Project Summary

The Stakeholders, Technology, And Research Clinical Research Network (STAR CRN) includes: (a) Vanderbilt Health System, (b) the Vanderbilt Healthcare Affiliated Network, (c) Meharry Medical College, (d) UNC Health Care System, (e) Duke Health Care System, (f) Health Sciences of South Carolina, (g) Wake Forest Baptist Health, and (h) Mayo Clinic. These systems include scores of academic and community hospitals, hundreds of practices, and approximately 12 million unique patients. The populations cared for by STAR CRN are diverse in age, race, ethnicity, socioeconomic, and urban/rural status. The objective of this CRN is to support projects in comparative effectiveness research, pragmatic clinical trials, and other research areas. A major goal is to support patient-centered research that is national in scope and addresses PCORI and other important public and consumer research priorities.

Key capacities of the STAR CRN include: the PCORnet® Common Data Model with standardized electronic health record data; ability to perform standardized queries for data research and for identification of patients for study recruitment; ability to leverage informatics tools for electronic identification, contact, consent, and recruitment of patients into studies; ability to leverage informatics tools for patient-reported data including collection of patient-reported outcomes over time; linkage to other data sources for more complete health record data including linkage to: Medicare, Medicaid, state health data, and commercial claims; robust stakeholder engagement including stakeholder advisory board reviews of research studies, identification of key stakeholders for projects, and the use of Community Engagement Studios for stakeholder input; and administrative efficiencies related to common regulatory processes, common contracting processes, data sharing, and other issues.

Currently, the STAR CRN operates as a distributed data network and maintains eight distinct data marts, with centralized coordination. These data marts have electronic health record data on over 14.9 million diverse patients with over 370 million clinical encounters. Data marts of the STAR CRN have passed all data curation cycles in the past two years, have responded to over 90 percent of recent query requests, and respond to queries within the required time allotments. Members of STAR CRN have deep expertise in data extraction, data curation, natural language processing, machine learning, and other approaches that help to drive quality and innovation. In addition, the team developed and leverage REDCap, a secure web application for building and managing online surveys and databases, to support data capture for research studies. During Phase III, the team anticipates further expansion of STAR data marts with increased patient volume, depth of data, and site expansion.

The STAR CRN has led and participated in projects funded by PCORI, NIH, FDA, CDC, industry, and other sources. To date, the team has had over 310 collaboration requests, and participated in over 90 funded projects. Recent studies that STAR has led or participated in have included: ADAPTABLE, PCORI Obesity Demonstration Projects, GUIDED-HF, PREVENTABLE, HERO, ACTIV-6, SENTINEL, and NEST. Members of STAR often serve as co-PIs on these national studies, or have led efforts related to data coordination, stakeholder engagement, or other activities. The STAR network has been the leading recruiter for ADAPTABLE, PREVENTABLE, and the HERO-HCQ study, with over 30 percent of recruited participants. STAR is currently leading efforts for PCORnet to launch the NIH ACTIV-6 initiative. During Phase III, STAR plans to expand efforts to lead and support national studies.

Stakeholder engagement is a vital cornerstone of all STAR activities. Stakeholders participate in all aspects of the STAR infrastructure including roles as members of the Executive Advisory and Leadership Committees, participating as co-PIs or co-Is on research projects, and review and input on all requests to use the STAR network for research. STAR will not participate in a project if it does not meet the standards set forth by its stakeholder review. During Phase III, the team will continue its robust mechanisms to garner input from stakeholders through surveys, interviews, community engagement studios, and other approaches. Health system leaders, public health officials, clinicians, and patients are all active collaborators with STAR and projects are frequently embedded within STAR systems to operate as learning health systems that seek to evaluate optimal approaches to care, disseminate findings, and implement findings to improve individual and population health.

Project Information

Russell Rothman, MD, MPP
Vanderbilt University Medical Center
STAR Phase 3 Clinical Research Network

Key Dates

September 2021
December 2024
Last updated: April 3, 2024