Recent Research in Chronic Disease
Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
Chronic Disease Management for Adolescents with T2DM
Dietary Antioxidants and Incidence of Adult-onset Asthma
Glycemic Relapse Prevention: Maintenance Dose Assessment
Longitudinal Diabetes Care
Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD)
Southern Community Cohort Study (SCCS)
Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
Medical Nutrition therapy (MNT) is essential for self-management of type 2 diabetes(T2DM). However, there have been few rigorous studies evaluating the role of different educational approaches to MNT, such as education that focuses on carbohydrate counting vs. plate method. Understanding the strengths and weaknesses of different approaches to MNT education could help educators to optimize the education they provide. Choosing a particular nutrition education approach may be particularly important for educating patients with low literacy or numeracy (math skills). Over 90 million Americans have low literacy or numeracy, and research has demonstrated that low literacy or numeracy is independently associated with worse diabetes knowledge, poorer understanding of nutrition labels, worse self-efficacy, and worse glycemic control. We propose a randomized trial to better evaluate: (1) the importance of nutrition education from a certified diabetes educator(CDE), (2) the similarities and differences between different nutrition education approaches, and (3) the unique role of health literacy and numeracy in patient’s response to nutrition education. 150 patients with T2DM will be randomized to: (1) “Usual care” from a primary care provider (PCP) plus 3 control visits with a health educator providing non-nutrition oriented diabetes education, (2) “Usual care” from a PCP plus 3 visits with an RD CDE focusing on carbohydrate counting, or (3) “Usual care” from a PCP plus 3 visits with an RD CDE focusing on a modified plate method. Patient will be followed for 6 months and outcomes will include: A1C, Weight/BMI, lipids, dietary behaviors, diabetes self-care activities, self-efficacy, and treatment satisfaction. Funded by the American Association of Diabetes EducatorsInvestigators: Russell L. Rothman, M.D., M.P.P. (PI); Ken Wallston, Ph.D.; Kathleen Wolff, M.S.N., A.P.R.N., B.C.-A.D.M.; Becky Gregory, R.D., L.D.N., C.D.E.; Dianne Davis, R.D., L.D.N., C.D.E.
Chronic Disease Management for Adolescents with T2DM
Type 2 diabetes (T2DM) is recognized as a growing problem among adolescents, particularly in minority populations. While T2DM previously represented less than 5% of new diabetes diagnoses in pediatrics, it now accounts for as much as 50% of new diagnoses. The treatment of T2DM in adolescents requires comprehensive care that includes behavioral and pharmacologic interventions. Studies show that approximately 50% of adolescents with chronic problems do not comply with care recommendations. This non-adherence can be exacerbated by patient, provider and system attributes. Addressing patient, provider and system barriers to care are crucial in the development of a successful comprehensive program for the treatment of T2DM in adolescents. This proposal will advance current knowledge about T2DM in adolescents through emphasis on identifying barriers to care, and applying this information to the development and evaluation of a comprehensive intervention to improve adolescent diabetes care. To accomplish these goals I will work with Dr. Robert Dittus, Director of the Vanderbilt Center for Health Services Research, Dr. William Russell, Division Chief of Pediatric Endocrinology, and Dr. David Schlundt, Co-director of the Behavioral Core of the Vanderbilt Diabetes Research and Training Center (DRTC) to further my career development in (1) adolescent diabetes, (2) methods for identifying and measuring psychosocial determinants of adolescent behavior, and (3) designing and evaluating interventions to improve self-management behaviors and treatment adherence in adolescents with T2DM. The specific aims of this research will be to: (1) perform surveys and focus groups to identify patient/parent barriers to care for adolescents with T2DM and strategies for addressing these barriers (2) examine provider and system barriers to proper management of adolescent T2DM, and (3) to use this information to develop and implement a randomized controlled trial of a new comprehensive diabetes management program for adolescents with T2DM. The process and results of this research will provide valuable insights into adolescent diabetes, and will accelerate my future independent investigation in adolescent T2DM. Funded by the National Institute of Diabetes and Digestive and Kidney Diseases Investigators: Russell L. Rothman, M.D., M.P.P. (PI); Shelagh Mulvaney, Ph.D.; David Schlundt, Ph.D.; William E. Russell, M.D.; Robert Dittus, M.D., M.P.H.
Dietary Antioxidants and Incidence of Adult-onset Asthma
The objectives of this application are to study the association of dietary and serum antioxidants and oxidative stress on adult-onset asthma incidence among a cohort of 75,000 women. We hypothesize that dietary antioxidants play a role in the development of asthma, particularly in persons with a family history of atopic disease. Questions related to dietary antioxidant intake that this application aims to address are whether dietary and serum antioxidants protect against development of adult-onset asthma, whether persons with atopic disease have higher indices of oxidative stress, and whether those with a genetic susceptibility to be atopic are protected by higher intake of dietary antioxidants. To examine these hypotheses, we will utilize an existing large prospective cohort, the Shanghai Women’s Health Study (SWHS), which tracks detailed information on dietary intake and environmental factors as they relate to cancer incidence and other chronic diseases. This prospective cohort study is being conducted among approximately 75,000 female residents of Shanghai, China between the ages of 35 and 69, where there is marked heterogeneity in dietary intake and 97 percent of the cohort are non-smokers. Measurements of free radicals will be made in baseline urine samples using an assay for isoprostanes, recently described lipid peroxidation products, to determine if there is a correlation between adult-onset asthma and increased markers of lipid peroxidation. Isoprostanes are considered the most accurate marker of oxidative stress currently available. Measurements of serum antioxidants will be made using baseline serum samples. We propose in this project: (1) an incidence study to determine the association between dietary antioxidants and incident asthma, and (2) a nested case control study examining (a) the correlation between a urinary measure of oxidative stress and incident asthma, and (b) the relationship between serum antioxidants and incident asthma. This series of studies, with the combination of three measures of antioxidant exposure and oxidant stress, are designed to uncover antioxidant-specific effects in the development of asthma. Funded by the National Institute of Allergy and Infectious Diseases Investigators: Tina V. Hartert, M.D., M.P.H. (PI)
Glycemic Relapse Prevention: Maintenance Dose Assessment
The broad, long-term objectives are to generate and test hypotheses leading to theories that guide improved care of patients with diabetes. The specific aims of this project are: 1) to compare the relative effectiveness of 3 precisely defined different follow-up management strategies for preventing glycemic relapse after acceptable glycemic control is achieved; 2) to determine patient characteristics that are predictive of successful/failed relapse prevention in order to better understand the target group most likely to respond to a given maintenance plan. This project addresses a gap in our knowledge as to how to maintain glycemic control after good glycemic control has been achieved. In addition, this project quantitatively addresses the maintenance dose required to prevent such relapse. The project has important health-relatedness as it allows us to translate the experimental success to the primary care setting where the majority of diabetes care occurs. The research design is a controlled trial of 150 subjects randomized into one of three varying intensity treatment arms: 1) routine ongoing standard care; 2) routine standard care plus every 3 month phone interaction with a nurse practitioner who targets all four self care behaviors (diet, activity, self monitoring of blood glucose and medication management) ; or 3) identical intervention as #2 except at a 1 month interval. This project, therefore, is unique in selecting subjects at entry who have already achieved adequate, albeit not ideal, glycemic control so as to assess the effectiveness of a “maintenance,” not “induction,” dose of diabetes care. Second, this line of inquiry does not attempt to answer the question of whether case management or increased resources improve glycemic control. Rather, this line of inquiry seeks to “unpack” the nature and intensity of diabetes care required to maintain glycemic control. Funded by the National Institute of Diabetes and Digestive and Kidney Diseases Investigators: Tom A. Elasy, M.D., M.P.H. (PI)
Longitudinal Diabetes Care
This proposal addresses a line of inquiry regarding an optimal "dose" of diabetes care required to sustain optimal longitudinal diabetes care. Employing a randomized clinical trial the study addresses four specific aims; l) assess the relative effectiveness of 3 management approaches, varying in intensity, for preventing glycemic relapse after acceptable glycemic control is achieved; 2) to determine patient characteristics and behaviors that are prospectively predictive of successful relapse prevention in order to better understand the target group most likely to respond to a given maintenance plan; 3) to determine prospectively the predictors of failure to prevent glycemic relapse so as to better identify subgroups in need of alternate maintenance strategies; and 4) to determine the differences in activity cost between intervention arms using activity based accounting. Funded by the National Institute of Diabetes and Digestive and Kidney DiseasesInvestigators: Tom A. Elasy, M.D., M.P.H. (PI)
Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD)
Serious medication errors are common after hospital discharge and cause significant patient morbidity. Errors are more common among patients taking cardiovascular medications and may also be more common among patients with low health literacy. On the other hand, patients with low health literacy may benefit more than other patients from interventions designed to improve knowledge and skills. The objective of this research is to reduce the incidence of serious medication errors during the first 30 days after hospital discharge among patients hospitalized with acute coronary syndromes (ACS) or heart failure (HF) exacerbation. The PILL-CVD study is a randomized controlled trial of a literacy-sensitive, pharmacist-based intervention in 862 patients discharged from the general medicine service at two academic medical centers: Vanderbilt University Hospital (VUH) and Brigham and Women’s Hospital (BWH). The study has two arms: 1) Usual Care: pharmacists performing only routine evaluations of medication orders, physicians performing medication reconciliation, and nurses providing medication counseling at discharge; and 2) Intervention: pharmacist assistance with medication reconciliation, pharmacist counseling of patients at the time of discharge, provision of a literacy-sensitive patient education tool detailing the discharge medications, and tailored telephone follow-up. The primary outcome is the number of serious medication errors within 30 days after hospital discharge. Serious medication errors consist of: 1) actual adverse drug events (ADEs) that could have been prevented (preventable ADEs), 2) actual ADEs that could have been reduced in severity or duration (ameliorable ADEs), and 3) medication discrepancies or non-adherence with the potential to cause adverse events (potential ADEs). Assessment of study outcomes is performed by trained clinician adjudicators who are blinded to treatment assignment. Subgroup analyses will be performed by level of health literacy to determine if patients with inadequate health literacy are more likely to benefit from the intervention. Program costs will also be assessed. If successful, this intervention could offer an important means of reducing medication errors in the post-hospitalization period. Funded by the National Heart Lung and Blood Institute Investigators: Sunil Kripalani, M.D. (PI)
Southern Community Cohort Study (SCCS)
It has long been known that cancer incidence and mortality are elevated among African Americans. The Southern Community Cohort Study (SCCS) is a landmark prospective investigation into the determinants of these disparities. Over the past five years, by partnering with Community Health Centers (CHCs), facilities providing basic health care mainly to the uninsured across 12 southern states, we have overcome barriers that have traditionally restricted participation of African Americans in health studies. The current phase of the SCCS, proposed herein, will enable completion of enrollment so that the cohort will include approximately 90,000 men and women, nearly 70% African American, age 40-79. The new enrollees will be recruited from CHCs and complete an in-person interview about medical, lifestyle and other characteristics, with > 90% expected to provide biologic specimens (blood, buccal cells, and/or urine). Follow up of the entire cohort to identify deaths and incident cancers and update exposure profiles will be carried out. We will implement enhanced approaches to active follow up. Longitudinal analyses and nested case-cohort studies using the interview data and biologic specimens will be initiated during this funding period to evaluate specific hypotheses about cancer among African Americans which can uniquely or with special advantage be assessed within the SCCS. The hypotheses are related to energy balance (weight gain, obesity and physical inactivity), vitamin D, inflammation, selenium and other nutrient intakes, tobacco metabolism, and cancer screening practices and their impact on incidence and/or mortality of the major cancers (lung, prostate, breast, and colon/rectum). Initial SCCS data show sometimes marked racial differences in these variables. The cohort possesses attributes, such as a 44% prevalence of obesity (reaching 57% among Black women) and a 44% prevalence of current smoking which place it at exceptionally high risk of cancer. The SCCS is thus unique among all cohorts and comprises a population of urban and rural blacks and whites, often of low income, seldom if ever included in previous studies. The SCCS is a national resource, with comprehensive biologic and questionnaire data available for assessing, both within the SCCS and in combination with other molecular epidemiology consortia, the etiology of cancer and reasons for the largely unexplained higher rates among blacks. The ultimate public health benefit will be progress towards the development of measures aimed at cancer prevention, the elimination of cancer inequalities, and reduction of the cancer burden among all groups. Funded by the National Cancer Institute Investigators: William Blot, Ph.D. (PI); Lisa Signorello, Ph.D. (PI); Maciej Buchowski, Ph.D.; Raymond Burk, M.D.; Qiuyin Cai, M.D., Ph.D.; Robert Dittus, M.D., M.P.H.; Jay H. Fowke, M.P.H., Ph.D.; Jirong Long, Ph.D.; Chun Li, Ph.D.; Charles E. Matthews, Ph.D.; Pierre Massion, M.D.; Joseph McLaughlin, Ph.D.; Neeraja Peterson, M.D.; David Schlundt, Ph.D.; Martha Shrubsole, Ph.D.; Xiao Ou Shu, M.D., Ph.D.; Robert Tarone, Ph.D.; Scott Williams, Ph.D.; Wei Zheng, M.D., Ph.D.