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Funded by National Institutes of Health

Funding Years: 2014-2016

Nearly half of patients undergoing coronary artery bypass grafting (CABG) nationwide are exposed to red blood cell (RBC) products. While large volumes (3+ units) of transfusions may be delivered to a given patient to preserve life in cases of acute blood loss, evidence suggests that even small amounts (1-2 units) of RBCs often transfused to address poor oxygen delivery are associated with a 16% increase in a patient's risk of mortality and a 27% increase in morbidity, even after case mix adjustment. It is vitally important to allocate RBC products appropriately, given both that cardiac surgery utilizes between 20-25% of the total national blood supply, and the Red Cross reports that 32 of their 36 regions had less than a day's supply available to meet hospital needs. In short, it is important to improve our understanding of how and in what context decisions are made regarding 1-2 units of RBCs, given its association with morbidity, mortality and resource utilization. Growing evidence suggests that some transfusions may be discretionary. In the state of Michigan, nearly 40% of CABG patients are exposed to 1-2 units of RBCs, although the absolute rate varies 32% across institutions. Center-specific variation in transfusion practices is likely attributed to thelack of consensus regarding the indications, setting and hematocrit trigger for transfusions. Given this uncertainty, transfusion rates may be the consequence of differences in organizational (e.g. protocols, types of decision-makers, lack of performance feedback regarding transfusion practice) and provider (e.g. knowledge, beliefs concerning the benefit/harm of transfusions, and inclination to transfuse) factors. Interventions to reduce the rate of unnecessary transfusions first require identifying the set of determinants (at the organizational or provider level) that mot fully explain the observed variation in RBC utilization across regional medical centers. We will use the prospective data and infrastructure of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC), a consortium of all 33 cardiac surgical programs in Michigan, to: (1) Develop, pilot, and implement surveys to hospitals and clinical providers within the state of Michigan to describe determinants of 1-2 units of RBC transfusions during cardiac surgery, and (2) Identify the primary organizational and provider characteristics contributing to variability in transfusions. Results from this study will set the sage for a behavioral modification study aimed at reducing the rate of RBC transfusions in the setting of cardiac surgery.

PI(s): Richard Prager, Donald Likosky

Co-I(s): Darin Zahuranec, Min Zhang, Marc Zimmerman, Milo Engoren

Funded by National Institutes of Health

Funding Years: 2011-2016

This proposal seeks to advance our understanding of the role of psychosocial and environmental health risk factors as well as medical care in understanding the large socioeconomic and racial/ethnic disparities in health and the way health changes with age in our society. It does so by proposing to extend to four waves and 15 years of follow-up an ongoing prospective study (known as Americans' Changing Lives) of a nationally representative sample of 3,617 adults aged 25 and over in the coterminous United States, who were first interviewed in 1986, with reinterviews of about 83 percent of the surviving members of the original sample already completed in 1989 and 1994, along with ongoing mortality ascertainment on the full original 1986 sample. A proposed fourth wave would be collected on about 83 percent of the surviving sample (estimated respondents - 2,300 of about 2,800 survivors) in 2001, primarily by telephone and in person as necessary, with mortality ascertainment continuing indefinitely and the hope and intent of reinterviewing surviving respondents again about 20-22.5 years after the baseline interview. The ongoing ACL study has generated a large body of publications both by staff of the ACL project and users of the public use data sets for the first two waves (with the third wave to be archived for public use by the end of 1999). ACL analyses and publications have illuminated to the role of a broad range of psychosocial factors, ranging from health behaviors through stress and adaptive resources to productive activities, in predicting health, changes in health and mortality, and in mediating or explaining socioeconomic differences in health. It has also played a major role in understanding the nature, causes, and consequences of paid and unpaid productive activities over the lifecourse. The proposed continuation and extension of the ACL project will address a number of aims: (1) continuing and enhancing ongoing analysis by extending prospective follow-up to 15 years, allowing for better analysis of- (a) time- varying covariates, (b) the impact of changes in risk factors on changes in health, and (c) potential reciprocal relationships between and among SES, psychosocial risk factors and health; (2) enhancing and improving the measurement of a number of variables already being considered in ongoing analysis, including SES (e.g., improving assessment of wealth), productive activities, religious beliefs and behaviors, and personality or dispositional factors (e.g., hostility, optimism, hopelessness, and John Henryism); (3) adding new measures to ACL 4 or (via archival data) to all waves of data for both medical care and exposures in physical and social environments; and (4) to undertake more focused analysis of racial/ethnic differences in health and explanations of them.

PI(s): Sarah Burgard

Co-I(s): Wen Ye, Michael Elliott, Philippa Clarke, Kenneth Langa

Funded by the National Institutes of Health

Funding Years: 2012-2017

Intraventricular hemorrhage (IVH) occurs in many patients with intracerebral and subarachnoid hemorrhage (SAH). Recent studies have found IVH is a predictor of poor outcome after intracerebral hemorrhage and that hydrocephalus develops in 55% intracerebral hemorrhage patients with IVH. Hydrocephalus is also a major problem in SAH. Early hydrocephalus occurs in 20-50% SAH patients and is associated with poor clinical grade. However, the mechanisms of IVH-induced hydrocephalus are not well understood. Lysis of erythrocytes results in iron accumulation in the brain and causes brain damage after intracerebral hemorrhage. However, the role of erythrocyte lysis and iron toxicity in IVH-induced brain injury and hydrocephalus has still to be elucidated. Erythrocyte lysis after IVH may start very early. Hemoglobin released from red blood cells reaches its peak concentration by the second day following injection of blood into the cerebrospinal fluid of dogs. Hemoglobin release, from lysis of erythrocytes in human intracranial hemorrhage, increases during the first few days. Erythrocyte lysis appears to result from either depletion of intracellulr energy reserves or activation of the complement system. We have established an IVH model in rats and long-term ventricular dilatation has been observed. Recently we have found that hydrocephalus occurs in a model of SAH which results in intraventricular blood. Our preliminary data have demonstrated: 1) Intraventricular injection of autologous whole blood causes iron accumulation, hydrocephalus, neuronal death and brain tissue loss in the hippocampus; 2) Intraventricular injection of lysed erythrocytes rather than packed erythrocytes causes hydrocephalus by 24 hours; 3) Heme oxygenase-1 and ferritin levels are increased significantly in the hippocampus and periventricular areas following IVH; 4) Intraventricular injection of iron alone can also result in acute hydrocephalus; 5) Deferoxamine, an iron chelator, reduces IVH-induced hydrocephalus and hippocampal tissue loss. In this application, we propose to test the following specific aims: 1) Determine whether erythrocyte lysis and hemoglobin release cause hydrocephalus and neuronal death following IVH; 2) Determine whether complement inhibition reduces erythrocyte lysis and IVH/SAH-induced brain injury; 3) Examine the natural time courses of iron buildup, oxidative stress and upregulation of iron handling proteins in the brain after IVH; 4) Determine whether heme oxygenase inhibition reduces heme degradation and IVH/SAH-induced brain injury; and 5) Determine whether iron chelation reduces oxidative stress, hydrocephalus and neuronal death after IVH/SAH in aged rats. The purpose of our project is to investigate the mechanisms of brain injury after IVH. The long-term goal of our studies is to limit hemorrhagic brain damage in patients.

PI(s): Guohua Xi

Co-I(s): Ya Hua, Richard Keep, Lewis Morgenstern

Funded by Department of Health and Human Services - National Institutes of Health Subcontracts

Funding Years: 2013 - 2015.

This application seeks to better understand the needs of patients undergoing genomic testing with respect to the understanding of an adaptation to genomic information through genomic counseling. Through an existing partnership between the Ohio State University Medical Center and the Coriell Institute's Personalized Medicine Collaborative, over 5000 participants have been enrolled in two studies aimed at evaluating the utility of personalized medicine. Both studies (parent study 1 - community cohort;parent study 2 - chronic disease cohort) involve genotyping and conveying genomic results for eight health conditions and one pharmacogenomic result directly to participants. This existing research collaboration provides the infrastructure and patient population to execute the following Study Aims.

  • Specific Aim 1 : To explore, through semi-structured participant interviews, the key elements desired to optimize patient understanding and empowerment in a genomic counseling session for multiplexed genetic and pharmacogenomic results. Working within the structure of the two existing Parent studies, we will gather feedback on current genetic counseling approaches (phone and in-person) on 60 study participants. Through phone interview, we will assess 1) perceived need for genomic counseling;2) reasons for pursuing or not pursuing genomic counseling;2) perceived barriers to genomic counseling 3) perceived utility of genomic counseling, 4) expectations of genomic counseling, 5) previous experience and familiarity with genomic counseling, and 6) preferences for alternative medical providers to assist with the interpretation of genomic information. These interviews will also provide insights on key issues regarding both the content and format of genomic counseling in this context.
  • Specific Aim 2 : To develop a genomic counseling service delivery model based on the data collected in Aim 1. A multidisciplinary team of experts with experience in genetic counseling and the development and evaluation of different methods of genetic education will lead the development of this new model.
  • Specific Aim 3 : To evaluate the impact of the novel genomic counseling delivery model (developed in Aim 2) compared to a traditional GC model and usual care (no counseling) on result comprehension, knowledge retention, perceived personal control, and satisfaction. We will survey 120 patients (40 randomized to genomic counseling;40 randomized to traditional genetic counseling;40 randomized to no counseling) on the outcomes of interest. Data generated will provide insight into the acceptability and feasibility of our proposed model and wil be used as a basis for planning future studies to evaluate the utility of this novel genomic counseling model. The proposed study is an essential step in the integration of genomic information into the healthcare system. Genetic counselors are a natural fit to facilitate the use of genomic information in medicine;however additional studies, such as those proposed must be done to understand how to best utilize genetic counseling services in this emerging field.

PI(s): J. Scott Roberts

Funded by VA Health Services Research and Development Career Development Award

Funding Years: 2015-2019

Heart attack and stroke, which together are called cardiovascular disease, cause over 1/3 of all deaths in VA patients. The current guidelines for the prevention of these conditions focus on lowering patients'blood pressure and cholesterol levels. A new treatment strategy, which I call benefit-based tailored treatment, that instead guides treatment decisions based on the likelihood that a medication would prevent a heart attack or stroke could prevent more cardiovascular disease, with lower medication use, and be more patient centered. The purpose of this Career Development Award is to develop and assess tools and approaches that could enable the implementation of benefit-based tailored treatment of cardiovascular disease, in particular a decision support tool and educational program for clinicians and a performance profiling system. The decision support tool will enable better care by showing clinicians patient-specific estimates of the likelihood that their medication decisions will prevent a cardiovascular disease event. The performance profiling system will encourage better care by assessing the quality of care provided at VA sites and in PACT teams based on how well the medical care provided follows this treatment strategy. The project will have three aims:
Aim 1 : In the first aim, I will seek to understand clinicians'and patients'perceptions of and receptivity to the use of benefit-based tailored treatment for cardiovascular disease. Information gained from qualitative research with clinicians will help assess and improve the usability and effectiveness of the decision support tool and educational program for clinicians, along with the acceptability of the treatment strategies in general. Information gained from focus groups with patients will help learn their priorities in cardiovascular disease prevention, to help identify ways to make the interventions and their assessments more patient-centered.
Aim 2 : In the second aim, the decision support tool and educational program will be assessed in a real-world randomized pilot study involving thirty clinicians. Half of the clinicians will be provided the decision support tool and education intervention for ten patients each, the other half will receive a traditional quality improvement program and treatment reminders. The study will have formative goals of ensuring that clinicians and patients believe the tool is valuable and does not disrupt care processes or workflow for anyone in the PACT team. This will be studied with qualitative and survey assessments. The primary summative outcome will be the influence of the intervention on clinicians'treatment decisions. Secondary outcomes will assess patients'satisfaction with their visits and their clinicians.
Aim 3 :
The third aim will develop and evaluate a novel performance measurement system based on benefit- based tailored treatment. First, the performance profiling system will be developed. Then the profiling system's ability to reliably differentiate high quality from low-quality care will be evaluated.

PI: Jeremy Sussman

Funded by Veterans Affairs Health Services Research & Development CDA-2

Funding Years: 2014-2015


Despite the availability of evidence-based strategies to prevent type 2 diabetes mellitus (T2DM), engagement in these strategies is low among at-risk Veterans. A key opportunity to engage at-risk Veterans in interventions to prevent T2DM is when they are informed they have prediabetes. It remains unclear how VHA communications to patients diagnosed with prediabetes could be optimized to improve their engagement in evidence-based preventive strategies.

  • Aim 1: To describe at-risk Veterans' current engagement in behaviors to prevent T2DM and the mediators of this engagement.
  • Aim 2: To examine the effects of receipt of a prediabetes diagnosis on at-risk Veterans' weight and engagement in behaviors to prevent T2DM.
  • Aim 3: To identify the effects of 4 strategies from behavioral economics and health psychology on weight, HbA1c, and engagement in behaviors to prevent T2DM among Veterans with prediabetes.

To accomplish Aim 1, we will survey 189 non-diabetic Veterans with risk factors for T2DM about their engagement in behaviors to prevent T2DM and mediators of this engagement such as risk perception, motivation, and awareness of and preferences for preventive strategies. To accomplish Aim 2, we will conduct a pilot randomized trial among the same 189 non-diabetic Veterans from Project 1 in which we will randomly assign 126 of these Veterans to undergo screening for T2DM using a hemoglobin A1c (HbA1c) test. The 63 Veterans who we project will have HbA1c values in the prediabetes range will receive that diagnosis and preventive recommendations from their PACT provider via brief standardized counseling. All 189 Veterans will have their weight tracked over the next year and will be surveyed immediately after the screening and brief counseling process, at 3 months, and at 1 year. Then we will compare changes in weight, engagement in behaviors to prevent T2DM, and mediators of this engagement between the 63 Veterans who we project will have prediabetes and the 63 Veterans who were not screened. Among the 63 Veterans with prediabetes, we will conduct 20 semi-structured interviews to gain insights into the effects of this diagnosis and brief counseling. To accomplish Aim 3, we will conduct a fractional factorial design experiment to evaluate the effectiveness of 4 innovative strategies from behavioral economics and health psychology in promoting weight loss, decreasing HbA1c, and increasing engagement in behaviors to prevent T2DM among 144 Veterans who are identified as having prediabetes through an HbA1c test. We will conduct qualitative evaluations of the acceptability of these strategies to patients.

PI(s): Jeffrey Kullgren

Funded by Health and Human Services, Department of-National Institutes of Health

Funding Years: 2013 - 2015.

With the aging of society and restructuring of families, it is increasingly important to understand how individuals become disabled. New disability is associated with increased mortality, substantial increases in medical costs (often borne by public payers), and a heavy burden on families and caregivers. While the disablement process?as theorized by Verburgge & Jette and their successors?has traditionally been seen as chronic and gradual, there is increasing recognition that acute events play a critical role in disability. Medical illnesses are not the only potentially disabling events. NIA & NINR recently posted PA-11-265, calling for ?Social and Behavioral Research on the Elderly in Disasters? in recognition that natural disasters are common, but we know little about their impact on health and disability. The National Research Council?s Committee on Population published a report in 2009 documenting not only our ignorance in this area, but, importantly, the potential value of studying disasters to understand fundamental processes in disability and health.
Our long-term research agenda is (a) to test the hypothesis that natural disasters cause enduring morbidity for survivors that is not fully addressed by existing health and welfare programs, and (b) to discover remediable mechanisms that generate that enduring morbidity. Here we propose a nationwide test of the association of living in a disaster area with individuals? long-term disability and health care use. To perform this test, we will combine the unique longitudinal resources of over 16,000 respondents in the linked Health and Retirement Study (HRS) / Medicare files with a newly constructed mapping of all FEMA disaster declarations between 1998 and 2012. We will address key gaps in the existing literature of detailed single-disaster studies with a generalizable perspective across time and space via these Specific Aims:
AIM 1: Quantify the association between the extent of a disaster ? measured as the repair cost to public infrastructure and increases in level of disability among survivors. We will follow respondents for an average of 5 years after the disaster. AIM 2: Quantify the association between the extent of a disaster and increases in the likelihood of hospitalization among survivors. AIM 3: Test the hypothesis that increases in level of disability and likelihood of hospitalization after disasters are worse for those living in counties with higher levels of poverty.
This proposal is specifically responsive to PA-11-265. This proposal is innovative because long-term effects of disasters, particularly for vulnerable older Americans, have been systematically neglected in previous research. It is significant because it will address the public health consequences of a relatively common but understudied exposure. Further, a key contribution of this R21 will be to evaluate the feasibility of the National Research Council conjecture that natural disasters can be studied as exogenous shocks to the environment, and that we can thereby test and elaborate usually endogenous mechanisms in the development of disability.

PI(s): Theodore Iwashyna

Co-I(s): Kenneth Langa, Yun Li, Anne Sales

Funded by Patient-Centered Outcomes Research Institute (PCORI)

Funding Years: 2013 - 2015.

Every year, more than 100,000 patients start dialysis to treat kidney failure in the United States. Two types of dialysis are available: hemodialysis (HD) and peritoneal dialysis (PD). HD is done with a machine in a dialysis clinic. PD can be done at home, if the patient or family is willing to perform his or her dialysis treatments. In general, patients survive as long on HD as they do on PD. Based on specific clinical parameters and a patient’s needs, one of the two dialysis types is usually going to be a better fit for a given patient. For example, older patients may not want to be responsible for performing their own treatment, and HD may be a better fit for them. On the other hand, PD may be a better choice for patients who want to be able to travel. The challenge for patients with kidney failure is to identify the dialysis type that best fits their lifestyle. However, there is very little information regarding factors that are important to patients starting dialysis, and often patients choose a dialysis type without fully understanding how it will impact their lives. Patients and their families need more information to be able to make better decisions. PD use is much lower in the United States than in other countries, perhaps reflecting the fact that many patients are not given appropriate information regarding this type of dialysis. Given recent financial pressure on kidney doctors to treat more patients with PD, it is even more important that patients receive better information when making a decision regarding dialysis type. The goal of this study is to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. To understand what is most important to them, we will interview more than 130 patients with kidney disease, some before and some after they start dialysis. We will compare factors reported as important across different types of patients; for example, among men and women, or among those who work outside of the house and those who do not. Using the infrastructure of an existing study of more than 6,800 dialysis patients, we will compare factors identified during the interviews between patients treated with HD and PD. Based on these results, we will develop a Web site presenting information on kidney disease and questions on personal preferences, which will help patients understand which dialysis type is better for them. Results from our study will provide practical information regarding the choice of dialysis type to patients with kidney disease and their families. Patients who are better informed will be able to identify and choose the best dialysis type for their lifestyle and needs. Providing scientific evidence to help patients in their decision process is of great importance, especially at such a stressful time in their lives.

PI(s): Angela Fagerlin, Laurie Lachance, Yi Li, Julie Wright

2016 Bishop Lecture featuring William Dale, MD, PhD

Wed, April 27, 2016, 10:30am
Location: 
Founders Room, Alumni Center, 200 Fletcher St., Ann Arbor, MI

The 2016 Bishop Lecture in Bioethics was presented by William Dale, MD, PhD, Associate Professor of Medicine; Chief, Section of Geriatrics & Palliative Medicine; and Director, Specialized Oncology Care & Research in the Elderly (SOCARE) Clinic at the University of Chicago. Dr. Dale presented, "Why Do We So Often Overtreat, Undertreat, and Mistreat Older Adults with Cancer?" The Bishop Lecture served as the keynote address during the CBSSM Research Colloquium.

Abstract: The US health care system is being confronted with the consequences of aging as the baby-boomers join Social Security and Medicare, with cancer care front-and-center.  Two recent IOM reports, Retooling for an Aging America and Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis, highlight these intersecting areas.  Delivering high quality care for older adults with cancer, at an affordable cost, in a transforming health delivery system will be addressed from a personal, clinical, and policy perspective.

William Dale, MD, PhD, is an Associate Professor of Medicine and the Section Chief of Geriatrics & Palliative Medicine at the University of Chicago, with a secondary appointment in Hematology/Oncology.  He is a board-certified internist and geriatrician with a doctorate in health policy. He completed his medical and graduate school training at the University of Chicago, did his residency in internal medicine and fellowship in geriatrics at the University of Pittsburgh, and then returned to the University of Chicago.

Dr. Dale has devoted his career to the care of older adults with cancer.  In 2006, He established, and now co-directs, the Specialized Oncology Care & Research in the Elderly (SOCARE) Clinic at the University of Chicago. SOCARE offers interdisciplinary, individualized, and integrated treatment for older cancer patients. It provides a special environment for addressing the issues relevant to older cancer patients and their loved ones and integrating research into this special clinic environment.

Dr. Dale is an international speaker who has published over 50 papers in top journals on medical decision making, behavioral economics, quality of life, and frailty assessment in older adults, particularly those with cancer. He and his team have shown the important role emotions like anxiety play in medical decisions for older adults. He has received grants from the National Institute on Aging (NIA), National Cancer Institute (NCI), American Cancer Society, and the Foundation of Informed Medical Decision Making. With NIH funding, he has co-led a series of national conferences with international experts on geriatric-oncology.  He is a co-investigator for the National Social Life, Health, and Aging Project (NSHAP), a survey and biomeasure collection on the health, well-being, and social life of over 3,000 older adults.

  • Click here for video-recording of the 2016 Bishop Lecture

Funded by the National Institutes of Health

Funding Years: 2013-2018

Chronic kidney disease (CKD) affects 20 million Americans. CKD can lead to end stage renal disease and is associated with morbidity and mortality at all stages. Early management decreases complications and may ameliorate disease progression, but is often reliant on patient self-care. Research suggests that a large proportion of patients lack fundamental knowledge about kidney disease, its implications, and self-care necessary to attenuate CKD progression to end stages. Patient decision aids are designed to facilitate disease communication, increase patient knowledge, clarify patients'values and engage patients in care. There have been no studies using patient decision aids in pre-dialysis CKD. Moreover, there is a paucity of data available to guide development of CKD patient decision aids for use in practice. The primary goal of this research proposal is to elicit stakeholder (i.e. patient and provider) input on information needs and preferences for developing a CKD decision aid that will 1) support patient-centered CKD communication, 2) facilitate shared learning and decision making between patients and providers, and 3) optimize patient engagement in care. To accomplish this objective, I propose to conduct three inter-related but independent studies. First, I will determine information needs and factors that influence self-care in patients with pre-dialysis CKD using structured interviews and a survey in 250 patients seen in the University of Michigan nephrology outpatient clinics. Second, I will identify physician perspectives about what they need to support patient CKD education and to effectively engage patients in care by conducting structured interviews of fifty physicians (25 primary care, 25 nephrology) who practice in the University of Michigan Ambulatory Clinics. The interviews and survey questions in the first two aims will be grounded on two quality improvement methods namely, cause/effect analysis and quality function deployment. Informed by the first two aims, I will develop and test a patient- centered decision aid, designed to facilitate patient-physician communication and support patient decision making and self-care in pre-dialysis kidney disease. The aid will be tested in a randomized trial with the decision aid the exposure, and intermediate patient modifiable characteristics (knowledge, self-efficacy, and treatment decisional conflict), as co-primary outcomes. The proposed research is likely to improve our understanding about the needs and preferences of key stakeholders involved in CKD communication and care, and provide insight into the effectiveness of patient-centered education interventions on outcomes in pre- dialysis kidney disease.

PI(s): Julie Wright, Angela Fagerlin

Co-I(s): Eve Kerr, Akinlolu Ojo

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