Kaiser Permanente Autism Family Biobank
Kaiser Permanente Autism Family Biobank
This project involves sending 3,751 DNA samples from the KP Autism Family Biobank to Mount Sinai School of Medicine to perform whole exome and whole genome sequencing.
Funder: Mount Sinai School of Medicine
Investigator: Croen, Lisa
Funder: Mount Sinai School of Medicine
Comparing the effects of pharmacological treatment for gestational diabetes on long-term maternal and child health outcomes
Comparing the effects of pharmacological treatment for gestational diabetes on long-term maternal and child health outcomes
This study will use real-world clinical data on pregnancies with gestational diabetes requiring pharmacological treatment to compare the risk of long-term maternal and child health outcomes associated with oral hypoglycemic agents (metformin and glyburide) in comparison to insulin. It will compare the risk of long-term effects of metformin and glyburide versus insulin on child neurodevelopmental and growth trajectory and obesity; compare the risk of long-term effects of metformin and glyburide versus insulin alone on mothers long-term cardiometabolic health (diabetes, diabetes severity and hypertension); and explore whether the risks vary by maternal race/ethnicity or obesity status.
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Investigator: Hedderson, Monique
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
The Relationship between Racial Residential Segregation and Prenatal Depression among US-born and non-US born Pregnant Individuals
Research supports that racial residential segregation is associated with depression, yet findings are inconsistent, sparse (among pregnant individuals), and differ by race, ethnicity, and nativity. The study seeks to explore the relationship between racial residential segregation and risk of prenatal depression diagnosis and severity among Asian, Hispanic, Black, and White US-born and non-US born pregnant individuals.
Funder: KPNC Community Health
Investigator: Kelly-Taylor, Kendria
Funder: Northern California Community Benefit Programs
A retrospective real-world study of treatment patterns and outcomes in pre-term infants 32-37 weeks gestational age with respiratory distress syndrome
A retrospective real-world study of treatment patterns and outcomes in pre-term infants 32-37 weeks gestational age with respiratory distress syndrome
To characterize treatment patterns and outcomes in infants 32-37 weeks with respiratory distress, short term outcomes will include modality of support and duration of treatment and long-term outcomes will include health care utilization in the first year of life and receipt of respiratory medications (diuretics, steroids, bronchodilators). Treatment and outcomes will be examined after stratifying by social determinants of health.
Funder: Chiesi USA
Investigator: Kuzniewicz, Michael
Funder: Chiesi USA
Developing Data Collection Methods to Understand Race-Related Factors Influencing Genital Herpes Infection Reporting and Acceptance of Prescribed Treatments: Uncovering Other Factors Impacting Treatment Effectiveness to Reduce Racial Disparities
Data Collection Methods to Understand Race-Related Factors Influencing Genital Herpes Infection Reporting and Acceptance of Prescribed Treatments
The study seeks to develop data collection methods to determine whether potential race-related factors impacting reporting of genital herpes infection, and acceptance of its treatment exist among African American women.
Funder: KPNC Community Health
Investigator: Li, De-Kun
Funder: Northern California Community Benefit Programs
Gestational Diabetes Screening: Are Changes in Recommended Timing Associated with Perinatal Outcomes?
Optimal screening practices for gestational diabetes in those with risk factors for gestational diabetes are unknown. Some experts recommend early (under 20 weeks gestation) screening plus repeat screening at the standard 24-28 week timeframe if not diagnosed via early screening. More recent data has called this recommendation into question, citing more costs than benefits of early screening. Kaiser Permanente Northern California initiated a recommendation against early screening in April 2020, the effects of which have yet to be studied. The goals of this study are to determine whether the decrease in the proportion of women screened for gestational diabetes before 24 weeks of gestation was safe in relation to maternal and newborn health outcomes that are common gestational diabetes-related complications. This evaluation will inform whether this practice change is safe enough to evolve into a permanent care delivery strategy. We also will compare resource utilization with this new practice compared to the historic strategy.
Investigator: Ferrara, Assiamira
Funder: TPMG Delivery Science Projects Program
UCSF-Kaiser Department of Research Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program
The University of California, San Francisco-Kaiser Permanente Northern California Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program offers mentored training to scholars to advance US women’s health through the study of sex and gender influences in health and disease. The program strengthens interdisciplinary research skills and trains researchers in women’s health for successful careers in team science focused on topics of public health importance, with the ultimate goal of improving women’s health.
Investigator: Ferrara, Assiamira
Funder: National Institute of Arthritis and Musculoskeletal and Skin Diseases
Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging — Extension Study
This study is an extension of the Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC). Our aims are to evaluate patterns of medical imaging and associated radiation exposure in children and adults and to determine the risk of pediatric cancers associated with pediatric exposure to medical imaging, focusing on leukemia and including children born in the health system.
Investigator: Li, De-Kun; Kwan, Marilyn
Funder: University of California, San Francisco (UCSF)
Characterizing uterine fibroid diagnosis and treatment in Asian and Pacific Islander patients
This study will characterize fibroid diagnosis rate, and treatment rate within 5 years of diagnosis, by racial/ethnic group (Asian/Pacific Islander, Black, White, Hispanic, Other) and Asian subgroups (Chinese, Japanese, Filipino, other Southeast Asian, South Asian, Pacific Islander, other/unspecified Asian). The proposed research is expected to provide some of the first evidence about the burden of fibroids among Asians and Pacific Islanders; and identify fibroid health disparities and/or treatment inequities among Asians and Pacific Islanders compared to other groups. The goal of this research is to ensure that Kaiser Permanente Northern California provides equitable access to high quality screening and surgical care for fibroids.
Investigator: Mitro, Susanna
Funder: Northern California Community Benefit Programs
Determining the modifying role of prenatal depression on the association between gestational diabetes mellitus and early childhood obesity
This study will explore the potential modifying (i.e., synergistic) impact of prenatal depression on the association between gestational diabetes mellitus (GDM) and childhood weight trajectories, as well as the risk of childhood obesity across various life stages. We hypothesize that a synergistic effect will occur in children born to mothers who experienced both GDM and prenatal depression during pregnancy, resulting in a more pronounced upward trajectory in childhood BMI and an increased likelihood of obesity at each life stage. We anticipate that the offspring of women facing both conditions will display accelerated weight gain and a higher risk of obesity at each life stage compared to those born to women who had only one or neither of these conditions during pregnancy.
Investigator: Peterson, Alicia
Funder: Northern California Community Benefit Programs
Elucidating the High and Heterogenous Risk of Gestational Diabetes among Asian Americans: An Integrative Approach of Metabolomics, Lifestyles and Social Determinants
This study will leverage the California Alpha-fetoprotein Screening Program (CA-AFSP) and the Pregnancy Environment and Lifestyle Study (PETALS) to identify metabolites and pathways among Asian American racial/ethnic subpopulations with gestational diabetes in the CA-AFSP discovery set; validate the shared and unique metabolites and pathways for gestational diabetes among all and each racial and ethnic subpopulation in PETALS; and examine the role of lifestyle factors and social determinants of health in the racial and ethnic specific GDM-related metabolites and pathways.
Investigator: Zhu, Yeyi
Funder: National Institute on Minority Health and Health Disparities
Early Life Exposure to Endocrine Disrupting Chemicals and Child Growth, Adiposity, and Neurodevelopment
This is a 7-year renewal of our current ECHO Cohort Study Site Early Life Exposures and Child Growth, Adiposity, and Neurodevelopment. We plan to extend the capacity of the ECHO Cohort to further investigate the roles of endocrine disruptor chemicals and health behaviors on child growth, adiposity and neurodevelopment and to follow our 2,000 children and their mothers currently enrolled in our ECHO Cohort and implement the ECHO Cohort Protocol.
Investigator: Ferrara, Assiamira; Croen, Lisa; Hedderson, Monique
Funder: National Institutes of Health
Preconception and Prenatal Health Impacting Factors and Child Health
The study will recruit a diverse cohort of 1,800 pregnant individuals, the conceiving partner, their resulting child, and will follow all of them at multiple visits after the child is born to contribute to the Environmental influences on Child Health Outcomes (ECHO) Program. We will examine the role of in utero exposure to psychological distress and substance use on child growth, adiposity, obesity, and neurodevelopment (ND) and the extent to which prenatal lifestyle factors and neighborhood factors may mitigate these associations. We will clarify the joint effects of maternal prenatal dietary patterns and the 24-hour movement and child growth, obesity, and ND and whether metabolomic signatures prenatally, at birth, and postnatally mediate these associations. There will also be a preconception pilot study to explore the role of maternal and paternal lifestyle factors on infant health to identify critical time periods to intervene on to prevent upstream risk factors for childhood obesity and ND.
Investigator: Hedderson, Monique; Zhu, Yeyi; Avalos, Lyndsay
Funder: National Institutes of Health
Management of Paxlovid eVisits by Pharmacists and Primary Care Physicians
This study will compare pharmacist management of e-visit requests for Paxlovid for COVID-19 with usual care management by primary care physicians regarding costs, time, clinical outcomes, and patient and clinician satisfaction.
Investigator: Lieu, Tracy
Funder: TPMG Delivery Science Projects Program
Understanding facilitators and barriers to achieving glycemic control among a diverse population with gestational diabetes
The SUNRISE project capitalizes on our previous qualitative research that demonstrated our ability to identify facilitators and barriers that contribute to health engagement among patients with gestational diabetes. The proposed supplement widens the potential impact of the parent project beyond the postpartum period. Information gained about gestational diabetes engagement during pregnancy will shed important light on the lived experiences of diverse populations most affected by both suboptimal glycemic control and suboptimal postpartum screening for overt diabetes.
Investigator: Ferrara, Assiamira
Funder: Northern California Community Benefit Programs
Center for upstream prevention of adiposity and diabetes mellitus
The UPSTREAM Center conducts research on the upstream prevention of adiposity and diabetes by identifying risk factors and conducting interventions early in the life to prevent the onset of these conditions. Our focus is on training the next generation of researchers, collaborating with TPMG clinicians to conduct delivery science research, translating findings into clinical care, and interacting with Community Health at Kaiser Permanente to inform health policies.
Investigator: Ferrara, Assiamira
Funder: Northern California Community Benefit Programs
GEARs Combining advances in Genomics and Environmental science to accelerate Actionable Research and practice in ASD
The Autism Centers of Excellence (ACE) program is a trans-NIH initiative that supports large-scale studies on autism spectrum disorder. A priority area for the ACE program is work that will advance our understanding of the biologic mechanisms underlying gene-environment interplay in autism. We intend to create a research consortium with infrastructure to enable the investigation of the interplay of environmental risks with genetic discoveries at scale; build infrastructure for experimental testing of functional biologic impacts of gene-environment interaction; and develop and implement a pipeline for dissemination of findings for primary and secondary prevention efforts.
Investigator: Croen, Lisa
Funder: National Institute of Environmental Health Sciences
Evaluation of the EmbrACE Intervention for Pregnant Adults with a History of Adverse Childhood Experiences
Feasibility study of a 6-week virtual intervention for pregnant women with high adverse childhood experience (ACE) exposure and moderate to moderate-severe depression to reduce perinatal depression symptoms. Study will enroll and randomize participants to the 6-week virtual EmbrACE program or to receive health education resources (active control).
Investigator: Avalos, Lyndsay
Funder: TPMG Delivery Science Projects Program
Wellness coaching during pregnancy and maternal weight outcomes
Study to determine if individuals who participated in Wellness Coaching have lower risk of high gestational weight gain and postpartum weight retention compared with individuals who did not participate in Wellness Coaching. Electronic health record data will be used to assess Wellness Coaching participation (including frequency and timing of participation) and weight outcomes (gestational weight gain and postpartum weight retention).
Investigator: Badon, Sylvia
Funder: KP National Office of Community Health
Associations between Glycemic Control Trajectories among Individuals with Gestational Diabetes and Obesity Risk and Growth Trajectories in the Offspring
The study will examine the association between glycemic control trajectories among individuals with gestational diabetes (GDM) included in the GDM registry and the risk of childhood obesity and growth trajectories in the offspring. Glycemic control trajectories provide unique insights into glycemic control patterns that account for heterogeneity between individuals with GDM and throughout the pregnancy period between GDM diagnosis and delivery.
Investigator: Chehab, Rana
Funder: KP National Office of Community Health
Evaluating patient engagement in “KP Connected Pregnancy Care” and its association with utilization, perinatal outcomes and patient satisfaction.
This cohort study evaluates a new prenatal care delivery pathway, KP Connected Pregnancy Care (KPCPC). KPCPC is an opt-in hybrid in-person and virtual care model using digital tools to expand remote patient monitoring and virtual visits for low-risk prenatal care patients. Study compares participation in KPCPC with standard in-person care pathway and patient satisfaction with prenatal care and health outcomes. It will explore if associations vary among patients at risk for health disparities due to racism or other social determinants of health.
Investigator: Hedderson, Monique
Funder: TPMG Delivery Science Projects Program
Prenatal medication exposure in autism, birth complications and developmental disabilities
Systematically investigate the effects of maternal medication use in pregnancy on offspring autism spectrum disorder (ASD) risk. Test the mechanisms underlying the associations between maternal medication use and ASD. Establish the specificity and generalizability of maternal medication effects on ASD.
Investigator: Croen, Lisa
Funder: National Institute of Child Health and Human Development
Healthcare transition outcomes among autistic youth at KPNC
The study follows a cohort of autistic and non-autistic youth longitudinally to examine several transition indicators measurable in the EHR including: continuation of medications and other treatments during the transition years; length of time elapsed between last pediatric appointment and first adult primary care appointment; and frequency of unnecessary visits to the emergency department and hospitalizations. Evidence will be used to enhance KP’s delivery model for the transition of autistic youth from pediatric to adult health care.
Investigator: Ames, Jennifer
Funder: Northern California Community Benefit Programs
SEED Follow-Up Study
SEED is a case-control study comparing children aged 2-5 years with autism spectrum disorder to children with other developmental disabilities. The SEED Follow-up Study is a longitudinal study designed to improve understanding of risk factors and expression of autism spectrum disorder from childhood through early adulthood. This study will help us better understand how adolescents and young adults with autism spectrum disorder differ from those with other developmental disabilities or from the general population in terms of: 1) Health service needs and utilization, community and social supports, bullying and discrimination, safety and suicide, family and financial impacts, and independence and adaptive behavior; 2) Other outcomes relevant to child age (e.g., planning for exit from high school and vocational training); 3) Self-report of various aspects relevant to relationships and quality of life in adolescence and early adulthood.
Investigator: Croen, Lisa
Funder: Centers for Disease Control and Prevention
Examining the Factors for the Rapid Rise of Colorectal Cancer in Young Adults: Does Increased Medical Use of Radiation and Imaging Technology Contribute to the Rise?
This study is examining whether the secular increase in use of medical radiation therapy and diagnostic imaging technology is associated with the corresponding secular increase in the risk of colorectal cancer among young adults age 50 and under.
Investigator: Li, De-Kun
Funder: Northern California Community Benefit Programs
Motivational Determinants of Postpartum Lifestyle Behaviors, Weight Retention, and Metabolic Syndrome
The proposed study aims to identify affective influences on key lifestyle behaviors (healthy eating and objectively measured self-weighing and physical activity) associated with postpartum weight retention and cardiometabolic profile (e.g., metabolic syndrome). We propose a longitudinal study design within a theory-driven framework that leverages PETALS, an existing population-based cohort. The ultimate objectives of this research are to identify novel, modifiable targets for interventions to improve postpartum weight trajectory and cardiometabolic outcomes among diverse women at risk for cardiovascular health disparities.
Investigator: Ferrara, Assiamira
Funder: National Heart, Lung, and Blood Institute
Comparative Effectiveness of Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity (SMM)
The goals of the study are to determine whether treating GHSV infection in pregnancy, especially earlier in pregnancy, is effective in mitigating the racial disparities in SMM, and GHSV infection, if untreated, contribute to racial disparities in the risk of SMM
Investigator: Li, De-Kun
Funder: Patient-Centered Outcomes Research Institute
Predictive Analytics for Newborn Bilirubin Management
Our objective is to integrate the bilirubin risk prediction model into the automated bilirubin assessment in the laboratory results and provide follow-up guidance on timing of repeat bilirubin testing. We hypothesize that integration of this model will lead to better risk- stratification and a decline in bilirubin testing without an increase in readmissions for phototherapy or severe hyperbilirubinemia. Our specific aims are to compare the 1) mean number of bilirubin results per infant 2) phototherapy readmissions and 3) incidence of severe hyperbilirubinemia among newborns managed using the bilirubin prediction model and automated follow-up recommendations compared to newborns managed at the discretion of individual physicians.
Investigator: Kuzniewicz, Michael
Funder: Northern California Community Benefit Programs
Optimizing a Scalable Intervention to Maximize Guideline-Recommended Diabetes Testing after GDM
We will leverage the multiphase optimization strategy (MOST) to efficiently identify, in a single experiment, which of four components of an outreach intervention motivate women with gestational diabetes to complete a recommended oral glucose tolerance test by 12 weeks and join a health system- or community-based lifestyle program for diabetes prevention.
Investigator: Ferrara, Assiamira
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Harnessing Electronic Health Records to Identify Participants and to Study Health Outcomes in Transition-Age Youth and Adults with Autism Spectrum Disorder
The goal of this K18 award is to determine changes in prevalence of common medical and psychiatric conditions and measures of health care utilization in an existing longitudinal cohort of autistic transition age youth (TAY) and adults within the Kaiser Permanente Northern California system.
Investigator: Croen, Lisa
Funder: National Institute of Mental Health
The Impact of Racial Residential Segregation on the Mental Health of Pregnant Women
We will create a large diverse cohort of more than 360,000 pregnant Black, Hispanic, Asian and white women to: examine the relationship between racial residential segregation and prenatal depression, anxiety and trauma (Aim 1); and prenatal depressive severity (Aim 2). Analyses will be stratified by race/ethnicity. This study has important public health, clinical and policy implications for addressing racial/ethnic mental health inequities in a vulnerable population, pregnant women.
Investigator: Avalos, Lyndsay
Funder: Northern California Community Benefit Programs
Understanding the risk of ectopic pregnancies among people seeking abortion: a retrospective case control study
This study aims to assess the incidence of ectopic pregnancy among people wanting pregnancy compared to people seeking abortion. The specific research questions are: Are people seeking abortion at lower risk of experiencing an ectopic pregnancy compared to people not seeking abortion? What are the unique risk factors for experiencing an ectopic pregnancy among people seeking abortion? How do people seeking abortion who are eventually diagnosed with ectopic pregnancies initially present for care? We will conduct a case-control study using a retrospective review of electronic health records of approximately 2,200 randomly chosen cases of ectopic pregnancies and a comparison group of 1,100 randomly chosen intrauterine pregnancies.
Investigator: Armstrong, Mary Anne
Funder: Fidelity Charitable
Treatment Initiation for New Episodes of Depression in Pregnant Women
This study will use rigorous methods and rich health care data from a diverse, multi-site study population to study psychotherapy and antidepressant treatments for new episodes of depression during pregnancy. Analyses will include examination of infant outcomes and breastfeeding.
Investigator: Avalos, Lyndsay
Funder: National Institute of Child Health and Human Development
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
This randomized controlled trial of an mHealth mindfulness intervention designed for Black and Latinx pregnant women at risk of developing postpartum depression will compare outcomes (depression, stress, sleep) of participants in the intervention with those in the control arm.
Investigator: Kubo, Ai; Avalos, Lyndsay
Funder: National Institute of Mental Health
Standardized ultrasound-based risk stratification for detection of ovarian cancer
This project, initiated in 2014, led to the development and large-scale implementation of a system for risk stratifying ovarian abnormalities seen on ultrasound to ensure that similar abnormalities are described in a similar way by radiologists. The system also allows clinical management to be consistent from patient to patient and aligned with actual ovarian cancer risk. A 2016 study showed the reporting categories defined by the system correlate with distinct levels of ovarian cancer risk. We are currently investigating the risks associated with specific ultrasound characteristics in a low-risk community-based population and how to improve the system to ensure prompt diagnosis of ovarian cancer while avoiding unnecessary surgery for women with benign ovarian cysts.
Investigator: Suh-Burgmann, Betty
Funder: The Permanente Medical Group
Implementation of large-scale HPV self-testing for cervical cancer screening
The goal of this project is to determine the best strategy for integrating a home-testing option for cervical cancer screening. The most sensitive screening test for cervical cancer and precancer is a PCR-based test for human papilloma virus (HPV), which was adopted in June 2020 as the primary screening method for women aged 25-64. Several large clinical trials have demonstrated the samples self-collected by patients for HPV testing are as accurate as samples collected by clinicians. The project aims to assess the acceptability and overall effectiveness of HPV self-testing using a prospective pragmatic cluster-randomized design. The study results will inform which patients are most likely to benefit from a home-testing strategy and factors that influence uptake and completion of screening.
Investigator: Suh-Burgmann, Betty
Funder: The Permanente Medical Group
Cervical Cancer Screening Follow-up
This study will use follow-up data on women with cervical specimens collected in the KPNC/NCI HPV biorepository and women in the cervical cancer screening program to investigate novel biomarkers of cervical pre-cancer and epidemiology of disease progression from HPV infection to cancer.
Investigator: Raine-Bennett, Tina
Funder: National Cancer Institute
Strategies for optimizing video care in a diverse population
This study will describe factors associated with the effective adoption of video visits in adult and family medicine after the start of the Covid-19 pandemic; identify medical centers and primary care physicians with higher-than-expected video visit rates after adjusting for patient demographics; and describe the strategies that account for their success.
Investigator: Lieu, Tracy
Funder: TPMG Delivery Science Projects Program
The Epidemiology of SARS-CoV-2 in Pregnancy and Infancy (ESPI) Network: ESPI-Electronic Cohort
Multisite study to describe the incidence, clinical presentation, treatment, clinical course, and outcomes of COVID-19 among pregnant women and up to six months postpartum, and estimate the incidence of COVID-19 hospitalizations and medically attended ambulatory care visits (including telehealth) during pregnancy and for infants up to six months of age.
Investigator: Li, De-Kun
Funder: Centers for Disease Control and Prevention
The Study of Women’s Health Across the Nation (SWAN)
SWAN VI aims to elucidate menopause transition characteristics and trajectories of midlife health markers (inflammation, metabolic and cardiovascular risk factors, body composition, and bone, genitourinary, and vascular health) that are related to the preservation of physical and cognitive functioning, avoidance or delay of adverse health outcomes, and enhancement of social and psychological well-being, all of which will optimize successful aging.
Investigator: Hedderson, Monique
Funder: National Institute on Aging
Blood Pressure, Obesity, and Diabetes in Relation to Perinatal and Postpartum Complications
By leveraging the KPNC Gestational diabetes and Glucose Tolerance Registry, which includes rich data on blood glucose levels, obesity, gestational weight gain, we will add blood pressure levels for the earliest years to evaluate the individual and joint impact of pregnancy blood pressure, blood glucose, and obesity categories on perinatal complications and examine whether associations of pregnancy blood pressure, blood glucose, and obesity categories with perinatal complications vary by race/ethnicity in the pregnant women in the KPNC integrated health care system.
Investigator: Zhu, Yeyi
Funder: National Heart, Lung, and Blood Institute
Can hydroxychloroquine prevent preeclampsia and preterm delivery in lupus pregnancy?
Pregnant women with lupus are at high risk to develop preeclampsia and preterm delivery. This work leverages three large population-based databases with detailed prescription and clinical data to determine whether use of hydroxychloroquine during pregnancy among women with lupus reduces the risk of preeclampsia and preterm delivery disentangling these outcomes from the effects of potential mediators. This study will provide key information on hydroxychloroquine use and prescription practices to improve the analytic paradigm and inform our clinical understanding hydroxychloroquine use in lupus pregnancy.
Investigator: Hedderson, Monique
Funder: National Institute of Arthritis and Musculoskeletal and Skin Diseases
Maternal Health in Pregnancy and Autism Risk – Genetic and Non-genetic Mechanisms
This study will systematically identify maternal diagnoses in pregnancy associated with autism spectrum disorder (ASD) in offspring; test if the association between maternal diagnoses and ASD is due to shared genetic factors using family data; and test the association between maternal diagnoses in pregnancy and child’s genetic liability for ASD.
Investigator: Croen, Lisa
Funder: National Institute of Mental Health
Autism Specific Patterns of DNA Methylation from Birth to Age 5
This study will examine potential differences in DNA methylation (DNAm) in early life, from birth through age 5, between children who are ultimately diagnosed with autism spectrum disorder and those typically developing. Results from this work will inform whether a large-scale effort for evaluating longitudinal DNAm and epigenetic clock changes in ASD is necessary.
Investigator: Croen, Lisa
Funder: National Institute of Child Health and Human Development
Autism Intervention Research Network on Physical Health
Establish an interdisciplinary Autism Intervention Research Network on Physical Health node that will lead, promote, and coordinate national research activities to improve the physical health and well-being of individuals with autism spectrum disorder across the lifespan, including children and adolescents as they transition to adulthood. The focus of this node is gender, sexuality, and reproductive health of autistic adults.
Projects include needs assessments, design of multi-site intervention research studies, small grants funding to facilitate training and mentorship to diverse new investigators, and publication of annual research supplement.
Investigator: Croen, Lisa
Funder: Health Resources and Services Administration
Interactions of Environmental Chemical Mixtures, Genetics, and Immune Pathways in Autism Spectrum Disorder
The goal of this K99/R00 Pathway to Independence Award is to receive mentored training in polygenic GWAS tools and complex mixtures modeling to position my career toward understanding the roles of GxE interactions and immune disruption in the etiology of autism spectrum disorder(ASD). This research will examine the interplay of cumulative exposure to endocrine-disrupting chemicals (EDCs), immune markers (cytokines/chemokines), and ASD; examine genetic (maternal and fetal) influences on mid-pregnancy circulating levels of EDCs; and combine K99 methodologic training in polygenic and complex mixtures tools to a study of GxE interactions in ASD. The K99 research will use data from the Early Markers for Autism study (EMA) with possible extension to the NIH ECHO or KPRB Birth Cohort studies during the R00 phase.
Investigator: Ames, Jennifer
Funder: National Institute of Environmental Health Sciences
Understanding Barriers to Reproductive Health Care among Women with Autism Spectrum Disorder
This project will examine both reproductive health disparities and OB/GYN health care gaps for 2300 adolescent and adult women with Autism Spectrum Disorder (ASD) receiving care at Kaiser Permanente Northern California, paying particular attention to differences across sociodemographic characteristics, co-occurring psychiatric and physical health conditions, and type and frequency of other interactions with the health care system. We will also characterize the epidemiology of pregnancy and obstetrics care utilization including frequency of recommended prenatal visits, screenings, and perinatal complications among women with ASD compared with a control sample of neurotypical women. Our findings will inform development of strategies for improving provider knowledge, care practices, and effective health care delivery for this vulnerable population.
Investigator: Ames, Jennifer
Funder: National Institute of Child Health and Human Development
COVID-19 Related Changes in Health Care Delivery and Health Outcomes Among Pregnant Women and Their Newborns
This study will examine the impacts that COVID-19 pandemic related changes in health care delivery had on health outcomes among pregnant women and their newborns in Kaiser Permanente Northern California. The study will also evaluate the clinical course of COVID-19 during pregnancy and its impact on health outcomes.
Investigator: Ferrara, Assiamira
Funder: TPMG Delivery Science Projects Program
Barriers to Obstetric/Gynecological Health Care for Women with Autism Spectrum Disorders
This study will identify the sociodemographic and health factors associated with low utilization of obstetrics/gynecology services among adult women with autism spectrum disorders and explore whether these women are at higher risk of adverse maternal and birth outcomes than women who do not have autism spectrum disorder.
Investigator: Ames, Jennifer
Funder: Northern California Community Benefit Programs
Using a 24-Hour Movement Framework to Improve Pregnancy Outcomes
The goal of this K99/R00 Pathway to Independence Award is to better understand associations of 24-hour movement profiles during pregnancy (consisting of physical activity, sedentary behavior, and sleep) and maternal and infant outcomes. This Award includes training in the analysis of accelerometer-measured physical activity data, compositional data analysis, sleep physiology and measurement, and collection of quantitative data.
Investigator: Badon, Sylvia
Funder: National Institute of Child Health and Human Development
Comparing the Effects of Prenatal Depression and its Treatment on Developmental Outcomes of the Offspring
This study will test the hypothesis that the underlying prenatal depression and use of SSRIs are independent risk factors for adverse neurodevelopmental outcomes. The aims of this study are: 1) evaluate the effect of untreated prenatal depression, compared to no prenatal depression, on neurodevelopmental outcomes of the offspring, after adjustment for confounders; 2) evaluate the effect of treatment for prenatal depression with SSRIs on neurodevelopmental outcomes of the offspring; 3) on a subsample of 2,000 children, evaluate prenatal depression and its treatment in parental interviews to identify less severe neurodevelopmental outcomes.
Investigator: Avalos, Lyndsay
Funder: National Institute of Child Health and Human Development
Racial/Ethnic Disparities in Perinatal Depression Treatment Utilization
The study will characterize racial/ethnic differences in perinatal depression treatment utilization, treatment engagement, and continued care by assembling a retrospective cohort of KPNC members entering prenatal care between 2012-2016. The study will also identify barriers to and facilitators of treatment utilization and opportunities for improvement in care delivery.
Investigator: Avalos, Lyndsay
Funder: Northern California Community Benefit Programs
Understanding racial-ethnic disparities in preterm birth sub-types and prenatal care utilization
The study will examine racial-ethnic disparities in the risk of preterm birth overall and by preterm birth sub-types. It will also study whether the racial-ethnic disparities in preterm births and preterm birth sub-types are modified by the level of prenatal care received.
Investigator: Hedderson, Monique
Funder: Northern California Community Benefit Programs
Maternal Marijuana Use During Pregnancy, Marijuana Legalization, and Adverse Obstetrical and Neonatal Outcomes: A 12-year Cohort Study (COVID-19 Revision)
As of March 26, 2020, there have been more than 80,000 cases and 1,000 deaths in the US due to COVID-19. Because it attacks the lungs, COVID-19 could be an especially serious threat to those who smoke or vape tobacco or cannabis. This study will use data from the Kaiser Permanente Northern California universal prenatal substance use screening program to examine whether women who use substances before or during pregnancy are at increased risk for COVID-19 onset and progression. We will also look at whether prenatal substance use rates rise during the pandemic overall or within certain subgroups, such as women with depression, anxiety, or low socioeconomic status.
Investigator: Young-Wolff, Kelly
Funder: National Institute on Drug Abuse
COVID-19 Response Grant
Adults with intellectual or developmental disabilities may be especially impacted by the ways the COVID-19 pandemic has led to drastic changes in usual daily routines and the way healthcare encounters have been transitioned to virtual (video, telephone) visits. This project will characterize healthcare utilization and health status among adults with autism spectrum disorders (ASD) during the COVID-19 pandemic, comparing to similar indices in the pre-COVID period. Among adults with chronic health conditions that require ongoing management (such as diabetes, heart disease, or mental health conditions), we will also compare healthcare utilization between adults with and without ASD.
Investigator: Croen, Lisa
Funder: Special Hope Foundation
Impact of In Utero Marijuana Exposure on Neurodevelopment, Behavior and Mental Health: A Longitudinal Birth Cohort Study
This study will investigate whether maternal prenatal marijuana use increases the risk of impairments in a child’s executive functioning and mental health, after accounting for other factors such as tobacco, alcohol, and other drug use; socioeconomic status, and maternal mental health postpartum. We will look at both the independent effects of prenatal marijuana use and the synergistic effects of concomitant substance use as well as differential effects by infant sex.
Investigator: Avalos, Lyndsay; Young-Wolff, Kelly
Funder: National Institute on Drug Abuse
Neurodevelopmental outcomes in infants receiving opioid-replacement
Infants with Neonatal Opioid Withdrawal Syndrome (NOWS) are often treated with prolonged opioid-replacement pharmacotherapy. Whether opioid exposure in-utero or significant opioid exposure used to treat withdrawal symptoms impacts neurodevelopmental outcomes is unknown. Our aim is to evaluate neurodevelopmental outcomes at ages 24-72 months in infants who received opioids-replacement pharmacotherapy (treated NOWS infants), compared to those who did not receive pharmacotherapy (untreated NOWS). Our secondary aim is to evaluate maternal demographic and clinical characteristics as potential risk modifiers associated with adverse neurodevelopmental outcomes.
Investigator: Kuzniewicz, Michael
MAESTRA: Maternal Antecedents of Encephalopathy in Term Infants
This study tests the hypothesis that established NICHD-approved electronic fetal monitoring (EFM) features used as standard care in the U.S. and other developed countries can exhibit improved sensitivity and specificity for predicting HIE when they are combined with novel EFM features that will be discovered by advanced signal processing and machine learning techniques. This study will abstract a large amount of detailed maternal, infant and fetal data from the electronic medical records of infants born at ≥ 36 weeks gestation in 2010-2020 at Kaiser Permanente Northern California.
Investigator: Kuzniewicz, Michael
Funder: National Institute of Child Health and Human Development
Does Centering Pregnancy impact patient satisfaction with prenatal care and maternal health and behavioral outcomes?
This longitudinal study of 350 women seeking prenatal care in Kaiser Permanente Northern California will compare patient satisfaction with prenatal care, maternal health and behavioral outcomes between women in group prenatal care (Centering Pregnancy) and traditional prenatal care
Investigator: Avalos, Lyndsay
Funder: TPMG Delivery Science Projects Program
ECHO Coordinating Center: Opportunities and Infrastructure Fund Component
The overall goal of this project is to demonstrate that the newly FDA-approved Airwave Oscillometry System (tremoFlo c-100, Thorasys) can be used to reliably and easily obtain lung function measurements in ECHO cohorts and that these oscillometry measures of respiratory resistance and compliance are important outcomes in relating pre-, peri-, and postnatal exposures to respiratory health throughout childhood.
Investigator: Ferrara, Assiamira
Funder: National Institutes of Health, Office of the Director
Exogenous surfactant utilization for respiratory failure in late and moderately preterm infants: impact on short- and long-term outcomes
The goal is to define and refine the current epidemiology, clinical characteristics, and treatment practices in respiratory failure in late and moderately preterm Infants. Specific aims include determining the incidence and epidemiology of respiratory failure in the neonates born at 32-36 weeks of gestation, describing disease severity and respiratory support by diagnostic category; describing the use of surfactant replacement therapy; and assessing the impact of surfactant replacement therapy on length of respiratory support, length of hospitalization, and respiratory outcomes in the first year of life.
Investigator: Kuzniewicz, Michael
Funder: Chiesi USA
Preventing Postpartum Depression: Exercise as Medicine
This intervention study will randomize 200 postpartum women at increased risk of postpartum depression to an eHealth physical activity intervention and assess the efficacy of the intervention on increasing physical activity and decreasing postpartum depressive symptoms. Additionally, this study will identify actionable areas for implementation of this eHealth intervention in an integrated health care delivery system.
Investigator: Avalos, Lyndsay; Badon, Sylvia
Funder: KP-NBA Partnership
Prenatal Depression and Antidepressant Exposure: Effects on Child Speech and Language Disorders
The aims of this study are to 1) Assess the relationship between untreated prenatal depression and the risk of speech and language disorders of offspring; 2) Compare the effectiveness of treatment of prenatal depression on speech and language disorders of offspring; 3) Evaluate whether the timing and duration of SSRI use during pregnancy is related to child speech and language disorders; and 4) Assess the extent to which these relationships differ by infant sex.
Investigator: Avalos, Lyndsay
Funder: Northern California Community Benefit Programs
Fetal Programming of Growth and Obesity: A Metabolomics Approach
This proposal uses a novel holistic framework that leverages both targeted and untargeted metabolomics approach, electronic health records data, and bioinformatics analytics to investigate the mechanisms by which the in-utero environment may infer risk of fetal growth extremes and altered infant growth trajectories and excess adiposity. It will also explore metabolomic signatures for maternal dietary factors during pregnancy, as a means to objectively capture dietary exposures in utero.
Investigator: Zhu, Yeyi
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Cluster-randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight and Obese Women
This randomized trial will test whether the implementation of an mHealth tool in the health-plan setting increases the proportion of overweight and obese women with appropriate total gestational weight gain, according to Institute of Medicine (IOM) guidelines in comparison to usual care. Primary outcomes include the proportion of women with total gestational weight gain meeting the IOM guidelines and the rate of gain from the first trimester to delivery (in kilograms per week).
Investigator: Hedderson, Monique
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Investigation of Prevalence of and Barriers to Achieving Optimal Glycemic Control among Women with Gestational Diabetes
This project aims to demonstrate that sufficient, high quality glycemic control data are available for investigating the determinants of and barriers to glycemic control among women with gestational diabetes in a cohort of 30,000 women at Kaiser Permanente Northern California from 2007-2017.
Investigator: Zhu, Yeyi
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Risk Prediction of Gestational Diabetes Treatment Modalities Utilizing Clinical and Laboratory Data in the EHR
This study aims to utilize data from the Kaiser Permanente Northern California Gestational Diabetes and Pregnancy Glucose Tolerance Registry for a cohort of 25,000 women diagnosed with gestational diabetes. The goal is to determine whether clinical and laboratory factors can be utilized to predict treatment modalities for this disease (medical nutrition therapy, glyburide, or insulin).
Investigator: Zhu, Yeyi
Funder: National Institutes of Health
Maternal Marijuana Use During Pregnancy, Marijuana Legalization, and Adverse Obstetrical and Neonatal Outcomes: A 12-year Cohort Study
The goal of this application is to examine the association between maternal marijuana use during pregnancy and adverse obstetrical and neonatal outcomes. We aim to: 1) Examine trends in prenatal marijuana use following the legalization of marijuana for recreational purposes in California; 2) Assess whether maternal marijuana use during pregnancy is associated with the risk of adverse maternal health and pregnancy outcomes; and 3) Assess whether maternal marijuana use during pregnancy is associated with the risk of adverse fetal and neonatal outcomes.
Investigator: Young-Wolff, Kelly; Avalos, Lyndsay
Funder: National Institute on Drug Abuse
Atopic Dermatitis Standing Cohort Using a Cohort of Kaiser Permanente Northern California Members
A cohort study of Kaiser Permanente Northern California patients with moderate-to-severe atopic dermatitis (AD) will be used to estimate baseline characteristics and background incidence rates of safety events. Data from this study will provide valuable information regarding the current incidence rates of adverse outcomes among patients with AD. Safety events of interest include: viral reactivation, malignancies, lymphoproliferative disorders, thrombocytopenia, major/minor bleeding events, major adverse cardiovascular events, alterations in lipid profiles, and thromboembolism.
Investigator: Hedderson, Monique
Funder: Pfizer Inc.
Expansion of Division of Research Perinatal Research Unit (EXPPRU)
Dedicated quantitative analytic support for obstetrics has not been available in Kaiser Permanente Northern California. An unusual opportunity has appeared: as a result of a project to develop a predictive model for obstetric complications, considerable development work has been conducted by a Division of Research (DOR) team. If linked to an ongoing program, the DOR Perinatal Research Unit, this development work could permit our region to enhance its ability to conduct sophisticated quantitative quality-assurance and utilization management in obstetrics.
This study will explore the opportunity to expand the extraordinarily successful Perinatal Research Unit so that it could monitor obstetrics, not just neonatology. In addition to the funds requested here, TPMG has committed to providing MD time.
Investigator: Kuzniewicz, Michael
Funder: Kaiser Permanente Program Offices
Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing after Gestational Diabetes Mellitus
Guideline-recommended postpartum screening is a critical step toward diabetes prevention after a diagnosis of gestational diabetes mellitus (GDM). However, patient uptake of postpartum screening remains suboptimal and uneven across racial/ethnic groups. This creates a missed opportunity for diabetes prevention or early treatment, particularly among minority women at highest risk. The goals of this project are to identify, refine, and assess the acceptability of individual components of a theory-driven outreach intervention that is feasible to implement in health system settings and designed to motivate racially/ethnically diverse women with GDM to complete postpartum screening. The results will inform future research aimed at equitably increasing screening uptake among diverse women at high risk for diabetes.
Investigator: Brown, Susan
Funder: Northern California Community Benefit Programs
Study on the Association of Uterine Perforation and IUD expulsion With Breastfeeding Status at the Time of IUD insertion and Postpartum Timing of IUD Insertion in Electronic Medical Record Databases – A Post-marketing Requirement for Mirena
The Food and Drug Administration (FDA) has required Bayer AG to conduct a post-marketing study in the U.S. to determine the incidence of uterine perforation and IUD expulsion by type of intrauterine device (IUD) used. The goal of this study is to quantify the risk of uterine perforation and IUD expulsion by: (1) breastfeeding status at the time of IUD insertion, (2) time periods postpartum when the IUD was inserted (e.g., 6 weeks or less, after 6 weeks and up to 14 weeks, more than 14 weeks and up to 52 weeks, or more than 52 weeks), and (3) type of IUD.
Investigator: Armstrong, Mary Anne
Funder: Bayer AG
Maternal Inflammation during Pregnancy and Neurodevelopmental Disorders
This study will utilize the Pregnancy Cohort from the Kaiser Permanente Northern California Research Program on Genes, Environment and Health to characterize the maternal immune profile over pregnancy and evaluate whether there are specific longitudinal patterns that are associated with neurodevelopmental outcomes in the offspring. The project will identify factors that are associated with longitudinal patterns of maternal immune markers over pregnancy and examine whether there is variability in risk factors across different neurodevelopmental outcomes. Factors to be examined include maternal demographic, lifestyle, clinical, and genetic factors.
Investigator: Croen, Lisa
Funder: National Institute of Child Health and Human Development
Optimizing Social Communication Measurement with the Social Responsiveness Scale
This project aims to: 1) compare the psychometric characteristics (including distributional properties, agreement with gold-standard diagnostic measures, and sensitivity and specificity) of short versus full Social Responsiveness Scale (SRS) scores, using existing child SRS data from the Environmental influences on Child Health Outcomes (ECHO) study; 2) use existing SRS data in ECHO to compare the performance of short versus full SRS scores in analyses of established risk factors for autism spectrum disorder (gestational age and parental age), as well as in assessment of familiality of scores (previously established for the full scale) in cohorts with available parental scores; and 3) A) develop a computer-adaptive testing (CAT)-based SRS, and B) conduct a separate validation of the 16-item short form administered as a standalone questionnaire (rather than relying on short form scores derived from responses to the full SRS) and of the newly developed CAT-based SRS in separate clinical and general population samples of children aged 3 to 5 years.
Investigator: Croen, Lisa
Funder: National Institutes of Health, Office of the Director
Incidence and Trend of Ectopic Pregnancy and Contraceptive Use
Incidence and management of ectopic pregnancy have undergone significant changes in recent decades. There is a general consensus that available effective contraceptive methods reduce the absolute risk of ectopic pregnancy. Ectopic pregnancy incidence rate has not been well-documented in the last decade, and the mix of methods of contraceptives used has changed significantly over this time period. The goal of this project is to assess the feasibility of and generate data using electronic health records on ectopic pregnancy incidence, risk factors, and management trends in the general population and in women using select contraceptive methods, particularly intrauterine devices.
Investigator: Raine-Bennett, Tina
Funder: Bayer AG
Surgical Referral and Outcomes Following Large-Scale Implementation of Standardized Ultrasound Reporting of Adnexal Masses
Investigator: Suh-Bergmann, Betty
Funder: The Permanente Medical Group
Improving Post-Discharge Bilirubin Management in Newborns
There is variation and overuse in bilirubin testing among newborns. Multiple repeat testing occurs despite most newborns being at low risk for reaching bilirubin levels that would require phototherapy. Among the Kaiser Permanente birth population, 45 percent have two or more tests and 10 percent four or more tests. While the tests themselves are relatively inexpensive, the burden on families is significant, given the need to bring their newborns into outpatient clinics for repeat testing and the stress of worrying about hyperbilirubinemia. Evidence-based approaches for repeat testing are lacking. The aims of this study are to develop total serum bilirubin nomograms based upon gestational age, develop predictive models for reaching bilirubin levels above the 95th percentile during the first week of life to guide clinicians on the need and timing of post-discharge bilirubin testing, and assess the utility of bilirubin screening at less than 24 hours of age.
Investigator: Kuzniewicz, Michael
Funder: Northern California Community Benefit Programs
Extremely Premature Births Cohort Study
The goal of this study is to understand the incidence of extremely preterm birth and associated adverse health conditions and growth abnormality.
Investigator: Li, De-Kun
Funder: Shire plc
Email Management Strategies and Stress Among Primary Care Physicians
Email between patients and physicians has enhanced health care service but has made many primary care physicians feel overloaded. Many physicians multitask throughout the day by responding to email while seeing patients for in-person, telephone, and video visits. Many gaps in understanding exist about how to reduce stress associated with email in health care settings. The aims of this study are to 1) examine observed patterns of email management and multitasking based on computerized data, 2) describe the range of strategies physicians report using to manage email via a qualitative study, and 3) evaluate the extent to which email management patterns and strategies are associated with stress, as measured by self-report on a structured survey and heart-rate monitoring. This study’s results will offer guidance on how physicians may reduce stress associated with email management. The findings will also inform the design of a future interventional study to facilitate effective email management.
Investigator: Lieu, Tracy
Funder: The Permanente Medical Group
Pregravid Biomarkers and Risk of Gestational Diabetes Mellitus Risk, Fetal Growth and Progression to Diabetes
This study will examine pregravid biomarkers of metabolic risk (adiponectin, high molecular weight adiponectin, c-reactive protein, liver enzymes, fetuin-A and LDL particle size) in relation to risk of gestational diabetes mellitus among women who participated in the Kaiser Permanente Northern California (KPNC) multiphasic health check-up (1985-1996) and had a subsequent pregnancy in KPNC.
Investigator: Hedderson, Monique
Funder: National Institute of Child Health and Human Development
Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
This study will estimate the incidence of pulmonary hypothyroid in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
Investigator: Hedderson, Monique
Funder: Bayer AG
Glyburide Versus Insulin for the Treatment of Women with Gestational Diabetes in Kaiser Permanente Northern California
We aim to compare the effectiveness and safety of glyburide and insulin at improving neonatal and maternal outcomes among women with gestational diabetes mellitus (GDM) requiring medication therapy in Kaiser Permanente Northern California from 2007 to 2016. We will use a cohort study design including women with GDM diagnosed from 2007 to 2016 where treatment groups contrasted are defined by therapy regimens (i.e., insulin versus glyburide or early versus late initiation of glyburide). This project will overcome shortcomings of past studies conducted in this area by using modern statistical methods that allow us to take advantage of variation in treatment patterns after the implementation of the universal Perinatal Center referral policy in 2007. More specifically, our approach consists of a cohort study with time-varying exposure to insulin and glyburide during pregnancy.
Investigator: Hedderson, Monique
Development and Testing of a Mobile-Health (m-health) Intervention tool to Help Obese Women Achieve Appropriate Gestational Weight Gain
To determine whether a mobile-health (m-health) tool (accessible via smartphone or website) intervention for obese pregnant improves patient satisfaction with their gestational weight gain, quality of life, stress and depression during pregnancy. Provider satisfaction with discussing gestational weight gain among their patients who used the m-health tool will also be assessed.
Investigator: Hedderson, Monique
Funder: The Permanente Medical Group
Study to Assess the Incidence of Type 1 Diabetes in Young Adults
This project with multiple principal investigators will address the following aims: 1) Develop and implement a case ascertainment strategy for the rapid, timely and complete identification of new onset diabetes cases among young adults; 2) Develop and implement procedures for the measurement of diabetes autoantibodies; 3) Establish a diverse, population-based registry of incident cases of diabetes among young adults; 4) Determine the incidence of type 1 diabetes.
Investigator: Ferrara, Assiamira
Funder: Centers for Disease Control and Prevention
New Opportunities to Prevent Diabetes in the Workplace
The study seeks to compare weight loss outcomes and patient engagement in two interventions derived from Diabetes Prevention Programs.
Investigator: Ferrara, Assiamira
Funder: Kaiser Foundation Hospitals
Comparative Effectiveness of Diabetes Prevention Strategies in Women with Gestational Diabetes Mellitus
It is a cluster randomized lifestyle intervention trial that assesses the effect of an organizational-level intervention on weight management in GDM patients. Randomization will occur at the medical center level; 44 medical centers of Kaiser Permanente Northern California (KP) will participate and data will be collected for more than 2,400 pregnant women with GDM. The intervention will be compared to usual care.
Investigator: Ferrara, Assiamira
Funder: Agency for Healthcare Research and Quality
Autism Adaptive Community-Based Treatment to Improve Outcomes Using Navigators (ACTION) Network
One of the greatest challenges in autism treatment is how to bridge the health care science-to-service gap and address disparities in access to evidence-based early intervention for children with autism spectrum disorder. This project will establish a new interdisciplinary network of eight institutions to blend implementation and clinical effectiveness research designs, with an overarching aim to study the individual and combined effects of three intervention components: 1) Infusing mobile technology for professional development and family education using the Autism Navigator collection of web-based courses and tools; 2) Engaging families to access resources and support when they first learn their child has autism spectrum disorder, using a brief engagement intervention by community healthcare workers as family navigators to accelerate access to care; and 3) Coaching families to embed evidence-based intervention strategies in everyday activities using the Early Social Interaction Parent Coaching model to improve outcomes for toddlers with autism spectrum disorder.
Investigator: Croen, Lisa
Funder: National Institutes of Health
Barriers to Health Care in a Latino Population with Autism Spectrum Disorder
This study will identify barriers to the use of recommended assessment, diagnostic, and treatment services among Latino children and adolescents with autism spectrum disorder. The study population will comprise Kaiser Permanente Northern California Latino members, and comparisons will be made between commercially insured versus federally insured (Medicaid) patients, and English versus Spanish speakers.
Investigator: Croen, Lisa; Gordon, Nancy
Funder: Northern California Community Benefit Programs
Understanding Patient Engagement in Lifestyle Programs for Diabetes Prevention among Women with a Recent History of GDM
While lifestyle programs to prevent type 2 diabetes are increasingly available, the drivers of patient engagement in them remain poorly understood. This study aims to identify characteristics of patient subgroups at risk for poor engagement, providing a basis for future targeted outreach efforts among women with a history of gestational diabetes.
Investigator: Brown, Susan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Prenatal Exposure to Metals and Risk for Autism Spectrum Disorder in MARBLES and EARLI
The peri-conceptual and prenatal periods of gestation are the most likely window of susceptibility for ASD; thus, maternal exposures and maternal genetic susceptibility are critical targets of investigation. Maternal exposure to heavy metals has been recognized for many years as a cause of fetal harm, particularly neurodevelopmental. In this study, we combine two prospective, enriched risk, pregnancy cohorts with available pregnancy and birth biosamples for metals and genetic measurement, with early-life developmental phenotype data, with age 3 ASD diagnosis status assessed by ASD researchers, and enough outcomes to provide adequate power given the enriched design. Further, we consider the utility of epigenetic measures in the study of these environmental risk factors, given evidence of the susceptibility of DNA methylation changes from metals exposure and the potential role of DNA methylation as a mediator of ASD risk or as a post-natal biomarker of metals exposure.
Investigator: Croen, Lisa
Funder: National Institute of Environmental Health Sciences
Health System Integration of Tools to Improve Primary Care for Autistic Adults
The objective of this project is to use a CBPR approach to understand how to best integrate the AASPIRE Healthcare Toolkit, an online healthcare toolkit aimed at improving primary care services for autistic adults, into the KP Northern CA healthcare system as we prepare for the larger effectiveness-implementation trial. We will do so by achieving the following specific aims: 1) To determine how to integrate use of the toolkit into the Kaiser systems. 2) To assess the acceptability and feasibility of both the intervention and the research protocols. 3) To further explore potential mechanisms of action.
Investigator: Croen, Lisa
Funder: National Institute of Mental Health
Understanding Family Economic Impact of Chronic Child Health Conditions
This study will address an important knowledge gap by estimating financial and time costs for families of children with autism. We will recruit 1,500 families of children 3-17 years old from geographically and ethnically diverse integrated health systems: Kaiser Permanente Northwest, Kaiser Permanente Northern California, Kaiser Permanente Georgia, Kaiser Permanente Hawaii and the OCHIN network of federally qualified health plans. Using the Family Economic Impact Interview, we will follow participating families for one year to collect information on family costs and examine what factors contribute to these costs.
Investigator: Croen, Lisa
Funder: National Institute of Child Health and Human Development
Risk of NTD among Live Births Exposed to Maternal Rx Opioids during Early Pregnancy
The objectives of this study are: 1) To measure the association between in utero exposure to prescription opioids during early pregnancy and primary neurulation defects. 2) To evaluate whether the risk of primary neurulation defects (i.e., craniorachischisis, anencephalus, and myelomeningocele) differs among live births exposed compared to live births unexposed to maternal prescription opioids from 18 to 56 days after last menstrual period.
Investigator: Li, De-Kun
Funder: U.S. Food and Drug Administration
Prenatal SSRI Exposure, Maternal and Child Genotype, and Autism Spectrum Disorders
The prevalence of Autism Spectrum Disorders (ASD) has increased rapidly over recent decades. Among many environmental exposures that have also increased in frequency is the use of anti-depressant medications during pregnancy. Approximately 10% of pregnant women are prescribed selective seratonin reuptake inhibitors (SSRIs) SSRIs and other anti-depressant medication cross the placenta and are secreted in breast milk, thus raising concerns about adverse effects on the fetus or infant. This study will expand upon previous findings of an association between prenatal SSRI exposure and autism risk by utilizing data and biospecimens already collected in the SEED study to explore main and joint effects of maternal antidepressant use, maternal psychiatric disease history, and maternal and child genetic susceptibility.
Investigator: Croen, Lisa
Funder: National Institute of Child Health and Human Development
Prospective Evaluation of Air Pollution, Cognition and Autism from Birth Onward
This study will examine the relationship between perinatal and early life air pollution exposure and early longitudinal measures of cognitive ability and ASD in two prospective samples – Markers of Autism Risk in Babies, Learning Early Signs (MARBLES) and Early Autism Risk Longitudinal Investigation (EARLI). Aim 1 is to assign air pollutant exposure using geographic information systems (GIS) technology and novel biomarker measurements. Aim 2 is to examine the effect of air pollutant exposure on the trajectory of cognitive development. Aim 3 is to evaluate the effect of air pollution exposure on cross-sectional and longitudinal measures of autistic traits and ASD diagnoses.
Investigator: Croen, Lisa
Funder: National Institute of Environmental Health Sciences
Neurodevelopment of Cognitive Control in Autism: Adolescence to Young Adulthood
This study compares the developmental trajectory of behavioral measures of cognitive control from adolescence into young adulthood in typical individuals (TYP) and individuals with Autism Spectrum Disorder (ASD). We predict that approximately 2/3 of those with ASD will show a persistent lag in performance on cognitive control tasks through young adulthood, and that in those with ASD, cognitive control abilities will predict performance in complex information processing. We will also examine the development of the neural mechanisms of cognitive control from adolescence to young adulthood. We hypothesize that those with ASD will employ more reactive cognitive control than their TYP counterparts. Lastly, we will investigate relationships between the two modes of cognitive control, and functional and mental health outcomes between adolescence and young adulthood in the ASD group.
Investigator: Croen, Lisa
Funder: National Institute of Mental Health
Prenatal, Intrapartum and Infant Antibiotic Use and Atopic Diseases in Childhood
This study has the following aims: 1) Assess prenatal, intrapartum and infant antibiotic exposure in relation to atopic dermatitis, allergic rhinitis and asthma. 2) Assess bias due to reverse causality, confounding by early life respiratory infections, and confounding by unmeasured or poorly measured maternal and child factors such as healthcare-seeking behaviors.
Investigator: Li, De-Kun
Funder: National Institute of Allergy and Infectious Diseases
Discovery of Pharmacogenomic Biomarkers for Metformin Response
The primary goal of this multi-site study is to identify genetic variants that impact response to metformin in patients with diabetes from multiple ethnic groups in the U.S. and Europe
Investigator: Hedderson, Monique
Funder: National Institute of General Medical Sciences
Incidence of Osteoporosis and Abnormal Lipid Profiles in Women Over Age 40, Who Test Positive for a BRCA1 or BRCA2 Mutation and Have Had a Risk-Reducing Salpingo-oophorectomy
This cohort study will use DXA scans to: 1) establish the incidence of abnormal DXA scans in women post testing positive for BRCA1 or 2 mutations who have undergone risk-reducing salpingo-oophorectomy (RRSO); and 2) identify risk factors for abnormal DXA tests. The study will also examine lipid profiles to: 1) establish the incidence of abnormal lipid profiles in women post testing positive for BRCA1 or 2 mutations who have undergone RRSO; and 2) identify risk factors for abnormal lipid profiles. Secondary aims are to evaluate the incidence of adverse health outcomes in women with BRCA mutations, undergoing RRSO, including sexual dysfunction, menopausal symptoms, increase in BMI, development of hypertension, hyperlipidemia, diabetes, depression, new cancers, including BRCA-related (ovary/peritoneal, breast, melanoma) and other cancers, and identify risk factors which are associated with adverse outcomes.
Investigator: Raine-Bennett, Tina
Funder: Kaiser Permanente Institutional Planned Giving
Folic Acid Prevention Pathways for ASD in High Risk Families
Autism spectrum disorders affect 1 in 68 children in the US. There is evidence for a potentially large role for the early in-utero environment, including gestational nutrition, in ASD etiology. Maternal folic acid is one of the first modifiable factors with the potential to reduce occurrence of ASD. In addition to being essential for neurodevelopment, folate is a primary methyl-donor for methylation reactions. The time near conception is an especially critical period for adequate methyl supply during cycles of active de-methylation and re-methylation during embryogenesis, interactions with genetic and environmental risk factors, and the greatest reduction in ASD risk associated with higher maternal folic acid intake. Using data and samples from mother-child pairs in two large prospective studies, this study proposes to examine specific pathways for prevention of ASD through maternal dietary and supplemental folate intake.
Investigator: Croen, Lisa
Funder: National Institute of Environmental Health Sciences
Early Life Exposure to Endocrine Disrupting Chemicals and Child Growth, Adiposity, and Neurodevelopment
We hypothesize that in-utero exposures to commonly used endocrine disrupting chemicals, such as PFCs and PBDEs, individually and/or in combination, have adverse effects on child obesity and neurodevelopment through possible common pathways. Our aims are:
Aim 1. To evaluate whether in-utero exposures to maternal PFCs and PBDEs, individually and/or in combination, are associated with infant growth, adiposity and neurodevelopment.
Aim 2. To evaluate whether in-utero PFCs and PBDEs exposures are associated with metabolic determinants of obesity and neurodevelopment .
Aim 3. To explore whether in-utero PFCs and PBDEs exposures are associated with infant patterns of DNA methylation.
Aim 4. To identify infant, maternal and paternal factors that modify the association of exposure to in-utero PFCs and PBDEs exposures and with infant growth, adiposity and neurodevelopment.
Investigator: Ferrara, Assiamira; Croen, Lisa
Funder: National Institutes of Health
Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment
The aims of this study are to: 1. Estimate risks of adverse pregnancy outcomes after antihypertensive medication exposure compared to a) untreated chronic or gestational hypertension, and b) healthy pregnancies with neither hypertension nor treatment. We will study: a) Maternal outcomes including cesarean delivery, postpartum hemorrhage, pre-eclampsia, and ICU admission; and b) Neonatal outcomes including preterm birth, small-for-gestational age, intensive care unit (NICU) stay, congenital malformations, and perinatal death. 2.Examine how risks vary for different antihypertensive agents. 3.Examine how risks vary according to the degree of blood pressure control achieved during treatment. 4. Examine how risks vary by obesity, GDM status and race/ethnicity.
Investigator: Avalos, Lyndsay
Funder: National Institute of Child Health and Human Development
Role of Pre-natal Vitamin D and Gene Interactions in Autism Spectrum Disorders: Leveraging an Existing Case-Control Study
This study is the first to investigate the role of perinatal vitamin D deficiency or insufficiency in ASD etiology, as modulated by race and genes involved in vitamin D metabolism and receptor activity, in a large, racially-diverse cohort. The role of vitamin D in a number of health conditions has gained recent attention, concurrent with high frequency of vitamin D deficiency/insufficiency being documented, attributed to changes in lifestyle. Evidence indicating higher risk of autism by factors shown to be related to lower vitamin D levels and recent advances in the understanding of the role of vitamin D on brain and immune function support a potential role in autism etiology that warrants rigorous investigation. A few studies of children with autism (or their mothers) have found lower vitamin D levels, but they all were limited by small samples and measurement of levels after the critical period of brain development.
Investigator: Croen, Lisa
Funder: National Institute of Child Health and Human Development
Impact of Folate, Obesity and Genetics on Maternal Depression
Research is desperately needed to inform safe and effective interventions for the prevention and treatment of maternal depression. An important first step to understanding whether nutrition may serve as an intervention and improve maternal mental health, is to elucidate the relationship between nutrition and depression during the peripartum period (during pregnancy and after). The aims of this study will address a gap in knowledge and provide insights into the relationship between nutrition and maternal depression which will take us a few steps closer to identifying whether dietary modifications or supplements may provide an inexpensive, easily modifiable intervention for the prevention of peripartum depression.
Investigator: Avalos, Lyndsay
Funder: National Institute of Mental Health
Engaging At-Risk Minority Women in Health System Diabetes Prevention Programs
The potential for efficacious lifestyle interventions to prevent type 2 diabetes hinges on patient engagement in real-world healthcare settings. Yet patient engagement strategies are suboptimal and attrition is often highparticularly concerning for ethnic minority women who bear disproportionate burdens of diabetes and diabetes risk factors and may be less likely to utilize evidence-based approaches to lifestyle change. The training objectives of this career development award are to strengthen expertise in diabetes, implementation science, health disparities, and biostatistics. The research objectives are to experimentally test feasible, theory-driven strategies to increase engagement in diabetes prevention programs among minority women at high risk for diabetes. These strategies will incorporate tailored diabetes risk information and basic psychosocial science (e.g., self-affirmation theory) to promote translation of diabetes prevention programs in a practice setting.
Investigator: Brown, Susan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Comparing Effectiveness of Treating Depression With and Without Comorbidity to Improve Fetal Health
The study is to determine (1) whether treating depression during pregnancy will reduce the risk of adverse pregnancy and pediatric outcomes; (2) which treatment is more effective in reducing these risks.
Investigator: Li, De-Kun
Funder: Patient-Centered Outcomes Research Institute
Medical Burden Associated with Preterm Labor and Preterm Birth in Kaiser Northern California
The aims of this study are to: 1) Characterize women in the Northern California Kaiser Permanente Medical Care Program (KPMCP) who received a diagnosis of preterm labor (PTL) between January 2001 and December 2010 and compare them to women without PTL who deliver at term. 2) Compare maternal and infant outcomes of pregnancies complicated by preterm labor versus those unaffected by PTL. 3) Evaluate the incremental cost of preterm delivery by week of gestational age. 4) Compare the maternal costs of pregnancies with PTL and without PTL.
Investigator: Kuzniewicz, Michael
Funder: GlaxoSmithKline PLC
Effectiveness of Treating Prenatal Depression to Reduce Postpartum Depression
This is a population-based two-stage cohort study that will take advantage of a new KPNC region-wide program of peripartum screening for depression which annually screens about 33,000 pregnant women for depression twice during pregnancy and once post-partum. The study will specifically determine: 1) What is the risk of preterm delivery and postpartume depression (PPD) among women who screen positive for depression during pregnancy compared to those who screen negative for depression. 2. What is the effect of three treatment regimens for depression (i.e., group and individual therapies, and pharmacological treatment) on reducing the risk of preterm delivery and PPD. 3) Which treatment is most effective in reducing the risk of preterm delivery and PPD. 4) Is the effectiveness of the treatment related to timing, dose, and duration of the treatment.
Investigator: Li, De-Kun
Funder: Agency for Healthcare Research and Quality
Climate Change and Health: Assessing the Risk of Preterm Delivery
The overall objective of this study is to examine the impact of climate change on the risk of preterm delivery (PTD) by using a case-crossover study design utilizing members of KPNC. In our first aim, we will assess the relationship between apparent temperature and PTD. Estimates will be adjusted for important air pollutants. In our second aim we will determine whether maternal factors (age, race/ethnicity and SES as measured by medicaid status) impact the relationship between apparent temperature and preterm delivery. Finally, we will explore whether additional maternal factors may impact the the relationships in the first aim. These additional factors include hypertension, smoking, alcohol use, medication use, gestational diabetes, depression, and pre-pregnancy BMI.
Investigator: Avalos, Lyndsay
Funder: National Institute of Environmental Health Sciences
California CADDRE-SEED Phase II
The goal of this project is to continue the SEED study, a case-control study of genetic and environmental risk factors for autism. The major goal of the project is to conduct a multi-site collaborative epidemiologic study to investigate risk and causal factors for Autism Spectrum Disorders (ASD) and phenotypic subgroups of ASD using a population-based case-cohort study design.
Investigator: Croen, Lisa
Funder: Centers for Disease Control and Prevention
Prenatal Depression: Registry, Treatment Effectiveness to Reduce Preterm Delivery
The goal of this study is to develop a perinatal depression registry to assess the relationship between prenatal depression and preterm delivery, and whether these relationships differ by race or ethnicity. Additionally, we will evaluate whether treatment for prenatal depression reduces the risk of preterm delivery and whether the effectiveness of treatment varies by race or ethnicity.
Investigator: Li, De-Kun
Funder: Health Resources and Services Administration
Appropriate Gestational Weight Gain in Overweight/Obese Women
Among overweight/obese pregnant women, we propose to develop and evaluate a randomized diet and physical activity intervention tailored to mothers and feasible in a health plan setting, with the goal of ameliorating inappropriate gestational weight gain.
Investigator: Ferrara, Assiamira
Funder: National Institute of Child Health and Human Development
Contraceptive Clinical Trials Network
The NICHD Contraceptive Clinical Trials Network (CCTN) will consist of up to 16 sites capable of performing female contraceptive clinical trials. Each site will work with the CCTN Statistical and Clinical Coordinating Center and NICHD to rapidly develop protocols and initiate clinical trials. The CCTN sites contractors will evaluate systematically the safety and efficacy of new female contraceptive drugs and devices as well as drug treatments of gynecologic conditions.
Investigator: Raine-Bennett, Tina
Funder: National Institute of Child Health and Human Development
Pharmacogenomics Study of Extreme Response to Metformin
In this collaboration with GlaxoSmithKline, University of California San Francisco and Kaiser Permanente Northern California, we propose to perform a genome-wide association study in 1,000 patients of European ancestry with extreme response phenotypes to metformin using genomewide array and human exome chip, which include rare nonsynonymous variants. Our aim is to determine whether rare variants, either acting alone or in combination, explain much of the variation in response to metformin, particularly in the extreme responder and non-responder groups.
Investigator: Hedderson, Monique
Funder: GlaxoSmithKline PLC
Prenatal Bisphenol A Exposure and Risk of Gestational Diabetes
This study will enroll 3,350 pregnant women during their first trimester, among whom a prospective nested case-control study of 300 gestational diabetes cases and 600 controls will be conducted to examine the association between early pregnancy levels of bisphenol-A (BPA) and the risk of GDM in the second trimester, as well as the association between BPA and high levels of metabolic markers of insulin resistance and liver enzymes, and the risk of having a large for gestational age (LGA) infant.
Investigator: Ferrara, Assiamira
Funder: National Institute of Environmental Health Sciences
Cohort Study of Pioglitazone and Bladder Cancer in Patients with Diabetes
This cohort study examines the possible association of pioglitazone use with the incidence of new bladder cancer in the Kaiser Permanente Northern California Diabetes Registry .
Investigator: Ferrara, Assiamira
Funder: Takeda Pharmaceuticals North America
Cohort Study of Pioglitazone and Cancer Incidence in Patients with Diabetes Mellitus
The objective of this study is to conduct exploratory analysis of the potential association between treatment with pioglitazone and risk of cancer at sites other than bladder using information available from a variety of KPNC electronic data sources.
Investigator: Ferrara, Assiamira
Funder: Takeda Pharmaceuticals North America
Translational Diabetes Prevention in GDM
This is a lifestyle intervention project tailored to pregnant and postpartum women with gestational diabetes (GDM) and designed to reduce risk factors for type 2 diabetes. The intervention will start during pregnancy soon after GDM diagnosis and will continue postpartum. It will be delivered by individual telephone counseling contacts and brief in-person counseling sessions. Patients will be randomly assigned to a lifestyle intervention or usual medical care. Among GDM patients we propose to implement and evaluate an intervention of diet and physical activity tailored to be practical in health plan settings and for postpartum mothers, with the primary goals of: a) reaching pre-pregnancy weight if women had normal pre-pregnancy weight; or b) reaching a 5% reduction from pre-pregnancy weight if overweight or obese prior to pregnancy.
Investigator: Ferrara, Assiamira
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
