Current Funding:
5 U01 HL105565 (Mark) 07.22.2011 – 12.31.2018 1.20 calendar
NIH/NHLBI $35,245
ISCHEMIA Trial
This is an 8,000-pateint trial of patients with moderate- to high-risk ischemia which randomizes patients to invasive angiography and potential revascularization vs. optimal medical therapy alone. The key secondary outcome is angina control, which will be measured by the Seattle Angina Questionnaire. Dr. Spertus is the Co-PI of the Economics and Quality of Life Core, with lead responsibility for the collection and analysis of health status data.
2 R01 NR013396 09.27.2011 – 12.31.2019 0.60 calendar
NIH/NINR (Cresci) $12,161
Genomic Variants Associated with Angina and Health Status Outcomes After AMI
Dr. Spertus is a co-Investigator in this grant, which will conduct GWAS analyses of patients enrolled in the TRIUMPH study of patient-centered outcomes. It will define the genetic contributions to observed inter-individual variation in post-MI angina, identify non-genomic factors that may moderate the genetic effects and test the feasibility of translating these insights into clinical care.
5 T32 HL110837 (Spertus) 07.01.2012 – 06.30.2022 1.20 calendar
NIH/NHLBI $318,156
Cardiovascular Outcomes Research Training Program
This 2-year postdoctoral fellowship training program provides curriculum, mentored research, and independent research experiences to train the next generation of leaders in the field of cardiovascular outcomes research. The program is designed to train scholars in quantifying patients’ outcomes, defining the determinants of these outcomes, comparing the effectiveness of alternative treatments, translating new knowledge into clinical care, and measuring and improving the quality of care. This renewable 5-year training grant will provide for 2 new fellows each year.
R01 HL114918 (Dudley, R. Adams) 08.01.2013-07.31.2018 1.20 calendar
NIH/NHLBI $26,161
Decisional Quality for Patients with Stable Coronary Artery Disease
This project will develop a patient-reported decisional quality questionnaire that will capture what patients know about percutaneous coronary interventions (PCI), what their preferences were for its use, and how a decision was made to use PCI (or not) in their case.
CE-1304-6677 (Smolderen) 10.01.2013-12.15.2017 0.60 calendar
PCORI (Patient-Centered Outcomes Research Institute) $13,081
Patient-centered Outcomes Recovery from Treating peripheral Arterial disease: Investigating Trajectories (PORTRAIT)- Phase II
The major goals of this project are to create a multi-center observational study, PORTRAIT, and collect serial assessments from patients of their health status to create a series of diverse patient portraits, resulting
in educational tools to inform patients about their treatment choices and outcomes.
CE-1304-6448 (Spertus) 10.01.2013-01.31.2018 1.20 calendar
PCORI (Patient-Centered Outcomes Research Institute) $11,850
Developing and testing a Personalized, Evidence-based, Shared Decision-Making Tool for Stent Selection in PCI
The major goals of this project are to create a shared decision-making tool (SDM) tool for stent selection that outlines the potential benefits, risks, and costs of drug eluting vs. bare metal stents and implement at two centers. The impact of the SDM tool on patient participation in SDM, knowledge transfer, decisional conflict, and stent selection will be analyzed and physician perception of the benefits and limitations of the SDM tool will be evaluated.
R01 AG047416 (Grady) 07.15.2015-03.31.2020 0.24 calendar
NIH $3,220 (sub only)
Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?
The major goals of this project are to compare health-related quality of life outcomes in older (60-80 years) advanced heart failure patients who undergo heart transplantation or destination therapy mechanical circulatory support and their caregivers. Comparisons will be made regarding risk factors for poorer health-related quality of life, adverse event and symptom burden, and cost-utility analyses.
16SFRN29020000 (Stehlik) 07.01.2017-06.30.2020 0.60 calendar
AHA SFRN $11,614
Patient-reported Outcomes (PRO) as an Indicator of Disease Transitions in Heart Failure
The goal is to examine the use of PRO results by clinicians, before and after training in PRO interpretation. An intervention designed for clinician sharing and discussing PRO scores with patients influences their understanding of disease, treatment goals and treatment preferences. Dr. Spertus is a co-Investigator on this grant.
CTSA (Barohn) 09.01.2017-08.31.2022 1.2 calendar
NIH-NHLBI ~$260,000 (awaiting Subaward)
A portion of the CTSA is the Frontiers’ Translational Endeavors core, which will lead a transformational approach to accelerating the translation of knowledge to clinical practice. Specifically, it will 1) provide novel training to emerging and existing scientists, 2) develop cores of expertise and the infrastructure for implementing knowledge into care, 3) educate our workforce on the role of entrepreneurship to sustain and improve the impact of translational research and 4) support innovative pilot grants that have the promise to transform care. Dr. John Spertus is co-PI for the Translational Endeavor Core.
Research Activities Since 2002:
2 T32 HL110837 (Spertus) 07/01/2017 – 06/30/2022
NIH/NHLBI $1,768.561
Cardiovascular Outcomes Research Training Program
This 2-year postdoctoral fellowship training program provides curriculum, mentored research, and independent research experiences to train the next generation of leaders in the field of cardiovascular outcomes research. The program is designed to train scholars in quantifying patients’ outcomes, defining the determinants of these outcomes, comparing the effectiveness of alternative treatments, translating new knowledge into clinical care, and measuring and improving the quality of care. This renewable 5-year training grant will provide for 2 new fellows each year.
1 T32 HL110837 (Spertus) 07/01/2012 – 06/30/2017
NIH/NHLBI $1,461,597
Cardiovascular Outcomes Research Training Program
This 2-year postdoctoral fellowship training program provides curriculum, mentored research, and independent research experiences to train the next generation of leaders in the field of cardiovascular outcomes research. The program is designed to train scholars in quantifying patients’ outcomes, defining the determinants of these outcomes, comparing the effectiveness of alternative treatments, translating new knowledge into clinical care, and measuring and improving the quality of care. This renewable 5-year training grant will provide for 2 new fellows each year.
Funding Announcement PI-12-001 (Smolderen) 06/01/2012 – 05/31/2014
Patient Centered Outcomes Research Institute (PCORI) $247,526
Patient Centered Outcomes Recovery from Treating PAD: Investigating Trajectories (PORTRAIT)
Dr. Spertus is a Co-Investigator on this project that will design and test the infrastructure for a study focused on patient-centered outcomes by partnering with a wide spectrum of patients and providers confronted with peripheral arterial disease (PAD). Critical input will be obtained from patients with PAD to help support a future, multi-center registry of PAD patients’ health status outcomes over time. Patients and providers from different centers will help define what outcomes they value the most, how best to develop the screening and research design, and how to be maximally inclusive of a wide variety of patients with PAD.
1 R01 NR013396 (Cresci) 09/27/2011 – 07/31/2014
NIH/NINR $58,860 for Spertus
GWAS Study of TRIUMPH to Identify Genetic Determinants of Symptoms
Dr. Spertus is a co-Investigator in this grant, which will conduct GWAS analyses of patients enrolled in the TRIUMPH study of patient-centered outcomes. It will define the genetic contributions to observed inter-individual variation in post-MI angina, identify non-genomic factors that may moderate the genetic effects and test the feasibility of translating these insights into clinical care.
1 U01 HL105565 (Mark and Spertus, Co-PIs) 06/01/2011 – 03/31/2019
NIH/NHLBI $680,606 for Spertus
ISCHEMIA Trial
This is an 8,000-pateint trial of patients with moderate- to high-risk ischemia which randomizes patients to invasive angiography and potential revascularization vs. optimal medical therapy alone. The key secondary outcome is angina control, which will be measured by the Seattle Angina Questionnaire. Dr. Spertus is the Co-PI of the Economics and Quality of Life Core, with lead responsibility for the collection and analysis of health status data.
1UL1RR033179-01 (Barohn) 06/01/2011 – 02/29/2016
NIH/NCRR $506,168 Total Costs - Spertus
Heartland Institute for Clinical and Translational Research
This CTSA aims to coordinate diverse resources throughout the Kansas City community to increase collaboration between basic scientists and clinical researchers to accelerate the identification and use of new discoveries. Dr. Spertus is the PI of the Personalized Medicine and Outcomes Core (PMOC) for this CTSA. He will oversee the provision of an infrastructure to support outcomes, translational and implementation research, be involved in the leadership of the Center and participate in the educational program.
1R01 HL096624-01 (Spertus) 09/30/2009 – 07/31/2012
NIH/NHLBI $3,714,787
Transforming PCI Informed Consent into an Evidence-based Decision-making Tool
This study tests the implementation and impact of a novel, web-based system to generate an individualized consent form with risk estimates and outcomes for patients undergoing percutaneous coronary intervention (PCI) at 6 different US hospitals.
1RC2HL102222-01 (Dorn) 09/30/2009 – 08/31/2011
NIH/NHLBI $200,050 for Spertus
Massively Parallel Resequencing of the Cardiac Exome in Heart Failure
This project will use microarrays and deep resequencing to identify specific gene variants associated with altered heart failure risk or disease progression and create a shared genetics trial infrastructure to conduct multi-center clinical trials of systolic heart failure.
AHA #: 0875149N (Spertus) 10/01/2008 – 09/30/2012
American Heart Association $2,374,872 for Full Project
AHA Pharmaceutical Roundtable Outcomes Research Center
A 2-year postdoctoral fellowship training program in outcomes research will be provided for a total of 5 fellows. A research study will be implemented at 3 centers on Transforming Informed Consent for PCI into an Evidence-based Decision-making Experience through the use of a web-based tool, the Patient Risk Information Services Manager (PRISM) that executes multivariable prediction models at the interface of care.
1R01DK080111-01 NIDDK (Shireman) 09/15/2008 – 07/31/2012
NIH/NHLBI $36,530 for Spertus
Are Cardioprotective Medications Effective in ESRD?
This project that will evaluate the survival and morbidity benefits of cardioprotective medications (beta-blockers, renin-angiotensin system antagonists, and HMG-CoA reductase inhibitors) in the end-stage renal disease population by linking the United States Renal Data System (tracking patient outcomes) with Medicaid drug data (tracking outpatient prescription medication usage).
NCDR Analytic Center (Spertus) 2007 - Present
American College of Cardiology Foundation
Under the direction of Dr. Spertus, Saint Luke’s Mid America Heart Institute performs analyses, under contract with the ACCF, on the NCDR registries, including PINNACLE, Cath/PCI, ICD, CARE, ACTION/GTWG and Impact. A number of specialized activities, including mapping the Appropriate Use Criteria and the development of risk models are periodically undertaken.
R01 HL081153-01A1K (Krumholz) 09/01/2007 – 05/31/2012
NIH/NHLBI $113,540 for Spertus
Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO)
The aims of this proposal are to characterize sex differences in outcomes following AMI (including mortality, hospitalization and health status); determine sex differences in the prevalence of demographic, clinical, and psychosocial risk factors; determine sex differences in quality of care; and determine sex differences in the prevalence of selected biological factors (including sex hormones, biomarkers and genetic variations).
R01 HL085347-02 (Cram) 05/01/2007 – 02/28/2012
NIH/NHLBI $120,000 for Spertus Component
Cardiac Care in Specialty and General Hospitals
The aims of this study are: 1) to examine the characteristics and outcomes of patients receiving care in specialty cardiac hospitals, and 2) to examine the impact of specialty hospitals on volume and outcomes of competing general hospitals.
Defining Associations of Health Status and Resource Utilization (Spertus) 11/01/2006 – 12/31/2007
Eli Lilly Corporation $62,750
The purpose of this investigation is to define the association between health status, as assessed by the Seattle Angina Questionnaire, and subsequent resource utilization in patients recovering from an acute myocardial infarction. This grant was a response to an RFP from Lilly.
R01-HL080228 (Krumholz, H) 070/01/2005 - 06/30/2010
National Heart, Lung and Blood Institute $89,852 for Spertus
Role: Co-Investigator
Telemonitoring to Improve Heart Failure Outcomes: This 4-year prospective randomized trial will define the incremental benefit of a telemonitoring program in improving the quality of care and outcomes in patients discharged from the hospital with heart failure.
TRIUMPHANT (Spertus) 05/01/2005 – 04/30/2009
Amgen, Inc. $2.1million direct costs for project
Role: PI
This study will supplement the TRIUMPH Registry, funded as part of the NHLBI SCCOR (P50 HL77113-01), to conduct 1- and 6-month in-home interviews so that blood specimen collections may be acquired for a range of biomarker, hematologic and lipid analyses may be conducted.
TRIUMPHANT Biomarker Substudy (Spertus) 05/01/2005 – 04/30/2009
Roche Diagnostics. $770,662 in Lab Reagents
Role: PI
This study will supplement the TRIUMPH Registry, funded as part of the NHLBI SCCOR (P50 HL77113-01), with biomarker assays for NT-proBNP, TnT, and hsCRP for the baseline, 1- and 6-month blood specimens.
TRIUMPHANT VAP Substudy (Spertus) 05/01/2005 – 04/30/2009
Atherotech $960,000 in Lab Reagents
Role: PI
This study will supplement the TRIUMPH Registry, funded as part of the NHLBI SCCOR (P50 HL77113-01), with extensive lipid analyses, including direct LDL, IDL, Lp(a), HDL2,3, triglycerides, etc. for the baseline, 1- and 6-month blood specimens.
TRIUMPH Economic Substudy (Spertus) 05/01/2005 – 04/01/2009
Lilly $1,363,600
Role: PI
This study will support 50% of the effort to adjudicate and transform resources utilization into costs for the TRIUMPH Study (NHLBI SCCOR P50 HL77113-01).
TRIUMPH Economic Substudy (Spertus) 05/01/2005 – 04/01/2009
BMS/Sanofi $1,363,600
Role: PI
This study will support 50% of the effort to adjudicate and transform resources utilization into costs for the TRIUMPH Study (NHLBI SCCOR P50 HL77113-01).
P50 HL77113-01 (Kelly, D) 01/01/2005 – 12/31/2009
NIH/NHLBI $7.3Million for Spertus Project
Role: PI for Project 4 - Investigating Racial Disparities in Outcomes after Acute Myocardial Infarction
This project is one of 3 that comprise a Specialized Center for Clinically—Oriented Research (SCCOR) devoted to understanding diabetic cardiomyopathy. Broadly, this SCCOR grant seeks to unravel the etiology of the adverse prognosis of diabetic patients recovering from an acute myocardial infarction. The major goals of this project are to describe racial differences in 1-year health status outcomes following Acute Myocardial Infarction as well as differences in AMI care, serum lipid profiles, and genetic variants.
P50 HL77113 Training Core (Cain, M) 01/01/2005 – 12/31/2009
NIH/ NHLBI $53,720 Spertus
Role: Co-Director
This is a supplemental training grant to train young investigators in translational research.
P20 RR020643-01 (Kelly, D) 09/01/2004 - 08/31/2007
National Heart Lung and Blood Institute $88,012 for Spertus
Role: Co-Investigator
Planning Interdisciplinary Studies of the Diabetic Heart: This planning grant is a 3-year effort to develop an interdisciplinary approach to the treatment of diabetic cardiovascular disease. Dr. Spertus will lead the patient-oriented research activities of this program.
ACTION Trial EQOL (Schulman, K) 09/01/2002 – 09/31/2007
NHLBI $119,000 total costs for Spertus
Role: Co-Investigator Quality of Life and Economics Study
This is a randomized trial of exercise in patients with heart failure.
Doris Duke Innovation in Clinical Research Award (Spertus) 07/01/2002 – 07/31/2005
Doris Duke Foundation $300,000
Creating the Patient-Refined Expectations for Deciding Invasive Cardiac Treatments (PREDICT) tool:
This application was funded by the Doris Duke Charitable Foundation’s Innovations in Clinical Research Award and will support the methodological work to create a tool for shared decision-making for selecting between CABG and PCI techniques of coronary revascularization based on projected patient outcomes.
The Prospective Evaluation of outcomes following Myocardial Infarction: Events and Recovery (PREMIER) Quality Improvement Registry (Spertus)
06/01/2002 – 06/30/2005
CV Therapeutics $2,203,000
This 19-center registry enrolled 2500 patients with acute myocardial infarction to describe patient and health care process determinants of health status after a myocardial infarction. It addressed many of the methodological gaps that currently prevent patients’ health status from being a marker of healthcare quality.
R01 HS011282 (Spertus) 08/01/2001 – 07/30/2004
AHRQ/NIH ~$1.9M
Risk-adjustment of 1-year health status in CAD
This study was a 2-center prospective registry of ACS patients to develop models to risk-adjust health status outcomes in acute coronary syndromes. It also carried with it a minority supplement and received foundation funding to support the collection of DNA for genetic analyses.
SMART/COURAGE (Boden, W) 01/01/1999 – 12/31/2006
Veterans Affairs Cooperative Studies $160,682 for Spertus
Role: Co-Investigator, Member of the Executive Steering Committee
This is a randomized trial of PCI vs. medical therapy in the treatment of occlusive coronary disease.
PENDING
R01 (Wickline/Hanson) 08/01/2013 – 07/31/2018
NIH
A Translational Blueprint for Exosome Biomedicine in Atherosclerosis
This project will establish a new multi-institutional Center for Exosome Biomedicine (CEB) to define exosomal multimarkers that delineate the state of the clinically silent or overt vascular inflammatory milieu in atherosclerosis, and to develop a pathogenesis-based toolkit for molecular imaging and therapy, ultimately using a patient’s own exosomes modified to home to disease sites and deliver site-targeted therapeutics. The short-term plan is to develop personalized exosome biomarker profiles that offer higher sensitivity for cellular phenotyping than do traditional nonspecific biomarkers. A longer-term extension of the effort will focus on manipulation of a patient’s own exosomes to prepare semisynthetic biocompatible carriers of targeting, imaging, and therapeutic drug and gene delivery for personalized medicine.
R01 (Mark) 04/01/2013 – 03/31/2020
NIH/NHLBI
ISCHEMIA Trial-Chronic Kidney Disease Companion Trial
This project will be a companion trial to the ongoing ISCHEMIA trial and will be a global, randomized, unblinded comparative effectiveness study of catheterization with revascularization if feasible (PCI or CABG) plus optimal medical therapy (OMT) versus OMT alone in stable patients with severe chronic kidney disease with at least moderate ischemia on myocardial stress imaging.
PCORI (Spertus) 01/01/13 – 12/31/14
Creation of a Shared Decision-making tool for Stent Selection
This project will leverage the PRISM infrastructure to execute ACC risk models for target vessel revascularization and create a shared decision-making tool for patients undergoing Percutaneous Coronary Intervention. Nurses in the cath lab will be trained as decision coaches so that patients are more informed of the benefits of DES and the responsibility (and risks) of dual anti-platelet therapy at the time that they discuss stent options with their physician.
Patents:
COUNTRY
|
SERIAL NUMBER
FILING DATE
|
PATENT NUMBER
ISSUE DATE
|
TITLE
|
US
|
10/165855
07-Jun-2002
|
8,744,867
03-Jun-2014
|
Method For Selecting A Clinical Treatment Plan Tailored To Patient Defined Health Goals
|
US
|
14/290872
29-May-2014
|
|
Method For Selecting A Clinical Treatment Plan Tailored To Patient Defined Health Goals
|
US
|
11/072209
04-Mar-2005
|
7,643,969
05-Jan-2010
|
Methods And Apparatus For Providing Decision Support
|
US
|
12/620985
18-Nov-2009
|
8,285,525
09-Oct-2012
|
Methods And Apparatus For Providing Decision Support
|
US
|
13/615,401
13-Sep-2012
|
8,560,281
15-Oct-2013
|
Methods and Systems for Utilizing Prediction Models in Healthcare
|
US
|
14/049,773
09-Oct-2013
|
8,744,815
03-Jun-2014
|
Methods and Systems for Utilizing Prediction Models in Healthcare
|
US
|
14/290724
29-May-2014
|
|
Methods and Systems for Utilizing Prediction Models in Healthcare
|
US
|
11/072,053
04-Mar-2005
|
7,853,456
14-Dec-2010
|
Systems And Methods For Risk Stratification Of Patient Populations
|
US
|
12/965,656
10-Dec-2010
|
8,311,849
13-Nov-2012
|
Systems And Methods For Risk Stratification Of Patient Populations
|
US
|
13/673,346
09-Nov-2012
|
8,515,780
20-Aug-2013
|
Systems And Methods For Risk Stratification Of Patient Populations
|
US
|
15/194215
27-Jun-2016
|
|
Systems And Methods For Utilizing Wireless Physiological Sensors
|
Additional Projects:
Founder, Health Outcomes Sciences, LLC (www.h-outcomes.com): Health Outcomes Sciences is a for-profit company that is commercializing the ePRSIM software. ePRISM executes risk prediction models within routine patient care to support personalized medicine that is evidence-based, patient-centered and that supports safer, more cost-effective shared medical decision-making. PRISM also provides the foundation to translate novel genetic, pharmacogenomics and biomarker discoveries to the bedside to support individualized, evidence-based care.
Founder, Cardiovascular Outcomes, Inc (CV Outcomes): Founded in March 2002, CV Outcomes is a non-profit, 501(c)(3) corporation dedicated to the advancement of outcomes research and quality assessment/improvement in cardiovascular disease. CV Outcomes serves as the administrative vehicle for the Cardiovascular Outcomes Research Consortium (CORC). It has also entered into a partnership with the American College of Cardiology for two of its three Guidelines Applied to Practice (GAP) projects. These demonstration projects in Chronic Stable Angina (based in Alabama) and Congestive Heart Failure (based in Oregon) will define the patient-centered advantages of optimal medical care by quantifying changes in patients’ health status with the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire. Please see www.cvoutcomes.org for further details.
Founder, Cardiovascular Outcomes Research Consortium (CORC): Founded in February 2001, CORC is a 14-center group of leaders in cardiovascular outcomes research who collaboratively conduct research in the methodology of outcomes assessment and quality improvement. Participating institutions include Yale, Harvard, Duke, Emory, Case-Western Reserve, Stanford, University of Colorado, University of Alberta, Northwestern, etc. The first CORC project enrolled 547 CHF patients from 13 centers into an outpatient cohort study to determine the minimal clinically important change in score on the Kansas City Cardiomyopathy Questionnaire. One calendar year elapsed from the enrollment of the first patient to the presentation of final results at the 2002 Scientific Sessions of the American College of Cardiology.
Founder, Epimetrics Corporation. Epimetrics, now defunct, was dedicated towards developing innovative, Web-based technologies to administer, score and facilitate the interpretation of health status measures so that their potential as research tools, markers of health care quality, and aids in patient care could be realized.
John A Spertus, MD, MPH 01/11/2018
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