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Funded by Patient-Centered Outcomes Research Institute (PCORI)

Funding Years: 2014 - 2018

Obesity is increasingly considered among the most important public health problems of our times. Bariatric surgery is arguably the only treatment that has proven effective in producing long-term weight loss for patients with morbid obesity. Bariatric surgery also results in resolution of obesity related comorbid conditions, improvements in quality of life, and increased survival.

There are currently four different bariatric surgical procedures in use: adjustable gastric banding, gastric bypass, sleeve gastrectomy, and duodenal switch. Bariatric surgery is considered a highly preference sensitive medical issue. Existing decision aids in bariatric surgery are limited in that they provide information about the average comparative risks and benefits of the treatment options, but do not provide customized estimates of the risks and benefits of the different procedures for individual patients. As a result of these draw-backs, decision aids are not frequently used in making treatment decisions in bariatric surgery.

Our proposal is highly innovative in that our decision support tool integrates data from a large clinical registry with individual patient data to provide patients with real-time, customized, accurate information regarding the risks and benefits of the treatment options to better inform decision making. This tool will be continuously updated to ensure that the data on risks and benefits that it provides are accurate and current. Our tool also provides information about other attributes of the treatment options that bariatric surgery patients and other relevant stakeholders feel are important for patients to consider in deciding whether and what type of bariatric surgery to have.

The proposed research promotes shared medical decision making for patients who are considering bariatric surgery for the treatment of morbid obesity. If our intervention proves effective, it will result in improved decision quality and outcomes of care for patients. It may also result in improved efficiency of care to the extent that it serves to augment or guide communication between the patient and physician to promote shared medical decision-making.

PI(s): Nancy Birkmeyer/Amir Ghaferi

Co-I(s): Lawrence An, Mousumi Banerjee, Angela Fagerlin, Sarah Hawley, Edward Norton, Lisa Prosser

Funded by: NIH

Funding Years: 2016-2020

In the past 30 years, the Incidence of thyroid cancer has tripled. The majority of the rise in thyroid cancer incidence is attributed to an increase in low-risk, well-differentiated thyroid cancer, a disease that has a 10-year mortality close to zero. Our previous work suggests that patients with low-risk thyroid cancer are at risk for overtreatment, defined as the use of Surgical and medical interventions in the absence of a clear survival benefit. The overtreatment of thyroid cancer has inherent costs, both to patient health and to society. The reason for the intensive management and potential overtreatment of low-risk thyroid cancer remains unclear. By using SEER-linked patient and physician Surveys, we plan to understand the Treatment decision making in low-risk thyroid cancer. We hypothesize that knowledge and attitudes influence decision making. Specifically, we anticipate that lack of knowledge of risks of death, recurrence and Treatment complications is associated with Treatment that is more intensive. in addition, we postulate that a general preference for active treatment will also be associated with more intensive cancer Treatment. Although both patient and physician perceptions of Treatment need (i.e., knowledge and attitudes) likely contribute to Treatment intensity, we anticipate that the primary driver will be physicians, even after controlling for their patients' perceptions. This study will serve as the foundation for future Intervention studies. By identifying the specific role of physician and patient knowledge and attitudes toward thyroid cancer Treatment, we will be able to create tailored educational interventions to personalize Surgical and medical care for thyroid cancer patients, thus minimizing overtreatment and its inherent risks and costs. As the rising Incidence, low mortality, and pattern of intensive Treatment make thyroid cancer arguably the best cancer model for overtreatment, this proposed study will also serve as a model to understand overtreatment in other malignancies.

PI: Megan Haymart

CO(s): Brian J. Zikmund-Fisher, PhD & Sarah Hawley, PhD. MPH

David Sandberg, PhD

Faculty

Dr. Sandberg is a pediatric psychologist and clinical researcher.  As a pediatric psychologist, he delivers psychoeducational and behavioral health services to persons with endocrine disorders and their families, in particular, conditions affecting linear growth or disorders of sex development (DSD), i.e., congenital conditions in which development of sex chromosomes, gonads or sex anatomy is atypical.

Last Name: 
Sandberg

Sarah Hawley, PhD, MPH

Faculty

Dr. Sarah T. Hawley is a Professor in the Division of General Medicine at the University of Michigan and a Research Investigator at the Ann Arbor VA Center of Excellence in Health Services Research & Development. She holds a PhD in health services research from the University of North Carolina and an MPH from Yale University Department of Public Health. Her primary research is in decision making related to cancer prevention and control, particularly among racial/ethnic minority and underserved populations.

Last Name: 
Hawley

2018 Bishop Lecture featuring Barbara Koenig, PhD

Tue, May 01, 2018, 11:15am
Location: 
Henderson Room, Michigan League, 911 N. University Avenue, Ann Arbor, MI

The 2018 Bishop Lecture in Bioethics was presented by Barbara Koenig, PhD, Professor of Bioethics and Medical Anthropology and Director of UCSF Bioethics at the University of California, San Francisco. Professor Koenig presented a talk entitled, " Does Enhancing Individual Choice and Control Promote Freedom? Challenges in Contemporary Bioethics." The Bishop Lecture serves as the keynote address during the CBSSM Research Colloquium.

Abstract: Over the past three decades, the discipline of bioethics has advocated for enhanced patient choice and control over a range of medical decisions, from care near the end of life to participation in clinical research. Using two current policy challenges in California—1) the advent of legally sanctioned medical aid in dying and, 2) efforts to share UC Health “big data” from the electronic health record in research with private sector partners—Professor Koenig will explore how current bioethics practices may unintentionally and ironically impede our shared goals of promoting human freedom.

Barbara A. Koenig, PhD is Professor of Bioethics and Medical Anthropology, based at the Institute for Health & Aging, University of California, San Francisco. She is the Director of “UCSF Bioethics,” a nascent program that spans ethics research, clinical ethics, and ethics education across the university’s four professional schools. Prof. Koenig pioneered the use of empirical methods in the study of ethical questions in science, medicine, and health. Prof. Koenig’s current focus is emerging genomic technologies, including biobanking policy and using deliberative democracy to engage communities about research governance. Her work has been continuously funded by the National Institutes of Health since 1991. Currently, she: 1) directs the ELSI component of a NICHD award focused on newborn screening in an era of whole genome analysis, 2) is P.I. of UCSF’s Program in Prenatal and Pediatric Genomic Sequencing (P3EGS), part of the CSER2 national network, and, 3) is supported by NCI to conduct an “embedded ethics” study of the Athena “Wisdom” PCORI-funded clinical trial of genomic risk-stratified breast cancer prevention. Previously, she directed an NHGRI-funded “Center of Excellence” in ELSI Research. Prof. Koenig was the founding executive director of the Center for Biomedical Ethics at Stanford University; she created and led the Bioethics Research Program at the Mayo Clinic in Rochester, Minn. She received her Ph.D. from the University of California, Berkeley and San Francisco joint program in Medical Anthropology. She is an active participant in policy, having served on the ethics committee that advises the director of the CDC and the Department of Health and Human Services “Secretary’s Advisory Committee on Genetic Testing.” She recently served on a state-wide “Health Data Governance Task Force” which advised UC’s president.

Click here for the video recording of the 2018 Bishop Lecture.

Funded by Health and Human Services, Department of-Agency for Health Care Research and Quality

Funding Years: 2013 - 2018.

The 2011 HHS report on multiple chronic conditions highlighted the prevalence, morbidity, and cost associated with clusters of co-occurring chronic conditions, both physical and mental. Collaborative chronic care models (CCMs) are effective in treating chronic medical and mental illnesses at little to no net healthcare cost. To date CCMs have primarily been implemented at the facility level and adopted by larger, public healthcare organizations. However, the vast majority of primary care and behavioral health practices providing commercially insured care are far too small to implement such models. Health plan-level CCMs can address this unmet need. Based on a groundbreaking partnership with Aetna Inc., the goal of this study is to implement a cross-diagnosis CCM designed to improve outcomes for persons with mood disorders with an eye towards developing a business case for a generalizable plan-level CCM for solo or small practices. Mood disorders (depression and bipolar disorder) were identified by Aetna as priority conditions because of their chronic nature and high healthcare costs. While evidence-based care parameters have been well established, quality of medical and psychiatric care and health outcomes are suboptimal for persons with mood disorders. We will conduct a randomized controlled trial of the cross-diagnosis CCM vs. education control among Aetna beneficiaries across the country who were hospitalized for unipolar depression or bipolar disorder and treated in solo or small primary care or behavioral health practices. At hospitalization discharge a total of 172 solo or small practices involving a total of 344 patients will be randomized to one year of outpatient treatment augmented by the CCM or education control. CCM care management will be fully remote from practice venues and patients, implemented by the Aetna care management center in Salt Lake City. The primary health outcomes are mood disorder symptoms, health-related quality of life, hospitalizations, and guideline-based mood disorders and cardiometabolic management. Secondary outcomes include determining the provider and organizational factors associated with CCM uptake and outcomes, cost effectiveness of the CCM compared to education control, and development of a business plan based on empirical data and stakeholder input. This proposed R18 addresses AHRQ's research demonstration and dissemination priorities, particularly around prevention and care management. In addition to this groundbreaking practice-research partnership focused on solo or small practices to further implement CCMs at the health plan level, this study may also lead to the evolution of the business case for cross-diagnosis CCMs in general, and the utility of plan-level panel management and remote technologies, especially with the advent of accountable care organizations and similar initiatives.

PI(s): Amy Kilbourne

Co-I(s): Daniel Eisenberg, H. Myra Kim

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

Funding Years: 2014 - 2017.

Suicide is a leading cause of death and suicide attempts are a major cause of disability, lost productivity, and health care costs. Suicide prevention is a research priority of the National Institutes of Health, and the US Surgeon General's National Strategy for Suicide Prevention calls for a shift towards recovery-oriented prevention efforts which promote hope and social support. Hopelessness and social isolation are two proximal risk factors for suicide which may be improved via peer mentorship, a form of peer support effective for preventing depression and repeat psychiatric hospitalizations. The primary aims of this study are to develop and pilot test a peer mentorship intervention for psychiatrically hospitalized patients at high risk for suicide. The intervention will be adapted by an expert panel from existing peer support training protocols to target suicide risk factors and to enhance suicide risk management. Protocols for training and supervising peer mentors and measures of intervention fidelity will also be developed. The intervention will then be pilot teste among 60 participants randomly assigned to receive the peer mentorship intervention plus usual care or usual care alone. Participants will be recruited from the inpatient psychiatry unit at the University of Michigan Health System. Inclusion criteria will include medical record documentation of suicidal ideation or suicide attempt at admission, and exclusion criteria will include significant cognitive impairment (according to the Mini-Cog), current receipt of peer support, or determination that peer mentorship may cause distress to the patient or the peer mentor. The peer mentorship intervention will include an in-person visit on the inpatient unit and regular in-person or telephone follow-up for 3 months post-discharge. The intervention will be delivered by peer specialists--individuals in stable recovery from serious mental illness who have received formal training and certification in peer support from the state of Michigan--with at least 6 months of professional peer support experience. The primary outcomes of the pilot study are acceptability and feasibility of the intervention as determined by: 1) >50% of eligible participants enroll in the study, 2) >70% of enrollees complete final follow- up measures at 6 months, and 3) among those assigned to the peer mentorship intervention, >80% complete an inpatient session and the median number of total sessions is at least 4. Peer mentorship sessions will be recorded and rated for fidelity. Measures of suicidal ideation and suicide attempts (the intended primary outcomes of a subsequent efficacy study) and secondary outcomes such as quality of life, functioning, depression, and service use will be obtained at baseline, 3 months, and 6 months post-enrollment by a research assistant blinded to study arm. An exploratory aim will be to measure potential mediators of intervention effectiveness including belongingness, burdensomeness, and hopelessness according to the interpersonal theory of suicide. If acceptability and feasibility are demonstrated, the study will result in a novel recovey-oriented suicide prevention intervention ready for a fully-powered randomized controlled efficacy trial.

PI(s): Paul Pfeiffer

Co-I(s): Mark Ilgen, H. Myra Kim, Cheryl King, Marcia Valenstein

Funded by National Institutes of Health.

Funding Years: 2013-2016

With the growing importance of biobank research, concerns have been raised about how to protect the interests of donors. The current ethics framework mainly focuses on protecting against risks to donors' welfare and to their privacy. However, there has been little systematic empirical, normative, or policy focus on the non-welfare interests of donors, i.e., concerns about the moral, societal, or religious implications of research using their donation that may affect their willingness to donate. Although important theoretical discussions, mentions in commission reports, and insights from several qualitative studies have drawn attention to the serious nature of these interests, we lack important data for policy development: (1) systematic data on the nature and extent of potential impact of non-welfare interests and (2) high quality (i.e., informed and considered) policy preferences of the public addressing how to balance these non-welfare interests with the promise of biobank research. Our project will fill these gaps with two complementary projects. First, a national survey will assess the contours of the potential impact of non-welfare interests on biobank research, by addressing: what kinds of non-welfare interests substantially affect willingness to donate biological materials?; how common are these interests?; how much do donors want to know about the potential involvement of such non-welfare interests when donating?; how are non-welfare interests affected by such factors as race or ethnicity, socioeconomic status, trust in medical research, religious beliefs and practice, or political orientation? Second, we will obtain considered, informed judgments of the public regarding how to handle the tension between the public good of biobanks and the conflicting non-welfare interests of potential donors, using a democratic deliberation method in which subjects will attend an all-day education and peer deliberation session. The impact of the deliberation will be validated using a randomized, experimental design. In summary, despite the ethical significance of non-welfare interests for biobank research, there is a paucity of systematic data regarding both their potential impact and the potential policy solutions. This project will provide a highly generalizable assessment of the potential impact of non-welfare interests as well as policy recommendations based on informed, deliberative opinions of the general public. Visit the NIH website for more information.

PI(s): Tom Tomlinson, Raymond De Vries 

Co-I(s): Karen Kelly-Blake, H. Myra Kim, Blake J Roessler 

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 National Institutes of Health.

Funding Years: 2013-2018

The clinical management of patients with cancer does not entail a "one size fits all" approach. In fact, studies of the genomic landscape of human cancers have demonstrated that cancers can have a multitude of mutations, a subset of which may be "actionable" with current drugs. Thus, the personalization of therapy for cancer will require molecular characterization of unique and shared genetic aberrations. In particular, patients who have advanced / refractory cancer and are candidates for clinical trials could potentially benefit by identifying eligibility for "targeted" drugs based on the "actionable" genesin their specific tumor. Growing technological advances in genomic sequencing has now made it possible to consider the use of sequence data in a clinical setting. Thus, the translation of high throughput sequencing would support a "personalized" strategy for cancer. However, the translation of clinical sequencing bears unique challenges including identifying patients who could benefit, developing informed consent and human subjects protections, outlining measurable outcomes, interpreting what results should be reported and validated, and how results should be reported. This proposal brings together expertise at the University of Michigan including clinical oncology, cancer genetics, genomic science/bioinformatics, clinical pathology, social and behavioral sciences, and bioethics in order to implement this clinical cancer sequencing project. We have focused our clinical sequencing effort on sarcomas and other rare cancers as this is an area of clinical strength at Michigan. Three integrated Projects have the following themes: Project 1) "Clinical Genomic Study" will identify patients with advanced or refractory sarcoma or rare cancers who are eligible for clinical trials, consent them to the study obtain biospecimens (tumor tissue, germline tissue), store clinical data, and assemble a multi-disciplinary Sequencing Tumor Board to deliberate on return of actionable or incidental genomic results; Project 2) "Sequencing & Analysis" will process biospecimens and perform comprehensive sequencing and analysis of tumors to identify point mutations, copy number changes, rearrangements/gene fusions, and aberrant gene expression under CLIA/CAP guidelines; Project 3) "Ethics & Psychosocial Analysis" will evaluate the clinician and patient response to the informed consent process, delivery of genomic sequence results, and use of genomic results.

PI(s): Arul Chinnaiyan (Main Study PI), Scott Roberts (Project 3 PI)

Co-I(s): Ajjai Alva, Rashmi Chugh, Ray De Vries, Jeffrey Innis, Lakshmi Kunju, Rohit Mehra, Nallasivam Palanisamy, Dan Robinson, Moche Talpaz, Scott Schuetze, David Smith, Elena Stoffel, Scott Tomlins, Brian Zikmund-Fisher

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