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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: NIH

Funding Years: 2016-2021

 

There is a fundamental gap in understanding how Mild Cognitive Impairment (MCI) influences treatment and Decision Making for serious illnesses, like Cardiovascular disease (CVD), in older patients. Poor understanding of Clinical Decision Making is a critical barrier to the design of interventions to improve the quality and outcomes of CVD care of in older patients with MCI. The long-term goal of this research is to develop, test, and disseminate interventions aimed to improve the quality and outcomes of CVD care and to reduce CVD-related disability in older Americans with MCI. The objective of this application is to determine the extent to which people with MCI are receiving sub-standard care for the two most common CVD events, Acute myocardial infarction (AMI) and acute ischemic stroke, increasing the chance of mortality and morbidity in a population with otherwise good quality of life, and to determine how MCI influences patient preferences and physician recommendations for treatment. AMI and acute ischemic stroke are excellent models of serious, acute illnesses with a wide range of effective therapies for acute management, Rehabilitation, and secondary prevention. Our central hypothesis is that older Adults with MCI are undertreated for CVD because patients and physicians overestimate their risk of dementia and underestimate their risk of CVD. This hypothesis has been formulated on the basis of preliminary data from the applicants' pilot research. The rationale for the proposed research is that understanding how patient preferences and physician recommendations contribute to underuse of CVD treatments in patients with MCI has the potential to translate into targeted interventions aimed to improve the quality and outcomes of care, resulting in new and innovative approaches to the treatment of CVD and other serious, acute illnesses in Adults with MCI. Guided by strong preliminary data, this hypothesis will be tested by pursuing two specific aims: 1) Compare AMI and stroke treatments between MCI patients and cognitively normal patients and explore differences in Clinical outcomes associated with treatment differences; and 2) Determine the influence of MCI on patient and surrogate preferences and physician recommendations for AMI and stroke treatment. Under the first aim, a health services research approach- shown to be feasible in the applicants' hands-will be used to quantify the extent and outcomes of treatment differences for AMI and acute ischemic stroke in older patients with MCI. Under the second aim, a multi-center, mixed-methods approach and a national physician survey, which also has been proven as feasible in the applicants' hands, will be used to determine the influence of MCI on patient preferences and physician recommendations for AMI and stroke treatment. This research proposal is innovative because it represents a new and substantially different way of addressing the important public health problem of enhancing the health of older Adults by determining the extent and causes of underuse of effective CVD treatments in those with MCI. The proposed research is significant because it is expected to vertically advance and expand understanding of how MCI influences treatment and Decision Making for AMI and ischemic stroke in older patients. Ultimately, such knowledge has the potential to inform the development of targeted interventions that will help to improve the quality and outcomes of CVD care and to reduce CVD-related disability in older Americans.

PI: Deborah Levine

CO(s): Darin Zahuranec, MD & Ken Lenga, MD. PhD.

Adult Ethics Committee

The Michigan Medicine Committee advisory groups are appointed by the Hospital's Office of Clinical Affairs. They review ethical or moral questions that may come up during an adult patient's care. The consultants facilitate communication among adult patients, their families and the treatment team to assist everyone in making appropriate choices when difficult decisions need to be made. The Committee's goal is to help everyone decide the right thing to do. The Michigan Medicine Adult Ethics Committee is a sub-committee of the Executive Committee on Clinical Affairs as determined by the Medical Staff Bylaws.

About Us

Sometimes patients, families and staff have very difficult choices and ethical questions they need to talk about. Discussions with the Ethics Committee can be helpful and reassuring when a difficult choice must be made (for example, questions on end-of-life care, or issues of confidentiality). The goal of the Committee is to facilitate communication among adult patients, their families and the treatment team to assist everyone in making appropriate choices, as well as to assist Michigan Medicine in complying with ethical regulatory standards, when difficult decisions need to be made. The Committee provides consultation to the treatment team, patients and families on ethical, moral or philosophical problems and issues encountered in the course of managing inpatient and outpatient care.

Committee members include physicians, residents, nurses and social workers, as well as medical students, an attorney/compliance officer, a chaplain, a medical ethics professor and members from the community.

The Adult Ethics Committee meets on the third Tuesday of the month, form 12-1:30pm, at University Hospital in dining room D, if you would like to attend as a guest, please contact Amy Lynn @ lynnam@med.umich.edu

What happens when a meeting with the Ethics Committee is requested?

The consultants on call review the patient's medical situation and treatment options. In addition, concerns and feelings of the patient, family members, and the health care team are discussed. Members of the committee may visit with patients, families and medical personnel to discuss these concerns.

Ethics Committee members discuss the information which has been gathered. The Ethics Committee makes suggestions about the best course of action. Often there are a number of options available in the course of a patient's care. Final decisions are made by the patient, family and the health care team.

Request a Consult

Monday-Friday
8:00 a.m. - 5:00 p.m. Call 734-615-1379
After normal business hours, please call 936-6267 and ask for the clinical ethicist on call to be paged.

Resources

Financial Assistance

Non-Beneficial Treatment

Advance Directives

Committee Bylaws

 

For upcoming Bioethics Grand Rounds see Events

Pediatric Ethics Committee

The Michigan Medicine Committee advisory groups are appointed by the Hospital's Office of Clinical Affairs. They review ethical or moral questions that may come up during a pediatrics patient's care. The consultants facilitate communication among patients, their families and the treatment team to assist everyone in making appropriate choices when difficult decisions need to be made. The Committee's goal is to help everyone decide the right thing to do. The Michigan Medicine Ethics Committee is a sub-committee of the Executive Committee on Clinical Affairs as determined by the Medical Staff Bylaws. 

About Us


The committee is available for consultation to family members, patients, staff, and health care providers. The committee may help you and your child’s medical team clarify facts, examine ethical issues, and assist in the resolution of disagreements about your child’s care. The committee includes people with additional training in medical ethics, doctors, nurses, social workers, a lawyer, a chaplain, an administrator, and members of the community
The University of Michigan has a Pediatric Ethics Committee because the best medical care requires not only medical skill but good moral judgment. The Committee’s main purpose is to offer help and guidance on moral and ethical questions, such as:

  • Should treatment be started or stopped?
  • How much should a child be told about his or her disease?
  • Is the promise of treatment worth the suffering it may cause?
  • What is the best thing to do when we must face the end of life?
  • What happens when a meeting with the Ethics Committee is requested?

The consultants on call review the patient's medical situation and treatment options. In addition, concerns and feelings of the patient, family members, and the health care team are discussed. Members of the committee may visit with patients, families and medical personnel to discuss these concerns.

Ethics Committee members discuss the information which has been gathered. The Ethics Committee makes suggestions about the best course of action. Often there are a number of options available in the course of a patient's care. Final decisions are made by the patient, family and the health care team.

The Pediatric Ethics Committee meets on the first Tuesday of the month from 12-1:30pm at University Hospital in dining rooms C&D. If you would like to attend as a guest, please contact Amy Lynn @ lynnam@med.umich.edu

Request a Consult

Monday-Friday
8:00 a.m. - 5:00 p.m. Call 734-615-1379
After normal business hours, please call 936-6267 and ask for the clinical ethicist on call to be paged.

Resources

Financial Assistance

Non-Beneficial Treatment

Committee Bylaws

 

For upcoming Bioethics Grand Rounds see Events

 

The Privileged Choices (Jan-08)

What's the difference between opting in and opting out of an activity? Who decides if people will be put automatically into one category or another? Click this interactive decision to learn how default options work.

Scenario 1

Imagine that you're a US Senator and that you serve on the Senate's Committee on Health, Education, Labor, and Pensions. The Infectious Diseases Society of America has come before your committee because they believe that too many health care workers are getting sick with influenza ("flu") each year and infecting others. As a result, your Senate committee is now considering a new bill that would require that all health care workers get annual influenza vaccinations ("flu shots") unless the worker specifically refuses this vaccination in writing.

Do you think you would support this bill for mandatory flu shots for health care workers?

  • Yes
  • No

Scenario 2

Imagine that you're the human resources director at a mid-sized company that's initiating an employee retirement plan. Management is concerned that many employees are not saving enough for retirement. They're considering a policy that would automatically deduct retirement contributions from all employees' wages unless the employee fills out and submits a form requesting exemption from the automatic deductions.

Do you think a policy of automatic retirement deductions is reasonable for your company to follow?

  • Yes 
  • No

Scenario 3

Organ transplants save many lives each year, but there are always too many deserving patients and too few organs available. To try to improve the number of organs available for donation, the state legislature in your state is considering a new policy that all people who die under certain well-defined circumstances will have their organs donated to others. The system would start in three years, after an information campaign. People who do not want to have their organs donated would be given the opportunity to sign a refusal of organ donation when they renewed their drivers' licenses or state ID cards, which expire every three years. Citizens without either of these cards could also sign the refusal at any drivers' license office in the state. This is a policy similar to ones already in place in some European countries.

Does this seem like an appropriate policy to you?

  • Yes 
  • No

How do your answers compare?

For many decisions in life, people encounter default options-that is, events or conditions that will be set in place if they don't actively choose an alternative. Some default options have clear benefits and are relatively straightforward to implement, such as having drug prescriptions default to "generic" unless the physician checks the "brand necessary" box. Others are more controversial, such as the automatic organ donation issue that you made a decision about.

Default options can strongly influence human behavior. For example, employees are much more likely to participate in a retirement plan if they're automatically enrolled (and must ask to be removed, or opt out) than if they must actively opt in to the plan. Researchers have found a number of reasons for this influence of default options, including people's aversion to change.

But default options can seem coercive also. So, an Institute of Medicine committee recently recommended against making organ donation automatic in the US. One reason was the committee's concern that Americans might not fully understand that they could opt out of donation or exactly how they could do so.

The policy scenarios presented to you here have been excerpted from a 2007 article in the New England Journal of Medicine titled "Harnessing the Power of Default Options to Improve Health Care," by Scott D. Halpern, MD, PhD, Peter A. Ubel, MD, and David A. Asch, MD, MBA. Dr. Ubel is the Director of the Center for Behavioral and Decision Sciences in Medicine.

This article provides guidance for policy-makers in setting default options, specifically in health care. Generally, default options in health care are intended to promote the use of interventions that improve care, reduce the use of interventions that put patients at risk, or serve broader societal agendas, such as cost containment.

In this NEJM article, the researchers argue that default options are often unavoidable-otherwise, how would an emergency-room physician decide on care for an uninsured patient? Many default options already exist but are hidden. Without either returning to an era of paternalism in medicine or adopting a laissez-faire approach, the authors present ways to use default options wisely but actively, based on clear findings in the medical literature.

Some examples of default policies that may improve health care quality:

  • routine HIV testing of all patients unless they opt out.
  • removal of urinary catheters in hospital patients after 72 hours unless a nurse or doctor documents why the catheter should be retained.
  • routine ventilation of all newly intubated patients with lung-protective settings unless or until other settings are ordered.

Drs. Halpern, Ubel, and Asch conclude, "Enacting policy changes by manipulating default options carries no more risk than ignoring such options that were previously set passively, and it offers far greater opportunities for benefit."

Read the article:

Harnessing the power of default options to improve health care.
Halpern SD, Ubel PA, Asch DA. New England Journal of Medicine 2007;357:1340-1344.

Leaving the Emergency Room in a Fog (Sep-09)

Consider this scenario:

Alfred made a visit to his local Emergency Room. What was his diagnosis? What did the medical team do for his problem? What was he supposed to do to continue care at home? And what symptoms was he supposed to watch for to alert him to return to the ER?

Alfred woke up at 4 am on Sunday morning with pain in his left foot. That place where his new running shoes had rubbed a raw spot earlier in the week was getting worse. By 9 am, the foot was red and swollen, with a large oozing sore, and Alfred decided to go to the Emergency Room at his local hospital.

Late on Sunday afternoon, Alfred returned home from the ER. He crutched his way into the house and collapsed on the sofa. His teenage son quizzed him.

"What did they say was wrong?"
"Oh, an infection," replied Alfred.
"Well, what did they do for it?"
"I think they cut a chunk out of my foot," said Alfred.
"Whoa! Did they give you any medicine?"
"Yeah, a shot," said Alfred.
"And what’s with the crutches?"
"I’m supposed to use them for a while," said Alfred, looking annoyed.
"How long a while?"
"It’s written down," said Alfred, digging a crumpled sheet of paper out of his pocket.
"Says here you should take some prescription and elevate your left leg for two days."
"Two days? I have to go to work tomorrow," groaned Alfred.
"And you’re supposed to go back to the ER if you have a fever or pain in your leg. Where’s the prescription?"
"Here, look through my wallet. Maybe I stuck it in there," said Alfred.
The good news is that Alfred recovered completely, with some assistance and cajoling from his son. But how common is it for people who go to the Emergency Room to be foggy about what happened and what they should do once they leave the ER?
What do you think is the percentage of ER patients who do not understand at least one of the following: their diagnosis, the emergency care they received, their discharge care, or their return instructions?
 
  • 38%
  • 48%
  • 78%
  • 88%

How do your answers compare?

A recent study in the Annals of Emergency Medicine found that 78% of emergency room patients showed deficient comprehension in at least one of these areas:
 
  • Diagnosis
  • Emergency care that was given
  • Post-ER care needs
  • Symptoms that would require a return to the ER
51% of patients showed deficient comprehension in two or more areas. Only 22% of reports from patients were in complete harmony with what their care teams reported in all four areas. The biggest area of misunderstanding was in patients' post-ER care needs, such as medications, self-care steps, follow-up from their regular doctors, or follow-up with specialists.
 
Even more alarming is that, according to the study, "most patients appear to be unaware of their lack of understanding and report inappropriate confidence in their comprehension and recall." The patients were quite sure of what they knew 80% of the time—even when what they knew was not right.
 
These results suggest that Emergency Room teams need to do a better job of making sure that patients go home with clear information and instructions—and that patients and their loved ones shouldn't leave until they fully comprehend their situation.
 
Lead author Kirsten G. Engel, MD, conducted this study, "Patient Comprehension of Emergency Department Care and Instructions," with Michele Heisler, MD, Dylan M. Smith, PhD , Claire H. Robinson, MPH, Jane H.Forman, ScD, MHS, and Peter A. Ubel, MD, most of whom are affiliated with CBDSM.
 
The researchers carried out detailed interviews with 140 English-speaking patients who visited one of two Emergency Departments in southeast Michigan and were released to go home. These interviews were compared with the patients' medical records, and the comparisons revealed serious mismatches between what the medical teams found or advised and what the patients comprehended.
 
"It is critical that emergency patients understand their diagnosis, their care, and, perhaps most important, their discharge instructions," says Kirsten Engel, a former UM Robert Wood Johnson Clinical Scholar who is now at Northwestern University. "It is disturbing that so many patients do not understand their post-Emergency-Department care, and that they do not even recognize where the gaps in understanding are. Patients who fail to follow discharge instructions may have a greater likelihood of complications after leaving the Emergency Department."
 
Peter A. Ubel, the study's senior author, agrees: "Doctors need to not only ask patients if they have questions, but ask them to explain, in their own words, what they think is wrong with their health and what they can do about it. And patients need to ask their doctors more questions, and even need to explain to their doctors what they think is going on."
 
Read the article:

 

Supporting information for: 2013 CBSSM Research Colloquium and Bishop Lecture (Ruth Macklin, PhD)

PhotoVoice:  Promoting individual wellbeing and improving disaster response policies in Japan and beyond

Mieko Yoshihama, PhD, ACSW, LMSW, Professor, School of Social Work, University of Michigan

Co-authors: Yukiko Nakamura, Ochanomizu University Department of Interdisciplinary Gender Studies, Tokyo, Japan; Tomoko Yunomae, Women's Network for East Japan Disaster

Conducted in collaboration with local women’s organizations, PhotoVoice Project is aimed at strengthening gender-informed disaster policies and response in Japan by engaging the very women affected by the disasters in the analyses of their own conditions and advocacy efforts.  PhotoVoice, a method of participatory action research, involves participants taking photographs of their lives and communities, followed by a series of small-group discussions about their experiences while sharing their photographs (Wang & Burris, 1997). 

After the Great East Japan Disasters of March 11, 2011, a diverse group of women (N=35) in five localities in the most disaster-affected areas of northern Japan participated in PhotoVoice group discussions (4-7 sessions in each location).  A significant minority of the participants have been assisting other disaster victims as part of their regular employment or through volunteer effort. 

The participants’ photographs and narratives identified various ways in which Japanese sociocultural and structural factors affected women’s vulnerabilities in and after disasters.  Traumatic stress and compassion fatigue were prevalent, yet denial and suppression were common response.  Facilitated group discussions served as a collective space for grieving the loss and rebuilding their lives.  Through repeated group discussions, participants also questioned and identified limitations and failures of the current disaster policies as well as those concerning nuclear energy.  Also evident were participants’ increased interest and desire to speak out, similar to the processes of politicalization and conscientization/conscientização (Freire, 1970). 

Findings of the project elucidate how individuals respond to trauma, dislocation, and devastation; how individual experiences are influenced by sociocultural and structural forces; and how individuals make sense of disaster and structural inequity, and to formulate action to address them.  Findings of the project also suggest that participatory action research such as PhotoVoice could promote participants’ growth and wellbeing by providing space for collective reflections, rebuilding, and action.

Mieko Yoshihama is a Professor of Social Work at the University of Michigan. Dr. Yoshihama's research interests are violence against women, immigrants, mental health, and community organizing. Combining research and social action at local, state, national, and international levels over the last 25 years, Dr. Yoshihama focuses on the prevention of gender-based violence and promotion of the safety and wellbeing of marginalized populations and communities.

 

Representing torture of women in custody in the U.S.

Carol Jacobsen, MFA, Professor, The University of Michigan Penny Stamps School of Art & Design, Women’s Studies; Human Rights Director, Michigan Women’s Justice & Clemency Project

More than a decade ago, Amnesty International launched its first ever campaign on torture in the U.S.  Working with human rights activists, including prisoners, attorneys, artists, and others, the ongoing campaign has focused on the four point chaining, rape, retaliation, medical neglect and other forms of abuse of women occurring in U.S. prisons.  As a grassroots, feminist filmmaker working with Amnesty on this issue, in my role as Director of the Michigan Women’s Justice & Clemency Project, and as an educator of visual art, women’s studies and human rights, many questions arise about issues of state and individual power, gender, race, representation, exploitation, censorship and voice as we struggle to make torture a visible and public issue in order to ultimately end it.  This presentation will include an excerpt from my film, Segregation Unit.

Segregation Unit, 30 min., 2000

Carol Jacobsen, Director

Narrated by Jamie Whitcomb following her release from prison, the film documents the torture she and many others have suffered (and continue to suffer) in Michigan prisons.  The film includes footage shot by guards that was obtained through subpoenas and the Freedom of Information Act in connection with Whitcomb’s successful lawsuit against the State.  Co-sponsored by Amnesty International, Segregation Unit is a nonprofit film available free to activists.

Carol Jacobsen is a social documentary artist whose works in video and photography draw on interviews, court files and records to address issues of women's criminalization, censorship and human rights.  Her work, co-sponsored by Amnesty International, is represented by Denise Bibro Gallery in New York, and has been exhibited and screened worldwide.  She has received awards from the National Endowment for the Arts, the Paul Robeson Foundation, Women in Film Foundation, Rockefeller Foundation and others. Her critical writings have appeared in the New York Law Review, Hastings Women's Law Journal, Signs Journal, Social Text, Art in America and other publications. She teaches Art, Women's Studies and Human Rights at UM, and serves as Director of the Michigan Women's Justice & Clemency Project, a grassroots advocacy and public education effort for freedom and human rights for incarcerated women.

 

Do non-welfare interests play a role in willingness to donate to biobanks?

Michele C. Gornick, PhD, Postdoctoral Research Fellow, VA Health Science, Research & Development and CBSSM, University of Michigan

Co-authors: Tom Tomlinson, PhD, Kerry Ryan, MA and Scott Kim, MD, PhD

Ethical debate has focused on protecting donor welfare and privacy interests.  Little attention has been given to individual donor concerns about the moral, societal, or religious implications of research using their donation. The current study explores the impact of non-welfare interests (NWIs) on participants’ willingness to donate de-identified tissue samples and medical records to biobanks through an experimental online survey (N=1276; 46.3% women; 19.6% racial minority).  Participants were more likely to donate to biobanks for NWI topics commonly associated with ‘science’ and medical research (evolution and stem cell research) than unfamiliar uses of biosamples (commercialization/corporate profit and risk assessment by insurance companies).  In addition, mode (single vs. multiple scenario) and timing (before vs. after blanket consent) of NWI disclosure affect individual’s willingness to donate.  Further, key subject characteristics influence participants’ willingness to donate, even after controlling for NWI scenario assignment (Racial minorities: OR = 0.59, 98% CI 0.34, 0.99, Evangelical Christians: OR = 0.55, 98% CI 0.35, 0.89, Liberal political views: OR = 1.66, 98% CI 1.06, 2.60). These data suggest that NWI issues have complex dimensions that require careful elicitation and evaluation of people’s opinions regarding them. Further, policy recommendations for biobank donation based only on welfare and privacy may neglect other interests that are highly vales by potential donors.

Michele Gornick is a Postdoctoral Research Fellow at the VA Center for Clinical Management Research and the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.  She received her PhD in Human Genetics and MA in Statistics from the University of Michigan.  Her research is in translational medicine, specifically dealing with ethical issues surrounding the communication of genomic information to cancer patients, physicians and other health care providers.

 

Which research? Public engagement and opinions about the research use of biobank samples

C. Daniel Myers, PhD, Robert Wood Johnson Scholar in Health Policy Research, Department of Health Management and Policy, School of Public Health, University of Michigan

Daniel B. Thiel, MA, Assistant Director,  Life Sciences and Society Program, School of Public Health, University of Michigan

Co-authors: Ann Mongoven, PhD, MPH; Jodyn Platt, MPH; Tevah Platt, MPH; Susan B. King; Sharon L. R. Kardia, PhD

Do potential biobank donors approve of using biobank samples for research, and do they care what kinds of research is done on their samples?  We explored this question in various public engagement forums related to the Michigan BioTrust for Health, a recently established state research biobank of de-identified leftover newborn screening bloodspots. Results suggest that that the type of public engagement affects participant responses about whether research using leftover bloodspots is appropriate, and what types of research are should be conducted.  In more superficial kinds of engagement participants show nearly-unanimous support for research, support that does not vary greatly across different kinds of research. However, more intensive forms of engagement find somewhat greater skepticism about research, and support that varies according to what aspect of a study is emphasized—target population, disease in question, type of analysis (e.g., genetic or not).  Furthermore, more intensive engagements facilitate deeper reflection on the inherently uncertain nature of biobank research applications.  This uncertainty brings issues of governance and oversight to the foreground. While there are some areas of broad consensus, there is also widespread disagreement on what kinds of research should and should not be pursued. On a practical level, this variation suggests that singular sources on public opinion may not be adequate to judge public support for biobanking, and that research and policy communities should consider best practices for eliciting educated public opinion on acceptable research. On a more conceptual level, the variety of conceptions of appropriate research uses suggests that informed consent and community oversight processes should account for this pluralistic conception of the public good. 

C. Daniel Myers is a Robert Wood Johnson Scholar in Health Policy at the University of Michigan School of Public Health. His research focuses on how political communication affects public attitudes, particularly in the context of public deliberation. He is currently involved in research projects on the role of stories sin political communication as well as on public deliberation about priorities for patient centered outcome research. He received his Ph.D. in Political Science from Princeton University and his B.A. in Political Science from Allegheny College. Starting in 2013 he will be an Assistant Professor of Political Science at the University of Minnesota.

Daniel Thiel is currently the Assistant Director of the Life Sciences and Society Program at the University of Michigan where he wears many hats, including directing a community engagement research project about the Michigan BioTrust for Health.  Prior to this position he taught classes in political philosophy, ethics and the philosophy of law at John Jay College in New York City. His research interests are primarily in the fields of bioethics, science and technology studies and social and political philosophy.  He completed an M.A. in Philosophy at Stony Brook University and a B.A. in Philosophy at U.C. Berkeley.

 

Whose sense of public good? Public engagement results from the Michigan BioTrust and ethical implications

Ann Mongoven, PhD, MPH, Assistant Professor, Center for Ethics and Humanities in the Life Sciences and Department of Pediatrics and Human Development, Michigan State University

Co-author: Meta Kreiner, MSc

Can policy-makers assume a consensus on what constitutes “the public good” of a public health biobank? If not, what are the implications for biobank ethical policies?  We explore these questions in relationship to public engagement on the Michigan BioTrust.  The BioTrust is a recently established state research biobank of de-identified leftover newborn screening bloodspots.  BioTrust guidelines require that any research using bloodspots be (a) health research and (b) in the public good.  The biobank operates with an opt-out “blanket” presumed consent policy for bloodspots saved before 2010, and an opt-in blanket consent policy for bloodspots saved from 2010 onward.

Community engagement on this issue suggests pluralistic conceptions of what constitutes the public good among Michigan residents.  While some types of research generate broad consensus; others generate significant disagreement.   Risk/benefit assessments also vary according to both degree and kind, including: potential for scientific/medical advances, economic considerations, and individual or group risk/benefit from biobank participation.  Because the bloodspots come from children, some focus on benefits/risks for children; others do not.  These results suggest pluralistic conceptions of what constitutes “public good” are at play when citizens assess both if and when the state should use biobank samples for research, and also whether they should allow research on their own children’s bloodspots.  

The results also have implications regarding informed consent processes and community oversight for a bloodspot biobank.  Lack of consensus on what research is “in the public good” adds empirical weight to ethical requirements that biobanks inform donors before using their bloodspots for research, make lay research descriptions available,  include community oversight in biobank governance, and ensure an opt-out mechanism.  They suggest the worthiness of considering “by-study” or “tiered” consent options while underscoring their practical challenges.  Significantly, even blanket consent and community oversight processes can be improved by acknowledging lack of consensus on what constitutes the public good as a risk of participation.

Ann Mongoven is an Assistant Professor at the Center for Ethics and Humanities in the Life Sciences, Michigan State University. She earned her Ph.D. in religious studies/ethics from the University of Virginia and a M.P.H. from the Johns Hopkins University Bloomberg School of Public Health. Mongoven is also a Michigan State University Lilly Teaching Fellow.

 

Citizen recommendations for communication about biobank participation and consent: Considering source, message, channel, receiver, and timing

Andrea C. Sexton, BA, Master of Arts Student, Health and Risk Communication, College of Communication Arts and Sciences, Michigan State University

Co-authors: Ann Mongoven, PhD, MPH; Meta Kreiner, MSc

Source, message, channel, and receiver are fundamental factors in models of the communication process.  Public and clinical health practitioners must consider these factors in order to design effective health communication.  This paper a) reports citizen recommendations for a multi-faceted educational campaign on the Michigan Biotrust; b) analyzes these recommendations by source, message, channel, and receiver characteristics; and c) argues that integrating these recommendations with communication theory suggests both practical strategies for recommendation implementation and extensions of theoretical models of the communication process. 

The Michigan BioTrust for health is a state research biobank containing bloodspots leftover after newborn bloodspot screening. In November of 2011, seven deliberative processes engaged a representative sample of Michigan citizens. Five sessions were conducted in-person, each in a different Michigan city. Two sessions were run as Facebook discussion groups.

The primary recommendation from these juries is a multi-faceted campaign to increase public awareness of the BioTrust and its consent processes. The deliberators propose specific suggestions about who should provide information, what content should be communicated, the mediums through which education should occur, and their impressions of citizen responses to current and recommended BioTrust communications.

In addition to identifying source, message, channel, and receiver characteristics, jury participants distinctly emphasize the importance of communication timing.  They consider the effect of timing on receivers’ motivation and ability to process information, investigate their options, and ask questions. They also suggest a relationship between timing of communication about the Biotrust and public attitude toward the BioTrust.

Exploring jury participants’ suggestions for education about the BioTrust has implications for clinical interactions, health education curriculums, and mass media campaigns regarding informed consent for biobanks, as well as ethical solicitation of biobank participation. Additionally, emphasis on timing as a key factor in communication may warrant further consideration in theoretical models of the communication process.

Andrea Sexton is a candidate for a Master’s of Arts in Health & Risk Communication at Michigan State University where she is a research assistant in the Center for Ethics and Humanities in the Life Sciences on a project researching community engagement on the Michigan BioTrust for Health. She has also contributed to health communication research on hand washing, health website quality, nutritional labeling, and community engagement in sustainable food system development. Andrea’s research interests include community engagement in health and environmental issues and health and risk decision making. She completed her B.A. in Linguistics & Psychology at the University of Michigan.

 

Comparing male and female BRCA mutation carriers’ communication of their BRCA test results to family members

Monica Marvin, MS, Associate Director of the Genetic Counseling Program;  Genetic Counselor in the Cancer Genetics Clinic; Clinical Assistant Professor; University of Michigan, Department of Human Genetics and Internal Medicine

Co-authors: Heidi Dreyfuss, MS; Lindsay Dohany, MS; Kara Milliron, MS;  Sofia Merajver, MD, PhD; Elena Stoffel, MD, MPH; Beverly Yashar, MS, PhD; and Dana Zakalik, MD

Current national guidelines state that patients with positive BRCA results should be urged to notify at-risk relatives.  Most research on communication of BRCA results is limited to communication by females and suggests that communication to males occurs less frequently. 

The objective of this exploratory study is to identify gender-related characteristics in communication of BRCA results to improve familial communication.

677 individuals who received genetic counseling from three clinics in Michigan were invited to participate.  Subjects completed a 34-item survey comprised of novel and previously published questions exploring whom they informed, information shared, method of communication, and factors impacting the decision to undergo testing and disclose results.  Communication patterns were examined within the entire cohort and comparisons were made between males and females.

Participants included 35 males and 202 females.  Overall greater than 78% of parents shared their test results with at least one of their children with a greater percentage of fathers disclosing to their children than mothers.  The disclosure was mostly done in-person and the information shared did not vary much between genders except a greater proportion of mothers with daughter(s) discussed the impact genetics can have on their daughter’s medical management than fathers with their daughter(s).  For both males and females, the top reasons for disclosing to children included: 1) wanting to inform them about their risk, 2) feeling the results will impact management, 3) wanting to encourage testing, and 4) having a close relationship. 

In genetic counseling, gender of a BRCA mutation carrier does not appear to greatly affect the frequency or method of communication of test results.  Furthermore, we found that communication to male and female relatives occurred with a similar frequency.  This suggests that current practice effectively enables comprehensive family communication.

Monica Marvin is a Clinical Assistant Professor in the Department of Human Genetics who serves as the Associate Director of the University of Michigan Graduate Program in Genetic Counseling.  She also functions as a clinical genetic counselor in the UM Cancer Genetics Clinic.  Monica obtained her Masters Degree in genetic counseling from the University of Michigan in 1994. Prior to returning to the University of Michigan in 2005, she worked as a genetic counselor at New Jersey Medical School and Spectrum Health in Grand Rapids, MI. In addition to her work here within the University, Monica is also active in national and state-wide efforts to advance the profession of genetic counseling.  

 

A Gift for All: Everyone has something to give - Approaching dialysis patients about donating their organs

Allyce Smith, MSW, Program Coordinator, National Kidney Foundation of Michigan

Co-authors: Ann Andrews, MPH; Jerry Yee, MD; Holly Riley, MSW; Remonia Chapman; Ken Resnicow, PhD

The organ donor waiting list continues to grow.  Individuals with End Stage Renal Disease (ESRD) are not typically viewed, by themselves or their health care team, as potential donors after death. However, ESRD patients are eligible to donate and may obtain a sense of empowerment in knowing they can give, as well as receive. Others feel that asking ESRD patients to sign up on the Donor Registry is unethical. This study will evaluate the effectiveness of using peer mentor to inform dialysis patients about their ability to sign up on the Donor Registry, ultimately increasing their numbers on the Registry.

Using a cluster randomized design, this controlled intervention study is conducted in collaboration with the National Kidney Foundation of Michigan (NKFM), the University of Michigan School of Public Health (UM SPH), Greenfield Health Systems (GHS), Henry Ford Health System, and Gift of Life Michigan.  Twelve dialysis units will be  randomized to an intervention or comparison group. Participants in the comparison units receive mailings about organ donation while patients in intervention units are assigned peer mentors and meet 7 times over a 4-month period. Peer mentors are individuals with ESRD who have adjusted positively to living with kidney disease and volunteer to lend support to others coping with kidney disease. Peer mentor-patient meetings cover coping with chronic illness and leaving a legacy through deceased organ donation.  During the meetings, peer mentors utilize Motivational Interviewing, a person-centered method of guiding patient decision-making and strengthening motivation for change.

The primary outcome is mail/internet registrations on the Donor Registry.  Pre/post surveys will be used to evaluate change in organ donation knowledge and attitudes, self-reported donation status, hope for the future, and quality of life.

To date, 150 Greenfield staff, 33 peer mentors, and over 280 patients have participated in 10 dialysis units.

Allyce Haney Smith has been a program coordinator at the National Kidney Foundation of Michigan since 2010. She graduated with her Master’s degree in Social Work from the University of Michigan. She currently coordinates the project, A Gift for All: Everyone Has Something to Give. In this role, Ms. Smith works to help empower patients to become more involved in their own care and end of life decisions.

 

Putting patient-physician communication in context: An empirical analysis of sequential organization and communication transitions during visits for new diagnoses of early stage prostate cancer.

Danielle Czarnecki, PhD Candidate, Department of Sociology, University of Michigan

Co-authors: Stephen G. Henry, MD; Valerie Kahn, MPH; Wen-Ying Sylvia Chou, PhD, MPH; Angela Fagerlin, PhD; Peter A. Ubel, MD; David R. Rovner, MD, FACP; Margaret Holmes-Rovner, PhD

Background: Patients and physicians typically schedule visits to discuss new diagnoses for which patients have multiple treatment options. How communication is organized during these visits is unknown.

Objective: To investigate the organization of communication tasks and the transitions between these tasks during visits in which patients and physicians discuss diagnosis and treatment of early stage prostate cancer.

Methods: We characterized the sequential organization of 40 visits in which patients received a new diagnosis of early stage prostate cancer. We used transcripts to identify communication tasks and develop a coding system to identify transitions between these tasks. We analyzed a) the organization of communication tasks during these visits and b) how patients and physicians communicate during transitions between tasks.

Results:  We identified five major communication tasks, which typically occurred in the following sequence: diagnosis delivery, risk classification, options talk, decision talk, and next steps. Visit organization was physician-driven. Patients resisted physicians’ attempts to transition from a) options talk to decision talk and b) decision talk to next steps by requesting more information about options and clarification about the decision making process, respectively. Physicians showed resistance when patients attempted to discuss decisions before physicians finished discussing treatment options. The overall organization of communication reflected physicians’ focus on delivering a thorough discussion of treatment options. Patient speech was relatively uncommon but increased towards the end of visits. Patients showed some uncertainty about the visit purpose and their role in the decision making process.

Conclusions: In visits discussing new diagnoses of prostate cancer, the overall visit organization and communication during transitions reveal an emphasis on discussing treatment options. Physicians’ focus on discussing options fulfills an important obligation for informed consent, but may not be responsive to patients’ informational or emotional needs.

Danielle Czarnecki is a doctoral candidate in the Department of Sociology at the University of Michigan. Her dissertation research is on religion and assisted reproductive technologies. She examines how infertile Catholic and Evangelical women navigate religious and scientific discourses in their attempts to build families.

Supporting information for: 2016 CBSSM Research Colloquium and Bishop Lecture (William Dale, MD, PhD)

Katrina Hauschildt, MA, PhD Candidate, Department of Sociology: “Language and Communication as Professionalization Projects in Clinical Ethics Consultation”


Although sociologists have examined the field of bioethics broadly, less empiric research has explored the process of clinical ethics consultation (CEC) in practice. This paper seeks to describe how UMHS’ CEC service focuses on communication, language, and terminology in professionalizing their membership and broadening the scope of their services. The CEC service established a specific communication standard for its written recommendations that emphasizes specificity and clarity for patients and their families, other providers, and members of the ethics committee. By identifying and reinforcing the importance of language and word choice in their own recommendations, newer members of the CEC are “trained” in how to craft recommendations, develop a specific jargon, and establish communication standards that differ from those used in other aspects of medical practice and documentation. The CEC service is often involved in addressing a variety of communication issues that arise in patient care, and these problems are thusly considered within the professional scope of the CEC service. By establishing the CEC service as an appropriate resource for dealing with communication issues between patients and their care team, the CEC service expands the professional boundaries of their work beyond strictly ethical expertise. The implications of these processes for professionalization and communication may be applicable to CEC services more broadly.


Devan Stahl, PhD, Assistant Professor of Clinical Ethics, Center for Ethics and Humanities in the Life Sciences, MSU: "Is there a right not to know?"


There is a widespread presumption within medicine that terminally ill patients have a “right not to know” their prognosis. Guidelines for giving bad news (SPIKES; ABCDE) all require that the patient be asked first. There may be a dark side to this practice, however: terminally ill patients’ ignorance or denial of their prognosis too often lasts to the very end, one important factor discouraging timely referral and use of palliative and hospice care. Because of a possible link between a right not to know one’s prognosis and the aggressive treatment that patients with advanced illness too often receive at the end of life, the claim that there is a right not to know needs much more serious examination than it has received.

The authors argue that patients with advanced illness do not have a right not to know their prognosis. Withholding prognostic information in deference to a right not to know impedes patients’ capacity to make informed autonomous decisions about their treatment, encourages denial, and increases the likelihood of poor end of life care.

Chithra Perumalswami, MD MSc, Robert Wood Johnson Foundation/Veterans Affairs Clinical Scholar: "Insurance Status of Elderly Americans and Location of Death"


Context:  The decision to forego curative treatments (which includes the Medicare Skilled Nursing Facility Medicare benefit) is not financially neutral for terminally ill patients who do not have concurrent insurance (Medicaid or private insurance) in that they are subsequently asked to pay for room and board of the nursing home if they choose the Medicare hospice benefit.  The association between insurance status and location of death is currently unknown.  
Purpose: To determine whether the concurrent insurance status with Medicare (Medicaid vs. private insurance) of decedents is associated with location of death in a nationally representative survey of elderly Americans.
Methods: Longitudinal analysis of 7,979 decedents aged 50 years or older in the Health and Retirement Study from 2000-2010 (6 biennial waves). We examined associations between insurance status and location of death (home, hospital, nursing home, hospice) using multinomial logistic regression models and adjusting for demographic, socioeconomic, and clinical variables.
Results:  Decedents with dual eligible insurance before or at the time of death were significantly more likely to die in a nursing home than to die in a hospital (relative risk ratio (RRR) 2.6; 95% CI, 1.9-3.6, p<0.001). 
Those dying in a nursing home tended to be unpartnered (widowed, separated or divorced, never married), cognitively impaired or with dementia. Elderly Americans less likely to die in a nursing home were blacks and Hispanics, individuals with cancer, and those with the highest wealth.
Conclusions:  Dual eligible patients are substantially more likely to die in a nursing home than a hospital, and therefore may miss out on valuable services at the end of life, including hospice care. This study may have several implications for current proposed Medicare policy changes to allow patients access to both curative care and hospice care at the same time. 

Lauren B. Smith, MD, Associate Professor, Department of Pathology/Ginny Sheffield, UM Medical Student (M3): "Special treatment for the VIP patient:  Is it ethical?  Is it dangerous?"


The care of VIP patients is often prioritized at medical centers and this prioritization may lead to disparate access to care and patient safety issues. VIP patients may be donors, celebrities, or other physicians. Allowing VIP patients access to earlier care or “special treatment” not only raises social justice issues, but also has been shown to lead to medical error and suboptimal treatment. Ethical considerations will be discussed and recommendations will be presented.

Naomi Laventhal, MD, MA, Assistant Professor, Department of Pediatrics and Communicable Diseases: "Roman Charity Redux: The Moral Obligations of the Breastfeeding Physician"


Female physicians must often reconcile the seemingly contradictory goals of valuing the health and well-being of their patients above all else, and actively mothering young children. One of the fundamental ethical precepts in medicine is for the physician to put the best interests of her patient ahead of her own.  For example the Fellowship Pledge of the American College of Surgeons states, “I pledge . . . to place the welfare and the rights of my patient above all else.” The challenge of weighing the needs of one’s own children against those of a patient is painfully acute for the breastfeeding physician. Is it ethically permissible to leave a busy clinic - or a patient in the under anesthesia in the operating room - in order to express breastmilk? Pragmatic strategies, such as mandates for appropriate space and time to pump, offer modest gains. However, we will suggest the need to re-envision the concept of “patient-first”, which is a vestige of the patriarchal hegemony that gave rise to our modern medical ethos, whereby nursing mothers are highly disadvantaged and virtually unable to reach the highest moral ideals of the profession.  Is the “right” to breastfeed absolute, or if should it be superseded by the needs of the patient? We will explore whether this issue is deeply personal, to be reconciled by affected individuals, or warrants an “outside-in” approach in which  physicians and bioethicists collectively and more philosophically consider whether and how to support women who choose to work and breastfeed.

Archana Bharadwaj, Graduate Student, UM School of Public Health: "Patient understanding and satisfaction regarding the clinical use of whole genome sequencing: Findings from the MedSeq Project"


Background: The expanded use of Whole Genome Sequencing (WGS) has generated excitement due its potential to tailor medical treatment. However, clinical use of WGS poses challenges for informed consent and disclosure of results. Few empirical studies have examined patients’ understanding of and satisfaction with the clinical communication of WGS results.
Methods: The MedSeq Project is a randomized clinical trial examining the impacts of WGS in primary care and cardiology. We analyzed survey data from patients’ initial enrollment and at multiple time points following physician disclosure of results. Domains of interest included understanding of informed consent, subjective understanding, satisfaction with communication of results, and decisional regret.
Results: Survey responses were provided by 202 participants (mean age = 55 years; 51% male; 80% college graduates). At enrollment, participants understood the majority of key facts about the study (mean = 19.6 / 22 items answered correctly), although some incorrectly answered items addressing results to be returned (e.g., 18% believed they would receive their entire DNA sequence. Higher informed consent knowledge scores were associated with female gender and higher genomic knowledge, subjective numeracy, and education levels (all p < .05). After results disclosure, participants had low scores of decisional regret regarding study participation; they also reported high levels of satisfaction with their physicians’ disclosure of results (mean = 5.9 on a 6-point scale), although ~20% of participants reported receiving “too much” information. Satisfaction with communication did not vary by participants’ demographics or other characteristics (e.g. genomic knowledge).
Conclusions: This study suggests that the intervention was well understood by patients, with low levels of decisional regret and high satisfaction with communication. Future research will need to examine these issues in more diverse samples, where misconceptions about the clinical WGS and concerns about information overload may be magnified.

Kayte Spector-Bagdady, JD, MBioethics, CBSSM Postdoctoral Research Fellow: "Direct‐to‐Consumer Biobanking"


23andMe is back on the market as the first direct‐to‐consumer genetic testing company that “includes reports that meet Food and Drug Administration standards for being clinically and scientifically valid.” Its current product includes 36 health‐related carrier‐status reports and consumers’ raw genetic data. But while its front‐end product is selling individual genetic tests online, its back‐end business model is amassing one of the largest privately owned genetic databases in the world.
This article argues that as the Department of Health and Human Services revises its regulation of research with human subjects as well as its proposal to exempt autosomal recessive carrier screens from premarket authorization it should contemplate the intersection of these areas of rulemaking—and consider how enhancing the security of federally funded research but loosening private access to biospecimens will drive more research into the private sector and result in less, not more, protection for human subjects.

Panel Presentation (Susan Goold, MD, MHSA, MA & colleagues): "Community engagement in setting research priorities: Representation, Participation and Evaluation"


We describe a 5-year project that engaged minority and underserved communities throughout the state of Michigan in deliberations about health research priorities to increase community voice in how limited health research resources are allocated. DECIDERS (Deliberative Engagement of Communities in DEcisions about Research Spending) formed a state-wide Steering Committee (SC) to develop a version of the deliberative exercise CHAT for health research priorities, then convened 47 groups to evaluate the tool and describe community research priorities.
Facilitators: Susan Goold and Zachary Rowe, Co-Directors
Panelists: Karen Calhoun, Charo Ledon, Esther Onaga, Lisa Szymecko

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