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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; National Insitute on Drug Abuse

Funding Years: 2012-2017

This application seeks a five-year continuation of the panel data collections of the Monitoring the Future (MTF) study, an ongoing epidemiological and etiological research and reporting project begun in 1975. In addition to being a basic research study, MTF has become one of the nation's most relied upon sources of information on trends in illicit drug, alcohol, and tobacco use among American adolescents, college students, and young and middle-aged adults. This application seeks continuation of the mail follow-up surveys of high school graduates (augmented with internet options) at modal ages 19-30, 35, 40, 45, 50, and now 55. The companion main application seeks to continue the in-school data collections and to support the analysis of all of the data in the study, including past and future panel data. (NIDA requests that the study seek continuation funding through two separate applications, as it has done in the last two rounds.)
The study's cohort-sequential longitudinal design permits the measurement and differentiation of three types of change: age (developmental), period (historical), and cohort. Each has different determinants, and all three types of change have been shown by MTF to occur for most drugs. Factors that may explain historical trends and cohort differences also are monitored. MTF is designed to document the developmental history and consequences of drug use and related attitudes from adolescence through middle adulthood, and to determine the individual and contextual characteristics and social role transitions that affect use and related attitudes. Research on risk and protective behaviors for the transmission of HIV/AIDS among adults ages 21-40 also will be continued. All of this work will be extended to new years, cohorts, and ages under this application and the companion main application. The study will examine the importance of many hypothesized determinants of drug use (including attitudes and beliefs and access), as well as a range of potential consequences (including physical and psychological health, status attainment, role performance, and drug abuse and dependence). Impacts of some policy changes on adolescents and young adults will be evaluated, including those of the new FDA cigarette labeling requirements. MTF will experiment with the use of internet response methods and pursue several new approaches to making its panel data more accessible to other investigators.
The study's very broad measurement covers (a) initiation, use, and cessation for over 50 categories and sub-categories of licit and illicit drugs, including alcohol and tobacco; (b) attitudes and beliefs about many of them, perceived availability, and peer norms; (c) other behaviors and individual characteristics; (d) aspects of key social environments (home, work, school) and social role statuses and transitions; and (e) risk and protective behaviors related to the spread of HIV/AIDS. Results will continue to elucidate drug use from adolescence through middle adulthood (including the introduction of new drugs) with major implications for the policy, research, prevention, and treatment agendas.

PI(s): Mick Couper

Co-I(s): Lloyd Johnston, Patrick O'Malley, John Schulenberg, Megan Patrick, Richard Miech

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

Sarah Hawley, PhD, MPH


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.

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