OneFlorida Clinical Research Consortium

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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 OneFlorida Clinical Research Consortium’s participation in PCORnet from 2015 to 2019. This report outlines OneFlorida’s achievements in building its research infrastructure capacity to create ways to

1. 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

OneFlorida Clinical Research Consortium brought together academic, government, and health systems across the state to collect data to address the area’s biggest health challenges. Led by the University of Florida, the network included 11 additional partners: AdventHealth; the Agency for Health Care Administration; Bond Community Health Center, Inc; Capital Health Plan; Florida State University; Health Choice Network; Nicklaus Children’s Hospital; Orlando Health; Tallahassee Memorial HealthCare; University of Florida Health; and University of Miami.

How does the network operate?

OneFlorida created a committee to manage network activities such as putting policies and procedures into place and approving and monitoring research studies. As the lead, the University of Florida ran the committee and had two voting members. Each partner organization had one voting member on the committee. Partner organizations led other network programs such as groups that focused on certain health conditions like heart disease, obesity, rare diseases, children’s health, and behavioral health.

All partners signed three agreements when they joined the network. The first agreement outlined the network’s expectations around how the partners should work together. The second explained how organizations should handle electronic patient data. The third allowed OneFlorida’s Institutional Review Board, or IRB, to oversee all network studies. An IRB is a group that makes sure studies are ethical and protect participants.

Network partners store patient data securely. To answer research questions, the network provides data that cannot be used to identify patients and follows strict security rules. The network carried out several data quality checks, including making sure that data follow CDM rules.

How did the network involve patients and other partners?

The network created a citizen scientist program to train community members on ways to participate in the healthcare system and research. Eight community members with diverse backgrounds served as citizen scientists who were paid by the University of Florida to provide feedback on network research studies at regular meetings. Researchers could also request that a citizen scientist join a study to offer their viewpoint. Citizen scientists participated in groups and committees throughout the network. One citizen scientist helped lead and served as a voting member of the committee that managed network activities. OneFlorida also surveyed and interviewed other patients in the community to get feedback on network activities.

Some doctors, known as clinical champions, worked together with other doctors to improve studies. Clinical champions received a small payment every year. Some got additional funds when they did a lot of work on a particular study.

Who is in the network?

As of 2019, OneFlorida’s database contains information on more than 5 million Florida residents. Data are available since 2012. Data come from patients who agreed to release their health information as well as electronic health records from partner organizations, Medicaid and Medicare claims, the Florida Cancer registry, and state vital statistics.

How is the network supporting research?

While a Partner Network in PCORnet, OneFlorida participated in 31 studies. OneFlorida co-led several PCORnet research groups that worked together to conduct studies. OneFlorida also combined its data set with another CDRN to create one of the largest databases on child health in the United States.

How does the network support future research?

OneFlorida follows PCORI standards to make sure its 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.

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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 health 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 into a consistent format, the Common Data Model (CDM), which is used by all the Partner Networks to enable rapid response to research-related questions.

PCORI funded OneFlorida Clinical Research Consortium’s participation in PCORnet from 2015 to 2019. This report outlines OneFlorida’s achievements in building its research infrastructure capacity to create mechanisms 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

OneFlorida Clinical Research Consortium brought together academic, government, and health systems to collect data to address the state’s biggest health challenges. Led by the University of Florida, the network included 11 additional partners: AdventHealth; the Agency for Health Care Administration; Bond Community Health Center, Inc; Capital Health Plan; Florida State University; Health Choice Network; Nicklaus Children’s Hospital; Orlando Health; Tallahassee Memorial HealthCare; University of Florida Health; and University of Miami.

Network Governance and Operations

OneFlorida established an executive committee to oversee network operations, including strategic planning, approving and monitoring research studies, and creating and implementing policies and procedures. As the lead, the University of Florida had two voting members who co-chaired the committee while each partner provided one voting member. Partner organizations led additional network groups such as disease-specific clinical research programs that emphasized areas such as cardiovascular disease, obesity, rare diseases, children’s health, and behavioral health.

All partners signed three agreements when they joined the network: a memorandum of understanding, which outlined the network’s expectations around collaboration; a data use agreement that covered the transfer of patient information; and a cooperative agreement that allowed the OneFlorida Institutional Review Board (IRB) to supersede partner IRBs.

All patient data are stored securely behind HIPAA-compliant firewalls. To answer research questions, the network provides deidentified data following stringent security procedures. The network institutes several data quality checks, including making sure that data adhere to the Common Data Model.

Stakeholder Engagement

The network created a citizen scientist program to train community members on ways to participate in the healthcare system and research. Eight community members with diverse backgrounds served as citizen scientists, paid by the University of Florida to provide feedback on network research studies at regular meetings. Researchers could also request that a citizen scientist join a study as an advisory member. Citizen scientists have participated in groups and committees throughout the network, with one serving as a voting member and co-chair of the executive committee. OneFlorida also surveyed and interviewed other patients in the community to elicit feedback on network activities.

Physician stakeholders known as clinical champions have collaborated with other clinicians on study design and implementation. Clinical champions received an annual stipend and additional funds based on their involvement in network studies.

Network Demographics

As of 2019, OneFlorida’s database contains information on more than 5 million Florida residents. Data are available since 2012. Data come from patients who consented to release their health information as well as electronic health records from partner organizations, Medicaid and Medicare claims, the Florida Cancer registry, and state vital statistics.

Demonstrating Research Capacity

While a Partner Network in PCORnet, OneFlorida participated in 21 observational studies, 7 clinical trials, and 3 interventional studies. OneFlorida co-led several PCORnet Collaborative Research Groups and combined its data set with another CDRN to create one of the largest databases on child health in the United States.

Future Opportunities

OneFlorida follows 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.