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

Funding Years: 2014 - 2016.

Mexican Americans (MAs) suffer more from stroke than non-Hispanic whites (NHWs). Ischemic stroke is more common in MAs and their neurologic, functional and cognitive outcomes after stroke are worse than in NHWs. The reasons for the disparity in post-stroke outcome are unclear. Pre-stroke function and initial stroke severity are similar between the two groups as are ischemic stroke sub-types. One potential explanation for the worse post-stroke neurologic, functional and cognitive outcome in MAs compared with NHWs is allocation and effectiveness of post-stroke rehabilitation. There is remarkably little data demonstrating whether rehabilitation is dosed differently for MAs compared with NHWs, and still less information about whether, for a given dose of rehabilitative services following stroke, there is differential benefit by ethnicity. The current application will utilize the existing population-based Brain Attack Surveillance in Corpus Christi (BASIC, NSR0138916) project's infrastructure and strong community relations to develop and pilot a method to collect the necessary data to determine the role of rehabilitation in ethnic disparities in post-stroke outcomes. Previous studies have suggested that looking at overall time spent in rehabilitation does not predict post-stroke outcome. However, specific components of physical, occupational and speech therapy, a practice-based approach, has been shown to be associated with stroke outcomes, and these associations have been shown to vary by race. However, this practice-based approach has not been implemented in a population-based manner across the range of settings where stroke patients receive rehabilitation services, and no study has used this approach in an ethnically diverse population. Therefore, our plan is to build on previous work by developing and utilizing a practice-based design in our population-based stroke study. Specifically, we will 1) continue to build the needed relationships with rehabilitation service providers in the community;2) work with local rehabilitation therapists to refine data collection instruments as part of the practice-based design;3) pilot test data collection of specific rehabilitation components of post-stroke rehabilitation across all rehabilitation settings;and 4) analyze this data to determine the feasibility of this approach for a larger study and to provide preliminary data on differences in access and effectiveness by ethnicity. In total, our infrastructure development, refinement of tools to measure specific therapy modalities and pilot testing will position us perfectly to submit an R01 application to identify ethnic differences in access to rehabilitation and specific rehabilitation services associated with improved functional outcome in MAs and NHWs.

PI(s): Lynda Lisabeth, Lewis Morgenstern

Funded by National Institutes of Health

Funding Years: 2014-2016

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

PI(s): Richard Prager, Donald Likosky

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

Funded by the National Institutes of Health

Funding Years: 2012-2017

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

PI(s): Guohua Xi

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

Funded by VA Health Services Research and Development Career Development Award

Funding Years: 2015-2019

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

PI: Jeremy Sussman

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

Funding Years: 2014-2015


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

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

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

PI(s): Jeffrey Kullgren

Funded by 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

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