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Funded by National Institutes of Health.

Funding Years: 2014-2019.

Randomized controlled trial (RCT) results diffuse into clinical practice slowly - the average time from trial completion to widespread adoption of a new treatment is nearly 20 years. These delays result in suboptimal treatment for patients with neurological diseases. In light of these delays and the enormous societal value of NINDS clinical trials findings, NINDS has recognized the need to accelerate implementation by promoting research to translate trial findings into routine care (T2 translational research). This application seeks to optimize translation of NINDS trials by personalizing clinical trial results ad addressing barriers to translation for clinicians and policy-makers. Using translational research methods, we can move from one-size-fits-all evidence-based medicine towards personalized medicine by estimating treatment benefit for individual patients. Other translational methods can evaluate and address stakeholder concerns that hinder translation. Because clinicians are often skeptical of trial results, changing practice requires convincing them not only that a treatment works in an RCT or that it works in academic medical centers, but that it will work for their patients. Similarly, if policy-makers and payers can be convinced that a new treatment is a good value (e.g., a favorable cost-benefit ratio), they can use their considerable influence on the healthcare delivery system to facilitate translation. Specifically, we will use translational research methods to address three important issues essential to improving trial translation: 1. estimating individual-level outcomes using multivariable outcome prediction 2. Estimating the impact of real world circumstances on outcomes using simulation analyses and 3. Cost effectiveness analysis. Results from these analyses can influence clinicians and policy-makers directly or through the use of tools, such as websites and mobile applications. This proposal has two key objectives. First, we will adapt translational research methods to clinical trials by addressing essential translation-relevant questions for the Carotid Revascularization Endarterectomy versus Stenting (CREST) trial. Second, we will develop a model to concurrently perform similar translational analyses in the Neurology Emergency Treatment Trials (NETT) network. These objectives will be addressed through 3 specific aims: 1. to estimate the expected net benefit of carotid endarterectomy (CEA) vs. carotid artery stenting (CAS) for individual patients in the CREST trial using refined multivariable outcome prediction methods. 2. To estimate the impact of personalized decision-making and real world circumstances (e.g., differing complication rates) on the net benefit of CAS vs. CEA for real world patients using simulation analyses. 3. To assess the feasibility of performing concurrent translational and cost analyses in NETT trials by evaluating a process implementation model in newly initiated and recently completed NETT trials. Dr. Burke has a unique background as a vascular neurologist with training in Translational research methodology through the highly regarded Robert Wood Johnson Clinical Scholars Program. In this proposal, Dr. Burke will develop the additional expertise in clinical trials, multivariable outcome prediction, simulation analyses and cost analyses to become a leader and independently-funded investigator in neurological translational research working to develop a new generation of NETT trials better designed to effectively inform real world clinical practice and improve patient outcomes. This proposal capitalizes on unique environmental strengths at the University of Michigan. Most importantly, Dr. Burke will be supported by an outstanding multi- disciplinary mentorship team including Dr. William Barsan the NETT Clinical Coordinating Center (CCC) principal investigator and a research leader in the emergency treatment of neurological diseases, Dr. Rodney Hayward a Professor of Internal Medicine and a pioneer in translational research and Dr. Lewis Morgenstern, a leader in neurological translational research. All three mentors have excellent track records in mentoring junior faculty and transitioning junior faculty to independence. In addition, Dr. Burke will have te opportunity to participate in a unique hands-on clinical trials immersion through the NETT to gain experience in clinical trial design, management and implementation. Finally, the University of Michigan has recently built the largest academic Translational Research center in the United States (the Institute for Health Policy and Innovation) which will support the advanced statistical methods required for this proposal.

PI(s): James Burke

PIHCD Working Group

Wed, February 04, 2015, 2:00pm to 3:00pm
Location: 
B004E NCRC Building 16

We will have a meeting next Wednesday February 4 at 2pm in B004E NCRC Building 16. Katie Williams will be presenting updated materials for a project about risk communication for Inflammatory Bowel Disease in pediatrics.

Brian Zikmund-Fisher, PhD, is the featured guest editor for a special supplement to Medical Decision Making's September/October 2010 issue, highlighting the DECISIONS study, a nationwide survey of adults in the US regarding common medical decisions.  Lead author on the main paper of the supplement, Zikmund-Fisher and co-authors (including CBSSM faculty Angela Fagerlin, PhD and Mick Couper, PhD) describe the DECISIONS study, a telephone interview of a nationally representative sample of 3010 adults age 40 and over faced with making a medical decision in the past two years.  Researchers defined medical decisions as the patient having initiated medications, been screened, or had surgery within the past 2 years or having discussed these actions with a health care provider during the same interval.  Key findings from the study:

Although patients frequently receive information about the benefits of a procedure or medication, they don't always learn about the disadvantages.

Healthcare providers don't always ask patients what they want to do.

Most patients don't use the Internet to help them make common medical decisions; healthcare professionals remain the most important source of information.

Patients often don't know as much as they think they do.  Many patients feel well informed even when they don't know key facts that would help them make a better decision.

African-Americans and Hispanics were less knowledgeable than other patients about medications to treat high cholesterol.  In addition, they were more likely to say their doctor made decisions about cholesterol medications for them.

Most patients think they are more likely to get cancer than they really are, and tend to view cancer screenings as more accurate than they are.

Men and women think about cancer risks differently.  Women are more active participants in cancer screening decisions regardless of their perception of risk, whereas men tended to get involved only if they felt at higher risk.

Jeffrey Kullgren, MS, MD, MPH

Faculty

Dr. Jeff Kullgren is a Research Scientist in the Center for Clinical Management Research at the VA Ann Arbor Healthcare System and an Assistant Professor in the Department of Internal Medicine at the University of Michigan Medical School and Institute for Healthcare Policy and Innovation.  Dr.

Last Name: 
Kullgren

The ethics of resuscitation (Sep-11)

Traditional ethical teaching suggests that a physician's assessment of a patient's best interest should guide the decision of whether to administer emergency life-sustaining therapy, absent guidance by the patient or family members.  In pediatric medicine, physicians may insist on life-saving therapy if they believe it is in a child's best interest to receive it, even if the parents seek to refuse it.  It is unclear exactly how physicians make such assessments, however, and whether/how these assessments influence decision-making in critical situations.  Consider the following scenario:

PIHCD Working Group

Wed, January 14, 2015, 3:00pm to 4:00pm
Location: 
TBD

Ray De Vries and Tom Tomlinson will be speaking about a deliberative democracy session on non-welfare interests in biobanking. They will be looking for feedback on materials including the presentations to be given by experts.

Funded by National Institutes of Health.

Funding Years: 2014-2019.

The quality and cost of cancer care varies widely across hospitals and health systems. A large body of research indicates that hospitals with better outcomes tend to have large case volumes and a defined focus on cancer care. These and other data have prompted many to advocate for specialized cancer hospitals, so-called "focused factories", as the best delivery system for achieving more efficient cancer care. However, reforms in the Affordable Care Act, including Accountable Care Organizations (ACO), are moving care away from this model. Although proponents argue that ACOs will improve efficiency by encouraging previously unaligned hospitals and physicians to evolve toward integrated delivery systems, others worry that the intended benefits will not accrue for patients with complex cancer diagnoses, and that ACOs will discourage referrals to hospitals with the greatest cancer expertise. To explore this issue, we propose a study that evaluates comprehensively the relationship between care delivery models and the quality, outcomes, and cost of cancer care in the United States. In the first aim, we will examine the impact of care delivery models on the quality of cancer care. Using national Medicare claims and linked SEER-Medicare data, we will identify cohorts of patients with breast, lung, prostate, and pancreatic cancer. We will then compare the quality of cancer care provided in different care delivery models based on levels of adherence with guideline recommendations and/or nationally-endorsed quality measures. We posit that cancer-focused hospitals will often have higher levels of adherence, due in part to their greater concentration of disease-specific expertise. In the second aim, we will assess the association between care delivery models and outcomes, including operative mortality, complications, hospitalizations, and long-term survival. We hypothesize that patients treated in cancer-focused hospitals will have better mortality outcomes, while greater delivery system integration will correlate with fewer hospitalizations following initial cancer therapy. In the third aim, we will examine cancer-related expenditures for these patient cohorts as they vary over time after diagnosis. We will also assess payments related to different clinical services including surgical procedures, systemic therapy, end-of-life care, and non-cancer-related treatments. We expect that cancer-focused hospitals will achieve savings around episodes of surgical care, and that patients treated in more integrated delivery systems will have lower longitudinal costs for their cancer care. Results from this study will prove invaluable to CMS policymakers and other stakeholders as they debate whether delivery system reforms deemed good for healthcare in general are also good for patients with cancer.

PI(s): David Miller

Co-I(s): Mousumi Banerjee, John Birkenmeyer, Jennifer Griggs, Edward Norton, Yun Zhang

 

In videos for The Trust Project, bioethicist and sociologist Raymond De Vries explores trust in medicine from a sociological perspective.

In How Trust Shapes the Medical Field: A Sociologist's Perspective, De Vries offers a historical perspective on trust in medicine:

  • What role did industrialization play in changing interpersonal trust?
  • What can we learn about trusting relationships from past societies?

In The Rise of Bioethics in Response to Medical Distrust: Key Findings, De Vries discusses some key research in the field of trust and bioethics:

  • How did the erosion of trust in medicine lead to the rise in the study of bioethics?
  • Does the bureaucracy that comes with research ethics committees enhance or undermine trust?

An another video, Evolution of Trust in Bioethics medical research ethics.

The Trust Project at Northwestern University features scholars and executives exploring Trust in videos that cover theory, research and practice. By combining multiple and diverse perspectives, The Trust Project aspires to illuminate new insights for research and management.

CBSSM Working Group Meeting-Jacob Kurlander

Tue, January 23, 2018, 4:00pm
Add to Calendar
Location: 
NCRC bldg 16 266C

Seeking feedback regarding developing a survey to assess the physicians' understanding of risks associated with proton pump inhibitors.Specifically, we are seeking input on the design of patient vignettes that include some randomized elements, and in the design of questions about providers quantitative estimates of PPI risk.

Working Group Meetings

Working group meetings provide an opportunity for investigators to receive feedback on research proposals, drafts of papers, grant applications, or any other aspects of projects at any stage of development. This meeting is designed as an informal working group not a formal presentation. For more details look under the How We Can Help section.

To see the schedule for upcoming meetings please check the Events calendar. The next PIHCD meeting is listed below.

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