific and technical merit by an initial review group, convened by the Division of Extramural Affairs, NHLBI solely to review these applications. The initial review will include an evaluation to determine scientific merit relative to other applications received in response to this RFA (triage). The NIH will withdraw from further competition those applications judged non-competitive for award and notify the applicant PI and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, a reverse site visit at the applicant's expense. Secondary review of applications will be conducted by the National Heart, Lung, and Blood Advisory Council. Review Criteria The review group will assess the scientific merit of the study, including: o The documentation of the need for improving hypertensive care in this segment of the population, and the soundness of the rationale for the selection of the intervention methods. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research, including appropriate determination and discussion of the required sample size and adequate recruitment plans in accordance with sample size estimate. o Qualifications and research experience of the PI and staff, including: administrative abilities of the PI and co-PIs; experience of the key investigators in the area of the proposed research, including experience in adequate recruitment of participants into research projects; ability of investigators and other key personnel to devote adequate time for proper conduct of the study, over the duration of the study; representation of minority individuals among investigators and staff. o Appropriateness of the proposed budget and duration in relation to the proposed research. Applicants must describe in their application the potential for involvement with one or more community service organizations and the potential for the transfer of ownership of the interventional program to these organizations. It is hoped that longevity of the program beyond the funded period can be achieved in this manner. Although the actual transfer of ownership to these organizations is not a requirement of the study, the potential for transfer will be carefully addressed in the review of applications, and those applications without such a description will be considered to be non-responsive to this RFA. AWARD CRITERIA Applications recommended by the National Heart, Lung, and Blood Advisory Council will be considered for award based upon scientific and technical merit (priority scores), programmatic priorities, and the availability of funds. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: P. Scott Allender, M.D. Prevention and Demonstration Research Branch Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-2465 Direct inquiries regarding fiscal matters to: William W. Darby Section Chief, Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7536 AUTHORITY AND REGULATIONS This project is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This project is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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