Mid-South Clinical Data Research Network

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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 Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN 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.

PCORI funded the Mid-South CDRN’s (Mid-South) participation in PCORnet from 2015 to 2019. This report outlines Mid-South’s achievements in building its research infrastructure capacity to

1. Create ways to involve patients, healthcare providers, health plans, and health systems in the research process and decision making about the network
2. Continue building the PCORnet CDM to add new types of data, ensure data quality, answer questions and requests, link to data outside the network, and keep data secure and private
3. Create an efficient infrastructure to carry out clinical trials
4. Create rules and guidance to protect people who take part in research studies, keep participants’ information confidential, and examine the risks of proposed studies
5. Work with PCORnet partners and partners outside the network to do research studies, build information systems, and share knowledge and practices
6. Create a plan to fund the network after PCORI funding ends

Network at a glance

The Mid-South CDRN collected electronic health record data for more than 20 million patients. The network collected data from university medical centers, hospitals, primary care and specialty doctors’ offices, and health clinics that serve diverse populations. Mid-South was led by Vanderbilt University Medical Center (VUMC). Mid-South’s focus was on research to improve health in the southern United States.

As of December 2019, the Mid-South CDRN changed its name to the Stakeholders, Technology, and Research (STAR) CRN.

How does the network operate?

Mid-South had policies and guidelines in place to oversee the network, decision making, and communication. The administrative team within VUMC managed daily operations. This team hosted weekly leadership meetings to communicate with all the sites, review research projects, and manage networkwide projects. The administrative team also managed new project requests, project kickoffs, stakeholder engagement, data quality and performance, and budgeting. The network scheduled regular meetings focused on daily operations and collaborations across sites, and at a yearly in-person meeting. Network partners stored patient data securely.

Mid-South also had processes in place for all network partners to use a single Institutional Review Board, a group that makes sure research is ethical.

How did the network involve patients and other partners?

Mid-South had a dedicated team that worked to include and value the perspectives of different partners throughout the network. Partners included patients, caregivers, community members, local organizations, researchers, health system leaders, and clinicians like doctors and nurses. The network established a nine-member stakeholder advisory council that included patient and community partners. The council reviewed proposals and plans to get research out into the community and provided feedback throughout all the phases of research studies. In addition, the council gave feedback on network policies. In addition to the council, the network also put together an oversight committee that provided high-level feedback from health system leaders, other experts, and community partners.

Mid-South developed materials for partners to use to learn more about proposal review processes, engaging members of the community, identifying patient collaborators, and learning how to become research partners. The network also held a face-to-face meeting of stakeholders, known as a community engagement studio, to get their feedback and published a newsletter for patients at a large primary care clinic.

Who is in the network?

Mid-South CDRN had data for 20,873,295 patients from rural and urban areas in the southern United States as of August 2018. The network also linked patient data to large data sets from health insurance companies, the Centers for Medicare and Medicaid Services, and state health departments.

How is the network supporting research?

While a Partner Network in PCORnet, the Mid-South CDRN participated in more than 60 projects. Mid-South also worked with other CDRNs, Patient-Powered Research Networks (PPRNs), and other research networks. PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations. The Mid-South CDRN also worked closely with pharmaceutical industry leaders, the National Institutes of Health, and the Food and Drug Administration.

How does the network support future research?

CDRNs follow PCORI standards to make sure their networks continue after PCORI’s funding ends. CDRNs format their data to the CDM and involve patients and healthcare providers in planning and carrying out research studies. CDRNs also take part in research with other networks in PCORnet and build relationships outside of PCORnet.

Glossary

Clinical Data Research Networks (CDRN): CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care.

Common Data Model (CDM): A CDM establishes a standard way of defining and formatting data.

Institutional Review Board (IRB): A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research in order to protect the ethical rights and privacy of the subjects involved.

PCORnet: PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research.

Overview

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 Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN 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.

PCORI funded the Mid-South CDRN’s (Mid-South) participation in PCORnet from 2015 to 2019. This report outlines Mid-South’s achievements in developing and optimizing research infrastructure capacity to

1. Engage patients, practicing clinicians, health plans, and health systems meaningfully in network governance and the research process
2. Continue building the PCORnet CDM to support new data elements, maintain high-quality data sets, respond to queries, link to external data sources, and ensure patient privacy and data security
3. Establish an efficient infrastructure for conducting clinical trials
4. Develop research oversight infrastructure that protects research subjects, preserves participants’ confidentiality, and evaluates the risks of proposed studies
5. Collaborate with PCORnet and external partners to conduct research studies, build infrastructure, and share knowledge and practices
6. Develop a plan for financial sustainability beyond the PCORI infrastructure-funding period

Network Infrastructure

The Mid-South CDRN had collected electronic health record data for more than 20 million patients as of August 2018. The network collected data from academic health centers; community hospitals; and a variety of outpatient practices including primary care, specialty practices, and safety net facilities serving diverse populations. Mid-South was led by Vanderbilt University Medical Center (VUMC). Mid-South’s focus was on research to improve health in the southern United States.

As of December 2019, the Mid-South CDRN changed its name to the Stakeholders, Technology, and Research (STAR) CRN.

Network Governance and Operations

Mid-South used a shared governance plan that allowed for multiple levels of oversight, decision making, and communication. An administrative team from VUMC managed daily operations, including hosting weekly leadership meetings to oversee site-level buy-in, review projects, and implement networkwide initiatives. The administrative team also oversaw new project requests, project implementation, regulatory efficiencies, stakeholder engagement, data quality and performance, and budgeting. Mid-South used SMART IRB and other PCORnet resources to streamline regulatory and contracting processes.

Mid-South incorporated systems within its network to support operations, including meetings focused on daily operations, cross-site collaborations, and governance. In addition, the network hosted an annual face-to-face meeting. Mid-South’s network partners stored patient data securely behind HIPAA-compliant firewalls.

Stakeholder Engagement

Mid-South had a dedicated engagement team that aimed to cultivate a research environment that valued stakeholder input and respected their perceptions of the importance and acceptability of research. Stakeholders included patients and caregivers from participating sites, community members, local institutions, researchers, clinicians, and health system leaders. The network established a standing nine-member stakeholder advisory council that included community members, patients, and patient partners. The council’s responsibilities included reviewing proposals and dissemination plans, providing feedback through all phases of research studies, and providing feedback on network policies. The network also convened an oversight committee that provided high-level feedback from health system leaders, clinicians, and patients.

Mid-South developed materials for partners to use to learn more about proposal review processes, engage members of the community, identify patient collaborators, and learn how to become research partners. The network also held a face-to-face meeting of stakeholders, known as a community engagement studio, to get their feedback and published a newsletter for patients at a large primary care clinic.

Network Demographics

As of August 2018, Mid-South CDRN included data for 20,873,295 patients over approximately 10 years. The network collected patient data from VUMC and its partner sites. The network also linked patient data to large external data sets from private health insurers, Medicare, TennCare Medicaid, and the Tennessee Department of Health Hospital Discharge Data System.

Demonstrating Research Capacity

While a Partner Network in PCORnet, the Mid-South CDRN participated in more than 60 funded studies, including randomized controlled trials, observational studies, secondary data analyses, and other studies. The Mid-South CDRN also formed close collaborations with other CDRNs, Patient-Powered Research Networks (PPRNs), and other research networks. PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations. The Mid-South CDRN also worked closely with pharmaceutical industry leaders, the National Institutes of Health, and the Food and Drug Administration.

Future Opportunities

CDRNs follow PCORI standards to enhance the sustainability of the network, including adhering to the CDM, fostering patient and clinician engagement at all stages of the research process, participating in multinetwork PCORnet research, and building external collaborations.