Cardiovascular Multicenter Observational Investigation of Lipid Care in the United States-2 (cvMOBIUS2)
cvMOBIUS2 – Patient-Centered Outcomes Research Institute (PCORI)
PI – Eric Peterson and Ann Marie Navar at Duke Clinical Research Institute
Describe the proportion of patients with established ASCVD who are treated according to ACC/AHA guideline recommendations for lipid lowering therapy.

Choosing Immune Suppression in Renal Transplantation by Efficacy and Morbidity (CISTEM2)
CISTEM2 – NIH
PI – Vikas Dharnidharka and David Axelrod at University of Missouri
This study seeks to extend results in CISTEM2 to dynamically optimize long term kidney transplant function through optimal immunosuppression management by integrating multiple transplant center electronic medical records datasets and deploying machine learning algorithms. With input from patient focus groups, the goal is to refine the existing CISTEM web-based decision support tool input to assist transplant recipients and their care teams make more informed and personalized choices to minimize morbidity and extend kidney graft survival.

COVID and Diabetes Assessment (CODA)
CODA – National Institute of Diabetes and Digestive and Kidney Diseases
PI – Russell Rothman at Vanderbilt
The COVID and Diabetes Assessment study’s goal is to gain a deeper understanding of what happens in the first one to two years after a diagnosis of diabetes.

Comparative Effectiveness Research for Neuroendocrine Tumors
NET-PRO – Patient-Centered Outcomes Research Institute (PCORI)
PI – Michael O’Rorke
NET-PRO aims to describe the frequency and sequencing of common treatment regimens in current use, and their association with various patient-reported outcomes (PROs), determine whether patient, clinical, and tumor characteristics impact on the choice of therapies, compare the effectiveness of peptide receptor radionuclide therapy regimens on outcomes of the disease and, finally, share the PCORnet infrastructure that this study generates to aid the conduct of future CER studies in this and other rare diseases.

Enhancing Capacity of the PCORnet Common Data Model to Support Patient-Centered Comparative Clinical Effectiveness Research (CDM Enhancement)
CDM Enhancement – Patient-Centered Outcomes Research Institute (PCORI)
PI – Russ Waitman at The University of Missouri
Iowa PI – Elizabeth Chrischilles
The goal of this project is to enhance the PCORnet Common Data Model (CDM) by loading new data into tables that are being added as part of the upgrade to CDM version 7, increasing the availability of research-ready data in several domains. The selection of these domains are based on input about PCORnet data infrastructure enhancement opportunities from sources including the NORC-authored papers commissioned by PCORI, the Intellectual and Developmental Disabilities (IDD) and Maternal Morbidity and Mortality (MMM) PCORnet roadmaps, and the PCORnet Innovation Workgroup.

Greater Plains Collaborative (GPC)
GPC – Patient-Centered Outcomes Research Institute (PCORI)
PI – Russ Waitman at University of Missouri
Iowa PI – Elizabeth Chrischilles
The Greater Plains Collaborative (GPC) is a network of 12 leading medical centers in nine states committed to a shared vision of improving healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination.

Iowa Geriatrics Workforce Enhancement Program (GWEP)
GWEP – HRSA
PI – Marianne Smith
The purpose of the GWEP is to develop a health care workforce that maximizes patient and family engagement and to improve health outcomes for older adults by integrating geriatrics with primary care.

Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)
IMPACt-LBP – National Center For Complementary & Integrative Health
PI – Christine Goertz at Duke Clinical Research Institute
Iowa PI – Barcey Levy
IMPACt-LBP seeks answers on the impact of a new multidisciplinary model of care for low back pain that places primary spine practitioners—chiropractors and physical therapists—at the forefront of the health care team approach.

Outcomes Database to prospectivelY aSSEss changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY-RCC)
ODYSSEY-RCC – Patient-Centered Outcomes Research Institute (PCORI)
PI – Dan George at Duke Clinical Research Institute
The primary goal of this prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with metastatic renal cell carcinoma (mRCC) in routine real-world clinical practice in the United States, including both community and academic treatment settings.

Personalized Risk Stratification in Atrial Fibrillation using Portable, Explainable Artificial Intelligence (AF-PBC)
AF-PBC – National Heart Lung and Blood Institute
PI – Benjamin Steinberg at the Denver Health and Hospital Authority
Iowa PI – Elizabeth Chrischilles
The study will use modern machine learning methods and large-scale electronic health record (EHR) data from more than 300,000 patients across the U.S. It will also integrate detailed, individual-level social information from Acxiom, a commercial consumer data source. Together, these data will allow the research team to identify new risk factors, build a more precise and equitable stroke risk prediction tool, and test its performance across multiple health systems. The goal is to develop a tool that is explainable, personalized, portable across different populations, and able to reduce disparities in stroke prevention for patients with AF.

Reducing Future Fracture and Improving Outcomes of Fragility Fracture (RESTORE)
RESTORE – Patient-Centered Outcomes Research Institute (PCORI)
PI – Kenneth Saag at UAB
RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.

Sentinel Initiative
Sentinel – FDA
PIs – Elizabeth Chrischilles and Ryan Carnahan
The Sentinel Initiative is a long-term effort to improve the FDA’s ability to identify and assess medical product safety issues.

Bariatric Surgery Impact on Cancer Screening (BASICS)
BASICS – National Cancer Institute
PI – Kathleen McTigue at University of Pittsburgh
Iowa PI – Betsy Chrischilles
The five-site patient-centered BASICS study uses electronic health record data to examine whether cancer screening practices change after bariatric surgery. Investigators are assessing and measuring cancer screening practices in the 3-5 years before, immediately before/preoperatively (1-year), and after bariatric/metabolic surgery (3-5 years or more) compared to matched comparison groups that did not undergo bariatric/metabolic surgery. The work has potential for expansion to broader questions around cancer-related health risks following bariatric surgery.

Evaluating Inclisiran for Cholesterol Management in Heart Disease (V-INCLUSION)
V-INCLUSION – Patient-Centered Outcomes Research Institute (PCORI)
PI – Neha Pagidipati at Duke Clinical Research Institute
Iowa PI – Marcelo Correia
V-INCLUSION seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.

HERO Trial and Registry
HERO – Patient-Centered Outcomes Research Institute (PCORI)
PI – Emily O’Brien at Duke University
Iowa PI – Loreen Herwaldt
This PCORnet demonstration project is a two-step process. First, health systems leaders will convene to develop priority topics for research using PCORnet (completed); and second, PCORI will release a limited competition funding announcement for up to five research studies.

Holden Comprehensive Cancer Center Support Grant – Rural Health Study and COVID-19 Study Supplements
PI – George Weiner
Supplement PI – Mary Charlton
Iowa Counties Health Study Survey – NCI (PDF format. Presented for archival purposes. Document might not comply with current accessibility rules.)
The purpose of these studies are to get information from persons living in rural areas to learn about how COVID-19 has affected their daily routines and help develop better health programs and policies for those areas.

Optimal Strategies to Estimate the Relative Effectiveness of Influenza Vaccines (SERVE)
SERVE – Centers for Disease Control and Prevention
PI – Joshua Petrie and Huong Nguyen at Marshfield Clinic
There are many different influenza vaccine products available for use in the United States, but most have not been directly compared to determine if one product might work better than another. This information is needed to inform policymakers, healthcare providers, and the public on how influenza vaccines should be best used. In addition, new influenza vaccine products are expected in the coming years given rapid technology advancements during the COVID-19 pandemic, and ongoing efforts to develop a universal influenza vaccine. Therefore, the goal of this project is to develop strategies for comparing the effectiveness of current and novel influenza vaccines.

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (PRESERVE)
PRESERVE – Angiodynamics, Inc.
PI – Jonathan Coleman at Memorial Sloan Kettering Cancer Center and Arvin George at John Hopkins Medicine
The PRESERVE Study was designed to evaluate the safety and effectiveness of the NanoKnife System when used for prostate tissue ablation in men with intermediate-risk prostate cancer.

RECOVER – AUTO
RECOVER – NIH
PIs – Stuart Katz, Leora Horwitz, and Andrea Troxel at NYU
Iowa PI – Alejandro Comellas Freymond
The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms. Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

An expert-guided machine-learning approach to estimate the incidence, risk and harms associated with diagnostic delays for infectious diseases.
Infectious Disease Diagnostics Study Information – AHRQ
PI – Phil Polgreen/Aaron Miller
The overarching goal of this research is to investigate diagnostic delays associated with infectious diseases using existing data along with methods from the fields of computer science and statistics.

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
ADAPTABLE Aspirin Study – Patient-Centered Outcomes Research Institute (PCORI)
PI – Adrian Hernandez and Matthew Roe at Duke University
Iowa PI – Saket Girotra
The purpose of this clinical trial is to compare the benefits and risks of two commonly used doses of aspirin—low-dose 81 mg (“baby aspirin”) and regular strength 325 mg—in preventing heart attacks and strokes in people with heart disease.

Comparative Effectiveness of Treatment Combinations Post MI in the Elderly
Comparative Effectiveness – AHRQ
PI – John Brooks/Mary Schroeder
This study will help clinicians, guideline-makers, and policy-makers understand the benefits, risks, and costs associated with post-MI secondary prevention treatment combinations.

Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes
Depression Treatment Study Information – AHRQ
PI – Carolyn Turvey
The purpose of this project is to develop a patient portal intervention to increase patient activation and promote collaborative decision making for patients with depression.

Extension Connection: Advancing Dementia Care for Rural and Hispanic Populations
PCORI – Patient-Centered Outcomes Research Institute (PCORI)
PI – Ryan Carnahan
The goal of this study is to test a new outreach and education strategy to improve dementia care for rural older adults and develop new dementia care training and resources for Hispanic and Latino care providers and patient families.

Health Systems PCORnet Demonstration Project – Phase II
Phase II – Patient-Centered Outcomes Research Institute (PCORI)
PI – Maureen Smith at the University of Wisconsin
Iowa PI – Elizabeth Chrischilles
This PCORnet demonstration project is a two-step process. First, health systems leaders will convene to develop priority topics for research using PCORnet (completed); and second, PCORI will release a limited competition funding announcement for up to five research studies.

Implementation of a Medication Care Plan to Reduce Unintentional Injury among Rural Older Adults
Study Information – NIH
PIs – Carri Casteel and Korey Kennelty
This study will identify mechanisms of improving healthcare system implementation of a medication care plan designed to reduce medically treated falls among older adults.

Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care Trial
ICARE – NIH
PI – Barry Carter
The trial will examine whether a centralized Prevention Health and Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.

MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
MEDFOCUS – NIH
PI – Barry Carter
The study will test whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics.

Mobile Cardiovascular Risk Service Trial
Iowa PHR
PI – Elizabeth Chrischilles
This project will develop and test a mobile application that supports a pharmacist-managed CVRS in order to disseminate and implement evidence-based guidelines in practice.

Molecular Testing Rapid Cycle Research
Rapid Cycle Research – Patient-Centered Outcomes Research Institute (PCORI)
PI – Elizabeth Chrischilles
This rapid-cycle descriptive analysis project aims to learn about the patterns of use of molecular biomarkers (tumor or germline) and associated targeted cancer therapies for patients with new-onset solid tumors (all single primary invasive solid tumors) cared for in a variety of community and academic care settings.
Final Report (PDF format. Note: Document is from 2018 and is presented for archival purposes. Might not conform with current accessibility rules.)

NEXT-D (Natural Experiments for Translation in Diabetes)
Next-D Study – CDC/NIDDK
PI – Bernard Black and Abel Kho at Northwestern University
Iowa PI – Michael Wright
This study examines how the Affordable Care Act expansion of Medicaid will affect diabetes diagnosis, treatment, and outcomes among the newly enrolled. We will compare differences that arise between some states expanding Medicaid and others choosing not to do so.

Observational data and treatment effectiveness: which methods work best?
K Award – NIH
PI – Linnea Polgreen
The objective of this application is to support the career development of Linnea Polgreen, PhD. Her long-term goal is to become an independent investigator with a research program focused on developing methods for determining the best treatment options based on observational data.

Online Way for Patients to Augment Registry Data (ONWARD) study
ONWARD Study – National Cancer Institute
PI – Elizabeth Chrischilles
This study is designed to answer the question: “Can patient-generated health data enhance cancer surveillance activities?
ONWARD Final Report (PDF format. Note: Presented for archival purposes. Document might not conform to current accessibility rules.)

PROVIDE-HF (Patient Reported Outcomes investigation following Initiation of Drug therapy with Entresto in Heart Failure)
PROVIDE-HF Study – Novartis Pharmaceuticals
PI – Bhanu Gupta at Kansas University
Iowa PI – Alexandros Briasoulis
The primary objective of the study is to investigate the change in patient-reported HF symptoms via the Kansas City Cardiomyopathy Questionnaire (KCCQ) following the initiation of sacubitril/valsartan through 12 weeks and to investigate the change in KCCQ following the initiation of sacubitril/valsartan by a responder analysis.

Share Thoughts on Breast Cancer
GPC Breast Cancer – Patient-Centered Outcomes Research Institute (PCORI)
PI – Elizabeth Chrischilles
The purpose of the Share Thoughts on Breast Cancer Study is to learn about the experiences of patients after they have been diagnosed with breast cancer in order to improve patient experiences and treatment.

Thromboembolic Events After Immunoglobulin Administration
Mini-Sentinal IVIG – FDA
PI – Elizabeth Chrischilles
This Mini-Sentinel safety assessment seeks to address the question: What is the effect of immunoglobulin (Ig) treatment on the risk of thromboembolic events (TEE)?

Are Cardioprotective Medications Effective in ESRD?
ESRD – AHRQ
PI – Theresa Shireman
Sub Contract – John Brooks This project will evaluate the effectiveness of cardioprotective medications in reducing cardiac deaths and hospitalizations in ESRD patients.

ARRA: Interpreting IV Estimates with Treatment Effect Heterogeneity: ACE/ARBs & Race
ARRA – Brooks – NIH
PI – John Brooks

Demonstration Of Quality Improvement Of Medication Therapy Management Services
MTM – AHRQ
PI – William Doucette
The aims of this study are to evaluate improvements to a medication therapy management program for Medicare Part D beneficiaries.

Detection and Analysis of Adverse Events Related to Regulated Products in Automated Healthcare Data: Efforts to Develop the Sentinel Initiative
FDA HHSF2232009100061 – Harvard Pilgrim Health Care
PI – Richard Platt at Harvard Pilgrim
Iowa Investigators – Elizabeth Chrischilles, Ryan Carnahan

Developing Evidence to Inform Decisions about Effectiveness Research Network-2
DEcIDE-2 – AHRQ
PI – Elizabeth Chrischilles
The DEcIDE Network conducts studies on the outcomes, effectiveness, safety, and usefulness of medical treatments and services.

Enhanced Data to Accelerate Complex Patient Comparative Effectiveness Research
Medicare CCW – AHRQ
View Fact Sheet from project
PI – Elizabeth Chrischilles
This collaborative effort proposes to use the Medicare Chronic Condition Warehouse (CCW) as our major input source to create a longitudinal cohort of 1.8 million Medicare beneficiaries admitted with AMI or stroke/TIA in 2007 and followed through 2008 for recurrent events, complications and death.

Improving Antipsychotic Appropriateness in Dementia Patients
IA-ADAPT website
IA-ADAPT– AHRQ
PI – Ryan Carnahan
This collaborative effort will adapt and disseminate the AHRQ comparative effectiveness research review and summary guide (CERSG) within a comprehensive program to guide providers in the care of patients with dementia and behavioral disturbances.

Lung Cancer Care Outcomes/Surveillance Consortium
CanCORS – Dana Farber Cancer Institute/NIH
PI – Robert Wallace
The overall goal of this study is to use the state of Iowa as a laboratory for determining the effects of lung cancer patient decision-making and clinician cancer management practices to determine those practices that maximize patient survivorship and quality of life.

Nighttime Dosing of Anti-Hypertensive Medications: A Pragmatic Clinical Trial
Nighttime Dosing – NIH
PI – Gary Rosenthal
This study will involve conducting a simple and practical clinical trial to determine if taking medication for high blood pressure at night, as opposed to in the morning, lead to a lower risk of cardiovascular disease in patients with hypertension. The study will collect data from electronic medical records and from personal health records and will use an innovative website to collect informed consent from patients.

Personal Health Records and Elder Medication Use Quality
PI – Elizabeth A Chrischilles The project conducted a randomized controlled trial among older adults of the effect of a current representative PHR system on patient-reported medication therapy management (MTM) behaviors, beliefs about medications, medication-use quality indicators, and on medication adherence.

Should High-Risk Statin Utilization Rates Be Increased for Complex AMI Patients?
Statin – AHRQ
PI – John Brooks
The aims of this research are to assess the comparative effectiveness of Moderate-Dose and High-Dose Statins on cardiovascular event free survival; side-effect risk; and healthcare costs in complex AMI patients using the Medicare Chronic Condition Data Warehouse (CCW).

The University of Iowa Older Adult CERT (UIOAC)
More information about the Iowa CERT – AHRQ
View Fact Sheets and Video from various Iowa CERT Projects
PI – Elizabeth A Chrischilles
The UIOAC is a part of the national CERTs (Centers for Education and Research on Therapeutics) and specifically deals with therapies for older adults and the effects of aging. The grant was funded by NIH/AHRQ.

A GIS Based Workbench to Interpret Cancer Maps
PI – Gerard Rushton
This goal of this research was to develop and test a methodology for identifying regions of excess cancer burden for breast and colorectal cancer in Iowa. The grant was funded by NCI.

An Initial Evaluation of Medication Therapy Management (MTM) Services in the Upper Midwest
PI – William Doucette

ARRA: University of Iowa Consumer Survey
PI – Elizabeth Chrischilles

Cancer Care and Outcomes Research Surveillance (CanCORS) Consortium
PI – Robert B. Wallace
The overall goal of this proposal was to use the state of Iowa as a laboratory for determining the effects of lung cancer patient decision-making and clinician cancer management practices to determine those practices that maximize patient survivorship and quality of life. The grant was funded by NCI.

Demonstration of a Regional Coalition Model for Pharmacy Performance Reporting through the Pharmacy Quality Alliance
PI – William Doucette

Economic Special Study Center. United States Renal Data System
Co-PI – John M Brooks
The study center was focused on projects related to assessing the over/or under utilization of resources within the provision of care for patients with end-stage renal disease.

Evaluation of Pharmaceutical Case Management in a Private Sector Health Plan
PI – William Doucette

Integrating Aging and Cancer Research
PI – Robert B. Wallace
This was a planning and development (P20) grant proposal to add a Developing Program in Cancer and Aging (CAP) to the research activities of the University of Iowa (UI) Holden Comprehensive Cancer Center (HCCC). The grant was funded by NIH.

Local Therapy of Breast Cancer in Community Populations
PI – John Brooks

Merck Predoctoral Fellowship in Epidemiology at The University of Iowa
PI – Elizabeth Chrischilles

Pharmaceutical Case Management and Living Well with a Disability
PI – Elizabeth A Chrischilles
The purpose of this randomized controlled trial was to test the effectiveness of an eight-week group-session health promotion program (Living Well with a Disability) augmented with a cooperative care model of medication management (Pharmaceutical Case Management). The grant was funded by CDC.

The Marginal Benefits of Adjuvant Treatments for Early-Stage Non-Small-Cell Lung Cancer: Estimation and Validation Using Instrumental Variable Techniques
PI – John M Brooks
This study assessed whether adjuvant treatments for early-stage lung cancer patients were over/or underused by estimating the benefits of these treatment using instrumental variable methods. The grant was funded by NCI.

Current HERCe projects

Care access, drug effects, aging and mobility disability
PI – Elizabeth A. Chrischilles
The goal of this project was to evaluate risk factors for and outcomes of secondary conditions overall, with a specific focus on adverse drug reactions (ADRs), among a population-based cohort of 2,384 persons aged 18 and over with mobility disablement sampled from Medicare aged and Medicare disabled enrollment files (the Prevention of Secondary Conditions study). The grant was funded by CDC.

Iowa Medicaid Pharmaceutical Case Management Program Evaluation
PI – Elizabeth Chrischilles
The purpose of this study was to test the effect of pharmaceutical case management (PCM) on medication safety and healthcare utilization. The grant was funded by the Iowa Department of Human Services.

Impact of Patient and Provider Characteristics on the Treatment, Outcomes and Costs of Neutropenia among Patients with NHL
PI – Elizabeth A. Chrischilles
The purpose of this study was to link cancer registry data with administrative data (discharge abstract, Medicare claims) to study neutropenic hospitalizations and their consequences among people with non-Hodgkin’s lymphoma. The grant was funded by Amgen Inc.

Linking Databases for Breast Cancer Research
PI – John Brooks
The purpose of the study was to link patients from the Iowa Surveillance, Epidemiology, and End Results (SEER) Registry to their respective inpatient discharge abstracts from an Iowa Health Care Cost and Utilization Project (HCUP)-formatted database and evaluate whether this linkage provides information related to cancer treatment variation. The grant was funded by NCI.

Lymphoma SPORE Developmental Research Award
PI – Elizabeth A. Chrischilles
The purpose of our proposed research was to determine whether anthracycline-containing combination chemotherapy was optimally used among patients with follicular lymphomas. The grant was funded by the Holden Comprehensive Cancer Center.

State Implementation Project for Preventing Secondary Conditions and Promoting the Health of Persons with Disabilities
PI – Elizabeth A. Chrischilles
The purpose of this project was to use a population-based, three-year longitudinal survey database linked to Medicare claims to study mobility limitations, secondary conditions, and risk factors for secondary conditions (the Prevention of Secondary Conditions (PSC) study database). The grant was funded by the Iowa Department of Public Health/CDC.

Unbiased Outcome Estimates from Conservative vs. Aggressive Treatment of Early Stage Prostate Cancer from Retrospective Data: An Instrumental Variables Approach
PI – Elizabeth Chrischilles
Instrumental variables (IV) techniques were used to estimate survival differences between treatment options among marginal patients with early stage prostate cancer diagnosed in SEER registry areas during 1986-1993.The grant was funded by the Department of Defense.