Aging and Geriatrics studies

People are living longer than ever before and we conduct studies to help improve the quality of life for the elderly. Our researchers examine all aspects of aging through studies related to osteoporosis and falls, safety of testosterone replacement in men, and dementia and Alzheimer’s disease.

Biobehavioral Vulnerability to Accelerated Aging in Breast Cancer Survivors

The aim of this project is to examine cellular and genomic markers of inflammation, telomere erosion, telomere length, and microarray data of 300 breast cancer survivors and comparison women who are enrolled in the KPSC-UCLA collaborative STRIVE1 and STRIVE2 studies.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

American Cancer Society

Funding Years:

2016 - 2019

Extended Herpes Zoster Vaccine Effectiveness in a Health Maintenance Organization

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2014 - 2024

Kaiser Permanente Southern California and Novavax Collaboration on RSV Epidemiology

The purpose of this study is to provide critical information about the predictors of severe RSV disease, describe epidemiology and burden of hospitalized RSV disease in older adults, and assess healthcare utilization associated with hospitalized RSV disease in older adults in a community setting. A population of hospitalized older adults testing positive for influenza will also be identified for comparison purposes.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novavax, Inc.

Funding Years:

2016 - 2018

Sleep Disturbance, Inflammation & Cellular Aging in Breast Cancer Survivors (STRIVE 2)

The goal of this prospective recruitment study is to evaluate longitudinal differences in the rates of change in inflammation and telomere erosion in breast cancer survivors vs. non-cancer comparison women to determine if such molecular changes are due to cancer biology, or its treatment, or consequences of aging.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2016 - 2019

A prospective cohort analysis of atypical femur fractures (AFF) in women from Kaiser Permanente Southern California (KPSC): identification of risk factors and construction of risk prediction models

The goals of this study are to develop multivariate risk prediction models to predict the 2-year risk of atypical femur fractures and 2-year risk of hip fracture. A secondary goal is to create a simple clinical tool that will allow clinicians and patients to estimate the risk of both types of fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2016 - 2017

Femur Fracture Outcomes Associated with Bisphosphonate Use

The goals of this study are to examine the association between long-term bisphosphonate use patterns and subsequent risk of major osteoporotic fracture and to estimate the association between long-term bisphosphonate use patterns and subsequent risk of atypical femur fracture.

Site Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

National Institute on Aging (NIA)

Funding Years:

2015 - 2018

Fracture, Osteopenia, and CT Utilization Study (FOCUS Study)

The aim of this study is to validate within a population of KPSC patients the ability of a CT-based Biomechanical CT analysis to identify patients with osteopenia who are at high risk for hip fracture.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2015 - 2017

Fracture, Osteopenia, and CT Utilization Study (FOCUS Study)

The aim of this study is to validate within a population of KPSC patients the ability of a CT-based Biomechanical CT analysis to identify patients with osteopenia who are at high risk for hip fracture.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Amgen, Inc.

Funding Years:

2016 - 2017

Pre-operative Assessment of Fusion-related Bone Failure

The objective of this case-cohort study is to apply biomechanical computed tomography (BCT) analysis and virtual stress testing (VST) to pre-operative CT scans for a cohort of candidates for spine-fusion surgery to predict clinical/surgical outcomes such as pedicle screw failure, endplate subsidence, proximal junctional failure, and overall surgery failure. We will be testing the hypothesis that VST indices can predict surgical failure independent of other known pre-operative risk factors or bone mineral density.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2018 - 2019

Predicting Two Year Risk of Major Osteoporosis-related Fractures

The primary objective of the study is to develop and validate clinical prediction models to estimate the 1-2 year risk of: (1) major osteoporosis-related fractures and (2) osteoporosis-related hip fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Amgen, Inc.

Funding Years:

2014 - 2017

Retrospective Cohort Study of Risk of Hip Fractures Associated with High Dose, Long-term Proton Pump Inhibitor (HD-PPI) Use and Cytochrome P450 Pharmacogenomics

The main goals of this study are to conduct two related cohort studies intended to address questions related to the association between PPI and HD-PPI use in a setting of complex medication usage patterns and to conduct a pharmacogenetics study exploring potential modification of the relationship between PPI use and hip fracture risk by CYP2C19 genotype.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

2014 - 2018

Skeletal Outcomes in Primary Hyperparathyroidism

The aim of the study is to retrospectively compare fracture rates and BMD changes in patients with PHPT who have received the following types of treatment: observation, bisphosphonate therapy, surgery, or both surgery and bisphosphonate therapy.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

University of California, Los Angeles (UCLA)

Funding Years:

2013 - 2019

Studying the relationship of hyponatremia on bone disease, fractures, and fall risk

A cross sectional and longitudinal study that seeks to establish or determine a relationship between hyponatremia and bone density disorders (osteoporosis); hyponatremia and vertebral fractures; hyponatremia and risk of hip fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Otsuka America Pharmaceutical Inc

Funding Years:

2015

A Cohort study of co-morbid conditions and risk of chemotherapy associated febrile neutropenia in patients with selected types of cancers in Kaiser Permanente Southern California

The goal of this study is to examine the association between chronic co-morbid conditions and risk of febrile neutropenia, and grade III and IV neutropenia associated with first cycle chemotherapy.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Amgen, Inc.

Funding Years:

2013 - 2016

A Registry to Improve Care and Research in Lung Cancer Screening

This is an award to demonstrate the feasibility of developing a registry of individuals who undergo lung cancer screening with low-dose CT.

Principal Investigator:

Michael K. Gould, MD, MS

Funding Source:

Cancer Research Network (CRN)

Funding Years:

2014 - 2016

An Examination of Chronic Health Problems of Survivors of Cancer

An Examination of Chronic Health Problems of Survivors of Cancer

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

City Of Hope

Funding Years:

2014 - 2016

Antidepressants and Breast Cancer Pharmacoepidemiology

This study examines drug interactions between tamoxifen and antidepressants in nearly 23,000 breast cancer survivors diagnosed with early stage disease in the two largest health plans in California.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2010 - 2014

Assessing Treatment Patterns and Quality Gaps in Non-Muscle Invasive Bladder Cancer Care

The goal of this study was to understand reasons for the use/non-use of intravesical chemotherapy or immunotherapy following the initial bladder tumor resection among patients with bladder cancer.

Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2013 - 2014

Biobehavioral Vulnerability to Accelerated Aging in Breast Cancer Survivors

The aim of this project is to examine cellular and genomic markers of inflammation, telomere erosion, telomere length, and microarray data of 300 breast cancer survivors and comparison women who are enrolled in the KPSC-UCLA collaborative STRIVE1 and STRIVE2 studies.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

American Cancer Society

Funding Years:

2016 - 2019

Breast cancer screening decisions in younger women: a hybrid effectiveness-implementation study

The major goals of the project are to evaluate the effectiveness of a web-based decision aid on improving knowledge about breast cancer screening in women age 40 to 49 and reducing decisional conflict about breast cancer screening, and to explore the acceptability and feasibility of large-scale implementation.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

Nat'l Cancer Inst

Funding Years:

2017

Cardiovascular toxicity following aromatase inhibitor use

The aim of this cohort is to assess the risk of cardiovascular disease associated with endocrine treatments for breast cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

California Breast Cancer Research Program (CBCRP)

Funding Years:

2013 - 2017

Chemotherapy Induced Compliances: FN risk in selected regimens

The goal of this observational study is to evaluate the average risk of febrile neutropenia (FN) in patients receiving chemotherapy regimens with previously undefined FN risk.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Amgen, Inc.

Funding Years:

2014 - 2016

Chronic Health Problems in Survivors of Adolescent and Young Adult Cancer

The goal of this project is to evaluate the long-term health outcomes, including mortality, second cancer and comorbidities among survivors of adolescent and young adult cancer. The magnitude of risk increase of specific late effects associated with specific cancer therapeutic exposure will also be characterized.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

American Cancer Society

Funding Years:

2015 - 2019

Chronic Myelogenous Leukemia and Outcomes of Tyrosine Kinase Inhibitor Therapy

The aim of this investigation initiated retrospective cohort study are to examine long-term health effects in the cohort of CML and determine if health effects vary by drug adherence to TKIs.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2013 - 2018

Developing tailored de-implementation strategies to reduce use of low-value cancer care services

The goal of this mixed methods study is to develop and test interventions to reduce use of surveillance biomarkers for early stage breast cancer patients.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2014 - 2015

Diet and Lifestyle in a Prospective Study of Bladder Cancer Survivors

This study will examine the role of cruciferous vegetable intake, in conjunction with genetic polymorphisms related to ITC metabolism, in potentially reducing disease recurrence and progression, and increasing the efficacy of intravesical bladder cancer treatment.

Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2014 - 2020

Economic, Epidemiologic and Clinical Burden Associated with Neutropenia and Febrile Neutropenia in Three Cancers

The primary objective of this study is to estimate the resource utilization and direct medical expenditure associated with neutropenia and febrile neutropenia, in Non-Hodgkin’s Lymphoma, Breast cancer and Lung cancer patients. The secondary objective is to determine the trend of incidence of neutropenia with and without fever in Non-Hodgkin’s Lymphoma, Breast cancer and Lung cancer. The study will also describe management patterns and evaluate trend of management patterns for febrile neutropenia. Lastly, we will also estimate the febrile neutropenia specific mortality rate in hospitalized patients by cancer type.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Amgen, Inc.

Funding Years:

2011 - 2015

Follow-up care and preventive service use among survivors of adolescent and young adult cancer.

This project aims to evaluate adherence to Children’s Oncology Group Long-Term Follow-up Guidelines and population preventive care guidelines among survivors of adolescent and young adult (AYA) cancer.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Nat'l Cancer Inst

Funding Years:

2016

Glargine Insulin and Risk of Cancer in Cohort of Patients with Diabetes

The goal of this project was to understand the cancer risks associated with use of glargine, an insulin medication. This study compared the risk of several types of cancer among individuals with diabetes who used glargine to those using NPH, another type of insulin.

Site Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

Sanofi-Aventis U.S. LLC

Funding Years:

2010 - 2013

Hereditary Cancer Moderate Risk Gene Results vs. Claus Model Breast Cancer Risk Score and Breast MRI

Dr. Haque was awarded travel funds to attend conferences related to hereditary cancers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

GeneDx

Funding Years:

2015 - 2018

Impact of Bariatric Surgery on Cancer Incidence in Severely Obese Adults

The goal of this project is to estimate the impact of bariatric surgery versus routine non-surgical care on the incidence of cancer (all types) in all severely obese patients (men and women).

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2014 - 2018

Implementing systematic distress screening in breast cancer

This project focuses on implementation and effectiveness of an evidence-based guideline recommendation for systematic distress screening for breast cancer patients.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

California Breast Cancer Research Progra

Funding Years:

2016

Kaiser Permanente NCI National Community Oncology Research Program-Cancer Care Delivery Research Program

The specific aim of the Cancer Care Delivery Research portion of this program is to conduct and help design cancer care delivery research within the National Community Oncology Research Program (NCORP

Principal Investigator:

Michael K. Gould, MD, MS

Funding Source:

Nat'l Cancer Inst

Funding Years:

2014

Molecular and Genetic Determinants of non-Hodgkin Lymphoma

The goal of this study is to investigate whether the genetic variation in the human leukocyte antigen and other key a priori genes linked to human leukocyte antigen, including tumor necrosis factor play a role in non-Hodgkin lymphoma prognosis and overall survival.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

Observational Study of the Epidemiology in Clinical Outcomes of Breast Cancer in Women with BRCA Mutations

This cohort study examines the long-term clinical outcomes of women with breast cancer who are BRCA mutation carriers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

AstraZeneca

Funding Years:

2015 - 2018

OPATS: Outcomes of Prostate Cancer Androgen Deprivation Therapy Study

The goal is to assess fatal and morbid outcomes up to 15 years following androgen deprivation therapy for men initially diagnosed with localized prostate cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2010 - 2014

PD-1/PD-L1 Blockage Plus Kinase Inhibitor Therapies for B cell Lymphomas

This study aims to explore rational combination therapies aimed at cytoreduction of advanced tumors followed by antibody-mediated immune checkpoint inhibition to stimulate adaptive T cell anti-lymphoma immunity. We will study a large cohort of human diffuse large B cell (DLBCL) samples and utilize syngeneic, immunocompetent mouse lymphoma models that mimic the varied sensitivity of human B cell NHL to kinase inhibitors

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Leukemia and Lymphoma Society

Funding Years:

2013 - 2016

Personalized Risk-Adaptive surveIllance Strategies in cancEr (PRAISE)

The major goals of this project are to develop innovative risk-adaptive models of cancer surveillance for colorectal, chronic myeloid leukemia, and prostate cancer using value-of-information statistical methodology.

Site Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

Nat'l Inst of Health

Funding Years:

2018

Pilot Study of Neutropenia in Cancer Patients with Co-Morbid Conditions

The goal of this study is to evaluate the feasibility of determining the occurrence of neutropenia and febrile neutropenia as well as cancer treatment using electronic medical records.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Amgen, Inc.

Funding Years:

2009

REPRISE 2: Is depression associated with prostate cancer progression?

This study examines if depression and its treatment can affect the course of prostate cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2018 - 2020

Risk of Cancer in Childhood and Adolescence Associated with Medical Imaging

The goal of this study it to evaluate patterns of medical imaging associated with cumulative exposure to radiation (CT, nuclear medicine, fluoroscopy, angiography, and radiography), and subsequent risk of childhood cancers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2015 - 2020

Sleep Disturbance, Inflammation & Cellular Aging in Breast Cancer Survivors (STRIVE 2)

The goal of this prospective recruitment study is to evaluate longitudinal differences in the rates of change in inflammation and telomere erosion in breast cancer survivors vs. non-cancer comparison women to determine if such molecular changes are due to cancer biology, or its treatment, or consequences of aging.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2016 - 2019

Sleep Inflammation and Depression Occurrence in Breast Cancer Survivors (STRIVE1)

The aim of this prospective study is to examine the association between sleep disturbance, cellular and genomic markers of inflammation, and depression occurrence in breast cancer survivors.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

Use of Multiple Biomarkers with the Risk of Ovarian Cancer Algorithm (ROCA) for Early Detection of Ovarian Cancer in Female Carriers of BRCA1 and BRCA2 mutations

The goal of this prospective recruitment study is to determine if ovarian cancer screening is enhanced by more frequent biomarker testing (CA125 & HE4) versus usual testing frequency in women with BRCA1/2 mutations.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Garfield Memorial Fund

Funding Years:

2016 - 2019

Using Stakeholder Perspectives to Improve Survivorship Care Plan Implementation

The goal of this study is to gain insight and understanding into planned and implemented processes of survivorship care in diverse health care settings.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2016 - 2017

An Observational Cohort Study of the Risk of Thromboembolic Events among Adult Patients Treated with KCENTRA® Compared with Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding.

The goal of this study is examine the risk of thromboembolic events among adult patients treated with KCENTRA compared with plasma for urgent reversal of vitamin K antagonist therapy in the setting of acute major bleeding.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

CSL Behring, LLC

Funding Years:

2014 - 2020

Approaches to Genetic Heterogeneity of Obstructive Sleep Apnea

The main goal of this study is to use state of the art approaches to identify relevant genes based on a very large sample of patients with Obstructive Sleep Apnea (OSA), a common disorder with multiple adverse consequences. It is known that OSA has a genetic basis, but to date no convincing gene variants have been identified. This study uses OSA obtained from multiple institutions in the United States. It is the largest study ever proposed for identifying genes for this common sleep disorder.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Automated Outreach to Increase Adherence to Cholesterol Lowering Medications in Patients Who Did Not Fill a New Prescription

The major goal of this project is to test the effectiveness of a low-cost, generalizable intervention to improve patient adherence to newly prescribed medications to lower cholesterol.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Merck & Co., Inc.

Funding Years:

2010 - 2012

Cardiovascular toxicity following aromatase inhibitor use

The aim of this cohort is to assess the risk of cardiovascular disease associated with endocrine treatments for breast cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

California Breast Cancer Research Program (CBCRP)

Funding Years:

2013 - 2017

Care of Mental, Physical, and Substance Use Syndromes (COMPASS)

KPSC is one of nine sites throughout the country funded by an Innovation Award from the Centers of Medicare and Medicaid to implement a coordinated care model for depressed patients with cardiovascular disease. We have the following goals for this project: 1. To implement in three stages a multiple condition collaborative care management model in primary care clinics of care systems in states. 2. To demonstrate that this model improves care quality, patient experience and health, provider satisfaction, and total healthcare costs for the Medicare and Medicaid patients with the targeted conditions. 3. To develop role descriptions and training for the two new types of workers required for this model – care managers and care consultants. 4. To identify the costs and payment models needed by care systems to sustain and spread this care model.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Institute for Clinical Systems Improvement (ICSI)

Funding Years:

2012 - 2015

CV Benefits and Safety of Glucose-Lowering Therapies in Adults with Diabetes

The primary goal of this study is to assess the impact of specific glucose-lowering strategies on cardiovascular events and on mortality in order to identify whether some glucose-lowering strategies confer more cardiovascular benefit than others.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2014 - 2018

Database Cohort Study to Assess the Risk of Serious Angioedema in Assocation with Sacubitril/Valsartan use in Black Patients with Heart Failuer in the U.S.

The overall goal of this study is to provide real-world estimates of the incidence of angioedema among both HF patients initiating sacubitril/valsartan and HF patients initiating an ACEI, with a primary focus on Black patients.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2016 - 2020

Development of a CKD Discordance Index to Identify High Healthcare Utilization

The goals of this pilot project are to develop a chronic kidney disease (CKD) discordance index defined by the presence of chronic conditions and treatments that oppose, contradict, or complicate CKD treatment or worsen kidney function in a subsample of CKD patients from KPSC

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute on Aging (NIA)

Funding Years:

2017 - 2018

Diagnosis of Hypertension in Specialty Clinics

High blood pressure can be missed in patients who do not have regular visits with their primary care provider. The goal of the present project is to estimate the efficacy of blood pressure assessments in specialty clinics. We will compare recognition, follow-up, and time-to-treatment between patients first recognized in specialty care to those in primary care.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2013

Disparities in Progression to Renal Replacement Therapy

This retrospective cohort study will explore the reasons for the increased incidence of end-stage renal disease in African Americans and Hispanics by focusing on quality of care for diabetes, hypertension, and chronic kidney disease.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2009 - 2013

Effectiveness of Gastric Sleeve vs. Gastric Bypass for Cardiovascular Disease (ENGAGE-CVD)

This study will include only bariatric surgery patients from Kaiser Permanente Southern California and is designed to achieve the following aims: 1) compare the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y Gastric Bypass (RYGB) in remission of risk factors for cardiovascular disease (CVD) and reduction in overall CVD risk using advanced statistical and econometric techniques.; 2) compare VSG and RYGB surgical safety using similar methods; and 3) understand the treatment effect heterogeneity in remission of CVD risk factors, reduction in overall CVD risk, and safety outcomes for patients with different racial/ethnic backgrounds, sexes, and disease burdens at the time of surgery.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

HIV Status and Incidence and Outcomes of Heart Failure

The overall goal of this study is to identify optimal treatment strategies to reduce the impact of cardiovascular disease complications in HIV-infected patients, focusing on the understudied diagnosis of heart failure

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016

HMO Research Network Cardiovascular Research Network (CVRN)

The purpose of this program is to establish a collaborative CVRN among 15 member plans of the HMO Research Network to create a unique national resource that leverages the network’s CV expertise, diverse community-based study populations, and rich electronic data systems.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2011 - 2013

Kaiser Permanente Real-world Heart Monitoring StrategY Evaluation, Treatment Patterns and Health Metrics (RHYTHM) Study

The overall goal of this study is to characterize the clinical utility of ZIO® Patch monitoring vs. other monitoring strategies by linking ZIO® Patch data on arrhythmia burden and timing to detailed clinical information.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

iRhythm Technologies, Inc.

Funding Years:

2015 - 2017

Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment

Evaluating the effect of treating mild-to-moderate hypertension in pregnancy, compare the risks of clinically important outcomes with different medications, and determine whether the benefits and risks vary by maternal race/ethnicity or obesity status.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute of Child Health and Human Development (NICHD)

Funding Years:

2015 - 2019

Optimizing Risk Stratification and Comparative Effectiveness Research for Atrial Fibrilliation

The major goals of this project was to develop a collaboration of population-based researchers as well as a research platform using a contemporary cohort of about 40,000 adults with atrial fibrillation to improve comparative effectiveness studies, risk stratification of outcomes and the planning and conduct of future observational studies and randomized trials for atrial fibrillation.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2009 - 2012

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020

RBC Heart Pragmatic Clinical Trial

The objective of the trial is to evaluate the effectiveness of systematic testing and treatment of reduced iron stores vs. usual care on the risk of hospitalization in older patients with heart failure and previously unexplained anemia. The goal of the pilot study is to determine the feasibility of conducting the full trial.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute on Aging (NIA)

Funding Years:

2018 - 2019

Statin Utilization in Patients with Critical Limb Ischemia

The major goal of this project is to assemble and characterize an analytic cohort of Kaiser Permanente Southern California members with incident critical limb ischemia (CLI) and to determine the rate of statin utilization and statin intensity among patients with CLI over time.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Amgen, Inc

Funding Years:

2016

The ACA Impact on Hypertension Treatment and Control

The major goal of this project is to describe the characteristics of newly enrolled versus established members following implementation or the Affordable Care Act and to examine hypertension prevalence and control rates among new and established members in the Kaiser Permanente Southern California region prior to and following the Affordable Care Act.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Southern California Permanente Medical Group (SCPMG)

Funding Years:

2016 - 2017

The Comparative effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism

The overall goal of this project is to provide information on the benefits and harms comparing different treatment options for the extended treatment of VTE, information that can be used by clinicians and patients in deciding on the optimal treatment strategy.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2020

The Economic Benefits of Triglyceride Lowering Among Patients with Diabetes and Severe Hypertriglyceridemia

The overall goal of this non-interventional study is to analyze the economic impact of triglyceride lowering and to determine whether this differs among patients who did and did not receive therapy to intentionally lower triglycerides.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

AstraZeneca

Funding Years:

2015 - 2016

The Health Care Burden of Moderately Elevated Triglycerides

The overall goals of this project are to describe the demographic and clinical characteristics of patients with moderately elevated triglycerides and to calculate the burden of disease in this cohort.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Amarin Corporation

Funding Years:

2016 - 2018

Trends in Incidence of Hospitalized Acute Myocardial Infarction

The major goal of this project is to examine recent trends in incidence of hospitalized myocardial infarction among members in the Kaiser Permanente Southern California region aged 35 years and older.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Southern California Permanente Medical Group (SCPMG)

Funding Years:

2015 - 2016

Understanding Screening and Statin Utilization Rates for Patients at Risk for Cardiovascular Disease for Kaiser Permanente Southern California (KPSC)

The overall objective of this study is to examine trends and patterns of lipid screening and statin utilization from 2009 to 2015.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Regeneron Pharmaceuticals, Inc.

Funding Years:

2015 - 2017

Chronic Health Problems in Survivors of Adolescent and Young Adult Cancer

The goal of this project is to evaluate the long-term health outcomes, including mortality, second cancer and comorbidities among survivors of adolescent and young adult cancer. The magnitude of risk increase of specific late effects associated with specific cancer therapeutic exposure will also be characterized.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

American Cancer Society

Funding Years:

2015 - 2019

Effects of air pollution and gestational diabetes on autism

The proposal will gather preliminary biomarker data in newborns in response to air pollution and gestational diabetes exposure in-utero

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

Nat'l Inst of Environ Health Sciences

Funding Years:

2017

Follow-up care and preventive service use among survivors of adolescent and young adult cancer.

This project aims to evaluate adherence to Children’s Oncology Group Long-Term Follow-up Guidelines and population preventive care guidelines among survivors of adolescent and young adult (AYA) cancer.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Nat'l Cancer Inst

Funding Years:

2016

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020

Post-licensure observational safety surveillance study of quadrivalent meningococcal ACWY conjugate vaccine

This study is an observational post-marketing safety study required by the United States Food and Drug Administration (FDA). The primary objective of this study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization (HMO) in the United States.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Vaccines and Diagnostics, Inc.

Funding Years:

2014 - 2018

Risk of Cancer in Childhood and Adolescence Associated with Medical Imaging

The goal of this study it to evaluate patterns of medical imaging associated with cumulative exposure to radiation (CT, nuclear medicine, fluoroscopy, angiography, and radiography), and subsequent risk of childhood cancers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2015 - 2020

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Follow-up Study

The HAPO Follow-up Study will recruit from the cohort of women and their offspring who participated in the original HAPO Study to test the hypothesis that hyperglycemia in pregnancy, less severe than overt diabetes, is independently associated with increased risk of adverse childhood and maternal outcomes 8-12 years later. The general aim of the study is to obtain measures of adiposity, glucose, insulin sensitivity and secretion, lipids, inflammation and blood pressure in 7,000 HAPO mother-offspring (aged 8-12) pairs of multiple ethnic/race groups from ten of the original HAPO field centers. (RO1DK061628)

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2012 - 2017

Trajectories of Physical Activity and Sedentary Time in Adolescent/Young Women (TAAG 3)

The major goals of this trial are to determine the effectiveness of a school and community-linked physical activity intervention to reduce the decline in physical activity in young women, a cohort who have been followed since middle school.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

Kaiser Permanente and Johns Hopkins Medicine Research Collaboration Committee

Funding Years:

2017 - 2018

Using Computational Approaches to Optimize Asthma Care Management

This project aims to improve the accuracy of computationally identifying high-risk asthma patients, it's assess potential impact on outcomes and to provide automated prediction result explanations for care management.

Site Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2018 - 2022

Archimedes IndiGO End-Stage Renal Disease Tool Development and Validation

Archimedes IndiGO will be used to predict outcomes for Chronic Kidney Disease and provide an interface for patient management. The accuracy of outcomes prediction will be tested in this study.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Kaiser Foundation Health Plan, Inc.

Funding Years:

2013 - 2015

Cholesterol-lowering medication as risk factors for amyotrophic lateral sclerosis

The primary objective of this study is to investigate whether the use of cholesterol-lowering medications increases the risk of developing ALS or influences the rate of disease progression among individuals who have ALS.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012 - 2013

Identification of risk factors for resistant Pseudomonas aeruginosa infections with or without ESBL among hospitalized patients and developments and validation of a risk predictive tool

This study aims to develop a clinical risk prediction tool for antibiotic resistant Pseudomonas infections among inpatients.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2016 - 2019

Multiple sclerosis clinical care physician fellowship program

Training and mentoring of resident in treatment of multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

National Multiple Sclerosis Society (NMSS)

Funding Years:

2013 - 2014

Archimedes IndiGO End-Stage Renal Disease Tool Development and Validation

Archimedes IndiGO will be used to predict outcomes for Chronic Kidney Disease and provide an interface for patient management. The accuracy of outcomes prediction will be tested in this study.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Kaiser Foundation Health Plan, Inc.

Funding Years:

2013 - 2015

ASCEND Clinical Trial

A clinical trial to study the efficacy of natalizumab on reducing disability progression in subjects with secondary progressive multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Biogen Idec, Inc.

Funding Years:

2011 - 2016

Cholesterol-lowering medication as risk factors for amyotrophic lateral sclerosis

The primary objective of this study is to investigate whether the use of cholesterol-lowering medications increases the risk of developing ALS or influences the rate of disease progression among individuals who have ALS.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012 - 2013

Chronic Myelogenous Leukemia and Outcomes of Tyrosine Kinase Inhibitor Therapy

The aim of this investigation initiated retrospective cohort study are to examine long-term health effects in the cohort of CML and determine if health effects vary by drug adherence to TKIs.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2013 - 2018

Effectiveness of Gastric Sleeve vs. Gastric Bypass for Cardiovascular Disease (ENGAGE-CVD)

This study will include only bariatric surgery patients from Kaiser Permanente Southern California and is designed to achieve the following aims: 1) compare the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y Gastric Bypass (RYGB) in remission of risk factors for cardiovascular disease (CVD) and reduction in overall CVD risk using advanced statistical and econometric techniques.; 2) compare VSG and RYGB surgical safety using similar methods; and 3) understand the treatment effect heterogeneity in remission of CVD risk factors, reduction in overall CVD risk, and safety outcomes for patients with different racial/ethnic backgrounds, sexes, and disease burdens at the time of surgery.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Occurrence of Herpes Zoster Among Elderly Population 60 or More Years of Age: A Comparison Between Vaccinated and Unvaccinated Population

The specific aims of the study are to evaluate the incidence of HZ among elderly population 60 or more years of age who were either vaccinated or not vaccinated with the vaccine and to evaluate whether some potential chronic conditions would modify the effect of the vaccine. The additional aims are to compare the healthcare utilization between vaccinated HZ cases and unvaccinated HZ cases, to compare the incidence of stroke in one year after HZ episode between vaccinated HZ cases and unvaccinated HZ cases, and to compare the incidence of HZ between concomitant and sequential administration of PPV 23 and Zostavax.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012

Optimizing Risk Stratification and Comparative Effectiveness Research for Atrial Fibrilliation

The major goals of this project was to develop a collaboration of population-based researchers as well as a research platform using a contemporary cohort of about 40,000 adults with atrial fibrillation to improve comparative effectiveness studies, risk stratification of outcomes and the planning and conduct of future observational studies and randomized trials for atrial fibrillation.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2009 - 2012

PCORnet Bariatric Study

This study is designed to address the following aims in over 30 clinical sites participating in the national Patient-Centered Outcomes Research Network (PCORnet) Bariatric Study: Aim 1: To what extent does weight loss and weight regain differ across bariatric surgical procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding) at 1, 3, and 5 years? Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years? Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years? Aim 4: To elicit patient preferences around the risks and benefits regarding the choice of (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and (c) follow-up care after bariatric surgery.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2018

Real World Effectiveness and Economic Impact of Subcutaneous Methotrexate compared to Oral Methotrexate Treatment for Rheumatoid Arthritis

This prospective study will evaluate the real-world effectiveness of subcutaneous vs. oral methotrexate treatment on disease activity and functional status of rheumatoid arthritis patients. We will also evaluate effectiveness on patient centered outcomes, treatment adherence, cost, and work productivity. Lastly, using a discrete choice experiment, we will estimate patient’s valuation of these outcomes and their willingness to pay.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Medac Pharma, Inc.

Funding Years:

2016

Skeletal Outcomes in Primary Hyperparathyroidism

The aim of the study is to retrospectively compare fracture rates and BMD changes in patients with PHPT who have received the following types of treatment: observation, bisphosphonate therapy, surgery, or both surgery and bisphosphonate therapy.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

University of California, Los Angeles (UCLA)

Funding Years:

2013 - 2019

The Comparative effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism

The overall goal of this project is to provide information on the benefits and harms comparing different treatment options for the extended treatment of VTE, information that can be used by clinicians and patients in deciding on the optimal treatment strategy.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2020

Use of Multiple Biomarkers with the Risk of Ovarian Cancer Algorithm (ROCA) for Early Detection of Ovarian Cancer in Female Carriers of BRCA1 and BRCA2 mutations

The goal of this prospective recruitment study is to determine if ovarian cancer screening is enhanced by more frequent biomarker testing (CA125 & HE4) versus usual testing frequency in women with BRCA1/2 mutations.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Garfield Memorial Fund

Funding Years:

2016 - 2019

Beta Cell Restoration through Fat Migation

The major goal of this project is to develop approaches that can arrest or reverse progressive Beta-cell disease.

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

Nat'l Inst of Diab & Digestive & Kidney

Funding Years:

2011

Care of Mental, Physical, and Substance Use Syndromes (COMPASS)

KPSC is one of nine sites throughout the country funded by an Innovation Award from the Centers of Medicare and Medicaid to implement a coordinated care model for depressed patients with cardiovascular disease. We have the following goals for this project: 1. To implement in three stages a multiple condition collaborative care management model in primary care clinics of care systems in states. 2. To demonstrate that this model improves care quality, patient experience and health, provider satisfaction, and total healthcare costs for the Medicare and Medicaid patients with the targeted conditions. 3. To develop role descriptions and training for the two new types of workers required for this model – care managers and care consultants. 4. To identify the costs and payment models needed by care systems to sustain and spread this care model.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Institute for Clinical Systems Improvement (ICSI)

Funding Years:

2012 - 2015

CV Benefits and Safety of Glucose-Lowering Therapies in Adults with Diabetes

The primary goal of this study is to assess the impact of specific glucose-lowering strategies on cardiovascular events and on mortality in order to identify whether some glucose-lowering strategies confer more cardiovascular benefit than others.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2014 - 2018

Disparities in Progression to Renal Replacement Therapy

This retrospective cohort study will explore the reasons for the increased incidence of end-stage renal disease in African Americans and Hispanics by focusing on quality of care for diabetes, hypertension, and chronic kidney disease.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2009 - 2013

Genetics of Beta Cell Failure in Mexican Americans: Phase II (Beta Gene II)

This application is proposed to call back ~400 individuals in our previous cross-sectional BetaGene cohort study (NIDDK 61628) and re-test them for phenotypes. Analysis will be conducted to determine which genes and how they interact with each other to impact the longitudinal changes in beta-cell function and other T2DM related traits.

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2009 - 2014

Glargine Insulin and Risk of Cancer in Cohort of Patients with Diabetes

The goal of this project was to understand the cancer risks associated with use of glargine, an insulin medication. This study compared the risk of several types of cancer among individuals with diabetes who used glargine to those using NPH, another type of insulin.

Site Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

Sanofi-Aventis U.S. LLC

Funding Years:

2010 - 2013

PCORnet Bariatric Study

This study is designed to address the following aims in over 30 clinical sites participating in the national Patient-Centered Outcomes Research Network (PCORnet) Bariatric Study: Aim 1: To what extent does weight loss and weight regain differ across bariatric surgical procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding) at 1, 3, and 5 years? Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years? Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years? Aim 4: To elicit patient preferences around the risks and benefits regarding the choice of (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and (c) follow-up care after bariatric surgery.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2018

Physiologic Consequence of Genetic Variation (BetaGene III)

The over-arching goal of this study is to assess the physiologic effect of genetic variation in humans and determine how variation in genes alters physiologic processes to contribute to diabetes pathogenesis.

Site Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

Nat'l Inst of Diab & Digestive & Kidney

Funding Years:

2015

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020

Randomized Trial of Exercise Promotion In Primary Care (EPPC)

To determine the feasibility of a primary care based, telephone counseling physical activity behavioral intervention for diabetics and prediabetics.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2014 - 2016

SEARCH Nutrition Ancillary Study 2 (SNAS2)

The goal of SNAS2 is to examine associations of nutritional factors with 1) markers of subclinical cardiovascular disease; 2) prevalence and severity of retinopathy; and 3) prevalence, severity and incidence of diabetic kidney disease in youth with type 1 diabetes and type 2 diabetes. (2R01DK077949)

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2014 - 2018

The Economic Benefits of Triglyceride Lowering Among Patients with Diabetes and Severe Hypertriglyceridemia

The overall goal of this non-interventional study is to analyze the economic impact of triglyceride lowering and to determine whether this differs among patients who did and did not receive therapy to intentionally lower triglycerides.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

AstraZeneca

Funding Years:

2015 - 2016

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Follow-up Study

The HAPO Follow-up Study will recruit from the cohort of women and their offspring who participated in the original HAPO Study to test the hypothesis that hyperglycemia in pregnancy, less severe than overt diabetes, is independently associated with increased risk of adverse childhood and maternal outcomes 8-12 years later. The general aim of the study is to obtain measures of adiposity, glucose, insulin sensitivity and secretion, lipids, inflammation and blood pressure in 7,000 HAPO mother-offspring (aged 8-12) pairs of multiple ethnic/race groups from ten of the original HAPO field centers. (RO1DK061628)

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2012 - 2017

The Role of Adipokines in Glucose Regulation and Metabolic Decline

This project measured a large panel of pro- and anti-inflammatory adipokines in existing blood samples collected from BetaGene I and II study participants, combine these data with genome-wide genetic variation, dietary and physical activity information, and elucidate the pathophysiological pathways that underlie metabolic decline leading to type 2 diabetes.

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2014 - 2018

Total Direct Medical Expenditure Associated with Transition to Diverticulitis

This study will estimate the economic, clinical and epidemiologic outcomes associated with the transition from diverticulosis to diverticulitis. We further assess these outcomes associated with recurrence of diverticulitis and also investigate mortality risk due to the disease and during surgical treatments. The study also examines the socio-demographic and other factors associated with diverticulitis and its recurrence; barrier’s to surgical treatment alternatives and associated utilization; other treatment options for this disease.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Shire Pharmaceuticals

Funding Years:

2009 - 2015

Approaches to Genetic Heterogeneity of Obstructive Sleep Apnea

The main goal of this study is to use state of the art approaches to identify relevant genes based on a very large sample of patients with Obstructive Sleep Apnea (OSA), a common disorder with multiple adverse consequences. It is known that OSA has a genetic basis, but to date no convincing gene variants have been identified. This study uses OSA obtained from multiple institutions in the United States. It is the largest study ever proposed for identifying genes for this common sleep disorder.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Genetics of Beta Cell Failure in Mexican Americans: Phase II (Beta Gene II)

This application is proposed to call back ~400 individuals in our previous cross-sectional BetaGene cohort study (NIDDK 61628) and re-test them for phenotypes. Analysis will be conducted to determine which genes and how they interact with each other to impact the longitudinal changes in beta-cell function and other T2DM related traits.

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2009 - 2014

Observational Study of the Epidemiology in Clinical Outcomes of Breast Cancer in Women with BRCA Mutations

This cohort study examines the long-term clinical outcomes of women with breast cancer who are BRCA mutation carriers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

AstraZeneca

Funding Years:

2015 - 2018

Physiologic Consequence of Genetic Variation (BetaGene III)

The over-arching goal of this study is to assess the physiologic effect of genetic variation in humans and determine how variation in genes alters physiologic processes to contribute to diabetes pathogenesis.

Site Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

Nat'l Inst of Diab & Digestive & Kidney

Funding Years:

2015

Effects of air pollution and gestational diabetes on autism

The proposal will gather preliminary biomarker data in newborns in response to air pollution and gestational diabetes exposure in-utero

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

Nat'l Inst of Environ Health Sciences

Funding Years:

2017

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Follow-up Study

The HAPO Follow-up Study will recruit from the cohort of women and their offspring who participated in the original HAPO Study to test the hypothesis that hyperglycemia in pregnancy, less severe than overt diabetes, is independently associated with increased risk of adverse childhood and maternal outcomes 8-12 years later. The general aim of the study is to obtain measures of adiposity, glucose, insulin sensitivity and secretion, lipids, inflammation and blood pressure in 7,000 HAPO mother-offspring (aged 8-12) pairs of multiple ethnic/race groups from ten of the original HAPO field centers. (RO1DK061628)

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2012 - 2017

The Virtual Visit for Women with Gestational Diabetes Mellitus (GDM)

This pilot study will address two specific aims: (1) to assess the acceptability of telemedicine technology to conduct virtual office visits alternating with regular office- based prenatal visits for women with GDM from the viewpoint of women with GDM and their health care providers using qualitative research methods, and (2) to assess the feasibility of this telemedicine-based intervention (Virtual Office Visit) for women with GDM. This information was be used to support a larger proposal to obtain funding to conduct a clinical trial to test the proposed intervention after it is refined based on input from patients and health care providers.

Principal Investigator:

David A. Sacks, MD

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2014

Disparities in Progression to Renal Replacement Therapy

This retrospective cohort study will explore the reasons for the increased incidence of end-stage renal disease in African Americans and Hispanics by focusing on quality of care for diabetes, hypertension, and chronic kidney disease.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2009 - 2013

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020

Trajectories of Physical Activity and Sedentary Time in Adolescent/Young Women (TAAG 3)

The major goals of this trial are to determine the effectiveness of a school and community-linked physical activity intervention to reduce the decline in physical activity in young women, a cohort who have been followed since middle school.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

Kaiser Permanente and Johns Hopkins Medicine Research Collaboration Committee

Funding Years:

2017 - 2018

Developing a Risk Prediction Model and Evaluating the Economic Burden of Ankylosing Spondylitis in an Integrated Healthcare System

The primary aim is to develop an ankylosing spondylitis risk prediction model using data from Kaiser’s electronic medical records (EMR). We will also evaluate medical expenditure, health related quality of life and work productivity losses associated with ankylosing spondylitis.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2020 - 2022

Economic, Epidemiologic and Clinical Burden Associated with Neutropenia and Febrile Neutropenia in Three Cancers

The primary objective of this study is to estimate the resource utilization and direct medical expenditure associated with neutropenia and febrile neutropenia, in Non-Hodgkin’s Lymphoma, Breast cancer and Lung cancer patients. The secondary objective is to determine the trend of incidence of neutropenia with and without fever in Non-Hodgkin’s Lymphoma, Breast cancer and Lung cancer. The study will also describe management patterns and evaluate trend of management patterns for febrile neutropenia. Lastly, we will also estimate the febrile neutropenia specific mortality rate in hospitalized patients by cancer type.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Amgen, Inc.

Funding Years:

2011 - 2015

Medical Expenditure Panel Survey (MEPS)

The aim of this study is to verify the cost of care for persons with multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

National Multiple Sclerosis Society (NMSS)

Funding Years:

2013

Patterns and Predictors of Transitions in Adult Attention-Deficit Hyperactivity Disorder

This study will estimate the epidemiologic and economic outcomes associated with the adult attention deficit hyperactivity disorder (ADHD). We also assess characteristics, predictors, and time frame for patients who transition to more complex ADHD within the inception cohort and generate prediction models for transition. The study also examines treatment patterns, medication adherence and healthcare utilization patterns of the inception cohort.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Shire Pharmaceuticals

Funding Years:

2009 - 2012

Real World Effectiveness and Economic Impact of Subcutaneous Methotrexate compared to Oral Methotrexate Treatment for Rheumatoid Arthritis

This prospective study will evaluate the real-world effectiveness of subcutaneous vs. oral methotrexate treatment on disease activity and functional status of rheumatoid arthritis patients. We will also evaluate effectiveness on patient centered outcomes, treatment adherence, cost, and work productivity. Lastly, using a discrete choice experiment, we will estimate patient’s valuation of these outcomes and their willingness to pay.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Medac Pharma, Inc.

Funding Years:

2016

Total Direct Medical Expenditure Associated with Transition to Diverticulitis

This study will estimate the economic, clinical and epidemiologic outcomes associated with the transition from diverticulosis to diverticulitis. We further assess these outcomes associated with recurrence of diverticulitis and also investigate mortality risk due to the disease and during surgical treatments. The study also examines the socio-demographic and other factors associated with diverticulitis and its recurrence; barrier’s to surgical treatment alternatives and associated utilization; other treatment options for this disease.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Shire Pharmaceuticals

Funding Years:

2009 - 2015

Assessing Treatment Patterns and Quality Gaps in Non-Muscle Invasive Bladder Cancer Care

The goal of this study was to understand reasons for the use/non-use of intravesical chemotherapy or immunotherapy following the initial bladder tumor resection among patients with bladder cancer.

Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2013 - 2014

Effectiveness of Gastric Sleeve vs. Gastric Bypass for Cardiovascular Disease (ENGAGE-CVD)

This study will include only bariatric surgery patients from Kaiser Permanente Southern California and is designed to achieve the following aims: 1) compare the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y Gastric Bypass (RYGB) in remission of risk factors for cardiovascular disease (CVD) and reduction in overall CVD risk using advanced statistical and econometric techniques.; 2) compare VSG and RYGB surgical safety using similar methods; and 3) understand the treatment effect heterogeneity in remission of CVD risk factors, reduction in overall CVD risk, and safety outcomes for patients with different racial/ethnic backgrounds, sexes, and disease burdens at the time of surgery.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Developing a Risk Prediction Model and Evaluating the Economic Burden of Ankylosing Spondylitis in an Integrated Healthcare System

The primary aim is to develop an ankylosing spondylitis risk prediction model using data from Kaiser’s electronic medical records (EMR). We will also evaluate medical expenditure, health related quality of life and work productivity losses associated with ankylosing spondylitis.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2020 - 2022

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Mental Health Research Network II

We have established a Mental Health Research Network including 13 established public-domain research centers based in integrated not-for-profit health systems. These systems provide care to a diverse population of 10 million people in 11 states, and they share rich and compatible data resources to support a range of effectiveness research. Diversity of member demographics, insurance coverage, and organization of health services make this network an ideal environment for studying variation in care, comparing effectiveness and cost of treatments across practice environments, and studying dissemination and health policies. Participating research centers are experienced in a wide range of clinical areas and research methods. The long-term objectives are to expand the Mental Health Research Network to include additional health systems and external investigators, to conduct multi-site observational and experimental studies of comparative effectiveness, to develop and evaluate methods for dissemination and implementation, and to become a national resource of research methods and effectiveness evidence for researchers, patients, providers and healthcare leaders.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2014 - 2019

Antimicrobial resistant E. coli before and after California Senate bill 27 (ARES): a natural experiment

This study will allow us to comprehensively evaluate the casual link between food animal use of antibiotics, food product contamination, and human disease. These findings will inform future policy interventions towards a potentially modifiable source of AMR to reduce the burden on human populations nationally and globally.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2017 - 2022

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Extended Herpes Zoster Vaccine Effectiveness in a Health Maintenance Organization

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2014 - 2024

GWU/Wellcome 1 Feasibility

To collect preliminary data to support the larger Wellcome grant.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

The George Washington University

Funding Years:

2018 - 2019

Learning from California Senate bill 27: a natural experiment

This study complements an ongoing R01 study to provide more compelling evidence regarding the impact of SB27 by examining all major meat types (chicken, turkey, pork and beef) that may be impacted by the bill. Likewise, we include collection of the frank foodborne pathogens, Salmonella and Campylobacter, to provide additional insights into the potential effectiveness of this policy intervention.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Wellcome Trust

Funding Years:

2018 - 2022

An Evaluation of the National Zero Suicide Model across Learning Healthcare Systems

Our project seeks to develop metrics to measure fidelity and outcomes for the National Zero Suicide Model components implemented in each system using electronic health records and insurance claims data sources that are easily extractable and generalizable to other systems. Then, we propose to use these metrics to conduct fidelity and outcome evaluation of the various Zero Suicide Initiative approaches in each system using Interrupted Time Series Designs, which are among the strongest, pragmatic designs appropriate for evaluating care system intervention and policy changes in ‘Learning Healthcare Systems.’ We hypothesize that the implementation of various National Zero Suicide Model components will significantly reduce suicidal behavior within and across the participating systems. We seek to accomplish the following aims: 1) Collaborate with health system leaders to develop EHR metrics to measure specific quality improvement targets and care processes tailored to local Zero Suicide Initiative implementation; 2) examine the fidelity of the specific Zero Suicide Initiative care processes implemented in each system; and 3) investigate suicide attempt and mortality outcomes within and across Zero Suicide Initiative healthcare system models.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2017 - 2022

Building Capacity for Stakeholder Engagement in the Mental Health Research Network

This Eugene Washington engagement award will be used primarily to support the development of the involvement of our patients with mental health conditions, their caregivers and/or families, and national mental health community and advocacy groups who represent them in all phases of mental health research. The goals of this project are to: 1) Add the patient, caregiver, and family stakeholder voice and the community and advocacy groups who represent them to the national Mental Health Research Network (MHRN) executive leadership team to develop a shared direction for the network and a shared national voice for mental health comparative effectiveness research (CER); 2) Develop and pilot a strategy for stakeholder engagement within one MHRN-affiliated health system and the communities it serves to identify priorities for mental health CER; and 3) Develop and submit at least one new research proposal using the processes used in #1 and #2 at the end of the engagement award.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2018 - 2020

Care of Mental, Physical, and Substance Use Syndromes (COMPASS)

KPSC is one of nine sites throughout the country funded by an Innovation Award from the Centers of Medicare and Medicaid to implement a coordinated care model for depressed patients with cardiovascular disease. We have the following goals for this project: 1. To implement in three stages a multiple condition collaborative care management model in primary care clinics of care systems in states. 2. To demonstrate that this model improves care quality, patient experience and health, provider satisfaction, and total healthcare costs for the Medicare and Medicaid patients with the targeted conditions. 3. To develop role descriptions and training for the two new types of workers required for this model – care managers and care consultants. 4. To identify the costs and payment models needed by care systems to sustain and spread this care model.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Institute for Clinical Systems Improvement (ICSI)

Funding Years:

2012 - 2015

Developing an HIV Specific-Specific Prevention Index Using Electronic Medical Record (HIV PI)

The goals of this study are to assess in HIV-infected patients, the degree of association between successful general clinical care by HIV disease-treating providers (reflected in overall adherence to recommended general prevention and screening guidelines) and higher-quality HIV-specific care and related clinical outcome.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Agency for Healthcare Research and Quality (AHRQ)

Funding Years:

2010 - 2013

Diagnosis of Hypertension in Specialty Clinics

High blood pressure can be missed in patients who do not have regular visits with their primary care provider. The goal of the present project is to estimate the efficacy of blood pressure assessments in specialty clinics. We will compare recognition, follow-up, and time-to-treatment between patients first recognized in specialty care to those in primary care.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2013

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning, (PCORI/PORTAL Network)

The PORTAL network propose to create a cohort of adults who are overweight or obese, including those who have pre-diabetes or diabetes. The cohort development activity will demonstrate that the PORTAL network is able to meet the 10 criteria for a clinical data research network specified by PCORI.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2014 - 2015

PAP Therapy and Acute Care Utilization in a Large Integrated Health System

This study will determine if clinically diagnosed sleep apnea for which a PAP machine has been prescribed is associated with a reduction in expensive acute care utilization and if significant variation in utilization exists to suggest treatment disparities.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

ResMed Foundation

Funding Years:

2013 - 2016

Risk of Cancer in Childhood and Adolescence Associated with Medical Imaging

The goal of this study it to evaluate patterns of medical imaging associated with cumulative exposure to radiation (CT, nuclear medicine, fluoroscopy, angiography, and radiography), and subsequent risk of childhood cancers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2015 - 2020

Risk Selection, Premium Stabilization, and Coverage Expansion (RISC) Assessing Adverse Selection in California's Individual Health Insurance Market, Phase I

This study examines the impact on health care utilization among California residents who began receiving health care under the Affordable Care Act.

Site Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Commonwealth Fund

Funding Years:

2015

The Virtual Visit for Women with Gestational Diabetes Mellitus (GDM)

This pilot study will address two specific aims: (1) to assess the acceptability of telemedicine technology to conduct virtual office visits alternating with regular office- based prenatal visits for women with GDM from the viewpoint of women with GDM and their health care providers using qualitative research methods, and (2) to assess the feasibility of this telemedicine-based intervention (Virtual Office Visit) for women with GDM. This information was be used to support a larger proposal to obtain funding to conduct a clinical trial to test the proposed intervention after it is refined based on input from patients and health care providers.

Principal Investigator:

David A. Sacks, MD

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2014

Trajectories of Physical Activity and Sedentary Time in Adolescent/Young Women (TAAG 3)

The major goals of this trial are to determine the effectiveness of a school and community-linked physical activity intervention to reduce the decline in physical activity in young women, a cohort who have been followed since middle school.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

Kaiser Permanente and Johns Hopkins Medicine Research Collaboration Committee

Funding Years:

2017 - 2018

Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

The purpose of this study is to test the dissemination of a Palliative Care Intervention (PCI) for patients with non-small cell lung cancer (NSCLC) and their primary family caregivers (FCG)

Principal Investigator:

Huong Q. Nguyen, PhD, RN

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2014 - 2018

Developing an HIV Specific-Specific Prevention Index Using Electronic Medical Record (HIV PI)

The goals of this study are to assess in HIV-infected patients, the degree of association between successful general clinical care by HIV disease-treating providers (reflected in overall adherence to recommended general prevention and screening guidelines) and higher-quality HIV-specific care and related clinical outcome.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Agency for Healthcare Research and Quality (AHRQ)

Funding Years:

2010 - 2013

Kaiser Permanente Southern California and Novavax Collaboration on RSV Epidemiology

The purpose of this study is to provide critical information about the predictors of severe RSV disease, describe epidemiology and burden of hospitalized RSV disease in older adults, and assess healthcare utilization associated with hospitalized RSV disease in older adults in a community setting. A population of hospitalized older adults testing positive for influenza will also be identified for comparison purposes.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novavax, Inc.

Funding Years:

2016 - 2018

Post-licensure observational safety surveillance study of quadrivalent meningococcal ACWY conjugate vaccine

This study is an observational post-marketing safety study required by the United States Food and Drug Administration (FDA). The primary objective of this study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization (HMO) in the United States.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Vaccines and Diagnostics, Inc.

Funding Years:

2014 - 2018

An Evaluation of the National Zero Suicide Model across Learning Healthcare Systems

Our project seeks to develop metrics to measure fidelity and outcomes for the National Zero Suicide Model components implemented in each system using electronic health records and insurance claims data sources that are easily extractable and generalizable to other systems. Then, we propose to use these metrics to conduct fidelity and outcome evaluation of the various Zero Suicide Initiative approaches in each system using Interrupted Time Series Designs, which are among the strongest, pragmatic designs appropriate for evaluating care system intervention and policy changes in ‘Learning Healthcare Systems.’ We hypothesize that the implementation of various National Zero Suicide Model components will significantly reduce suicidal behavior within and across the participating systems. We seek to accomplish the following aims: 1) Collaborate with health system leaders to develop EHR metrics to measure specific quality improvement targets and care processes tailored to local Zero Suicide Initiative implementation; 2) examine the fidelity of the specific Zero Suicide Initiative care processes implemented in each system; and 3) investigate suicide attempt and mortality outcomes within and across Zero Suicide Initiative healthcare system models.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2017 - 2022

Breast cancer screening decisions in younger women: a hybrid effectiveness-implementation study

The major goals of the project are to evaluate the effectiveness of a web-based decision aid on improving knowledge about breast cancer screening in women age 40 to 49 and reducing decisional conflict about breast cancer screening, and to explore the acceptability and feasibility of large-scale implementation.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

Nat'l Cancer Inst

Funding Years:

2017

Developing tailored de-implementation strategies to reduce use of low-value cancer care services

The goal of this mixed methods study is to develop and test interventions to reduce use of surveillance biomarkers for early stage breast cancer patients.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2014 - 2015

Implementing systematic distress screening in breast cancer

This project focuses on implementation and effectiveness of an evidence-based guideline recommendation for systematic distress screening for breast cancer patients.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

California Breast Cancer Research Progra

Funding Years:

2016

Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

The purpose of this study is to test the dissemination of a Palliative Care Intervention (PCI) for patients with non-small cell lung cancer (NSCLC) and their primary family caregivers (FCG)

Principal Investigator:

Huong Q. Nguyen, PhD, RN

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2014 - 2018

A Retrospective Natural History Study of Coccifioidmycosis in California

Knowledge gaps exist regarding disease risk factors, presenting signs and symptoms, diagnostic approaches, and treatment for coccidiodomycosis infection. This study evaluates a large cohort of patients with community-acquired pneumonia in Southern California to assess cocci testing practices; additionally we evaluate a large cohort of patients diagnosed with cocci during 2011 to assess the natural history of infection.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2014 - 2017

Antimicrobial resistant E. coli before and after California Senate bill 27 (ARES): a natural experiment

This study will allow us to comprehensively evaluate the casual link between food animal use of antibiotics, food product contamination, and human disease. These findings will inform future policy interventions towards a potentially modifiable source of AMR to reduce the burden on human populations nationally and globally.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2017 - 2022

Comparison of vaccine effectiveness against hospitalization for influenza between cell-based and egg-based influenza vaccines

The proposed study aims to compare the vaccine effectiveness (VE) against hospitalization for influenza between Flucelvax Quadrivalent and egg-based influenza vaccines used in Kaiser Permanente Southern California (KPSC) during the 2017-2018 season.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Seqirus, Inc.

Funding Years:

2018 - 2019

Economic, Epidemiologic and Clinical Burden Associated with Neutropenia and Febrile Neutropenia in Three Cancers

The primary objective of this study is to estimate the resource utilization and direct medical expenditure associated with neutropenia and febrile neutropenia, in Non-Hodgkin’s Lymphoma, Breast cancer and Lung cancer patients. The secondary objective is to determine the trend of incidence of neutropenia with and without fever in Non-Hodgkin’s Lymphoma, Breast cancer and Lung cancer. The study will also describe management patterns and evaluate trend of management patterns for febrile neutropenia. Lastly, we will also estimate the febrile neutropenia specific mortality rate in hospitalized patients by cancer type.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Amgen, Inc.

Funding Years:

2011 - 2015

GWU/Wellcome 1 Feasibility

To collect preliminary data to support the larger Wellcome grant.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

The George Washington University

Funding Years:

2018 - 2019

HIV Status and Incidence and Outcomes of Heart Failure

The overall goal of this study is to identify optimal treatment strategies to reduce the impact of cardiovascular disease complications in HIV-infected patients, focusing on the understudied diagnosis of heart failure

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016

Identification of risk factors for resistant Pseudomonas aeruginosa infections with or without ESBL among hospitalized patients and developments and validation of a risk predictive tool

This study aims to develop a clinical risk prediction tool for antibiotic resistant Pseudomonas infections among inpatients.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2016 - 2019

Kidney Function Decline in Patients with CKD and Untreated Hepatitis C Infection

Studies evaluating the role of hepatitis C viral (HCV) infection on the progression of CKD are few and conflicting. Therefore, we evaluated the association of untreated HCV on kidney function decline in patients with stage 3-5 CKD.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2014 - 2017

Learning from California Senate bill 27: a natural experiment

This study complements an ongoing R01 study to provide more compelling evidence regarding the impact of SB27 by examining all major meat types (chicken, turkey, pork and beef) that may be impacted by the bill. Likewise, we include collection of the frank foodborne pathogens, Salmonella and Campylobacter, to provide additional insights into the potential effectiveness of this policy intervention.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Wellcome Trust

Funding Years:

2018 - 2022

A prospective cohort analysis of atypical femur fractures (AFF) in women from Kaiser Permanente Southern California (KPSC): identification of risk factors and construction of risk prediction models

The goals of this study are to develop multivariate risk prediction models to predict the 2-year risk of atypical femur fractures and 2-year risk of hip fracture. A secondary goal is to create a simple clinical tool that will allow clinicians and patients to estimate the risk of both types of fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2016 - 2017

Femur Fracture Outcomes Associated with Bisphosphonate Use

The goals of this study are to examine the association between long-term bisphosphonate use patterns and subsequent risk of major osteoporotic fracture and to estimate the association between long-term bisphosphonate use patterns and subsequent risk of atypical femur fracture.

Site Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

National Institute on Aging (NIA)

Funding Years:

2015 - 2018

Fracture, Osteopenia, and CT Utilization Study (FOCUS Study)

The aim of this study is to validate within a population of KPSC patients the ability of a CT-based Biomechanical CT analysis to identify patients with osteopenia who are at high risk for hip fracture.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Amgen, Inc.

Funding Years:

2016 - 2017

Fracture, Osteopenia, and CT Utilization Study (FOCUS Study)

The aim of this study is to validate within a population of KPSC patients the ability of a CT-based Biomechanical CT analysis to identify patients with osteopenia who are at high risk for hip fracture.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2015 - 2017

Predicting Two Year Risk of Major Osteoporosis-related Fractures

The primary objective of the study is to develop and validate clinical prediction models to estimate the 1-2 year risk of: (1) major osteoporosis-related fractures and (2) osteoporosis-related hip fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Amgen, Inc.

Funding Years:

2014 - 2017

Retrospective Cohort Study of Risk of Hip Fractures Associated with High Dose, Long-term Proton Pump Inhibitor (HD-PPI) Use and Cytochrome P450 Pharmacogenomics

The main goals of this study are to conduct two related cohort studies intended to address questions related to the association between PPI and HD-PPI use in a setting of complex medication usage patterns and to conduct a pharmacogenetics study exploring potential modification of the relationship between PPI use and hip fracture risk by CYP2C19 genotype.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

2014 - 2018

Studying the relationship of hyponatremia on bone disease, fractures, and fall risk

A cross sectional and longitudinal study that seeks to establish or determine a relationship between hyponatremia and bone density disorders (osteoporosis); hyponatremia and vertebral fractures; hyponatremia and risk of hip fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Otsuka America Pharmaceutical Inc

Funding Years:

2015

Identification of risk factors for resistant Pseudomonas aeruginosa infections with or without ESBL among hospitalized patients and developments and validation of a risk predictive tool

This study aims to develop a clinical risk prediction tool for antibiotic resistant Pseudomonas infections among inpatients.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2016 - 2019

Archimedes IndiGO End-Stage Renal Disease Tool Development and Validation

Archimedes IndiGO will be used to predict outcomes for Chronic Kidney Disease and provide an interface for patient management. The accuracy of outcomes prediction will be tested in this study.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Kaiser Foundation Health Plan, Inc.

Funding Years:

2013 - 2015

Development of a CKD Discordance Index to Identify High Healthcare Utilization

The goals of this pilot project are to develop a chronic kidney disease (CKD) discordance index defined by the presence of chronic conditions and treatments that oppose, contradict, or complicate CKD treatment or worsen kidney function in a subsample of CKD patients from KPSC

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute on Aging (NIA)

Funding Years:

2017 - 2018

Disparities in Progression to Renal Replacement Therapy

This retrospective cohort study will explore the reasons for the increased incidence of end-stage renal disease in African Americans and Hispanics by focusing on quality of care for diabetes, hypertension, and chronic kidney disease.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2009 - 2013

Electronic Clinical Surveillance to Measure and Improve Safety in Ambulatory Care

This study seeks to determine the incidence of three types of medical errors and the underlying factors that contribute to them within the ambulatory care settings of a large, diverse integrated delivery system. Specifically, we are studying delayed diagnosis of kidney disease (diagnostic error), use of contraindicated medications among patients with a history of falls (treatment error), and lack of annual monitoring for patients on angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (preventive error).

Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

Agency for Healthcare Research and Quality (AHRQ)

Funding Years:

2015 - 2018

Kidney Function Decline in Patients with CKD and Untreated Hepatitis C Infection

Studies evaluating the role of hepatitis C viral (HCV) infection on the progression of CKD are few and conflicting. Therefore, we evaluated the association of untreated HCV on kidney function decline in patients with stage 3-5 CKD.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2014 - 2017

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020

Boostrix immunization in pregnant women

The goal of the Boostrix study is to examine pre-specified pregnancy-related adverse events in a cohort of women vaccinated with Boostrix at 27 weeks gestation or beyond compared to a matched historical unvaccinated control group.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2017 - 2021

Elective Induction of Labor and Pregnancy Outcomes

In 2008, 23% of births in the United States (nearly 1 million) were initiated by induction. Many inductions are elective, that is, performed without a medical or obstetric indication, typically for the woman’s comfort or convenience. In prior studies, this proportion has ranged from 13 to 49% of inductions. This suggests that 130,000 to 490,000 births in the U.S. each year are initiated by elective induction. As a pilot study, we examined the prevalence of induction from 2001-8 using linked electronic health data and birth certificate data at two integrated health care delivery systems, Kaiser Permanente Southern California (KPSC) and Group Health (GH). The prevalence of induction rose from 24% to 30%. Among all births, the prevalence of induction with no documented indication rose from 4.7% to 8.4%. At KPSC, we examined trends by race and ethnicity. Induction with no documented indication was more common in whites than any other group, but similar increases were seen in all groups.

Principal Investigator:

Darios Getahun, MD, PhD, MPH

Funding Source:

National Institute of Child Health and Human Development (NICHD)

Funding Years:

2013 - 2017

Flame Retardant and Adverse Perinatal Oucome

Polybrominated diphenyl ether(s) (PBDEs) have been in widespread use in home construction, furniture, clothing and electronic appliances for decades. PBDEs save lives by giving occupants valuable time to extinguish or escape from a spreading fire, however, with time, they leach into the environment and have become one of the most prevalent of the persistent organic pollutants (POPs). Concentrations of PBDEs have been increasing in human tissues since their introduction into consumer products. Breast-milk and plasma concentrations of PBDEs are 10 to 100-fold higher in the United States than other countries. Studies of pregnancy tissues indicate that PBDEs are present in amniotic fluid, umbilical cord plasma, umbilical cord tissue, placenta, and fetal membranes. The role of these flame retardants on adverse pregnancy outcomes is understudied, however, some recent reports have shown significant effects on birth weight. PBDEs may affect human health as endocrine disruptors. Overt and subclinical hypothyroidism increases the risk for preterm birth through an unknown mechanism. Furthermore, T4 reduced the production of proinflammatory cytokines, reduced inflammation, improved bacterial clearance and survival in animal models of sepsis. We hypothesize that exposure of pregnant women to PBDEs may reduce bioactivity of the T3 and T4 leading to a proinflammatory environment and increasing their risk for preterm birth.

Principal Investigator:

Darios Getahun, MD, PhD, MPH

Funding Source:

National Institute of Environmental Health Sciences (NIEHS)

Funding Years:

2013 - 2017

Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment

Evaluating the effect of treating mild-to-moderate hypertension in pregnancy, compare the risks of clinically important outcomes with different medications, and determine whether the benefits and risks vary by maternal race/ethnicity or obesity status.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute of Child Health and Human Development (NICHD)

Funding Years:

2015 - 2019

Prenatal Antibiotic Use and Body Weight in Children

The goal of this study is to examine the potential relationship between antibiotic use during pregnancy and pediatric weight problems. Particular focus is given to infants exposed to intrapartum Group B streptococcus prophylaxis and its impact on a child's body weight.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2017 - 2019

Risk of Cancer in Childhood and Adolescence Associated with Medical Imaging

The goal of this study it to evaluate patterns of medical imaging associated with cumulative exposure to radiation (CT, nuclear medicine, fluoroscopy, angiography, and radiography), and subsequent risk of childhood cancers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2015 - 2020

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Follow-up Study

The HAPO Follow-up Study will recruit from the cohort of women and their offspring who participated in the original HAPO Study to test the hypothesis that hyperglycemia in pregnancy, less severe than overt diabetes, is independently associated with increased risk of adverse childhood and maternal outcomes 8-12 years later. The general aim of the study is to obtain measures of adiposity, glucose, insulin sensitivity and secretion, lipids, inflammation and blood pressure in 7,000 HAPO mother-offspring (aged 8-12) pairs of multiple ethnic/race groups from ten of the original HAPO field centers. (RO1DK061628)

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2012 - 2017

Automated Outreach to Increase Adherence to Cholesterol Lowering Medications in Patients Who Did Not Fill a New Prescription

The major goal of this project is to test the effectiveness of a low-cost, generalizable intervention to improve patient adherence to newly prescribed medications to lower cholesterol.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Merck & Co., Inc.

Funding Years:

2010 - 2012

Patterns and Predictors of Transitions in Adult Attention-Deficit Hyperactivity Disorder

This study will estimate the epidemiologic and economic outcomes associated with the adult attention deficit hyperactivity disorder (ADHD). We also assess characteristics, predictors, and time frame for patients who transition to more complex ADHD within the inception cohort and generate prediction models for transition. The study also examines treatment patterns, medication adherence and healthcare utilization patterns of the inception cohort.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Shire Pharmaceuticals

Funding Years:

2009 - 2012

OPATS: Outcomes of Prostate Cancer Androgen Deprivation Therapy Study

The goal is to assess fatal and morbid outcomes up to 15 years following androgen deprivation therapy for men initially diagnosed with localized prostate cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2010 - 2014

REPRISE 2: Is depression associated with prostate cancer progression?

This study examines if depression and its treatment can affect the course of prostate cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2018 - 2020

An Evaluation of the National Zero Suicide Model across Learning Healthcare Systems

Our project seeks to develop metrics to measure fidelity and outcomes for the National Zero Suicide Model components implemented in each system using electronic health records and insurance claims data sources that are easily extractable and generalizable to other systems. Then, we propose to use these metrics to conduct fidelity and outcome evaluation of the various Zero Suicide Initiative approaches in each system using Interrupted Time Series Designs, which are among the strongest, pragmatic designs appropriate for evaluating care system intervention and policy changes in ‘Learning Healthcare Systems.’ We hypothesize that the implementation of various National Zero Suicide Model components will significantly reduce suicidal behavior within and across the participating systems. We seek to accomplish the following aims: 1) Collaborate with health system leaders to develop EHR metrics to measure specific quality improvement targets and care processes tailored to local Zero Suicide Initiative implementation; 2) examine the fidelity of the specific Zero Suicide Initiative care processes implemented in each system; and 3) investigate suicide attempt and mortality outcomes within and across Zero Suicide Initiative healthcare system models.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2017 - 2022

Biobehavioral Vulnerability to Accelerated Aging in Breast Cancer Survivors

The aim of this project is to examine cellular and genomic markers of inflammation, telomere erosion, telomere length, and microarray data of 300 breast cancer survivors and comparison women who are enrolled in the KPSC-UCLA collaborative STRIVE1 and STRIVE2 studies.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

American Cancer Society

Funding Years:

2016 - 2019

Building Capacity for Stakeholder Engagement in the Mental Health Research Network

This Eugene Washington engagement award will be used primarily to support the development of the involvement of our patients with mental health conditions, their caregivers and/or families, and national mental health community and advocacy groups who represent them in all phases of mental health research. The goals of this project are to: 1) Add the patient, caregiver, and family stakeholder voice and the community and advocacy groups who represent them to the national Mental Health Research Network (MHRN) executive leadership team to develop a shared direction for the network and a shared national voice for mental health comparative effectiveness research (CER); 2) Develop and pilot a strategy for stakeholder engagement within one MHRN-affiliated health system and the communities it serves to identify priorities for mental health CER; and 3) Develop and submit at least one new research proposal using the processes used in #1 and #2 at the end of the engagement award.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2018 - 2020

Care of Mental, Physical, and Substance Use Syndromes (COMPASS)

KPSC is one of nine sites throughout the country funded by an Innovation Award from the Centers of Medicare and Medicaid to implement a coordinated care model for depressed patients with cardiovascular disease. We have the following goals for this project: 1. To implement in three stages a multiple condition collaborative care management model in primary care clinics of care systems in states. 2. To demonstrate that this model improves care quality, patient experience and health, provider satisfaction, and total healthcare costs for the Medicare and Medicaid patients with the targeted conditions. 3. To develop role descriptions and training for the two new types of workers required for this model – care managers and care consultants. 4. To identify the costs and payment models needed by care systems to sustain and spread this care model.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Institute for Clinical Systems Improvement (ICSI)

Funding Years:

2012 - 2015

Depression and Functional Outcomes in COPD: Impact of Genetics and Inflammation

This is a longitudinal observational study of the biological causes and functional consequences of depression in patients with stable COPD.

Principal Investigator:

Huong Q. Nguyen, PhD, RN

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2013 - 2016

Development of a Population-Based Risk Calculator for Suicidal Behavior

We will use population-based data from seven large health systems to develop an evidence-based risk calculator for mental health and primary care clinicians. In order to address the gaps in evidence described above, we will expand current MHRN work on prediction of suicide risk by (1) expansion to a larger and more diverse sample, (2) Inclusion of encounters with “missing" risk assessments, (3) Examination of specific psychiatric and substance use diagnoses, and (4) applying analytic methods to account for potential biases due to patient- and provider-driven timing of assessments.

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2015 - 2017

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Mental Health Research Network II

We have established a Mental Health Research Network including 13 established public-domain research centers based in integrated not-for-profit health systems. These systems provide care to a diverse population of 10 million people in 11 states, and they share rich and compatible data resources to support a range of effectiveness research. Diversity of member demographics, insurance coverage, and organization of health services make this network an ideal environment for studying variation in care, comparing effectiveness and cost of treatments across practice environments, and studying dissemination and health policies. Participating research centers are experienced in a wide range of clinical areas and research methods. The long-term objectives are to expand the Mental Health Research Network to include additional health systems and external investigators, to conduct multi-site observational and experimental studies of comparative effectiveness, to develop and evaluate methods for dissemination and implementation, and to become a national resource of research methods and effectiveness evidence for researchers, patients, providers and healthcare leaders.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2014 - 2019

Patterns and Predictors of Transitions in Adult Attention-Deficit Hyperactivity Disorder

This study will estimate the epidemiologic and economic outcomes associated with the adult attention deficit hyperactivity disorder (ADHD). We also assess characteristics, predictors, and time frame for patients who transition to more complex ADHD within the inception cohort and generate prediction models for transition. The study also examines treatment patterns, medication adherence and healthcare utilization patterns of the inception cohort.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Shire Pharmaceuticals

Funding Years:

2009 - 2012

REPRISE 2: Is depression associated with prostate cancer progression?

This study examines if depression and its treatment can affect the course of prostate cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2018 - 2020

Sleep Disturbance, Inflammation & Cellular Aging in Breast Cancer Survivors (STRIVE 2)

The goal of this prospective recruitment study is to evaluate longitudinal differences in the rates of change in inflammation and telomere erosion in breast cancer survivors vs. non-cancer comparison women to determine if such molecular changes are due to cancer biology, or its treatment, or consequences of aging.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2016 - 2019

Sleep Inflammation and Depression Occurrence in Breast Cancer Survivors (STRIVE1)

The aim of this prospective study is to examine the association between sleep disturbance, cellular and genomic markers of inflammation, and depression occurrence in breast cancer survivors.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

Chronic Myelogenous Leukemia and Outcomes of Tyrosine Kinase Inhibitor Therapy

The aim of this investigation initiated retrospective cohort study are to examine long-term health effects in the cohort of CML and determine if health effects vary by drug adherence to TKIs.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2013 - 2018

GWU/Wellcome 1 Feasibility

To collect preliminary data to support the larger Wellcome grant.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

The George Washington University

Funding Years:

2018 - 2019

Learning from California Senate bill 27: a natural experiment

This study complements an ongoing R01 study to provide more compelling evidence regarding the impact of SB27 by examining all major meat types (chicken, turkey, pork and beef) that may be impacted by the bill. Likewise, we include collection of the frank foodborne pathogens, Salmonella and Campylobacter, to provide additional insights into the potential effectiveness of this policy intervention.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Wellcome Trust

Funding Years:

2018 - 2022

Molecular and Genetic Determinants of non-Hodgkin Lymphoma

The goal of this study is to investigate whether the genetic variation in the human leukocyte antigen and other key a priori genes linked to human leukocyte antigen, including tumor necrosis factor play a role in non-Hodgkin lymphoma prognosis and overall survival.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

Observational Study of the Epidemiology in Clinical Outcomes of Breast Cancer in Women with BRCA Mutations

This cohort study examines the long-term clinical outcomes of women with breast cancer who are BRCA mutation carriers.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

AstraZeneca

Funding Years:

2015 - 2018

PD-1/PD-L1 Blockage Plus Kinase Inhibitor Therapies for B cell Lymphomas

This study aims to explore rational combination therapies aimed at cytoreduction of advanced tumors followed by antibody-mediated immune checkpoint inhibition to stimulate adaptive T cell anti-lymphoma immunity. We will study a large cohort of human diffuse large B cell (DLBCL) samples and utilize syngeneic, immunocompetent mouse lymphoma models that mimic the varied sensitivity of human B cell NHL to kinase inhibitors

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Leukemia and Lymphoma Society

Funding Years:

2013 - 2016

ASCEND Clinical Trial

A clinical trial to study the efficacy of natalizumab on reducing disability progression in subjects with secondary progressive multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Biogen Idec, Inc.

Funding Years:

2011 - 2016

Cholesterol-lowering medication as risk factors for amyotrophic lateral sclerosis

The primary objective of this study is to investigate whether the use of cholesterol-lowering medications increases the risk of developing ALS or influences the rate of disease progression among individuals who have ALS.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012 - 2013

Medical Expenditure Panel Survey (MEPS)

The aim of this study is to verify the cost of care for persons with multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

National Multiple Sclerosis Society (NMSS)

Funding Years:

2013

Multiple sclerosis clinical care physician fellowship program

Training and mentoring of resident in treatment of multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

National Multiple Sclerosis Society (NMSS)

Funding Years:

2013 - 2014

Zoster Vaccine and Risk Factors of Zoster and Post-Herpetic Neuralgia

The aims of the study are to determine the incidence of reactivation of Oka strain VZV in community-dwelling persons vaccinated with zoster vaccines; to test clinical isolates for evidence of recombination between vaccine and wild-type strains VZV; to identify risk factors of HZ among individuals vaccinated with zoster vaccines; to identify risk factors for post-herpetic neuralgia (PHN) among HZ cases who were either vaccinated or unvaccinated with zoster vaccines, and to compare the clinical manifestations and risk of PHN between vaccinated and unvaccinated individuals.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Years:

2011 - 2017

Effectiveness of Gastric Sleeve vs. Gastric Bypass for Cardiovascular Disease (ENGAGE-CVD)

This study will include only bariatric surgery patients from Kaiser Permanente Southern California and is designed to achieve the following aims: 1) compare the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y Gastric Bypass (RYGB) in remission of risk factors for cardiovascular disease (CVD) and reduction in overall CVD risk using advanced statistical and econometric techniques.; 2) compare VSG and RYGB surgical safety using similar methods; and 3) understand the treatment effect heterogeneity in remission of CVD risk factors, reduction in overall CVD risk, and safety outcomes for patients with different racial/ethnic backgrounds, sexes, and disease burdens at the time of surgery.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Impact of Bariatric Surgery on Cancer Incidence in Severely Obese Adults

The goal of this project is to estimate the impact of bariatric surgery versus routine non-surgical care on the incidence of cancer (all types) in all severely obese patients (men and women).

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2014 - 2018

Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning, (PCORI/PORTAL Network)

The PORTAL network propose to create a cohort of adults who are overweight or obese, including those who have pre-diabetes or diabetes. The cohort development activity will demonstrate that the PORTAL network is able to meet the 10 criteria for a clinical data research network specified by PCORI.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2014 - 2015

PCORnet Bariatric Study

This study is designed to address the following aims in over 30 clinical sites participating in the national Patient-Centered Outcomes Research Network (PCORnet) Bariatric Study: Aim 1: To what extent does weight loss and weight regain differ across bariatric surgical procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding) at 1, 3, and 5 years? Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years? Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years? Aim 4: To elicit patient preferences around the risks and benefits regarding the choice of (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and (c) follow-up care after bariatric surgery.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2018

Prenatal Antibiotic Use and Body Weight in Children

The goal of this study is to examine the potential relationship between antibiotic use during pregnancy and pediatric weight problems. Particular focus is given to infants exposed to intrapartum Group B streptococcus prophylaxis and its impact on a child's body weight.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2017 - 2019

Randomized Trial of Exercise Promotion In Primary Care (EPPC)

To determine the feasibility of a primary care based, telephone counseling physical activity behavioral intervention for diabetics and prediabetics.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2014 - 2016

The Role of Adipokines in Glucose Regulation and Metabolic Decline

This project measured a large panel of pro- and anti-inflammatory adipokines in existing blood samples collected from BetaGene I and II study participants, combine these data with genome-wide genetic variation, dietary and physical activity information, and elucidate the pathophysiological pathways that underlie metabolic decline leading to type 2 diabetes.

Principal Investigator:

Anny Hui Xiang, PhD, MS

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2014 - 2018

Using Computational Approaches to Optimize Asthma Care Management

This project aims to improve the accuracy of computationally identifying high-risk asthma patients, it's assess potential impact on outcomes and to provide automated prediction result explanations for care management.

Site Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2018 - 2022

Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

The purpose of this study is to test the dissemination of a Palliative Care Intervention (PCI) for patients with non-small cell lung cancer (NSCLC) and their primary family caregivers (FCG)

Principal Investigator:

Huong Q. Nguyen, PhD, RN

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2014 - 2018

A Registry to Improve Care and Research in Lung Cancer Screening

This is an award to demonstrate the feasibility of developing a registry of individuals who undergo lung cancer screening with low-dose CT.

Principal Investigator:

Michael K. Gould, MD, MS

Funding Source:

Cancer Research Network (CRN)

Funding Years:

2014 - 2016

Developing a Risk Prediction Model and Evaluating the Economic Burden of Ankylosing Spondylitis in an Integrated Healthcare System

The primary aim is to develop an ankylosing spondylitis risk prediction model using data from Kaiser’s electronic medical records (EMR). We will also evaluate medical expenditure, health related quality of life and work productivity losses associated with ankylosing spondylitis.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2020 - 2022

Mental Health Research Network II

We have established a Mental Health Research Network including 13 established public-domain research centers based in integrated not-for-profit health systems. These systems provide care to a diverse population of 10 million people in 11 states, and they share rich and compatible data resources to support a range of effectiveness research. Diversity of member demographics, insurance coverage, and organization of health services make this network an ideal environment for studying variation in care, comparing effectiveness and cost of treatments across practice environments, and studying dissemination and health policies. Participating research centers are experienced in a wide range of clinical areas and research methods. The long-term objectives are to expand the Mental Health Research Network to include additional health systems and external investigators, to conduct multi-site observational and experimental studies of comparative effectiveness, to develop and evaluate methods for dissemination and implementation, and to become a national resource of research methods and effectiveness evidence for researchers, patients, providers and healthcare leaders.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Institute of Mental Health (NIMH)

Funding Years:

2014 - 2019

PCORnet Bariatric Study

This study is designed to address the following aims in over 30 clinical sites participating in the national Patient-Centered Outcomes Research Network (PCORnet) Bariatric Study: Aim 1: To what extent does weight loss and weight regain differ across bariatric surgical procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding) at 1, 3, and 5 years? Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years? Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years? Aim 4: To elicit patient preferences around the risks and benefits regarding the choice of (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and (c) follow-up care after bariatric surgery.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2018

Real World Effectiveness and Economic Impact of Subcutaneous Methotrexate compared to Oral Methotrexate Treatment for Rheumatoid Arthritis

This prospective study will evaluate the real-world effectiveness of subcutaneous vs. oral methotrexate treatment on disease activity and functional status of rheumatoid arthritis patients. We will also evaluate effectiveness on patient centered outcomes, treatment adherence, cost, and work productivity. Lastly, using a discrete choice experiment, we will estimate patient’s valuation of these outcomes and their willingness to pay.

Principal Investigator:

Aniket A. Kawatkar, PhD, MS

Funding Source:

Medac Pharma, Inc.

Funding Years:

2016

Sleep Disturbance, Inflammation & Cellular Aging in Breast Cancer Survivors (STRIVE 2)

The goal of this prospective recruitment study is to evaluate longitudinal differences in the rates of change in inflammation and telomere erosion in breast cancer survivors vs. non-cancer comparison women to determine if such molecular changes are due to cancer biology, or its treatment, or consequences of aging.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2016 - 2019

Sleep Inflammation and Depression Occurrence in Breast Cancer Survivors (STRIVE1)

The aim of this prospective study is to examine the association between sleep disturbance, cellular and genomic markers of inflammation, and depression occurrence in breast cancer survivors.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

Cardiovascular toxicity following aromatase inhibitor use

The aim of this cohort is to assess the risk of cardiovascular disease associated with endocrine treatments for breast cancer.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

California Breast Cancer Research Program (CBCRP)

Funding Years:

2013 - 2017

Database Cohort Study to Assess the Risk of Serious Angioedema in Assocation with Sacubitril/Valsartan use in Black Patients with Heart Failuer in the U.S.

The overall goal of this study is to provide real-world estimates of the incidence of angioedema among both HF patients initiating sacubitril/valsartan and HF patients initiating an ACEI, with a primary focus on Black patients.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2016 - 2020

Glargine Insulin and Risk of Cancer in Cohort of Patients with Diabetes

The goal of this project was to understand the cancer risks associated with use of glargine, an insulin medication. This study compared the risk of several types of cancer among individuals with diabetes who used glargine to those using NPH, another type of insulin.

Site Principal Investigator:

Kim N. Danforth, ScD, MPH

Funding Source:

Sanofi-Aventis U.S. LLC

Funding Years:

2010 - 2013

HEPLISAV-B Post Marketing Surveillance Study

The primary objective of this post-marketing observational surveillance study is to compare the occurrence of acute myocardial infarction (AMI) in recipients of HEPLISAV-B with recipients of another hepatitis B vaccine.

Principal Investigator:

Steven J. Jacobsen, MD, PhD

Funding Source:

Dynavax Technologies

Funding Years:

2017 - 2020

Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment

Evaluating the effect of treating mild-to-moderate hypertension in pregnancy, compare the risks of clinically important outcomes with different medications, and determine whether the benefits and risks vary by maternal race/ethnicity or obesity status.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute of Child Health and Human Development (NICHD)

Funding Years:

2015 - 2019

Retrospective Cohort Study of Risk of Hip Fractures Associated with High Dose, Long-term Proton Pump Inhibitor (HD-PPI) Use and Cytochrome P450 Pharmacogenomics

The main goals of this study are to conduct two related cohort studies intended to address questions related to the association between PPI and HD-PPI use in a setting of complex medication usage patterns and to conduct a pharmacogenetics study exploring potential modification of the relationship between PPI use and hip fracture risk by CYP2C19 genotype.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

2014 - 2018

The Comparative effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism

The overall goal of this project is to provide information on the benefits and harms comparing different treatment options for the extended treatment of VTE, information that can be used by clinicians and patients in deciding on the optimal treatment strategy.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2020

Vaccine Safety Datalink Project-CDC

VSD is a multi-site study of vaccine safety in a network of managed care organizations from across the US. The VSD project allows for planned immunization safety studies as well as timely investigations of hypotheses that arise from review of medical literature, reports to the Vaccine Adverse Event Reporting System (VAERS), changes in immunization schedules, or the introduction of new vaccines.

:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2017 - 2022

An Intervention Study of Reminder Letter for Gardasil Regimen Completion

The goal of this randomized intervention study is to evaluate the effectiveness of a quarterly mailing intervention on human papillomavirus vaccine three-dose regimen completion.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Merck & Co., Inc.

Funding Years:

2012 - 2016

Care of Mental, Physical, and Substance Use Syndromes (COMPASS)

KPSC is one of nine sites throughout the country funded by an Innovation Award from the Centers of Medicare and Medicaid to implement a coordinated care model for depressed patients with cardiovascular disease. We have the following goals for this project: 1. To implement in three stages a multiple condition collaborative care management model in primary care clinics of care systems in states. 2. To demonstrate that this model improves care quality, patient experience and health, provider satisfaction, and total healthcare costs for the Medicare and Medicaid patients with the targeted conditions. 3. To develop role descriptions and training for the two new types of workers required for this model – care managers and care consultants. 4. To identify the costs and payment models needed by care systems to sustain and spread this care model.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Institute for Clinical Systems Improvement (ICSI)

Funding Years:

2012 - 2015

Developing an HIV Specific-Specific Prevention Index Using Electronic Medical Record (HIV PI)

The goals of this study are to assess in HIV-infected patients, the degree of association between successful general clinical care by HIV disease-treating providers (reflected in overall adherence to recommended general prevention and screening guidelines) and higher-quality HIV-specific care and related clinical outcome.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Agency for Healthcare Research and Quality (AHRQ)

Funding Years:

2010 - 2013

Randomized Trial of Exercise Promotion In Primary Care (EPPC)

To determine the feasibility of a primary care based, telephone counseling physical activity behavioral intervention for diabetics and prediabetics.

Principal Investigator:

Deborah Rohm Young, PhD, MBA

Funding Source:

National Institutes of Health (NIH)

Funding Years:

2014 - 2016

An In-Depth Interview Study of Immunization Providers in a Large Managed Care Organization to Understand Practice Patterns, Barriers and Facilitators for Administering the 3-Dose HPV Vaccine Series

The primary objective of this study is to identify immunization providers’ opinions on practice patterns, barriers and facilitators for Gardasil 3-dose regimen completion among those who initiated the Gardasil vaccine.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Merck Sharp and Dohme Corp.

Funding Years:

2013 - 2016

Building Capacity for Stakeholder Engagement in the Mental Health Research Network

This Eugene Washington engagement award will be used primarily to support the development of the involvement of our patients with mental health conditions, their caregivers and/or families, and national mental health community and advocacy groups who represent them in all phases of mental health research. The goals of this project are to: 1) Add the patient, caregiver, and family stakeholder voice and the community and advocacy groups who represent them to the national Mental Health Research Network (MHRN) executive leadership team to develop a shared direction for the network and a shared national voice for mental health comparative effectiveness research (CER); 2) Develop and pilot a strategy for stakeholder engagement within one MHRN-affiliated health system and the communities it serves to identify priorities for mental health CER; and 3) Develop and submit at least one new research proposal using the processes used in #1 and #2 at the end of the engagement award.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2018 - 2020

Developing tailored de-implementation strategies to reduce use of low-value cancer care services

The goal of this mixed methods study is to develop and test interventions to reduce use of surveillance biomarkers for early stage breast cancer patients.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

Kaiser Permanente, Southern California

Funding Years:

2014 - 2015

Using Stakeholder Perspectives to Improve Survivorship Care Plan Implementation

The goal of this study is to gain insight and understanding into planned and implemented processes of survivorship care in diverse health care settings.

Principal Investigator:

Erin E. Hahn, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2016 - 2017

An In-Depth Interview Study of Immunization Providers in a Large Managed Care Organization to Understand Practice Patterns, Barriers and Facilitators for Administering the 3-Dose HPV Vaccine Series

The primary objective of this study is to identify immunization providers’ opinions on practice patterns, barriers and facilitators for Gardasil 3-dose regimen completion among those who initiated the Gardasil vaccine.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Merck Sharp and Dohme Corp.

Funding Years:

2013 - 2016

Care of Mental, Physical, and Substance Use Syndromes (COMPASS)

KPSC is one of nine sites throughout the country funded by an Innovation Award from the Centers of Medicare and Medicaid to implement a coordinated care model for depressed patients with cardiovascular disease. We have the following goals for this project: 1. To implement in three stages a multiple condition collaborative care management model in primary care clinics of care systems in states. 2. To demonstrate that this model improves care quality, patient experience and health, provider satisfaction, and total healthcare costs for the Medicare and Medicaid patients with the targeted conditions. 3. To develop role descriptions and training for the two new types of workers required for this model – care managers and care consultants. 4. To identify the costs and payment models needed by care systems to sustain and spread this care model.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Institute for Clinical Systems Improvement (ICSI)

Funding Years:

2012 - 2015

Effects of Emergency Department Crowding on Patient Safety

We will determine if Emergency Department crowding results in worse patient outcomes. Emergency department crowding is a nationwide phenomenon affecting the acute care system. This proposal will assess the impact of visit-level exposures of emergency department crowding on patient safety outcomes, including death in the emergency department, inpatient, and outpatient settings. The long-term goal of this research program is to guide the design and evaluation of health systems interventions to mitigate the impacts of ED crowding on patient safety.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Agency for Healthcare Research and Quality (AHRQ)

Funding Years:

2010 - 2012

Approaches to Genetic Heterogeneity of Obstructive Sleep Apnea

The main goal of this study is to use state of the art approaches to identify relevant genes based on a very large sample of patients with Obstructive Sleep Apnea (OSA), a common disorder with multiple adverse consequences. It is known that OSA has a genetic basis, but to date no convincing gene variants have been identified. This study uses OSA obtained from multiple institutions in the United States. It is the largest study ever proposed for identifying genes for this common sleep disorder.

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Biobehavioral Vulnerability to Accelerated Aging in Breast Cancer Survivors

The aim of this project is to examine cellular and genomic markers of inflammation, telomere erosion, telomere length, and microarray data of 300 breast cancer survivors and comparison women who are enrolled in the KPSC-UCLA collaborative STRIVE1 and STRIVE2 studies.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

American Cancer Society

Funding Years:

2016 - 2019

PAP Therapy and Acute Care Utilization in a Large Integrated Health System

This study will determine if clinically diagnosed sleep apnea for which a PAP machine has been prescribed is associated with a reduction in expensive acute care utilization and if significant variation in utilization exists to suggest treatment disparities.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

ResMed Foundation

Funding Years:

2013 - 2016

Sleep Inflammation and Depression Occurrence in Breast Cancer Survivors (STRIVE1)

The aim of this prospective study is to examine the association between sleep disturbance, cellular and genomic markers of inflammation, and depression occurrence in breast cancer survivors.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020

Using Computational Approaches to Optimize Asthma Care Management

This project aims to improve the accuracy of computationally identifying high-risk asthma patients, it's assess potential impact on outcomes and to provide automated prediction result explanations for care management.

Site Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2018 - 2022

Boostrix immunization in pregnant women

The goal of the Boostrix study is to examine pre-specified pregnancy-related adverse events in a cohort of women vaccinated with Boostrix at 27 weeks gestation or beyond compared to a matched historical unvaccinated control group.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2017 - 2021

Comparison of vaccine effectiveness against hospitalization for influenza between cell-based and egg-based influenza vaccines

The proposed study aims to compare the vaccine effectiveness (VE) against hospitalization for influenza between Flucelvax Quadrivalent and egg-based influenza vaccines used in Kaiser Permanente Southern California (KPSC) during the 2017-2018 season.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Seqirus, Inc.

Funding Years:

2018 - 2019

EPI-ZOSTER-031 VE, Long-term effectiveness study of Shingrix in US adults>=50 years

The objective is to conduct a long-term study at KPSC to assess vaccine effectiveness among individuals receiving recombinant zoster vaccine (RZV) compared to individuals not receiving RZV.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2018 - 2034

Extended Herpes Zoster Vaccine Effectiveness in a Health Maintenance Organization

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2014 - 2024

HEPLISAV-B Post Marketing Surveillance Study

The primary objective of this post-marketing observational surveillance study is to compare the occurrence of acute myocardial infarction (AMI) in recipients of HEPLISAV-B with recipients of another hepatitis B vaccine.

Principal Investigator:

Steven J. Jacobsen, MD, PhD

Funding Source:

Dynavax Technologies

Funding Years:

2017 - 2020

Impact of the introduction of the HZ/su Vaccine on clinical outcomes and payer budgets over a short-to-intermediate horizon- HO-17-18378

The objective of the study is to understand the impact of the introduction of recombinant zoster vaccine (RZV) for herpes zoster (HZ) over a short-to-intermediate time frame in collaboration with GlaxoSmithKline (GSK).

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2018 - 2019

Kaiser Permanente Southern California and Novavax Collaboration on RSV Epidemiology

The purpose of this study is to provide critical information about the predictors of severe RSV disease, describe epidemiology and burden of hospitalized RSV disease in older adults, and assess healthcare utilization associated with hospitalized RSV disease in older adults in a community setting. A population of hospitalized older adults testing positive for influenza will also be identified for comparison purposes.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novavax, Inc.

Funding Years:

2016 - 2018

Long Term Herpes Zoster Vaccine Effectiveness in a Health Maintenance Organization

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Prevention and Public Health Fund (PPHF)

Funding Years:

2013 - 2016

Measuring Effectiveness of Two Doses of Varicella Vaccine in Los Angeles County

The primary objective of this study is to calculate the incremental effectiveness of the 2-dose varicella vaccination regimen in preventing breakthrough disease compared to the 1-dose regimen among children aged 5 to 14 years in Antelope Valley, California.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2010 - 2011

Menveo Post-Licensure Safety Study

These studies are initiated to fulfill this post-marketing commitment between Novartis Vaccines and Diagnostics and the FDA to expand the safety profile of this vaccine in this age group. These are observational studies and are expected to span multiple years within KPSC. Subjects will be immunized with Menveo as part of their routine care. Subjects who have been vaccinated with Menveo and have experienced an event of interest during the first year are selected for analysis; and subjects ages 11-21 years of age are selected for analysis using the SCCS methodology, which sums the occurrence of events that fall within a risk window and those that do not fall within these windows.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2011 - 2018

Menveo Pregnancy Registry Study

The objective of the Menveo Pregnancy Registry is to evaluate pregnancy outcomes among women immunized with the Menveo vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2015 - 2018

Occurrence of Herpes Zoster Among Elderly Population 60 or More Years of Age: A Comparison Between Vaccinated and Unvaccinated Population

The specific aims of the study are to evaluate the incidence of HZ among elderly population 60 or more years of age who were either vaccinated or not vaccinated with the vaccine and to evaluate whether some potential chronic conditions would modify the effect of the vaccine. The additional aims are to compare the healthcare utilization between vaccinated HZ cases and unvaccinated HZ cases, to compare the incidence of stroke in one year after HZ episode between vaccinated HZ cases and unvaccinated HZ cases, and to compare the incidence of HZ between concomitant and sequential administration of PPV 23 and Zostavax.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012

Post-licensure observational safety surveillance study of quadrivalent meningococcal ACWY conjugate vaccine

This study is an observational post-marketing safety study required by the United States Food and Drug Administration (FDA). The primary objective of this study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization (HMO) in the United States.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Vaccines and Diagnostics, Inc.

Funding Years:

2014 - 2018

Vaccine Safety Datalink Project-CDC

VSD is a multi-site study of vaccine safety in a network of managed care organizations from across the US. The VSD project allows for planned immunization safety studies as well as timely investigations of hypotheses that arise from review of medical literature, reports to the Vaccine Adverse Event Reporting System (VAERS), changes in immunization schedules, or the introduction of new vaccines.

:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2017 - 2022

Zoster Vaccine and Risk Factors of Zoster and Post-Herpetic Neuralgia

The aims of the study are to determine the incidence of reactivation of Oka strain VZV in community-dwelling persons vaccinated with zoster vaccines; to test clinical isolates for evidence of recombination between vaccine and wild-type strains VZV; to identify risk factors of HZ among individuals vaccinated with zoster vaccines; to identify risk factors for post-herpetic neuralgia (PHN) among HZ cases who were either vaccinated or unvaccinated with zoster vaccines, and to compare the clinical manifestations and risk of PHN between vaccinated and unvaccinated individuals.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Years:

2011 - 2017

A prospective cohort analysis of atypical femur fractures (AFF) in women from Kaiser Permanente Southern California (KPSC): identification of risk factors and construction of risk prediction models

The goals of this study are to develop multivariate risk prediction models to predict the 2-year risk of atypical femur fractures and 2-year risk of hip fracture. A secondary goal is to create a simple clinical tool that will allow clinicians and patients to estimate the risk of both types of fractures.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

Merck & Co., Inc.

Funding Years:

2016 - 2017

An Intervention Study of Reminder Letter for Gardasil Regimen Completion

The goal of this randomized intervention study is to evaluate the effectiveness of a quarterly mailing intervention on human papillomavirus vaccine three-dose regimen completion.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Merck & Co., Inc.

Funding Years:

2012 - 2016

Antidepressants and Breast Cancer Pharmacoepidemiology

This study examines drug interactions between tamoxifen and antidepressants in nearly 23,000 breast cancer survivors diagnosed with early stage disease in the two largest health plans in California.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2010 - 2014

Boostrix immunization in pregnant women

The goal of the Boostrix study is to examine pre-specified pregnancy-related adverse events in a cohort of women vaccinated with Boostrix at 27 weeks gestation or beyond compared to a matched historical unvaccinated control group.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2017 - 2021

Impact of Bariatric Surgery on Cancer Incidence in Severely Obese Adults

The goal of this project is to estimate the impact of bariatric surgery versus routine non-surgical care on the incidence of cancer (all types) in all severely obese patients (men and women).

Principal Investigator:

Corinna Koebnick, PhD, MSc

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2014 - 2018

Incidence and trend of ectopic pregnancy 2008-2017: a population-based study

Examining the recent trends in ectopic pregnancy among women of childbearing ages.

Principal Investigator:

Darios Getahun, MD, PhD, MPH

Funding Source:

Bayer Pharmaceuticals Corporation

Funding Years:

2018 - 2019

Menveo Pregnancy Registry Study

The objective of the Menveo Pregnancy Registry is to evaluate pregnancy outcomes among women immunized with the Menveo vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2015 - 2018

Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment

Evaluating the effect of treating mild-to-moderate hypertension in pregnancy, compare the risks of clinically important outcomes with different medications, and determine whether the benefits and risks vary by maternal race/ethnicity or obesity status.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Institute of Child Health and Human Development (NICHD)

Funding Years:

2015 - 2019

Sleep Inflammation and Depression Occurrence in Breast Cancer Survivors (STRIVE1)

The aim of this prospective study is to examine the association between sleep disturbance, cellular and genomic markers of inflammation, and depression occurrence in breast cancer survivors.

Site Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2012 - 2017

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Follow-up Study

The HAPO Follow-up Study will recruit from the cohort of women and their offspring who participated in the original HAPO Study to test the hypothesis that hyperglycemia in pregnancy, less severe than overt diabetes, is independently associated with increased risk of adverse childhood and maternal outcomes 8-12 years later. The general aim of the study is to obtain measures of adiposity, glucose, insulin sensitivity and secretion, lipids, inflammation and blood pressure in 7,000 HAPO mother-offspring (aged 8-12) pairs of multiple ethnic/race groups from ten of the original HAPO field centers. (RO1DK061628)

Site Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Years:

2012 - 2017

Use of Multiple Biomarkers with the Risk of Ovarian Cancer Algorithm (ROCA) for Early Detection of Ovarian Cancer in Female Carriers of BRCA1 and BRCA2 mutations

The goal of this prospective recruitment study is to determine if ovarian cancer screening is enhanced by more frequent biomarker testing (CA125 & HE4) versus usual testing frequency in women with BRCA1/2 mutations.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Garfield Memorial Fund

Funding Years:

2016 - 2019