Posted by ImproveCareNow™ on October 25, 2011
Below is a summary of the Enhanced Registries grant
Building Modular Chronic Disease Registries for QI and Comparative Effectiveness Research
A learning healthcare system comprises a community of front-line clinicians, patients, and scientists who view each clinical encounter as an opportunity to learn and to improve patient outcomes. In its most advanced state, it combines comparative effectiveness (CE) research with quality improvement (QI) science to ensure the delivery of new knowledge at the point of care.
Electronic health records (EHRs) have the potential to become the tool for learning at the point-of-care, although most are patient-focused and do not natively support the population management required by a learning healthcare system. Registries are designed to do this, but generally operate independently of institutional EHRs. We propose to change this by building upon existing open-source software to create a modular, versatile, and scalable registry that can be populated by EHRs. We will test its ability to support QI and CE research within the ImproveCareNow practice-based research and improvement initiative. Our specific aims are to: (Aim 1) enhance an existing registry to support a learning healthcare system for pediatric inflammatory bowel disease (IBD) by capturing needed data directly from electronic health records, improving the quality of collected data using new tools we have developed for recording clinical data during a patient encounter, and facilitating interventions to improve the quality of care for children; (Aim 2) use quality improvement methods to implement enhanced IBD-registry features to enable management of IBD care center populations and increase patient participation in care; (Aim 3) use data from the enhanced registry to compare the effectiveness of alternative treatment strategies for pediatric Crohn’s Disease patients, with a special focus on timing of biologic agents; (Aim 4) develop governance structures for the network that engages patients and provides oversight of privacy, confidentiality, and data access, as well as scientific and technical concerns. The project will form a unique community of children, families, clinicians, informaticians, QI specialists, and CE researchers who work together to improve patient outcomes using learning healthcare system principles. Our long-term goal is to extend this work to other chronic disease communities devoted to advancing the health of children.
The project, funded by the Agency for Healthcare Research and Quality, will be undertaken by investigators at the Cincinnati Children’s Hospital Medical Center, Children’s Hospital of Philadelphia, Nationwide Children’s Hospital, Nemours Children’s Clinics, The Children’s Hospital Denver, the University of North Carolina Chapel Hill, and the University of Vermont, in cooperation with the participating sites of the ImproveCareNow Collaborative Network.
SPECIFIC AIMS
New biomedical discoveries, advances in information technology, and implementation research offer the potential for immediate, continuous, and transformative improvement in health care, but not within our current healthcare system. As envisioned by the Institute of Medicine,1 a learning healthcare system comprises a community of front-line clinicians, patients, and scientists who view each clinical encounter as an opportunity to learn and to improve patient outcomes. They rely on large registries and open-science networks that foster collaborative improvement, research, data sharing, and innovation.2-4 The registry captures, manages, and provides access to condition-specific information in a uniform way for a list of specific patients to support their clinical care.5 In its most advanced state, a learning healthcare system combines comparative effectiveness (CE) research (T2 translation) with quality improvement (QI) science (T3 translation) to advance patient outcomes.6 We propose to achieve this vision of a learning healthcare system by using open-source informatics tools to enhance an existing registry for children with inflammatory bowel disease (IBD) to enable better standardization and customization of care and CE research to create new knowledge about what care is best for which patients.
As part of federal initiatives to speed the introduction and “meaningful use” of health information technology nationally, the Centers for Medicare & Medicaid Services provides incentive payments to providers that electronically capture clinical data from patients to improve quality, outcomes, and efficiency.7 Electronic health record (EHR) systems have the potential to become the tool for learning at the point-of-care, although most are patient-focused and do not natively support the population management functionality required by a patient registry. The national transition to EHRs lends urgency to the tasks of developing software and processes to populate registries with data entered once (i.e., single data entry for clinical care, QI, and CE research). Recent advances in data sharing technologies using open-source tools8-11 and new methods for network-based research and innovation provide opportunities for creating a national, distributed, pediatric data network based upon capture of EHR data into registries.
We propose to build upon existing open-source software,9, 11, 12 with which we have extensive experience, to create an enhanced registry that is modular, versatile (i.e., can support longitudinal comparative effectiveness research and advanced QI) and scalable to many chronic conditions that affect children (a priority population). The Pediatric EHR Data Sharing Network (PEDSNet), the governance institution, will manage the data network and be developed to ensure its sustainability and growth as an open-science community. We will test our ability to provide optimal support of QI and CE research (an implementation sciences agenda13) within the successful ImproveCareNow practice-based research and improvement initiative.14, 15 Currently, all ImproveCareNow network sites collect clinical care data using structured, paper-based clinical encounter forms. Data are then entered into a centralized clinical registry via a web-based interface (i.e., sequential entry of clinical data into 2 sources). We will change this laborious, error-prone process to collect data once at the point of care. Our aims are to:
- Aim 1: Enhance an existing registry to support a learning healthcare system for pediatric inflammatory bowel disease by capturing needed data directly from electronic health records, improving the quality of collected data using new tools we have developed for recording clinical information during a patient encounter, and facilitating interventions to improve the quality of care for children.
- Aim 2: Use Quality Improvement methods to implement enhanced IBD-registry features to enable management of IBD care center patient populations and to increase patient participation in care.
- Aim 3: Use data from the enhanced registry to compare the effectiveness of alternative treatment strategies for pediatric Crohn’s disease (CD) patients, with a special focus on timing of biologic agents.
- Aim 4: Develop governance structures for the network that engages patients and provides oversight of privacy, confidentiality, and data access, as well as scientific and technical concerns.
The project will form a unique community of children and youth with IBD, their families, pediatric IBD clinicians, informaticians, QI specialists, and CE researchers who will work together to improve patient outcomes using learning healthcare system principles. Our long-term goal is to develop an approach and set of tools to extend this work to other chronic disease communities devoted to advancing the health of children.