Whole Person Navigation: Pragmatic randomized trial of combined social resource and care system navigation for adults with multiple chronic conditions
This study will develop a prediction tool to identify patients at highest risk for not closing MCC-related care gaps over time; adapt existing evidence-based protocols for patient navigation interventions to the combined social and medical needs of MCC patients; and test this tailored care strategy in a pragmatic, patient-level randomized clinical trial in three Kaiser Permanente care systems across three states.
Investigator: Grant, Richard
Funder: Agency for Healthcare Research and Quality
Race/ethnic Differences Among Older Patients with Type 2 Diabetes at Risk for Hypoglycemia
This is a supplement to the ongoing study: Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Prescribing in High-Risk Older Patients with Type 2 Diabetes. The funding will allow Jose Mejia, BA, to join the study team and receive mentoring while focusing on racial and ethnic differences in trial participants and outcomes.
Investigator: Grant, Richard
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Identifying pre-sepsis opportunities for early, targeted intervention – Equipment Supplement
This supplement seeks to enhance our computing capabilities by leveraging powerful GPU architecture and high-speed storage/networking to now incorporate imaging, text, and time series data into our predictive models through applying open-source deep learning and large language model techniques.
Investigator: Liu, Vincent
Funder: National Institute of General Medical Sciences
Risk-stratified care for KPNC members with newly diagnosed diabetes: A randomized trial
This pragmatic, randomized trial will compare proactive and tailored outreach for high-risk patients by a PCP, diabetes care manager, health educator, and nutritionist vs. usual care on diabetes outcomes. High-risk patients will be identified using a previously developed and validated predictive model.
Investigator: Gopalan, Anjali
Funder: TPMG Delivery Science Projects Program
Comparative Effectiveness Study of the Effect of Initiating Real-time Continuous Glucose Monitoring on Progression of Renal Disease in Adults with Type 2 Diabetes
This study is evaluating the impact of initiating continuous glucose monitoring (CGM) in adults with type 2 diabetes on the progression of kidney disease and changes in glycemic control. Difference-in-difference models will be specified to evaluate pre-post changes in eGFR, urinary albumin excretion, and HbA1c.
Investigator: Karter, Andrew
Funder: Dexcom, Inc.
Informing best practices for evaluation and treatment of myocardial injury during sepsis
Informing best practices for evaluation and treatment of myocardial injury during sepsis
Sepsis imposes an enormous burden on morbidity and mortality with sepsis patients frequently experiencing cardiovascular organ dysfunction. This study will use data from KPNC and Intermountain Healthcare to define patterns of testing, treatment, and outcomes related to troponin in sepsis.
Funder: National Heart, Lung, and Blood Institute
Investigator: Liu, Vincent
Funder: National Heart, Lung, and Blood Institute
Identifying patient subgroups and processes of care that cause outcome differences following ICU vs. ward triage among patients with acute respiratory failure and sepsis
ICU vs. ward triage among patients with acute respiratory failure and sepsis
Each year, millions of patients with acute respiratory failure or sepsis present to U.S. emergency departments at high risk for death but without requirements for life support. Admission of these patients to intensive care units or hospital wards varies considerably with hospital capacity strain, and significantly impacts patient outcomes. Using detailed electronic health record data, instrumental variable and mediation analyses, and machine learning, we will identify the subgroups, care processes, and complications of care that account for these triage-related outcomes, thereby promoting personalized triage and better outcomes.
Funder: National Heart, Lung, and Blood Institute
Investigator: Liu, Vincent
Funder: National Heart, Lung, and Blood Institute
Preventing hospitalizations for COPD exacerbations due to air pollution from wildfire smoke
Preventing hospitalizations for COPD exacerbations due to air pollution from wildfire smoke
Goal is to identify COPD patients at high risk of hospitalization from air pollution due to wildfire smoke, identify barriers to utilization of interventions that mitigate exposure to air pollution from wildfire smoke and pilot an intervention (education+masks+air purifiers) to mitigate exposure of COPD patients to particulate matter from wildfire smoke.
Funder: National Heart, Lung, and Blood Institute
Investigator: Myers, Laura
Funder: National Heart, Lung, and Blood Institute
Employing Computational Linguistics In Patient-Provider Secure Exchanges for Comparative Effectiveness Research
Employing Computational Linguistics In Patient-Provider Secure Exchanges for Comparative Effectiveness Research
This methods-focused project aims to develop novel methods to deidentify secure message text data, and to identify when such exchanges involve comparative effectiveness deliberations related to two or more clinical options in patients with diabetes. These new methods will support research examining the extent of comparative effectiveness deliberations in routine online care.
Funder: Patient-Centered Outcomes Research Institute
Investigator: Reed, Mary
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Evaluating biologic and social determinants of health to improve diabetes prevention and address health inequities in Latino patients.
Evaluating biologic and social determinants of health to improve diabetes prevention and address health inequities in Latino patients
This study will develop and externally validate models to predict incident type 2 diabetes in Latino adults that uniquely incorporate metabolic dysfunction-associated steatotic liver disease (MASLD), Social determinants of Health factors, and their interaction to enhance our understanding of their role in predicting type 2 diabetes in this population. The study will evaluate enrollment and engagement in type 2 diabetes prevention programs among Latino adults, along with engagement with stakeholders to co-design outreach messages based on the model results that have the potential to increase participation in type 2 diabetes prevention programs and ultimately decrease type 2 diabetes incidence in Latino adults.
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Investigator: Rodriguez, Luis
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Implementation study of a new clinical guideline for hypoglycemia prevention
Hypoglycemia in diabetes patients is common, morbid, and costly. A TPMG-funded team (led by Drs. Lisa Gilliam and Richard Grant) worked with clinical stakeholders to develop a new expert consensus Kaiser Permanente Northern California (KPNC) clinical guideline called Hypoglycemia on a Page (HOAP). HOAP guides proactive, protocol-driven hypoglycemia prevention in KPNC members with diabetes and was published in the KPNC clinical library in May 2023, and disseminated for use by KPNC primary care physicians and accountable population managers who provide diabetes care. This 2024 Community Health proposal will evaluate a natural experiment by comparing trends in ED visits and hospitalizations for hypoglycemia before and after HOAP dissemination across KPNC. We hypothesize that implementation of HOAP will be associated with fewer ED visits and hospitalizations for hypoglycemia.
Investigator: Karter, Andrew
Funder: Northern California Community Benefit Programs
AIM-HI grant management and collaborative hub
This grant funds 5 health-system-based prospective evaluations of the implementation of machine-learning-based diagnostic decision support (ML-DDS) algorithms that will be coordinated through the Kaiser Permanente Augmented Intelligence in Medicine and Healthcare Initiative (AIM-HI). A secondary goal of the grant is to create an International Collaboration Hub for Design and Execution of Clinical AI Evaluation Studies.
Investigator: Liu, Vincent
Funder: Gordon and Betty Moore Foundation
Remote blood pressure monitoring during pregnancy: patient characteristics and clinical impacts
This study will examine uptake and outcome impacts of remote blood pressure monitoring for pregnant women with hypertension in Kaiser Permanente Northern California in 2022-2023, after the initial COVID-19 emergency, to inform ongoing operational and clinical programs.Our primary research questions are: What patient characteristics are associated with use of remote monitoring among eligible patients (compared with non-remote monitoring follow-up) and to what degree does enrollment in and use of remote blood pressure monitoring impact patient health care utilization and/or clinical outcomes.
Investigator: Reed, Mary
Funder: Northern California Community Benefit Programs
Safety and Operational Impacts of Emergency Department Mis-Triage
In this study we will broadly characterize the potential safety and operational implications of under- and over-triage among adult and pediatric patients. We will conduct a sub-analysis specifically among patients with an emergency department diagnosis of severe sepsis or septic shock, for whom delays in care are associated with worse outcomes.
Investigator: Sax, Dana
Funder: Northern California Community Benefit Programs
Improving safety and quality of emergency care using machine learning-based clinical decision support at triage
Using a dataset of over 6 million ED encounters across 21 KPNC medical centers, we will use machine-learning methods to develop triage models that predict critical illness, hospital admission, and fast-track eligibility among pediatric and adult patients. We will incorporate unstructured data, identify clinically relevant probability thresholds for each outcome, and validate the models on a retrospective dataset to assess predictive accuracy and then prospectively in the EHR. We will pilot test at 2 EDs to assess feasibility, incorporating stakeholder engagement. Lastly, we plan a pragmatic, step-wedge trial to study the impact of the tool on safety and accuracy of triage predictions, disparities in triage predictions, ED length of stay, and nursing acceptance and adoption of the tool.
Investigator: Sax, Dana
Funder: Agency for Healthcare Research and Quality
Machine Learning Applied to EHR Data as a Means of Improving Biosurveillance and Diagnostic Excellence: A Pilot Project
We aim to develop and extend methods of probabilistic modeling of temporal electronic health record (EHR) data, using non-stationary Gaussian processes, hidden Markov models, and composite mixture models, to identify opportunities to conduct clinical biosurveillance and to achieve diagnostic excellence. Building off collaboration between KP DOR and the Lawrence Livermore National Laboratory, this proposal will use population-level EHR data, AI/ML methods and advanced computing to evaluate associations between health system diagnostic testing/treatment and prevalent/incident health conditions and to identify areas of potential diagnostic uncertainty.
Investigator: Liu, Vincent
Development and validation of a prediction model of time to suicide attempt
Prediction models have the potential to transform targeted prevention strategies for suicide, a leading cause of death in the U.S. The work of our partners in the Mental Health Research Network demonstrated that predictive machine learning algorithms for suicide risk based on electronic health record data can accurately identify individuals with elevated suicide risk. However, a key limitation of current suicide prediction models is that the outcome window of prediction is 90 days post-visit. This means that current models do not necessarily distinguish between someone who is at imminent risk for suicide, and someone whose suicide attempt may occur months after the point of prediction. To address this limitation, we will develop models that predict time to suicide attempt and evaluate their overall performance, as well as performance across racial-ethnic categories where differences in suicide rates have been observed.
Investigator: Papini, Santiago
Funder: Northern California Community Benefit Programs
Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Prescribing in High-Risk Older Patients with Type 2 Diabetes
This 3-arm randomized pragmatic clinical trial will test the efficacy of patient-focused continuous glucose monitoring (Arm 1 – “patient-only CGM”) and patient/provider-focused continuous glucose monitoring (Arm 2 – “patient + provider CGM”) intervention strategies, compared to an active comparator (Arm 3 “usual care”) within Kaiser Permanente Northern California. Our 3-arm design allows us to examine whether patient-education and training alone is sufficient to realize a benefit from continuous glucose monitoring without implementing major workflow changes in busy primary care practices. If successful, this study will improve safety, including reduced incidence of severe hypoglycemia and patient-centered outcomes, and improve care processes for older patients with type 2 diabetes.
Investigator: Grant, Richard
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Testing a new population management model for hypoglycemia prevention in high-risk KPNC members
This study explores whether using a Hypoglycemia Champion to target high-risk patients with type 2 diabetes is a feasible and effective model of care to reduce hypoglycemia risk in this population. We will develop an evidence-based, expert consensus clinical guideline, Hypoglycemia on a Page, involving stakeholders across multiple KP regions; develop a workflow for use by a Hypoglycemia Champion (HC), a clinical pharmacist who will apply the Hypoglycemia on a Page guideline to manage high-risk patients; and conduct a pragmatic, randomized trial of the proactive HC intervention vs. usual care on diabetes regimen safety among high-risk patients.
Investigator: Grant, Richard
Funder: TPMG Delivery Science Projects Program
Antenatal pulmonary embolism diagnostics (APED) in the COVID-19 era
Our multispecialty team will utilize the Kaiser Permanente Northern California (KPNC) Perinatal Obstetrics Database to identify approximately 1,500 gravid patients undergoing pulmonary embolism (PE) diagnostics in the COVID-19 era. We will describe the patients undergoing diagnostic testing for PE, what clinical settings and specialists are involved, and the diagnostic strategies undertaken and their outcomes. Results of this large, contemporary community-based study will fill gaps in the literature and inform next steps within KPNC to improve our antenatal PE diagnostic guidelines and direct physician education efforts.
Investigator: Vinson, David
Funder: KP National Office of Community Health
Assessing the Long-term Impact of COVID-induced Telemedicine Expansion on Dementia Care
The major goal of this project is to generate robust evidence on the impact of the COVID-induced shift to telemedicine on dementia care. Specifically, during the COVID-19 pandemic, we seek to characterize disparities in use of ambulatory telemedicine for persons with dementia, assess the impact of telemedicine on diagnosis and outcomes for persons with dementia during, and characterize clinician and caregiver experience with ambulatory telemedicine.
Investigator: Reed, Mary
Funder: National Institute on Aging
Relaxed Glycemic Control and the Risk of Infections in Older Adults with Type 2 Diabetes
Older adults with poorly controlled type 2 diabetes (T2D) have a higher risk of infection than patients with good glycemic control. However tight glycemic control (e.g., A1C under 7%) in older adults has other risks. In a longitudinal cohort of T2D patients age 65 and older, we will evaluate the incidence of infections when glycemic control is relaxed to levels recommended by current guidelines.
Investigator: Karter, Andrew
Funder: National Institute on Aging
Health Economic Analysis of Automated Insulin Delivery Systems
Safely administering insulin to manage blood glucose is challenging for people with type 1 diabetes (T1D). Artificial pancreas or automated insulin delivery (AID) systems mimic pancreatic function by measuring blood glucose (using real-time continuous glucose monitoring), calculating insulin requirements, and automatically delivering insulin via an insulin pump. This study will determine if AID systems provide good value compared with standard insulin delivery. We will support the external validation of a computer simulation model (Swedish National Diabetes Register T1D model) which will then be used to estimate the long-term cost-effectiveness (from the US health care system and payer perspective) of AID systems compared with standard therapy among T1D patients. This is a collaboration among DOR, University of Michigan, Jaeb Center for Health Research, and University of Oxford.
Investigator: Karter, Andrew
Funder: The Leona M. and Harry B. Helmsley Charitable Trust
Trends in Diabetes Screening, Risk Factors and Incidence Before and After the SARS-CoV-2 Pandemic Between the California Medi-Cal and Commercially-Insured Populations
Using quasi-experimental research methods, this study is assessing the extent to which disparities in type 2 diabetes prevention and outcomes were exacerbated during the coronavirus disease 2019 (COVID-19) pandemic between the Medi-Cal and commercially-insured populations. The career development plan for this diversity supplement is to receive high-quality mentorship from experts in type 2 diabetes prevention, health disparities, biostatistics and evaluation of natural experiments.
Investigator: Rodriguez, Luis
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Post-acute sequelae of SARS-CoV-2 infection (PASC) in adult KPNC members
This study will establish a cohort of adult KPNC members with prior SARS-CoV-2 infection and identify those with a confirmed diagnosis of post-acute sequelae of SARS-CoV-2 infection to examine predictors, clinical care characteristics, and associated diagnostic and specialty care utilization.
Investigator: Reed, Mary
Funder: TPMG Delivery Science Projects Program
Do health and health care indicators differ by preferred language in Latinx and Chinese Adults? A health and health care disparities study.
Limited English proficiency may be an important social determinant of health and health care access. This study will use electronic health record data to describe and compare health risks, chronic health conditions, quality metrics, and health care use by language preference for 2 cohorts of adults aged 25-84 who were KPNC members during calendar year 2019: Latino adults with Spanish vs. English spoken language preference and Chinese adults with Chinese dialect vs. English spoken language preference. Study results will improve understanding of whether and how limited English proficiency contributes to disparities in health and health care utilization in these 2 ethnic groups in a health care delivery system that has made extensive efforts to mitigate language barriers to care delivery.
Investigator: Gordon, Nancy
Funder: KP National Office of Community Health
Detection and Mitigation of Algorithmic Bias in Predictive Models of Suicide Risk
This project will assess the potential impact of algorithmic bias on the allocation of preventive care for suicide and compare the performance of methods designed to mitigate algorithmic bias.
Investigator: Papini, Santiago
Funder: Section Pilot Grants
Predictive modeling of adverse mental health outcomes following acute hospitalizations for serious illness: A machine learning approach with natural language processing
This study addresses predicting risk of post-traumatic stress disorder and other mental health conditions following hospitalization for life-threatening conditions.
We will use an existing, retrospective cohort of 408,377 patients hospitalized with severe illness, including sepsis, to develop and validate predictive models of mental health diagnoses using only electronic health record data, including features extracted with natural language processing from symptoms recorded in clinician notes.
Investigator: Papini, Santiago
Funder: Section Pilot Grants
Social Risk Screening and Social Risk Prediction: Research Consultation and Planning
Kaiser Permanente has set a national goal to increase social health screening among members. Dr. Grant and his DOR Complex Care Team will work with KP National Office of Community Health in a consultative role to address barriers and facilitators to social health screening. Work will focus on evaluating and implementing novel informatics-based strategies to guide member self-screening and to inform more intensive screening strategies. An additional goal of this work is to develop potential larger scale implementation and evaluation interventions.
Investigator: Grant, Richard
Funder: KP National Office of Community Health
A Social Needs Network for Evaluation and Translation (SONNET): Addressing the Social, Economic and Behavioral Needs of Kaiser Permanente Members
Social Needs Network for Evaluation and Translation (SONNET) is a national network of applied researchers who help design, evaluate, and implement effective social health interventions to improve member health across Kaiser Permanente. The SONNET Evaluation and Research Committee (ERC) is responsible for guiding the overall strategic direction and activities of the Network.
Investigator: Grant, Richard
Funder: Kaiser Permanente Program Office
Evaluation of Risk-Based Predictive Models to Inform the Efficiency of Perioperative Systems
We previously developed an automated electronic health record-based risk stratification tool, called the Comorbidity Assessment and Surgical Triage (CAST) score, which we implemented in KP HealthConnect to improve triage of elective surgical patients to perioperative medicine clinic visit types in real-time. This project seeks to improve the efficiency of operative workflows by evaluating the impact of CAST implementation on pre-operative workflows and surgical outcomes; characterizing patients with discordant risk assessments between CAST and the clinician; and evaluating the association between CAST and operative resources, including surgical case duration.
Investigator: Liu, Vincent
Funder: TPMG Delivery Science Projects Program
Turning back the clock on sepsis: Defining the epidemiology and opportunities of pre-sepsis
We intend to determine the epidemiology of pre-sepsis, including ambulatory and prehospital care settings, to identify modifiable care delays, opportunities for primary sepsis prevention, and to improve early sepsis care for vulnerable populations. The objectives include determining the epidemiology of pre-sepsis care across ambulatory and prehospital settings using linked EHR data; measuring delays in pre-sepsis care; and understanding the patient-level variation in pre-sepsis care and delays in vulnerable populations. The project is a collaboration between KPNC and University of Pittsburgh Medical Center.
Investigator: Liu, Vincent
Funder: Gordon and Betty Moore Foundation
Quantifying Racial/ethnic Differences in the Relationship Between Glucose Concentrations and Hemoglobin A1c
Physicians rely on hemoglobin A1c (A1C), an integrated measure of glycemia (blood glucose), to make treatment decisions for patients with diabetes. There is evidence that, given comparable glycemia, A1C results in African Americans can be significantly higher than in whites with similar mean glucose. Racial differences in glycosylation (and thus differences in A1c results) could lead to inequities in diabetes diagnosis, performance measures (e.g., HEDIS), treatment (e.g., unnecessary treatment intensification), and hypoglycemia risk. It is unknown how the A1C-glucose relationship varies in other groups, e.g., Latinx or Asians. Further, it is unclear to what extent observed racial differences may be attributable to innate physiologic factors (e.g., sickle cell trait) or socioeconomics for which race may be a surrogate. We propose to collect glucose data from continuous glucose monitoring (CGM) devices and compare them to A1C data to better understand racial biases in the A1C-glucose relationship.
Investigator: Karter, Andrew
Funder: Northern California Community Benefit Programs
Comparative effectiveness of intermittently scanned continuous glucose monitors among patients with basal-bolus insulin-treated type 2 diabetes
This study will characterize patients selected by their providers for intermittently-scanned, continuous glucose monitor (isCGM) initiation and estimate the effect of isCGM initiation (relative to non-initiators) on clinical outcomes. We hypothesize that 1) among basal-bolus insulin treated, type 2 diabetes patients, those with poorer glycemic control and history of acute metabolic events are more likely selected by physicians for isCGM initiation, and 2) isCGM initiation will result in significant improvement in glycemic control (based on hemoglobin A1c), reduced risk of hypoglycemia and hyperglycemia (both based on emergency department or hospital utilization), compared with non-initiators. This comparative effectiveness research will be based on a difference-in-differences analysis of changes in these outcomes associated with isCGM initiation, compared to a reference group of patients who do not use isCGM (usual care).
Investigator: Karter, Andrew
Funder: TPMG Delivery Science Projects Program
Social Risk Prediction Working Group
Our DOR Complex Care Team is working with Dr. Anand Shah and his team in a consultative role to address barriers and facilitators to social health screening. This work focuses on evaluating and implementing novel informatics-based strategies to guide member self-screening and to inform more intensive screening strategies. An additional goal of this work is to develop potential larger scale implementation and evaluation interventions. The DOR Complex Care team will also work closely with stakeholders and care redesign partners to address social health screening.
Investigator: Grant, Richard
Funder: Kaiser Permanente Program Office
Tailoring initial type 2 diabetes care to meet the needs of younger Latinx adults: A randomized pilot study
Our goal is to evaluate the effectiveness of a proactive, tailored care intervention in improving early outcomes for Latinx individuals with younger-onset type 2 diabetes. We will also conduct post-intervention interviews with study participants to identify components of the intervention that may have contributed to the observed outcomes and perform an environmental scan of type 2 diabetes care and resources in our partner Kaiser Permanente regions to lay the groundwork for future dissemination of the intervention.
Investigator: Gopalan, Anjali
Funder: American Diabetes Association
Diabetes Research for Equity through Advanced Multilevel Science Center for Diabetes Translational Research (DREAMS-CDTR)
The Diabetes Research for Equity through Advanced Multilevel Science Center for Diabetes Translational Research(DREAMS-CDTR) supports diabetes translational research through mentoring and supporting junior faculty, and by fostering collaborations between investigators and health care systems. This is an infrastructure and training grant, and does not directly fund research studies.
Investigator: Schmittdiel, Julie
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Barriers and Facilitators to TracFone/CareLink Implementation in Two Kaiser Permanente Regions
This study will evaluate TracFone/CareLink program within Kaiser Permanente (KP) Digital Health Equity portfolio. It will involve engaging local leaders, end users, and KP members in the planning, implementation, and initial assessment of barriers and facilitators of the TracFone/CareLink program.
Investigator: Grant, Richard
Funder: Northern California Community Benefit Programs
Tailoring care to meet the needs of younger Latinx adults with newly diagnosed type 2 diabetes
We will evaluate a culturally responsive community health worker (CHW) intervention targeting younger-onset Latinx individuals with a new type 2 diabetes (T2D) diagnosis (AURORA [Active Outreach to Younger Latinx]). The AURORA strategy centers on a CHW who will proactively conduct three telemedicine visits tailored to with the following five goals: 1) T2D self-management education, 2) assessment of individual’s self-management support needs, 3) motivational interviewing to support behavior change, 4) pragmatic skills training, including use of crucial technologies to support self-management, and 5) matching member’s needs with existing KPNC T2D resources.
Investigator: Gopalan, Anjali
Funder: Garfield Memorial Fund
Women’s Multi-Ethnic Health and Lifestyle Survey
We propose to survey White, Black, Latina, Filipina, Chinese, South Asian, Vietnamese, and Japanese women aged 35-79 to characterize and compare these racial/ethnic groups on behaviors and risks related to 7 lifestyle medicine domains (diet, physical activity, sleep, stress management, tobacco avoidance, limited alcohol use, positive social connections) and 1 mental health domain (feelings of depression and anxiety). We will also collect data about potential facilitators and barriers to having a healthy lifestyle, including socioeconomic factors (education, income), social risks (financial strain, psychosocial stressors, experienced discrimination/harassment, social support), familiarity with and interest in plant-based diets, and beliefs about the extent to which different lifestyle practices can improve health and longevity. Survey data will be linked with EHR data to describe subgroups of women who already have prediabetes and selected chronic conditions.
Investigator: Gordon, Nancy
Funder: Northern California Community Benefit Programs
A Pragmatic Randomized Controlled Trial of a Bundled, Pharmacist-Led Hyperpolypharmacy Deprescribing Intervention
This randomized controlled trial study is testing an intervention to reduce unsafe medication use in patients aged 75 years and older. The intervention uses collaborative drug therapy management between physicians and pharmacists, standard-of-care treatment protocols, shared decision-making, and the CEASE deprescribing protocol. Following physician authorization, it is administered by ambulatory care pharmacists working over multiple deprescribing cycles to reduce doses, switch to safer drugs, and discontinue medications while monitoring for adverse drug withdrawal effects. Outcomes include the number of medications used and the diagnosis of conditions related to medication overuse. The safety of the intervention is also being evaluated.
Investigator: Herrinton, Lisa
Funder: TPMG Delivery Science Projects Program
The Delivery Science Targeted Analysis Program: A Partnership between the Division of Research and The Permanente Medical Group-Project 3
The Delivery Science Rapid Analysis Program will create a mechanism to solicit, prioritize, and address rapidly researchable analytic questions with high value to TPMG’s quality improvement initiatives and DOR’s research agenda. The program will focus on short-term observational data analyses that can be completed within 6 months and the findings will be disseminated widely within Kaiser Permanente and externally.
Investigator: Schmittdiel, Julie
Funder: TPMG Delivery Science Projects Program
Using predictive analytics to tailor care for patients with newly diagnosed type 2 diabetes
In a population of adults newly diagnosed with type 2 diabetes (T2D) from 2010-2015 and followed for 5 years this study will use machine learning-based predictive analytic methods to develop and validate predictive models using EHR-derived patient data available at the time of T2D diagnosis to identify patients at increased risk for suboptimal 1-year and 5-year glycemic trends. Secondary predictive models will be developed to identify individuals at increased risk for other adverse T2D-outcomes, including microalbuminuria, microvascular disease, and macrovascular disease. The study will also develop and validate predictive models that include data from the first year following T2D diagnosis to identify patients at increased risk for suboptimal 5-year glycemic trends.
Investigator: Gopalan, Anjali
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Reducing Variation in Hospitalization and Processes of Care in Emergency Department Patients with Atrial Fibrillation: A Stepped Wedge Cluster Randomized Trial
This stepped-wedge cluster randomized trial will stagger implementation of a clinical decision support system (CDSS) across 13 KPNC emergency departments to assist emergency physicians and hospitalists in the comprehensive management of patients with atrial fibrillation/flutter. We will compare hospitalization rates, processes of care, and stroke prevention actions between emergency departments with and without the CDSS intervention.
Investigator: Vinson, David
Funder: TPMG Delivery Science Projects Program
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
COVID-19: Antecedents to Hospitalization and Deterioration
This study will characterize and compare antecedents to hospitalization and in-hospital deterioration among patients with COVID-19 and comparator patients with influenza. We will quantify pre-existing comorbidities, medication adherence, and temporal factors prior to hospitalization with COVID-19 or influenza. We will also characterize the antecedents and time course of infections in these 2 groups of patients and quantify the relative contribution of 4 key groups of predictors for non-elective hospitalization and adverse outcomes (critical illness, death): demographics, pre-existing comorbidities, medication adherence, and time to treatment for patients who went to the emergency department.
Investigator: Escobar, Gabriel
Funder: AstraZeneca PLC
Effectiveness and safety of treatments for hospitalized patients with COVID-19
Examine the safety and effectiveness of current treatments for hospitalized patients with COVID-19 and identify patient characteristics and time periods during the disease course that are associated with more favorable treatment response.
Investigator: Liu, Vincent
Funder: Garfield Memorial Fund
Building an Evidence Case for Capturing Educational Attainment in the EHR as a Social Determinant of Health
Educational attainment is an important social determinant of health, but it is not included in the electronic health records of a majority of adults. When the information is available, it is frequently not captured in a way that makes it easy to use in large data-only studies. This study will build evidence for the value of including educational attainment as a discrete categorical variable in electronic health records by examining the association of educational attainment with prevalence of chronic health conditions, obesity and smoking, quality metrics, and use of health care services and the patient portal among Medicaid enrollees aged 25-64 and a cohort of Medicare-aged (65-89 years) adults. The study will also examine differences by education across and within race/ethnic groups and within age groups, adjusted for sex and race/ethnicity. Lastly, we will evaluate different cut-points for educational attainment to make recommendations on ways to dichotomize education as a risk predictor.
Investigator: Gordon, Nancy
Funder: Northern California Community Benefit Programs
Tools for Outpatient and Population Management of SARS-COV-2 Infection (TOPS2)
This project aims to improve The Permanente Medical Group’s capability for outpatient and population management of adults with COVID-19. It will identify the spatial, temporal, and racial distribution of coronavirus infections; characterize the clinical progression of coronavirus infection; and synthesize these findings to develop both simple predictive models and job aids that can help clinicians in the outpatient setting and complex risk adjustment models for population management. The tools we develop will help general internists and family practitioners predict the likely temporal and clinical trajectory of patients initally seen as outpatients or in the emergency department.
Investigator: Escobar, Gabriel
Funder: TPMG Delivery Science Projects Program
Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia
The goal of this study is to apply the patient-centered advance care planning paradigm of values elicitation and decision-making and communication preparation to hypoglycemia-related adverse outcomes in vulnerable older patients with type 2 diabetes. This will involve a randomized clinical trial comparing a web-based diabetes-specific advanced care planning tool vs. usual care among patients 75 years and older at increased risk for hypoglycemic events.
Investigator: Grant, Richard
Funder: National Institute on Aging
Patient experiences with Value-Based Insurance Designs (VBID) in Kaiser Permanente: Plan Knowledge and Medication Behavior
The study will examine patient knowledge and experience in a Value-based insurance designs plan by surveying 1,000 patients newly enrolling in a VBID plan. The survey will collect patient knowledge of their plan, patient-reported medication behavior (including specific cost barriers to adherence and financial burden, and preferences for receiving additional education/nudges about medication costs and hypothetical behavior changes with free preventive medications.
Investigator: Reed, Mary
Funder: Northern California Community Benefit Programs
Age- and race/ethnic-based disparities in diabetes outcomes among younger adults with newly diagnosed Type 2 Diabetes
This study will conduct focus groups with KPNC members (age 45) with newly diagnosed Type 2 diabetes to learn about members’ experiences with this new diagnosis and to identify early facilitators of and barriers to effective diabetes management in this group.
Investigator: Gopalan, Anjali
Funder: Northern California Community Benefit Programs
Prevalence of Social Risks and Association of Social Risks with Health and Well-Being Among Non-Safety Net Middle-Aged and Older Adult Members in Kaiser Permanente Northern California
This study will gather data to estimate the prevalence of several different social and financial risk factors among adults aged 35-84 and assess whether risk factor prevalence significantly differs across age, race, health status, and income groups.
Investigator: Grant, Richard
Funder: Northern California Community Benefit Programs
Impact of the COVID Pandemic on KP Members with Complex Medical and Social Needs
The COVID epidemic has exposed the fragility of the social network that supports our most complex and vulnerable members. We have established an interdisciplinary team of researchers, clinicians, and operational leaders at KPNC, KPCO, KPWA to study socially determined barriers to care among adult members with complex medical & social needs. Among these patients, we propose to: 1) examine the role of self-reported barriers (e.g. financial need, housing instability, social isolation, frailty) on risk of COVID infection; 2) among COVID infected patients, examine the role of these barriers on disease severity; 3) examine the impact of social distancing & KP care re-organization on chronic medical & mental health care, and 4) re-contact previously interviewed complex patients to investigate in the impact of social distancing & KP care re-organization on their health and care. Results will help inform new care strategies for our most vulnerable members with complex medical and social needs.
Investigator: Grant, Richard
Funder: Garfield Memorial Fund
Complex Patients: DOR Research Team
My team has been working collaboration with The Permanente Medical Group and Kaiser Foundation Health Plan to implement and evaluate care models to improve health outcomes of medically and socially complex patients. We are currently conducting a rapid cycle randmomized clinical trial to evaluate MYQOL, a new care management program developed at KP Central Valley designed to reduce hospital and emergency department readmissions among complex patients. These efforts will help guide TPMG and KFHP plans to improve the care of complex patients.
Investigator: Grant, Richard
Funder: Kaiser Foundation Health Plan
Reducing Treatment Risk in Older Patients with Diabetes: Comparative Effectiveness of Academic Detailing with and without Pre-Visit Patient Preparation
This pragmatic, randomized clinical trial will compare the effect of primary care physician academic detailing with or without patient pre-visit preparation on insulin de-prescribing rates among older patients with type 2 diabetes at high risk for insulin-related hypoglycemia. We will also examine changes in patient-reported diabetes distress, decisional confidence, and perceived quality of care. In a subset of visits from both study arms, we will also compare the content and quality of patient-provider conversations through analysis of visit audio-recordings.
Investigator: Grant, Richard
Funder: Patient-Centered Outcomes Research Institute
Hospital Alternatives (HALT)
The SRI team will (a) assess results of previous internal and external deployments of alternatives to hospitalization, (b) define strategies to quantify the potential pool of Kaiser Permanente Northern California patients who would be eligible for such alternatives, (c) develop appropriate predictive models to support planned and possible deployment strategies, (d) identify synergies with other SRI projects, and (e) determine sequencing of efforts from a compliance standpoint.
Investigator: Escobar, Gabriel
Funder: Kaiser Foundation Hospitals
Use of Digital Information Technologies and Health Information Resources by Limited English Proficient Latino and Chinese Adult Members
The
goal of this research is to learn about use of digital information
technologies (DIT) and the kp.org website and patient portal, preferred
modalities for receiving health information and advice, and social
determinants of DIT use and health information preferences by members by
limited English proficient (LEP) Spanish and Chinese patients. Study data
will be collected using anonymous self-administered questionnaires
distributed and collected by line staff in dedicated La Salud and Chinese
modules in several Kaiser Permanente Northern California medical facilities.
We will also compare use of the patient portal during a 12-month period prior
to the survey by LEP Spanish and Chinese speakers who receive care in
dedicated bilingual modules vs. at-large modules to evaluate generalizability
of survey results.
Investigator: Gordon, Nancy
Funder: Garfield Memorial Fund
Understanding and Informing Early Hospital Antibiotic Prescribing for Potential Infection
The goals of this study are to (1) examine temporal trends in early hospital antibiotic prescribing patterns over the past 5 years, to assess for unintended consequences associated with earlier antibiotics in severe sepsis/septic shock; (2) quantify the patient-level harm associated with receipt of unnecessary antibiotics; and (3) identify subsets of patients, discernable in real-time with high certainty, who benefit from immediate antibiotics, versus the subsets of patients for whom it is safe to delay antibiotics by 3 hours (thereby allowing time for rapid diagnostics, such as procalcitonin).
Investigator: Liu, Vincent
Funder: Agency for Healthcare Research and Quality
Sepsis on FHIR
Overall 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 are to determine that incidence and epidemiology of respiratory failure in neonates born 32-36 weeks of gestation between 2012 and 2017 in Kaiser Permanente Northern California facilities; describe disease severity and respiratory support by diagnostic category; describe use of surfactant replacement therapy; and assess the impact of surfactant replacement therapy on length of respiratory support, length of hospitalization, and respiratory outcomes in the first year of life.
Investigator: Liu, Vincent
Funder: Moore Foundation
Development, Reevaluation, and Implementation of Outcome/Efficiency Measures for Hospital and Eligible Clinicians
The goal of this project is to assist with measure development and testing for the Hospital-Wide Mortality (HWM) hybrid and HWM claims-only measures. This includes providing consulting support to the Yale Center for Outcomes Research and Evaluation team and defining key data elements.
Investigator: Escobar, Gabriel
Funder: Centers for Medicare and Medicaid Services
Metformin Initiation and Early Adherence among Kaiser Permanente Northern California Members with Newly Diagnosed Type 2 Diabetes
Aim 1: Identify patient-level predictors of metformin treatment during the year following type 2 diabetes diagnosis. Examined factors will include: demographics, such as age, race/ethnicity, gender, and rural versus urban; clinical characteristics, such as A1c at diagnosis, diabetes-related comorbidities (hypertension, renal disease), number/type of other medications used, and gastrointestinal comorbidities (irritable bowel, H. pylori); and other care-related factors, such as medication copays, in-person visit copays, flu vaccination (proxy for openness to traditional treatment approaches), length of Kaiser Permanente Northern California membership, and primary care physician (PCP) contact/empanelment time.
Aim 2: Identify provider-level predictors of early metformin treatment during the year following type 2 diabetes diagnosis. Examined factors will include: ordering provider type, such as PCP vs. other medical doctor versus other (e.g., population manager); PCP characteristics, such as PCP-member race concordance, PCP years in practice, and number of type 2 diabetes patients in panel; and primary Kaiser Permanente Northern California facility.
Investigator: Gopalan, Anjali
Funder: Northern California Community Benefit Programs
Care System Analytics to Support Primary Care Patients with Complex Medical and Social Needs
This study will leverage the rich electronic data sources within Kaiser Permanente to create pragmatic tools for improving health and equity among primary care patients with the highest medical and social needs. Aim 1: Use advanced analytic methods to predict actionable nonmedical barriers to care experienced by patients with multiple chronic conditions; Aim 2: Implement a dashboard linked to the electronic health record that will enable care providers to sort and manage registries of patients with multiple chronic conditions; and Aim 3: Pilot the use and implementation of this dashboard tool in 3 geographically distinct, high-need communities served by three Kaiser Permanente regions (Northern California, Washington, Colorado).
Investigator: Grant, Richard
Funder: Agency for Healthcare Research and Quality
Drug Benefit Design and Adherence Disparities in Older Adults
Our prior study examined the impact of one aspect of Medicare Part D, the removal of limits on the number of reimbursable prescriptions per month (drug caps) on racial differences in chronic disease treatment among dual Medicare and Medicaid enrollees with complex medical conditions. Among dual enrollees with diabetes and common comorbidities, white-black treatment gaps that were present at baseline (e.g., lipid lowering therapy, antidepressants) persisted among patients 65 and older) and worsened among women and those 65 and younger. The primary objective of this study is to enhance our understanding of persistent disparities in treatment adherence and the equity effects of changes in drug coverage in order to reduce disparities in treatment adherence among older adults with complex medical conditions.
Investigator: Adams, Alyce
Funder: National Institute on Aging
Optimizing Medical Decision-Making for Older Patients with Type 2 Diabetes
Medicare-age patients with type 2 diabetes are projected to double in the next 25 years and have high rates of complications and adverse drug events. However, older patients are largely excluded from the major clinical trials of diabetes care. This lack of clinical evidence has led to conflicting and ambiguous recommendations for care. The study will provide new evidence needed to care for these patients. Aim 1: Characterize variation in patient-reported outcomes, patient-provider relationships, and treatment preferences. Aim 2: Determine glycemic control levels associated with the lowest risk of adverse outcomes, including micro- and macrovascular outcomes, hypoglycemia, and death. Aim 3: Develop a risk-based decision support tool for evidence-based, individualized diabetes care for older adults with diabetes.
Investigator: Karter, Andrew
Funder: National Institute on Aging
Improving Outcomes and Care Experience among Dual-Eligible Members
This study will be one of the first to examine the relationship between health-system factors across the continuum of care (pharmacy, hospital, primary care) and health-care quality and outcomes among vulnerable, dual-eligible, managed-care members. In addition, we will use geographically-tagged data on social determinants of health, or neighborhoods where these members live, to identify geographic clusters of patients who are at higher risk for suboptimal health outcomes. Further, we will leverage simulation methods to evaluate the potential impact of addressing these factors on future utilization.
Investigator: Adams, Alyce
Funder: TPMG Delivery Science Projects Program
Healthy Eating as a Means for Active Living in Heart Failure (HEAL-HF) Study
There is an unmet clinical need to better understand the impact of lifestyle choices with respect to diet and nutrition in high-risk heart failure patients who have been recently hospitalized. We will conduct a survey-based project using a combination of questionnaires to assess 4 clinically relevant domains: food access and security, dietary composition and quality, nutritional awareness and understanding, and attitudes toward nutrition-related research. The survey itself will take no more than 15 to 30 minutes to complete and will be administered via telephone to 1,000 consecutive patients recently hospitalized with a primary diagnosis of heart failure who are responsible for their own meal planning. In addition to the survey elements, outcomes of interest will include subsequent heart failure hospitalization, all-cause hospitalization, and mortality occurring within 30 days. These outcomes will be passively collected via Kaiser Permanente HealthConnect electronic health records.
Investigator: Go, Alan; Ambrosy, Andrew; Gordon, Nancy
Funder: Northern California Community Benefit Programs
Health Outcomes of Interest Validation of Serious Infections Among an Immunocompromised Population
Kaiser Permanente Northern California will participate with the FDA Sentinel to validate the diagnosis of health outcomes of interest.
Investigator: Herrinton, Lisa
Funder: U.S. Food and Drug Administration
Understanding Housing Insecurity and Risk for Homelessness in the Kaiser Permanente Northern California Member Population
This project will examine patient and community-level correlates of housing instability and homelessness using observational data sources. These formative analyses will develop variables to operationalize housing instability using administrative and clinical data, and explore potential predictors of housing stability and homelessness within the Kaiser Permanente Northern California member population. Sensitivity analyses will attempt to identify populations and geographic areas with greater risk that can be used to target future pilot interventions to prevent homelessness in Kaiser Permanente members.
Investigator: Schmittdiel, Julie
Funder: Northern California Community Benefit Programs
Assessing and Optimizing the Impact of an Electronic Clinical Decision Support Tool for Chest Pain Risk Stratification in the Emergency Department STEWARD Project (Phase 3)
Conducted with co-investigator Dustin G. Mark, MD, this study helps emergency physicians with estimates of individual patient risk for patients with chest pain. The research team will evaluate impacts on guideline-supported acute coronary syndrome evaluations.
Investigator: Reed, Mary
Funder: The Permanente Medical Group
Using EHR Audit Logs to Capture Diagnostic Pathways and Time to Diagnosis
Rapid expansions in the use of electronic health record (EHR) systems also contribute to large expansions in the availability of metadata. These highly granular metadata may prove particularly useful for understanding how frontline clinicians interact with clinical information when making diagnostic decisions. This project aims to characterize EHR audit log data and advance nascent understanding of the potential to leverage these to provide novel insights into the diagnostic process, with a focus on time to diagnosis, and ultimately inform the achievement of diagnostic excellence.
Investigator: Liu, Vincent
Funder: Gordon and Betty Moore Foundation
Targeting Cardiovascular Events to Improve Patient Outcomes After Sepsis
Sepsis is the most common illness leading to hospitalization in the United States, affecting more than 1 million Americans each year. While short-term mortality has improved over prior decades, sepsis survivors face numerous post-hospital sequelae that negatively impact long-term morbidity and mortality. Cardiovascular complications are among the most common reasons for re-hospitalization and death after sepsis, with approximately 1 in 3 severe sepsis patients experiencing a cardiovascular complication in the year after sepsis hospitalization. This project seeks to identify risk factors for post-sepsis cardiovascular risk based on granular inpatient data collected during hospitalization, and identify potential opportunities to reduce post-sepsis cardiovascular risk.
Investigator: Liu, Vincent
Funder: National Heart, Lung, and Blood Institute
Comparative Effectiveness of Virtual Care in Dermatology for Diagnosing Rash
The benefit of teledermatology for triaging skin rashes is not adequately understood. The study will assess how implementation of teledermatology (technology and staffing) improves the effectiveness and efficiency of diagnosis, including wait time to diagnosis, therapies, and need for follow-up visits.
Investigator: Herrinton, Lisa
Funder: The Permanente Medical Group
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
The Initial Care of Younger Adults with Newly Diagnosed Type 2 Diabetes
In a population of adults with newly diagnosed, early onset type 2 diabetes, this study will identify patient-, provider-, and system-level predictors of inadequate glycemic control within one year following diagnosis. A longitudinal, retrospective cohort analysis of electronic health record data will be conducted to examine associations between select factors and early glycemic control. This study will also explore barriers to and facilitators of type 2 diabetes care; patients and providers will be engaged in a qualitative process to identify barriers and facilitators affecting early diabetes care. Lastly, this project will examine associations between patient-reported factors and early glycemic control. To extend characterization of potentially modifiable care barriers in this population, validated instruments (selected based on existing literature and study findings) will be used to survey a cohort of patients and follow this cohort prospectively for one year to assess relationships between responses and glycemic control.
Investigator: Gopalan, Anjali
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Similarities and Differences in Health Indicators and Health Care Use Among Asian Ethnic Groups
This study will examine whether significant differences across Asian ethnic groups in prevalence of chronic diseases, behavioral/psychosocial risk factors, preventive service use, and patient portal use are masked when statistics are reported for “Asians.” It will utilize electronic health records and clinical/administrative data for a cohort of adults aged 20 to 89 who were Kaiser Permanente Northern California (KPNC) members throughout 2016 to compare six Asian ethnic groups (Filipino, Chinese, Korean, Japanese, South Asian, and Southeast Asian) on prevalence of chronic health conditions, obesity, and smoking status; Healthcare Effectiveness Data and Information Set (HEDIS) quality indicators of chronic disease management and cancer screening; and patient portal use during 2016. Pooled data weighted from the 2011, 2014/2015, and 2017 KPNC Member Health Surveys will also be used to compare the Asian ethnic groups on sociodemographic characteristics, health status, health behaviors, and information technology (IT) use. Asian ethnic groups will also be compared with non-Hispanic whites, blacks, and Latinos.
Investigator: Gordon, Nancy
Funder: Northern California Community Benefit Programs
Benchmarking Hospital Quality – Template Matching
In this study, Kaiser Permanente Northern California researchers will serve as consultants for U.S. Department of Veterans Affairs (VA) researchers to evaluate the utility of template matching techniques, compared with standard regression techniques, for comparing hospital quality.
Investigator: Liu, Vincent
Funder: U.S. Department of Veterans Affairs
Predicting Successful Onboarding in the Medi-Cal Population
The purpose of this project is to examine quality indicators for key chronic conditions such as diabetes and asthma for the Medi-Cal population served by Kaiser Permanente Northern California and to see how these indicators vary by different population definitions/denominators. Key predictors will include patient characteristics and socioeconomic indicators at the census block level, as well as elements of the Medi-Cal onboarding process across the region.
Investigator: Schmittdiel, Julie
Funder: Kaiser Foundation Hospitals
Supplement to T32 Training Program in Diabetes Translational Research
This administrative supplement solicited by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will provide two to six medical students with summer training opportunities in translational research. This supplement allows the existing T32 program based at the Kaiser Permanente Northern California Division of Research to host students who are participating in a broader NIDDK-administered program for introducing medical students to research in diabetes and diabetes prevention.
Investigator: Grant, Richard; Schmittdiel, Julie
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
T32 Training Program in Diabetes Translational Research
Diabetes remains a leading cause of morbidity and mortality, and it is a significant burden to the U.S. health care system, patients, and their families. The knowledge and skills necessary to overcome the final translational block from evidence into practice require unique training in the area of delivery science, which includes health services research, translational research, and dissemination and implementation methods. To meet this need, the Kaiser Permanente Northern California Division of Research has created the Diabetes Delivery Science Training Program. This new program will directly address the need to augment the current research workforce by focusing on the skills needed to identify and overcome barriers to effective diabetes care within existing large-scale health care delivery systems. Two post-doctoral scientists will be enrolled per year for a two-year training program.
Investigator: Grant, Richard
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
CORAL Meaningful Outcomes & Missed Opportunities
A relatively small proportion of patients with complex needs represent a major source of cost and utilization. The fundamental principle that distinguishes complex needs patients from other high-cost patients with well-defined medical issues is that “complex needs” is a highly heterogeneous category with poorly defined inclusion criteria and treatment goals. To move this field forward, this 18-month, inter-regional research project aims to better define actionable subgroups of patients with complex care needs. A generalizable typology of distinct subgroups of patients with complex care needs will be created using clinical and patient-reported data and care outcomes across three Kaiser Permanente delivery systems (Kaiser Permanente Northern California, Kaiser Permanente of Colorado, and Kaiser Permanente Washington). Important unmet care needs will be identified for patients within each of the main subgroups, and a novel set of meaningful outcomes that reflect complex patients’ clinical and personal needs will be elicited using interviews and focused chart reviews.
Investigator: Grant, Richard
Funder: Garfield Memorial Fund
Identifying Pre-Sepsis Opportunities for Early, Targeted Intervention
Early evidence suggests there will be ongoing waves of COVID-19 outbreak that can be mitigated through effective community-level prediction models and intervention. This project will Identify pre-sepsis opportunities for early, targeted intervention to inform community-level mitigation strategies of upcoming COVID19 surges.
Investigator: Liu, Vincent
Funder: National Institute of General Medical Sciences
It Takes a Network: A Network Science- and Command Center-Based Approach to Hospital Error Detection, Prevention, and Mitigation
This project aims to develop a set of algorithms for generic error detection, prevention, and mitigation in the hospital setting. The goal is to develop algorithms that can operate in real time so as to support an existing infrastructure (the eHospital Safety Net, a Kaiser Permanente Northern California system that involves trained registered nurses who monitor the inpatient hospital record in real time, remotely). To develop these algorithms, network science, neural networks, and machine learning will be employed to identify discrete, transient (temporal frame of one to two hours) patient clusters at high risk for errors and process failures. This project builds on work conducted by the same team (assignment of severity of illness scores in real time, and quantification of in-hospital ecological markers such as occupancy and hourly change in census), as well as existing systems such as the Hospital Throughput Monitor. It expands on this work by developing an approach to quantify cognitive load on networks of caregivers and patients as well as hospital units. The project involves a collaboration with Stanford University.
Investigator: Escobar, Gabriel
Funder: Kaiser Foundation Hospitals
Advancing Geriatrics Infrastructure and Network Growth (AGING) Initiative
The Advancing Geriatrics Infrastructure and Network Growth (AGING) Initiative was initiated in 2014 to bridge the Health Care Systems Research Network (HCSRN) with the Older Americans Independence Centers (OAICs, also known as “Pepper Centers”) in order to advance an interdisciplinary research agenda focused on older adults with multiple chronic conditions. The overarching aim of this current project is to build upon AGING’s efforts to create a mature and sustainable infrastructure to advance an interdisciplinary research agenda to improve the care and well-being of these adults.
Investigator: Adams, Alyce
Funder: National Institute on Aging
Social and Functional Predictors of Rehospitalization: YCLS and PROMIS (SDH2)
This project aims to determine whether fields included in the National Institutes of Health’s Patient Reported Outcomes Measurement System (PROMIS) questionnaires for cognition and physical function, as well as those in the Your Current Life Situation (YCLS) questionnaire can enhance our ability to predict rehospitalization. 1600 patients will be interviewed shortly before their hospital discharge from the Kaiser Permanente Northern California Oakland, San Leandro, and Walnut Creek Hospitals. Patients at low or medium risk for rehospitalization will be oversampled. Data from the interviews will be combined with an existing real time rehospitalization score in use in all Kaiser Permanente Northern California hospitals. If successful, the project would permit better targeting of patients in need of support following hospitalization.
Investigator: Escobar, Gabriel
Funder: Kaiser Permanente Program Offices
Evaluation of the Effectiveness and Implementation of Regionalized Care of Testicular Cancer
This study has three primary aims: 1) to evaluate the effectiveness of Testicular Cancer Redesign on rates of use of guideline-adherent and avoidable utilization; 2) to evaluate users’ ability to adopt and maintain use of Testicular Cancer Redesign workflow changes and tools, guided by the RE-AIM framework, using information from audits, key-stakeholder interviews, and surveys; and 3) to identify contextual factors at the medical-center level that mediate the effectiveness and sustainability of implementation using interviews and surveys of key stakeholders, testing the hypothesis that implementation of the intervention will vary across medical centers because of differences in local context.
Investigator: Herrinton, Lisa
Funder: The Permanente Medical Group
Does Information about Members’ Social Determinants of Health Improve Prediction of Risk for Hospitalization, Emergency Department Visits, and Outpatient Utilization?
The new Kaiser Permanente Your Current Life Situation (YCLS) screening questionnaire will be mailed to a random sample of 7,000 adult members of Kaiser Permanente Northern California (KPNC), oversampling patients at low to medium risk for hospitalization. After receiving responses, YCLS data will be linked with existing variables known to be predictors of utilization, including age, sex, COPS2 (COmorbidity Point Score, version 2), abLAPS (abbreviated Laboratory-based Acute Physiology Score), other composite indices currently available in KPNC electronic databases, and U.S. census-derived socioeconomic status data. The linked data will be analyzed to determine the extent to which the YCLS data improves prediction of hospitalization, emergency department use, and total outpatient utilization, and, if improvement in prediction is found after incorporating YCLS data, which specific items from the YCLS have the greatest impact. Responses to the YCLS survey, weighted to the adult membership, will also be used to estimate prevalence of KPNC adult members’ social and economic needs.
Investigator: Gordon, Nancy; Escobar, Gabriel
Funder: Kaiser Permanente Program Offices
Social and Functional Predictors of Rehospitalization: YCLS and PROMIS
This study aims to determine whether specific items from two questionnaires currently in use at Kaiser Permanente Northern California (the Your Current Life Situation questionnaire and selected functional status questionnaires from the National Institutes of Health’s Patient Reported Outcomes Measurement System) could enhance the ability to predict a patient’s risk of rehospitalization. To achieve this goal, approximately 2,000 patients will be approached on the day of discharge at three hospitals with a target goal of enrolling 1,600. Data from the questionnaires will be combined with other electronic data in order to modify existing algorithms used in the current Kaiser Permanente Northern California real-time rehospitalization prediction model.
Investigator: Escobar, Gabriel
Funder: Kaiser Permanente Program Offices
Characterizing and Predicting Adverse Drug Events Outside the Hospital
This study aims to employ machine learning methods to develop predictive models for adverse drug events, or ADEs, that result in patients using the emergency department and/or being hospitalized (non-nosocomial ADEs, NNADEs). Based on work with a pharmacist expert panel that will include examination of literature as well as KPNC ADE data, six candidate drugs that are currently not the focus of preventive efforts will be selected. A population database that will include geographic information system data as well as ADEs will then be built. Finally, using machine learning methods, the investigators will attempt to develop predictive models for ADEs involving the six selected candidate drugs.
Investigator: Escobar, Gabriel
Funder: Gordon and Betty Moore Foundation
Patient Choice of Telemedicine Encounters
Investigator: Reed, Mary
Funder: Agency for Healthcare Research and Quality
The Role of Bariatric Surgery in the Management of Nonalcoholic Fatty Liver Disease
This project is proposed by University of California, San Francisco (UCSF) gastroenterology fellow Suzanne Sharpton, who is also earning an M.S. in public health. She is supported by Kaiser Permanente gastroenterologist Varun Saxton and bariatric surgeon Robert Li, as well as her UCSF mentor. The project has three specific aims. The first is to examine changes in hepatic fibrosis at baseline, 6, and 12 months post-surgery among morbidly obese adults who underwent bariatric surgery and had nonalcoholic steatohepatitis on a liver biopsy at baseline. The second is to compare the change in nonalcoholic fatty liver disease fibrosis score between Roux-en-Y gastric bypass versus sleeve gastrectomy. The third aim is to compare the rate of cardiovascular morbidity after bariatric surgery in morbidly obese adults with and without histologic evidence of nonalcoholic steatohepatitis at baseline.
Investigator: Herrinton, Lisa
Funder: East Bay Community Foundation
FY16 Sentinel Infrastructure, Methods and Surveillance
This project consists of tasks required for data partners in the Food and Drug Administration’s Sentinel Initiative under the initiative’s “Year 4 Infrastructure” statement of work. Most of the requirements involve data partner staff running data requests or returning data and documents of various types to the Sentinel Coordinating Center via the Sentinel PopMedNet Distributed Query Tool System.
Investigator: Herrinton, Lisa
Funder: U.S. Food and Drug Administration
Pre-Visit Prioritization for Complex Primary Care Patients with Diabetes
Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. For these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. In parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. These twin trends present a formidable challenge to effective diabetes primary care. This study addresses the hypothesis that among complex patients not meeting diabetes management goals, an approach to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) prior to each primary care visit will result in more effective diabetes management over time. To test this hypothesis, the project will involve design, implementation, and evaluation of a web-based tool linked to electronic health records that will enable complex patients to easily define care priorities from an inclusive list.
Investigator: Grant, Richard
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Does Combining Asians Into One Group Mask Important Ethnic Group Differences in Health and Health Care Use?
This study will examine whether significant differences across Asian ethnic groups in prevalence of chronic diseases, behavioral and psychosocial risk factors, preventive service use, and patient-portal use are masked when statistics are reported for Asians. We will use a very large cohort of adults aged 20 to 90 who were members of Kaiser Permanente Northern California for two or more years as of December 2016 to compare six Asian ethnic groups (Filipino, Chinese, Korean, Japanese, South Asian, and Southeast Asian). Electronic health record and clinical and administrative data linked to the cohort will be used to compare prevalence of chronic conditions, HEDIS (Healthcare Effectiveness Data and Information Set) performance on chronic disease management and cancer screening, frequency of smoking, frequency of obesity and exercise, and patient-portal use. Pooled data from the 2011 and 2014-15 Member Health Surveys will be used to compare Asian ethnic groups on sociodemographic characteristics, health status, and health behavior and psychosocial risks. Asian ethnic groups will also be compared with non-Hispanic white, black, and Latino adults.
Investigator: Gordon, Nancy
Funder: Northern California Community Benefit Programs
Early Detection of Obstetric Complications: Development of Predictive Models Suitable for Real-Time Surveillance During Labor, Delivery, and the Postpartum Period
This is a feasibility study to determine whether data from Kaiser Permanente HealthConnect® can be harnessed to predict obstetric complications in real time. The long-term goal is to develop algorithms that could be instantiated in the electronic record to provide clinicians with discrete probability estimates with lead times of 6 to 12 hours. If successful, the algorithms would be instantiated using methods similar to those employed with the Advanced Alert Monitor, the early warning system currently in operation at Kaiser Permanente Northern California.
Investigator: Escobar, Gabriel
Funder: Kaiser Permanente Program Offices
Recovery or Disability? Trajectories After Pneumonia: Integrating 12 Months of Frequent Patient-Reported Measures with EMR Data
This is a pilot study to determine the feasibility of conducting a prospective study that aims to characterize longitudinal trajectories among patients with pneumonia. To achieve this goal, we will attempt to enroll 150 pneumonia patients at the time of hospital discharge, with a goal of retaining 100. Enrolled patients will be interviewed in the hospital, within 1 week of hospital discharge, and then again at 1.5, 3, and 4.5 months post-discharge. Our long-term objectives are to characterize post-discharge trajectories, with special emphasis on the impact of rehospitalization on a patient’s subsequent trajectory. The co-principal investigator will be Theodore Iwashyna, MD, PhD, of the University of Michigan.
Investigator: Escobar, Gabriel
Funder: National Institute on Aging
Benefits of Intensive Care Unit Admission for Patients with Acute Respiratory Failure or Sepsis
Ideal and optimally efficient use of intensive care unit (ICU) resources would create benefits across the health care system. Ideal use of ICU resources requires a needs assessment to determine which categories of patients commonly admitted to ICUs derive true net benefit on average from ICU admission versus admission to a regular hospital floor. This project aims to conduct such a needs assessment, which has never before been done.
Investigator: Liu, Vincent
Funder: National Heart, Lung, and Blood Institute
Using Peer Support To Aid in PRevention and Treatment in Prediabetes (UPSTART)
This intervention trial has three specific aims: 1) To implement and test the effectiveness of a peer support model to initiate and sustain healthy diabetes-prevention behaviors in a lower-income, diverse population of prediabetes patients across three different care settings (Kaiser Permanente Northern California, the Department of Veterans Affairs, and a Federally Qualified Health Center); 2) To examine the patient, provider, and system-level mediators and moderators of the effectiveness of the peer support model across the three intervention sites; and 3) To examine the cost-effectiveness of the peer support model, and assess other factors related to the barriers and facilitators to adoption and spread, using the Consolidated Framework for Implementation Research.
Investigator: Schmittdiel, Julie
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
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
Does Free Medicines Coverage Improve Diabetes Self-Care and Outcomes for Diverse Populations?
A quasi-experimental longitudinal study to evaluate the impact of KPHI WellRx — a program intended to engage patients more effectively in their self-care — among a diverse cohort of patients with diabetes. The study will evaluate: (1) the offering of the free WellRx Pilot from January 2012 through December 2014 to selected employers and patients; and (2) the end of the free program with the option for selected employers to purchase WellRx beginning in 2015.
Investigator: Adams, Alyce
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Predictive Modeling to Aid Clinical Decision-Making and Improve Diabetic Peripheral Neuropathy Outcomes
This 18-month research project will bring together a multidisciplinary team of scientists and clinicians from four Kaiser Permanente regions (Kaiser Permanente Northern California, Kaiser Permanente Colorado, Kaiser Permanente Hawaii, and Kaiser Permanente of the Mid-Atlantic States) to identify patients most likely to benefit from intensive monitoring of diabetic peripheral neuropathy symptoms using predictive modeling strategies. The long-term goal of this study is to improve medical management of diabetic peripheral neuropathy while enhancing both the patient and provider experience and reducing healthcare costs.
Investigator: Adams, Alyce
Funder: Garfield Memorial Fund
Predicting Final Visual Acuity Following Cataract Surgery
The objective of this study is to predict visual acuity and incidence rates of complications after cataract surgery.
Investigator: Herrinton, Lisa
Funder: National Eye Institute
CTSI Institutional Career Development Core
The Clinical and Translational Science Institute (CTSI) facilitates the rapid translation of research to improvements in patient and community health. It is a cross-school, campus-wide institute with scientist leaders at its helm. To achieve its goals, CTSI provides infrastructure, services and training to support clinical and translational research. To advance its mission, it develops broad coalitions and partnerships at the local and national levels to enable a transformation of the research environment.
Investigator: Grant, Richard
Funder: National Center for Advancing Translational Sciences
Preferences, Management and Outcomes in the Oldest Patients with Diabetes
The aim of this study is to develop, pilot and conduct a survey among older diabetes patients (75 years of age or older) or their caregiver surrogates to collect data on: 1) self-management barriers (e.g., poor functional status, financial barriers, inadequate health literacy, depression); 2) treatment preferences (e.g., goals, attitudes regarding de-intensification and intensification, use of insulin, perceived risks and benefits of treatment); and 3) patient-reported outcomes (PROs) not commonly or comprehensively captured in the electronic medical record (e.g., health-related quality of life, falls, urinary incontinence, chronic pain).
Investigator: Karter, Andrew
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Mentored Research to Improve Care for Complex Patients With Diabetes
K24 Midcareer Investigator Awards in Patient-Oriented Research are designed to support established scientists with a track record of mentoring to devote time to research mentorship for junior investigators. The overarching goal of this K24 award is to develop innovative approaches to improving the care of complex patients with type 2 diabetes, including the growing number of Latinos with diabetes, by developing new care models and innovative tools to support patients and providers in achieving more effective diabetes primary care. Specific research aims are to: 1) Examine the relationship between patient visit priorities and PCP care plans; 2) Adapt pre-visit prioritization for Low-English-Proficiency and Spanish-speaking Latinos; and 3) Learn how to effectively implement alternative health IT platforms such as smart phones, interactive voice response, and other novel modalities for pre-visit prioritization. The project will provide ample mentored research opportunities for highly promising mentees with an interest and passion for patient-oriented research to improve the care of patients with type 2 diabetes.
Investigator: Grant, Richard
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Respiratory Syncytial Virus Infection in Preterm Infants: Six Seasons; Experience in an Integrated Health Care Delivery System
We will study the impact of the change in the American Academy of Pediatrics’s palivizumab recommendations in a large cohort of infants (300,000) of all gestations over a 7-year period (2010- 2016). We will quantify and characterize the following over this period: 1) occurrence of bronchiolitis in children 24 months of age; 2) testing patterns for Respiratory Syncytial Virus (RSV); 3) RSV immunoprophylaxis utilization; and 4) health care utilization among infants and children with RSV infection, with particular emphasis on hospitalization and use of intensive care.
Investigator: Escobar, Gabriel
Funder: AstraZeneca PLC
Long-term Benefits and Risks of Bariatric Surgery in Integrated Care Systems
The objective of this study is to provide surveillance of bariatric surgery outcomes and safety.
Investigator: Herrinton, Lisa
Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
This project aims to test the impact of changing the default mode for palliative care consultation in hospitalized patients from an “opt in” to an “opt out” model. This will be tested in 10-12 Ascension Health hospitals using a stepped wedge design. No KP patients are involved, and Dr. Escobar’s primary role will be to assist in the UH2 (planning phase), which has the following aims: develop electronic medical record algorithms to identify patients meeting palliative care triggers; validate data capture of all proposed outcomes in a sample of de-identified patients; validate methods for tracking adherence to electronically generated palliative care orders; establish mechanisms and materials for notifying patients and providers about the research; complete regulatory compliance components, including defining strategy for IRB approval, trial registry, and DSMB assembly.
Investigator: Escobar, Gabriel
Funder: National Institute on Aging
M-S Data Expansion: Integration of Kaiser Permanente Hospital Data to the Sentinel Distributed Database
Investigator: Herrinton, Lisa
Funder: U.S. Food and Drug Administration
Advance Alert Monitor Operations
The Systems Research Initiative will provide project management and operational consultation for the spread of the Advance Alert Monitor within KPNC between 10/1/16 and 9/30/18. During this time Division of Research will complete the following tasks: continue the support of AAM initiation in all KPNC hospitals; troubleshoot transition from Q6 hours to Q1 hours alarm firing; provide parameters, guidelines, variables, and oversight for quality control algorithms; recalibrate the AAM model twice (once during first year and once during second year); develop documentation for the AAM algorithm and its components; develop documentation for model recalibration; collaborate with KPIT to develop documentation of the Java application; collaborate to hand off operation of AAM to appropriate entities TBD; manual chart abstraction for evaluation of adherence to Life Care Planning program; and preliminary and final outcomes analysis, including submission of manuscripts for publication.
Investigator: Escobar, Gabriel
Funder: Kaiser Foundation Health Plan
The Safety and Effectiveness of Diabetes Quality Metrics in Elderly Patients
Improving health care quality for seniors with complex chronic conditions is a critical issue for health services and health policy research. Widely-used quality metrics for patients with chronic illness put forth by agencies such as HEDIS and CMS are often based on clinical trials evidence of reduced risk for clinical outcomes in younger study populations with fewer comorbidities, and may not be generalizable or appropriate for elderly patients. The primary goal of this study is to compare the effectiveness of meeting standard national quality metrics for diabetes medication adherence for specific medications, and to meeting HbA1c targets, on preventing adverse events, hospitalizations, and ED visits in elderly patients with diabetes.
Investigator: Schmittdiel, Julie
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Development, Reevaluation and Implementation of Outcome/Efficiency Measures
This project aims to test the feasibility of employing clinical data from comprehensive electronic medical record systems (such as the Epic EMR) for developing, testing and validating potential publicly-reported quality, process, outcomes and risk-adjustment measures on hospitalized adult patients.
Investigator: Escobar, Gabriel
Funder: Centers for Medicare and Medicaid Services
Delivery Science Rapid Analysis Program II
The purpose of the Delivery Science Rapid Analysis Program is to create a mechanism that will solicit, prioritize and address rapidly-researchable analytic questions with high-value to both TPMG”s quality improvement initiatives and DOR”s research agenda. The Rapid Analysis program will specifically focus on short-term observational data analyses that can be completed within 6 months. The Delivery Science Rapid Analysis Program will provide timely, strategic data for quality improvement efforts at QOS and TPMG, and disseminate its findings widely both within Kaiser and externally.
Investigator: Schmittdiel, Julie
Funder: The Permanente Medical Group
Early Detection, Prevention and Mitigation of Impending Physiologic Deterioration in Hospitalized Patients Outside the ICU: A Pilot Project
An electronic alert system targeting adult patients in 3 hospital units (ward, telemetry, and transitional care unit) will be deployed at two KPNC hospitals (South San Francisco and Sacramento). The alert system provides early (12 hours) warning about a patient’s impending risk of deterioration as well as global risk around the time of admission to the hospital. It will be coupled with changes in clinician workflow (e.g., use of an automated checklist for patients who have triggered an alert) as well as frequent feedback on hospital adverse events from the DOR. To evaluate the pilot intervention, a difference in differences analysis will be conducted in which adverse outcome rates in the two pilot sites will be compared against the remaining 19 KPNC hospitals. Data from the pilot will be used to estimate duration of a stepped wedge cluster randomized trial involving all remaining KPNC hospitals.
Investigator: Escobar, Gabriel
Funder: Gordon and Betty Moore Foundation
Diabetes Screening and Care Received by the Mentally Ill in an Integrated System
This observational study will examine the level of fasting plasma glucose (FPG) and A1c testing in patients with severe mental illness, and examine patient-level predictors of testing and FPG/A1c values.
Investigator: Schmittdiel, Julie
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities
Previous research has shown that mail order pharmacy use is associated with improved adherence to cardiometabolic medications, and better LDL-C control in new statin users. In addition, mail order use is more common among white patients and those with higher SES. The purpose of this dissemination and implementation study is to conduct a randomized encouragement trial to test the effectiveness of strategies to encourage mail order pharmacy use in the overall population and among groups at risk for disparities in health outcomes, and to see if increased mail order use results in improved adherence and intermediate CVD risk factor outcomes.
Investigator: Schmittdiel, Julie
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Data-Driven Precision Medicine in Sepsis
Sepsis is a common and costly disease which contributes to nearly 1 in 2 hospital deaths in our healthcare system. While aggressive early treatment with quantitative resuscitation has demonstrated benefit, many other interventions have not demonstrated efficacy likely resulting from an incomplete understanding of sepsis disease mechanisms. This study seeks to address three questions through innovative approaches to using observational data: (1) what factors can improve our characterization and phenotyping of sepsis patients; (2) what are the potential benefits of using quantitative resuscitation in less severe sepsis subgroups; and (3) how does acute organ dysfunction impact long-term mortality and utilization among sepsis survivors
Investigator: Liu, Vincent
Funder: National Institute of General Medical Sciences
Cardiovascular Benefits and Safety of Glucose-Lowering Therapies in Adults with Diabetes
Cardiovascular (CV) events are the most common cause of death among adults with type 2 diabetes. While the benefits and safety of commonly used blood pressure and cholesterol medications are well established, much less is known about the CV benefits and safety of many commonly used therapies to control glucose. In this project, we carefully assess the impact of specific glucose-lowering strategies on CV events (myocardial infarction and stroke) and on mortality, in order to identify whether some glucose-lowering strategies confer more CV benefit or risks than others. To address this important clinical and public health concern, we will test several specific comparative effectiveness hypotheses, in an electronic medical record-linked Health Care Systems Research Network-based registry of over 650,000 adults with diabetes receiving care in 4 large U.S. health care systems.
Investigator: Schmittdiel, Julie
Funder: National Heart, Lung, and Blood Institute
Balancing Treatment Outcomes and Medication Burden among Patients with Symptomatic Diabetic Peripheral Neuropathy
This project is a continuation of a study we recently conducted to identify and prioritize treatment outcomes of relevance to patients with diabetic peripheral neuropathy (DPN). DPN affects 30% to 50% of all adults with diabetes and symptoms such as pain, tingling, numbness or a burning sensation in the extremities can be sudden and severe. Currently, only two prescription medications are approved for treatment of DPN symptoms, though many more are routinely used in practice. Clinical trials suggest that commonly used therapies have similar efficacy with respect to pain relief. However, side effects are common and little is known about the relative efficacy of these medications in addressing other patient-valued outcomes (e.g., quality of life). The goal of the proposal is to evaluate whether a clinical decision aid that includes information on patient treatment preferences can improve treatment persistence and outcomes that are important to patients.
Investigator: Adams, Alyce
Funder: Patient-Centered Outcomes Research Institute
CAREER: Managing Patient Flows with Congestion Effects
This project will employ simulation methods to analyze emergency department, hospital, and ICU data, including physiologic markers of severity of illness, with a view to identifying specific patient flow, hospital and ED occupancy states, and processes of care (e.g., early goal-directed therapy for sepsis) associated with improved patient outcomes (e.g., death, unplanned transfer to intensive care) as well as improved system states (e.g., absence of ED overflow conditions, absence of census-driven discharges from hospital units).
Investigator: Escobar, Gabriel
Funder: National Science Foundation
Development of Predictive Models for Recurrent Clostridium Difficile Infection (rCDI)
This project will examine predictors of and outcomes after recurrent Clostridium difficile infection in adults. Predictors will include age, sex, diagnoses, severity of illness, hospital length of stay, and antibiotic exposure. Outcomes will include hospital utilization, particularly use of intensive care, mortality, and other major morbidity (e.g., major bowel surgery). The initial cohort will consist of adults 18 years of age or older who (a) were members on 1/1/02, (b) did not have any C difficile infection between 9/1/01 and 12/31/01, and (c) developed C difficile infection on or after 1/1/02. These patients will then be divided into those that did and did not have a recurrent (2nd) C difficile infection.
Investigator: Escobar, Gabriel
Funder: Merck ＆ Company, Inc.
Multi-Component Behavioral Intervention for Complex Patients with CVD Risk
Disease management programs have had success in CVD risk factor control among uncomplicated patients but often fall short in more complex patients. New approaches are needed to address the multiple barriers faced by CVD patients with complex medical and behavioral comorbidity. We propose to develop and implement a multi-component intervention that includes patient activation, patient engagement, broad brush screening for undiagnosed behavioral health conditions, and creation of personal care plans tailored to each individuals unique set of barriers, motivators, and clinical goals. By focusing on core health skills and cross-cutting barriers to care in high risk patients not meeting clinical treatment goals, we are designing this intervention to be widely generalizable to all patients with multiple complex chronic conditions. We will conduct a randomized clinical trial of the intervention vs. usual care to examine effectiveness on proximal outcomes and CVD risk factor control.
Investigator: Grant, Richard
Funder: National Heart, Lung, and Blood Institute
Interactive Personal Health Records: Use of a Web-Portal by Patients with Complex Chronic Conditions
Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. This study will examine the impact of implementation and use of consumer health IT tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.
Investigator: Reed, Mary
Funder: Patient-Centered Outcomes Research Institute
Aligning the Visit Priorities of Complex Patients and their Primary Care Providers
The primary care visit is a key opportunity for catalyzing changes in care for complex patients with multiple heath issues. With too many items to address in the time allotted, however, the decision of which items to focus on requires prioritization. Prior studies have shown that: 1) patients and providers often have discordant priorities, 2) this discordance is associated with less effective care (e.g., poor adherence, lack of medication intensification), and, conversely, 3) collaborative interactions with informed, activated patients and prepared providers lead to better clinical outcomes. We hypothesize that a systematic approach that enables patients and providers to align visit priorities will result in more effective, patient-centered care because explicitly negotiated management decisions that address both patient and provider priorities are more likely to be adopted. This project will include focus groups and a pilot clinical trial examining impact on patient-centered outcomes.
Investigator: Grant, Richard
Funder: Patient-Centered Outcomes Research Institute
Impact of Integrated Patient-Facing Health IT Tools on Quality and Resource Use for Patients with Diabetes
This is a quasi-experimental study of the effect of Health IT use on the quality and efficiency of outpatient care for patients with multiple chronic diseases.
Investigator: Reed, Mary
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
