EXPIRED
OVERCOMING BARRIERS TO TREATMENT ADHERENCE IN MINORITIES AND PERSONS LIVING IN POVERTY Release Date: January 25, 2001 RFA: RFA-HL-01-005 National Heart, Lung, Blood Institute (http://www.nhlbi.nih.gov) National Cancer Institute (http://www.nci.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute of Nursing Research (http://www.ninr.nih.gov/) Letter of Intent Receipt Date: February 22, 2001 Application Receipt Date: March 22, 2001 PURPOSE The National Heart, Lung, and Blood Institute, the National Cancer Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research invite applications for research project (R01) grants to evaluate interventions in clinical care settings designed to improve adherence to medically prescribed lifestyle and medical regimens used to treat heart, lung, blood or sleep diseases, disorders or conditions, cancer, or diabetes. The populations targetted by this RFA are racial and ethnic minorities and/or persons living in poverty. The burden of disease is not borne equally by all population groups in the United States, for example, differences in disease morbidity and mortality exist as a function of race, ethnicity, and socioeconomic status. A key aspect of this program is to encourage research to evaluate innovative yet practical methods that overcome patient, provider and medical systems barriers which impede or erode treatment adherence among racial and ethnic minorities and persons living in poverty in the United States. To be responsive to this RFA, an application must meet the following criteria: o The adherence intervention(s) must be designed to improve patient adherence to a behavioral or medical regimen used to prevent progression or recurrence of an existing heart, lung, blood or sleep disease, disorder, or condition, cancer or diabetes. Studies that focus on cancer may also involve interventions designed to promote the adaptation of healthful behavior post-treatment. o The study population must consist of one or more racial or ethnic minority groups or groups and/or persons living in poverty. o The objective of the adherence intervention(s) tested and the primary outcome of interest must be patient adherence to a behavioral or medical regimen. o The primary measure(s) of adherence proposed must be one or more well-defined, valid and reliable assessments of individual-level patient adherence behavior. o The adherence intervention(s) must be designed to improve patient adherence by targetting the individual patient, his/her formal or informal health-care providers, the health care system or environment, or a combination of these. o The application must propose a specific randomized design to evaluate the effectiveness of one or more adherence interventions. o The adherence intervention(s) to be tested must be grounded in an explicit theoretical framework. o Evidence of the feasibility of the intervention(s), its acceptability to the target population used, and its ability to address the particular barrier or barriers relevant to the population selected, must be provided. This RFA is responsive to Congressional Report Language for the FY 2001 Appropriations that encourages research on health disparities, and that encourages "expanded research on innovative theories about behavioral, cultural, social, psychological, and environmental methods to increase adherence to lifestyle and medical regimens" (see http://www.nih.gov/news/#special). The RFA is based on recommendations made by a recent NHLBI Working Group on Adherence to Medical and Lifestyle Interventions, by a recent NIDDK Working Group and Conference on Behavioral Science Research and Diabetes, and by advisory groups to NHLBI and the NIDDK. This RFA is also responsive to the challenge raised by the President"s Cancer Panel and more recently in a report by the Institute of Medicine, Ensuring Quality of Cancer Care, to understand and address those factors affecting "why specific segments of the population (e.g., members of certain racial or ethnic groups, older patients) do not receive appropriate cancer care." In addition, the RFA is responsive to the request raised by the recent Progress Review Groups on Prostate, Breast and Colorectal Cancer to test behavioral interventions to improve the disease-free survival of and other health outcomes for survivors. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Overcoming Barriers to Treatment Adherence in Minorities and Persons Living in Poverty, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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. However, foreign organizations may participate if they are components of domestic, U.S. organizations or via contractual or consortium agreements with domestic, U.S. organizations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) regular research grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed four (4) years. This RFA is a one- time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2001. FUNDS AVAILABLE The National Heart, Lung, and Blood Institute, National Cancer Institute, National Institute of Diabetes and Digestive and Kidney Diseases and National Institute of Nursing Research intend to commit approximately $5,750,000 in total costs in FY 2001 to fund 8 - 9 new grants in response to this RFA. The NHLBI will provide $3 million per year in total costs, the NCI will commit $1 million in total costs per year, the NIDDK $1 million in total costs per year, and the NINR, up to $750 K in total costs per year. The participating Institutes will fund research projects in their areas of responsibility. An applicant may request a project period of up to 4 years. Budgets in excess of $500,000 direct costs per year must be strongly justified. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the participating Institutes provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, there is no plan to reissue this RFA. RESEARCH OBJECTIVES Background The steady decline in morbidity and mortality from coronary heart disease, stroke, and tuberculosis, as well as recent progress in reducing the morbidity associated with asthma and various blood disorders and diabetes, can be attributed to advances in the prevention and treatment of these diseases and disorders over the past 50 years. Unfortunately, the full impact of these medical advances is often not realized because they are not adopted by patients or are not consistently maintained over time. Rates of patient noncompliance with prescribed treatments range from 30% to 60%, and estimates are that 50% of patients prescribed medication do not receive the full benefits of treatment because of inadequate adherence (Rogers & Bullman, 1995). At the same time, survival of persons diagnosed with cancer is also improving. Today, almost 60% of adults diagnosed with cancer will be alive in five years (ACS, Facts and Figures, 2000). For those diagnosed with early stage or localized prostate, breast or colon cancer 5 year survival is even higher (92%, 77% and 65 %, respectively). Some of the success in treating these cancers is attributable to the growing use of effective screening methods and hence diagnosis of earlier, more treatable forms of the disease, more effective adjuvant treatments have also contributed to better prognoses. Despite the seriousness of a cancer diagnosis, some patients do not adhere to or face health care systems barriers to obtaining recommended therapies and fail to receive any or a complete course of adjuvant chemotherapy, radiation or hormonal therapy. Further, with the number of cancer survivors growing, research is needed to test whether or not adjuvant therapies or health behavior change during what is often considered a "teachable moment" can be useful in reducing risks of cancer recurrence or other chronic health problems (e.g., heart disease, pulmonary dysfunction, osteoporosis). Testing these hypotheses will require intervention programs that yield long-term adherence to treatment regimens or maintenance of health behavior change. Diseases of the heart, lungs, and blood and sleep disorders. The evidence for poor utilization of medical treatments for heart, lung and blood diseases and for sleep disorders is striking. In the case of antihypertensive therapy, recent studies show that, despite the availability of convenient, once-daily dosing regimens with relatively few side effects, only 27% of known hypertensives in the U.S., and 55% of treated hypertensives, maintain target blood pressures (JNC-VI, 1997). Further, it is estimated that up to 50% of patients who begin antihypertensive therapy drop out of care within one year (Haynes, 1995), and of those who remain in treatment, about one-half take less than 80% of their medication (Haynes et al., 1980). Since blood pressure control has been found to be significantly better in patients taking at least 80% of their medication compared with those taking less than 50%, the low adherence rates reported for antihypertensive regimens have important implications for the management of hypertension and associated cardiovascular complications. Another area of need concerns sickle cell disease (SCD). Newborn screening programs are in place to identify newborns with sickle cell disease, and prophylactic penicillin is recommended until about age seven, but this regimen requires periodic visits to healthcare providers. Sickle cell patients who have been placed on transfusion regimens with subsequent need to undergo chelation therapy face treatments which can be frightening, painful, and otherwise burdensome, resulting in potential adherence problems. Hydroxyurea, the only proven effective therapy for SCD, can effect substantial improvements in sickle cell crises and complications. However, appropriate use of hydroxyurea is of particular concern, when used inappropriately, its benefits may not be realized, and when taken in too great a quantity, patients may be at risk for malignancies or birth defects. Finally, adolescent sickle cell patients face potential adherence problems when transitioning from pediatric to adult care because they are removed from the supportive umbrella of parent and pediatric health care providers. Nonadherence to treatment has also been found to be a problem for beta- blockers prescribed for patients post-myocardial infarction, lipid- lowering agents used to treat high blood cholesterol, anticoagulation in atrial fibrillation, angiotensin converting-enzyme inhibitors in heart failure, anti-inflammatory therapy in asthma, and treatments for chronic obstructive pulmonary disease and sleep apnea. Lack of adherence to treatment regimens for tuberculosis has been documented, and presents the additional consequence of contributing to the development of multi- drug resistant strains that are more difficult to control and may lead to spreading infection. With respect to behavioral interventions, many studies have demonstrated good initial success with major lifestyle changes for preventing and managing heart, lung, and blood diseases, but maintenance of such changes beyond 1-2 years is much less satisfactory. Cancer. With regard to cancer treatment, patients who fail to receive a full course of prescribed cancer therapy have an increased chance of recurrence and potentially poorer survival outcomes (Richardson et al., 1990). For example, McCready et al. found that the rate of recurrence among postmenopausal women who underwent lumpectomy without adjuvant therapy was 24%, compared to those compliant with adjuvant therapy (McCready et al., 2000). Similarly, de Csepel et al. also found a higher lifetime rate of recurrence (22%) among elderly women treated with breast conservation surgery without adjuvant therapy who did not fully adhere to recommendations for radiation therapy following breast cancer surgery (de Csepel et al., 2000). Between 15-30% of women treated with breast conserving surgery do not undergo postoperative radiotherapy (Athas et al., 2000). Follow-up to adjuvant treatment for women receiving breast conserving surgery is lower among rural, elderly and other underserved populations. For example, only 36% of women treated with breast conserving surgery at a rural southern institution fully adhered to the recommendation for radiation therapy and clinical follow-up after breast conserving surgery which led to higher local failure rates (Li et al., 2000). Once treatment ends, cancer survivors need to be carefully followed for potential late effects of disease. Because of their treatments, many are at increased risk of developing secondary tumors or other chronic conditions, such as osteoporosis, diabetes and cardiovascular diseases. Cancer survivors are thus an important target population for health- promotion interventions. To date, there is limited information about the health behaviors of patients beyond the active cancer treatment period. Demark-Wahnefried and colleagues (2000) found that 55% of their sample of 978 survivors ate fewer than 5 daily servings of fruits and vegetables. Prostate cancer survivors ate even fewer servings than breast cancer survivors. Over 30% indicated they did not adhere to a low fat diet, with prostate cancer patients again indicating worse practice than breast cancer survivors in this area. 42% of survivors did not engage in routine exercise and 8% were current smokers. In this study, receptivity of the survivors to interventions to promote lifestyle changes was stated to be high. Physical activity can significantly improve functional (i.e., fatigue, nausea, functional capacity) and emotional (i.e., mood, distress, self-esteem) quality of life of cancer patients (Courneya & Friednereich, 1999). It is not known to what extent changes in health-related behavior contributes to reduced risk of recurrence or other co-morbid illnesses. Trials are underway to test whether dietary changes increase survival from breast cancer (Pierce et al., 1997, Rock et al., 1997). However, it is reasonable to assume that changes in health-related behavior can contribute to an overall improved quality of life. Diabetes. Health care practices demonstrated to improve diabetes outcomes have recently been shown to be significantly underutilized. Self-monitoring of blood glucose, glycemic control, regular foot care, and ophthalmic examinations have all been shown to markedly reduce the incidence and progession of diabetic complications. These findings have resulted in the American Diabetes Association (ADA): Standards of Medical Care for Patients with Diabetes Mellitus. However, less than 2% of adults with diabetes receive the full level of care that has been recommended by the ADA. Self-monitoring of blood glucose, following the ADA guidelines, is performed by only one in five adults with diabetes. Only four in ten individuals that saw their health care provider for diabetes care had their feet examined or received a dilated eye exam during the previous year. And according to the NHANES, only 42% of individuals achieve the ADA recommended HbA1c level of 7 or lower. Behavioral interventions clearly need to be developed to improve adherence to demonstrated mechanisms that improve diabetes outcome. More than 25 years ago, nonadherence of patients to medical and behavioral treatments was identified by Sackett and Haynes (1976) as a major public health problem. In the intervening time period, numerous studies have been conducted to identify factors that predict nonadherence and strategies that improve adherence, defined as following medical, behavioral or other health-related recommendations made by a healthcare professional. The most robust finding is that aspects of the therapeutic regimen (regimen complexity, difficulty or ease of use of medication, dosing frequency, duration of therapy) are the best predictors of patient adherence (Dunbar-Jacob & Stunkard, 1979). In addition, interpersonal factors, such as social support and provider behaviors (Dunbar-Jacob & Stunkard, 1979), as well as psychological distress (i.e., depression and anxiety, Colleoni et al., 2000, Ayres et al., 1994), more serious mental disorders, and substance abuse (Rand & Weeks, 1998), affect adherence. However, personality traits have not been consistently shown to predict adherence (Dunbar-Jacob et al., 1998). Research shows that adherence is enhanced when regimens are simple, easy to follow, of short duration, do not involve disruptions in lifestyle and are linked to reductions in symptoms or pain (Dunbar-Jacob & Stunkard, 1979). More intensive, comprehensive approaches (e.g., combining several types of adherence-promoting strategies) appear to be more successful (Mullen et al., 1992, Roter et al., 1998), and tailoring the intervention to address the individual=s reasons for not adhering also may be helpful. However, even more limited educational interventions also may be effective. For example, Richardson and colleagues (1990) found that a one-hour educational session with a nurse and additional hospital and/or home component was associated with improved allopurinol compliance in newly diagnosed hematologic malignancy. Finally, physicians= communicative skills and rapport with the patient are associated with better adherence (Becker, 1985, Hall et al., 1988, Stewart, 1996). However, gaps remain in our knowledge of how best to improve patient adherence to therapeutic strategies for diseases of the heart, lung, and blood vessels, cancer, diabetes and sleep disorders. This is especially true for certain population groups, such as racial and ethnic minorities and individuals living in poverty, which often demonstrate poorer adherence rates relative to other segments of the population. In fact, many of the disparities that exist in health outcome based on cultural, ethnic and socioeconomic factors may to some extent reflect disparities in the adoption and maintenance of healthy lifestyles and adherence to medical regimens. Racial and SES disparities in adherence to prescribed behavioral and medical regimens are often based on financial, logistical and cultural barriers that, while not unique to minorities and the poor, often occur more frequently or have greater impact in poor and minority communities. Examples of barriers frequently encountered by these groups when attempting to follow recommended health and treatment recommendations include the following: (1) Financial constraints. Many individuals from lower socioeconomic strata lack health insurance and are unable to afford required medical devices and medications. The cost of therapy, the medical visit and/or the time off from work for the same may significantly reduce disposable income. Good health may become a low priority for the patient and/or the patient"s family because of competing needs and limited resources. (2) Logistical barriers. Health care resources may be inconveniently located, transportation and/or dependent care may be unavailable or difficult to obtain, or obtaining health care conflicts with work requirements. (3) Cultural barriers. These include mistrust by some minority groups of medical personnel and medical systems, lack of cultural sensitivity on the part of health care providers, and differences between patients and health care providers regarding the meaning and importance of an illness, its causes, consequences and treatment. Cultural practices, and health knowledge and beliefs are all important determinants of the effectiveness of patient-physician interactions. Physicians may not fully recognize educational, social, cultural, or economic barriers to routinely prescribed therapy. Similarly, a patient"s expectations and understandings of the physician or health provider"s role may present additional obstacles. Issues such as the legacy of racial segregation, stigma associated with disease and mistrust of health care facilities tend to alienate minorities from medical systems. (4) Environmental stressors. Minority groups and individuals living in poverty encounter many stressors, both physical and psychological, on a daily basis. The demands associated with survival in harsh environments B obtaining food, housing, work, and ensuring the physical safety of one"s self and family -- cause strain and tax the psychological resources needed to deal with health concerns. The types of jobs held by lower SES workers often involve stressful conditions and even physical hazards. Shift work, which is performed by disproportionate numbers of minorities and individuals from lower socioeconomic strata, frequently results in sleep deprivation. Lack of sleep is emerging as an important contributing factor to cardiovascular disease, increased severity of inflammatory disease, diminished mental and physical health, and may also play an important role in adherence to prescribed health recommendations. Given the presence of these chronic, multiple barriers to adherence, it is not surprising that following prescribed health recommendations poses a special challenge for ethnic minority and lower socioeconomic groups. A major research priority is therefore the development of effective interventions in clinical care settings for improving adherence to medical and lifestyle regimens for these underserved groups so that the full benefits of medical advances in the treatment of heart, lung and blood diseases, cancer, diabetes and sleep disorders can be realized for all segments of the U.S. population. Criteria for Responsiveness Applicants responding to this solicitation must propose a study which evaluates the effects of an adherence intervention strategy or strategies on treatment adherence in a minority and/or low SES population. To be considered responsive, studies must meet all of the following criteria: (1) The adherence intervention must be designed to improve patient adherence to either a behavioral or medical regimen, or both, used to prevent recurrence or progression of an existing heart, lung, blood or sleep disease, disorder, or condition, cancer, or diabetes. The regimen must involve either a behavioral treatment or treatments (e.g., counseling for smoking cessation or to reach dietary or physical activity goals) or medical therapies (e.g., medication regimens or devices used to treat the disease or condition), or combinations of the two. The following describes Institute-specific areas of focus: National Heart, Lung, and Blood Institute: The National Heart, Lung, and Blood Institute is interested in studies that evaluate adherence interventions in minority and lower SES patients who have been diagnosed with and are being treated for a broad range of heart, lung, blood and sleep diseases, disorders or conditions. A list of therapies and conditions relevant to this RFA (these are examples only, not an exhaustive list) include: antihypertensive and cholesterol-lowering medications, medications used to treat myocardial infarction and congestive heart failure, weight loss regimens in obese individuals, lifestyle change (e.g., smoking cessation, dietary and physical activity regimens for persons with hypertension, high blood cholesterol, myocardial infarction), and treatments for asthma, chronic obstructive pulmonary disease, tuberculosis (latent and active), sickle cell disease, and sleep disorders such as sleep apnea. National Cancer Institute: The National Cancer Institute is interested in applications for research in persons diagnosed with cancer, focusing on racial/ethnic minorities and persons living in poverty. Studies of persons with breast, colon and prostate cancer would be most feasible, as these are high incidence cancers with relatively high, long-term survival following treatment. The research study should evaluate interventions designed to increase compliance with and/or overcome barriers to receiving adjuvant therapy (chemotherapy, radiation or hormonal therapy), to facilitate earlier diagnosis of recurrent cancer through increased adherence to recommendations for follow-up care, or to reduce the risk of other co-morbid conditions (e.g., osteoporosis, cardiovascular disease, or other cancers) through adoption of lifestyle changes. Thus, the research should address either (1) interventions designed to improve adherence to adjuvant treatment recommendations known to improve survival, such as the use of tamoxifen for breast cancer, or (2) maintenance of lifestyle changes that could increase long-term survival, enhance quality of life, or reduce co-morbidity. Appropriate behavioral interventions would include, but not be limited to weight control, physical activity, dietary change, and smoking cessation. Of particular interest is the development and evaluation of theory based models to guide interventions to promote long-term adherence to treatment regimens and/or maintenance of healthful behavior. National Institute of Diabetes and Digestive and Kidney Diseases: The National Institute of Diabetes and Digestive and Kidney Disease is interested in development and translation of effective interventions to increase adherence to medical regimens for diabetes, obesity, genetic metabolic diseases and endocrine, renal, urologic, hematologic, digestive and liver diseases for ethnic minorities and persons living in poverty. Examples of topics of interest to NIDDK include: interventions to increase adherence to medications used to treat hyperglycemia and behaviors affecting glycemic control and other diabetes outcomes, interventions to improve post-transplant medication compliance, improved treatment of depression in patients with diabetes or on dialysis, interventions targeted at increasing compliance in adolescents, and studies of interactions between care providers and patients leading to improved adherence and outcome. National Institute of Nursing Research: For the purposes of this RFA, NINR is interested in research studies that involve nursing interventions or have a direct impact on patient care by a health team, or studies that involve nursing, patient, or health care system strategies to improve appropriate patient adherence to pharmacological and behavioral treatments, as well as to health care practices and regimens provided by nurses and health care providers other than physicians, and that are targetted to minority or low income persons. The NINR is especially interested in funding meritorious applications by nurse investigators where such applications are in concert with the mission of NINR. (2) The study population must consist of a racial or ethnic minority group or groups and/or persons living in poverty. Applicants must target as their study population a minority group or groups or a population living in poverty, or both. For the purposes of this program, racial/ethnic minorities include African Americans, Hispanics, Asians/Pacific Islanders, and Native Americans. With regard to poverty, the purpose of the program is to identify and employ interventions which effectively reduce economic and other barriers to adherence. Therefore, poverty is broadly defined to include measures beyond FY 2000 HHS poverty guidelines (i.e., $17,050 for a family of four) and may also include persons eligible for federal assistance programs (e.g., food stamps, welfare, Head Start, earned income credit, supplemental security income, block grants, temporary assstance for needy families) and persons without health insurance. Applicants must provide detailed information describing the population to be studied. Detailed justification for the proposed sample size is required, as is evidence that the projected sample size is attainable. Documentation of access to sufficient numbers of study participants to satisfy power requirements of the study must be provided. (3) The objective of the adherence intervention(s) tested, and the primary outcome of interest, must be patient adherence to behavioral or medical regimens, rather than provider adherence to clinical guidelines. While physician or health care provider compliance to treatment guidelines is a major problem affecting translation of research findings to clinical practice, the focus of studies responsive to this RFA should be on improving the degree to which patients adhere to medical or behavioral regimens, rather than on improving the extent to which physicians or providers adhere to clinical guidelines. Thus, the intervention(s) used should have as its(their) goal increasing the extent to which patients" adhere to the behavioral or medical regimens of interest. (4) The primary measure(s) of adherence proposed must be well-defined, valid and reliable assessments of individual-level patient adherence behavior, not just broad indicators of health care utilization or health outcomes. Primary outcome measures should assess the adherence of individual patients, using one or more well-defined, reliable and valid adherence assessment tools (e.g., patient self-report, pill count, electronic monitoring). The specific adherence measures to be used should be well- justified. Use of multiple measures of adherence is encouraged, especially when self-report measures are employed. If self-report is used, the measure must be previously validated. The applicant is encouraged to make use of the most recent advances and/or innovations in adherence measurement (e.g., electronic monitoring systems), where feasible. Applicants may also propose measurement of provider attitudes or behavior (e.g., provider self-report of patient adherence) and use of broader indicators of adherence, health care utilization and health outcomes (pharmacy records) as secondary measures of patient adherence. (5) The adherence intervention(s) must be designed to improve patient adherence by targetting the individual patient, his/her formal or informal health-care providers, the health care system or environment, or a combination of these. Although the goal of the adherence intervention is to change patient behavior, the proposed intervention(s) may attempt to do so by targetting either the patient (e.g., through dissemination of information, provision of education, or use of behavioral, affective or cognitive techniques that enhance patient adherence), the health care provider (e.g., through the use of strategies that improve provider communication or rapport with patients or teach other skills that encourage patient adherence), the health care environment (e.g., by structuring the practice setting to support provider counseling of patients in adherence) or any combination of these. For example, an intervention may seek to increase a patient=s motivation to adhere, improve a health care provider=s communication skills, and/or alter aspects of the practice setting to eliminate barriers and provide incentives for health care personnel to use communication/counseling skills to encourage patient adherence. Where levels other than the patient are targetted by the intervention (e.g., both patients and providers receive an intervention, or there is an attempt to change both the provider=s behavior and the health care environment), the applicant must explicitly address any design issues or threats to validity that occur with such designs (e.g., rather than randomizing individual patients, randomization at the provider or even health care practice level may be required). (6) The application must propose a specific randomized design to evaluate the effectiveness of one or more adherence interventions. The applicant should propose to use an experimental design in which the individuals or groups targetted by the intervention (e.g., individual patients, providers or health care practices) are randomly assigned to one or more adherence intervention conditions, and the effectiveness of the interventions in enhancing patient adherence is assessed relative to each other and/or to a usual care control group. (7) The adherence intervention(s) to be tested must be grounded in an explicit theoretical framework. The proposed adherence intervention(s) must be based in a clearly explicated theoretical framework, and the applicant must describe in detail the theoretical underpinnings of the adherence intervention(s). Innovative or novel approaches that enable minorities and people living in poverty to address barriers to adherence, either by tailoring a proven adherence intervention to the cultural/economic needs of the study group OR by using a novel intervention uniquely suited to the specific study population, are encouraged. (8) Evidence of the feasibility of the intervention(s), its acceptability to the target population used, and its ability to address the particular barrier or barriers relevant to the population selected, must be provided. The applicant must present evidence that the intervention(s) will be feasible and acceptable for the target population, e.g., data or prior literature supporting the use of the intervention with the target population and showing the potential for success of the intervention for the target group(s). The applicant must also discuss how the intervention will be tailored to meet the particular needs of and address the specific barriers to adherence for the targetted group(s). A clear characterization and discussion of the barriers specific to the population targetted, and the plan and rationale for how the adherence interventions proposed will be tailored to overcome these barriers, are essential. To ensure that the interventions can be translated directly to the clinical care setting, strategies that are relatively simple, practical and readily incorporated into medical settings that serve minority and lower SES populations are encouraged. Project Schedule The maximum duration of the research projects will be four years. A project timetable is provided below, however, variations in project length within this period and variations of program phases may occur due to differences in the time needed for recruitment, intervention, and follow-up. Phase 1 (6 months): Protocol refinement, pre-tests of measures, staff training, study start-up activities. Phase 2 (3 years): Recruitment of participants, intervention, and follow-up activities, preliminary data analysis. Phase 3 (6 months): Data analysis and reporting. Investigators will meet at or near the beginning of Phase 1 to discuss study design and share problems and solutions prior to the beginning of recruitment, and annually thereafter until the end of the study. REFERENCES Athas WF, Adams-Cameron M, Hunt WC, Amir-Fazli A, Key CR. Travel distance to radiation therapy and receipt of radiotherapy following breast conserving surgery. J Natl Cancer Inst 2000,92:269-271. Ayres A, Hoon PW, Franzoni JB, Matheny KB, Cotanch PH, Takayanagi S. Influence of mood and adjustment to cancer on compliance with chemotherapy among breast cancer patients. J Psychosom Res 1994,38:393- 402. Bastarrachea J, Hortobagyi GN, Smith TL, Shu-Wan CK. Obesity as an adverse prognostic factor for patients receiving adjuvant chemotherapy for breast cancer. Ann Int Med 1993, 119:18-25 Becker MH. Patient adherence to pescribed therapies. Medical Care 1985,23:539-55. Cancer Facts and Figures 2000. Atlanta, GA: American Cancer Society, 2000. Colleoni M, Mandala M, Peruzzotti G, Robertson C, Bredart A, Goldhirsch A. Depression and degree of acceptance of adjuvant cytotoxic drugs. Lancet 2000, 356, 1326-1327. Courneya KS, Friedenreich CM. Physical exercise and quality of life following cancer diagnosis: a literature review. Ann Behav Med 1999, 21:171-179. de Cespel J, Tartter PI, Gajdos C. When not to give radiation after breast conservation surgery for breast cancer. J Surg Oncol 2000:74:273-277. Demark-Wahnefried W, Peterson B, Mcbride C, Lipkus I, Clipp E. Current health behaviors and readiness to pursue life-style changes among men and women diagnosed with early stage prostate and breast carcinomas. Cancer 2000,88:674-684. Demark-Wahnefried W, Winer EP, Rimer BK. Why women gain weight with adjuvant chemotherapy for breast Cancer. J Clin Oncol 1993, 11:1418- 1429. Dunbar-Jacob, JM, Schlenk EA, Burke LE, Matthews JT. Predictors of patient adherence: Patient characteristics. In Shumaker SA, Schron EB, Ockene JK, McBee WL (Eds.) The Handbook of Health Behavior Change, 2nd Edition. New York: Springer Publishing Company, 1998,491-511. Dunbar-Jacob J, Stunkard AJ. Adherence to diet and drug regimen. Nutrition, Lipids, and Coronary Heart Disease. Levy R, Rifkind B, Dennis B, Ernst N. (Eds.) New York: Raven Press, 1979,391-423. Hall JA, Roter DL, Klatz NR. Meta-analysis of correlates of provider behavior in medical encounters. Medical Care 1988,26:657. Haynes RB. Improving patient compliance in the management of hypertension. In: Kaplan NM, Ram CV (Eds.) Individualized Therapy of Hypertension. New York: Marcel Dekker Inc., 1995,257-73. Haynes RB, Taylor W, Sackett DL, et al. Can simple clinical measurements detect patient noncompliance? Hypertension 1980,2:757-64. Herbert JR, Jurley TG, Ma y. The effect of dietary exposure on recurrence and mortality in early stage breast cancer. Breast Cancer Res Treat 1998, 51:17-28. Hoagland AC, Morrow GR, Bennett JM, Carnrike CL Jr. Oncologists= views of cancer patient noncompliance. Am J Clin Oncol 1983, 6: 239-244. Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Prevention, Detection, and Treatment of High Blood Pressure (JNC VI). Arch Intern Med 1997,157:2413-46. Kawachi I. Physical and psychological consequences of weight gain. J Clin Psychiatry 1999, 60: suppl 21: 5-9. Li BD, Brown WA, Ampil FL,, Burton GV, Yu H, McDonald JC. Patient compliance is critical for equivalent clinical outcomes for breast cancer treated by breast-conservation therapy. Ann Surg 2000,231:883- 889. McCready DR, Chapman JA, Hanna WM, Kahn HJ, Yap K, Fish EB, Lickley HL. Factors associated with local breast cancer recurrence after lumpectomy alone: postmenopausal patients. Ann Surg Oncol 2000,7:562-567. Mullen PD, Mains DA, Velez R. A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns 1992,19:143-62. Pierce JP, Faeber S, Wright FA, Newman V, Flatt SW, Kealey S, Rock CL, Haynick W, Greenberg ER. Feasibility of a randomized trial of a high vegetable diet to prevent breast cancer recurrence. Nutr Cancer 1997, 28:282-288. Rand C, Weeks K. Measuring adherence with medication regimens in clinical care and research. In Shumaker SA, Schron EB, Ockene JK, McBee WL (Eds.) The Handbook of Health Behavior Change, 2nd Edition. New York: Springer Publishing Company, 1998,114-132. Richardson JL, Shelton DR, Krailo M, Levine AM. The effect of comp- 0liance with treatment on survival among patients with hematologic malignancies. J Clin Oncol 1990,8:356-364. Rock CL, Newman V, Flatt SW, Faerber S, Wright FA, Pierce JP. Nutrient intakes from foods and dietary supplements in women at risk for breast cancer recurrence. The Women"s Healthy Eating and Living Study Group. Nutr Cancer 1997, 29:133-139. Rogers PG, Bullman WR. Prescription medicine compliance: A review of the baseline of knowledge. A report of the National Council on Patient Information and Education. J Pharmacoepidemiology 1995,2:3-36. Roter DL, Hall JA, Merisca R, Nordstrom B, Cretin D, and Svarstad B. Effectiveness of interventions to improve patient compliance. Medical Care 1998, 36:1138-61. Sackett DL, Haynes RB (Eds.) Compliance with therapeutic regimens. Baltimore: Johns Hopkins University Press, 1976. Schapira MM, McAuliffe TL, Nattinger AB. Underutilization of mammography in older breast cancer survivors. Medical Care 2000, 38:281-289. Smith TJ, Davidson NE, Schapira DV, Grunfeld E, Muus HB, Vogel VG 3rd, Somerfield MR. American Society of Clinical Oncology 1998 update of recommended breast cancer surveillance guidelines. J Clin Oncol 1999, 17:1080-1082. Stewart MA. Effective physician-patient communication and health outcomes: A review. Can Med Assoc J 1996,152:1423. SPECIAL REQUIREMENTS (a) DATA SAFETY AND MONITORING. A clinical trial entails a relationship between participants and investigators, both of whom must fulfill certain obligations for the effort to succeed. Participants must be fully informed of the study requirements throughout the conduct of the trial and should comply with the rigors of the research protocol or be allowed the opportunity to withdraw from participation. The investigators must protect the health and safety of participants, inform participants of information relevant to their continued participation, and pursue the research objectives with scientific diligence. In 1994, the NIH Office of Extramural Research established the Committee on Clinical Trial Monitoring to review the oversight and management practices of the ICs for phase III clinical trials. One of the outcomes of this Committee"s review was a strong recommendation that "all trials, even those that pose little likelihood of harm, should consider an external monitoring body." Applicants should describe the organizational structures and procedures they will employ to ensure the safety of participants and the validity and integrity of the data. (For a statement of issues and concerns, see "NIH Policy for Data And Safety Monitoring," NIH Guide to Grants and Contracts, Release Date: June 10, 1998, http://grants.nih.gov/grants/guide/notice-files/not98-084.html). At the time of the award, applicants should be prepared to make adjustments to their procedures based upon NHLBI policy. (b) ANNUAL MEETINGS. Applicants funded under this RFA will be required to attend meetings in which study plans, findings and issues of common interest and concern will be shared and discussed. Applications should include in their budgets funds for attending (1) an initial meeting at or near the time of the award and (2) an annual meeting thereafter until the end of funding. For budgeting purposes, applicants should assume that the meetings would be for two days in Bethesda, Maryland at the National Institutes of Health and require the attendance of at least the Principal Investigator. (c) USE OF EXISTING STUDIES. Applications should consider taking advantage of other research projects (e.g., clinical trials about to be implemented) that could be expanded by adding a research component on adherence. Such projects might provide access to subject populations or settings as well as reduce the costs of conducting research. (d) FINAL REPORT. At the completion of the project, the Principal Investigator (PI) must provide a report to the Project Office with: (a) detailed recommendations concerning the adherence intervention(s) evaluated, based on the study"s findings, (b) a complete description of the intervention(s) used in the study, to include a description of the rationale for and underlying theoretical bases for the intervention(s), a description of the intervention procedures used (e.g., manuals of procedures), and any intervention materials used, ( c) training, certification and quality control procedures for ensuring effective implementation of the recommended adherence intervention(s), and (d) how the theoretical approach used could be generalized to, and the interventions be tailored for, other modalities, populations or diseases. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b/ all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human subjects that was published in the NIH Guide for Grants and contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by February 22, 2001, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Susan Czajkowski at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, e-mail: [email protected]. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/forms.htm. Because we expect that there will not be any applications requesting less than $250,000 in direct costs for all years, applications should be in the standard (non-modular) format with a detailed budget. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies of the application in one package to: CENTER FOR SCIENTIFIC REVIEWNATIONAL INSTITUTES OF HEALTH6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Applications must be received by March 22, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR 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 CSR and responsiveness by NIH staff. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council for the relevant Institute. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the application assess the fidelity of the adherence intervention (i.e., delivery of the adherence intervention as intended) and provide a detailed, detailed, realistic project schedule? (3) Innovation: Does the application propose an innovative approach to overcoming the barriers to adherence encountered by minorities and/or people living in poverty, either by tailoring a proven adherence intervention to meet the special needs (i.e., cultural/economic needs) of the chosen study group OR by using a novel intervention that, while based in theory and supported by previous literature in the area, represents a new approach that is uniquely suited to the specific study population? (4) Investigators: Is each investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? (6) Translation: Do the intervention strategies tested have the ability to be translated into everyday practice settings utilized by minority and/or low income patients (e.g., by using interventions that require a miniumum of expertise and training of personnel, that make use of providers other than physicians to carry out the intervention, and/or through use of cost-effectiveness analysis to demonstrate the feasibility of incorporating interventions into minority and lower- income clinical practice settings)? In addition to the above criteria list, in accordance with NIH policy, all applications will also be reviewed with respect to o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: February 22, 2001 Application Receipt Date: March 22, 2001 Peer Review Date: June/July, 2001 Council Review: August, 2001 Earliest Anticipated Start Date: September 30, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES 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: NHLBI Dr. Susan Czajkowski Behavioral Medicine Research Group Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 8114 6701 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0406 FAX: 301-480-1773 e-mail: [email protected] Dr. Patrice Desvigne-Nickens Heart Research Program Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 9158 6701 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0497 e-mail: [email protected] Ms. Virginia Taggart Division of Lung Diseases National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 10214 6701 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0202 e-mail: [email protected] Dr. Ellen M. Werner Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 10182, MSC 7950 Bethesda, MD 20892-7950 Telephone: 301-435-0077 e-mail: [email protected] Dr. Michael Twery National Center for Sleep and Sleep Disorders Research National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 10018 6701 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0202 e-mail: [email protected] NCI Dr. Linda Nebeling Chief, Health Promotion Research Branch National Cancer Institute Division of Cancer Control and Population Sciences 6130 Executive Blvd., EPN 4080, MSC 7335 Bethesda, MD 20892-7335 Telephone: 301-496-8520 FAX: 301-480-2087 e-mail: [email protected] NIDDK Dr. Sanford A. Garfield Senior Advisor for Biometry Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Boulevard, Room 685 Bethesda, MD 20892-5460 Telephone: 301-594-8803 FAX: 301-480-3503 e-mail: [email protected] NINR Dr. Hilary Sigmon Division of Extramural Activities National Institute of Nursing Research National Institutes of Health Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 e-mail: [email protected] Direct inquiries regarding review issues to: Dr. Michael Micklin Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 3178, MSC 7848 Bethesda, MD 20892-7848 (20817 for express mail) Telephone: 301-435-1258 e-mail: [email protected] Direct inquiries regarding FISCAL MATTERS to: Ms. Diane Drew Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 7157A 6701 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0179 e-mail: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.937 (NHLBI). 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 program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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