Mid-South CDRN: The Mid-South CDRN currently encompasses 3 large health systems: (1) the Vanderbilt University
(VU) Health System and local partner sites engaging over 2 million patients, (2) the growing Vanderbilt Healthcare
Affiliated Network (VHAN) which includes 34 community hospitals and over 350 practices reaching over 3 million
patients in the Mid-South Region, and (3) Greenway Health, with access to 1600 clinics in the PrimeResearch network
reaching over 14 million patients across the nation. The Vanderbilt community also includes a robust alliance with
Meharry Medical College, an academic health center with a mission to improve the lives of minority and underserved
populations through health care and research. Meharry operates Nashville General Hospital, a publicly supported,
community hospital and has long-standing ties to the Matthew Walker Comprehensive Health Center, a Federally
Qualified Health Center each of which use commercial EHR systems. The Mid-South CDRN also partners with the
Carolinas Collaborative, a consortium of 4 academic health systems (Duke, UNC, MUSC, USC/Palmetto
Health/Greenville Health) and multiple community health systems across North Carolina (NC) and South Carolina (SC).
The collaboration is managed by Health Sciences South Carolina (HSSC). These health systems have agreed to federate
their data and have already piloted data sharing using the PCORNet common data model. The Carolinas Collaborative
includes 3 CTSA sites, 27 inpatient facilities and 800-plus primary care specialty practices in both urban and rural areas.
Current Common Data Model: The Mid-South CDRN connects four different clinical Systems’ networks. By design,
each selected network is made up of its own health information technologies (HIT). To facilitate efficient and consistent
data queries across sites, the Mid-South CDRN uses of the PCORnet CDM as the main syntactic and semantic standard.
The data quality and validation procedures employed within the VUMC PCORnt node are consistent with the overall
policies employed by the VUMC research data warehouse from which that datamart is derived. The main issue identified
relates to the reliance on an aggregation system for individual encounters. The Greenway datamart will be populated using
a process that leverages existing MU reporting infrastructure and is expected to include a robust set of data quality and
validation processes. The VHAN datamart will be populated using the HIE infrastructure and associated data management
and quality procedures which are still in active development.
FACILITY 1 : VANDERBILT
Vanderbilt University Medical Center : Vanderbilt University Medical Center (VUMC) will house the CDRN. VUMC
is a comprehensive health care facility dedicated to patient care, research, and the education of health care professionals.
Its reputation for excellence in each of these areas has made Vanderbilt a major patient referral center, including for
patients with rare conditions and those which have been refractory to diagnosis and/or treatment in other settings. The
clinical facilities are mentioned here to demonstrate the degree to which, as an institution, we are deeply invested in the
transformative effect of the PCORI CDRN initiative. Except for Stallworth, these facilities are fully owned and operated
by Vanderbilt University with their leadership reporting through standard university channels to the Vice Chancellor for
Health Affairs. Our University Hospital is a triple-towered, 658 bed structure with approximately 50,000 inpatient stays
per year, and the region's only Level I Trauma Center. Monroe Carell Jr. Children's Hospital at Vanderbilt is the most
comprehensive children's hospital in the state, providing the highest level of neonatal intensive care in Tennessee (TN).
The Children's Hospital cared for patients from 44 states in the past year, and treats all children regardless of ability to
pay. The Vanderbilt Clinic comprises more than 95 outpatient specialty practices which collectively see over 1,000,000
patient visits per year. The Psychiatric Hospital at Vanderbilt provides the focus for mental health care at the institution,
Vanderbilt’s Page Campbell Heart Institute offers a comprehensive heart program, and Vanderbilt’s Stallworth
Rehabilitation Hospital (a joint venture with HealthSouth, Vanderbilt provides medical staffing and direction) provides
complete inpatient and outpatient services for patients with neurological and orthopedic disabilities and degenerative
conditions. The Vanderbilt Transplant Center performed 638 transplants for patients in 2010. The Vanderbilt Ingram
Cancer Center cares for 4,500 new cancer patients each year, and more than 65,000 outpatient visits annually. Through
these activities we have developed a collective understanding of the profound need for new discovery, and the complex
challenges associated with translating scientific discoveries to medical practice. On the research side, Vanderbilt has more
than 450 research laboratories and support for competitive research grants from all external sources was more than $450
million in FY 2011; approximately 545 graduate students and 520 postdoctoral fellows are involved in research.
The Vanderbilt Clinic comprises more than 95 outpatient specialty practices in several campus locations, including
The Vanderbilt Clinic building, Medical Arts building, One-hundred Oaks and the Village at Vanderbilt. It offers the most
up-to-date diagnostic and treatment services for patients in a friendly, convenient environment. The Psychiatric Hospital at
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Vanderbilt (see below) provides the focus for mental health care at the institution. The Vanderbilt Page Campbell Heart
Institute offers a comprehensive heart program offering diagnosis, medical treatment, minimally invasive therapies, surgical
intervention and disease management, tailored to each individual’s unique needs. The Vanderbilt Stallworth Rehabilitation
Hospital provides complete inpatient and outpatient services for pediatric and adult patients with neurological and
orthopedic injuries or disabilities, degenerative conditions and certain chronic ailments. It also hosts the Vanderbilt Center
for Multiple Sclerosis, the Nashville Area Junior Chamber of Commerce gymnasium and elements of the Junior League
Center for Chronic Illnesses and Disabilities of Children. The Vanderbilt Transplant Center has extensive clinical experience
in each of the established transplant programs, excellent clinical outcomes and experienced leadership. All programs have
survival figures that surpass the national average.
Patient-centered outcomes research to improve the level of care for patients a major component of Vanderbilt’s
mission, which is directly aligned with the CDRN. See Letters of Support by Drs. Balser, Pinson, Benard, and Dittus.
REDCap: Our web-based data collection tool, REDCap has been used in over 161,000 projects in 90 countries. REDCap
is a secure, web-based application designed to support data capture for research studies.27 REDCap supports
standardization and shared data management for networked clinical research. It will support our CDRN in two ways. First,
primary data collection tools will be developed in REDCap, which allows for electronic data entry and organization and
provides a user-friendly interface for data entry (similar to tools like SurveyMonkey) with data validation; audit trails for
tracking data manipulation and export procedures; and, branching logic and calculated fields. This approach will provide
the platform to create a model for intuitive, just-in-time actionable methods to collect, maintain, and integrate nontraditional patient information in a quality manner. Second, REDCap already contains preliminary procedures for
importing data from external sources such as EHRs which would allow the EHR to directly feed case report forms. 28 We
integrated PROMIS Computer Adaptive Tests into REDCap to enable immediate data capture. Other enabling
technologies in development include clinical decision support for study randomization, embedding patient-reported
outcomes (PRO) within the EMR, and an integrated tissue repository.
MyHealthAtVanderbilt: The My Health at Vanderbilt (MHAV) patient portal is a secure electronic health record system
designed for patients to view and manage their healthcare. MHAV is overseen by co-Investigator Trent Rosenbloom. Over
the past decade, Vanderbilt has developed and deployed MHAV as a state-of-the-art, web-based patient portal to enable
secure communication between patients and their healthcare providers, to allow patients to access test results and reports
from their medical record, and to provide a mechanism for patients to learn about their health conditions. Currently, more
than 220,000 total patients use MHAV over 4000 times per day. By design, MHAV can be readily utilized to facilitate rapid
primary data collection in a large patient population. This example is provided to show that we have developed and applied
the expertise to communicate meaningfully with patients as a part of their healthcare, including the integrated
processes, interface, and privacy regulations associated with doing so, and have the capacity to collect primary data from
large patient populations for the purposes of CER.
MyResearchAtVanderbilt: In December 2014 VICTR surveyed all users of the My Health at Vanderbilt patient portal to
request their contact preferences for research. This has created a repository of over 19,000 patients that are willing to be
contacted directly for research known as MyResearch. Investigators may submit a request to contact participants through
MyResearch with an IRB approved study description. Participants may be filtered using the inclusion and exclusion criteria
of the study through the Research Derivative, or by comparing to a list of eligible participants the investigator has obtained.
This tool will provide a rapid, efficient panel of participant representatives to participate in research and give input on
research ideas. A web portal is being developed to provide patients with the ability to change their contact preferences, view
studies in which they are participating, view targeted advertisements for studies, and dissemination of study results. We
have also developed patient-facing tools that allow for ecological momentary assessment of patient activities and PRO.
Vanderbilt has built confidentiality-preserving tools that also enable efficient research.
The Synthetic Derivative (SD): The SD contains all clinical information in the EMR and its associated entry-order
relational database but is stripped of personal identifiers and modified in other ways to improve data reusability. The name
‘synthetic derivative’ comes from both alterations (e.g. date shifting to mask actual dates, which protects against reidentification) and extractions (e.g. of textual and structured information that is identifiable). The SD currently contains >69
million documents on 2 million patients and is refreshed regularly to add new clinical information from the EMR as it is
accrued. The de-identification methodology is based primarily on the systematic removal of the fields that are specified in
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Section 164.514 of the HIPAA privacy rule. The centralized de-identification of the entire EMR promotes privacy for
patients The SD contains data beginning in the early 1990s; data since 2005 include nearly all inpatient and outpatient billing
codes, laboratory values, reports, and clinical documentation, almost all in electronic formats available for searching. Both
structured (e.g., name–value pairs of laboratory tests, ICD9/10 diagnosis codes) and unstructured but searchable data (e.g.,
narrative progress and procedure notes) are included. The SD also involves a shared service core (Precision Phenomics)
which involves technical personnel who perform custom programming for algorithm development (as would be needed in
some high complexity disease/drug scenarios for more granular patient cohort establishment). These have been built into
the budget. The SD can be used for searching and aggregating sets of cases for genomic analysis or as a stand-alone clinical
research resource. As a byproduct of the clinical system, the SD contains phenotypic information that can be mined for the
valid development of cases and controls with no additional study procedures. There are currently >150 IRB approved users
of the SD. Studies using the resource are classified as “non-human subjects” research in accordance with the provisions of
Title 45 Code of Federal Regulations part 46, and have ongoing oversight from the Institutional Review Board and internal
and external ethical boards.
The Research Derivative (RD): The RD is a database of clinical and administrative data developed to enable clinical
research. The RD brings together data from myriad sources including billing codes, patient demographics, lab results,
medications, and clinical narratives from over five different health information systems. The data has been structured to
maximize feature searching and phenotype identification. Natural language processing and other informatics methods
have been applied to transform unstructured data into information critical to electronic phenotype identification. The
resource is well suited for rapid, efficient extraction of clinical data on a defined cohort using specific tests or phenotypes
as inclusion criteria to deliver identified or de-identified datasets, recurring reports, and up-to-date counts of subjects
meeting inclusion criteria. Instead of labor- and cost-intensive manual chart review that is often required to identify and
study a targeted patient population which normally occurs over months, the RD allows database analyst-driven extraction
of a specified clinical dataset on the scale of hours to days. This resource will be leveraged for rapid and cost-efficient
clinical data mining.
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