The Stakeholder, Technology, and Research (STAR) CRN is a partnership of eight health systems throughout the United States, led by Vanderbilt University Medical Center (VUMC). The STAR CRN is committed to improving healthcare delivery, especially in the area of health disparities, by supporting health systems research, patient-centered outcomes research, and pragmatic clinical trials.
The STAR CRN provides data and research infrastructure to support patient-centered research to meet the needs of patients across the country, but particularly in areas where incidence of diabetes, obesity, and heart disease are relatively high. The network is advancing more complete and comprehensive data sets for research by providing per project linkage of clinical data from its participating sites to complementary data sources, including both Medicare and Medicaid claims, as well as claims from private health plans and state health departments. This data linkage provides a more complete picture of patients’ healthcare experience and is essential for providing the necessary depth of data for real-world evidence studies.
To maximize research opportunities, the STAR CRN actively engages with a multitude of different stakeholders, including patients, community members, local institutions, researchers, clinicians, and health system leaders. The network is committed to maintaining key partnerships and utilizes various methods such as interactive web conferences, opportunities to provide a facilitative review of study proposals to the STAR CRN upon intake and submission, engagement surveys to determine best practices and inform strategic decisions for the network, presentations, and leadership meetings to engage stakeholders. To uphold STAR’s patient-centric model, patient engagement is a network priority. This engagement includes Community Engagement Studios (CES), a disease-agnostic, structured approach for meaningful engagement of community and patient/patient stakeholders in all research phases, in conjunction with the Clinical and Translational Science Awards program of the National Institutes of Health. The STAR CRN is working to roll out the use of CES to other Partner Networks engaged in PCORnet. CES engages community experts such as patients, caregivers, and community organizations to act as consultants by responding to inquiries from researchers to strengthen research proposals. The CES toolkit can be found here.
The STAR CRN is managed by the Leadership Team Committee, comprising the network principal investigator (PI), site-level PIs, and two stakeholders. Daily operations are managed by the Administrative Team housed at VUMC. The Leadership Team reviews and approves networkwide research requests, reviews data quality metrics, approves internal policies and procedures, and reviews stakeholder engagement strategies. The Leadership Team is also advised by the larger STAR Stakeholder Advisory Council, consisting of patients, community members, and clinicians who help prioritize research opportunities and review all incoming studies to ascertain engagement of patients. Input from stakeholders is used to inform the research design, implementation, analysis, dissemination and/or priority setting. The Oversight Council comprises health systems leaders, clinicians, and patients who provide key strategic oversight and a central Informatics team that provides information on data quality and consistency and query performance for the entire network.
PCORnet is intended to serve as a national resource for conducting rapid, efficient, patient-centered observational and interventional randomized research that improves healthcare delivery and health outcomes. Over the course of this project period the STAR CRN will enhance and optimize its infrastructure to support a variety of patient-centered studies by:
Ensuring meaningful engagement of patients, caregivers, clinicians, delivery systems, payors, and researchers, in all phases of the research process
Operating through a network model in which data remains at the source while allowing approved researchers within and outside the network to access it securely through a central point
Facilitating the public sharing of resources and reusable tools to make research more efficient and reproducible
Using the PCORnet CDM, which standardizes the data collected when patients receive care so that it is comparable across health systems and can be used for patient-centered outcomes research
Using streamlined processes such as one central IRB for studies involving multiple systems and standardized data use agreements, to enable research to be quicker and more efficient
The Stakeholder, Technology, and Research Clinical Research Network
Clinical Research Network
Vanderbilt University Medical Center
Health Sciences South Carolina
Meharry Medical College
The University of North Carolina at Chapel Hill
Vanderbilt Health Affiliated Network
Wake Forest Baptist Health
PCORI funded the development of PCORnet®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships. Clinical Research Networks (CRNs) are one type of network supported by PCORI. CRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CRN transforms data gathered from routine patient care across its participating health systems to a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.
This study received additional funding in 2020 to quickly initiate new research related to COVID-19. The additional research is in progress. PCORI will post the research findings on this page once the results are final.
Recent data suggests the development of coagulopathy as a result of the inflammatory response to SARS-CoV-2 infection is associated with poorer outcomes in patients with COVID-19. The enhancement to this project utilizes the PCORnet Distributed Research Network Operations Center, vanguard Clinical Research Network (CRN) sites, and the PCORnet COVID-19 Common Data Model (CDM) to optimize and validate key COVID-19 data elements related to the treatment and outcomes associated with COVID-19 coagulopathy. This initial work will help to inform future work to better understand the prevalence and role of coagulopathy in COVID-19 and potential treatment options.
In the enhancement:
Vanguard CRN slides will load priority data elements into their PCORnet COVID-19 CDM
PCORnet COVID-19 CDMs at participating sites will be assessed for research readiness
Priority data elements will be validated by the CRNs through provenance surveys
Coordinating Center and CRNs will perform limited validations of case definitions and derived data elements