Electronic Health Data Initiatives for Research

The six PROSPECT studies are focused on developing new clinical infrastructure and improving the methodology for collecting prospective data from electronic clinical data to generate new evidence on the comparative effectiveness of healthcare interventions. The primary purpose of the PROSPECT Studies is to advance the quality, depth, and scale of the electronic data collection infrastructure as a basis for CER.An overarching aim of the PROSPECT program is to substantially enhance the nation’s capacity to systematically collect prospective data to inform CER on diagnostics, therapeutics, devices, behavioral interventions, and procedures used in clinical care.

The two Enhanced Registries for Quality Improvement (QI) and CER projects are focused on further developing an existing patient registry to track health outcomes, measure quality and performance, and support CER. The primary purpose of these projects is to enhance the electronic clinical capability of an existing registry for two purposes: 1) creating and analyzing valid data for CER, and 2) enhancing the ability to monitor and advance QI in clinical care.

The three Scalable Distributed Research Networks (DRN) for CER projects are linking data by building and expanding the existing electronic health data infrastructure with an emphasis on developing the capability of near real-time data extraction and analysis, as well as new data collection at the point-of-care (with minimal impact on clinical workflow).The projects aim to enable the collection of comprehensive longitudinal data across diverse healthcare delivery settings (e.g. ambulatory, in-patient, and long-term care facilities) in order to evaluate the effectiveness of clinical interventions for a diverse set of health conditions.

The primary goal of this project is to create and evaluate an Internet-based “Comparative Effectiveness Research Hub” (CER Hub) where researchers can collaboratively develop standardized problem-specific processors of electronic clinical data (with medical classifier applications, or MediClass) in support of CER studies. The project aims to develop a platform for CER with the capacity to generalize along dimensions to function in any EMR data environment, to integrate health care information from diverse settings and clinical practices, and to address any CER questions where both free text and coded EMR data would be required.

Comparative Outcomes Management with Electronic Data Technology (COMET): The goal of this project is to develop a new electronic data network infrastructure that will prospectively enable access to and the sharing of clinical and research data between four Clinical Centers (CCs). The development of this new, broad, scalable, and sustainable electronic data network will enable the collection of longitudinal data content (both digital and physical) by each of the four CCs. Ultimately, the project will develop a light, open-source informatics platform with single-point access, and will serve as a federated query tool that builds domain specific ontologies across the network.

The AcademyHealth Electronic Data Methods (EDM) Forum is an initiative to collect, synthesize, and share lessons learned from research projects that are developing and using electronic clinical data to conduct comparative effectiveness research (CER) and patient-centered outcomes research (PCOR).

The Indiana PROSPECT builds on the Indiana Network for Patient Care (INPC) which is the nation’s largest health information exchange (HIE) that contains over 4 billion structured observations and 78 million text documents for over 26 million patients across the entire network. This resource is already used for a variety of clinical outcomes and clinical effectiveness research. The project will enhance the infrastructure to capture richer clinical data and enhance the ability to incorporate patient outcomes, improve capture of device utilization data, incorporate genomic and other high throughput results, and identify patient for recruitment and enrollment technologies.

SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM): The overall goal of this project is to develop a comprehensive, longitudinal clinical registry of a population of approximately 1.3 million insured patients with diabetes mellitus and a similar database of all members without diabetes from 11 integrated health care delivery systems. The registry will cover the period from 2005-2013, draw from demographic and clinical data elements in EHRs and other system databases, capture patient-reported data where it is already being routinely collected, and calculate and add data on medication adherence.

The Washington Heights Initiative Community-based Comparative Effectiveness Research (WICER) project advances comparative effectiveness research (CER) through creating a robust community-focused data infrastructure that supports innovative studies of public health problems. WICER is built on an existing institution-focused data foundation at Columbia University. WICER contains a research data warehouse that integrates patient-level data, including clinical data from multiple facilities, settings and sites of care, with person-level self-reported information collected via community survey. It maps the linked data to variables that support CER studies. Three CER studies demonstrating the WICER infrastructure and methods are prospectively studying the diagnosis, treatment and management of hypertension.

The Population-Based Effectiveness in Asthma and Lung Disease (PEAL): This project will create a new infrastructure to accelerate comparative effectiveness research (CER) in asthma and other lung diseases in diverse populations. The Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network will create a highly detailed, standardized, linked computerized datasets from a state Medicaid plan and four health plans. CER will be conducted on asthma controller medications, evaluating adherence and other real-world factors. This project is innovative in that it will link claims, electronic medical records, patient and provider data, and will build new linkages with a Medicaid plan to include vulnerable groups who are disproportionately burdened by asthma.

The Scalable National Network for Effectiveness Research (SCANNER) project aims to develop a secure, scalable distributed infrastructure that facilitates collaborative comparative effectiveness research (CER) among widely dispersed institutions and provides flexibility to participant sites in the means for data sharing. This flexibility will be implemented by allowing codification of data sharing policies - each institution will specify its own policies. SCANNER will connect diverse healthcare delivery settings with secure infrastructure that utilizes data collected at the point of care.

The overall goals of the Scalable Architecture for Federated Therapeutic Inquiries Network (SAFTINet) project are to enhance the capacity and capability of a safety net-focused distributed research network to conduct prospective comparative effectiveness research (CER) via a multi-setting, multi-state organization. SAFTINet will federate geographically dispersed safety net entities that collectively serve markedly diverse underserved populations. This multi-state project will allow researchers, health policy experts, payers, and clinicians to better understand the impact of a wide variety of health care interventions on health outcomes for minority, underserved and socioeconomically disadvantage populations by supporting CER.

The Scalable PArtnering Network for CER: Across Lifespan, Conditions, and Settings (SPAN) is developing a distributed research network that is interoperable across a range of health care systems and sites, incorporating large and diverse patient populations. The network infrastructure has the capability to conduct large CER studies using data collected on patient-reported outcomes collected by electronic health records at the point of care. The project addresses the important issue of governance to oversee all aspects of managing and conducting multi-site research with confidential health information.

Surgical Care and Outcomes Assessment Program CER Translation Network (SCOAP CERTAIN) builds a learning healthcare system focused on improving the effectiveness, quality and safety of surgical and interventional care. SCOAP CERTAIN leverages the success of the SCOAP registry to improve existing use of data for quality improvement (QI), and to extend the registry into comparative effectiveness research (CER). SCOAP CERTAIN builds an automated flow of electronic health information using cutting edge informatics tools and evaluates the use and value of automated data retrieval from across diverse healthcare settings including the use of novel text mining tools. Project aims will greatly enhance existing QI by delivering more comprehensive and timely data about performance of evidence-based care, and in relieving manual staff and resource burden to participating hospitals.

The overall goal of this project is to support a learning healthcare system by building an open-access data sharing network focusing on a pediatric population to improve care and increase patient participation. The modular, versatile, and scalable registry will be populated by electronic health records (EHRs) and used to support quality improvement (QI) and comparative effectiveness research (CER).

The Beacon Community Cooperative Agreement Program is focused on demonstrating ways in which health IT investments and Meaningful Use of electronic health records (EHR) can advance the vision of patient-centered care while achieving the three-part aim of better health, better care at lower cost. The HHS Office of the National Coordinator for Health IT (ONC) selected 17 communities across the United States that have already made inroads in the development of secure, private, and accurate systems of EHR adoption and health information exchange (a $250 million investment over three years). Each of the communities, with its unique population and regional context, is actively pursuing efforts to 1) build and strengthen the health IT infrastructure and exchange capabilities within communities, position each community to pursue a new level of sustainable health care quality and efficiency over the coming years; 2) Translate investments in health IT in the short run to measureable improvements in cost, quality and population health and; 3) Develop innovative approaches to performance measurement, technology and care delivery to accelerate evidence generation.

BEIN

Through the Beacon Evidence and Innovation Network (BEIN), AcademyHealth has joined with The Commonwealth Fund, the Office of the National Coordinator for Health Information Technology (ONC), and other experts to assist the 17 selected communities of the Beacon Community Cooperative Agreement Program in identifying, documenting, and disseminating the lessons and results of their individual efforts in a systematic way. The ultimate goal of this initiative is to generate actionable, rigorous evidence from the Beacons on identifying strategies for leveraging health information technology to improve patient care and reduce costs.

caBIG

The National Cancer Institute's Center for Bioinformatics and Information Technology launched the caBIG® (cancer Biomedical Informatics Grid®) initiative in 2004 to mobilize digital capabilities for researchers in order to accelerate scientific discoveries. The vision of the caBIG® program is enhanced cancer research that leverages state-of-the art digital capabilities.

CER HIT/Informatics Task Force

The ‘CER HIT/Informatics Task Force’ is a component of the CTSA KFC focusing on HIT/Informatics specifically for CER.

CONCERT

CONCERT (COPD outcomes based network for clinical effectiveness and research translation), is a 5 year old multi-center collaboration of investigators with expertise in epidemiology, statistics, health services research, cost-effectiveness analysis, clinical trials, performance measurement, quality improvement, implementation research, and multi-center data coordination. CONCERT's goal is to employ effectiveness and translational research methodologies to improve the care and outcomes of patients with COPD.

CTSA CER KFC

The Comparative Effectiveness Research (CER) Key Function Committee builds the field of comparative effectiveness research (CER) and patient-centered outcomes research by creating a learning community across CTSA institutions, spurring the development of methods, expanding training and education, promoting community and public engagement, applying CER findings and sharing successes and lessons learned.

Dartmouth Care Collaborative (High Value Health Care Collaborative)

A collaboration between the Mayo Clinic, Denver Health, Intermountain Healthcare, Dartmouth-Hitchcock, Cleveland Clinic, Baylor Health Care System, Beaumont Hospitals, MaineHealth, Scott & White Health Care, Sutter Health, UCLA Health System, University of Iowa Health Care, Virginia Mason Medical Center, and The Dartmouth Institute for Health Policy and Clinical Practice (TDI) focused on improving health care, lowering costs, and moving best practices out to the national provider community. All members of the HVHCC have a commitment to the Collaborative process, including sharing care pathways, costs, and outcomes data with their partners and the public as they adopt best practices and new, expanded standards of measurement.

DARTNet

DARTNet Institute is a collaboration of practice-based research networks that are working to build a national collection of electronic health record (EHR) data, claims data, and patient reported outcomes data.

DEcIDE

The DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network is a collection of research centers that the Agency for Healthcare Research and Quality (AHRQ) created in 2005. These centers gather new knowledge and information on specific treatments. The DEcIDE Network conducts studies on the outcomes, effectiveness, safety, and usefulness of medical treatments and services.

Federal HIT Taskforce (ONC)

The Federal Health Information Technology Task Force, which ONC co-chairs with the Office of Management and Budget, and involves numerous other federal agencies, including CMS, Department of Veterans Affairs, Social Security Administration, Department of Defense, Department of Commerce, Department of Agriculture, and the Office of Personnel Management. The overall goal of the Task Force is to promote communication and information sharing between different federal agencies who are each involved with health IT while adhering to high standard of privacy and security.

HITIDE (VA)

The HITIDE initiative (facilitted by the HITIDE subgroup, established in 2011) aims to advance the development of interoperable health IT systems by leveraging the existing testbed environments of Federal agency health IT systems for a virtual, active, innovation ecosystem. The alliance of testbeds represents agency health IT / electronic health record production systems, and provides a “playing field” for prototyping and testing interoperability innovations. Key components of HITIDE are the governance and policy mechanisms that enable trusted users to get fast-track access to a test environment and, once in the environment, access to the tools and components hosted in the environment.

HMORN

The HMORN is a consortium of 16 Health Maintenance Organizations that have formal, recognized research capabilities. The HMORN vision is to be a research partner of choice for those seeking to shape health and health care delivery with the goal of being recognized as the Nation’s premier resource for population-based health and health care research, contributing to national and global dialogues, promoting and establishing the Network as a preferred research partner of funding agencies, fostering Network-led collaborative studies, sharing methodologies, best practices, and consultative expertise.

i2b2

i2b2 (Informatics for Integrating Biology and the Bedside) is an NIH-funded National Center for Biomedical Computing based at Partners HealthCare System. The i2b2 Center is developing a scalable informatics framework that will enable clinical researchers to use existing clinical data for discovery research and, when combined with IRB-approved genomic data, facilitate the design of targeted therapies for individual patients with diseases having genetic origins.

iDASH

Created as a National Center for Biomedical Computing (NCBC) under the auspices of the NIH Roadmap for Bioinformatics and Computational Biology, iDASH is a Biomedical Cyberinfrastructure (BCI) that provides innovative services, algorithms, open-source software, and data storage as well as training.

Janus Clinical Trial Repository (FDA)

A clinical trial data repository (or data warehouse) sanctioned by the U.S. Food and Drug Administration (FDA). The Janus data model has capabilities to load and store findings, events, interventions and inclusion data. The goals of Janus are to create an integrated data platform for most commercial tools for review, analysis and reporting; reduce the overall cost of existing information gathering and submissions development processes as well as review and analysis of information; provide a common data model that is based on the SDTM standard to represent four classes of clinical data submitted to regulatory agencies: tabulation datasets, patient profiles, listings, etc.; provide central access to standardized data, and provide common data views across collaborative partners; and support cross-trial analyses for data mining and help detect clinical trends and address clinical hypotheses, and perform more advanced, robust analysis. This will enable the ability to contrast and compare data from multiple clinical trials to help improve efficacy and safety; Facilitate a more efficient review process and ability to locate and query data more easily through automated processes and data standards and; Provide a potentially broader data view for all clinical trials with proper security, de-identified patient data, and proper agreements in place to share data.

mini-Sentinel

Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration (FDA) to inform and facilitate development of a fully operational active surveillance system, the Sentinel System, for monitoring the safety of FDA-regulated medical products. Mini-Sentinel is one piece of the Sentinel Initiative, a multi-faceted effort by the FDA to develop a national electronic system that will complement existing methods of safety surveillance.

MPCD

Under a contract with the Centers for Medicare and Medicaid Services (CMS), OptumInsight (formerly Ingenix) is developing a Multi-Payer Claims Database (MPCD), which will include longitudinal claims data to support comparative effectiveness research (CER). Development of the MPCD is a key element of the national effort to strengthen the data infrastructure and methods for CER. The requirements of the MPCD include: A sample that reflects the U.S. population demographically and geographically; Information for the purposes of understanding variation in utilization across payers, providers, and geographies; The statistical power for users to conduct “hypothesis testing” analysis for subpopulations or specific medical interventions not found in large enough numbers in other databases; A combination of CMS and private-payer data at a national level; Meaningful access to administrative data from public and private payer sources for researchers seeking to better the public health; and A platform from which to explore future incorporation of additional data sources and data types (e.g. clinical data, EHR data, etc.).

OMOP

The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership designed to help improve the monitoring of drugs for safety. The partnership is conducting a multi-year initiative to research methods that are feasible and useful to analyze existing healthcare databases to identify and evaluate safety and benefit issues of drugs already on the market.

PACES (FDA)

The Partnership in Applied Comparative Effectiveness Science (PACES) initiative aims to advance comparative effectiveness research (CER) by leveraging the Food and Drug Administration’s (FDA) immense and previously unused stores of data. The FDA has established a database to improve the agency’s management of data and create structured, scientific data repositories. Utilizing the database, the agency aims to build CER data standards, infrastructure, tools, skills, and capacity. The PACES initiative will facilitate the development of CER studies, which will allow the FDA to better understand which interventions are most effective for patients under specific circumstances-a key part of the FDA’s public health mission. The Johns Hopkins University (JHU), CMTP, Buccaneer Computer Systems and Services, Inc and the Lewin Group are partners with CMS on the PACES initiative.

Physio-MIMI

Physio-MIMI (Multi-Modality, Multi-Resource Information Integration environment) is an NCRR-funded, multi-CTSA site project designed to develop novel, flexible informatics methodologies, tools and infrastructure to facilitate the collection, management, and analysis of clinical and physiological data.

Query Health (ONC)

The Query Health Initiative aims to identify the standards and services for distributed population health queries to certified EHRs and other patient data sources, such as HIEs, originating in the routine course of patient care. As a result, information requestors will be able to create and securely distribute queries to data sources directly or via optional network data partners, who serve as intermediaries. The information requestors can distribute queries to data sources, or network data partners, who support the distributed queries; however the data sources ultimately retain control over the decision whether to respond to a query as well asmaintain control over the data to be released. Network data partners, when used, may examine queries and pass them on to data sources, and may aggregate and modify the data returned, performing such tasks as masking of provider organization, etc. Data sources, such as a provider organizations, will execute the query against a standard clinical information model, securely return the results of the query directly to the requester or via the network data partner. The Initiative will develop models for the technical and financial sustainability as well as best practices for organizations, management and coordination, data use, data sharing; giving consideration to privacy, security and consent requirements.It will also address methods for extensibility of the clinical information model; specifically those data elements, terminologies, and code sets that enable the queries and results expression.

REDCap

The REDCap Consortium is comprised of 362 active institutional partners from CTSA, GCRC, RCMI and other institutions, and it supports a secure web application (REDCap) designed exclusively to support data capture for research studies. The REDCap application allows users to build and manage online surveys and databases quickly and securely, and is currently in production use or development build-status for more than 34,380 projects with over 47,550 users spanning numerous research focus areas across the consortium.

SHARP

The purpose of the Strategic Health IT Advanced Research Projects (SHARP) Program is to fund research focused on achieving breakthrough advances to address well-documented problems that have impeded adoption of health IT and to accelerate progress towards achieving nationwide meaningful use of health IT in support of a high-performing, continuously-learning health care system.

VINCI (VA)

VINCI is an initiative to improve researchers' access to VA data and to facilitate the analysis of those data while ensuring Veterans' privacy and data security. The mission of VINCI is to improve the healthcare of Veterans by providing researchers access to integrated national datasets and tools for analysis in a secure, high-performance computing environment.